Regular blog readers know how we feel about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), review denied (Cal. Jan. 21, 2009) – the case that held an innovator drug manufacturer potentially liable for “misrepresentations” even though it did not manufacture the drug that allegedly harmed the plaintiff. We criticized virtually every aspect of Conte here, here, here, and here. We gave Conte our nod as the worst judicial decision of 2008 in our field. Bexis wrote an amicus brief in support of the ultimately unsuccessful effort to get the California Supreme Court to review the Conte decision. In short, we thought Conte was bad news all around.

Last week we put up a guest post with some good news about Conte – in the year since it had been decided, no other court had found its reasoning to be persuasive. Our guest posters observed:

For those keeping score, this makes 31 courts in 19 states that have refused to impose liability on a brand name drug manufacturer for injuries caused by its competitors’ generic drugs.

We took that as a very subtle rebuke. It had to be subtle – it’s our blog, after all.

But they have a point. After all, isn’t keeping score one of the things we do? We maintain current scorecards on drug/vaccine preemption, medical device preemption, cross-jurisdictional class-action tolling (if you don’t know, don’t ask), and no present injury plaintiffs.

Well guys, it worked – you got us off our duffs. We haven’t put together a scorecard on a new topic in over a year, so that sounded like a good idea. What follows is a chronological list of every judicial decision we know of that addresses the issue of whether a innovator (also known as “pioneer,” “name brand,” or “listed”) drug manufacturer can be liable in a suit where the plaintiff only took a generic version of that drug, which was manufactured and marketed by somebody else.

  • Foster v. American Home Products Corp., 29 F.3d 165, 168, 171 (4th Cir. July 14, 1994) (applying Maryland law).  Promethazine (Phenergan) case.  Innovator manufacturer not liable under negligent misrepresentation theory.
  • Flynn v. American Home Products Corp., 627 N.W.2d 342, 350-52 (Minn. App. May 15, 2001). Fenfluramine (Pondimin) case.  Innovator manufacturer not liable under fraudulent misrepresentation, negligent misrepresentation, or consumer fraud theories.
  • Beutella v. A.H. Robins Co., 2001 WL 35669202, at *2-3 (Utah Dist. Dec. 10, 2001). Metoclopramide (Reglan) case.  Innovator manufacturer not liable under any (unspecified) theory.
  • DaCosta v. Novartis AG, 2002 WL 31957424, at *8-9 (D. Or. March 1, 2002).  Ergot alkaloid (Migranal) case.  Innovator manufacturer not liable under strict liability, or fraud theories.
  • Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under negligence, negligent misrepresentation, fraud, conspiracy, or malice theories.
  • Sloan v. Wyeth, 2004 WL 5767103, at *?? [most of the opinion] (N.J. Super L.D. Oct. 13, 2004). Metoclopramide (Reglan) case.  Innovator manufacturer not liable under fraud, negligent misrepresentation, fraudulent concealment, or consumer fraud theories.
  • Sheeks v. American Home Products Corp., 2004 WL 4056060, at *1-2 (Colo. Dist. Oct. 15, 2004).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under negligent misrepresentation or statutory products liability theories.
  • Reynolds v. Anton, 2004 WL 5000272, at *?? [at end of opinion] (Ga. Super. Oct. 28, 2004) (Westlaw didn’t provide jump cites to state trial orders for a time, which ticks us off).  Methylphenidate (Ritalin) case.  Innovator manufacturer not liable under overpromotion or any other theory for failure of proximate causation.
  • Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under products liability, negligence, Restatement (Second) of Torts §323 (1965), negligent misrepresentation, breach of warranty, or consumer fraud.
  • Tarver v. Wyeth, Inc., 2005 WL 4052382, at *2 (Mag. W.D. La. June 7, 2005), adopted, 2006 WL 1517546, at *2-3 (W.D. La. Jan. 26, 2006).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under statutory product liability or negligent misrepresentation theories.
  • Sharp v. Leichus, 2006 WL 515532, at *2-6 (Fla. Cir. Feb. 17, 2006), aff’d per curiam, 952 So.2d 555 (Fla. App. Jan 22, 2007).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under fraud, negligent misrepresentation, fraudulent concealment, or market share theories.
  • Possa v. Eli Lilly & Co., 2006 WL 6393160, at *1, slip op. at 2-3 (M.D. La. May 10, 2006).  Fluoxetine (Prozac) case.  Innovator manufacturer not liable under statutory product liability theory.
  • Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 539-43 (E.D. Pa. May 25, 2006), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556  U.S. 1101 (2009).  Paroxetine (Paxil) case.  Innovator manufacturer not liable under all (negligence, negligence per se, negligent misrepresentation, fraud, consumer fraud, infliction of emotional distress, or implied warranty) theories for lack of duty or causation.
  • Goldych v. Eli Lilly & Co., 66 Fed. R. Serv.3d 799, 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006).  Fluoxetine (Prozac) case. Innovator manufacturer not liable under negligence, negligent misrepresentation, fraud, fraudulent concealment, or consumer fraud theories.
  • LeBlanc v. Wyeth, Inc., 2006 WL 2883030, at *5-6 (W.D. La. Oct. 5, 2006).  Amiodarone (Cordarone) case.  Innovator manufacturer not liable under statutory product liability theory.
  • Adamson v. Ortho-McNeil Pharmaceutical, Inc., 463 F. Supp.2d 496, 505 (D.N.J. Nov. 16, 2006), reconsideration denied, 2007 WL 604790 (D.N.J. Feb. 20, 2007).  TriNessa (Tri-Cyclen) non-personal injury case.  Innovator manufacturer not liable under consumer fraud theory for not advertising that generic drug was available more cheaply.
  • Rossi v. Hoffmann-LaRoche, 2007 WL 7632318, slip op. at 9-13 (N.J. Super. L.D. Jan. 3, 2007).  Mefloquine (Lariam) case.  Innovator manufacturer not liable to generic manufacturer in cross-claim under statutory product liability, consumer fraud, failure to warn, contribution, or indemnity.
  • Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 WL 5787186, at *2-3 (S.D. Ala. April 24, 2007).  Cephalexin (Keflex) case. Innovator manufacturer not liable under Restatement (Second) of Torts §402B (1965), strict liability, negligence, failure to test, failure to train physicians, express warranty, or implied warranty theories.  Not overruled by Weeks on these theories.
  • Green v. Wyeth Pharmaceuticals, Inc., 2007 WL 6428717, at *1 (Ala. Cir. May 14, 2007).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under any (unspecified) theory.  Overruled by Weeks as to fraudulent misrepresentation.
  • Clark v. Pfizer, Inc., 2008 WL 7668730 (Pa. C.P. March 17, 2008). Gabapentin (Neurontin) non-personal injury case.  Innovator manufacturer not liable under warranty theory. Name brand manufacturer could be liable under negligent misrepresentation or intentional misrepresentation theories for sums paid to generic manufacturers for off-label uses.
  • Swicegood v. Pliva, Inc., 543 F. Supp.2d 1351, 1354-59 (N.D. Ga. April 2, 2008).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under strict liability, negligence, fraudulent misrepresentation, negligent misrepresentation, Restatement (Second) of Torts §324A (1965), concealment, or implied warranty theories.
  • Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under statutory product liability, negligence, fraud, or misrepresentation theories.  Affirmed on other grounds, 623 F.3d 271 (5th Cir. 2010).
  • Stanley v. Wyeth, Inc., 991 So.2d 31, 33-35 (La. App. May 2, 2008).  Amiodarone (Cordarone) case.  Innovator manufacturer not liable under statutory product liability or negligent misrepresentation theories.
  • Westerlund v. Wyeth, Inc., 2008 WL 5592753, at *3 (N.J. Super. Law Div. Oct. 20, 2008).  Amiodarone (Cordarone) case.  Innovator manufacturer not liable under statutory product liability or any other theory.
  • Buchanan v. Wyeth Pharmaceuticals, Inc., 2008 WL 7136137, slip op. at 1 (Ala. Cir. Dale Co. October 20, 2008).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under any theory.  Overruled by Weeks as to fraudulent misrepresentation.
  • Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, 309-311 (Cal. App. Nov. 7, 2008), review denied (Cal. Jan. 21, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under strict liability theory. Innovator manufacturer may be liable under negligent misrepresentation or fraudulent misrepresentation theories.
  • Huck v. Trimark Physicians Group, 2009 WL 3760458, slip op. at 1-2 (Iowa Dist. Feb. 27, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under any (unspecified) theories.  Affirmed see below.
  • Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under any (unspecified) theories for lack of duty.
  • Schrock v. Wyeth, Inc., 601 F. Supp.2d 1262, 1266 (W.D. Okla. March 11, 2009). Metoclopramide (Reglan) case.  Innovator manufacturer not liable under any (unspecified) theory for failure of causation.  Affirmed – see below.
  • Moretti v. Wyeth, Inc., 2009 WL 749532, at *3-4 (D. Nev. March 20, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under Restatement (Second) of Torts §§310, 311, 323 (1965), misrepresentation by omission, constructive fraud, negligent misrepresentation, or fraudulent concealment theories.  Conte rejected as contrary to law and policy.  Affirmed see below.
  • Short v. Eli Lilly & Co., 2009 WL 9867531, at *4-9, slip op. (Ind. Super. Marion Co. March 25, 2009).  Fluoxetine (Prozac) case.  Innovator manufacturer not liable under statutory product liability or misrepresentation theories.  Conte rejected as contrary to law.
  • Fields v. Wyeth, Inc., 613 F. Supp.2d 1056, 1060-61 (W.D. Ark. May 11, 2009). Metoclopramide (Reglan) case.  Innovator manufacturer not liable under statutory product liability, strict liability, negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, or implied warranty theories.
  • Stoddard v. Wyeth, Inc., 630 F. Supp.2d 631, 633-34 (E.D.N.C. June 24, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under express warranty, implied warranty, negligence, negligent omission, negligent misrepresentation, negligent undertaking, fraud, intentional infliction of emotional distress, negligent infliction of emotional distress, or consumer fraud theories.
  • Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279, 309 n.40 (D.N.H. Sept. 30, 2009). Sulindac case.  Dictum recognizing “widespread rejection” of theories of “innovator liability.”
  • Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under statutory product liability, negligence, strict liability, implied warranty, misrepresentation, fraudulent concealment, consumer fraud, or gross negligence. Conte rejected as anomalous and contrary to law.
  • Meade v. Parsley, 2009 WL 3806716, at *2-3 (slip op.) (S.D.W. Va. Nov. 13, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under strict liability, breach of express and implied warranties, negligence, misrepresentation, fraud, consumer fraud, or intentional infliction of emotional distress.  Conte is considered and rejected.
  • Morris v. Wyeth, Inc., 2009 WL 4064103, at *4-6 (slip op.) (W.D. La. Nov. 23, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable under statutory product liability theory (within which all other causes of action are subsumed).
  • Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. Nov. 27, 2009) (affirming 2008 WL 4724286).  Metoclopramide (Reglan) case.  Innovator manufacturer not liable for various common law torts including negligent representation and fraud.  Reaffirmed in pertinent part and vacated in part on other grounds, 658 F.3d 867 (8th Cir. Sept. 29, 2011).
  • Dietrich v. Wyeth, Inc., 2009 WL 4924722, slip op. at 3-6 (Fla. Cir. 15th Cir. Dec. 21, 2009).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, strict liability, breach of warranties, misrepresentation and fraud, and negligence per se. Conte rejected as a “lone outlier against the overwhelming weight of authority.”  Id. at 10.
  • Levine v. Wyeth, Inc., 684 F. Supp.2d 1338, 1344-46 (M.D. Fla. Feb. 10, 2010), adopting magistrate’s report in Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, negligence per se, strict liability, breach of warranties, component part liability, misrepresentation and fraud.  Conte rejected as “run[ning] counter to the overwhelming majority of case law.”  Report at 7.
  • Goodridge v. Pfizer Canada, Inc., 2010 ONSC 1095, slip op. (Ont. Super. Feb. 18, 2010). Gabapentin (Neurontin) case.  Innovator manufacturers not liable for negligence under Canadian law where plaintiff only took generic drug.  Other theories of liabilty are not recognized in Canada.  American precedent not discussed.  Paragraphs 62-105.
  • Couick v. Wyeth, Inc., 691 F. Supp.2d 643, 645-46 (W.D.N.C. March 8, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, misrepresentation by omission, negligent misrepresentation, constructive fraud, fraud by concealment, intentional infliction of emotional distress, negligent infliction of emotional distress, unfair and deceptive trade practices, or breach of express and implied warranties under North Carolina’s statutory product liability statute.
  • Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable on any theory (unspecified).  Conte rejected as “not persua[sive].”
  • Howe v. Wyeth Inc., 2010 WL 1708857, at *3-4 (M.D. Fla. Apr. 26, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, strict liability, breach of warranties, fraud, and negligence per se.  Following Levine v. Wyeth, above.
  • Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. April 28, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, strict products liability, breach of warranty, fraud, and consumer fraud.  Conte rejected as “stretch[ing] the concept of foreseeability too far.”
  • Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under any theory.
  • Craig v. Pfizer, Inc., 2010 WL 2649545, at *2-4 (Mag. E.D. La. May 26, 2010), adopted, 2010 WL 2649544 (W.D. La. June 29, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under statutory product liability, consumer fraud, breach of warranty, or fraud and misrepresentation.
  • Phelps v. Wyeth, Inc., 2010 WL 2553619, at *2-3 (Mag. D. Or. May 28, 2010), adopted, 2010 WL 2553614 (D. Or. June 21, 2010).  Metoclopramide (Reglan) case.  Summary judgment granted.  Innovator manufacturers not liable for negligence, strict liability, breach of warranties, misrepresentation and fraud, or gross negligence.  Conte is “not persuasive.”  Reconsideration denied, post-Mensingslip op. at *3-5 (D. Or. Nov. 23, 2011).  Foster remains good law after Mensing, there remains no basis for liability.  Adopted a second time on the same grounds.  857 F. Supp.2d 1114, 1120-22 (D. Or. April 24, 2012) (also rejecting Conte).
  • Mosley v. Wyeth, Inc., 719 F. Supp.2d 1340, 1345-51 (S.D. Ala. June 28, 2010).   Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligent misrepresentation, fraud, or warranty theories.  Overruled by Weeks.
  • Neal v. Teva Pharmaceuticals USA, Inc., 2010 WL 2640170, at *2 (W.D. Ark. July 1, 2010).   Metoclopramide (Reglan) case.  Innovator manufacturers not liable for statutory product liability, negligence, breach of warranties, express and implied, negligent and fraudulent misrepresentation, and gross negligence.
  • Fisher v. Pelstring, 2010 WL 2998474, at *2-9 (D.S.C. July 28, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for strict liability, negligence, fraud, fraudulent concealment, constructive fraud, consumer fraud, misrepresentation, breach of express or implied warranty, breach of undertaking, or intentional infliction of emotional distress.  Conte is in direct conflict with the weight of authority.
  • Kellogg v. Wyeth, 762 F. Supp.2d 694, 705-08 (D. Vt. Oct. 20, 2010).  Metoclopramide (Reglan) case.   Innovator manufacturers can be liable under Vermont law for negligence or fraud, but not strict liability, where the prescribers testified they relied upon “drug manufacturers” for warnings, even though the plaintiff did not ingest a name brand drug.
  • Cooper v. Wyeth, Inc., 2010 WL 4318816, at *2-3, slip op. (M.D. La. Oct. 26, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under statutory product liability theory, and no other theories are recognized.
  • Gross v. Pfizer, Inc., 2010 WL 4485774, at *2-3, slip op. (D. Md. Nov. 9, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, breach of warranty, strict product liability, and misrepresentation.  Conte is a minority view and Maryland would not follow it.  Reconsideration denied, 2011 WL 4005266 (D. Md. Sept. 7, 2011), Mensing does not require reconsideration, as there is no claim under Maryland law.
  • Simpson v. Wyeth, Inc., 2010 WL 5485812, at *3-5 (N.D. Ala. Dec. 9, 2010).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for misrepresentation, fraud by concealment or suppression and failure to warn.  Overruled by Weeks as to fraudulent misrepresentation.
  • Overton v. Wyeth, Inc., 2011 WL 1343392, at *6-7 (Mag. S.D. Ala. March 15, 2011), adopted, 2011 WL 1343391 (S.D. Ala. April 7, 2011).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for fraudulent or negligent misrepresentation, or breach of warranty.  Overruled by Weeks as to fraudulent misrepresentation.
  • Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. Sept. 22, 2011) (applying Kentucky law).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for fraud, fraudulent concealment, or tortious misrepresentation for failure to warn about risks of a product that did not cause the plaintiff’s injury.  Just because a company is in the same business as a tortfeasor does not make it automatically liable for harm caused by that tortfeasor’s product.  Rejecting Conte.
  • Morris v. Wyeth, Inc., 2011 WL 4975317, at *3-4 (W.D. La. Oct. 19, 2011).  Metoclopramide (Reglan) case.  Mensing does not change Louisiana law which does not impose a duty upon an innovator drug manufacturer running to the consumer of a generic product that did not take the defendant’s drug.  Barring claims for negligent misrepresentation under Louisiana common law.
  • Metz v. Wyeth, Inc., 830 F. Supp.2d 1291, 1293-95 (M.D. Fla. Nov. 18, 2011).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence, strict liability, breach of warranty, misrepresentation, fraud, or negligence per se for failure to warn about risks of a product that did not cause the plaintiff’s injury.  Foster remains good law, as preemption was hardly central to that court’s decision.  Innovator manufacturers owe no duty of care to generic drug consumers.  That generic claims may be preempted does does not compel a change in state law concerning innovator drugs.  Affirmed by unpublished order, No. 12-13321, slip op. (11th Cir. Aug. 1, 2013).
  • Moore v. Mylan, Inc., 840 F. Supp.2d 1337, 1344 (N.D. Ga. Jan. 5, 2012).  Phenytoin (Dilantin) case.  Plaintiff’s complaint dismissed because it did not specify any manufacturer.  Strict liability and negligence claims dismissed.  Plaintiff may file an amended complaint complying with this ruling.
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 856 F. Supp.2d 904, 910-13 (E.D. Ky. Feb. 5, 2012).  Propoxyphene (Darvon/Darvocet) case.  Innovator manufacturers not liable under Georgia, Louisiana, Indiana, Kentucky, New Jersey, and Texas law for any claim involving a plaintiff that did not ingest its product.  Product identification is a fundamental element of all product related torts.  Fraud and misrepresentation are product liability claims subject to the product identification requirement.  Innovator manufacturers owe no duty to consumers of generic products.  Conte and Kellogg are a minority view.  Federalism does not allow diversity courts to expand state-law liability.  Affirmed, 756 F.3d 917, see below.
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 767595, at *2-9 (E.D. Ky. March 7, 2012).  Propoxyphene (Darvon/Darvocet) case.  Under Connecticut, Georgia, Indiana, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Texas law, original name innovator manufacturer owes no duty to and is not liable for any claim involving a plaintiff that did not ingest its product.  Allegations that the original manufacturer continued to make some product for its successor and for generic manufacturers are not enough without corresponding allegations that the defendant made the particular drug that the plaintiff took.  Without allegations that the product was mis-manufactured, there is no liability because warning claims are preempted.  Affirmed, 756 F.3d 917, see below.
  • Lukas-Werner v. Novo Nordisk, A/S, No. 1009-13177, transcript at 25-26 (Or. Cir. Multnomah Co. May 11, 2012).  17 Beta Estradial (Activella) case.  Innovator manufacturers not liable for negligence for failing to warn someone who didn’t take their drugs.
  • Condouris v. Wyeth, 2012 WL 2401776, slip op. (N.J. Super. Law Div. June 26, 2012).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable for negligence for failing to warn someone who didn’t take their drugs.  All actions attacking product warnings are “product liability” actions under the New Jersey product liability statute.  Mensing has no effect on state law.   Conte is not New Jersey law.
  • Lashley v. Pfizer, Inc., 877 F. Supp.2d 466, 471-76 (S.D. Miss. June 27, 2012).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under statutory product liability misrepresentation theories and all common-law theories are subsumed.  Affirmed 750 F.3d 470 (5th Cir. 2014), see below.
  • Lyman v. Pfizer, Inc., 2012 WL 2970627, at *17-18 (D. Vt. July 20, 2012).  Metoclopramide (Reglan) case.  Even under a Conte rationale, reliance on an innovator manufacturer’s old warnings or statements, where current warnings have materially changed, is not justifiable as a matter of law.  Summary judgment granted on lack of reliance.
  • Strayhorn v. Wyeth Pharmaceuticals, Inc., 882 F. Supp.2d 1020, 1028-31  (W.D. Tenn. Aug. 8, 2012).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under statutory product liability theories.  To the extent that common-law theories for negligence, fraud, misrepresentation, suppression, constructive fraud, breach of warranty, or misrepresentation survive the statute, they fail to state a claim where the plaintiff neither purchased nor used an innovator product.  Conte is an “extreme outlier,” and a federal court sitting in diversity should not expand state law.  Affirmed, 737 F.3d 387, see below.
  • Eckhardt v. Qualitest Pharmaceuticals, Inc., 889 F. Supp.2d 901, 905-10 (S.D. Tex. Aug. 9, 2012).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under statutory product liability theories for other, generic products.  Misrepresentation-related claims are statutory product liability claims.  To the extent common-law claims exist, innovator manufacturers are not liable for generic drug warnings under theories of negligence, misrepresentation, fraud, participatory liability, suppression of evidence, warranty or consumer fraud.  Affirmed, 751 F.3d 674, below.
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *3-4 (E.D. Ky. Aug. 21, 2012).  Propoxyphene (Darvon/Darvocet) case.  Under Arkansas, Connecticut, Georgia, Kentucky, Louisiana, Massachusetts, Mississippi, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, and West Virginia law, innovator manufacturers not liable for any claim involving a plaintiff that did not ingest its product.  Product identification is a fundamental element of all product related torts.  Misrepresentation of a product is a product liability claim subject to the product identification requirement.  No relevant state has adopted Conte.  Federalism does not allow diversity courts to expand state-law liability.  Affirmed, 756 F.3d 917, below.
  • Phares v. Actavis-Elizabeth LLC, 892 F. Supp.2d 835, 843-46 (S.D. Tex. Aug. 30, 2012).  Metoclopramide (Reglan) case.  All claims involving products are “product liability” claims.  Innovator manufacturers not liable under statutory product liability theories for other, generic products.  Reconsideration denied, 2015 WL 12780637, at *4-5 (S.D. Tex. March 19, 2015).
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *4-8 (E.D. Ky. Sept. 5, 2012).  Propoxyphene (Darvon/Darvocet) case. Innovator manufacturers not liable for any claim involving a plaintiff that did not ingest its product under Arizona, North Carolina, South Carolina, Nebraska, New Jersey, West Virginia, Florida, and New Hampshire law.  Affirmed, 756 F.3d 917, see below.
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842271, at *5-7 (E.D. Ky. Sept. 5, 2012).  Propoxyphene (Darvon/Darvocet) case.  Innovator manufacturers sued by California plaintiffs might be liable under Conte for injuries from a generic product.  A California trial court is obligated to apply ConteO’Neill asbestos case is distinguishable.
  • Baymiller v. Ranbaxy Pharmaceuticals Inc., 894 F. Supp.2d 1302, 1307-11 (D. Nev. Sept. 6, 2012). Paroxetine (Plavix) case. Innovator manufacturers not liable under any theory (strict liability, negligence, warranty, fraud/negligent misrepresentation, elder abuse) for not warning someone who didn’t take their drugs. Conte stands alone and is contrary to Nevada law and public policy.
  • Del Valle v. Pliva, Inc., 2012 WL 4747259, at *5-8 (S.D. Tex. Sept. 12, 2012).  Metoclopramide (Reglan) case.  All claims involving products are “product liability” claims.  Innovator manufacturers not liable under statutory product liability theories for other, generic products.  Conte is inapplicable to the Texas statute.  Affirmed 750 F.3d 470 (5th Cir. Feb. 21, 2014), see below.
  • Hogue v. Pfizer, Inc., 893 F. Supp.2d 914, 917-19  (S.D. Ohio Sept. 27, 2012).  Metoclopramide (Reglan) case.  All non-statutory product liability claims have been abolished.  All claims relating to a product are product liability claims.  Non-active fraud, resembling failure to warn, is a product-related claim abolished by OPLA.  The statute requires that the defendant have manufactured the product.  There is no exception for inventors or “primary manufacturers.”  Mensing has no bearing on the scope of state product liability law.
  • Madden v. Teva Pharmaceuticals, USA, Inc., 2012 WL 4757253, slip op. (Pa. C.P. Phila. Co. Oct. 1, 2012).  Zolpidem (Ambien) case.  Innovator manufacturers not liable under Washington state product liability statute (which subsumes common-law theories such as negligence and misrepresentation) for not warning someone who didn’t take their drugs.  The “relevant product” is the one to which the plaintiff was exposed.  Innovator liability for generic drug injury has been overwhelmingly rejected.
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D. Ky. Oct. 10, 2012).  Propoxyphene (Darvon/Darvocet) case.   Innovator manufacturers not liable for any claim involving a plaintiff that did not ingest its product under Arizona, Florida, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, or West Virginia law.  One case where ingestion of a branded drug was alleged survives dismissal.  Misrepresentation claims cannot exist against a defendant that did not manufacture the product that the plaintiff ingested.  Affirmed, 756 F.3d 917, below.
  • Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 183-84 (5th Cir. Oct. 25, 2012).  Metoclopramide (Reglan) case.  The Supreme Court’s Mensing preemption decision did not impair Foster, which was a case interpreting Maryland common law.  Even if it did, Louisiana law does not hold manufacturers liable to plaintiffs that did not use their products.
  • Matherne v. Bayer Healthcare Pharmaceuticals, Inc., 2012 WL 12991011 (E.D. La. Nov. 2, 2012).   Ciprofloxacin (Cipro) case.  Innovator manufacturers not liable under Louisiana product liability statute on any theory for products they did not manufacture.
  • Gardley-Starks v. Pfizer, Inc., 917 F. Supp.2d 597, 601-04 (N.D. Miss. Jan. 10, 2013).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Mississippi state product liability statute (which subsumes common-law theories such as negligence and misrepresentation) for not warning someone who didn’t take their drugs.
  • Washington v. Medicis Pharmaceuticals Corp., 2013 WL 496063, at *3-4 (S.D. Miss. Feb. 7, 2013).  Minocycline (Minocin/Solodyn) case.   Innovator manufacturers not liable under Mississippi product liability statute under any product liability theory.  Innovator liability has not been recognized.  Conte is a minority view.
  • Bennett v. Hoffmann-LaRoche Inc., 2013 WL 1191899, at *3-6 (E.D.N.C. March 22, 2013).  Mefloquine (Lariam) case.  Innovator manufactuer cannot be liable under North Carolina product liability statute under any product liability theory because it is not responsible for injuries stemming from the use of another manufacturer’s generic bioequivalent.  Plaintiff produced sufficient product identification evidence to survive summary judgment
  • Chatman v. Pfizer, Inc., 960 F. Supp.2d 641, 652-53 (S.D. Miss. March 27, 2013). Metoclopramide (Reglan) case.   Innovator manufacturers not liable under Mississippi state product liability statute (which subsumes common-law theories such as negligence and misrepresentation) for not warning someone who didn’t take their drugs.  Remainder of opinion, allowing a misrepresentation claim for affirmative misstatements has been withdrawn.  See 2014 WL 4546042, below.
  • Huck v. Trimark Physicians Group, 834 N.W.2d 82 (table), 2013 WL 1749774, at *3-4, slip op. (Iowa App. April 24, 2013).  Metoclopramide (Reglan) case.   Innovator manufacturers not liable for any claim involving a plaintiff that did not ingest its product.  Mensing does not change state law.  Regardless of the theory of liability, such as strict liability, negligence, misrepresentation, or breach of warranties only the product manufacturer is liable for product-related injuries.  Affirmed, 850 N.W.2d 353, below.
  • Bell v. Pfizer, Inc., 716 F.3d 1087, 1092-93 (8th Cir. June 14, 2013). Metoclopramide (Reglan) case.   Innovator manufacturers not liable under Arkansas state product liability statute for failure-to-warn, negligence, strict liability; breach of implied warranties, misrepresentation, suppression of evidence, fraud, and gross negligence.  The statute applies to any theory involving a product and requires that the plaintiff have used the product.  Affirming 2011 WL 904161, above.
  • Guarino v. Wyeth, 719 F.3d 1245, 1251-53 (11th Cir. June 25, 2013).   Metoclopramide (Reglan) case.   Affirming summary judgment.  An innovator manufacturer is not liable under Florida law for negligence, strict liability, breach of warranty, misrepresentation and fraud, or negligence per se where it did not make the product that allegedly injured the plaintiff.  A “mountain of authority” supports rejection of innovator liability.  Affirming, 2012 WL 1138631, above.
  • Fullington v. PLIVA, Inc., 720 F.3d 739, 744 (8th Cir. July 15, 2013).  Metoclopramide (Reglan) case.   Affirming summary judgment.  Innovator manufacturers not liable under Arkansas state product liability statute for strict liability, negligence, misrepresentation, fraudulent concealment, suppression of evidence, and breach of the implied warranties.  Only the manufacturer of the product taken by the plaintiff may be sued under the Arkansas statute.  Affirming 2010 WL 3632747 (E.D. Ark. Sept. 17, 2010), reconsideration denied, 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011).
  • In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2013 WL 5184129, at *2, slip op. (E.D. Ky. July 29, 2013).  Propoxyphene (Darvon/Darvocet) case.    Innovator manufacturers not liable for misrepresentation claims involving a plaintiff that did not ingest its product under Georgia or Texas law.
  • Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059, at *20-24, slip op. (E.D. Mo. July 29, 2013).  Metoclopramide (Reglan) case.  Granting summary judgment.  An innovator manufacturer is not liable under Kentucky law for negligence, negligent misrepresentation, negligent supply of information for the guidance of others, breach of warranty, misrepresentation, fraud, or strict liability.  Affirmed, 451 S.W.3d 694, below.
  • Schrock v. Wyeth, Inc., 727 F.3d 1273, 1281-84 (10th Cir. Aug. 28, 2013).  Metoclopramide (Reglan) case.  Summary judgment affirmed.   Innovator manufacturers not liable under Oklahoma law for negligence, strict product liability, breach of warranties, misrepresentation, or fraud.  Federal courts should not recognize novel expansions of state law.   Affirming 601 F. Supp.2d 1262, above.
  • Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).  Sertraline (Zoloft) case.  Motion to dismiss granted.  Innovator manufacturers not liable under any (unspecified, except for voluntary assumption of duty) theory.
  • Tillman v. Woldenberg Village, Inc., 2013 WL 6198864, at *5, slip op. (E.D. La. Nov. 27, 2013).  Phenytoin (Dilantin) case.  Motion for judgment on the pleadings granted.  Innovator manufacturers not liable under Louisiana product liability statute on any theory for products they did not manufacture.
  • Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 387, 401-06 (6th Cir. Dec. 2, 2013).  Metoclopramide (Reglan) case.   Summary judgment affirmed.   An innovator manufacturer is not liable under the Tennessee product liability statute for negligent misrepresentation, fraudulent misrepresentation, express or implied warranty.  Conte is an outlier.  Federal courts should not recognize novel expansions of state law.  Affirming 882 F. Supp.2d 1020, above.
  • Lashley & Del Valle v. Pfizer, Inc., 750 F.3d 470, 470-78 (5th Cir. Feb. 21, 2014).  Metoclopramide (Reglan) case. Summary judgment affirmed in two cases.  An innovator manufacturer is not liable under the Mississippi product liability statute or under Texas law under any theory for injuries caused by the ingestion of generic products that the defendants did not manufacture.
  • Dolin v. SmithKlineBeecham Corp., 62 F. Supp.3d 705, 712-23 (N.D. Ill. Feb. 28 2014).  Paroxetine (Paxil) case.  Summary judgment granted in part and denied in part.  An innovator manufacturer cannot be liable under Illinois product liability law for injuries caused by a product they did not manufacture.  The innovator might be liable under common-law negligence, which is separate from product liability.  Reversed on other grounds Dolin v. GlaxoSmithKline LLC, ___ F.3d ___, 2018 WL 4001208 (7th Cir. Aug. 22, 2018).
  • Stewart v. Sanofi Aventis U.S., LLC, 15 F. Supp.3d 1151, 1153-55 (N.D. Ala. April 10, 2014).  Zolpidem (Ambien) case.  Judgment on the pleadings granted.  An innovator manufacturer is not liable under the Indiana product liability statute for failure to warn about a product it did not manufacture.
  • Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 680-82 (5th Cir. May 13, 2014).  Metoclopramide (Reglan) case.   Summary judgment affirmed.  Innovator manufacturers not liable under Texas product liability statute, common-law negligent misrepresentation, or fraud to plaintiffs who ingested only generic products.   There is no duty.  Affirming, 889 F. Supp.2d 901, above.
  • Tanner v. Alaven Pharmaceutical LLC, 2014 WL 2404287, at *1 (Ga. Super. May 27, 2014).   Metoclopramide (Reglan) case.   Summary judgment granted.  Innovator manufacturers not liable under Georgia law under any theory.  Affirmed, 2015 WL 7431346, see below.
  • Dement v. Alaven Pharmaceutical LLC, 2014 WL 2404289, at *1 (Ga. Super. May 27, 2014).   Metoclopramide (Reglan) case.   Summary judgment granted.  Innovator manufacturers not liable under Georgia law under any theory.  Affirmed, 780 S.E.2d 735, see below.
  • Hendricks v. Pharmacia Corp., 2014 WL 2515478, at *5-6 (Mag. S.D. Ohio June 4, 2014), adopted, 2014 WL 4961550 (S.D. Ohio Oct. 2, 2014).  Phenytoin (Dilantin) case.  Motion to dismiss granted. Innovator manufacturers not liable under the Ohio product liability statute.
  • Colas v. Abbvie, Inc., 2014 WL 2699756, at *2-3, slip op. (N.D. Ill. June 13, 2014).  Biaxin (clarithromycin) case.  Motion to dismiss granted in part.  An innovator manufacturer cannot be liable under Virginia law for failure to warn or negligence per se for injuries caused by a product it did not manufacture.  Fraud claims allowed to continue without discussion of product identification.
  • Moretti v. Wyeth, Inc., 579 F. Appx. 563, 564-65 (9th Cir. June 17, 2014).  Metoclopramide (Reglan) case.   Summary judgment affirmed.  Innovator manufacturer not liable under Nevada law for misrepresentation by omission, constructive fraud, negligent misrepresentation, or fraudulent concealment theories. Non-manufacturers are under no duty to disclose regarding other person’s products.
  • In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 836-39, 940-54 (6th Cir. June 27, 2014).  Propoxyphene (Darvon/Darvocet) cases.   Innovator manufacturers not liable for misrepresentation claims involving plaintiffs that did not ingest its product under Arkansas, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington, or West Virginia law.  Federalism does not allow diversity courts to expand state-law liability.  If misrepresentation claims are considered to be product liability claims, then product identification is a fundamental element of all product related torts.  If misrepresentation claims are not considered to be product liability claims, then innovator manufacturers owe no duties to consumers of competing generic products.   Conte and Kellogg are a minority view.  Dolin is rejected.    One case where ingestion of a branded drug was alleged survives dismissal.  Affirming, 856 F. Supp.2d 904, 2012 WL 767595, 2012 WL 3610237, 2012 WL 3842045, and 2012 WL 4831632, above.
  • Huck v. Wyeth, Inc., 850 N.W.2d 353, 369-81 (Iowa July 11, 2014), cert. denied, 135 S.Ct. 1699 (March 30, 2015).  Metoclopramide (Reglan) case.  Innovator liabilty not recognized under product liability, negligence (Restatement Third, Physical Harm §7), negligent misrepresentation (Restatement Second §552), or fraud.  Allowing such liability would turn the law upside down.  Conte and Weeks are outliers.  Extensive policy discussion.  Note:  This is a 3-1-3 decision.
  • Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-16 (5th Cir. July 11, 2014).  Metoclopramide (Reglan) case. Innovator manufacturers not liable under Louisiana product liability statute.  Innovator manufacturers owe no duties to persons taking generic drugs.
  • Willis v. Schwarz-Pharma, Inc., 62 F. Supp.3d 560, 567-68 (E.D. Tex. July 23, 2014). Metoclopramide (Reglan) case. Innovator manufacturers not liable under Texas product liability statute for warning defects, negligence, implied warranty, and fraud.  Texas law does not impose duties on those who did not supply the product alleged to cause injury.
  • Cardinal v. Elsevier Inc., 2014 WL 10937406, at *2-3 (Mass. Super. Aug. 11, 2014).  Metoclopramide (Reglan) case.  Oklahoma law does not recognize innovator liability under either negligence or strict liability.  A label is not a separate product.
  • Wyeth, Inc. v. Weeks, 159 So.3d 649, 656-76 (Ala. Aug. 15, 2014). Metoclopramide (Reglan) case. Innovator manufacturers not liable under AMELD for failure to warn of risks of generic drugs. Innovator manufacturers may be liable under separate misrepresentation theories.  Prospectively overruled by statute, as discussed here.
  • Franzman v. Wyeth, Inc., 451 S.W.3d 676, 689-92 (Mo. App. Aug. 26, 2014).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Kentucky product liability statute for any claims involving generic drugs.  Innovator manufacturers owe no duties to persons taking generic drugs.
  • Nicely v. Wyeth, Inc., 451 S.W.3d 694, 2014 WL 4210385, at *3 (Mo. App. Aug. 26, 2014).  Metoclopramide (Reglan) case.  Analysis is same as Franzman.
  • Chatman v. Pfizer, Inc., 2014 WL 4546042, at *2-3, slip op. at 2, 5-6 (S.D. Miss. Sept. 11, 2014). Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Mississippi product liability statute (which subsumes common-law theories such as negligence and misrepresentation) for not warning someone who didn’t take their drugs and not liable for for misrepresentation for lack of duty.   Vacating portion of 960 F. Supp.2d 641 that survived summary judgment in light of Lashley.
  • Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1251-53 (N.D. Ala. Oct. 1, 2014).  Amiodarone (Cordarone) case.  Innovator liability under Weeks exists only for fraud and misrepresentation claims.   Weeks does not allow claims for failure to provide a medication guide.  Off-label promotion claims predating the plaintiff’s prescription by over five years are irrelevant.  Warning claims not asserting misrepresentations to the plaintiff’s doctor are not permitted under Weeks.
  • Anselmo v. Sanofi-Aventis, Inc. USA, 2014 WL 8849464, at *1-3, slip op. (Kan. Dist. Oct. 13, 2014).  Zolpidem (Ambien) case.  Innovator manufacturers not liable under Kansas product liability statute for any theory of innovator liability, including negligent design.  Conte is incompatible with Kansas law.
  • Truddle v. Wyeth LLC, 2015 WL 160696, at *4 (N.D. Miss. Jan. 12, 2015).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Mississippi product liability statute for not warning someone who didn’t take their drugs.
  • Allain v. Wyeth Pharmaceuticals, 2015 WL 178038, at *4 (N.D. Ala. Jan. 14, 2015).  Amiodarone (Cordarone) case.  Innovator liability under Weeks exists only for fraud and misrepresentation claims.  It does not apply to mere failure to warn claims and does not create an affirmative duty for innovator companies to supply information to generic drug users.
  • Phares v. Actavis-Elizabeth LLC, 2015 WL 12780637, at *4-5 (S.D. Tex. March 19, 2015).  Metoclopramide (Reglan) case.  Innovator liability does not exist under Texas law on a fraud theory.  Fraud is a product liability theory.
  • Guvenoz v. Target Corp., 30 N.E.3d 404, 409 n.1 (Ill. App. March 27, 2015).  Dictum recognizing that under Illinois law, plaintiffs cannot recover from brand-name drug manufacturers whose products they did not ingest.
  • Whitener v. Pliva, Inc., 606 F. Appx. 762, 766 n.2 (5th Cir. Apr. 9, 2015).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Louisiana product liability statute.
  • McNair v. Johnson & Johnson, 2015 WL 3935787, at *4-6, slip op. at 12-17 (S.D.W. Va. June 26, 2015).  Levofloxacin (Levaquin) case.  Innovator liability not recognized under West Virginia product liability or warranty law for failure to warn of risks of generic drugs.  Affirmed on certified questions, 2018 WL 2186550 below
  • PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. Nov. 20, 2015), cert. denied (Ga. March 7, 2016).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Georgia law for strict liability, negligence concerning alleged misrepresentations to users of generic products.  Agreeing with “overwhelming national consensus.”  Affirming 2014 WL 2404289 and 2014 WL 2404289, above, in pertinent part.
  • Neeley v. Wolters Kluwer Health, Inc., 311 F.R.D. 427, 430 (E.D. Ky. Dec. 15, 2015).  Metoclopramide (Reglan) case.  Innovator manufacturers not liable under Kentucky law under any theory.  Prior summary judgment issued in Missouri will not be disturbed.
  • Tsavaris v. Pfizer, Inc., 154 F. Supp.3d 1327, 1339-41 (S.D. Fla. Jan. 7, 2016).  Estradiol/norethindrone acetate (Activella) case.   Innovator manufacturers not liable under Florida law under any tort theory.  Contrary cases are outliers.
  • Brown v. Janssen, Inc., 2016 CarswellOnt 12959, slip op. at 1 (Ont. Super. April 7, 2016).  Gabapentin (Neurontin) case.  Innovator manufacturers not liable under Canadian law under any theory.
  • Rafferty v. Merck & Co., 2016 WL 3064255, at *5-7 (Mass. Super. May 23, 2016).  Finasteride (Proscar) case.  Innovator manufacturers not liable under Massachusetts law in strict liability or negligence.  The FDA’s proposed rule does not support creation of innovator liability.  Reversed 92 N.E.3d 1205.
  • Perdue v. Wyeth Pharmaceuticals, 209 F. Supp.3d 847, 853-54 (E.D.N.C. July 20, 2016).  Cordarone/aminodarone case. Innovator manufacturers not liable under North Carolina law.
  • In re Mirapex Products Liability Litigation, 2016 WL 4217758, at *5 (Mag. D. Minn. June 16, 2016), adopted, 2016 WL 4203422 (D. Minn. Aug. 9, 2016).  Mirapex/pramipexole dihydrochloride case.  Innovator manufacturers not liable under exclusive Indiana product liability statute under any theory.  Agreeing with the “vast majority of courts.”
  • Mitchell v. Wyeth Pharmaceuticals, Inc., 2016 WL 11479893, at *3-4 (Mag. W.D. Tex. Dec. 16, 2016).  Cordarone/aminodarone case. Innovator manufacturers not liable under   Texas law.  Allegations of off-label promotion do not change this result.
  • Wells v. Wyeth Pharmaceuticals, Inc., 233 F. Supp.3d 534, 539-40 (W.D. Tex. Jan. 11, 2017).  Cordarone/aminodarone case.  Innovator manufacturers not liable under Texas law.  Allegations of off-label promotion do not change this result.
  • Coleson v. Janssen Pharmaceutical, Inc., ___ F. Supp.3d ___, 2017 WL 1745508, at *3-5, slip op. (S.D.N.Y. May 3, 2017).  Risperdahl/risperdone case.  Innovator manufacturers not liable under New York law.  These defendants had no oversight in the manufacturing of the generic drugs and earned no profit from the sale of the generic drugs.  Therefore, the concerns that apply in asbestos cases do not favor liability for non-manufacturers of generic drugs.
  • In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *4, 6-15 (D. Mass. Aug. 4, 2017).  Zofran/ondansetron case.  Following “overwhelming majority of courts.”  Innovator manufacturers not liable for alleged misrepresentations under any theory under Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma law.  “Negligent undertaking” innovator liability based on alleged off-label promotion was one of the theories rejected.
  • Garner v. Johnson & Johnson, 2017 WL 6945335 (C.D. Ill. Sept. 6, 2017).  Levofloxacin (Levaquin) case.  Illinois would allow innovator liability under negligence and negligent misrepresentation theories.  Fraud claims dismissed.
  • T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18 (Cal. Dec. 21, 2017).  Terbutaline (Brethine) case.  Innovator liability is the law of California, and may be imposed even on an innovator manufacturer that had already sold the rights to its product and left the market.
  • Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. March 16, 2018).  Finasteride (Proscar) case.  Massachusetts recognizes innovator liability where a brand-name manufacturer intentionally fails to update its label despite knowing of an unreasonable risk of death or grave bodily injury, or of facts that would disclose this risk to any reasonable person.  Reversing 2016 WL 3064255, above.
  • McNair v. Johnson & Johnson, ___ S.E.2d ___, 2018 WL 2186550, at *4-12, slip op. (W. Va. May 11, 2018).  Levofloxacin (Levaquin) case.  West Virginia does not recognize innovator liability under strict liability, negligence, or negligent misrepresentation.  Congress can change Mensing if it desires.  Traditional common law and a state statute limit liability for products to manufacturers and sellers.  Affirming result in 2015 WL 3935787, above.
  • In re Zofran (Ondansetron) Products Liability Litigation, 2018 WL 2317525, at *2-3 (D. Mass. May 21, 2018).  Zofran/ondansetron case.  Following majority view.  Recent California and Massachusetts decisions do not tip balance of predicting state law.  Innovator manufacturers not liable for alleged misrepresentations under any theory under Oklahoma, Connecticut, or New Jersey law.
  • Preston v Janssen Pharmaceuticals, Inc., 2018 WL 5017045 (N.Y. Sup. Oct. 12, 2018).  Topamax/topiramate case.  New York does not recognize innovator liability under any theory.  Pharmacy records establish lack of exposure to branded drug.

After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected bwary preemption, was resoundingly answered “yes.”

But since then, we’ve said repeatedly that we don’t expect plaintiffs to just fold their tents and go away – and they haven’t. Rather, we expect the other side to look for loopholes in Riegel – even if we don’t think there are any – especially in the area of so-called “parallel” claims.

Anyway, it’s been six months since Riegel was decided, and the decisions addressing such arguments are starting to pile up. So we’ve decided to resurrect and revamp our device preemption scorecard with special emphasis on what Riegel “loophole” arguments are made and how courts decide them. So here goes (drumroll, please), the new and updated druganddevicelaw device PMA preemption scorecard:

  1. Strini v. Edwards Lifesciences Corp., 2008 WL 820192 (Mag. N.D.N.Y. March 26, 2008). Heart valve prosthesis case.  Preemption issues cannot be decided in context of a discovery motion. “Parallel” violation claims might escape preemption.
  2. Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D.S.C. April 1, 2008).  Device not stated, but probably some sort of pacemaker.  No “parallel” violation claims pleaded; action preempted in its entirety.
  3. Despain v. Bradburn, 282 S.W.3d 814 (Ark. April 10, 2008). Plaintiff’s claims preempted against manufacturer of hearing device. No manufacturing defect claim pleaded.
  4. O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008), mandamus denied, 24 So.3d (Fla. App. 2009). Drug eluting coronary stent.  Off-label use does not preclude preemption where the defect (in design claim) or risk (in warning claim) is common to both on- and off-label use. True “parallel” violation claims, including off-label promotion are not preempted. Express warranty claims are not preempted. Fraud claims amounting to fraud on the FDA are preempted under Buckman. Unfair trade practice claims are preempted.
  5. Troutman v. Curtis, 185 P.3d 930 (Kan. June 20, 2008). Plaintiff barely pleaded, and entirely failed to prove, any unpreempted “parallel” violation claims against manufacturer of suturing device.
  6. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008). Novasure endometrial ablation device.  A claim based on the activities of defendant’s on-site representative escapes preemption as not regulated by the FDA.
  7. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008). Taking judicial notice of FDA PMA for defendant’s adhesion barrier device. Plaintiff failed to plead any unpreempted “parallel” violation claims either before or after FDA approval. Express warranty claims are unpreempted but inadequately pleaded. Leave granted to amend.
  8. Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008). Plaintiff failed to prove any unpreempted “parallel” violation claims involving Targis microwave device. Negligent failure to train claims are preempted as “in addition to” the FDA’s requirements imposed upon the device.
  9. McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917 (N.D. Ill. Aug. 6, 2008). Violation claims involving information the manufacturer of a knee implant provided to the FDA are preempted by Buckman. No evidence supports post-approval claims, even if they could be unpreempted. Riegel overrules contrary anti-preemption precedent. Congressional legislation to overturn Riegel is of no significance until it is passed.
  10. Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). FDA filed suit against manufacturer of cochlear ear device for violating Good Manufacturing Practices requirements. Plaintiff’s strict liability and implied warranty claims that manufacturer sold adulterated product not preempted under Riegel.  Renewed motion denied, Purcel v. Advanced Bionics Corp.slip op. (N.D. Tex. June 24, 2010).
  11. Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 (D. Minn. Aug. 18, 2008). Doctrine of res ipsa loquitur cannot be invoked to show that a device that failed had necessarily been manufactured improperly. Allegations about information withheld from FDA are preempted by Buckman, and would be an improper private right of action to enforce the FDCA. All claims in case involving an implantable cardioverter-defibrillator, including consumer protection, and breach of unspecified warranties, are preempted.
  12. Kavalir v. Medtronic, Inc., 2008 WL 4087950 (N.D. Ill. Aug. 27, 2008). Preemption motion to dismiss denied because available information did not conclusively establish that the  implantable cardioverter-defibrillator in question had PMA approval.
  13. Walker v. Medtronic, Inc., 2008 WL 4186854 (S.D.W. Va. Sept. 9, 2008). Preemption motion denied without prejudice in infusion pump case. Plaintiff could amend complaint to allege “parallel” FDCA violations, but the issue would be rejoined after discovery concerning the defendant’s evidence that it was in full compliance.
  14. Carson v. Depuy Spine, Inc., 2008 WL 7258800, order (C.D. Cal. Sept. 17, 2008). Summary judgment on preemption grounds granted against all claims spinal disc implant case. Allegations of off-label promotion as “parallel” claim failed: (1) because mere sales rep presence during an off-label surgery isn’t promotion, and (2) for lack of evidence of reliance or causation.  Affirmed 365 F. Appx. 812 (9th Cir. 2010).
  15. Rollins v. St. Jude Medical, Diag Division, Inc., 2008 WL 11395511 (Mag. W.D. La. Sept. 25, 2008).  Motion to dismiss granted in part and denied in part in Angio-Seal case.  All claims based on FDCA compliant acts are preempted.  Claims alleging violations not preempted.  Failure to train and report escape preemption only if violations occurred.  Failure to report the plaintiff’s incident could not possibly be causal.
  16. Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. Oct. 22, 2008). Motion to dismiss on preemption grounds granted in hip implant case. Plaintiff failed to plead any facts supporting “parallel” claims. Preemption cannot be avoided by reference to adulteration and misbranding because there is no private right of action under the FDCA. Express warranty claims involving product labeling are preempted.
  17. Rollins v. St. Jude Medical, 583 F. Supp.2d 790 (W.D. La. Oct. 20, 2008). Motion to dismiss plaintiff’s claim that defendants failed to abide by FDA reporting requirements granted in part and denied in part in Angio-Seal case. Plaintiff conceded that all claims were preempted except failure to manufacture/package in accordance with FDA specifications, failure to train, and failure to abide by reporting requirements. Noncompliance claims not preempted. Manufacturing defect claim based on product recall not preempted. Failure to train claim preempted to the extent of FDA compliance. Failure to report claim dismissed for lack of causation.
  18. Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174 (N.D. Ill. Nov. 26, 2008). Summary judgment granted against all claims concerning total knee replacement prosthesis. No factual dispute as to compliance with FDA requirements. Rejected loopholes: fraud on the FDA (preempted), post-approval defect (relies on dissent; no proof); congress might change the statute (hasn’t).
  19. Lake v. Kardjian, 22 Misc.3d 960, 874 N.Y.S.2d 751 (N.Y. Sup. Dec. 17, 2008). Summary judgment granted against all claims concerning Targis transurethral microwave therapy system. Plaintiff failed to identify any specific statement exceeding FDA-approved warnings that could qualify as an unpreempted express warranty. Post approval failure to report claims are preempted either as fraud on the FDA or prohibited private FDCA violation claims.
  20. Huber v. Howmedica Osteonics Corp., 2008 WL 5451072 (D.N.J. Dec. 31, 2008). Motion to dismiss denied against complaint alleging solely a claim for express warranty in total hip replacement litigation. The court considered itself bound by pre-Riegel Third Circuit precedent. The question whether express warranty claims are preempted was certified to the Third Circuit. Huber v. Howmedica Osteonics Corp., 2009 WL 2998160 (D.N.J. March 10, 2009).
  21. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. Jan. 5, 2009), reconsideration denied, 2009 WL 294353 (D. Minn. Feb. 5, 2009), leave to amend complaint denied, 2009 WL 1361313 (D. Minn. May 12, 2009). Motion to dismiss granted against all claims in Sprint Fidelis MDL. Manufacturing defect claims not “parallel” because no specific violations alleged, or allegable given generality of FDA regulations. Parallel claims do not exist without a specific FDA regulation for state-law claims to parallel. Adulteration claims amount to prohibited private attempts to enforce the FDCA. Negligence per se only supplies a standard of care, and cannot resurrect an otherwise preempted claim. An express warranty of “safety” would require a jury to find a device unsafe, which is preempted. This is an appealable order, motion practice in the district court appears exhausted, and the matter is currently on appeal.
  22. Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. Jan. 12, 2009). Motion to dismiss denied as to claims “based on theories that [defendant] failed to comply with federal requirements for manufacturing” a hip replacement prosthesis. Surviving claims include those for express and implied warranty and consumer fraud. All non-violation claims had been voluntarily dismissed.
  23. Means v. Howmedica Osteonics Corp., 2009 WL 347407 (S.D. Ind. Feb. 11, 2009), minute order following Hofts in hip replacement prosthesis case.
  24. Blunt v. Medtronic, Inc., 315 Wis.2d 612, 760 N.W.2d 396 (Wis. Feb. 17, 2009). Pre-Riegel ruling in favor of PMA preemption affirmed in implantable defibrillator case. Both PMA and supplemental PMA have equal preemptive effect. Supplemental approval does not diminish the preemptive effect of initial approval.
  25. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009). Motion to dismiss granted as to claims involving total hip prosthesis. All claims except manufacturing defect are preempted, including consumer fraud. Warning letters and recalls not involving the device in question do not create parallel claims. A plaintiff must plead how a particular violation caused injury. The manufacturing claim must be more specifically pleaded. Express warranty claims not based on the approved labeling would escape preemption.
  26. Shertzer v. Howmedica Osteonics Corp., 2009 WL 535997 (S.D. Ind. March 3, 2009), minute order following Hofts in hip replacement prosthesis case.
  27. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009). Motion to dismiss granted in part and denied in part as to claims involving hip prosthesis. Violation claims, even if not preempted under Lohr, are preempted as attempted private FDCA enforcement under Buckman. Express warranty claims are not preempted, but are insufficiently pleaded. Manufacturing defect claims are preempted without specific allegations of a deviation from FDA-approved specifications.
  28. Dorsey v. Allergan, Inc., 2009 WL 703290, slip op. (M.D. Tenn. March 11, 2009). Summary judgment granted as to claims involving investigational breast implants. Riegel applies to Class III devices marketed pursuant to an IDE or its equivalent. FDA approval of both adjunct (equivalent to an IDE) and core studies (an actual IDE) has preemptive effect.
  29. Gortarez v. White Memorial Medical Center, 2009 WL 8710587 (Cal. Super. March 23, 2009).   Summary judgment granted as to claims, including failure to train physicians, involving a laser and shaft unit.  Training requirements were part of the PMA approval.  Fraud on the FDA claims are preempted by Buckman.  No parallel claims were alleged.
  30. Mitaro v. Medtronic, Inc., 23 Misc. 3d 1122(A), 886 N.Y.S.2d 71, 2009 WL 1272398 (N.Y. Sup. April 9, 2009) (unreported). Motion to dismiss granted against almost all claims, including consumer fraud, in implantable cardiac defibrillator case. Manufacturing defect claim could be a parallel violation claim. Negligence per se claim is preempted both as restating other preempted claims and as attempted private FDCA enforcement. Express warranty claim preempted only to the extent it relies upon FDA-approved statements. Claims predicated on false statements to the FDA are preempted under Buckman. A product recall does not vitiate preemption.  The Appellate Division affirmed in a one-paragraph opinion, Mitaro v. Medtronic, Inc., 73 A.D.3d 1142, 900 N.Y.S.2d 899 (N.Y.A.D. May 25, 2010).
  31. Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009). Motion to dismiss granted as to all claims in anti-adhesive surgical barrier case. Negligence per se claims related to events that post-dated plaintiff’s injuries and thus couldn’t possibly be causal. All other claims are preempted. Express preemption claims based on FDA-approved language are preempted.
  32. Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226 (D. Nev. May 1, 2009). Granting summary judgment against all claims in a spinal implant disc case, including express warranty because the claimed warranty concerned aspects of device safety and effectiveness. Plaintiff had no evidence to support allegations of violation of FDA manufacturing standards. Allegations of fraud on the FDA are preempted under Buckman and as they are a prohibited attempt at private FDCA enforcement, would not constitute negligence per se under Nevada law.
  33. Mullin v. Guidant Corp., 114 Conn.App. 279, 970 A.2d 733 (Conn. App. May 12, 2009), affirming Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super. April 8, 2008). All claims, including manufacturing defect and express and implied warranties, are preempted in action involving implantable defibrillator. Plaintiff did not plead anything that could be considered a “parallel” violation claim. Preemption does not deprive a court of subject matter jurisdiction.  The Connecticut Supreme Court declined to review the case.  292 Conn. 921, 974 A.2d 722 (2009).
  34. Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. June 5, 2009). Judgment on the pleadings granted as to all claims in drug eluding stent case. A “parallel” claim involves conduct “forbidden” by the FDCA. Even a claim involving prohibited conduct may be impliedly preempted as an improper private FDCA action under Buckman. To escape Buckman, a claim must rely on traditional state tort theories. Preemption applies to off-label uses. A combination of a drug and a device will be treated as a device for preemption purposes where the FDA has regulated the product as a device.  The device cannot be divided into components.  Allegations that the FDA is poorly run do not defeat preemption. Allegations of promoting off-label use escape preemption only if, in addition to violating the FDCA, the promotion failed to warn of risks in violation of the common law. All other warning related claims are preempted. Fraud claims must be specifically pleaded. Express warranty claims based upo the device’s label are preempted. Manufacturing defect claims must allege a violation in the particular device at issue. Any claims not dismissed with prejudice must be repleaded. This case is reportedly on appeal in the Eighth Circuit at No. 09-2870.
  35. Bencomo v. Guidant Corp., 2009 WL 1951821, slip op. (E.D. La. June 30, 2009). Summary judgment on preemption granted against express warranty claims involving embolis capture system. Alleged contradiction between patient material and product labeling could not support a claim where the language in both sets of material were FDA approved. A claim dependent upon the falsity of FDA approved language cannot be a parallel claim.
  36. Colombini v. Westchester County Health Care Corp., 24 Misc.3d 1222(A), 899 N.Y.S.2d 58, 2009 WL 2170230 (N.Y. Sup. July 6, 2009). Summary judgment granted against all claims in action involving an MRI device. That the device had been downclassified to Class II did not eliminate preemption, as the device was initially PMA approved. Plaintiffs could not point to any FDA design requirement that defendant violated, therefore there was no viable parallel claim.
  37. Prudhel v. Endologix Inc., 2009 WL 2045559 (E.D. Cal. July 9, 2009). Motion to dismiss granted in part in aortic stent case. Alleged express warranty of safety was preempted. Alleged parallel claims are preempted when they impose greater requirements on compliant manufacturers. Parallel claims that require “more than mere noncompliance” are not preempted. A manufacturing defect claim, involving product recalls, survives preemption. Strict liability, negligence, and implied warranty claims are preempted.
  38. Cenac v. Hubble, 2009 WL 10678961 (E.D. La. July 31, 2009), motion to dismiss denied on all claims in SynchroMed medication pump case.  However, since plaintiffs failed to plead any unpreempted parallel claim, they must file an amended complaint doing so.
  39. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009). Motion to dismiss granted against all claims in ceramic total hip replacement case. Finding broad preemption of state tort claims that “incidentally” regulate medical devices. Parallel violation allegations can escape express preemption, but are subject to implied preemption. Rejects argument that preemption may only be decided on summary judgment. Rather than vitiating the preemption defense, allegations of fraud on the FDA are themselves preempted. FDA warning letters issued after plaintiff’s surgery, and thus not relating to the product implanted in plaintiff cannot support an unpreempted parallel claim. To plead an unpreempted parallel violation claim requires alleging a specific federal requirement, how it was violated, and how the violation caused this plaintiff’s injury. Express warranty and consumer fraud claims are too vaguely pleaded to escape preemption.
  40. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 2600517, slip op. (M.D. Ga. Aug. 24, 2009). Motion to dismiss granted against punitive damages claim asserted under New Jersey law because fraud on the FDA exception to the statutory ban on punitive damages against FDA-approved products is barred by preemption under Buckman.  Cautionary note:  this opinion was vacated on state-law grounds (whether the product was covered by the statutory ban in the first place) in In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 4280829 (M.D. Ga. Nov 24, 2009).
  41. William Beaumont Hospital v. Medtronic, Inc., 2009 WL 2849546 (E.D. Mich. Aug. 31, 2009). Motion to dismiss granted in part. All claims based on alleged inadequacy of warnings are preempted in case concerning pain pump refill kits. Contribution claims based upon the negligent distribution of an incorrect free sample that was not in fact the same device as represented are not preempted.
  42. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009). Summary judgment granted against all claims in two cases involving vagus nerve stimulation devices. Unknown manufacturing defects inferred from alleged device malfunction were preempted because proof of a failure to manufacture the device to comply with FDA design requirements was shown.  Affirmed memorandum, 388 F. Appx. 169 (3d Cir. July 30, 2010).
  43. Musembi v. DePuy Spine, Inc., 2009 WL 106938061 (D. Nev. Sept. 21, 2009). Summary judgment granted against all claims, including express warranty in case involving artificial invertebral disc.  No mention of any parallel claims.  No collateral estoppel by pre-Riegel decisions.
  44. Mansoor v. American Medical Systems, Inc., 2009 WL 10693227 (D. Nev. Nov. 19, 2009).  Summary judgment granted against all claims in case involving urinary control system.  No mention of any parallel claims.
  45. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009). Summary judgment granted against all claims in ruptured breast implant case involving IDE device. Claims of lack of valid consent are factually false. No pleaded facts support any violation claim. That PMA approval occurred only after the plaintiff’s device was implanted does not prevent preemption, since essentially the same device was approved. A non-waiver clause in an informed consent form does not override preemption.
  46. In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867, slip op. (Minn. Dist. Hennepin Co. Oct. 20, 2009). Motion to dismiss granted against all claims in state court Sprint Fidelis litigation. Express warranty and consumer fraud claims preempted. Purported “parallel” claims dismissed because: (1) they are disguised private attempts to enforce the FDCA, which are impliedly preempted under Buckman; (2) there is no parallel state law claim for failure to follow the conditions of an FDA PMA; (3) there is no federal requirement to submit a CBE (it’s strictly voluntary); (4) claims challenging the sufficiency of a defendant’s submissions to the FDA are disguised fraud-on-the-FDA claims; (5) plaintiffs’ design claims would impose rigid specificity that FDA regulations do not; (6) nothing in the FDA’s regulations requires withdrawal of a device because an allegedly “safer” model was later approved; (7) there is no obligation to submit a PMA supplement immediately after learning of problems with an existing device; (8) certain alleged violations were not causally connected to any plaintiff’s injuries; (9) adulteration claims are disguised private attempts to enforce the FDCA; negligence per se claims are disguised private attempts to enforce the FDCA; (10) a statute that does not authorize a private cause of action cannot be the basis of a negligence per se claim under state law; and (11) the regulations subject to plaintiff’s negligence per se claims are only administrative requirements and do not prescribe standards of care owed to any individual.
  47. Williams v. Endologix, Inc.slip op., 2009 WL 3554581 (Ky. Cir. Oct. 30, 2009). Summary judgment granted against all claims in some kind (aortic stent?) of PMA device litigation, except claims “premised upon” FDCA violations, which the court considered parallel claims.
  48. McQuiston v. Boston Scientific Corp., 2009 WL 4016120, slip op. (W.D. La. Nov. 19, 2009). Summary judgment granted against all claims in a drug eluting stent case involving a combination device. Express warranty claim preempted. Plaintiff did not plead a “parallel violation” claim.
  49. Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009) (bench opinion).  Motion to dismiss granted against all claims, including express warranty, in ceramic total hip prosthesis case.  No violation claims were properly pleaded.  A 2006 recall cannot be causally relevant to a device implanted in 2003.  Twiqbal bars speculative parallel violation claims.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  The New Jersey punitive damages exception is preempted as based upon fraud on the FDA.  Rejecting Hofts.
  50. Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. Dec. 28, 2009).  Motion to dismiss granted against plaintiff’s sole “negligence per se” claim involving a medication pump.  The allegedly violated Good Manufacturing Practices were too “vague and open-ended” to constitute a non-preempted parallel violation claim because they “would necessarily result in the imposition of standards that are different from or in addition to those imposed by the FDCA.”
  51. Risavich v. Heart Rhythm Consultants, 2010 WL 9585790 (N.Y. Sup. Feb. 1, 2010).  Summary judgment granted against all claims in action involving an inplantable cardiac defibrillator.  Both PMA and supplemental PMA have equal preemptive effect.  Plaintiff failed to plead a parallel claim with specificity.  Implied warranty claims are preempted.
  52. Banner v. Cyberonics, Inc., 2010 WL 455286 (D.N.J. Feb. 4, 2010), summary judgment granted on all claims in action involving a vagus nerve stimulator.  A claimed that a device is a “lemon” because it malfunctioned in unspecified ways does not establish any FDA violation. There was no dispute that the device was manufactured according to FDA specifications.
  53. McGuan v. Endovascular Technologies, Inc., 182 Cal. App.4th 974, 106 Cal. Rptr.3d 277 (Cal. App. Feb. 9, 2010), affirming Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008), and McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008).  Summary judgment affirmed against all claims in case involving an endograft device.  Claimed “parallel” violation claim was really a preempted fraud on the FDA claim.  The defendant’s guilty plea did not establish the exception to Buckman because the FDA reapproved the device after the alleged fraud and the guilty plea did not require removal of the device from the market.
  54. Rankin v. Boston Scientific Corp., 2010 WL 672135 (E.D. Ky. Feb. 19, 2010), summary judgment granted on all claims in action involving a balloon catheter.  An allegation that the product failed under normal use does not establish a violation of FDA regulations.
  55. Heisner v. Genzyme Corp., 2010 WL 894054, slip op. (N.D. Ill. March 8, 2010).  Dismissing with prejudice a complaint that had been amended three times (see above for two earlier dismissals).  The device CBE requirements, being voluntary, could not be parallel to a post-sale duty to warn.  A failure to report adverse events to the FDA was not “defect” as required by strict liability.  Negligence per se claims involving post-injury events could not possibly be causal.
  56. Wheeler v. Depuy Spine, Inc., 706 F. Supp.2d 1264 (S.D. Fla. March 9, 2010), summary judgment granted on almost all claims in action involving off-label use of an artificial spinal disc.  Non-violation-related product liability claims are preempted.  Claims seeking to enforce the FDCA, that defendant “permitted” off-label use, and that defendant withheld adverse reaction reports were all preempted under Buckman.  A hearing will be held on express warranty claims, which are vulnerable to both preemption and non-preemption defenses.  Express warranty claim later dismissed on non-preemption grounds, 740 F. Supp.2d 1132.
  57. Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. March 15, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Preemption of product liability claims was conceded.  Redhibition is equivalent to a breach of implied warranty and it preempted.
  58. Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. March 23, 2010), motion to dismiss granted against all claims involving hip prosthesis.  Plaintiffs pleaded no violation claims, so all tort claims were preempted.  Express warranty were inadequately pleaded.
  59. Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010), motion to dismiss granted on all claims involving total hip prosthesis. Generalized manufacturing defect allegations that do not mention FDCA violations cannot be recast as parallel violation claims. No causal link pleaded between FDA warning letters and device implanted in plaintiff.
  60. Adams v. I-Flow Corp., 2010 WL 1339948 (C.D. Cal. March 30, 2010), motion to strike claim that defendants failed to warn the FDA stricken as a fraud on the FDA claim preempted by Buckman.
  61. Lewkut v. Stryker Corp., 724 F. Supp.2d 648 (S.D. Tex. April 16, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  All claims, including manufacturing defect and consumer fraud, are preempted.  Plaintiff’s claim that his device was “adulterated” because a component was recalled for GMP issues is preempted under 21 U.S.C. §337(a) because adulteration claims are improper private enforcement of the FDCA.  Reconsideration denied, Lewkut v. Stryker Corp., 2010 WL 2542215 (S.D. Tex. June 21, 2010).
  62. Cenac v. Hubbell, No. CV 09-3686, 2010 WL 11537934 (E.D. La. April 16, 2010), motion to dismiss denied on all claims in SynchroMed medication pump case.  However, plaintiffs have still failed to plead any unpreempted parallel claim, and must file an amended complaint doing so.   All claims except those based on FDCA violations are preempted.  The GMPs at issue impose no specific requirements, and are too vague to support an unpreempted parallel claim.  Dismissed on subsequent motion, 2010 WL 4174573, below.
  63. Franklin v. Medtronic, Inc., 2010 WL 2543579 (Mag. D. Colo. May 12, 2010), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010), summary judgment granted on all claims involving implantable defibrillator. Failure to recall claim was not a parallel claim because recall under the FDCA is a voluntary remedial action. Express warranty claims are preempted. FDA regulatory claim was conclusory under TwIqbal, and an improper attempted private FDCA cause of action.
  64. Van Dyke v. Howmedica Osteonics Corp., 2010 WL 8490858, tr. at 22-30 (D. Mont. May 14, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Express warranty claims and consumer fraud claims based on FDA-approved labeling are preempted.  Claims asserting a right to sue for FDCA violations are preempted by Buckman.
  65. Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010), motion to dismiss denied as to “parallel” violation claims in total hip prosthesis case where a device recall applied to the plaintiff’s device.   A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  The public FDA record is subject to judicial notice.  Manufacturing defect theories based upon a claimed FDCA violation that formed the basis for the recall of the plaintiff’s device adequately states an unpreempted claim.  Reconsideration denied, 2010 WL 4238594 (E.D. Tenn. Oct. 21, 2010).
  66. Huber v. Medtronic, Inc., 2010 WL 4602686 (Cal. Super. June 4, 2010), summary judgment granted against all claims involving implanted PMA device.  No parallel claims alleged.
  67. Kallal v. Ciba Vision Corp., 2010 WL 2330365 (N.D. Ill. June 9, 2010), motion to dismiss granted in part on claims involving Optix contact lens.  All design and testing claims are preempted.  A parallel violation claim was sufficiently pleaded.  Plaintiff’s pleading that the violated standard was FDA-imposed was sufficient; defendant’s argument that the standard was only internal will not be decided on motion to dismiss.  There is a reasonable inference that a product purchased shortly before a recall was covered by the recall; it was not necessary to plead product identification numbers.  Remaining violation claim later dismissed on summary judgment because plaintiff could not prove a violation or causation, see below 2013 WL 328985.
  68. Howard v. Sulzer Orthopedics, Inc., 382 F. Appx. 436 (6th Cir. June 16, 2010) (unpublished), order preempting negligence per se claim in knee prosthesis case reversed.   While the FDA Good Manufacturing Practice plaintiff claims was violated could be read two different ways, other FDA materials suggest that a specific duty was imposed, therefore the regulation was enforceable.
  69. Steen v. Medtronic, Inc., 2010 WL 2573455 (N.D. Tex. June 25, 2010), motion to dismiss granted on all claims, including express and implied warranty, involving an Adapta pacemaker.  No parallel violation claim alleged.
  70. Poole v. Hologic, Inc., 2010 WL 3021528 (W.D. La. July 29, 2010), judgment on the pleadings granted on all claims, including express and implied warranty, involving a “controlled endometrial ablation aystem.”  No parallel violation claim alleged.
  71. Raleigh v. Alcon Laboratories, Inc., 403 Ill. App.3d 863, 934 N.E.2d 530 (Ill. App. Aug. 6, 2010), affirming summary judgment order preempting all claims in intraocular lens case.  No parallel violation claim alleged.  Further appeal denied, 942 N.E.2d 461 (Ill. 2010).
  72. Gow v. Medtronic, Inc., 2010 WL 3643754 (Ky. Cir. Aug. 26, 2010), summary judgment granted against all claims involving implantable infusion pump, including express preemption and consumer fraud.  Plaintiff fail to plead violation of FDA requirements with any detail and does not identify what was violated.  An FDA recall did not affect PMA approval.
  73. Aaronson v. American Medical Systems, 2010 WL 3603618 (E.D.N.Y. Sept. 7, 2010), motion to dismiss denied in case involving penile implant.  It was unclear at the pleading claim whether the device was actually a PMA device. Limited discovery on the device’s regulatory status is allowed and, if it is a PMA device, plaintiff has 14 days to file a more specific complaint.  Dismissed for failure to file amended complaint, 2012 WL 1712378.
  74. Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010), motion to dismiss granted on all claims involving a total hip prosthesis.  Preemption extends to express warranty and consumer fraud claims.  Plaintiff fail to plead violation of FDA manufacturing requirements with any detail.  Rejecting “lax” pleading standard of Hofts.  Plaintiff must plead a “device-specific” violation and causation by the violation.  Later decision dismissing most claims, 788 F. Supp.2d 145, see below.
  75. Sanders v. Advanced Neuromodulation Systems, Inc., 44 So.3d 960 (Miss. Sept. 30, 2010), summary judgment affirmed on all claims involving a spinal cord stimulator.  Preemption was not defeated by the manufacturer’s unsuccessful attempt to have the device downclassified to Class II.  The FDA did not misinterpret its regulations in deciding that the device was Class III and requiring premarket approval.
  76. Bagumyan v. Medtronic, Inc., 2010 WL 4009891 (Cal. App. Oct. 14, 2010) (unpublished), summary judgment affirmed on all claims involving a Sprint Fidelis pacemaker lead. Supplemental PMA approval is equally preemptive as initial approval. The PMA process cannot be re-examined to test the quality of the FDA’s actual review.  Parallel requirements arguments fail for lack of any citation to anything allegedly violated.  Affirming 2008 WL 8071256 (Cal. Super. Dec. 29, 2008).
  77. In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. Oct. 15, 2010), summary judgment affirmed on all claims involving the Sprint Fidelis MDL.  With respect to parallel claims, express preemption under Riegel and implied preemption under Buckman create only a “narrow gap” for state-law claims.  Failure to warn claims not alleging any violation of FDA regulations are not “parallel” claims and are preempted.  Even if additional warnings were allowed they were not required; thus the claim is “different from or in addition to” and is preempted.  Levineinvolving implied preemption, is inapposite.  There is no federal requirement that unmodified products be removed from the market when a modified device is approved.  Claims that the defendant provided the FDA with insufficient information or withheld adverse event reports are private enforcement barred by Buckman.  Absent “concrete” allegations of FDCA violations, design defect claims are preempted.  General allegations of failure to comply with FDA Good Manufacturing Practices are too vague to escape preemption, and are a “frontal assault” on the FDA’s risk/benefit conclusion.  Express warranty claims based on “safety and effectiveness” would require a jury to find a device unsafe, creating a preempted conflict.
  78. Scoggins v. Boston Scientific Corp., 2010 WL 8911977, slip op. (Mass. Super. Oct. 18, 2010), summary judgment granted in part and denied in part in action involving drug eluting stent.  Off-label use does not preclude preemption.  Design defect claims are preempted.  Manufacturing defect claims that also allege FDCA violations escape preemption.  Attacks on off-label promotion allowed by the FDCA safe harbor are expressly preempted.  Most warning claims are preempted, unless plaintiff can show a reporting violation that also violates state common law.  A parallel claim for illegal off-label promotion that is also false escapes preemption.   Express warranty and consumer fraud claims based on FDA-approved statements are preempted, but any other statements are not.
  79. Cenac v. Hubble, 2010 WL 4174573, slip op. (E.D. La. Oct. 21, 2010), motion to dismiss granted on all claims in SynchroMed medication pump case.  GMPs and certain other regulations are too vague to support a “parallel” violation claim.  Allegations of post-PMA adverse event reporting violations are preempted fraud on the FDA claims.  Express and implied warranty claims are preempted.  Dismissed on subsequent motion, 2010 WL 4174573, below.
  80. Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010), motion to dismiss granted on all claims in Trident total hip implant case.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  Plaintiff should have modified allegations concerning the applicability of a product recall once the facts were clear, but Rule 11 sanctions will not be imposed.  A product recall not involving the product at issue cannot form the basis of a “parallel” violation claim.  An adulteration claim is a prohibited private FDCA right of action.
  81. Bishoff v. Medtronic, Inc., 2010 WL 4852650, slip op. (N.D.W. Va. Nov. 22, 2010), motion to dismiss granted on all claims in pacemaker lead case.  Manufacturing defect/negligence per se claims were improperly pleaded because they didn’t identify “how or why” there was a regulatory violation.  Express warranty claims were improperly pleaded.  Implied warranty for a particular purpose claims were preempted.
  82. Norks v. Endovascular Technologies, Inc., 2010 WL 4681417 (Cal. App. Nov. 19, 2010) (unpublished), summary judgment affirmed (2008 WL 5267875) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.  Fraud on the FDA claims were preempted, thus an amendment was properly denied as futile.
  83. Robinson v. Endovascular Technologies, Inc., 190 Cal. App.4th 1490, 119 Cal.Rptr.3d 158 (Cal. App. Nov. 19, 2010), summary judgment affirmed (2008 WL 5267874) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.
  84. Burgos v. Satiety, Inc., 2010 WL 4907764 (E.D.N.Y. Nov. 30, 2010), summary judgment granted on all claims, including breach of warranty, in investigational gastric stapling system device case.  IDE devices are subject to FDA supervision that’s identical to PMA for preemption purposes.  Blanket reference to violation of unspecified statutes and regulations cannot suffice to state a parallel violation claim.  Plaintiff can amend.  Motion to dismiss (2011 WL 1327684) and summary judgment (2013 WL 801729) later granted against all claims, see below.
  85. Warren v. Howmedica Osteonics Corp., 2010 WL 5093097 (E.D. Mo. Dec. 8, 2010), motion for reconsideration denied, 2011 WL 1226975 (March 29, 2011), claims based solely on FDCA violations survive preemption in Trident total hip implant case.  The court follows Hofts with respect to pleading and allows violation claims without pleading causation.
  86. Barnes v. Howmedica Osteonics Corp., 2010 WL 11565343 (N.D. Ala. Dec. 14, 2010), summary judgment granted on all claims in case involving hip implant.  Implied warranty preempted.  Parallel claim inadequately pleaded.  A recall does not establish an FDCA violation.  Vague regulatory claim would also be impliedly preempted.
  87. Pardo v. Medtronic Inc., 2010 WL 5300847 (E.D. La. Dec. 15, 2010), summary judgment granted on all claims in case involving brain stimulation device.  Terse order is unclear which claims are barred as preempted and which are barred for other reasons.  Off-label use does not defeat preemption.
  88. Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. Dec. 23, 2010), reversing Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), manufacturing-related claims based solely on FDCA violations survive a motion to dismiss on the basis of preemption in Trident total hip implant case.  Violation claims related to FDA GMPs are sufficiently specific, at the pleading stage, to escape preemption.  The claims are not impliedly preempted because as pleaded there is no conflict with the federal regulations.   Before a plaintiff has discovery, it is not necessary to plead specifically what regulation was violated and how, as to do so may be impossible.
  89. Couvillier v. Allergan, Inc., 2011 WL 8879258, slip op. (Mag. W.D. La. Jan. 20, 2011), adopted 2011 WL 8879259 (W.D. La. Feb. 9, 2011), motion to dismiss granted against all claims involving breast implant.  No parallel claims mentioned.
  90. Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. Jan. 21, 2011), reversing Hughes v. Boston Scientific Corp., 669 F. Supp.2d 701 (S.D. Miss. Nov. 12, 2009).  All warning and design product liability claims were properly dismissed as preempted.  Violation claims that paralleled traditional state warning and negligence per se claims were not preempted under Riegel.  A formal FDA finding of violation is not required to avoid preemption.  Unexplained FDA silence is not equivalent to approval.  Because the plaintiff’s violation claims paralleled existing state tort claims, there was no preemption under Buckman.
  91. Funk v. Stryker Corp., 631 F.3d 777 (5th Cir.  2011), affirming Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009), dismissal of all claims against hip implant as preempted is affirmed.  Dismissal of violation claims based upon res ipsa loquitur are implied preempted.  Plaintiff failed to plead any other violation claim with sufficient specificity.  It was proper to take judicial notice of FDA PMA documents.
  92. Cafferty v. Cayuga Medical Center, 2011 WL 541809 (N.D.N.Y. Feb. 8, 2011), motion to dismiss granted against all claims against intraocular lens.  Without any positive allegation of a violation of FDA regulations, a manufacturing defect claim is preempted.  Res ipsa loquitur cannot establish a regulatory violation.
  93. Cohen v. Guidant Corp., 2011 WL 637472, slip op. (C.D. Cal. Feb. 15, 2011), motion to dismiss granted against all claims involving pacemaker.  Plaintiff pleaded only boilerplate FDA regulations as a parallel claim with no attempt to plead that they caused him injury.
  94. Timberlake v. Synthes Spine, Inc., 2011 WL 711075 (S.D. Tex. Feb. 18, 2011), summary judgment granted against all claims, including express warranty, involving artificial intervertebral spinal disc.  Plaintiff’s fraud on the FDA claim was impliedly preempted by Buckman.  Plaintiff had no evidence to establish a causal violation claim.
  95. Nimtz v. Cepin, 2011 WL 831182 (S.D. Cal. March 3, 2011), motion to dismiss granted against all claims involving pacemaker. Plaintiff did not allege a parallel violation claim.
  96. Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. March 8, 2011), summary judgment affirmed against all claims against spinal pain pump system.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff is not entitled to any inference of defect due to the loss of a critical component because a defect was not the most probable cause of injury with other causes not ruled out.  Claims against sales representative dismissed under same rationale.  Affirming 641 F. Supp. 2d 1270 (M.D. Fla. July 22, 2009).
  97. Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303 (D.P.R. March 8, 2011), summary judgment granted against some claims against impulse generator.  Plaintiff’s claim that he did not receive any of the FDA-approved warnings concerning the device is not preempted because it does not seek any changes in the approved warnings.  Manufacturing defect claims are preempted because a failure does not equal a violation and because plaintiff does not tie a subsequent recall to the device at issue.  Design defect claims are preempted.
  98. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011), motion to dismiss granted against all claims involving hip implant.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff neither pleaded a violation of a device-specific FDA requirement, nor that any violation pertained to the implanted device.
  99. Warren v. Stryker Corp., 2011 WL 1226975 (E.D. Mo. March 29, 2011), motion to dismiss denied in part against parallel violation claims involving hip implant.  Allowing plaintiffs to use discovery to determine which particular PMA specifications defendants may have violated.
  100. Knight v. St. Jude Medical, 2011 WL 1230815 (W.D. Mich. March 31, 2011), motion to dismiss granted against all claims involving internal cardiac defibrillator except allegations that manufacturer’s representative was aware of the malfunctioning of the particular device and failed to warn the treating physicians.  Adopting 2011 WL 1230819 (Mag. W.D. Mich. Jan. 11, 2011).  Summary judgment granted against remaining claims, 2012 WL 5878804 (W.D. Mich. Nov. 21, 2012).
  101. Schwartz v. Mulhall, 2011 WL 10989741 (N.Y. Sup. April 12, 2011), summary judgment granted against all claims involving penile prosthesis.  Claims were indistinguishable from Riegel.  No parallel claim mentioned.
  102. Godfrey v. Advanced Neuromodulation Systems, Inc., 2011 WL 7768092 (W.D. La. April 4, 2011), summary judgment granted against all claims involving implantable pulse generator.  A manufacturing defect claim predicated on violation of FDA regulations would not have been preempted, but plaintiff alleged only deviations from the manufacturer’s own standards, and the latter claim is preempted.  Design and express warranty claims are preempted.
  103. Burgos v. Satiety, Inc., 2011 WL 1327684 (E.D.N.Y. April 5, 2011), motion to dismiss granted against most claims involving IDE stomach stapling device.  Negligent manufacturing claim is dismissed as it does not allege a parallel violation claim.  Regulatory claim involving record-keeping fails because plaintiff claims injury from the device, not from faulty records.  Vague allegations of failure to comply with IDE survive motion to dismiss and will be the subject of “cabined” discovery.  Summary judgment (2013 WL 801729) later granted against remaining claims, see below.
  104. Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. April 18, 2011), motion to dismiss granted against all but two claims involving hip implant.  Manufacturing-based parallel claim survived preemption because an FDA warning letter specified the nature of the claimed violation.  Failure to warn and failure to report claims are preempted.  Information dating from after the plaintiff’s surgery could have no plausible causal effect.  Claims concerning failure to identify and correct device problems are preempted.  Claims concerning failure to control a nonconforming product are preempted.  Claims alleging failure to develop practices and procedures are preempted.  Express warranty claims based upon statements beyond what the FDA required are not preempted.  Other express warranty claims are dismissed either as preempted or as inadequately pled.  Implied warranty claims escape preemption only to the extent they incorporate unpreempted manufacturing claims, but are barred by the statute of limitations.
  105. Kinetic Co. v. Medtronic, Inc., 2011 WL 1485601, slip op. (D. Minn. April 19, 2011), motion for judgment on the pleadings granted against all but one claim brought by third-party payer concerning recalled implantable cardiac defibrillator.  Express warranty and consumer fraud claims are preempted.  Allegations of misrepresentations to the FDA are preempted private attempts to enforce the FDCA.  Having not pleaded any warning-related claims that come close to surviving preemption, plaintiff is not entitled to discovery “to fish for claims of which it is not aware.”  Claim based on alleged promise to pay for certain expenses has nothing to do with the FDA and is not preempted.
  106. Llado-Carreno v. Guidant Corp., 2011 WL 6223409 (S.D. Fla. May 16, 2011), motion to dismiss granted in case involving an implantable cardiac defibrillator.  A conclusory violation claim cannot defeat preemption.  Any violation claim must state specifically what regulation was violated.
  107. Walsh v. Abbott Vascular, 2011 WL 2038572 (E.D. Cal. May 23, 2011), summary judgment denied in case involving a perclose device.  Defendant failed to establish that the Class III device was in fact the one used in the plaintiff’s surgery.
  108. Wilhite v. Howmedica Osteonics Corp., 833 F. Supp.2d 753 (N.D. Ohio June 20, 2011), summary judgment granted against all claims in case involving hip implant.  The complaint does not contain parallel violation requirements.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.
  109. DeLeon v. Johnson & Johnson, 2011 WL 2618957 (S.D. Tex. July 1, 2011), motion to dismiss granted against all claims in case involving an artificial spinal disc.  No parallel violation claim asserted.
  110. Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694  (W.D. Tenn. Aug. 4, 2011), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant. Claims based on:  (1) failure to submit PMA, (2) failure to identify a change in a report to the FDA, and (3) adulteration based on (1) and (2)  are preempted.  PMA approval and reporting requirements are administrative, not safety, requirements.  Failure to submit claims are disguised fraud on the FDA claims.  Claims of deviation from PMA supplement manufacturing/design requirements and failure to test a modified device are not preempted.  All other GMP claims are too vague and general to support a parallel neglilgence per se claims.
  111. Norton v. Independence Technology, LLC, 2011 WL 3584491 (E.D. Cal. Aug. 15, 2011), motion to dismiss granted against all claims in case involving a motorized, stair-climbing wheelchair.  No parallel violation claim asserted.
  112. Austin v. Medtronic, Inc., 2011 WL 13228412 (N.D. Tex. Aug. 18, 2011),motion to dismiss granted against all claims in case involving pain pump.  No parallel claim pleaded.  No entitlement to discovery.
  113. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011), motion to dismiss technically denied due to plaintiff’s request to amend complaint.  All claims, including express and implied warranty, as pleaded are preempted.  A conclusory violation claim cannot defeat preemption.  Any violation claim must state specifically what regulation was violated, how the violation occurred, and how the violation was causal.  Rejecting Hofts.  A negligence per se claim that merely alleges an FDCA violation is an impliedly preempted private right of action.  A parallel claim cannot be based on the learned intermediary rule, since the rule’s duties are not identical to FDA regulations, and are thus not “genuinely equivalent.”  FDA-approved statements cannot serve as a basis for breach of express warranty or fraud.  An unjust enrichment claim contingent upon preempted claims is likewise preempted.
  114. Horn v. Boston Scientific Neuromodulation Corp., 2011 WL 3893812 (S.D. Ga. Aug. 26, 2011), summary judgment granted against all but one claim involving spinal cord stimulator.  Implied warranty is preempted.  Plaintiff’s negligence per se claim is preempted because it only alleges non-specific violations of broad, generic quality system regulations.  An express warranty claim based on a promise of a five-year battery life, was not preempted.  That promise is not a preempted general promise of safety.
  115. Hanna v. Kaiser Foundation Hospitals, 2011 WL 10621777 (Cal Super. Sept. 13, 2011), demurrer sustained against all claims involving unstated device.  No parallel claims asserted.  Leave to amend parallel claims permitted
  116. Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011), motion to dismiss granted against all claims involving penile prosthesis.  Preemption under Riegel includes devices approved under product development protocols.  No FDCA violation claim alleged.
  117. Haynes v. Cyberonics, Inc., 2011 WL  903238 (N.D. Ga. Sept. 6, 2011), summary judgment granted agains all claims, including an express warranty claim, involving vagal nerve stimulator.   Plaintiff did not have evidence of any violation of FDA regulations that could serve as the basis of a parallel claim.
  118. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011), motion to dismiss granted against all claims involving hip implant.  No parallel violation claims asserted in the original complaint.  Leave to amend denied.  Amended violation claims were generic and did not specify what federal regulations were violated, or how.  Rejecting Hofts (plaintiff lifted his amended allegations verbatim from Hofts).  Plaintiff’s amended express warranty claim, asserting generalized safety promises, was also preempted.
  119. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011), motion to dismiss granted against all claims involving hip implant. Plaintiff failed to plead what FDA requirements were violated, or how.  General allegations about FDA “warnings” were insufficient.
  120. Tierney v. AGA Medical Corp., 2011 WL 7400469, slip op. (D. Neb. Nov. 18, 2011), motion to dismiss granted against all claims involving septal occluder.  FDA documents concerning the device are subject to judicial notice.  Claims alleging an allergy to an FDA-approved ingredient are preempted.  Plaintiff will be permitted to amend to allege factually supported violation claims concerning design or manufacture.  Plaintiff is not entitled to discovery beyond publicly available documents.  Motion to amend denied, 2012 WL 395545 (D. Neb. Feb. 7, 2012), plaintiff belatedly pleaded an amended failure to report claim that has nothing to do with the facts of his injury.
  121. Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443 (E.D. Pa. Nov. 29, 2011), motion for summary judgment granted against all claims involving an insulin delivery system, except express warranty.  The entire system underwent PMA or a PMA supplement.  Preemption relates to a device as a whole, not its component parts.  A recall of a related, but different product, does not affect preemption.  Plaintiff has no evidence of violations of FDA manufacturing, doctor’s prescription, or warning requirements.  A plaintiff who had not yet been implanted with a device when it was recalled, and who received FDA-approved post-recall warnings, was not within the scope of the recall.
  122. Bush v. Thoratec Corp., 837 F. Supp.2d 603 (E.D. La. Nov. 29, 2011), motion to dismiss granted (with leave to amend) against all claims involving a ventricular assist system.  The limited savings clause in §360h(d) does not defeat express preemption under §360k.  An attempted parallel claim that the defendant’s failure to report to the FDA resulted in a less strict voluntary recall is preempted under Buckman because it turns upon speculation about what the FDA might have done.  Claims alleging breach of disclosure duties owed to the FDA are preempted.  Almost all remaining claims dismissed, 2012 WL 2513669 (E.D. La. June 28, 2012), see below.
  123. Haile v. Kaiser Permanente Medical Group, 2011 WL 13151488 (Cal.Super. Nov. 29, 2011), demurrer granted against all claims involving implantable defibrillator.  No parallel claim pleaded.
  124. Callaway v. American Medical Systems, Inc., 2011 WL 7724268 (Mag. W.D. La. Dec. 8, 2011), adopted, 2012 WL 1354573 (W.D. La. Jan. 24, 2012), motion to dismiss granted against all claims involving a penile prosthesis.  The complaint is utterly devoid of factual content suggesting an unpreempted claim.
  125. Erickson v. Boston Scientific Corp., 846 F. Supp.2d 1085 (C.D. Cal. Dec. 12, 2011), judgment on the pleadings granted against all claims involving several pacemakers.  PMA and product development protocol supplements are equivalent to PMA and are preemptive.  Parallel violation claims must allege specifically what was violated.  A product recall does not vitiate preemption.
  126. Duggan v. Medtronic, Inc., 840 F. Supp.2d 466 (D. Mass. Jan. 10, 2012), summary judgment granted against all claims involving insulin delivery system.  The entire system underwent PMA or a PMA supplement.  Preemption relates to a device as a whole, not its component parts.  Preemption is governed by the scope of the FDA’s approval letter, not reassessment of the PMA.
  127. Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. Jan. 25, 2012), affirming grant of summary judgment on all claims in action involving spinal pain pump.  The claimed violation did not involve any aspecct of the device that was mandatory.  The only mechanism for creating a binding performance requirement is through creation of an FDA performance standard.  Treating non-binding standards as if they were binding creates a different standard and is therefore preempted.   Affirming 2010 WL 4822135 (S.D.W. Va. Nov. 24, 2010).
  128. Gillman v. Boston Scientific Corp., 2012 WL 892239 (Mag. D. Or. Jan. 27, 2012), approved, 2012 WL 882788 (D. Or. March 13, 2012), motion to dismiss granted against most claims involving spinal cord stimulator.  No parallel violation claim is alleged.  Negligent misreprestentation that there were trained doctors available in the state to which plaintiff was moving did not involve an FDA-approved statement and escaped preemption.  However, there was no special relationship to support that claim.
  129. Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. Jan. 31, 2012), affirming in part and reversing in part grant of motion to dismiss on all claims in a knee replacement case.  PMA approval is a legal conclusion and should not be taken as true on a motion to dismiss.  Judicial notice of PMA status from publicly available FDA documents is proper.  The entire device system was PMA approved, not just some components.  Plaintiff successfully stated a parallel claim based on alleged FDCA manufacturing violations that paralleled state manufacturing defect claims.  Plaintiff alleged what FDA standards were violated, that the violation affected the device actually implanted, specifically alleged the violation, and alleged how the violation could have caused the particular injury that the plaintiff suffered.  The preliminary nature of an FDA warning letter did not matter for purposes of pleading.  A formal finding by the FDA is not a prerequisite.  The general nature of some FDA regulations becomes specific when the particular PMA is approved.  A claim can be based on a manufacturer’s failed to satisfy a standard required by the FDA in its approval of the PMA for the device.  Plaintiff cannot make a claim based on a manufacturer’s failure to do something different than what the FDA approved.  Since the FDA found a violation, there is little chance that litigation would produce a different reading of the standard than the FDA.  A FDA violation based negligence claim is not a purely FDCA-based claim violating Buckman where state law provides an equivalent manufacturing defect theory.  Even if negligence per se is not available, the violation could be evidence of simple negligence.  The manufacturing violation-based claim survives whether sounding in strict liability, negligence, or warranty.  All warning and “marketing” claims are preempted.  Express warranty claims are preempted.  Affirming and reversing 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010).
  130. Viserta v. St. Jude Medical, 2012 WL 667814 (D.S.C. Feb. 29, 2012), motion to dismiss granted against all claims involving cardiac defibrillator leads.  Plaintiff’s attempt to plead a parallel manufacturing claim fails for lack of any specificity as to what standards were violated how.  Adverse event reports, are not linked to anything relevant to this plaintiff.
  131. Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. March 14, 2012), motion to dismiss granted against all claims involving artificial hip prosthesis.  A product recall is not an admission of regulatory violations.  Negligence and res ipsa claims are preempted.  Violations of FDA regulations are too vaguely pleaded.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Warranty claims based on FDA-approved labeling are preempted.  Non-device specific good manufacturing practices relied on by plaintiff are too vague to serve as a parallel claim.
  132. Cameron v. Boston Scientific Corp., 2012 WL 1592535 (N.D. Ohio April 12, 2012), summary judgment granted against all claims involving thermal ablation device. Plaintiffs have no evidence to support any parallel claim.  Adopted 2012 WL 1592532 (N.D. Ohio May 4, 2012).
  133. Cooley v. Medtronic, Inc., 2012 WL 1380265 (E.D. Ky. April 20, 2012), motion to dismiss granted against all claims involving implantable cardiac defibrillator, including express warranty, fraud, and emotional distress.  Plaintiff did not assert any parallel claims.
  134. Hinkel v. St. Jude Medical, Inc., 869 F. Supp.2d 739 (E.D. La. April 23, 2012), summary judgment granted against all claims involving an implantable spinal pulse generator, including express warranty under LPLA.  FDA standards are not the same as the LPLA.
  135. Lowe v. Medtronic, Inc., 2012 WL 3656468, slip op. (C.D. Cal. May 9, 2012), motion to dismiss granted against all claims involving implantable difibrillator.  Failure to report claims are impliedly preempted by Buckman.  Parallel claims inadequately preempted due to failure to plead the violation or causation with specificity.  A warning letter and a recall do not establish a parallel claim.
  136. Cline v. Advanced Neuromodulation Systems, 914 F. Supp.2d 1290 (N.D. Ga. June 15, 2012), motion to dismiss granted in part and denied in part in case involving implantable pulse generator.  An express warranty of battery life, beyond the FDA-approved labeling, was not preempted.  Vague allegations of violations of good manufacturing practices were inadequate to plead a parallel claim.  Motion to amend allowed, 2012 WL 7009687 (N.D. Ga. Nov. 7, 2012), see below.  Most claims preempted, 2014 U.S. Dist. Lexis 56669 (N.D. Ga. March 31, 2014), see below.
  137. Reuter v. Medtronic, Inc., 2012 WL 3635955, slip op. (New Jersey Super. Law. Div. June 18, 2012), summary judgment granted against all claims involving a pacemaker.  No parallel claim alleged.  Motion to amend to add negligence claim based on presence of a technician denied, since the technician could not advise the physician on medical procedures.
  138. Bush v. Thoratec Corp., 2012 WL 2513669 (E.D. La. June 28, 2012), motion to dismiss granted against all claims involving a heart pump except post-sale duty to warn-based claim predicated on non-compliance with FDA regulation regarding contents of recall letter.  Vague regulations can support violation claims at the pleading stage.  A prior FDA finding of violation is not required. Whether the claimed violation is genuinely parallel can only be decided on summary judgment.
  139. Hammarlund v. Stryker Corp., 2012 WL 12868486 (S.D. Cal. July 16, 2012), motion to dismiss granted against all claims involving hip implant.  No parallel claim sufficiently pleaded.  First amended complaint dismissed, 2013 WL 12095239 (S.D. Cal. March 20, 2013), plaintiff failed to allege that recall included her device.  Second amended complaint allowed in part, 2014 WL 12515349 (S.D. Cal. Jan. 9, 2014), plaintiff could assert an unpreempted failure to report claim.
  140. Phillips v. Medtronic, Inc., 2012 WL 3641487, slip op. (Mass. Super. July 10, 2012), motion to dismiss granted against all claims involving spinal pain pump.  Alleged FDA regulatory violations could not be causal because they did not involve risk of the injuries plaintiff alleged.  While negligent pharmacovigilence claims paralleling federal regulations are not expressly preempted, they are impliedly preempted under Buckman.
  141. Steiden v. Genzyme Biosurgery, 2012 WL 2923225 (W.D. Ky. July 17, 2012), motion to dismiss granted against all product liability claims involving Synvisc-One but denies as to parallel claim, allegations of adulteration, supported by immediate injury were sufficiently specific to state an unpreempted claim.  Plaintiff did not have to state specifically how FDA regulations were violated.
  142. Weston v. Kim’s Dollar Store, 399 S.C. 303, 731 S.E.2d 864 (S.C. Aug. 8, 2012), grant of partial summary judgment affirmed in litigation concerning colored contact lenses.  Express preemption provisions should be construed broadly.  Colored contact lenses are PMA medical devices.   All claims based on warning, labeling, design, marketing, or misbranding were properly dismissed as preempted.  Defendant conceded that a negligent manufacturing claim may survive preemption as a parallel claim.  Affirming as modified 684 S.E.2d 769 (S.C. App. July 15, 2009).
  143. Cornett v. Johnson & Johnson, 211 N.J. 362, 48 A.3d 1041 (N.J. Aug. 9, 2012), grant of motion to dismiss affirmed against most, but not all, claims involving a drug eluting stent.  Failure to warn claims are preempted.  Fraud on the FDA claims concerning the approval process are preempted, as are claims that require proof of fraud on the agency.  Off-label use did not go through the FDA’s regulatory process, therefore failure to warn claims not involving agency fraud that pertain to off-label uses are not preempted.  Warning claims based on legal (safe harbor) off-label promotion are preempted.  Express warranty claims survive preemption to the extent based on statements not subject to FDA approval.  All other express warranty claims are preempted.  Affirming as modified, 998 A.2d 543 (N.J. Super. A.D. July 23, 2010).
  144. Mayen v. Tigges, 2012 WL 3553378 (N.Y. Sup. Aug. 17, 2012) (in table at 36 Misc.3d 1231(A), 959 N.Y.S.2d 90), motion to dismiss granted against all claims involving knee implant, including express and implied warranty.  Request for discovery denied.
  145. Ali v. Allergan United States, 2012 WL 3692396 (E.D. Va. Aug. 23, 2012), motion to dismiss granted against all claims involving stomach band, including express and implied warranty.  Plaintiff must allege what federal regulations were violated, and how the violation caused injury.  Plaintiff must allege Initial failure of PMA did not establish anything.  Recall was non-causal unless the device in question was recalled due to the risk at issue.  Disagrees with Hofts.  Request for discovery denied.  Currently on appeal.
  146. Delfino v. Medtronic, Inc., 2012 WL 12925029 (Minn. Dist. Aug. 29, 2012), motion to dismiss granted against all claims involving an implanted defibrillator.  Parallel claims insufficiently pleaded.  A recall does not infer a violation.
  147. Hawkins v. Medtronic, Inc., 909 F. Supp.2d 901 (S.D. Ohio Sept. 24, 2012), motion to dismiss granted in part and denied in part in case involving implantable pulse generator.  Vague allegations of FDCA violations in design, warning, manufacturing, and implied warranty cannot be held entirely preempted on motion to dismiss.  Ignoring TwIqbal pleading standards in favor or earlier “precise contours” language in Lohr.  Negligent handling claims have no FDCA equivalent and are dismissed as preempted.  Express warranty not preempted because it does not require finding that any FDA-approved statements are untrue.  Fraud claims would require finding FDA-approved statements are untrue and are preempted.  Failure to report claims are preempted by BuckmanInterlocutory certification denied, 2012 WL 6059361 (S.D. Ohio Dec. 6, 2012),
  148. McClelland v. Medtronic, Inc., 2012 WL 5077401, slip op. (M.D. Fla. Sept. 27, 2012), motion to dismiss granted against all claims involving an implanted pacemaker.  Documents in the FDA public record are judicially noticeable.  Under Florida law, the violation of a statute can only give rise to civil liability if the statute indicates an intention to create a private cause of action.  The FDCA explicitly bars private rights of action.  All non-parallel violation claims are preempted under Riegel.  There is no FDCA requirement that a manufacturer contact doctors or patients directly, without FDA involvement, concerning alleged device defects.  There is no parallel in Florida common law to an FDCA violation claim, so parallel violation claims do not state a claim under state law.  Claims based onf FDCA disclosure requirements are impliedly preempted.  Renewed motion granted (see below).
  149. Killen v. Stryker Spine, 2012 WL 4482371 (Mag. E.D. Pa. Sept. 28, 2012), motion to dismiss granted in part and denied in part in case involving an investigational cervical intervertebral device.  Preemption under Riegel applies to IDE devices.  Plaintiff pleaded parallel violation claims as well as could be expected without discovery.  The express warranty claim is preempted as pleaded but may be amended to specify any non-FDA-approved statement upon which the claim is based.  Fraud claims are preempted to the extent they involve FDA-approved statements, but not as to follow-up medical care.  Adopted 2012 WL 4498865 (W.D. Pa. Sept. 28, 2012).
  150. Tillman v. Smith & Nephew, Inc., 2012 WL 6681698 (N.D. Ill. Nov. 1, 2012).  Taking judicial notice of FDA PMA for defendant’s hip resurfacing system.  Plaintiff did not plead any parallel claims, only preempted claims concerning “defects.”  Plaintiff must replead facts establishing a parallel claim or suffer dismissal.
  151. Cline v. Advanced Neuromodulation Systems, 921 F. Supp.2d 1374 (N.D. Ga. Nov. 7, 2012), motion to amend complaint to add parallel claim granted in case involving spial cord stimulator.  Warning letter provided specific regulatory violations and causation was adequately pled.  Unidentified regulations or vague GMPS would not have been sufficient.  The claim is not impliedly preempted because it parallels a manufacturing defect claim.  Most claims preempted, 2014 U.S. Dist. Lexis 56669 (N.D. Ga. March 31, 2014) see below.
  152. Hesik v. Boston Scientific Corp., 2012 WL 12897111 (D.S.C. Nov. 16, 2012), motion to dismiss denied in action involving defibrillator.  Only an unpreempted parallel claim is alleged, and it is sufficiently pleaded   Later decision see below, 2014 WL 5644699.
  153. Raborn v. Albea, 2012 WL 6600475 (La. Dist. Dec. 7, 2012), exception of no cause of action (motion to dismiss?) granted against all claims involving bone growth stimulator.  Claims involving alleged off-label use are preempted as imposing different requirements than the FDA.  Claims involving off-label promotion are also preempted as private enforcement under Buckman.
  154. Littlebear v. Advanced Bionics, 896 F. Supp.2d 1085 (N.D. Okla. Dec. 19, 2012), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Claims that defendant did not meet a specific moisture level are preempted because the PMA did not impose such a requirement.  A GMP regulation to evaluate suppliers is too vague to support a parallel claim.  Fraud and consumer protection claims are preempted; there is no FDA regulation requiring disclosure.  Failure to obtain supplemental PMA claims are impliedly preempted under Buckman.  This is not a safety requirement and there is no private right to enforce the FDCA.  Claims alleging deviation from PMA requirements are not preempted.  Negligence per se claims are attempts to enforce the FDCA and are preempted.
  155. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc),  motion to dismiss affirmed in part and reversed in part in case involving PMA pain pump.  All claims not involving “parallel” violations of the FDCA were properly held preempted.  Presumption against preemption applies.  A claim for failure to warn a third party (the FDA) about reportable adverse events is an unpreempted parallel claim under Riegel. Since the claim does not involve the FDA’s pre-market approval process it is preempted under Buckman.  Reversing 2010 WL 4483970 (N.D. Ariz. Nov. 9, 2010).
  156. Sons v. Medtronic Inc., 915 F. Supp.2d 776 (W.D. La. Jan. 14, 2013),  motion to dismiss granted against all claims in case involving pacemaker.   Claims for design defect, manufacturing defect, failure to warn, negligence, and strict liability are preempted.  No parallel claim alleged.  Even if a claim for failure to train isn’t preempted, it does not state a claim because the manufacturer is not responsible for the practice of medicine.
  157. Simmons v. Boston Scientific Corp., 2013 WL 12130261 (C.D. Cal. Jan. 14, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  Vague GMPs cannot be basis of a parallel claim.  Failure to report claim improperly pleaded.  Failure to recall claim preempted where FDA never ordered recall.  Negligence per se preempted.
  158. Desai v. Sorin CRM USA, Inc., 2013 WL 163298 (D.N.J. Jan. 15, 2013), motion to dismiss granted against all claims in case involving cardiac defibrillator.  Judicial notice may be taken of the FDA website’s list of PMA approvals.  Claims for negligence, defective design, and failure to warn are preempted.  Allegations of deviations from FDA standards for design and manufacture are conclusory.  A failure does not establish an FDCA violation.  Discovery may not be based on vague allegations.
  159. Kallal v. Ciba Vision Corp., 2013 WL 328985 (N.D. Ill. Jan. 28, 2013), summary judgment granted in case involving contact lenses.  Lenses were not subject to recall.  Fact of adverse reaction does not establish a defect or an FDCA violation.  Plaintiff failed to establish a violation of an FDA requirement, as opposed to an internal corporate specification.
  160. Thomas v. Alcon Laboratories, 116 F. Supp.3d 1361 (N.D. Ga. Jan. 29, 2013), motion to dismiss granted against all claims in case involving contact lens.  FDA PMA may be established by judicial notice.  Express and implied warranty claims based on general safety allegations are preempted.  Violations of vague GMPs cannot be parallel claims due to differing interpretations of such regulations.  The parallel claim was also inadequately causally related to the plaintiff’s device.
  161. Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. Feb. 6, 2013), motion to dismiss granted against all claims in case involving bone growth stimulator.  Off-label use does not limit express preemption under Riegel.  Alleged illegal promotion does not make all the plaintiff’s claims “parallel.”  Fraudulent inducement, misrepresentation, constructive fraud, and negligence claims are expressly preempted to the extent they seek changes to device labeling, marketing, design, or manufacturing.  These claims are impliedly preempted under Buckman to the extent they depend on alleged off-label promotion.  Off-label use and promotion are inherently FDCA-based concepts, thus tort claims based thereon are in substance claims violating the FDCA, which the statute forbids.  Allegations of false statements to physicians, whether or not involving off-label promotion, are inadequately pleaded.  Failure to warn, design defect, and negligence claims are preempted.  Warranty claims involving journal articles and opinion leaders allege that the product was not safe or effective, and are preempted.  Discovery is unnecessary.  Affirmed by 784 F.3d 1335 below.
  162. Gale v. Smith & Nephew, 989 F. Supp.2d 243 (S.D.N.Y. Feb. 13, 2013), motion to dismiss granted in part and denied in part in case involving hip resurfacing system.  Design, warning and manufacturing defect claims preempted.  Express and implied warranty claims preempted.  Fraud on the FDA claims brought as a consumer fraud claim are probably preempted, but are not pleaded sufficiently to state a claim.  Post sale duty to warn claim preempted.  Negligent coduct of recall claim not preempted.  Failure to comply with PMA reporting requirements not preempted.  Ruling on amended complaint, see below.
  163. Lamere v. St. Jude Medical, Inc., 827 N.W.2d 782 (Minn. App. Feb 19, 2013), summary judgment affirmed in case involving mechanical heart valve.  Allegedly violated GMPs were too vague to support a parallel manufacturing defect claim.  Plaintiff did not indicate how alleged violations were causal.  A manufacturing defect claim unrelated to any alleged FDCA violation was preempted.  Affirming, 2012 WL 3635953, slip op. (Minn. Dist. Jan. 18, 2012) and 2011 WL 10550518 (Minn. Dist. Feb. 7, 2011).
  164. Anderson v. Boston Scientific Corp., 2013 WL 632379 (S.D. Ohio Feb. 20, 2013), motion to dismiss granted in case involving spinal cord stimulator.  All claims are based on state law defects, not any violation of the FDCA.  Negligence claim concerning actios of sales representative fails to plausibly allege causation.
  165. Gray v. Stryker Corp., 2013 WL 633120 (S.D. Ind. Feb. 20, 2013), motion to dismiss denied in case involving hip implant.  Judicial notice may be taken of the FDA approvals on the agency’s website.  Manufacturing defect claims are only preempted if the defendant complied with FDA requirements.  Plaintiff is suing about the same recalled device as in Bausch and has adequately pleaded violation claims of a similar nature.  Pleading the specific regulations violated is not required.
  166. Burgos v. Satiety, Inc., 2013 WL 801729 (E.D.N.Y. March 5, 2013), motion for summary judgment granted against remaining manufacturing defect claim in case involving investigational stomach stapling system. Plaintiff lacked any evidence of how the device violated FDA regulations.  In the absence of any evidence of a violation, plaintiff could not create a question of fact from a spoliation inference, even if such an inference were proper.  A settlement offer is not evidence of a violation.  A product-related injury does not support an inference of a violation.
  167. Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670 (W.D. Ky. March 8, 2013), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Failure to obtain PMA supplement did not render either the device or the component unapproved.  Negligence per se failed on state law grounds.  Fraud, fraudulent omission, and misrepresentation either sought preempted label changes or involved the FDA and were preempeted under Buckman. A design claim based on deviation from the relevant supplemental PMA survived preemption, but other design claims were preempted.  Failure to obtain supplemental PMA claims are impliedly preempted under Buckman.  A GMP regulation requiring testing under actual or simulated use conditions was sufficiently specific to survive preemption as a parallel claim; all other GMPs were too vague.  Claims that defendant should have conducted life cycle testing are preempted because the PMA did not impose such a requirement.  Other Negligence claims follow the strict liability analysis.
  168. Smith v. St. Jude Medical Cardiac Rhythm Management Division, 2013 WL 1104427 (D. Md. March 13, 2013), motion to dismiss granted in case involving pacemaker.  All claims, including express and implied warranties, were preempted or inadequately pleaded.  Parallel claims were inadequately pleaded and unlike Bausch did not allege any action taken by the FDA.
  169. Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, slip op. (D.N.J. March 18, 2013), summary judgment granted against all claims in case involving PMA knee implant.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Parallel violation claim not pleaded with requisite particularity.  Preemption requires specific requirements and cannot be defeated with vague allegations of FDCA violations.  Express warranty preempted because it involves FDA-approved statements.  Fraud is subsumed by state product liability statute.  Affirmed 2014 U.S. App. Lexis 718 (see below).
  170. Lasalle v. Pappas, 2013 WL 1130726 (E.D. La. March 18, 2013), motion to dismiss granted in case involving unidentified device.  All of plaintiff’s claims are not only preempted, but also fail under TwIqbal.  Plaintiff is not entitled to discovery to look for possible “parallel” claims.
  171. Kubicki v. Medtronic, Inc., 2013 WL 1739580 (D.D.C. March 21, 2013), motion to dismiss granted in part and denied in part in case involving insulin pain pump.  Fraud, consumer fraud, and misrepresentation claims are insufficiently pleaded.  Mixed in with preempted claims are various allegations of FDCA violations.  Because these claims may reasonably be understood to assert violations, they survive preemption.  Nothing more is required at the pleading stage.  Express warranty claims may also survive preemption to the extent they are based on advertising or some other non-FDA-approved communication.
  172. Simmons v. Boston Scientific Corp., 2013 WL 1207421, slip op. (C.D. Cal. March 25, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  All non-parallel claims preempted.  Parallel claims were inadequately pleaded.  Plaintiff pleaded no facts supporting a Stengel failure to warn the FDA claim.  No deviations from FDA-approved design were pleaded.  GMPs were too generic to support manufacturing-related violation claims.  A product recall does not establish a violation.  Since this was plaintiff’s third amendment, no further leave to amend was appropriate.  Defendant was awarded costs.
  173. Stokes v. I-Flow Corp., 2013 WL 1715427 (M.D. Fla. April 8, 2013), motion to dismiss granted against all claims in case involving pain pump.  A claim that a defendant failed to comply with the FDA’s rejection of a marketing use is an attempted private FDCA cause of action under Buckman.  Design and warning claims differ from FDA requirements and are preempted.  Plaintiff’s negligence claim does not parallel any FDA regulation.  Reporting obligations are owed to the FDA, not to the medical community.
  174. Messner v. Medtronic, Inc., 2013 WL 1655218 (N.Y. Sup. April 9, 2013) (in table at 39 Misc.3d 1213(A), 975 N.Y.S.2d 367), motion to dismiss granted in part and denied in part in case involving porcine heart valve.  Claims based on defective design, negligence, implied warranty improper labeling preempted.  Parallel claims based on improper manufacturing, including related warning and express warranty claims, not preempted.
  175. Lipscomb v. Depuy Orthopaedics, Inc., 2013 WL 12136500 (M.D.N.C. April 11, 2013), motion for summary judgment granted against all claims in case involving knee implant.  No parallel claims asserted.
  176. Elmore v. Smith & Nephew Inc., 2013 WL 1707956 (N.D. Ill. April 19, 2013), motion to dismiss denied in case involving hip implant.  Only parallel claims were pleaded.  Defect claims based on failure to follow GMPs are parallel.  Common-law claims based on FDA violations are not preempted so long as the same conduct would result in independent liability.  Reconsideration denied, 2013 U.S. Dist. Lexis 101085 (N.D. Ill. July 1, 2013)
  177. Knoppel v. St. Jude Medical, Inc., 2013 WL 3803612 (C.D. Cal. May 7, 2013), motion to dismiss granted against all claims, predominantly design claims, in case involving cardiac defibrillator.  All claims that require a different design or manufacturing process than what the FDA approved are preempted.  No parallel claims alleged.
  178. Kaiser v. Depuy Spine, Inc., 944 F. Supp.2d 1187 (M.D. Fla. May 14, 2013), motion to dismiss granted against all claims in case involving artificial spinal disc.  Allegations that the defendant failed to design, test, manufacture, market, sell, promote, label, and/or distribute the device in accordance with FDA requirements failed under TwIqbal.  Plaintiff failed to allege that the defendant violated any applicable FDA performance standard; the violation plaintiff claimed was not an FDA performance standard.  State law does not allow pursuit of parallel claims based on FDA violations.
  179. McClelland v. Medtronic, Inc., 944 F. Supp.2d 1193 (M.D. Fla. May 16, 2013), motion to dismiss granted against the only remaining claim in case involving an implanted pacemaker. Failure to report adverse event claims are preempted. To the extent the alleged duty is owed to the device user, it is expressly preempted. There is no FDCA duty to inform patients of adverse events. To the extent the alleged duty is owed to the FDA, it is preempted as private FDCA enforcement. Prior decision discussed above.
  180. Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp.2d 1006 (D. Minn. June 18, 2013), motion to amend denied in large part in case involving pacemaker leads.  Failure to report adverse event claims are preempted.  A state law post-sale duty to warn product users is not the same as a duty to report adverse events to the FDA.  FDA adverse event reports are not necessarily public and available to users.  No state recognizes a tort cause of action for failure to report to a federal agency.  Because there is no recognized state-law parallel, the reporting claims are also preempted under Buckman as improper private FDCA causes of action.  An express warranty of “safety” is preempted because no non-FDA-approved labeling statements are specified.  Certain factual amendments may not be futile because their causal relevance to the plaintiffs’ injuries cannot be determined on the pleadings.
  181. Lederman v. Howmedica Osteonics Corp., 950 F. Supp.2d 1246 (M.D. Fla. June 19, 2013), motion to dismiss granted against against all claims in case involving hip implant.  Manufacturing defect claims are preempted unless alleged as parallel claims.  Plaintiff’s parallel claim pleading is insufficient.  He fails to explain how FDA warning letters relate to his device, manufactured three years before the letter.  Plaintiff must specify how the device violated a particular FDA regulation.  Plaintiff has leave to amend.
  182. Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. June 24, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator. Allegations concerning off-label promotion and use are not parallel to any FDA regulation, but rather are improper private attempts to enforce the FDCA.  Plaintiff given leave to amend.
  183. Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592 (D. Vt. June 25, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  All non-FDA-related claims are preempted.  Allegations that fail to identify the alleged regulatory violations cannot defeat preemption.  Allegations solely concerning off-label promotion and use are not parallel claims because there is no FDA regulation barring such activity.  Aff’d mem.No. 14-3491, 616 F. Appx. 433 (2d Cir. June 9, 2015).
  184. McBride v. Medtronic, Inc., 2013 WL 3491085 (W.D. La. July 10, 2013), motion to dismiss granted against against all claims in case involving an infusion pump.  Taking judicial notice of FDA PMA.  A manufacturing defect claim asserting deviation from the manufacturer’s specifications is not a parallel claim and is preempted.  Under the exclusive state statute, claims for negligence per se are subsumed.  Therefore, there is no state-law basis for asserting parallel claims.  All failure to warn claims are preempted.
  185. Gavin v. Medtronic, Inc., 2013 WL 3791612, slip op. (E.D. La. July 19, 2013),  motion to dismiss granted in part and denied in part in case involving an infusion pump.  Preemption applies to off-label uses.  Preemption depends on FDA approval, not how the device was ultimately used.  PMA preemption applies to off-label use of a component of a product system separately from the rest of the system.  The component remains PMA approved.  Claims that defendant should have warned about off-label uses vary from FDA approved warnings and are preempted.  A claim based on failure to report adverse events survives express preemption.  Various causes of action dismissed under exclusive state statute.  Express warranty claims attacking FDA-approved labeling are preempted, and nothing else is pleaded.  Implied warranty claims are preempted.  State law does not recognize claims based on violations of federal regulations.  Off-label use and promotion are purely FDA-related concepts, so claims based on such allegations are impliedly preempted under Buckman.
  186. Eggerling v. Advanced Bionics, L.L.C., 958 F. Supp.2d 1029 (N.D. Iowa July 24, 2013), summary judgment granted in part and denied in part in case involving cochlear ear device.  Preemption is not an appropriate subject for collateral estoppel.  Failure to obtain PMA supplement did not render either the device or the component unapproved.  Parallel claims based on broad administrative GMPs are preempted.  Design and manufacturing claims based on deviation from the relevant supplemental PMA is not preempted.  A GMP regulation requiring testing under actual or simulated use conditions was sufficiently specific to survive preemption as a parallel claim.  Claims that defendant should have conducted life cycle testing are preempted because the PMA did not impose such a requirement.
  187. Houston v. Medtronic, Inc., 957 F. Supp.2d 1166 (C.D. Cal. July 30, 2013), motion to dismiss granted against against all claims in case involving an infusion pump.  Taking judicial notice of FDA PMA.  PMA preemption applies to off-label use of a component of a product system separately from the rest of the system. The component remains PMA approved.   Off-label use occurs “with respect to” a device, so claims concerning such use are within the scope of express preemption.  Claims concerning warnings, including post-sale warnings, about off-label use are preempted as in addition to the warnings the FDA requires.  What the FDA merely permits, state law cannot make mandatory.  Design defect claims are preempted.  Off-label use claims exist solely because of the FDA’s labeling requirements, and are therefore impliedly preempted as attempts to enforce the FDCA.  All other parallel claims do not state what was violated, and are inadequately pleaded.  Allegations of false off-label promotion would state an unpreempted parallel claim, however the claims are not pleaded with particularity under Rule 9(b).  An express waranty claim alleging false statements not constituting labeling would not be preempted, but is inadequately pleaded.  Renewed motion to dismiss granted in part and denied in part – see below.
  188. Harris v. Medtronic, Inc., 2013 WL 4011624 (Cal. Super. Aug. 1, 2013), demurrer with leave to amend granted against all claims in case involving a bone growth stimulator.  The fraud claim must be repleaded to avoid fraud on the FDA and product labeling.  Warning claims cannot be based on FDA-approved labeling.  Design defect claims cannot be based on off-label use.  PMA covers devices, not uses.
  189. Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Aug. 7, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  Claims requiring labeling about off-label use are expressly preempted.  Claims, including consumer fraud, are impliedly preempted under Buckman to the extent they depend on alleged illegal off-label promotion.  The label is an FDA concept.  All non-off-label claims would require changes to FDA-approved aspects and are expressly preempted.  Fraudulent off-label promotion claims are not preempted, but are not pleaded with particularity.
  190. Halsey v. Smith & Nephew, Inc., 2013 WL 12226936 (D. Vt. Aug. 13, 2013), motion to dismiss granted against against all claims in case involving a hip implant.  All of plaintiff’s claims impose liability in the absence of any violation of the FDCA.  Later motion 2014 WL 12717702, below.
  191. Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. Aug. 8, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  There is no state claim for off-label promotion.  Off-label promotion is not necessarily illegal; the only statutory prohibition has ceased to be effective.  Claims are impliedly preempted under Buckman to the extent they depend on alleged illegal off-label promotion.  Failure to warn, design defect, negligence, strict liability, warranty, fraud, negligence per se, and misrepresentation claims that would require changes to FDA-approved warnings or labelsare expressly preempted.  Violation claims cannot be based on information provided to the FDA.
  192. Scianneaux v. St. Jude Medical, S.C., 961 F. Supp.2d 808 (E.D. La. Aug. 19, 2013), motion to dismiss granted against against all claims in case involving an implantable cardiac defibrillator.  Taking judicial notice of documents on FDA website.  Plaintiff failed to plead an unpreempted violation claim.  A recall does not defeat preemption.
  193. Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. Aug. 21, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator.  Taking judicial notice of device labeling.  While off-label use claims can be expressly preempted, off-label promotion claims are not.  The FDA does not review off-label promotion; it is essentially unregulated.  Applying presumption against preemption.  Claims based on the fact of off-label promotion would be impliedly preempted.  Parallel claim analysis is not necessary for claims involving off-label promotion.  Negligence per se claims are preempted under Buckman.  Tort claims not concerning off-label promotion are preempted under Riegel, except for failure to report adverse events, which are not preempted.
  194. McDonald-Lerner v. Neurocare Associates, P.A., 2013 WL 7394926 (Md. Dist. Aug. 29, 2013), motion to dismiss denied in case involving a bone growth stimulator.  The FDA does not review off-label uses or statements, therefore there is no preemption of claims alleging off-label promotion.  All claims are parallel.  Truthful off-label promotion should be illegal.  Overruled by McCormick, see below.
  195. Alton v. Medtronic, Inc., 970 F. Supp.2d 1069 (D. Or. Sept. 6, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator.  Judicial notice taken of adjudicative facts in documents, including FDA documents.  Off-label promotion does not necessarily violate the FDCA, but is only evidence; disagreeing with Ramirez.  Off-label promotion does not eliminate preemption.  Fraud, negligence, and strict liability claims based on introduction of a misbranded device by virtue of off-label promotion survive both express and implied preemption.  Other warning claims that would impose additional labeling obligations are preempted.  Design defect claims are preempted.  Express warranty claims are preempted to the extent based on FDA-approved statements, but not where based on off-label statements.
  196. Gale v. Smith & Nephew, Inc., 2013 WL 9874422 (S.D.N.Y. Sept. 13, 2013), motion to dismiss amended complaint granted in part and denied in part in action involving hip prosthesis.  Manufacturing defect claim based on vague FDA GMPs preempted.  Claims that device was labeled for the wrong size parallel FDA regulations and survive.  Failure to warn physicians about adverse events is preempted, since the FDCA does not require such warnings.  Allegations of failure to report adverse events are not preempted.  See above for prior ruling.
  197. Kraushaar v. Colopoast Corp., 2013 WL 12154726 (Cal.Super. Sept. 17, 2013), demurrer overruled in action involving a penile prosthesis.  Refusing to take judicial notice of FDA documents.  Defendant failed to prove that the device was PMA approved or that it satisfied FDA specifications.
  198. Stout v. Advanced Bionics, LLC, 2013 WL 12133966 (W.D. Pa. Sept. 19, 2013), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Lack of a PMA supplement did not negate the PMA, and claim for failure to seek a supplement is barred as private FDCA enforcement.  Failure to test preempted where tests not FDA required.  Violation of vague GMPs preempted.  Negligence per se based on un-pre-approved design changes survives as a parallel claim.
  199. Suckow v. Medtronic, Inc., 971 F. Supp.2d 1042 (D. Nev. Sept. 20, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  Plaintiff failed to plead a parallel violation claim.  Supplemental PMA is preemptive.  Strict liability and express warranty claims are preempted.
  200. Bueno v. St. Jude Medical Inc., 2013 WL 12142536 (C.D. Cal. Sept. 24, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator leads.  Failure to plead the nature of injury renders causation of any parallel claim implausible.
  201. Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393 (C.D. Cal. Sept. 24, 2013), motion to dismiss granted in part and denied in part in case involving an implantable defibrillator.  Manufacturing defect and warning claims based on failure to report to FDA survive preemption.  Negligence per se survives preemption.  Reporting claim fails to allege causation.  Res ipsa claim preempted.
  202. Weber v. Allergan, Inc., 2013 WL 11310512 (D. Ariz. Sept. 25, 2013), motion to dismiss granted against all claims in case involving breast implants.  Plaintiff pleaded no parallel claims.  Reversed 621 Fed. Appx. 401 (9th Cir. Oct. 23, 2015), plaintiff should have been given a chance to plead parallel claims.
  203. McPhee v DePuy Orthopedics, Inc., 2013 WL 5462762, slip op. (W.D. Pa. Sept. 30, 2013), motion to dismiss granted against against all claims in case involving knee implant.  Plaintiffs fail to plead a parallel claim alleging manufacturing violations.  Plaintiffs fail to plead how regulations were violated.  The cited GMP regulations are too general to form the basis of a violation claim.  Implied warranty claims are preempted.  Express warranty claims are not preempted, but are insufficiently pleaded.
  204. Eidson v. Medtronic, Inc., 981 F. Supp.2d 868 (N.D. Cal. Oct. 3, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator. Judicial notice taken of documents on FDA website.  All claims challenging labeling are preempted.  Use of fewer than all components of device system did not defeat preemption.  Fraud and negligence claims based on alleged untruthful off-label promotion survive both express and implied preemption.  Warnng claim based on failure to report adverse events is not preempted, but claim is dismissed with leave to amend for failure to plead causation.  Neglligence claim alleging illegal off-label promotion is impliedly preempted as an FDCA violation claim.  See below for decision on amended claims
  205. Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. App. Oct. 11, 2013), affirming denial of summary judgment in case involving implantable cardiac defibrillator.  Plaintiff’s sole remaining claim, concerning statements made by a company technician during surgery were not preempted because it did not involve FDA-approved statements on labeling.
  206. Bradley v. Baxter Healthcare Corp., 2013 WL 5952060 (Mag. W.D.N.C. Oct. 18, 2013), adopted without separate opinion, 2013 WL 5952060 (W.D.N.C. Nov. 6, 2013) motion to dismiss granted against against all claims in case involving gelfoam.  All claims seek to change or add to federal requirements.  A general allegation of violating “good manufacturing practices” was insufficient to state a parallel claim.
  207. Chao v. Smith & Nephew, Inc., 2013 WL 6157587, slip op. (S.D. Cal. Oct. 22, 2013), summary judgment granted in part and denied in part in case brought by physician involving total hip replacement.  Design defect claim preempted.  Claim of violation of FDA training requirements for physicians is a parallel claim and not preempted, but a violation may not have occurred.
  208. Brown v. DePuy Orthopaedics, Inc., 978 F. Supp.2d 1266 (M.D. Fla. Oct. 24, 2013), motion to dismiss granted against all claims in case involving knee implant.  Warning and design claims are preempted.  A parallel claim based on an FDA warning letter fails because for lack of causal nexis, given an unexplained two-year gap between the time of the FDA inspection and the manufacture of plaintiff’s device.   The parellel claim is also impliedly preempted, as it amounts to an attempted FDCA private right of action.  There is no analogous state law action because Florida law does not permit actions to enforce FDA requirements.
  209. Cook v. Coe, 2013 WL 6154562, slip op. (Cal. Super. Nov. 18, 2013), demurrer (motion to dismiss) granted against all claims in case involving a bone growth stimulator.  Preemption is not defeated by a presumption.  Any claims that would change the FDA-approved warnings are preempted.  Claims alleging promotion of off-label uses and failure to seek a supplemental PMA are preempted as attempts to enforce the FDCA.  Misrepresentation about off-label use would not be preempted, but are inadequately pleaded.
  210. Kashani-Matts v. Medtronic, Inc., 2013 WL 6172234, slip op. (C.D. Cal. Nov. 22, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator.  All warning claims preempted.  Design defect claims preempted.  Fraud claims based on FDA-approved warnings are preempted.  Fraudulent misrepresentations in the context of off-label promotion would not be preempted, but are inadequately pleaded.  Amended complaint dismissed see below.
  211. Simon v. Smith & Nephew, Inc., 2013 WL 6244525, slip op. (S.D.N.Y. Dec. 3, 2013), motion to dismiss granted against all claims in case involving a hip replacement system.  Taking judicial notice of FDA website documents.  Claims based on a physician’s mixing components of different PMA-approved systems are preempted.  A voluntary recall does not establish a parallel violation claim.  A different product is not an alternative design.  Preemption extends to all components of a PMA system.  Implied warranty claims preempted for similar reasons.  Reconsideration  denied, 2014 WL 1257780 (March 26, 2014).
  212. Frederick v. Smith & Nephew, Inc., 2013 WL 6275644 (N.D. Ohio Dec. 4, 2013), motion to dismiss denied in case involving a hip replacement system.  The complaint does not clearly establish the PMA status of all the components allegedly used, so preemption cannot be determined at this time.
  213. Comella v. Smith & Nephew Inc., 2013 WL 6504427, slip op. (N.D. Ill. Dec. 11, 2013), motion to dismiss granted in part and denied in part in case involving a hip replacement system.  Claims that the defendant failed to advise the FDA after approval about product dangers is an unpreempted parallel claim.  Claims that the defendant failed to warn the public are preempted.  Failure to report adverse event claims are not agency fraud claims preempted under Buckman.  The claims are sufficiently pleaded under Bausch.
  214. Ledet v. Medtronic, Inc., 2013 WL 6858858, slip op. (S.D. Miss. Dec. 30, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator.  Off-label use does not affect PMA preemption because the analysis does not depend on use of the device.  Fraud claims based on labeling are expressly preempted.  Fraud and negligence claims based on off-label promotion are impliedly preempted as attempts to enforce the FDCA.  Warning, design, warranty, and negligent misrepresentation claims are expressly preempted.
  215. McDonald v. Lester E. Cox Medical Centers, 2014 WL 58773, slip op. (Mo. Cir. Jan. 2, 2014), summary judgment granted against all claims in case involving a implantable cardiac defibrillator.  All claims are preempted.  Plaintiff failed to establish any facts providing a basis of liability on the conduct of the defendant’s sales representative.  There is no proof of any representations that would qualify as express warranties.
  216. Wells v. Allergan, Inc., 2014 WL 117773, slip op. (D.S.C. Jan. 13, 2014), motion to dismiss granted against all claims in case involving injectable gel dermal fillers.  During PMA, the FDA evaluates everything about the device, from labeling to safety, preempting all claims except “parallel” violations.  Plaintiff failed to plead defect, violation, or causation as to any violation claim.  Plaintiff is not entitled to discovery.
  217. Smith v. Depuy Orthopaedics, Inc., 552 F. Appx. 192 (3d Cir. Jan. 14, 2014), summary judgment affirmed against all claims in case involving PMA knee implant.  PMA supplements are equally preemptive.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Plaintiff does not need discovery to know that all the components were incorporated into a PMA.  Affirming 2013 WL 1108555.
  218. Morris v. Rotolo, 2014 Mass. Super. Lexis 220 (Mass. Super. Jan. 15, 2014), motion to dismiss granted against all claims against manufacturer in case involving hydrothermal ablator.  Plaintiff failed to plead any parallel claims.  Merely pleading that the defentant violated unspecified regulations is insufficient.
  219. Poll v. Stryker Sustainability Solutions, Inc., 2014 WL 199150 (D. Ariz. Jan. 17, 2014), motion to dismiss granted in part and denied in part in case involving hip implant.  Judicial notice taken of documents on FDA website.  Failure to submit adverse event reports can be the basis of a warning claim surviving preemption, however the claim is inadequately pleaded.  Strict liability and warranty claims based on FDA-approved labeling are preempted.
  220. Coleman v. Medtronic, Inc., 223 Cal. App.4th 413, 167 Cal. Rptr.3d 300 (Cal. App. Jan. 27, 2014), review accepted by the California Supreme Court – opinion vacated and uncitable.
  221. Bohnenstiehl v. Wright Medical Group, Inc., 2014 WL 319652 (E.D. Mo. Jan. 29, 2014),  motion to dismiss granted in case involving femoral implant against express and implied warranty claims.  Preemption not mentioned with respect to other claims.
  222. Hawkins v. Medtronic, Inc., 2014 WL 346622, slip  op. (E.D. Cal. Jan. 30, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Off-label use does not trump PMA preemption.  All PMA components are protected by preemption.  Off-label promotion does not trump PMA preemption.  Defective warning claims preempted.  A new “intended use” would require changes to PMA labeling.  Off-label promotion can be the basis of a parallel claim.  Failure to report claims are insufficiently pleaded.  Claims affecting the PMA label are preempted.  Fraud and misrepresentation claims concerning off-label promotion are not preempted, but are insufficiently pleaded.  Off-label promotion is a disguised FDCA claim, whereas negligent failure to warn is a traditional state law claim.  Negligent warning claims that would alter PMA warnings are preempted.
  223. Rodriguez v. American Medical Systems, 2014 WL 429431 (S.D. Tex. Feb. 4, 2014), summary judgment against all claims in penile prosthesis case.  Preemption under Riegel applies to devices approved under a product development protocol.  A parallel claim cannot be assumed from the fact that plaintiff was injured.  Affirmed, see below.
  224. Halsey v. Smith & Nephew, Inc., 2014 WL 12717702 (D. Vt. Feb. 4, 2014), motion to dismiss granted in part and denied in part in case involving hip implant.  Plaintiff adequately pleaded a parallel manufacturing defect claim based on an FDA recall.  State law claims, including warnings, untethered to this claimed violation are preempted.  The FDA ordered neither warnings nor a recall.  Earlier motion 2013 WL 12226936, above.
  225. Scovil v. Medtronic, Inc., 995 F. Supp.2d 1082 (D. Ariz. Feb. 7, 2014), motion to dismiss granted against most claims in action involving bone growth device.  Off-label promotion claims preempted because only the FDA can enforce its prohibition.  Design and manufacturing claims based on risks of off-label use are preempted.  Any warning claim concerning off-label uses is in addition to the label and therefore preempted.  Disagreeing with Ramirez.  All negligence claims are preempted except marketing involving off-label promotion.  Fraud and consumer fraud claims involving off-label promotion are not preempted.  Warranties were disclaimed.
  226. Kashani-Matts v. Medtronic, Inc., 2014 WL 819392 (C.D. Cal. Feb. 14, 2014), motion to dismiss amended complaint granted in action involving bone growth device.  Vague statements that the device’s labeling did not meet FDA requirements were insufficient to state parallel claims.  “Magic words” are not enough.
  227. Starks v. Coloplast Corp., 2014 WL 617130, slip op. (E.D. Pa. Feb. 18, 2014),  motion to dismiss granted against all claims, including implied warranty, in action involving penile implant.  Judicial notice taken of FDA documents.  A subsequent PMA takes precedence over an earlier 510k approval of some components for preemption purposes.  Parallel claims cannot be boilerplate.  Express warranty claims are inadequately pleaded.
  228. Kitchen v. Biomet, Inc.,  2014 WL 694226 (E.D. Ky. Feb. 21, 2014), motion to dismiss granted against all claims, in action involving knee implant.  All non-parallel claims, including express and implied warranty, are preempted.  Parallel claim allegations are insufficiently pleaded.
  229. Harris v. Medtronic, Inc., 2014 WL 866063 (Cal. Super. Feb. 27, 2014).  Demurrer granted in part and denied in part in action involving bone growth device.  Failure to report adverse event claims are not preempted.  Failure to warn and fraud claims based on off-label promotion are preempted.  FDA regulations about off-label promotion are not genuinely equivalent to any state-law claim.  Negligence per se claims concerning off-label promotion are not preempted.  Fraud claims concerning statements made to the FDA are fraud on the FDA claims and are preempted.  Fraud claims based on  affirmatively false off-label promotion are not preempted.  Genuine equivalence not present liability could exist under the state law without a violation of federal law.
  230. Marse v. Medtronic, Inc., 2014 WL 987829 (Minn. Dist. March 12, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption. Affirmed in part and reversed in partAngeles v. Medtronic, below.
  231. Schuler v. Medtronic, Inc., 2014 WL 988516, slip op. (C.D. Cal. March 12, 2014), motion to dismiss granted against all claims in action involving bone growth device.  All claims would require additional disclosure.  Off-label promotion is not barred by federal law and cannot give rise to a parallel claim.
  232. Seeberg v. Medtronic, Inc., 2014 WL 1102740 (Minn. Dist. March 12, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption. Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  233. Younkin v. Medtronic, Inc., 2014 WL 1102738 (Minn. Dist. March 12, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption. Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  234. Swisher v. Stryker Corp., 2014 WL 1153716 (W.D. Okla. March 14, 2014), motion to dismiss granted against negligence per se claims in action involving hip resurfacing system.  Conclusory statements that the defendant violated multiple regulations are not sufficient to plead a parallel claim.  Causation and the nature of the violation are required.  Motion to dismiss amended complaint denied, as claims now sufficiently pleaded, 2014 WL 12160770 (W.D. Okla. June 17, 2014).
  235. Hayter v. Medtronic, Inc., 2014 WL 8165507 (Cal. Super. March 14, 2014), demurrer sustained in part and overruled in part in action involving bone growth device. Fraud and warning claims based on false off-label promotion or failure to report are not preempted.  Other design and warning claims are.  Experss warranty based on voluntary statements about off-label uses are not preempted.  Design defect claims preempted.
  236. Bertini v. Smith & Nephew, Inc., 8 F. Supp.3d 246 (E.D.N.Y. March 17, 2014), motion to dismiss granted against all claims in action involving hip replacement system.  Judicial notice taken of FDA approval/clearance documents.  Where components of a PMA approved device and a 510k cleared device are mixed, preemption could be complex.  Focusing on the system as a whole, the only defects that could be causal are those relating to the PMA components.  While mixing components was off-label, preemption is not concerned with how devices are used.  Off-label use is not a defect.  Failure to warn is not parallel to claims about violating reporting requirements.  FDA reporting requirements do not require warnings directly to doctors or patients.  No reliance was alleged with respect to off-label promotion.  Consumer expectation-based implied warranty claims are preempted.
  237. Mead v. Medtronic, Inc., 2014 WL 1102737 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device.  Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.
  238. Davenport v. Medtronic, Inc., 2014 WL 1102736 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.  Affirmed in part and reversed in partAngeles v. Medtronic, below.
  239. Starovasnik v. Medtronic, Inc., 2014 WL 1102742 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out fraudulent off-label promotion or agency claims that survive preemption.  Affirmed in part and reversed in partAngeles v. Medtronic, below.
  240. Beaudry v. Medtronic, Inc., 2014 WL 1102741 (Minn. Dist. March 19, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device.   Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption.  Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  241. Herron v. Smith & Nephew, Inc., 7 F. Supp.3d 1043 (E.D. Cal. March 21, 2014), motion to dismiss granted in part and denied in part in action involving hip resurfacing system.  Allegations of a mislabeled component adequately state a parallel claim.  Other undefined or jargon-filled allegations are dismissed.  Claims asserting that the FDA did not do its job are preempted.  Much of the complaint is too vague to determine if parallel claims are being made, and must be repleaded.
  242. Schouest v. Medtronic, Inc., 13 F. Supp.3d 692 (S.D. Tex. March 24, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption extends to all components of a device system, whether or not used together.  All claims that seek to have the defendant do more than the FDA has required are preempted.   The FDA does not define nor explicitly ban, off-label promotion.  Claims including express warranty based on false off-label promotion are not preempted.  Warning and implied warranty claims about off-label use are preempted.  Design claims are preempted.  Mere off-label promotion claims are preempted by Buckman.  If plaintiff can identify a state law duty to report adverse events, such a claim would not be preempted.  Amended complaint dismissed with prejudice see below.
  243. McConologue v. Smith & Nephew, Inc., 8 F. Supp.3d 93 (D. Conn. March 24, 2014), motion to dismiss granted in part and denied in part in action involving hip replacement system. Blanket preemption rejected in light of parallel claim exception.  A device not manufactured in accordance with a PMA remains a “device intended for human use,” and preemption applies.  A manufacturing defect claim predicated on failure to follow PMA standards survives preemption as does misrepresentation and implied warranty claims predicated on the manufacturing defect.  Independent state law claims are not parallel and are preempted.  Warning and design claims preempted.  Testing claims TwIqballed.
  244. Blankenship v. Medtronic, Inc., 6 F. Supp.3d 979 (E.D. Mo. March 25, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Taking judicial notice of FDA approvals and supplements.  Making what is permissive into something mandatory is preempted.  General references to violating GMPs fail to establish a parallel claim.  Violations of the PMA would state a parallel claim.  Off-label promotion is prohibited by federal law but not unlawful under traditional state law.  Manufacturing defect and negligence claims based on off-label promotion are preempted as imposing different requirements.  Demands for warnings about off-label uses are preempted.  Failure to file adverse event report claims are preempted.  Design defect claims seeking anything other than what the FDA required are preempted.  Off-label promotion only exists by virtue of the FDCA.  Negligence per se is not based independently tortious conduct.  Non-disclosure of facts about FDA approval is not a state-law tort.  A claim of fraudulent off-label promotion would not be preempted, but is inadequately pleaded.
  245. Burkett v. Smith & Nephew, 2014 WL 1315315, slip op. (E.D.N.Y. March 31, 2014), motion to dismiss granted against all claims in action involving hip replacement system. A PMA supplement supports preemption.  Violation allegations involving vague GMPs do not support preemption.  Nor was causation pleaded between the alleged violation and the plaintiff’s injury.  Design and warning claims preempted, in negligence as well as strict liability.  Fraud express/implied warranty, and consumer protection claims inadequately pleaded to escape preemption.
  246. Simoneau v. Stryker Corp., 2014 WL 1289426, slip op. (D. Conn. March 31, 2014), motion to dismiss granted in part and denied in part in action involving hip replacement system.  In light of FDA warning letters and product recalls, claims alleging manufacturing defects are parallel and not preempted.  Allowing reliance at pleading stage on general GMPs.  Recalls were pleaded to involve components implanted specifically in plaintiff.  Warning and design based claims are preempted.  Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA.  Express warranty claims inadequately pleaded.
  247. Cline v. Advanced Neuromodulation Systems, 17 F. Supp.3d 1275 (N.D. Ga. March 31, 2014), motion to dismiss granted in part and denied in part in action involving a spinal cord stimulator.  Strict liability claims are preempted because, whether or not a “duty” is involved, they would require changes in the device triggering the express preemption clause.  The battery life claim is preempted because there is no FDA performance standard to that effect.  A design validation claim is preempted because there is no showing that the defendant’s validation was contrary to FDA regulations.  Several FDA violation claims fail because they lack any causal connection to the failure plaintiff alleged.  One parallel claim based on a recall has a sufficient causal relationship and thus survives preemption as a parallel claim.
  248. Houston v. Medtronic, Inc., 2014 WL 1364455, slip op. (C.D. Cal. April 2, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption applies to devices, not uses of devices or promotion of uses of devices.  FDA requirements extend to off-label use and promotion.  Ramirez is wrongly decided.  Failure to report claims to the FDA are not preempted. Fraudlulent promotion of off-label use can escape preemption.  Plaintiff pleaded his physician’s exposure to fraudulent promotion with sufficient particularity.  Express warranty is not preempted and is adequately pleaded.
  249. Brady v. Medtronic, Inc., 2014 WL 1377830, slip op. (S.D. Fla. April 8, 2014), motion to dismiss granted in action involving bone growth device.  Preemption does not turn on how a device is marketed.  Fraud claims against FDA-approved labeling are preempted.  Fraud claims involving off-label promotion are not preempted, but not pleaded with particularity.  Negligent warning and design claims are preempted.  Negligence claims based on illegal promotion are preempted as attempts to enforce the FDCA.  Express warranty claims not involving FDA labeling may not be preempted, but are not properly pleaded.
  250. Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp.3d 1021 (D. Haw. April 10, 2014), motion to dismiss granted in action involving bone growth device.  Documents on FDA website judicially noticed.  All claims challenging contents of FDA-approved label are preempted.  Off-label promotion claims can be preempted (rejecting Ramirez).  Design and off-label promotion claims preempted, except fraud.  Fraud, concealment, and misrepresentation claims not preempted, but inadequately pleaded.  Failure to report claims inadequately pleaded.  Express warranty claims outside the label not preempted but inadequately pleaded.
  251. Eidson v. Medtronic, Inc., 40 F. Supp.3d 1202 (N.D. Cal. May 13, 2013).  Renewed motion to dismiss granted in part and denied in part.   Claims alleging affirmatively fraudulent off-label promotion are not preempted.  Failure to warn claims based on overpromotion and deceptive off-label promotion are expressly preempted, but claims alleging failure to report adverse events to the FDA are not.
  252. Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014), motion to dismiss granted in action involving implantable cardiac defibrillator.  Parallel claims not pleaded where the violation of allegedly parallel regulations did not articulate a defect with any specificity. Nor was causation alleged.  Nor was the nature of the allegedly parallel state-law cause of action.
  253. Reed v. Medtronic, Inc., 2014 WL 1930221 (Cal. App. May 15, 2014) (unpublished), summary judgment reversed because plaintiff should have been allowed to amend complaint.  Plaintiff did not appeal entry of summary judgment against all prior product liability claims.  A claim that an employee of the defendant negligently programmed a device is not a requirement “with respect to a device,” as it does not challenge any aspect of the device.  Such a claim is not a parallel claim because no violation is involved.
  254. Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235 (N.D. Cal. May 28, 2014), motion to dismiss granted in action involving breast implants.   Plaintiff concedes that all her pleaded claims were preempted, but failed to allege an adequate parellel claim.  Failure to report adverse events alleged only an FDCA violation.
  255. Hornbeck v. Medtronic, Inc.,  2014 WL 2510817 (N.D. Ill. June 2, 2014), motion for judgment on the pleadings denied in action involving bone growth device.  All plaintiffs’ claims involve FDCA violations, so they are parallel claims.  By promoting off-label use the defendant removed itself from the protection of preemption.  Because the FDA only approved the components for use together, preemption cannot apply to components used separately.
  256. Johnson v. Hologic, Inc., 2014 WL 2581421, slip op. (E.D. Cal. June 6, 2014), judgment on the pleadings granted against all claims in action involving a mammography machine.  Documents on FDA website judicially noticed.  No parallel claims were pleaded.
  257. Franzese v. St. Jude Medical, Inc., 2014 WL 2863087 (E.D.N.Y. June 23, 2014), motion to dismiss granted in action involving implantable cardiac defibrillator.  PMA documents judicially noticed.  Parallel claims alleging violations of vague GMPs are preempted.  Nonspecific adulteration claims are preempted.  Design defect claims are preempted.  A warning letter issued three years after manufacture does not establish causation.  Express and implied warranty claims based on FDA-approved labeling are preempted.  Negligence claims preempted for same reasons as strict liability.  Negligent misrepresentation claims inadequately pleaded.
  258. Pinsonneault v. St. Jude Medical, Inc., 2014 WL 2879754 (D. Minn. June 24, 2014), summary judgment granted in large part in action involving implantable cardiac defibrillator.  A manufacturer’s purely internal manufacturing specifications do not become FDCA requirements simply because the FDCA requires manufacturers to have such specifications.  None of plaintiff’s alleged manufacturing defects violate any actual FDCA requirement so plaintiffs have no parallel unpreempted claims.
  259. Dunbar v. Medtronic, Inc., 2014 WL 3056026, slip op. (C.D. Cal. June 25, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device. Warning and design claims expressly preempted.  There is no traditional tort claim for off-label preemption, so negligence and negligence per se claims based on such allegations are impliedly preempted.  Express warranty claims are not preempted, but are inadequately pleaded on basis of the bargain and notice grounds.
  260. Edwards v. Ethicon, Inc., 30 F. Supp.3d 554 (S.D.W. Va. July 8, 2014), summary judgment denied in action involving vaginal mesh.  That a device system had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k.
  261. Huskey v. Ethicon, Inc., 29 F. Supp.3d 736 (S.D.W. Va. July 8, 2014), summary judgment denied in action involving vaginal mesh. That a device system had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k.
  262. Highfield v. Perard, 2014 WL 3773976, slip op. (Pa. C.P. Clarion Co. July 16, 2014), preliminary objections granted against third-party complaint in action involving thermal ablation device.  A failure to maintain/inspect claim would impose extra requirements to the PMA process and is preempted.  There is no private right to enforce the FDCA.  Alleging violation of non-device-specific GMPs is insufficient to state a parallel violation claim.  General violation claims do not provide a causal nexus between the violation and the alleged injury.
  263. Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818 (W.D. Ky. July 21, 2014), motion to dismiss granted in part and denied in part in action involving implantable cardiac defibrillator.  Specifically pleaded manufacturing defects in violation of GMPs are not preempted.  FDA requirements are in both PMA and supplemental PMAs.  Failure to report to FDA warning claim not preempted.
  264. Martin v. Medtronic, Inc., 32 F. Supp.3d 1026 (D. Ariz. July 23, 2014), motion to dismiss granted in action involving bone growth device.  Judicial notice taken of FDA approvals. Preemption applies to off-label uses, rejecting Ramirez.  Misrepresentation can be a parallel state duty in cases of untruthful off-label promotion.  Fraud claims based on FDA-approved labeling are preempted.  Fraud claims based on untruthful off-label promotion are not preempted but are inadequately pleaded.  Warning claims based on off-label promotion are preempted.  Failure to report adverse events to the FDA is not preempted, but plaintiffs fail to allege how such a failure caused them injury.  Design defect claims preempted.  Negligence claim based on off-label promotion impliedly preempted.  Express warranty claim based on untruthful off-label promotion not preempted but warranty must be pleaded.  Second complaint dismissed, see below.
  265. Thibodeau v. Cochlear Ltd., 2014 WL 3700868 (D. Ariz. July 25, 2014), motion to dismiss granted in part and denied in part in action involving cochlear implant.  An unexplained list of 30 allegedly violated regulations is conclusory and cannot defeat preemption.  Negligence per se is impliedly preempted as directly based on an FDCA violation.  All warning-based claims, including express warranties, are preempted.  Allegations of failure to warn the FDA are not preempted.
  266. Scanlon v. Medtronic, Inc., 61 F. Supp.3d 403 (D. Del. July 28, 2014), motion to dismiss granted in action involving bone growth device. Judicial notice taken of FDA approvals and other documents.  Motion for discovery denied.  Off-label promotion claims preempted, and are not parallel claims.  Warning and negligence prempted as adding requirements.  No federal requirement to seek label change.  Misrepresentation claim preempted where label complied with FDCA.  False promotion and failure to report would not exist apart from FDCA and are implied preempted.
  267. Huggins v. Medtronic, Inc., 2014 WL 4262211 (Colo. Dist. July 28, 2014), motion to dismiss denied in action involving bone growth device.  Everything is a parallel claim.
  268. Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014), partial motion to dismiss (all but manufacturing claims) granted in action involving hip implant.  Warning, design, and implied warranty claims are preempted.  Express warranty based on manufacturing defect would not be preempted, but is inadequately pleaded.
  269. Blankenship v. Medtronic, Inc., 2014 WL 3818485 (E.D. Mo. Aug. 4, 2014), motion to dismiss denied in action involving bone growth device against repleaded fraud claims concerning off-label promotion.  Fraud claims adequately pleaded.
  270. Zaccarello v. Medtronic, Inc., 38 F. Supp.3d 1061 (W.D. Mo. Aug. 6, 2014), motion to dismiss granted in part and denied in part in action involving in action involving bone growth device.  Design, manufacture, and warning claims preempted.  Express warranty, fraud, and consumer fraud escape preemption to the extent based on false off-label promotion, but express warranty and fraud are inadequately pleaded.  Improper promotion and negligence per se impliedly preempted as disguised FDCA causes of action.
  271. Vitale v. Medtronic, Inc., 2014 WL 3893294, slip op. (C.D. Cal. Aug. 8, 2014), motion to dismiss granted in action involving bone growth device.  All claims are expressly or impliedly preempted.
  272. Arthur v. Medtronic, Inc., 2014 WL 3894365, slip op. (E.D. Mo. Aug. 11, 2014), motion to dismiss granted in part and denied in part in action involving in action involving bone growth device.  Judicial notice given to FDA documents.  Off-label promotion is subject to misbranding, which is an FDA requirement.  Design, warning, and warranty claims expressly preempted.  Negligence claims based on off-label promotion impliedly preempted as private FDCA actions.  The concept of “off-label” is a creature of the FDCA.  Fraudulent misrepresentation and express warranty claims involving false off-label promotion are not preempted, but inadequately pleaded.
  273. Gall v. Stryker Orthopaedics, 2014 WL 12614471 (C.D. Cal. Aug. 14, 2014), motion to dismiss granted part and denied in part in action involving hip implant.  All claims other than those based on a Stengel failure to report theory preempted.
  274. Toubian v. Boston Scientific Corp., 2014 WL 12607702 (C.D. Cal. Aug. 19, 2014), motion to dismiss granted part and denied in part in action involving implantable defibrillator.  Parallel manufacturing claim based on GMPs survives preemption and is adequately pleaded.  GMPs need not be specific.
  275. Arvizu v. Medtronic, Inc., 41 F. Supp.3d 783 (D. Ariz. Aug. 25, 2014), motion to dismiss granted part and denied in part in action involving in action involving bone growth device.  Judicial notice given to FDA documents.  Off-label promotion does not negate preemption.  FDA approves devices, not uses.  Fraud involving FDA-approved statements is preempted, but fraudulent off-label promotion is not.  Warning claims other than failure to report are preempted.  Design defect preempted.  Truthful off-label promotion claims preempted because not state-law duty to refrain from such promotion.  Express promotion not preempted, but inadequately pleaded.
  276. Carlson v. Medtronic Inc., 2014 WL 11514911 (S.D. Miss. Aug. 28, 2014), motion to dismiss granted against all claims in action involving pain pump.  Parallel manufacturing defect claim inadequately pleaded.
  277. Tansey v. Cochlear Ltd., 2014 WL 4829453 (E.D.N.Y. Sept. 26, 2014),  motion to dismiss granted in part and denied in part in action involving cochlear implant.  Manufacturing defect claims are parellel and not preempted.  Design defect claims are preempted. Warning claims rely on an FDA recall occurring more than a year later, which fails to plead causation.  Failure to inspect claims are TwIbaled.  Related negligence claims follow the defect allegations.
  278. McCormick v. Medtronic, Inc., 101 A.3d 467 (Md. App. Oct. 7. 2014), dismissal of all claims affirmed in part and reversed in part.  Allegations of misrepresentations (fraud, misrepresentation, consumer fraud, express warranty) made in the context of off-label promotion are neither expressly or impliedly preempted.  Rejects Ramirez.  All claims that challenge the FDA-approved warnings or design of a PMA device are preempted.  Failure to disclose information in the course of the approval process are impliedly preempted.  Pure off-label promotion claims, not depending on falsity are impliedly preempted.  Both are seeking to enforce the FDCA.  Strict liability is preempted.  Breach of warranty is preempted to the extent based on FDA labeling, otherwise it is not.  Plaintiffs failed to plead fraud with particularity.
  279. Sluss v. Medtronic Sofamor Danek USA, Inc., No. BC 496524, slip op. (Cal. Super. Oct. 15, 2014), demurrer granted in part and overruled in part in action involving in action involving bone growth device.  All claims preempted except for those relating to negligent off-label promotion and failure to report adverse events.  Strict liability off-label promotion is preempted as are all design claims and warnings not concerning off-label promotion.
  280. Anderson v. Medtronic, Inc., 2014 WL 5528664, slip op. (Minn. Dist. Oct. 16, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Fraud and constructive fraud based on false off-label promotion are inadequately pleaded because they rely on generalized fraud on the market allegations.  All other claims are preempted, including negligence, strict liability, express and implied warranty, several consumer fraud/trade practices statutes, and unjust enrichment.
  281. Lindler v. Mentor Worldwide LLC, 2014 WL 6390307 (D.S.C. Oct. 23, 2014), motion to dismiss granted against all claims in action involving breast implants.  All claims preempted, except express warranty, which is inadequately pleaded.
  282. Hesik v. Boston Scientific Corp., 2014 WL 5644699 (D.S.C. Nov. 4, 2014), summary judgment granted in part and denied in part in action involving defibrillator.  All claims dismissed except for alleged 5-year express warranty, which is arguably beyond anything required by the FDA.  Violations of vague FDA regulations cannot escape preemption as parallel claims.  Implied warranty claims are preempted.  Earlier decision see above 2012 WL 12897111.
  283. Stanifer v. Corin USA Ltd., 2014 WL 5823319 (M.D. Fla. Nov. 10, 2014), motion to dismiss granted against all claims in action involving hip resurfacing device.  Only parallel claims escape preemption and plaintiff did not plead any.  Judicial notice of FDA approval is proper.  Request for pre-complaint discovery is denied.
  284. Farrand v. Stryker Corp., 2014 WL 11514684 (S.D. Iowa Nov. 12, 2014), summary judgment granted in part and denied in part in action involving hip implant.  “Not strong enough” claim preempted.  Warning, testing, and warranty claims preempted.  “Marginal” manufacturing defect parallel claim based on warning letter survives preemption as pleaded, to the extent it alleges only violations of FDA standards.
  285. David v. Medtronic, Inc., 2014 WL 12626709 (Cal. Super. Nov. 18, 2014), demurrer sustained against all claims in action involving bone growth device.  Judicial notice taken of official FDA acts. All plaintiff’s claims may be preempted, but they are too vaguely pleaded to dismiss with prejudice.  Fraud on the FDA is preempted.
  286. Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Nov 21, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Off-label use does not oust preemption.  Preemption does not depend on using all of the approved components.  The FDA approves devices, not uses.  Parallel claims must involve a substantially equivalent state-law theory.  Neither off-label promotion nor failure to report are parallel claims.  They have no equivalent state liability theories.  Private enforcement of the FDCA is impliedly preempted.  Fraud is not properly pleaded.  Without pleading physician-specific reliance, plaintiff is alleging improper fraud on the market.  All claims attacking FDA-approved labels and design are preempted.  Without pleading physician-specific causation, failure to report claims do not allege any state law claim, and are dismissed.  Any warranty created by off-label promotion must become part of the basis of the bargain to avoid preemption.  Reconsideration denied  2015 WL 4081908 (Ky. Cir. July 1, 2015)
  287. Martin v. Medtronic, Inc., 63 F. Supp.3d 1050 (D. Ariz. Nov. 24, 2014), motion to dismiss granted against all claims in action involving bone growth device.  All claims previously dismissed as preempted are again dismissed.  Failure to report claims dismissed for failing to plead causation.  Fraud is sufficiently pleaded, with reliance on a specified article and the author’s agency by specified financial ties.  Other promotional allegations insufficiently pleaded.  Allegations of reliance upon unspecified medical literature are not enough.  General allegations about product safety dismissed as fraud on the market.  Express warranty inadequately pleaded.  Entire complaint dismissed as prolix and redundant with leave to amend.  Subsequent history:  Entire complaint dismissed with prejudice because of plaintiff’s repeated pleading prolixity.  2015 WL 1477903 (D. Ariz. April 1, 2015)
  288. Pitkow v. Lautin, 2014 WL 11351492, slip op. (N.Y. Sup. N.Y. Co. Dec. 9, 2014), summary judgment granted against all claims against injectable body sculpturing device). Preemption applies to products promoted for off-label use.  No parallel state-law claim alleged.  All claims about off-label promotion also preempted under Buckman.  Affirmed 29 N.Y.S.3d 805 (N.Y. App. Div. May 12, 2016).
  289. Hernandez v. Stryker Corp., 2014 WL 7044171, slip op. (W.D. Wash. Dec. 11, 2014), motion to dismiss granted against all claims in action involving total hip implant.   Vague references to “adulteration” and FDA warning letters do not plead sufficient facts to establish a parallel claim.  Causation fails because plaintiff fails to link letters to her claim.  The allegedly violated GMPs do not specify any steps that the defendant was required to take.  Express warranty claims based on FDA-approved labeling are preempted.
  290. Brook v. Sanofi Aventis LLC, 2014 WL 7272243 (S.D. Ohio Dec. 18, 2014),  motion to dismiss denied in action involving cosmetic injection.  Citing Bausch, the court refuses to decide any preemption issue without discovery into whether a parallel claim exists.
  291. Rodriguez v. American Medical Systems, 597 F. Appx. 226 (5th Cir. Dec. 31, 2014), summary judgment affirmed against all claims in penile prosthesis case.  Plaintiff could not create a factual dispute about the device’s PMA approval.  Plaintiff failed to plead a plausible parallel claim.  Affirming 2014 WL 429431, above.
  292. Johnson v. Hologic, Inc., 2015 WL 75240 (E.D. Cal. Jan. 5, 2015), judgment on the pleadings granted against all amended claims in action involving a mammography machine.  Plaintiff failed to plead a viable parallel claim.  An failure to report adverse events cannot possibly be causal where the event in question is the one that injured the plaintiff.
  293. Morton v. Medtronic, Inc., 2015 WL 12778750 (Mag. D. Minn. Jan. 5, 2015), adopted 2015 WL 12780468 (D. Minn. Feb. 19, 2015), motion to dismiss granted against all claims in action involving implantable defibrillator.  All state-law claims, including manufacturing defect and express/implied warranty preempted.  No parallel claims alleged.
  294. Beavers-Gabriel v. Medtronic, Inc., 2015 WL 143944 (D. Haw. Jan. 9, 2015), motion to dismiss remaining claims of amended complaint denied in action bone growth device.  False off-label promotion claims are not preempted and are adequately pleaded.  Failure to report claims are not preempted under Stengel.
  295. Tone v. Studin, 2015 WL 725420 (N.Y. Sup. Jan. 20, 2015), summary judgment granted against all claims in action involving injectable body sculpturing device. Preemption applies to products promoted for off-label use.  No parallel state-law claim alleged.  All claims about off-label promotion also preempted under Buckman.  Affirmed 51 N.Y.S.3d 548 (N.Y. App. Div. March 29, 2017).
  296. Garross v. Medtronic, Inc., 77 F. Supp.3d 809 (E.D. Wis. Jan. 21, 2015), motion to dismiss denied in action involving bone growth device.  Fraud claims based in false off-label preemption are not preempted.  Negligence and strict liability claims based on failure to report adverse events, or failure to seek approval of promoted indications are parallel claims and are not preempted.  Judicial notice given to FDA-approved warnings.
  297. Wright v. Medtronic, Inc., 81 F. Supp.3d 600 (W.D. Mich. Jan. 23, 2015), motion to dismiss granted against most claims in action involving bone growth device.  Federal law does not explicitly ban off-label promotion.  Off-label promotion does not defeat preemption because preemption applies to devices, not uses.  There is no state-law duty to refrain from off-label promotion.  Design and warning claims preempted.  Fraudulent promotion is not preempted and, as amended, is adequately pleaded.  Express warranty is not preempted, but was disclaimed.
  298. Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619 (W.D. Mich. Jan. 23, 2015), motion to dismiss granted against all claims in action involving bone growth device.  Federal law does not explicitly ban off-label promotion.  Off-label promotion does not defeat preemption because preemption applies to devices, not uses.  There is no state-law duty to refrain from off-label promotion.  Any duty to provide truthful information to the FDA is preempted by Buckman.   Design and warning claims preempted.  Express warranty is not preempted, but was disclaimed and inadequately pleaded.  Affirmed on procedural grounds, 2015 U.S. App. Lexis 22582 (6th Cir. Dec. 15, 2015)
  299. Holland v. Frey, 2015 WL 606105 (Cal. Super. Jan. 26, 2015), demurrer denied in action involving “Precision SCS” device.  While a malfunction claim would be preempted, plaintiff is suing only over what a sales representative allegedly said about the malfunction.  Sales representative conduct is not subject to preemption.
  300. Buccelli v. Mayer, 2015 WL 398594, slip op. (Fla. Dist. Jan. 28, 2015), motion to dismiss granted against all claims in action involving bone growth device.   All claims whatever theory challenging FDA approved design and labeling are expressly preempted.  Fraudulent off-label promotion claims are insufficiently pleaded.  No allegations specific to plaintiff’s surgeon.  Warning claims based on off-label promotion are expressly preempted.  Negligent marketing claims grounded in off-label promotion are impliedly preempted under Buckman.  Express warranty claims are not preempted, but do not plead any warranty that became the basis of the bargain.
  301. Murray v. Hogan, 2015 WL 609599, slip op. (N.H. Super. Feb. 2, 2015), summary judgment/motion to dismiss granted in part in action involving knee implant.  All plaintiff’s direct liability claims against the defendant are preempted.  Plaintiff granted leave to attempt to plead a parallel claim.  Vicarious liabiltiy claims based on sales rep conduct in the operating room are not preempted.
  302. Kennedy v. Naka, 2015 WL 1486985 (N.Y. Sup. Feb. 11, 2015), summary judgment granted against all claims in action involving artificial heart valve, except express warranty, which was inadequately pleaded.
  303. Millman v. Medtronic, 2015 WL 778779, slip op. (D.N.J. Feb. 24, 2015), motion to dismiss granted against all claims in action involving deep brain stimulator.  All claims, including warranty, are preempted.  Fraud claim based on sales rep statements inadequately pleaded, but would not be preempted.
  304. Scovil v. Medtronic Inc., 2015 WL 880614 (D. Nev. March 2, 2015), motion to dismiss amended complaint granted in part in action involving bone growth device.   Parallel manufacturing defect claim inadequately pleaded.  Failure to report claim not preempted.  Negligence and fraud claims not preempted to the extent based on illegal off-label promotion.  Implied warranty claims dismissed on state law grounds.  Express warranty improperly pleaded.
  305. Teixeria v. St. Jude Medical, Inc., 2015 WL 902616 (Mag. W.D.N.Y. March 3, 2015), motion to dismiss granted in part in action involving implantable defibrillator.    Manufacturing defect claims paralleling a recall and FDA warning letter survive preemption.  More general negligence claims are preempted to the extent they assert duties beyond FDA requirements. Warning and design-based warranty claims preempted.  Misrepresentation preempted because FDA regs do not require any communication with doctors or patients, except warning labels.  Warranty claims based on the same manufacturing defect theory and on vaguely alleged direct statements are not preempted.  Adopted in part and rejected in part, 2016 WL 3547932, below.
  306. Jones v. Medtronic, Inc., 89 F. Supp.3d 1035 (D. Ariz. March 6, 2015), motion to dismiss granted with prejudice against all claims in action involving bone growth device.   Vague claims about unspecified devices are inadequately pleaded.  Plaintiff’s fraud claim escapes preemption but is inadequately pleaded.  Off-label promotion does not defeat preemption, rejecting Ramirez.  Preemption bars assertion of state-law duties based on off-label promotion that differ from FDA warning requirements.  Design defect claims preempted.  Affirmed in part and reversed in part, 2018 WL 3912167 below..
  307. Michajlun v. Bausch & Lomb, Inc., 2015 WL 1119733 (S.D. Cal. March 11, 2015), motion to dismiss granted in part in action involving intraocular lens.  Warning-related claims based on advertising that paraphrased FDA-approved labeling preempted.  Failure to report not reported and sufficiently causal.  Consumer fraud claims preempted as requiring different labeling.  UCL “unlawful” action claims predicated on FDCA violations are impliedly preempted under Buckman.
  308. Byrnes v. Small, 60 F. Supp.3d 1289 (M.D. Fla. March 18, 2015), motion to dismiss granted against all claims in action involving bone growth device.  All warning and design claims preempted.  Failure to report claims impliedly preempted as private FDCA enforcement.  No state-law reporting duty exists.  False off-label promotion claims (fraud, misrepresentation) not preempted, but inadequately pleaded.  Ramirez rejected.  All negligence theories preempted.  See below for ruling on repleaded complaint
  309. Schouest v. Medtronic, Inc., 92 F. Supp.3d 606  (S.D. Tex. March 20, 2015), motion to dismiss amended complaint granted with prejudice against all remaining claims in action involving bone growth device.  There cannot be a parallel claim for for failure to report adverse events to the FDA because no such state law duty exists.  Express warranty and consumer fraud claims inadequately pleaded.  Fraud and misrepresentation theories inadequately pleaded.
  310. Jackson v. St. Jude Medical Neuromodulation Division, 2015 WL 1456650, slip op. (M.D. Fla. March 30, 2015), motion to dismiss granted against all claims in action involving neurostimulation device.  Negligence, strict liability and warranty all preempted.  Plaintiff’s general allegations cannot be the basis for a parallel claim.  A parallel claim would fail because Florida state law does not recognize claims based on FDCA violation. Private violation claims are impliedly preempted under Buckman.
  311. Brady v. Medtronic, Inc., 2015 WL 11181971 (S.D. Fla. March 30, 2015), motion to dismiss denied in action involving  bone growth device.  Allegations of fraudulent off-label promotion are neither expressly nor impliedly preempted.
  312. Shuker v. Smith & Nephew PLC, 2015 WL 1475368 (E.D. Pa. March 31, 2015), motion to dismiss amended complaint granted in action involving knee implant.  Use of PMA components with 510k components does not deprive the PMA components of preemption.  Off-label combination of components did not create a new non-approved and non-preempted device.  Off-label use does not render preemption inapplicable.  All plaintiff’s generalized claims preempted.  Express warranty and false off-label promotion not preempted but inadequately pleaded. Timing renders any failure to report claim implausible.  Second dismissal, see 2016 WL 5461900, below.
  313. Morton v. Allegran, Inc.,  2015 WL 12839493 (D.N.J. April 2, 2015), motion to dismiss granted against all claims in action involving stomach band.  All claims not based on parallel violation claims, including express warranty, are preempted.  Manufacturing defect claims asserting parallel claims were inadequately pleaded.
  314. Dwyer v. Boston Scientific Corp., 2015 WL 3384894 (Mass. Super. April 2, 2015), motion to dismiss denied in case involving defibrillator. Parallel claims for manufacturing defect not preempted where defendant admitted failure in letter and violations of GMPs alleged.  Manufacturing defects violating nonspecific GMPs are permissible.  No other claims alleged.
  315. Hafer v. Medtronic, Inc., 99 F. Supp.3d 844 (W.D. Tenn. April 13, 2015), motions to dismiss granted against all claims in multiple actions involving bone growth device.  Allegations of illegal off-label promotion do not displace preemption, rejecting Ramirez.  Claims attacking off-label promotion are impliedly preempted under Buckman as private FDCA enforcement.  “Off’-label” is purely federal.  Preemption affects devices, not uses or specific components.  Physician off-label mixing of non-PMA components does not affect preemption, nor were the non-PMA components alleged to be defective or to have caused harm.  Warning, design and implied warranty claims preempted.  Failure to report adverse events was preempted private FDCA enforcement.  False off-label promotion wasn’t preempted, but was not pleaded to establish prescriber-specific reliance.  Express warranty wasn’t preempted.
  316. Angeles v. Medtronic, Inc., 863 N.W.2d 404 (Minn. App. April 20, 2015), affirming in part and reversing in part dismissal of all claims in action involving bone growth device.  Preemption is not precluded by off-label use.  It is not essential that all components of a system be used.  Off-label use can be standard of care.  Rejecting Ramirez and Hornbeck.  Off-label promotion claims are preempted unless they further allege that false information was conveyed.  No state law duty to refrain from off-label promotion.  A failure to report claim would not be preempted, but must be sufficiently pleaded, including causation.  Design-related claims preempted.  Breach of voluntarily made express warranties are not preempted, if not based on FDA-approved labeling.  Fraud inadequately pleaded.  Superseding StarovasnikMarse, and Davenport, above.
  317. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. April 21, 2015), dismissal of all claims affirmed in action involving bone growth device.  All strict liability, negligence, warranty, and misrepresentation claims are preempted unless parellel federal duties exist that are at least as broad as the state-law claims.  No parallel design or warranty claims are advanced.  Warning-related claims are not parallel because plaintiff’s off-label promotoin claims go beyond warnings, and exceed the scope of federal requirements.  Plaintiff cannot force revision of a warning where federal regulations preclude preclude revision.  Plaintiff fails to identify any parallel federal requirement that the defendant violated.  Neither off-label use nor off-label promotion preclude preemption.  Preemption is tied to devices, not uses.  Congress did not write the statute to limit preemption to labeled uses.  Riegel found preemption in an off-label use situation.  Warranty and fraud not pleaded with specificity.  Affirming 921 F. Supp.2d 1206, above.
  318. Williams v. CIBA Vision Corp., 100 F. Supp.3d 585 (S.D. Miss. April 27, 2015), motion to dismiss granted against all claims in action involving intraocular lens.  Plaintiff failed to allege any specific facts how the device in question actually deviated from applicable FDA manufacturing requirements.  Without a viable parallel claim the action was preempted.
  319. Anderson v. Medtronic, Inc., 2015 WL 2115342, slip op. (S.D. Cal. May 6, 2015), motion to dismiss granted against all claims in action involving bone growth device.  Off-label promotion does not vitiate preemption, rejecting Ramirez.   FDA regulates such promotion.  No state law claims for off-label promotion.  It is impliedly preempted as a disguised FDCA violation claim.  Off-label promotion claims would require different warnings and are expressly preempted.  Plaintiff did not attempt to plead a failure to report claim.  Warranty and fraud claims inadequately pleaded for lack of prescriber-related allegations.  Negligence per se claims are impliedly preempted.
  320. Caton v. Stryker Sustainability Solutions, Inc., 2015 WL 12426110 (C.D. Cal. May 12, 2015), motion to dismiss granted against all claims in action involving hip implant.  Adequately pleaded manufacturing defect claims were parallel.  Failure to report information to FDA survived preemption, provided plaintiff pleaded:  (1) causation; (2) a duty to report the information at issue; and (3) that defendant actually had received adverse incidents that were not reported.
  321. McAfee v. Medtronic, Inc., 2015 WL 3617755, slip op. (N.D. Ind. June 4, 2015), motion to dismiss granted in part and denied in part in action involving defibrillator.  All failure to warn claims preempted except parallel claim for failure to report to FDA.  Failure to report to physicians is preempted as not parallel.  Negligent design and manufacture claims preempted.  Res ipsa claims preempted.  Reconsideration granted and motion granted, 2016 WL 2588807 (N.D. Ind. May 5, 2016), plaintiff failed to plead causation for reporting-based claim.
  322. Clements v. Sanofi-Aventis, U.S., Inc., 2015 WL 3648911 (D.N.J. June 11, 2015), motion to dismiss granted against all claims in action involving injectable facial sculpting material.  All claims permitted by state product liability statute are preempted except parallel claims, which are inadequately pleaded.  Off-label promotion claims must be specifically pleaded, and may be preempted anyway.
  323. Leroy v. Medtronic, Inc., 2015 WL 4600880 (N.D. Fla. July 29, 2015), motion to dismiss granted against all claims in action involving implantable defibrillator.  Judicial notice taken of public FDA records.  A voluntary recall does not preclude preemption.  Parallel claim inadequately pleaded.
  324. Becker v. Smith & Nephew, Inc., 2015 WL 4647982 (D.N.J. Aug. 5, 2015), motion to dismiss granted against all claims in action involving hip implant.  Judicial notice taken of PMA status.  Plaintiff may not plead vague FDCA violations and fill in the blanks through discovery.  Express warranty claims must state the warranty.  Only non-FDA approved warranty language could escape preemption.
  325. Seedman v. Cochlear Americas, 2015 WL 4768239 (C.D. Cal. Aug. 10, 2015), motion to dismiss granted in part and denied in part in action involving cochlear implant.  Manufacturing defect claim survives as parallel claim and is adequately pleaded.  Design defect, negligent misrepresentation, and implied warranty preempted.  Conclusory failure to report claim allowed.  A catch-all negligence per se claim survives as to manufacturing defect, but everything else is preempted.
  326. Spier v. Coloplast Corp., 121 F. Supp.3d 809 (E.D. Tenn. Aug. 17, 2015), motion to dismiss granted against all claims in action involving penile prosthesis.  Plaintiff did not attempt to plead a parallel claim.  Express warranty also inadequately pleaded.
  327. Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733 (D. Md. Aug. 18, 2015), motion to dismiss granted in part and denied in part in action involving hip implant.  Design and implied warranty preempted.  Warning claim alleging failure to report adverse events not preempted as parallel to post-sale duty to warn.  Manufacturing defect claim not preempted.  Express warranty only preempted as to FDA-approved statements.  Failure to conduct studies impliedly preempted as FDCA enforcement.  Manufacturing defect claim insufficiently pleaded.
  328. Riddell v. Howmedica Osteonics Corp., 2015 WL 5167039 (S.D. Miss. Sept. 3, 2015), motion to dismiss granted in part and denied in part in action involving knee implant.  Non-preempted manufacturing parallel claim adequately pleaded.  Design and warranty claims preempted or inadequately pleaded.  Uncertain if preemption sought as to warning claims.
  329. Latimer v. Medtronic, Inc., 2015 WL 5222644, slip op. (Ga. Super. Sept. 4, 2015), motion to dismiss granted against all claims in action involving bone growth device.  FDA labels subject to judicial notice. No presumption against preemption in a PMA preemption case.  Off-label promotion does not vitiate preemption, rejecting Ramirez.  PMA based on devices, not uses, and not off-label promotion.  Preemption does not vary by component.  No state law claims for off-label promotion.  Off-label is FDA concept.  It is impliedly preempted as a disguised FDCA violation claim.  Warning, design, fraud and consumer fraud by omission, express and implied warranty expressly preempted.  Design defect impliedly preempted as impossible under Bartlett.  Failure to report claim inadequately pleaded, and nonexistent under state law.  Reporting does not encompass journal articles.  Implied warranty claims also impliedly preempted.  Affirmative fraud inadequately pleaded.
  330. Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015), motion to dismiss granted against all claims in action involving breast implant.  Manufacturing-related FDCA violations and warranty claims conclusorily pleaded.
  331. Gall v. Stryker Orthopaedics, 2015 WL 12803805 (Cal. Super. Sept. 17, 2015), judgment on the pleadings granted in part and denied in part in action involving hip implant.  Design, manufacturing, warning, and testing claims preempted, except for failure to report.  Warranty claims preempted to the extent based on FDA-approved statements.  Fraud claims preempted by Buckman “regardless to whom those representations were made.”  See below for subsequent opinion.
  332. Marmol v. St. Jude Medical Center, 132 F. Supp.3d 1359 (M.D. Fla. Sept. 24, 2015), motion to dismiss granted against all claims in action involving pacemaker lead.  Judicial notice taken of FDA website documents, but not their contents.  Manufacturing defect claim not parallel because state law does not recognize FDCA-based negligence per se.  For the same reasons a failure to report-based warning claim also cannot be parallel.  In the absence of state-law duty to make reports to a government agency, plaintiff’s claim is an improper private attempt to enforce the FDCA.
  333. Humana Inc. v. Medtronic Sofamor Danek USA, Inc., 133 F. Supp.3d 1068 (W.D. Tenn. Sept. 25, 2015), motion to dismiss granted against almost all claims in third-party payer action involving bone growth device.  Express and implied warranty and fraud by omission claims preempted.  All other claims, except some federal Medicare claims dismissed for various non-preemption reasons.
  334. Stanfield v. Boston Scientific Corp., 166 F. Supp.3d 873 (S.D. Tex. Sept. 30, 2015), motion to dismiss granted against all claims in action involving pacemaker.  Judicial notice taken of FDA PMA.  PMA supplements and product development protocols are equally preemptive.  No parallel claim pleaded.
  335. Wood v. Medtronic, Inc., 2015 WL 5793602, slip op. (W.D.N.Y. Oct. 2, 2015), motion to dismiss granted against all claims in action involving bone growth device.  Fraud and manufacturing defect inadequately pleaded.  All other claims preempted.
  336. Allen v. Zimmer Holdings, Inc., 2015 WL 6637232 (D. Nev. Oct. 30, 2015), motion to dismiss granted against all claims in action involving a hip prosthesis.  Devices originally cleared as drugs prior to the Medical Device Amendments are treated as having PMA.  A subsequent reclassificationi to Class II does not affect preemption, which is determined as of the time of FDA approval.  All components of a PMA device enjoy PMA preemption.  Plaintiff did not allege any parallel claims.
  337. Conklin v. Banner Health, 2015 WL 10688305 (Ariz. Super. Oct. 30, 2015), motion to dismiss granted against all claims in action involving an infusion pump.  Warranty claims preempted.  Failure to report claim failed to allege causation.  Negligence per se alleging FDCA violations impliedly preempted as private FDCA enforcement.  Affirmed  ___ P.3d ___, 2018 WL 6613311, below.
  338. Byrnes v. Small, 142 F. Supp.3d 1262 (M.D. Fla. Nov. 9, 2015), motion to dismiss granted against almost all claims in amended complaint action involving bone growth device.  Fraudulent omission claims are preempted, but allegations of affirmatively false off-label promotion escape preemption as parallel claims.  All negligence claims that are sufficiently pleaded are preempted.  Express warranty claims insufficiently pleaded.  Prior opinion 60 F. Supp.3d 1289, above.
  339. Ward v. St. Jude Medical, Inc., 2015 WL 12516628 (S.D. Fla. Nov. 9, 2015), motion to dismiss granted against all claims in action involving defibrillator.  Plaintiff pleaded no parallel claims, merely mentioning a recall and unspecified violations is insufficient.
  340. Mink v. Smith & Nephew, Inc., 145 F. Supp.3d 1208 (S.D. Fla. Nov. 19, 2015), motion to dismiss granted against all claims in action involving hip prosthesis.  A list of allegedly violated FDCA regulations, without facts supporting how they were allegedly breached or how the breach was causal, is insufficient to plead a parallel violation.  Contract claim and misrepresentation claims pertaining to plaintiff’s participation in a post-marketing clinical trial were preempted by FDA post-marketing requirements.  No parallel claim exists because Florida law does not require post-surgical monitoring.  Buckman preempts any claim that plaintiff was dropped from the study to avoid FDA reporting requirements.  Reversed in part, 2017 WL 2723913.
  341. Lyles v. Medtronic, Inc., 2015 WL 9997860 (Mag. W.D. La. Nov. 23, 2015), adopted, 2016 U.S. Dist. Lexis 6924 (W.D. La. Jan. 20, 2016), motion to dismiss granted against all claims in action involving bone growth device.  Judicial notice taken of FDA documents.  All warning claims preempted.  Statutory exclusivity means all informational claims are warning claims.  Reconsideration denied, 2016 U.S. Dist. Lexis 59775 (W.D. La. May 4, 2016). Motion for relief from judgment denied, 2016 WL 4540870 (W.D. La. Aug. 31, 2016).  On appeal at
  342. Funke v. Sorin Group USA, Inc., 147 F. Supp.3d 1017 (C.D. Cal. Nov. 24, 2015), motion to dismiss granted against all claims in action involving bioprosthetic heart valve.  Failure to report adverse events inadequately pleaded.  Judicial notice taken of FDA adverse event database that shows reports contrary to plaintiff’s allegations.  No duty to report foreign adverse events prior to PMA.  State reporting duties not parallel to FDA requirements are preempted.  Plaintiff’s manufacturing defect allegations are really a preempted design defect claim.  Negligence and misrepresentation claims also preempted.
  343. Marion v. Smith & Nephew, Inc., 2015 WL 7756063 (D. Utah Dec. 1, 2015), motion to dismiss granted against all claims in action involving hip prosthesis.  No parallel claim pleaded.  Implied preemption eliminates remaining arguments.  Second opinion on amended complaint below.
  344. Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188 (E.D.N.Y. Dec. 7, 2015), motion to dismiss granted against all claims in action involving implantable cardiac defibrillator.  Manufacturing defect claims asserting violation of vague GMPs are preempted.  State law does not require submission of PMA supplements, so no parallel claim can exist.  That purely federal claim is further preempted as attempted private enforcement of the FDA.  Failure to report claims are not parallel.  Filing adverse event reports with FDA is not the same as warning doctors of risks.
  345. Raab v. Smith & Nephew Inc., 150 F. Supp.3d 671 (S.D.W. Va. Dec. 15, 2015), motion to dismiss granted in part and denied in part in action involving hip implant.  Plaintiff had two surgeries, the first with a PMA system, parts of which were replaced in the second surgery with non-PMA components of another system.  A valid parallel claim cannot challenge the FDA’s regulatory process or FDA requirements imposed under that process.  Parallel manufacturing defect claims may be stated for violations of general GMPs as negligence per se or under a malfunction theory.  Design defect claims are preempted.  Warning/marketing claims alleging off-label promotion of the mixing of Class III and Class II components from different systems are preempted because no facts establishing FDCA violations or any parallel state duty are alleged.  Off-label use is not a violation.  Preemption not asserted against claims solely involving the non-PMA components.
  346. Smith v. St. Jude Medical, 2015 WL 9094383 (S.D. Miss. Dec. 16, 2015), motion to dismiss granted against all claims in action involving neurostimulator.  Pro se complaint did not make any parallel claim.  Extensive judicial notice of FDA-related documents.
  347. Day v. HowMedica Osteonics Corp., 2015 U.S. Dist. Lexis 189268 (Mag. D. Colo. Dec. 24, 2015), motion to dismiss granted against all claims in action involving cervical disc system.  Product was IDE device in a clinical trial.  CMP violations cannot serve as parallel claims because IDE devices are exempt from them.  FDA Warning letter did not involve the device.  All information-based claims including express warranty preempted.
  348. Grubbs v. Synthes, 2016 WL 360610 (M.D. Fla. Jan. 19, 2016), motion to dismiss granted against all claims in action involving knee implant.  No parallel claims alleged.  Plaintiff did not establish that the device had been recalled.
  349. Gall v. Stryker Orthopaedics, 2016 WL 7011530 (Cal. Super. Jan. 19, 2016), judgment on the pleadings granted in part and denied in part in action involving hip implant.  Judicial notice taken of various FDA documents.  Manufacturing defect and failure to report warning claims not preempted.  Duty to test preempted as different from FDCA.  See Earlier opinion, above.
  350. Nevolas v. Boston Scientific Corp., 2016 WL 347721 (W.D. Okla. Jan. 28, 2016), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Plaintiff failed to plead parallel claims.  Alleged violations of non-specific GMP regulations do not state parallel claims.  Confidential PMAs do not justify vague pleadings.  Amended complaint dismissed 2016 WL 1532259 (W.D. Okla. April 15, 2016), violations still too vague.  On appeal No. 16-6127 (10th Cir.)
  351. Money v. Johnson & Johnson, 2016 WL 368128 (N.D. Cal. Feb. 1, 2016), judgment on the pleadings granted against all claims in action involving contact lenses.  No parallel claims pleaded.
  352. De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. Feb. 2, 2016), motion to dismiss granted against all claims in action involving implantable contraceptive.  Violation claims must be causal.  Adulteration is not necessarily a design or manufacturing defect.  Negligent training preempted by FDA approval of training manuals.  Manuals judicially noticed.  Failure to report claim noncausal.  Implied warranty preempted.   Express warranty and fraud claims involving FDA-approved statements preempted; rest inadequately pleaded.
  353. Morris v. Greenky, 2016 WL 10703473 (N.Y. Sup. Feb. 9, 2016), motion to dismiss granted against all claims in action involving hip prosthesis.  Generally applicable FDA GMPs are too vague for their violation to serve as the basis for a parallel claim.
  354. Ellis v. Smith & Nephew, Inc., 2016 WL 7319397 (D.S.C. Feb. 16, 2016), motion to dismiss granted against all claims in action involving hip implant.  Parallel claims did not allege either the violation or causation.  A recall does not defeat preemption.  Express and implied warranty and consumer fraud preempted.  Failure to report preempted as private FDCA enforcement.  Plaintiff not entitled to discovery.
  355. Medali v. Bayer Healthcare LLC, 2016 WL 2348545 (Cal. Super. Feb. 16, 2016), demurrer granted against all claims in action involving implantable contraceptive.  Plaintiff did not plead any parallel claim, and must replead.
  356. Felger v. Smith & Nephew, Inc., 2016 WL 8673054 (D. Alaska March 4, 2016), motion to dismiss granted against all claims in action involving hip implant.  All claims are preempted except possibly parallel claims involving manufacturing defects or failure to report, but those claims are insufficiently pleaded.
  357. Mink v. Smith & Nephew, Inc., 169 F. Supp.3d 1321 (S.D. Fla. March 14, 2016), renewed motion to dismiss granted against all claims in action involving hip prosthesis.  While plaintiff’s parallel claim allegations might plausibly allege a violation of the FDCA, they fail under express preemption to state a parallel claim and under implied preemption, both because Florida does not allow FDCA-based negligence per se claims.  A contract claim, involving plaintiff’s termination from a post-marketing clinical trial, cannot be a parallel claim because the termination is not alleged to have violated any regulation.
  358. Thompson v. St. Jude Medical, Inc., 2016 WL 1089978 (S.D. Ind. March 21, 2016), motion to dismiss granted against all claims in action involving defibrillator.  Although plaintiff references a recall, no specific FDA regulatory violation is identified.  Nor did plaintiff plead how any violation caused injury or even how the device was defective or malfunctioned.
  359. McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. March 22, 2016), judgment on the pleadings granted in part and denied in part in action involving implantable contraceptive.  Rejects attorney general argument that PMA preemption requires subject matter specific FDA regulations.  Negligent training claim based on violation of FDA training requirements not preempted, but inadequately pleaded.  Same for negligent risk management.  Same for express warranty.  Same for negligent manufacturing.  Negligent entrustment claim preempted.  Express warranty not preempted.  Fraudulent concealment impliedly preempted as private FDCA enforcement.  Fraud not preempted, except as to FDA-approved statements, but not specifically pleaded.  Misrepresentation survives under lesser pleading standards.  Failure to report not preempted.  Subsequent decision, see below.
  360. Morgan v Medtronic, Inc., 172 F. Supp.3d 959 (S.D. Tex. March 23, 2016), motion to dismiss granted against all claims in action involving spinal pain pump.  Judicial notice of FDA approval documents.  No parallel claim asserted.  Express warranty claim expressly preempted.
  361. Ward v. St. Jude Medical, Inc., 2016 WL 1208789, slip. op. (S.D. Fla. March 28, 2016), motion to dismiss granted against all claims in action involving implantable defibrillator.  No parallel claims alleged, and they would be preempted in any event as attempts to privately enforce the FDCA because Florida does not recognize such claims under state law.
  362. Schmidt v. Boston Scientific Corp., 2016 WL 1274824 (N.D. Ohio March 31, 2016), motion to dismiss granted against all claims in action involving implantable defibrillators.   Plaintiff failed to plead a parallel claim with boilerplate that failed to identify allegedly violated regulations.
  363. Brandt v. Medtronic, Inc., 179 F. Supp.3d 967 (D. Nev. March 31, 2016), motion to dismiss granted against all claims in action involving gastric device.  Taking judicial notice of FDA documents.  PMA preemption applies to devices cleared under the FDA’s humanitarian device exemption.  All warning and design claims preempted.  Fraud on the FDA allegations impliedly preempted.  Plaintiff allowed to replead a possible failure to report parallel claim.
  364. Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April. 6, 2016), motion to dismiss granted against all claims in action involving infusion pump.  Taking judicial notice of FDA documents.  Alleged parallel claims are not alleged to be causal.  Adulteration and misbranding claims are impliedly preempted as private FDCA enforcement.  Express warranty claims preempted and inadequately pleaded.  Implied warranty, fraud, and consumer fraud preempted.  Failure to train preempted because no allegations that FDA-required training not provided.
  365. Yosowitz v. Covidien LP, 182 F. Supp.3d 683 (S.D. Tex. April 23, 2016), motion to dismiss granted against all claims in action involving embolization device.  Taking judicial notice of FDA documents.  Parallel claims insufficiently alleged.  Express and implied warranty preempted.  A recall does not revoke a PMA.  FDCA violation claim impliedly preempted as private FDCA enforcement.
  366. Glennen v. Allergan, Inc., 202 Cal. Rptr.3d 68 (Cal. App. April 29, 2016), grant of demurrer against all claims affirmed.  Failure to train claim preempted because no allegation that FDA required surgeon training that was not provided.  General GMPs do not mandate surgeon training since the FDA does not regulate the practice of medicine.  Since there is no state law duty to train surgeons, claim is also impliedly preempted as private FDCA enforcement.
  367. Money v. Johnson, 2016 WL 3055875 (N.D. Cal. May 31, 2016), judgment on the pleadings granted in part and denied in part in action involving contact lens.  Manufacturing defect and implied warranty claims based on claimed manufacturing violations survive preemption as parallel claims also supported under state law.  General GMP claims would be preempted.  Battery claim preempted.
  368. Lutz-Cummings v. Medtronic, Inc., 2016 WL 3082314 (Minn. Dist. May 31, 2016), motion to dismiss granted against all claims in action involving infusion pump.  Plaintiff’s violation claims involved only general GMPs and were therefore not parallel claims.  Post-sale duty to warn and failure to train claims preempted.  Failure to report claim fails to plead causation.  No state-law duty to refrain from off-label promotion so that claim impliedly preempted as private FDCA enforcement.
  369. Frere v. Medtronic, Inc., 2016 WL 9455137 (C.D. Cal. June 1, 2016), motion to dismiss granted in part and denied in part in action involving pain pump.  Non-violation claims preempted.  Violation claims, including failure to report,  not preempted.  Express and implied warranty claims preempted.  Negligence per se and consumer fraud impliedly preempted as private FDCA enforcement.
  370. Potolicchio v. Medtronic, Inc., 2016 WL 3129186 (E.D. Tenn. June 2, 2016), judgment on the pleadings granted against all claims in action involving infusion pump.  Parallel claims must plead causation.  Violation claims relating to a different version of the product cannot be causal.  No state-law duty to report to FDA.  On appeal, No. 16-6069 (6th Cir.).
  371. Laverty v. Smith & Nephew, Inc., 197 F. Supp.3d 1026 (N.D. Ill. June 23, 2016), partial judgment on the pleadings denied in action involving hip implant.  Plaintiff’s warning claim based on allegations of failure to report adverse events to the FDA was a parallel claim.  Report claim was not disguised FDCA enforcement.
  372. Gates v. Medtronic, Inc., 192 F. Supp.3d 704 (W.D. Tex. June 29, 2016), motion to dismiss granted against all claims in action involving defibrillator lead.  FDA regulates post-recall communications, so claim attacking post-recall statements is preempted.
  373. Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. June 30, 2016), motion to dismiss granted against all claims in action involving implantable defibrillator.  Express warranty preempted, whether or not volunteered.  Sales rep warranties not pleaded.  Warning letter claim could not be causal.  Disapproving information and belief pleading.  Approving in part and disapproving in part 2015 WL 902616 above.
  374. LaFountain v. Smith & Nephew, Inc., 2016 WL 3919796 (D. Conn. July 18, 2016), motion to dismiss granted in part and denied in part in action involving hip implant.  All claims except failure to report and express warranty preempted.  Express warranty improperly pleaded.  Claims solely involving 510k cleared component not preempted.  Fraud on the FDA and off-label promotion claims impliedly preempted.
  375. Stiltner v. Medtronic, Inc., 2016 WL 4005471 (Minn. Dist. July 25, 2016), motion to dismiss granted against all claims in action involving pain pump.  Parallel claims based on warning letters or failure to report adverse event must plead device- and plaintiff-specific causation.  Vague GMPs cannot be the basis of a parallel claim.  Warranty and consumer protection claims are preempted claims seeking additional warnings.
  376. Norman v. Bayer Corp., 2016 WL 4007547 (D. Conn. July 26, 2016), motion to dismiss granted against all claims in action involving contraceptive device.  Parallel claims based on FDA actions did not plead causation, because no facts tie the FDA actions to the plaintiff’s device.  Buckman preemption of failure to report claim.  No parallel state claim exists.  Negligence per se is private FDCA enforcement.  Misrepresentation and express warranty preempted for attacking FDA-approved statements.
  377. Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 27, 2016), motion to dismiss granted in part and denied in part in action involving hip implant.  Failure to report claim presented as negligence per se survives.  No state-law argument against negligence per se in opinion.  Claims of misstatement in PMA process barred as fraud on the FDA claim.  Manufacturing defect preempted as not parallel.  Warning and implied warranty preempted.  Express warranty and several other claims inadequately pleaded.
  378. Skinner v. St. Jude Medical, Inc., 2016 WL 4054931 (W.D. La. July 27, 2016), motion to dismiss granted against all claims in action involving heart valve.  Parallel claim not alleged.
  379. Nagel v. Smith & Nephew, 2016 WL 4098715 (D. Conn. July 28, 2016), motion to dismiss granted against all claims in action involving hip implant.  In cases involving device components subject to mixed levels of FDA approval, PMA preemption applies to all claims that implicate a PMA component.  Only claims entirely divorced from PMA components escape preemption.  Off-label use is legal and does not affect preemption.  Strict liability, negligence, misrepresentation and warranty claims all preempted.
  380. Lance v. Bayer Essure, Inc., 2016 WL 4417248, slip op. (Cal. Super. Aug. 2, 2016), demurrer sustained in part and overruled in part in action involving contraceptive device.  Failure to report adverse event claims are not preempted.  All other warning claims preempted.  Advertising-related claims survive because similarity to FDA-approved labels cannot be decided on demurrer.  Manufacturing and training claims are inadequately pleaded.
  381. Aemisegger v. Medtronic, Inc., 2016 WL 6079941 (Ill. Cir. Aug. 17, 2016), partial motion to dismiss granted in action involving pain pump.  Manufacturing claims may allege violations of non-specific GMPs.  Parallel claims based on an FDA recall must allege causation.  Plaintiff’s injuries could not possibly have been caused by the issue over which the recall occurred.
  382. Weaver v. Ethicon, Inc., 2016 WL 4430855 (S.D. Cal. Aug. 22, 2016), motion to dismiss granted against all claims in action involving self-absorbing surgical matrix.  No parallel claims alleged.  Second motion granted, see below.  Third motion granted in part, see below.
  383. Crissi v. Johnson & Johnson Vision Care, 2016 WL 4502038 (E.D.N.Y. Aug. 22, 2016), judgment on the pleadings granted in action involving extended wear contact lenses.  No parallel claim pleaded.  All relevant promotional materials were FDA approved.
  384. Richardson v. Bayer Healthcare Pharmaceuticals Inc., 2016 WL 4546369 (D. Idaho Aug. 30, 2016), judgment on the pleadings granted in part and denied in part inaction involving contraceptive device.  All claims except failure to report preempted.
  385. White v. Medtronic, Inc., 2016 WL 4539494 (E.D. Pa. Aug. 31, 2016), motion to dismiss granted in part and denied in part in action involving pain pump.  Express warranty not preempted as a voluntary action.  Manufacturing defect not preempted as parallel claim.
  386. Blair v. Medtronic, Inc., 2016 WL 9149503 (N.D. Cal. Sept. 12, 2016), motion to dismiss granted against all claims in action involving neurostimulator.  Judicial notice taken of premarket approval FDA documents.  All negligence, warranty, and strict liability claims preempted.  No parallel claims pleaded.
  387. Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio Sept. 22, 2016), motion to dismiss granted against all claims in action involving bone growth device.  Judicial notice taken of PMA and approved labeling.  Rejects Bausch pleading standard.  PMA component used off-label entitled to full PMA preemption.  Off-label use does not vitiate preemption.  Failure to report does not state a claim and is preempted as not parallel to any state-law claim.  Design claim preempted and inadequately pleaded.  Express warranty involves safety/effectiveness, so is preempted; also inadequately pleaded.  Parallel claims for failure to report and illegal off-label preemption have FDCA violations as a “critical element” and are impliedly preempted.  Fraud inadequately pleaded under 9(b).
  388. Lane v. Boston Scientific Corp., 2016 WL 5369596 (N.D. Ind. Sept. 26, 2016), motion to dismiss denied in action involving spinal stimulator.  Plaintiff’s parallel claims were sufficiently pleaded under Bausch.
  389. Shuker v. Smith & Nephew PLC, 211 F. Supp.3d 695 (E.D. Pa. Sept. 29, 2016), motion to dismiss granted against all claims in action involving hip implant.  Plaintiff’s only parallel claim, for off-label promotion, failed to plead a plausible cause of action, as the document in question could not be construed as off-label promotion.  First dismissal, see 2015 WL 1475368 above.  Affirmed in part and reversed in part below
  390. Mihok v. Medtronic, Inc., 2016 WL 8309087 (Conn. Super. Oct. 20, 2016), motion to strike denied in action involving a pain pump.  Refusing to decide preemption before discovery.
  391. Roberts v. Medtronic, Inc., 2016 WL 6585137 (Minn. Dist. Nov. 4, 2016), motion to dismiss granted against all claims in action involving a pain pump.  Plaintiff failed to plead a parallel claim because violations of vague GMPs are insufficient.  Plaintiff also failed to plead how violations caused injury.  Failure to report and fraud claims also inadequately pleaded to establish a parallel claim.
  392. Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016), renewed motion to dismiss granted against all claims in action involving surgical packing.  Judicial notice taken of FDA documents.  Parallel claims, including failure to report, pleaded violations and causation in conclusory fashion.  Nature of claim and causation must be pleaded.  Warning claim preempted.  Third motion granted in part, see below.
  393. Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016), motion to dismiss granted against all claims in action involving a pacemaker lead.  Judicial notice taken of FDA approval and supplemental approvals.  Supplemental approvals are preemptive.  Preemption not lost by late filing of a PMA supplement, resulting in FDA approval after the device’s use in the plaintiff.  Prior FDA requirements remain in place and preempt design, warning, and manufacturing claims.  Claims based on the late filing are Buckman preempted as private FDA enforcement.
  394. Wildman v. Medtronic, Inc., 221 F. Supp.3d 804 (W.D. Tex. Dec. 22, 2016), judgment on the pleadings granted against all claims in action involving a spinal neurostimulator.  No presumption against preemption in express preemption.  PMA supplement is preemptive.  Battery life warranty claim expressly preempted because the warranty’s contents were dictated by FDA approved statements.  Reversed in part, 2017 WL 4926804, see below.
  395. Parra v. Coloplast Corp., 2017 WL 24794 (E.D. La. Jan. 3, 2017), motion to dismiss granted against all claims in action involving a penile implant.  No parallel claims pleaded.  Nature of express warranty not pleaded.
  396. Babayev v. Medtronic, Inc., 228 F. Supp.3d 192 (E.D.N.Y. Jan. 6, 2017), summary judgment granted against all claims in action involving a neurostimulator.  All common-law claims preempted.  Parallel claims inadequately pleaded and lack factual basis.  Express warranty claims inadequately pleaded.  Vague and open-ended GMPs cannot support parallel claims.  Installation GMPs do not apply to manufacturers of implanted devices.  Surgeons are the installers.  Alleged violations are non-causal.
  397. Godelia v. Zoll Services, LLC, 2017 WL 201826 (S.D. Fla. Jan. 18, 2017), motion to dismiss granted against all claims in action involving an external defibrillator.  All common-law claims preempted.  Parallel claims cannot be based on post-incident warning letter involving different risk plaintiff did not suffer.  Fraud and warranty claims preempted as attack on warnings.  Buckman preemption of parallel claims because state law doesn’t recognize them.  Affirmed in part and reversed in part, 881 F.3d 1309 below.
  398. Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., 216 So.3d 665 (Fla. App. Feb. 15, 2017), grant of summary judgment affirmed against spoliation claim involving spinal pain pump system.  Spoliation claim depended on there being an unpreempted parallel claim.  Parallel claims for violating the FDCA do not exist in Florida.
  399. Silver v. Medtronic, Inc., 236 F. Supp.3d 889 (M.D. Pa. Feb. 21, 2017), motion to dismiss denied in action involving pain pump (other claims dismissed on state law grounds).  Parallel manufacturing defect claim stated by GMP violations from warning letter.  Failure to report warning claim not preempted.  Express warranty not preempted as a voluntary action.
  400. Weaver v. Ethicon, Inc., 2017 WL 680725 (S.D. Cal. Feb. 21, 2017), third motion to dismiss granted against all claims in action involving surgical packing.  Manufacturing defect preempted for not matching FDA enforcement and lack of causation.  No actual failure to report alleged.  Failure to report plaintiff’s own incident cannot be causal.
  401. McLaughlin v. Bayer Corp., 2017 WL 697047 (E.D. Pa. Feb. 21, 2017), second motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Failure to train claim not preempted to the extent it alleges deviation from PMA-mandated training.  Preempted to the extent duties to monitor, certify, or ensure competence are alleged, which go beyond PMA requirements.  Failure to withdraw from market preempted.  Most fraud claims preempted because they involve FDA-approved statements.
  402. Martin v. Medtronic, Inc., 2017 WL 825410 (E.D. Cal. Feb. 24, 2017), motion to dismiss granted against all claims in action involving pain pump.  Express warranty, warning and fraud expressly preempted.  Duty to train not governed by FDA requirements, therefore expressly preempted.  Manufacturing defect, implied warranty, fraud and consumer fraud all based entirely on FDCA violations and therefore impliedly preempted by Buckman.
  403. Chester v. Boston Scientific Corp., 2017 WL 751424 (D.N.J. Feb. 27, 2017), motion to dismiss granted against all claims in action involving implantable defibrillator.  All claims under NJ product liability statute preempted.  Parallel claim not properly pleaded, and would be expressly preempted for lack of any equivalent state-law claims. Failure to report claim also impliedly preempted as private FDCA enforcement.  No discovery allowed.
  404. Lawrence v. Medtronic, 2017 WL 826963 (C.D. Cal. Feb. 27, 2017), motion to dismiss granted against all claims in action involving pain pump.  Parallel claims must plead the nature of the FDCA violation and causation.  All non-violation claims preempted.  On appeal at No. 18-55621 (9th Cir.).
  405. Warstler v. Medtronic, Inc., 238 F. Supp.3d 978 (N.D. Ohio Feb. 28, 2017), motion to dismiss granted against all claims in action involving pain pump.  Parallel claims must be specifically pleaded.  Plaintiff not entitled to discovery.  Plaintiff’s “manufacturing” claim is really a preempted design claim.  Parallel claims cannot be based on vague GMPs.  Failure to report preempted.  No parallel Ohio common law claim.  PMA supplements preemptive.  Express and implied warranty and misrepresentation preempted.  Reconsideration denied, 2017 WL 3088037 (N.D. Ohio July 20, 2017).
  406. Tufts v. Medtronic, Inc., 2017 WL 1062520 (D.S.C. March 21, 2017), motion to dismiss granted against all claims in action involving pain pump.  All common-law claims preempted.  No parallel claims alleged.
  407. Rand v. Smith & Nephew, Inc., 2017 WL 8229320 (C.D. Cal. April 5, 2017), motion to dismiss granted against all claims in action involving hip implant.  Design, express and implied warranty, fraudulent concealment, and all parallel claims expressly preempted, except for failure to report allegations, which are inadequately pleaded.  Violation allegations involving actions not relevant to plaintiff’s condition are not causal.
  408. Cavender v. Medtronic, Inc., 2017 WL 1365354 (N.D. Ind. April 14, 2017), motion to dismiss granted in part and denied in part in action involving defibrillator lead.  Parallel claims are adequately pleaded under Bausch.
  409. Canary v. Medtronic, Inc., 2017 WL 1382298 (E.D. Mich. April 18, 2017), motion to dismiss granted in part and denied in part in action involving spinal stimulator. Design and warning defect claims preempted.  Manufacturing defect parallel claim based on misreading of GMP.  Fraud claim based on statements of manufacturer’s representative survives preemption.
  410. Paturzo v. Boston Scientific Corp., 2017 WL 8220600 (C.D. Cal. April 21, 2017), motion to dismiss granted against all claims in action involving an implantable defibrillator.  Manufacturing defect claim lists regulations without any connecting facts.  Design, warning, and warranty preempted.  Failure to report preempted for failure to identify any actually unreported events.
  411. Russell v. Johnson & Johnson, Inc., 2017 WL 2261136 (Ky. Cir. May 8, 2017), judgment on the pleadings granted against all claims, including warranty, in action involving a cardiac catheter.  Judicial notice of FDA documents given. Requirements imposed through PMA, PMA supplement, and IDE processes were all specific to devices and thus preemptive.  Plaintiff alleged no parallel claims.  Informed consent, fraud, consumer fraud, and unjust enrichment claims preempted as restating warning claim.
  412. Burrell v. Bayer Corp., 260 F. Supp.3d 485 (W.D.N.C. May 10, 2017), motion to dismiss granted against all claims in action involving contraceptive device.  Failure to report impliedly preempted as private FDCA enforcement, and could not possible be causal because FDA already had the information and did not act.  All other claims, including express warranty and consumer fraud, are expressly preempted.  Rejects Hofts pleading standard.  On appeal at No. 17-1715 (4th Cir.).
  413. Beardslee v. UCLA Medical Center, 2017 WL 7411062 (Cal. Super. May 16, 2017), demurrer granted against all claims in action involving cardiac assist device.  No parallel claim alleged.  Amended complaint dismissed, see below, 2017 WL 7411060.
  414. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. June 26, 2017), reversing in part grant of motion to dismiss.  Parallel violation claims are state-law causes of action.  Manufacturing defect and misrepresentation claims are parallel claims and are adequately pleaded.  Plaintiffs need not plead violations specifically.  Failure to report claims involve a duty owed to the FDA that is not a traditional state-law duty and are impliedly preempted.  Misrepresentations about clinical trial were outside what the FDA required, and because they were voluntarily made, not private FDCA enforcement.  Reversing in part 145 F. Supp.3d 1208.
  415. Beardslee v. UCLA Medical Center, 2017 WL 7411060 (Cal. Super. August 10, 2017), demurrer with prejudice granted against all claims in action involving cardiac assist device.  Parallel claim and express warranty allegations were boilerplate.  Implied warranty of safety preempted.  Original complaint dismissed, see above, 2017 WL 7411062.
  416. Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), motion to dismiss granted against all claims in action involving contraceptive device.  General GMPs do not support a parallel claim, and in any event plaintiff has failed to plead any violation related to her claims.
  417. Connelly v. St. Jude Medical, Inc., No. 5:17-cv-02006-EJD, 2017 WL 3619612 (N.D. Cal. Aug. 23, 2017), motion to dismiss granted in part and denied in part in action involving implantable cardiac defibrillator.  Parallel manufacturing and design claims adequately pleaded.  Negligence per se impliedly preempted.
  418. Brackin v. Medtronic, Inc., 2017 WL 5957204 (W.D. Tenn. Sept. 14, 2017), motion to dismiss denied in action involving insulin pump.  The evidence did not establish that the product had been pre-market approved.  Alleged GMP violations were sufficiently definite to be actionable.
  419. Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), motion to dismiss granted against all claims in action involving breast implant.  Parallel claim alleging improper conduct of FDA-mandated post-marketing clinical trials impliedly preempted by Buckman as private FDCA enforcement.  No analogous state-law cause of action exists.  Second order below.
  420. Freed v. St. Jude Medical, Inc., 2017 WL 4102583 (D. Del. Sept. 15, 2017), motion to dismiss granted against all claims in action involving neurostimulator.  PMA approval is judicially noticeable.  Preemption extends to all components of a PMA device system.  Parallel claims not pleaded.  Express warranty and adulteration claims preempted.
  421. Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. Sept. 20, 2017), grant of motion to dismiss reversed in action involving bone growth stimulator.  Only claim at issue was false off-label promotion.  State-law warning claim was parallel to adulteration, and therefore not preempted.  No parallel claim for failure to report or adequate directions for use.  Even though not preempted, dismissal was proper for failure to plead physician-specific causation, but dismissal should have been without prejudice.
  422. Golden v. Brown, slip op., 2017 WL 4239015 (Colo. Dist. Sept. 24, 2017), second motion to dismiss granted against all claims in action involving pain pump.  Parallel claims must plead causation.  A recall does not support a presumption of an FDCA violation.  Vague GMPs do not support parallel claims.  Failure to report adverse events to the FDA are not analogous to state-law warning claims.  They are expressly and impliedly preempted.  Express warranty claims are expressly preempted.
  423. Fisk v. Medtronic, Inc., 2017 WL 4247983 (N.D. Ind. Sept. 25, 2017), motion to dismiss granted in part and denied in part in action involving pain pump.  Since a plaintiff need not plead around preemption as an affirmative defense, specific violations and causation need not be pleaded under Bausch.  Manufacturing defect and failure to report claims survive preemption.  Other warning claims dismissed.  Warranty claims dismissed on state law grounds.
  424. Kodger v. Zimmer Biomet Holdings, Inc., 2017 WL 4348997 (N.D. Ohio Sept. 29, 2017), motion to dismiss denied.  Only manufacturing defect claim asserted, and plaintiff alleged violations of specific GMP standards.
  425. Dunstan v. Bayer Essure, 2017 WL 4392046 (E.D. Pa. Oct. 3, 2017), motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Prior rulings in 172 F. Supp.3d 804, and 172 F. Supp.3d 804, above adhered to.  Negligent misrepresentation preempted where statements approved by FDA, but not as to other statements.
  426. Martin v. Medtronic, Inc., 2017 WL 4574160 (E.D. Cal. Oct. 13, 2017), motion to dismiss granted against all claims in action involving pain pump.  Express warranty preempted as directed against FDA approved statements.  Manufacturing and reporting claims survive preemption but are inadequately pleaded.  Neither claim adequately pleads causation.  Warning letters did not involve plaintiff’s device or were after the fact.  No unreported adverse events are identified.  On appeal at 17-17284 (9th Cir.).
  427. Wildman v. Medtronic, Inc., 874 F.3d 862 (5th Cir. Oct. 31, 2017), reversing in part dismissal of express warranty claims in action involving spinal neurostimulator.  Detailed express warranty went beyond language that FDA had approved, and therefore escaped preemption.  While battery life statement was approved by FDA, statements about rest of device were not.  Plaintiff must plead on remand that device failure was caused by a component other than the battery.  Reversing 221 F. Supp.3d 804, above.
  428. Westmoreland v. Medtronic, Inc., 2017 WL 5132669 (E.D. Mo. Nov. 6, 2017), motion to dismiss granted in part and denied in part in action involving an aortic graft.  Negligence claims concerning the conduct of a sales representative during surgery did not involve FDA-regulated and are not preempted.  Plaintiff failed to allege agency.
  429. Laux v. Mentor Worldwide, LLC, 2017 WL 5186329 (C.D. Cal. Nov. 8, 2017), summary judgment against all claims in action involving breast implants.  Vague GMPs cannot be the basis of a parallel claim.  Plaintiff did not specify which GMP was violated.  On appeal at 17-56832.
  430. Hart v. Medtronic, Inc., 2017 WL 5951698 (D.N.J. Nov. 30, 2017), motion to dismiss granted against all claims in action involving pain pump.  Plaintiff failed to allege a parallel claim.  Express warranty of “safety” preempted.
  431. Moody v. Allergan USA, Inc., 2017 WL 6949742 (W.D.N.Y. Dec. 5, 2017), adopted, 2018 WL 451824 (W.D.N.Y. Jan. 17, 2018), motion to dismiss granted against all claims in action involving gastric band.  Manufacturing defect claims require specific pleading of how product at issue differed from other units.  Consumer fraud claims fail to plead statements not approved by the FDA, or to plead reliance.
  432. Williams v. Bayer Corp., 541 S.W.3d 594 (Mo. App. Dec. 5, 2017), affirming in part and reversing in part grant of motion to dismiss claims involving implantable contraceptive.  Consumer fraud, fraud and express warranty claims preempted where they involve FDA-approved statements.  Failure to report expressly preempted to extent that claimed FDA reaction was removal from market, but not impliedly preempted. Manufacturing-related claims not preempted.  Post-PMA warning claim expressly preempted.  Failure to train claim not preempted to the extent it alleges deviation from PMA-mandated training.  Preempted to the extent training would go beyond PMA requirements.
  433. Bailey v. Medtronic, Inc., 2017 WL 6035329 (S.D. Ind. Dec. 6, 2017), motion to dismiss granted in part and denied in part in action involving defibrillator.  Warranty claims improperly pleaded.  Manufacturing defect claim can be parallel claim.
  434. Gravitt v. Mentor Worldwide, LLC, 289 F. Supp.3d 877 (N.D. Ill. Jan. 11, 2018), motion to dismiss granted in part and denied in part in action involving breast implants.  Claims based on alleged deficiencies in post-marketing studies that did not violate the PMA are expressly preempted.  Claims based on study deficiencies that violated the PMA are impliedly preempted as private FDCA enforcement.  Claims about violations at manufacturing facilities are preempted as not parallel to manufacturing defects.  Failure to report not preempted.  Second motion, 2018 WL 2933609 below.
  435. Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129 (D.D.C. Feb. 5, 2018), summary judgment granted in part and denied in part in action involving insulin pump.  PMA extends to all components of a device system.  Alleged violations of vague GMPs are insufficient to create a parallel claim.  Warning letter did not involve component plaintiff claimed was defective.  Failure to report claim was not parallel to any existing state-law tort and involves speculative causation.  Failure to recall imposes differing requirements.  Manufacturing defect claim not preempted.
  436. Godelia v. Doe, 881 F.3d 1309 (11th Cir. Feb. 8, 2018), affirming in part and reversing in pgoart dismissal of action involving external defibrillator.  Manufacturing defect claim not preempted.  Misrepresentation claim not preempted because it went beyond FDA requirements.  Affirming in part and reversing in part 2017 WL 201826, above.
  437. Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. Mar. 1, 2018), affirming in part and reversing in part dismissal of action involving hip implant.  Refusing to recognize abolition of presumption against preemption in product liability cases.  Off-label use of device components does not preclude preemption.  Preemption is to be evaluated as to each component separately.  All non-parallel claims against PMA component are preempted.  False off-label promotion claim was adequately pleaded and not preempted.  Affirming in part and reversing in part 211 F. Supp.3d 695, above.
  438. Rowe v. Mentor Worldwide LLC, 297 F. Supp.3d 1288 (M.D. Fla. March 2, 2018), motion to dismiss granted in part and denied in part in action involving breast implants.  Failure to report and negligence per se are impliedly preempted as private FDCA enforcement.  Warning and design preempted.  Manufacturing may be unpreempted but must be repleaded.  Misrepresentation fails Rule 9(b).  Warranty fails on state-law grounds.
  439. Mize v. Mentor Worldwide LLC., 2018 WL 1364257, slip op. (Cal. Super. March 13, 2018), demurrer sustained as to all claims in action involving breast implant.  No parallel claims are adequately alleged except failure to report, which cannot possibly be causal because it involves events years after plaintiff’s surgery.
  440. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 300 F. Supp.3d 732 (D. Md. March 26, 2018), motion to dismiss granted in part and denied in part in action involving hip implants.  Design and warning claims preempted.  All parallel claims escape preemption, including negligence per se.
  441. Jones v. Medtronic, Inc., 2018 WL 1462169 (Minn. App. March 26, 2018) (unpublished), grant of motion to dismiss affirmed in part and reversed in part.  Manufacturing defect, failure to report, and warranty claims survive preemption.  Negligence, negligence per se, and consumer fraud claims preempted.
  442. Romer v. Stryker Corp., 2018 WL 1496971 (M.D. Fla. March 27, 2018), motion to dismiss granted in part and denied in part in action involving hip implant.  Negligence per se-based parallel manufacturing defect claim survives preemption.  Strict liability and negligence claims preempted.
  443. In re Essure Product Cases, 2018 WL 1734205, slip op. (Cal. Super. March 28, 2018), summary judgment granted in part and denied in part in action involving contraceptive implant.  Express warranty claims preempted where attacking FDA approved information.  Preemption applies no differently to advertising.  Preemption applies to FDA approved statements, even if the FDA later approves changes to the material.
  444. In re Essure Product Cases, 2018 WL 3602859, slip op. (Cal. Super. March 28, 2018), motion to strike granted in action involving contraceptive implant.  There is no separate cause of action for negligent post-market surveillance, so that cannot be a parallel claim.
  445. Plourde v. Sorin Group USA, Inc., 2018 WL 1542361 (D. Mass. March 29, 2018), motion to dismiss granted in part and denied in part in action involving porcine heart valve.  Failure to report claim survives preemption.  All other claims are preempted.
  446. Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. April 4, 2018), motion to dismiss granted against all claims in action involving gastric band.  All non-parallel claims expressly preempted.  Parallel claim based on permissive regulation expressly preempted because no obligation imposed.  Failure to file CBE warning update expressly preempted.  Failure to report and postmarket surveillance claims impliedly preempted.  Fraud claim too vague to escape preemption.
  447. Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), summary judgment granted in action involving implantable cardioverter defibrillator.  None of the alleged defects violated the manufacturing requirements applicable to the device.  Plaintiff misconstrued those requirements.  A PMA does not prohibit anything not specifically allowed.  Such a prohibition is preempted as “in addition to” FDA requirements.  Longevity projections are not PMA performance standards  A device malfunction does not establish an FDCA regulatory violation.  That long after implantation the device was no longer performing to specification does not establish a violation at the time of sale.  Plaintiff’s engineering expert excluded as not qualified to interpret FDA PMA requirements.  Implied warranty claim, asserting that device was not safe or effective, was impliedly preempted.
  448. Ebrahimi v. Mentor Worldwide LLC, 2018 WL 2448095, slip op. (C.D. Cal. May 25, 2018), motion to dismiss granted against all remaining claims in action involving breast implant.  Technical defects in studies are not adverse events required to be reported to the FDA.  No causation pleaded from alleged failure to report.  Alleged violations of general FDA regulations were too vaguely pleaded.  Plaintiff granted leave to amend.  See below.
  449. Neils v. Steinberg, ___ N.Y.S.3d ___, 2018 WL 2709488 (N.Y. Sup. June 5, 2018), motion to dismiss granted against all claims in action involving intraocular lens.  Express and implied warranty nad negligence claims all would be in different from or in addition to FDA requirements.
  450. Gravitt v. Mentor Worldwide, LLC, 2018 WL 2933609 (N.D. Ill. June 12, 2018), motion to dismiss granted in part and denied in part in action involving breast implants.  Most of plaintiff’s allegations about the conduct of post-marketing studies are not FDCA violations and are expressly preempted.  The others have no common-law equivalent and are preempted as private FDCA enforcement.  No causation where FDA aware of alleged deficiencies and took no action.  Failure to report survives preemption.  Prior ruling, 289 F. Supp.3d 877, above.
  451. Spellman v. Smith & Nephew, Inc., 726 F. Appx. 629 (9th Cir. June 13, 2018), grant of motion to dismiss reversed in action involving knee implant.  Failure to report claims were sufficiently pleaded and escaped preemption.  Plaintiff should have been allowed to amend manufacturing defect allegations.
  452. Benyak v. Medtronic, Inc., 2018 WL 3005915 (Ill. App. June 14, 2018) (unpublished), grant of motion to dismiss affirmed in action involving pain pump.  No presumption against preemption.  Design and manufacturing claims preempted.  No parallel manufacturing claim alleged.  Failure to instruct was a preempted warning claim.
  453. Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. July 12, 2018), motion to dismiss denied in action involving pacemaker leads.  Plaintiff’s only claim, for negligent warning based on failure to report adverse events to the FDA is neither expressly no impliedly preempted.
  454. Reed v. St. Jude Medical, No. CV 17-5560 (JRT/HB), slip op. (Mag. D. Minn. July 24, 2018), adopted, 2018 WL 4251872 (D. Minn. Sept. 6, 2018), motion to dismiss granted against all claims in action involving heart valve.  No parallel claims alleged.  A malfunction does not establish a violation.
  455. Bryant v. Thoratec Corp., No. 2:17-CV-169-KS-MTP, slip op., 2018 WL _______ (S.D. Miss. July 30, 2018), motion to dismiss granted against all claims in action involving left ventricular assist device.   FDA documents subject to judicial notice.  Recall-related claim preempted for adding to federal requirements.  Failure to report plaintiff’s incident cannot possibly be causal.  Direct to patient warning claim violating learned intermediary rule cannot be a parallel claim.  Warning claims preempted.  Manufacturing defect claims are conclusory.
  456. Jones v. Medtronic, Inc., ___ Fed. Appx. ___, No. 15-15653, 2018 WL 3912167 (9th Cir. Aug. 16, 2018), grant of motion to dismissed affirmed in part and reversed in part in action involving bone growth device.  All claims except failure to report, failure to update, and manufacturing defect preempted.  Fraud and negligence per se preempted.
  457. Roemer v. Corin Group, PLC, 2018 WL 4281470 (M.D. Fla. Sept. 9, 2018), motion to dismiss granted against all claims in action involving hip implant.  All claims expressly preempted, except for negligence per se and failure to report, which were impliedly preempted under Buckman as private attempts to enforce the FDCA.
  458. Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), motion to dismiss denied in action involving breast implant.  Plaintiff abandoned all claim except manufacturing defect.  Plaintiff allowed to infer both a manufacturing defect and an FDCA violation from the fact of an alleged malfunction.
  459. Bowlen v. Coloplast A/S, , 2018 WL 4469319 (W.D. Pa. Sept. 18, 2018), motion to dismiss granted in part and denied in part in action involving penile implant.  Warning claims are sufficiently pleaded as parallel claims.  Design defect claims dismissed.
  460. A.F. v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sept. 28, 2018), motion to dismiss granted in part and denied in part in action involving heart valve.  All claims dismissed except failure to report.
  461. Mize v. Mentor Worldwide LLC, 2018 WL 5085716, slip op. (Cal. Super. Oct. 1, 2018), motion to dismiss granted in action involving investigational breast implant.  Failure to report claim is preempted, since it does not involve actual unreported events, but only speculation that more adverse events would have been discovered if studies had been conducted differently.
  462. Shelp v. Allergan, Inc., 2018 WL 5734664 (W.D. Wash. Nov. 2, 2018), motion to dismiss granted in action involving breast implant.  All claims dismissed, including consumer fraud.  No parallel violation claim alleged.
  463. Conklin v. Medtronic, Inc., ___ P.3d ___, 2018 WL 6613311 (Ariz. Dec. 18, 2018), reversal of grant of motion to dismiss reversed in action involving infusion pump.  Arizona does tho recognize claims for failure to report adverse events to the FDA.  Because no parallel state law claim exists, failure to report claims are impermissible attempts at private FDCA enforcement preempted by Buckman.
  464. Ezell v. Medtronic PLC, 2018 WL 6928917 (W.D. La. Dec. 19, 2018), adopted, 2019 WL 97041 (W.D. La. Jan. 3, 2019), motion to dismiss granted against all claims in action involving drug eluding stent.   Judicial notice of FDA approvals.  Parallel claims are not pleaded with sufficient specificity.  Failure to recall claim preempted.
  465. Shelp v. Allergan, Inc., 2018 WL 6694287 (W.D. Wash. Dec. 20, 2018), motion to dismiss granted against all claims in action involving breast implant.  Judicial notice taken of FDA PMA.  Consumer protection claim is really failure to warn.  No parallel claim attempted.
  466. Cashen v. Johnson & Johnson, slip op., 2018 WL 6809093 (New Jersey Super. Law Div. Dec.24, 2018), motion to dismiss granted against all claims in action involving breast implant.  Statutory product liability, express warranty, and fraud claims preempted.  Other claims abrogated by state law.
  467. Ebrahimi v. Mentor Worldwide LLC, 2018 WL ________, slip op. (C.D. Cal. Dec. 27, 2018), motion to dismiss granted without leave to amend against all remaining claims in action involving breast implant.  Defendant’s internal laboratory test results did not create any FDA-imposed standard the violation of which could serve as the basis of a manufacturing defect claim.  Other allegations are too general.

 

The quote “insanity is doing the same thing over and over and expecting a different result” has been attributed variously to Benjamin Franklin and Albert Einstein. That probably means neither of them said it. But whoever did, we think the principle applies to class action litigation involving mass torts.

We’ve kvetched before about plaintiffs’ persistent – yet almost universally futile – assertion of class actions in product liability litigation involving prescription medical products. Name a mass tort from the last decade or so – Vioxx, Baycol, SSRIs, Defibrillators, Prempro, Oxy-Contin, PPA, Propulsid. Chances are very high that there’s been an attempt to certify a class action. Chances are equally high that the class action either wasn’t certified, or else certification was reversed on appeal.

In the personal injury context, no class action certified over opposition has survived appeal since the Supreme Court’s landmark Amchem and Ortiz decisions in the mid-1990s. The most recent notable failure in the drug/device context was In re St. Jude Medical, Inc., 522 F.3d 836 (8th Cir. 2008).

We’ve speculated that a prime reason why the other side keeps this up is that they get something for nothing from even unsuccessful class actions – that something being class action tolling. Getting rid of class action tolling, we’ve suggested, would cut way down on the pursuit of futile class actions in drug/device product liability litigation.

That goes double for cross-jurisdictional class action tolling – the claim that the filing of an unsuccessful class action in, say Pennsylvania, would toll the statute of limitations for potential plaintiffs in some other state, say Illinois. That’s true because mass torts, by their very nature, are themselves cross jurisdictional.

Well, we’ve decided to do something about it. We recently saw another cross-jurisdictional class action tolling case the other day that we liked – Clemens v. DaimlerChrysler Corp., 530 F.3d 852 (9th Cir. 2008), modified on other grounds, 2008 WL 2840662 (9th Cir. July 24, 2008) – and we decided that cross-jurisdictional class action tolling is another area where we could keep a scorecard.

After all, the law has been mostly favorable to the defense position, so getting ahold of all of it is a much bigger problem for our side than for theirs.

These are the subissues that we see as significant in cross-jurisdictional class action tolling: (1) the venue, because the statute of limitations in our area of interest is state-specific; (2) whether the claims involve personal injury or not, because some courts are more tempted to toll state-law antitrust or securities claims (again, not our primary area of interest) where the claims mirror federal claims as to which United States Supreme Court decisions mandate tolling; and (3) if the original class was actually certified (an issue in some older cases). We’ll mention that issue too, because plaintiffs relying upon certified classes had more arguments to make in favor of tolling.

Although we considered doing this scorecard on a state by state, rather than chronological, basis, we decided against it because some cases involve more than one jurisdiction – and we’re too lazy to type in a bunch of cases more than once.

So what follows is a list of all decisions we know of that address cross-jurisdictional class action tolling. As always, let us know if we miss something.

  1. Lee v. Grand Rapids Board of Education, 384 N.W.2d 165 (Mich. App. Jan. 21, 1986). Michigan recognizes cross-jurisdictional class action tolling where the prior class was certified. Non-personal injury case.
  2. In re Agent Orange Products Liability Litigation, 818 F.2d 210 (2d Cir. April 21, 1987).  Hawaii would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  3. Jolly v. Eli Lilly & Co., 751 P.2d 923 (Cal. Feb. 14, 1988).  California does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  4. Singer v. Eli Lilly & Co., 549 N.Y.S.2d 654 (N.Y. App. Div. March 16, 1990).  New York does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  5. Hyatt Corp. v. Occidental Fire & Casualty Co., 801 S.W.2d 382 (Mo. App. Nov. 6, 1990). Missouri recognizes cross-jurisdictional class action tolling where the prior class was certified and settled.  Insurance coverage dispute concerning personal injury claims.
  6. Thoubboron v. Ford Motor Co., 624 A.2d 1210 (D.C. App. May 17, 1993). The District of Columbia does not recognize cross-jurisdictional class action tolling. Personal injury case.
  7. Bell v. Showa Denko K.K., 899 S.W.2d 749 (Tex. App. May 17, 1995).  Texas does not recognize cross-jurisdictional class action tolling. Personal injury case.
  8. Barela v. Showa Denko K.K., 1996 WL 316544 (D.N.M. Feb. 28, 1996).  New Mexico would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  9. Vaught v. Showa Denko K.K., 107 F.3d 1137 (5th Cir. March 10, 1997).  Texas would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  10. In re Norplant Contraceptive Products Liability Litigation, 173 F.R.D. 185 (E.D. Tex. April 30, 1997).  Texas would recognize cross-jurisdictional class action tolling in at least some personal injury cases.  Abrogated by Newby v. Enron Corp., 542 F.3d 463, below.
  11. Portwood v. Ford Motor Co., 701 N.E.2d 1102 (Ill. Oct. 1, 1998).  Illinois does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  12. Senger Brothers Nursery, Inc. v. E.I. Dupont de Nemours & Co., 184 F.R.D. 674 (M.D. Fla. Feb. 5, 1999).  Florida would not recognize cross-jurisdictional class action tolling.  Property damage chemical exposure case.
  13. Staub v. Eastman Kodak Co., 726 A.2d 955 (New Jersey Super. April 5, 1999).  New Jersey recognizes cross-jurisdictional class action tolling.  Personal injury case.
  14. Wade v. Danek Medical, Inc., 182 F.3d 281 (4th Cir. July 2, 1999).  Virginia would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  15. Thelen v. Massachusetts Mutual Life Insurance Co., 111 F. Supp.2d 688 (D. Md. March 30, 2000).  Maryland would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  16. Smith v. Cutter Biological, 770 So.2d 392 (La. App. Sept. 6, 2000).  Louisiana would recognize cross-jurisdictional class action tolling, but only with respect to a class action that had been certified.  Personal injury case.
  17. Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805 (Tenn. Dec. 21, 2000).  Tennessee does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  18. Prieto v. John Hancock Mutual Life Insurance Co., 132 F. Supp.2d 506 (N.D. Tex. Jan. 12, 2001).  Texas would recognize cross-jurisdictional class action tolling where the prior class was certified and settled.  Non-personal injury case.  Abrogated by Newby v. Enron Corp., 542 F.3d 463, below.
  19. Primavera Familienstifung v. Askin, 130 F. Supp.2d 450 (S.D.N.Y. Feb. 5, 2001), partial reconsideration granted on other grounds, 137 F. Supp.2d 438 (S.D.N.Y. 2001). Connecticut would recognize cross-jurisdictional class action tolling in securities cases. Specifically distinguishing personal injury precedent.  Abrogated by Casey v. Merck & Co., 653 F.3d 95 (2d Cir. Dec. 6, 2011), for failure to look to state law.
  20. Ravitch v. Pricewaterhouse, 793 A.2d 939 (Pa. Super. Feb. 25, 2002), affirming 2000 WL 35496909.  Pennsylvania does not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  21. Vaccariello v. Smith & Nephew Richards, Inc., 763 N.E.2d 160 (Ohio March 6, 2002).  Ohio recognizes cross-jurisdictional class action tolling. Personal injury case.
  22. In re New England Mutual Life Insurance Co. Sales Practices Litigation, 2003 WL 25953191(D. Mass. May 20, 2003).  Pennsylvania does not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  23. Johnson v. American Home Products Corp., 62 Pa. D. & C.4th 20 (Pa. C.P. Philadelphia Co. June 11, 2003). Pennsylvania does not recognize cross-jurisdictional class action tolling even where the class action was certified. Personal injury case.
  24. In re West Virginia Rezulin Litigation, 585 S.E.2d 52 (W. Va. July 3, 2003).  West Virginia allows cross-jurisdictional class action tolling.  Personal injury case.
  25. In re Lorazepam & Clorazepate Antitrust Litigation, 2004 WL 7081446 (D.D.C. May 18, 2004).  Mississippi does not allow class actions at all and certainly would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  26. Williams v. Dow Chemical Co., 2004 WL 1348932 (S.D.N.Y. June 16, 2004).  Illinois does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  27. Todd v. F. Hoffman-La Roche, Ltd., 2004 WL 5238952 (Kan. Dist. Aug. 20, 2004).  Kansas does not recognize cross-jurisdictional class action tolling.   Non-personal injury case.
  28. In re Linerboard Antitrust Litigation, 223 F.R.D. 335 (E.D. Pa. Aug. 27, 2004).  Colorado, Indiana, Kansas, South Carolina, and Tennessee would recognize cross-jurisdictional class action tolling in antitrust cases. Distinguishing personal injury precedent.
  29. In re General American Life Insurance Co. Sales Practices Litigation, 391 F.3d 907 (8th Cir. Dec. 6, 2004). Overriding Pennsylvania law to permit cross-jurisdictional class action tolling in federal court of state law economic loss claims.
  30. In re Rezulin Products Liability Litigation, 2005 WL 26867 (S.D.N.Y. Jan. 5, 2005).  New Mexico would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  31. Stone v. Wyeth, 2005 WL 3589423 (Pa. C.P. Philadelphia Co. Aug. 1, 2005).  Pennsylvania does not recognize cross-jurisdictional class action tolling even where the class action was certified.  Personal injury case.
  32. Bozeman v. Lucent Technologies, Inc., 2005 WL 2145911 (M.D. Ala. Aug. 31, 2005).  Alabama would not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  33. In re Copper Antitrust Litigation, 436 F.3d 782 (7th Cir. Feb. 5, 2006).  Rejecting reverse cross-jurisdictional class action tolling.  A state-law class action cannot toll a federal statute of limitation, even in a case based on the same facts.
  34. In re Rezulin Products Liability Litigation, 2006 WL 695253 (S.D.N.Y. March 15, 2006).  Florida does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  35. In re Vitamins Antitrust Litigation, 183 F. Appx. 1 (D.C. Cir. May 15, 2006).  Florida would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  36. In re Enron Corporation Securities Derivitive and ERISA Litigation, 465 F. Supp.2d 687 (S.D. Tex. Dec. 8, 2006). Predicting that Texas would not recognize cross-jurisdictional class action tolling. Ohio recognizes cross-jurisdictional class action tolling.  Non-personal injury case.
  37. Thornton v. State Farm Mutual Auto Insurance Co., 2006 WL 3359448 (N.D. Ohio Nov. 17, 2006).  Ohio only recognizes cross-jurisdictional class action tolling for cases filed in federal court, not for cases filed in other states’ courts.  Non-personal injury case.
  38. In re Dynamic Random Access Memory (Dram) Antitrust Litigation, 516 F. Supp.2d 1072 (N.D. Cal. June 1, 2007). Alaska, Idaho, Louisiana, Montana, Oregon, Utah, and Wyoming would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  39. In re Vioxx Products Liability Litigation, 522 F. Supp.2d 799 (E.D. La. Nov. 8, 2007).  Pennsylvania and Illinois do not recognize cross-jurisdictional class action tolling. Predicting that Puerto Rico would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  40. In re Vioxx Products Liability Litigation, 2007 WL 3334339 (E.D. La. Nov. 8, 2007). Texas and California do not recognize cross-jurisdictional class action tolling. Indiana would not recognize cross-jurisdictional class action tolling. Personal injury case.
  41. In re Vioxx Products Liability Litigation, 2007 WL 3353404 (E.D. La. Nov. 8, 2007).  Kentucky would not recognize cross-jurisdictional class action tolling.  Tennessee does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  42. Champion v. Homa, 2008 WL 900967 (M.D. Ala. March 31, 2008).  Alabama, California, Colorado, Florida, Iowa, Kansas, Kentucky, Michigan, Nebraska, Ohio, and Washington would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  43. One Star v. Sisters of St. Francis, 752 N.W.2d 668 (S.D. 2008).  South Dakota does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  44. Love v. Wyeth, 569 F. Supp.2d 1228 (N.D. Ala. July 24, 2008).  Predicting that Alabama would not recognize cross-jurisdictional class action tolling.  Personal injury case.
  45. Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. July 24, 2008).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  46. Newport v. Dell, Inc., 2008 WL 4347311 (D. Ariz. Aug. 21, 2008).  Predicting that Arizona would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  47. Newby v. Enron Corp., 542 F.3d 463 (5th Cir. Sept. 8, 2008). Predicting that Texas would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  48. Shimari v. CACI International, Inc., 2008 WL 7348184 (E.D. Va. Nov. 25, 2008).  Predicting that Virginia would extend a holding recognizing cross-jurisdictional tolling in an individual case to class actions.  Personal injury, non-product liability case.
  49.  Easterly v. Metropolitan Life Insurance Co., 2009 WL 350595 (Ky. App. Feb. 13, 2009) (unpublished). Kentucky does not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  50. Hatfield v. Halifax PLC, 564 F.3d 1177 (9th Cir. May 8, 2009). California does not recognize cross-jurisdictional class action tolling.  Permits equitable tolling for California residents only.  Non-personal injury case.
  51. In re Urethane Antitrust Litigation, 663 F. Supp.2d 1067 (D. Kan. Aug. 14, 2009). Tennessee does not recognize cross-jurisdictional class action tolling.  Predicting that Indiana would not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  52. New York Hormone Replacement Therapy Litigation (Ansley), 2009 WL 4905232 (N.Y. Sup. Nov. 30, 2009).  New York does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  53. In re Fosamax Products Liability Litigation, 694 F. Supp.2d 253 (S.D.N.Y. March 15, 2010), aff’d, 678 F.3d 134 (2d Cir. 2012) (see below).  Predicting that Virginia will not recognize cross-jurisdictional class action tolling.  Personal injury case.
  54. Ottaviano v. Home Depot, Inc., USA, 701 F. Supp.2d 1005 (N.D. Ill. March 23, 2010).  Illinois does not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  55. Torkie-Tork v. Wyeth, 739 F. Supp.2d 887 (E.D. Va. June 16, 2010).  Predicting (contrary to Wade) that Virginia statutorily allows cross-jurisdictional class action tolling. Personal injury case.
  56. Arandell Corp. v. American Electric Power Co., 2010 WL 3667004 (S.D. Ohio Sept. 15, 2010).  Ohio only recognizes cross-jurisdictional class action tolling for cases filed in federal court, not for cases filed in other states’ courts.   Non-personal injury case.
  57. In re Aredia & Zometa Products Liability Litigation, 754 F. Supp.2d 939 (M.D. Tenn. Dec. 7, 2010).  Tennessee does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  58. Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. Dec. 30, 2010).  Montana recognizes cross-jurisdictional class action tolling. Personal injury case.
  59. Centaur Classic Convertible Arbitrage Fund Ltd. v. Countrywide Financial Corp., 878 F. Supp.2d 1009 (C.D. Cal. Jan. 20, 2011).  California does not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  60. Ramirez v. Fidelity National Title Insurance Co.,  2011 WL 13047300 (D. Ariz. March 31, 2011).  Arizona has not recognized cross-jurisdictional class action tolling. Non-personal injury case.
  61. Sawyer v. Atlas Heating & Sheet Metal Works, Inc., 642 F.3d 560 (7th Cir. May 26, 2011).  Cross-jurisdictional class action tolling is not a concept that applies in federal courts.  Federal courts should follow the federal tolling rule regardless of where cases originate.
  62. State Treasurer of Michigan v. Countrywide Financial Corp., 2011 WL 13220150 (C.D. Cal. Aug. 22, 2011).  California does not recognize cross-jurisdictional class action tolling. Non-personal injury case.
  63. Soward v. Deutsch Bank AG, 814 F. Supp.2d 272 (S.D.N.Y. Sept. 1, 2011).  Refusing to predict that New York would adopt cross-jurisdictional class action tolling.  Non-personal injury case.
  64. Casey v. Merck & Co., 722 S.E.2d 842 (Va. March 2, 2012).  Virginia does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  65. In re Countrywide Finamcial Corp. Mortgage-Backed Securities Litigation, 860 F. Supp.2d 1062 (C.D. Cal. Mar. 9, 2012).  Oklahoma would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  66. In re Countrywide Finamcial Corp. Mortgage-Backed Securities Litigation, 2012 WL 1097244 (C.D. Cal. Mar. 9, 2012).  California does not recognize cross-jurisdictional class action tolling.  Although Ohio does, plaintiffs brought their Ohio claims initially in a California court.  Non-personal injury case.
  67. Irby v. Novartis Pharmaceuticals Corp., 212 WL 897787 (N.J. Super. L.D. March 16, 2012).  Virginia does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  68. Casey v. Merck & Co., 678 F.3d 134 (2d Cir. May 1, 2012).  Virginia does not recognize cross-jurisdictional class action tolling. Personal injury case.
  69. Flick v. Wyeth LLC, 2012 WL 4458181 (W.D. Va. June 6, 2012).  Virginia does not recognize cross-jurisdictional class action tolling. Personal injury case.
  70. In re TFT-LCD (Flat Panel) Antitrust Litigation, 2012 WL 3155693 (N.D. Cal. Aug. 2, 2012).  Refusing to predict that Massachusetts would adopt cross-jurisdictional class action tolling. Non-personal injury case.
  71. Adams v. Deutsche Bank AG & Deutsche Bank Securities, Inc., 2012 WL 12884365 (S.D.N.Y. Sept. 24, 2012).  New York does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.  Affirmed, 529 F. Appx. 98 (2d Cir. 2013) (on the basis of Florida not allowing any class action tolling).
  72. Quinn v. La. Citizens Property Insurance Corp., 118 So. 3d 1011 (La. Nov. 2, 2012).  Louisiana does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  73. FDIC v. Countrywide Financial Corp.,  2012 WL 5900973 (C.D. Cal. Nov. 21, 2012).  California would not recognize cross-jurisdictional class action tolling.  A federal securities law claim cannot be tolled by a similar state-court action.  Non-personal injury case.
  74. Patterson v. Novartis Pharmaceuticals Corp., 909 F. Supp.2d 116 (D.R.I. Dec. 19, 2012). Refusing to predict that Massachusetts would adopt cross-jurisdictional class action tolling.  Personal injury case.
  75. Vincent v. Money Store, 915 F. Supp. 2d 553 (S.D.N.Y. Jan. 4, 2013).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  76. Becnel v. Deutsche Bank, AG, 507 F. Appx. 71 (2d Cir. Jan. 11, 2013).  Florida does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  77. In re Countrywide Financial Corporation Mortgage-Backed Securities Litigation, 934 F. Supp.2d 1219 (C.D. Cal. March 21, 2013).  Statutes of limitations for federal claims cannot be tolled by state-court class actions involving similar claims.  State court action cannot control how federal statutes of limitations operate.  Non-personal injury case.
  78. Blanco v. AMVAC Chemical Corp., 67 A.3d 392 (Del. June 10, 2013).  Delaware recognizes cross-jurisdictional class action tolling. Personal injury case.
  79. NCUA Board v. Morgan Stanley & Co., 2013 WL 4736247 (D. Kans. Sept. 3, 2013).  California, Illinois, and Texas do not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  80. Adedje v. Westat, Inc., 75 A.3d 401 (Md. App. Sept. 6, 2013).  Maryland does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  81. Kaufman v. Sirius XM Radio, Inc., 980 N.Y.S.2d 276 (table), 2013 WL 5429364 (N.Y. Sup. Sept. 17, 2013).  New York does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  82. Forde v. Waterman Steamship Corp., 2013 WL 5309453  (S.D.N.Y. Sept. 18, 2013).  Maritime law does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  83. Chaverri v. Dole Food Co. Inc., 546 F. Appx. 409 (5th Cir. Sept. 19, 2013).  Louisiana does not recognize cross-jurisdictional class action tolling.  Personal injury case.
  84. Hendrix v. Novartis Pharmaceutical Corp., 975 F. Supp.2d 1100 (C.D. Cal. Oct. 2, 2013).  California does not recognize cross-jurisdictional class action tolling.  Personal injury case.  Affirmed, 647 F.Appx. 749 (9th Cir. 2016).
  85. Hopper v. Novartis Pharmaceuticals Corp., 2013 WL 8147354 (D.S.C. Dec. 9, 2013).  Alabama would not recognize cross-jurisdictional class action tolling.   Federal courts should not predict expansion of state law.  Personal injury case.
  86. NCUA Board v. Morgan Stanley & Co., 2013 WL 6842596 (D. Kans. Dec. 27, 2013).  So few states recognize cross-jurisdictional class action tolling, that tolling should not be allowed for claims originating in state court.  Non-personal injury case.
  87. In re Bear Stearns Cos. Securities, Derivative, & ERISA Litigation, 995 F. Supp.2d 291 (S.D.N.Y. Feb. 5, 2014).  New York does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.  Affirmed on other grounds, 829 F.3d 173 (2d Cir. 2016).
  88. In re Ford Tailgate Litigation, 2014 WL 1007066 (N.D. Cal. March 12, 2014).   California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  89. In re Cathode Ray Tube CRT Antitrust Litigation, 2014 WL 1091589 (N.D. Cal. March 13, 2014).  Kansas, Michigan, and Minnesota would not not recognize cross-jurisdictional class action tolling, at least with respect to complaints filed in federal court.  Non-personal injury case.
  90. In re Cathode Ray Tube CRT Antitrust Litigation, 27 F. Supp.3d 1015 (N.D. Cal. March 13, 2014).  Tennessee, New York, California, and Florida do not recognize cross-jurisdictional class action tolling.  New Jersey only recognizes it only for claims actually raised by former class members.  Non-personal injury case.
  91. Wang v. Bear Stearns Cos., 14 F. Supp.3d 537 (S.D.N.Y. April 16, 2014).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  92. In re HSBC Bank, USA, N.A., Debit Card Overdraft Fee Litig., 14 F. Supp. 3d 99 (E.D.N.Y. April 21, 2014).  New York would allow cross-jurisdictional class action tolling where the prior class was certified.   Non-personal injury case.
  93. Rolwing v. Nestle Holdings, Inc., 437 S.W.3d 180 (Mo. June 10, 2014).  Missouri does not recognize cross-jurisdictional class action tolling.  American Pipe does not apply to separate state-court class actions.  Only the legislature can decide to toll statutes of limitations.  Non-personal injury case.
  94. Smith v. Transport Services Co., 148 So.3d 903 (La. July 1, 2014).  Louisiana’s rejection of cross-jurisdictional class action tolling does not extend to a case originating in Louisiana state court but removed to federal court by the defendant.  Personal injury case.
  95. In re BP p.l.c. Securities Litigation,  51 F. Supp.3d 693 (S.D. Tex. Sept. 30, 2014).  Texas does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  96. Coe v. Philips Oral Healthcare Inc., 2014 WL 5162912 (W.D. Wash. Oct. 14, 2014).  New York does not recognize cross-jurisdictional class action tolling.   Federal courts should not predict expansion of state law.  Non-personal injury case.
  97. Lewis v. Pella Corp., 2014 WL 7264893 (D.S.C. Dec. 17, 2014).  Missouri does not recognize cross-jurisdictional class action tolling.   Non-personal injury case.
  98. Romig v. Pella Corp., 2014 WL 7264388 (D.S.C. Dec. 18, 2014).  New York would not recognize cross-jurisdictional class action tolling.   Federal courts should not predict expansion of state law.  Non-personal injury case.
  99. Schwartz v. Pella Corp., 2014 WL 7264948 (D.S.C. Dec. 18, 2014).  Minnesota would not recognize cross-jurisdictional class action tolling.   Federal courts should not predict expansion of state law.  Non-personal injury case.
  100. Alexander v. Pella Corp., 2015 WL 1798859 (D.S.C. April 21, 2015).  Washington State would not recognize cross-jurisdictional class action tolling.   Non-personal injury case.
  101. Wegner v. Pella Corp., 2015 WL 2089658 (D.S.C. May 5, 2015).  Iowa would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  102. Pohutsky v. Pella Corp., 2015 WL 2379496 (D.S.C. May 19, 2015).  Maryland does not recognize cross-jurisdictional class action tolling.   Federal courts should not predict expansion of state law.   Non-personal injury case.
  103. Germinaro v. Fidelity National Title Insurance Co., 107 F. Supp.3d 439 (W.D. Pa. May 27, 2015).  Pennsylvania does not recognize cross-jurisdictional class action tolling.   Non-personal injury case.
  104. Rader v. Greenberg Traurig, LLP, 352 P.3d 465 (Ariz. App. June 23, 2015).  Arizona does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  105. In re Dairy Farmers of America, Inc. Cheese Antitrust Litigation, 2015 WL 3988488 (N.D. Ill. June 29, 2015).  California and Florida do  not recognize cross-jurisdictional class action tolling.  Arkansas, Minnesota and North Carolina would not recognize cross-jurisdictional class action tolling.  Federal courts should not predict expansion of state law.   Non-personal injury case.
  106. In re LIBOR-Based Financial Instruments Antitrust Litigation, 2015 WL 4634541 (S.D.N.Y. Aug. 4, 2015).  Displaying bias in favor of cross-jurisdictional class action tolling.  Predicting tolling for California, Connecticut, Iowa, New Jersey, New York, and Ohio. Pennsylvania and Virginia reject cross-jurisdictional class-action tolling.
  107. Kancilia v. Winburn, 2015 WL 13333689 (D. Ariz. Sept. 9, 2015).  Arizona does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.  Affirmed on other grounds, 678 F. Appx. 531 (9th Cir. 2017).
  108. Patrickson v. Dole Food Co., 368 P.3d 959  (Haw. Oct. 21, 2015).  Hawaii allows cross-jurisdictional class action tolling.  Non-personal injury case.
  109. Dineen v. Pella Corp., 2015 WL 6688040 (D.S.C. Oct. 30, 2015).  Florida would not not recognize cross-jurisdictional class action tolling.   Non-personal injury case.
  110. In re LIBOR-Based Financial Instruments Antitrust Litigation2015 WL 6243526 (S.D.N.Y. Oct. 4, 2015).  Displaying bias in favor of cross-jurisdictional class action tolling.  Predicting tolling for California, Connecticut, Iowa, New Jersey, New York, and Ohio. Kansas, Pennsylvania and Virginia reject cross-jurisdictional class-action tolling.  Non-personal injury case.
  111. Gould v. Helen of Troy Ltd., 2017 WL 1319810 (S.D.N.Y. March 30, 2017).  New York does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  112. Famular v. Whirlpool Corp., 2017 WL 2470844 (S.D.N.Y. June 7, 2017).  Predicting that New York would adopt cross-jurisdictional class action tolling.  Federal courts may freely predict expansion of state law.  Non-personal injury case.
  113. Boelter v. Hearst Communications, Inc., 269 F. Supp.3d 172 (S.D.N.Y. Sept. 7, 2017).  Michigan has adopted a statute that allows cross-jurisdictional class action tolling.  Non-personal injury case.
  114. Garcia v. Ocwen Loan Servicing, LLC, 2017 WL 8222634 (C.D. Cal. Oct. 31, 2017).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  115. Mix v. Ocwen Loan Servicing, LLC, 2017 WL 5549795 (W.D. Wash. Nov. 17, 2017).  Washington State would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  116. Embree v. Ocwen Loan Servicing, LLC, 2017 WL 5632666 (E.D. Wash. Nov. 22, 2017).  Washington State would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  117. Brandt v. Ocwen Loan Servicing, LLC, 2017 WL 5878581 (E.D. Cal. Nov. 29, 2017).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  118. Archon Corp. v. Eighth Judicial District Court, 407 P.3d 702 (Nev. 2017).  Declining to decide, on mandamus, whether Nevada would recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  119. Geismar v. Ocwen Loan Servicing, LLC, 2018 WL 276813 (N.D. Cal. Jan. 3, 2018).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  120. Chavez v. Occidental Chemical Corp., 2018 WL 352810 (S.D.N.Y. Jan. 10, 2018).  Predicting that New York would adopt cross-jurisdictional class action tolling.  Personal injury case.   Reconsideration denied, 2018 WL 620488 (S.D.N.Y. Jan. 29, 2018).
  121. Wilchfort v. Knight, 307 F. Supp.3d 64 (E.D.N.Y. March 30, 2018).  Predicting that Florida would not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  122. Yi v. BMW of North America, LLC, 2018 WL 3359016, at *8 (C.D. Cal. May 24, 2018).  California does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  123. Weatherly v. Pershing, LLC, 322 F. Supp.3d 746 (N.D. Tex. July 12, 2018).  Florida does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  124. Edelson PC v. Bandas Law Firm PC, 2018 WL 34960856 (N.D. Ill. July 20, 2018).  Illinois does not recognize cross-jurisdictional class action tolling.  Non-personal injury case.
  125. Hart v. BHH, LLC, 323 F. Supp.3d 560 (S.D.N.Y. Sept. 5, 2018).   Predicting that New York would adopt cross-jurisdictional class action tolling.  Non-personal injury case.

Regular readers know that we’ve been keeping two “scorecards” – one for drug preemption, and one for device preemption. While we continue to update the drug preemption scorecard religiously, the device preemption scorecard is no longer necessary after Riegel settled the basic preemption issues – mostly in favor of our position.

Gluttons for (inflicting) punishment that we are, we’ve decided to create something different, a “cheet sheet,” to replace medical device preemption. What follows is a list – that we’ll keep current as best we can – of all drug and medical device decisions that have rejected claims brought by plaintiffs who have suffered no present injury. Cases in this scorecard will include both increased risk claims and claims involving intangible (as opposed to out of pocket) economic loss.  This differs from a scorecard, in that it includes only decisions that are favorable to the defense side.  This is a more contentious area, and we don’t believe in doing the other side’s research for them.

We thought about including non-drug/device cases but, frankly, even we have our limits. To try to keep up with the law on an ongoing basis beyond drugs and medical devices would just be too much work.

So with that introduction, here’s our cheat sheet for drug and medical device decisions concerning no-injury claims. If you know of something we don’t have, by all means send us an email.

  1. Woodill v. Parke Davis & Co., 374 N.E.2d 683 (Ill. App Jan. 27, 1978). Bystander emotional distress of parents of child injured by Pitocin was insufficient injury in the absence of an intentional tort. This decision was affirmed on other grounds. Woodill v Parke Davis & Co., 402 N.E.2d 194 (Ill. Feb. 22, 1980).
  2. Mink v. University of Chicago, 460 F. Supp. 713 (N.D. Ill. Mar. 17, 1978). Increased risk/fear of cancer from exposure to DES is not sufficient injury.
  3. Payton v. Abbott Labs, 437 N.E.2d 171 (Mass. June. 22, 1982). Increased risk/fear of future serious disease from exposure to DES is not sufficient injury.
  4. Plummer v. Abbott Laboratories, 568 F. Supp. 920 (D.R.I. July 1, 1983). Fear of increased risk of cancer from exposure to DES is not sufficient injury.
  5. Colby v. E.R. Squibb & Sons, Inc., 589 F. Supp. 714 (D. Kan. July 9, 1984). Asymptomatic, undetectable cancer from exposure to DES is not sufficient injury.
  6. Rall v. Medtronic, Inc., 1986 WL 22271 (D. Nev. Oct. 15, 1986). Fear of increased risk of pacemaker lead failure is not sufficient injury.
  7. Hahn v. Sterling Drug, Inc., 805 F.2d 1480 (11th Cir. Dec. 16, 1986). Bystander emotional distress of parents of child injured by Campho-Phenique is insufficient injury under the “impact rule.” Hahn applied Georgia law.
  8. Hagepanos v. Shiley, Inc., 1988 WL 35752 (4th Cir. Apr. 18, 1988) (unpublished, in table at 846 F.2d 71). Increased risk/fear of heart valve failure is not sufficient injury. Hangepanos applied Maryland law.
  9. Taylor v. Medtronics, Inc., 861 F.2d 980 (6th Cir. Nov. 22, 1988). Risk of pacemaker lead failure is not sufficient injury where plaintiff’s lead never failed. Taylor applied Ohio law.
  10. Kent v. Shiley, Inc., 1989 WL 88307 (D. Or. Jan. 24, 1989). Fear of increased risk of heart valve failure is not sufficient injury. Kent was affirmed in an unpublished opinion. Pryor v. Shiley, Inc., 1990 WL 159582 (9th Cir. Oct. 18, 1990) (in table at 916 F.2d 716).
  11. O’Brien v. Medtronic, Inc., 439 N.W.2d 151 (Wis. App. Mar. 14, 1989). Increased risk of pacemaker failure is not sufficient injury, even where plaintiff had medically unnecessary explant surgery. A further appeal was denied.
  12. Sill v. Shiley, Inc., 735 F. Supp. 337 (W.D. Mo. June 1, 1989). Fear of increased risk of heart valve failure is not sufficient injury. Sill was affirmed without published opinion. Sill v. Shiley, Inc., 909 F.2d 508 (8th Cir. 1990).
  13. Brinkman v. Shiley, Inc., 732 F. Supp. 33 (M.D. Pa. June 7, 1989). Fear of increased risk of heart valve failure is not sufficient injury. Brinkman was affirmed without published opinion. Brinkman v. Shiley, Inc., 902 F.2d 1558 (3d Cir. Nov. 24, 1989).
  14. Khan v. Shiley Inc., 266 Cal. Rptr. 106 (Cal. App. Jan. 30, 1990). Increased risk/fear of heart valve failure is not sufficient injury, except in an action for fraud, which was allowed to proceed. A further appeal was denied.
  15. Spuhl v. Shiley, Inc., 795 S.W.2d 573 (Mo. App. Aug. 14, 1990). Fear of increased risk of heart valve failure is not sufficient injury. A further appeal was denied.
  16. Burk v. Sage Products, Inc., 747 F. Supp. 285 (E.D. Pa. Sept. 27, 1990). Fear of AIDS from needlestick was not sufficient injury, without proof of actual exposure.
  17. Lauterbach v. Shiley, Inc., 1991 WL 148137 (S.D. Tex. Mar. 29, 1991). Fear of increased risk of heart valve failure is not sufficient injury.
  18. Willett v. Baxter International, Inc., 929 F.2d 1094 (5th Cir. May 1, 1991). Fear of increased risk of heart valve failure is not sufficient injury. Willett applied Louisiana law.
  19. Murphy v. Shiley, Inc., 1991 WL 135505 (9th Cr. 1991) (unpublished, in table at 940 F.2d 668). Fear of increased risk of heart valve failure is not sufficient injury. Murphy applied Washington law).
  20. Bravman v. Baxter Healthcare Corp., 794 F. Supp. 96 (S.D.N.Y. May 18, 1992). Increased risk/fear of heart valve failure is not sufficient injury. Reversed in part, Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 74 (2d Cir. 1993), plaintiff could bring claim for excessive noise, but not for a failure that had not occurred.
  21. Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273 (Haw. Sept. 30. 1992). Where the plaintiff had medically indicated explant surgery, increased risk of heart valve failure was sufficient injury.
  22. Walus v. Pfizer, Inc., 812 F. Supp. 41 (D.N.J. Jan. 22, 1993). Fear of increased risk of heart valve failure is not sufficient injury.
  23. Mattaliano v. Shiley, Inc., 1993 WL 13145778 (D.N.J. Feb. 25, 1993). Fear of increased risk of heart valve failure is not sufficient injury.
  24. Nesom v. Tri Hawk International, 985 F.2d 208 (5th Cir. Mar. 8, 1993). Fear of future injury from tissue transplant not sufficient injury. Nesom applied Louisiana law.
  25. Angus v. Shiley Inc., 989 F.2d 142 (3d Cir. Mar. 29, 1993). Fear of increased risk of heart valve failure is not sufficient injury. Angus applied Pennsylvania law.
  26. Upjohn Co. v. Freeman, 885 S.W.2d 538 (Tex. App. Aug. 26, 1994). Loss of consortium claim is derivative and fails where spouse was not injured by use of Halcion. A further appeal was denied.
  27. Lareau v. Page, 39 F.3d 384 (1st Cir. Nov. 14, 1994). Consumer fraud claim for failure to warn of unrealized risk of brain tumor from exposure to Thorotrast is not sufficient injury. Lareau applied Massachusetts law.
  28. Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. Feb. 7, 1995). Where the plaintiff had medically indicated explant surgery, increased risk of heart valve failure was sufficient injury. Michael applied Pennsylvania law.
  29. Cameron v. American Dental Technologies, Inc., 1995 WL 599871 (E.D. Mich. June 8, 1995). Misrepresentation claim about capability of medical laser is barred by economic loss rule where there is no claim of physical injury.
  30. Martin v. American Medical Systems, Inc., 1995 WL 680630 (S.D. Ind. Oct. 25, 1995). Risk of penile implant failure is not sufficient injury to create a “case or controversy” that confers Article III standing to sue upon members of class that had not suffered failure, nor is it sufficient state-law injury.
  31. Pfizer, Inc. v. Farsian, 682 So.2d 405 (Ala. Aug. 30, 1996). Increased risk/fear of heart valve failure is not sufficient injury. Fraud case.
  32. Vitolo v. Dow Corning Corp., 651 N.Y.S.2d 104 (N.Y. App. Div. Dec. 9, 1996). Prescriber’s claim for economic harm from negative publicity about breast implants he implanted isnot sufficient injury in tort or warranty.
  33. In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863 (D. Minn. Nov. 13, 1998). Increased risk of breast implant failure is not sufficient injury. Minnesota Breast Implant applied Arizona law.
  34. Wiggins v. Boston Scientific Corp., 1999 WL 94615 (E.D. Pa. Jan. 7, 1999). Asymptomatic presence of broken piece of guide wire in plaintiff’s body is not sufficient injury. Reconsideration denied, Wiggins v. Boston Scientific Corp., 1999 WL 200672 (E.D. Pa. Apr. 8, 1999).
  35. Petito v. A.H. Robins Co., 750 So.2d 103 (Fla. App. Dec. 22, 1999). Uninjured users of fen-phen may pursue claims for medical monitoring. A further appeal was denied.
  36. McGeehan v. Becton-Dickinson & Co., 2000 WL 33128993 (Pa. C.P. Dec. 18, 2000). Where employers paid all expenses of needlestick plaintiffs no injury supports medical monitoring claim.
  37. Fetick v. American Cyanamid Co., 38 S.W.3d 415 (Mo. Mar. 6, 2001). Prescribing physician’s mental suffering in fraud case involving alleged risks of oral polio vaccine, where plaintiff was not physically injured and was not suing on behalf of injured patient, is not sufficient injury.
  38. Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315 (5th Cir. Feb. 15, 2002). Increased risk of injury from Duract is not sufficient injury to create a “case or controversy” that confers Article III standing to sue. Question of sufficiency of injury under Texas law not presented.
  39. Cartiglia v. Johnson & Johnson Co., 2002 WL 1009473 (N.J. Super. Law Div. Apr. 24, 2002). Consumer fraud claims of patients using Propulsid who suffered no physical injury and did not allege paying for the drug alleged insufficient injury.
  40. In re Propulsid Products Liability Litigation, 208 F.R.D. 133 (E.D. La. June 4, 2002). Medical monitoring and restitution claims by persons not injured by Propulsid stated sufficient injury to create a “case or controversy” that confers Article III standing to sue. State-law injury issues not addressed.
  41. Wood v. Wyeth-Ayerst Laboratories, Division of American Home Products, 82 S.W.3d 849 (Ky. Aug. 22, 2002). Increased risk of heart disease from exposure to Fenfluramine not sufficient injury. No cause of action for medical monitoring.
  42. Nishi v. Ethicon, Inc., 2003 WL 917978 (N.D. Cal. Feb. 26, 2003). Unfair competition claim for restitution brought by plaintiff not suffering any out of pocket loss from contaminated sutures is not sufficient injury to create a “case or controversy” that confers Article III standing to sue. Nor does plaintiff have standing to represent the general public.
  43. Friedman v. Merck & Co., 131 Cal. Rptr.2d 885 (Cal. App. Mar. 26, 2003). Risk of emotional injury from vegan’s exposure to animal products in tuberculosis test is not sufficient injury. A further appeal was denied.
  44. In re St. Jude Medical, Inc. Silzone Heart Valves Products Liability Litigation, 2003 WL 1589527 (D. Minn. Mar. 27, 2003). Subclinical injuries from implantation of Silzone heart valves are sufficient to create a “case or controversy” that confers Article III standing to sue. Reversed on other grounds, In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. Oct. 12, 2005) (class action should not have been certified).
  45. Tedford v. Warner-Lambert Co., 327 F.3d 423 (5th Cir. Apr. 7, 2003). Increased risk/fear of future injury from Rezulin is not sufficient injury. Tedford applied Texas law.
  46. Desiano v. Warner-Lambert Co., 326 F.3d 339 (2d Cir. Apr. 18, 2003). Consumer fraud claims that plaintiffs purchased higher priced Rezulin over available lower priced alternatives allege sufficient injury. Desiano applied New Jersey law.
  47. Searfoss v. Johnson & Johnson, 2003 WL 23785715 (Pa. C.P. May 29, 2003). Asymptomatic heart condition from exposure to Propulsid is not sufficient injury. Affirmed by uncitable memorandum opinion, Searfoss v. Johnson & Johnson, 2004 WL 792789 (Pa. Super. Jan. 8. 2004) (in table at 847 A.2d 766).
  48. In re West Virginia Rezulin Litigation, 585 S.E.2d 52 (W. Va. July 3, 2003). Uninjured users of Rezulin may pursue claims for medical monitoring.
  49. Albertson v. Wyeth Inc., 63 Pa. D. & C.4th 514 (Pa. C.P. July 8, 2003). Uninjured users of fen-phen may pursue claims for medical monitoring.
  50. N.J. Citizen Action v. Schering-Plough Corp., 842 A.2d 174 (N.J. App. Div. July 15, 2003). Consumer fraud claims that plaintiffs purchased Claritin at artificially increased prices do not allege sufficient injury. A further appeal was denied.
  51. Williams v. Purdue Pharma Co., 297 F. Supp.2d 171 (D.D.C. Dec. 31, 2003). Consumer fraud claims that plaintiffs purchased Oxycontin at artificially increased prices do not allege sufficient injury.
  52. Heindel v. Pfizer Inc., 381 F. Supp.2d 364 (D.N.J. June 7, 2004). Consumer fraud and warranty claims that plaintiffs purchased Celebrex or Vioxx at artificially increased prices do not allege sufficient injury. The drugs were effective for their indicated use. Heindel applied New Jersey and Pennsylvania law. Pennsylvania claims are also barred by the economic loss rule.
  53. Lewis v. Bayer AG, 70 Pa. D. & C.4th 52 (Pa. C.P. Nov. 18, 2004). Uninjured users of Baycol may pursue claims for medical monitoring.
  54. Sutton v. St. Jude Medical S.C., Inc., 419 F.3d 568 (6th Cir. Aug. 23, 2005). Increased risk of aortic connector failure is sufficient injury to create a “case or controversy” that confers Article III standing to sue. Question of sufficiency of injury under Tennessee law is not presented.
  55. Taylor v. Pharmacia-Upjohn Co., 2005 WL 3502052 (S.D. Miss. Dec. 19, 2005). Fear of increased risk of cancer from exposure to Depo-Provera is not sufficient injury where significant exposure is not established.
  56. Buckland v. Threshold Enterprises, Inc., 2006 WL 5574742 (Cal. Super. June 19, 2006). Having lawyer spend money to buy product on plaintiff’s behalf held insufficient injury under consumer fraud statute.
  57. Conway v. A.I. DuPont Hospital for Children, 2007 WL 560502 (E.D. Pa. Feb. 14, 2007). Medical monitoring claim for future out of pocket expenses incurred as a result of implantation of stent is viable without present injury.
  58. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 484 F. Supp.2d 973 (D. Minn. Apr. 16, 2007). Claims of third party payers that purchased implantable defibrillators based upon misconduct directed to prescribing physicians are not sufficient injury to create a “case or controversy” that confers Article III standing to sue. Question of sufficiency of injury under state law is not presented. Reconsideration granted, in part, to change dismissal to “without prejudice.” In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 2028137 (D. Minn. May 9, 2007).
  59. Prohias v. Pfizer, Inc., 485 F. Supp.2d 1329 (S.D. Fla. Apr. 24, 2007). Consumer fraud claims that plaintiffs purchased Lipitor at artificially increased prices do not allege sufficient injury. The drug was effective for its indicated use.
  60. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289 (D. Minn. June 12, 2007). Where the plaintiff had medically indicated explant surgery, increased risk of defibrillator failure is sufficient injury. The case applied California law.
  61. In re Bextra & Celebrex Marketing, Sales Practices & Product Liability Litigation, 2007 WL 2028408 (N.D. Cal. July 10, 2007). Consumer fraud claims that plaintiffs purchased higher priced Bextra and Celebrex over available lower priced alternatives allege sufficient injury.
  62. International Union of Operating Engineers Local No. 68 Welfare Fund v. Merck & Co., 929 A.2d 1076 (N.J. Sept. 6, 2007). Consumer fraud claims that plaintiffs purchased Vioxx at artificially increased prices do not allege sufficient injury.
  63. Simonet v. SmithKline Beecham Corp., 506 F. Supp.2d 77 (D.P.R. Aug. 3, 2007). Tort claims that Paxil did not function as intended and was therefore ineffective are barred by economic loss rule where plaintiff suffered no physical injury.
  64. Lorenzi v. Pfizer, Inc., 519 F. Supp.2d 742 (N.D. Ohio Oct. 24, 2007). Asymptomatic loss of bone mineral density from exposure to Depo-Provera is not sufficient injury.
  65. Parker v. Howmedica Osteonics Corp., 2008 WL 141628 (D.N.J. Jan 14, 2008). Consumer fraud claims for possible future costs of medical care not yet incurred due to implantation of total hip replacement do not allege sufficient injury.
  66. Sarrazine v. Louis Garzone Funeral Home, 2008 WL 204986 (Pa. C.P. Jan. 14, 2008), aff’d mem., 959 A.2d 982 (Pa. Super. 2008). Fear of infection from allograft is not sufficient injury absent proof of actual exposure to infectious agent.
  67. Aberbach v. Biomedical Tissue Services, Ltd., 854 N.Y.S.2d 143 (N.Y. App. Div. Feb. 26, 2008). “Potential” for infection by bone paste is not sufficient injury.
  68. Clark v. Pfizer, Inc., 2008 Phila. Ct. Com. Pl. Lexis 74 (Pa. C.P. Mar. 14, 2008). Tort claims of purchasers of Neurontin for off-label uses are not barred by economic loss rule.
  69. Sinclair v. Merck & Co., 948 A.2d 587 (N.J. June 4, 2008). Uninjured users of Vioxx may not pursue claims for medical monitoring.
  70. Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314 (N.D. Fla. July 10, 2008). Asymptomatic loss of bone mineral density from exposure to Depo-Provera is not sufficient injury.
  71. Clayworth v. Pfizer, Inc., 83 Cal. Rptr.3d 45 (Cal. App. July 25, 2008). Pharmacies that passed on any artificially high drug charges to their customers did not sustain any cognizable injury for antitrust or consumer protection purposes.
  72. Oliver v. Pharmacia & Upjohn Co., C.A. No. 06-5737 §B(2), 2008 WL 4691626 (E.D. La. Oct. 6, 2008). Asymptomatic loss of bone mineral density from exposure to Depo-Provera is not sufficient injury.
  73. Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009). Plaintiff had no cognizable harm from purchase of a recalled drug that was neither ineffective nor caused the plaintiff harm. Plaintiff has no claim at all concerning other drugs she never purchased.
  74. Degelmann v. Advanced Medical Optics, Inc., 2010 WL 55874 (N.D. Cal. Jan. 4, 2010).  Plaintiffs lack Article III standing to sue for consumer fraud under California statute.  They never heard of the risk of the product before a recall, stopped using the product before the recall, do not claim for suffering the risk, used the product normally, and it behaved as expected.  They cannot claim to have lost any money, as they would have bought another brand had they not bought this one.
  75. Mitchell v. Proctor & Gamble, 2010 WL 728222 (S.D. Ohio March 1, 2010).  Mere allegation of increased risk, without allegation of actual causation, of damages is insufficient to plead compensable injury under Twombly/Iqbal.
  76. Watkins v. Omni Life Science Inc., ___ F. Supp.2d ___, 2010 WL 809820, slip op. (D. Mass. March 9, 2010).  Fear of/increased risk of hip implant failure is not sufficient injury, nor is loss of the benefit of the bargain where the implant remains intact.
  77. Cohen v. Guidant Corp., No. 2:05-cv-08070-R, slip op. (C.D. Cal. Feb. 15, 2011), fear of future injury is not compensable in California.
  78. In re McNeil Consumer Healthcare Marketing & Sales Practices Litigation, 2011 WL 2802854 (E.D. Pa. July 15, 2011).  Plaintiffs lack Article III standing to sue for economic injuries from various recalled products.  Plaintiffs do not allege that they bought any particular product or that they were injured by any particular recall.  Injuries to others are insufficient.
  79. Barker v. Carefusion 303 Inc., No. 1:11-cv-00938-TWP-DKL, slip op. (S.D. Ind. Nov. 28, 2012).  Pure bystander emotional distress from witnessing injury to another is not “physical injury” as required by the Indiana product liability statute.
  80. In re Trasylol Products Liability Litigation,  2013 WL 1192300 (S.D. Fla. March 22, 2013).  “[T]hat a patient experiences a brief medical complication, one he both knew about consented to, and one which fully resolved, required no traumatic long-term therapy, or had any ascertainable effects, falls far short of an adequate ‘injury.’”
  81. Carter v. Alcon Laboratories, 2014 U.S. Dist. Lexis 32381 (E.D. Mo. March 13, 2014).  Plaintiffs alleging consumer protection violations from single use medications allegedly containing excessive product for a single use failed to allege any cognizable injury.  The defendant had a legal right to charge the same amount for a smaller-sized amount of product.
  82. Travelers Indemnity Co. v. Cephalon, Inc., C.A. No. 12-4191, 2014 U.S. Dist. Lexis 95075 (E.D. Pa. July 14, 2014).  Third party payers lack Article III standing to sue for economic losses absent evidence that the product is unsafe or ineffective.  Getting the product that was paid for, even if more expensive than alternatives, is not injury.
  83. In re Avandia Marketing, Sales Practices & Products Liability Litigation, MDL No. 1871, slip op. (E.D. Pa. April 16, 2015).  Theory of damages under Missouri consumer fraud statute that a loss was incurred because the drug was not as advertised, despite doing its job in treating the condition and not causing injury is “absurd” because there has been no demonstrable loss of any benefit.
  84. Cottrell v. Alcon Laboratories, Inc., 2015 U.S. Dist. Lexis 81830 (D.N.J. June 24, 2015).  Theory that consumers defrauded by eyedrops dispensed in wasteful “too large” drops, failed to allege any cognizable injury, defeating standing.  Nobody was hurt, the drops worked, and everyone was able to use the drops in the intended matter.
  85. Sheller, P.C. v. U.S. Dept. of HHS, C.A. No. 15-0440, slip op. (E.D. Pa. Aug. 11, 2015).  Neither a law firm’s increased expenses in contingent fee litigation nor claimed impingement of its ethical obligations to its clients or to the general public constituted “injury” sufficient to give it standing to sue the FDA over denial of a citizen’s petition that would have improved its litigating position against a third party and/or evaded a confidentiality agreement the the plaintiff law firm made during other litigation.
  86. In re Alloderm Litigation, 2015 WL 5022616 (New Jersey Super. Law Div. Aug. 14, 2015).  New Jersey product liability does not allow recovery for a plaintiff being at risk of an unmanifested injury.
  87. Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. March 6, 2017).  Affirming dismissal of class action alleging that eye drops could have been designed more efficiently.  No standing because no injury.  “[T]hat a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; it is just a regret.”
  88. Cure v. Intuitive Surgical Inc., ___ F. Appx. ___, 2017 WL 3381848 (11th Cir. Aug. 7, 2017).  Class action alleging subclinical injury dismissed.  Mere exposure to a potentially harmful substance not actionable injury under Georgia law.
  89. Looney v. Moore, ___ F.3d ___,  2018 WL 1547260 (11th Cir. March 30, 2018).  Mere increased risk of future injury is not cognizable under Alabama law in product liability, negligence or informed consent.
  90. Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018).  Alleged increased risk of future injury from the presence of a properly functioning medical device failed to state cognizable injury under product liability, warranty, fraud, or consumer fraud theories.
  91. In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Liability Litigation, ___ F.3d ___, 2018 WL 4225028 (3d Cir. Sept. 6, 2018).  Alleged buyers remorse by product purchaser, absent personal injury or even increased risk of personal injury is insufficient injury to permit standing to sue in federal court.

Sharp-eyed readers of our blog (those who really need to get a life) will notice something different today. For the rest of you … well, we’ll tell you. Over on the right-hand margin, in our Archives section, just below our Index of Posts, there are two more links, one to “Drug Preemption Scorecard” and the other to “Device Preemption Scorecard.”

These are here for a reason. We’ve decided that, as new preemption decisions come down, or as the status of existing decisions changes, we’ll update the prior scorecard posts to include the new information. Henceforth (a nifty little lawyer jargon word) these posts can be your “one-stop shopping” location for current information about preemption decisions. Of course, if we find a particular decision of significant interest, we’ll blog about it specifically. But not every preemption decision warrants a separate post.

The device preemption scorecard has already been updated once.

The converse of our doing this is as follows: If you’ve got a new preemption decision (pro or con – although we like pro a lot better) that you don’t see on the list, by all means pass it along to us. We can’t add what we don’t know about.

It was probably inevitable, but our drug preemption scorecard has prompted some folks who must be gluttons for punishment to request a similar rundown of how medical device preemption has been faring lately. Since we’re always looking for things to blog about (and because of the identity of some of the people asking us) we’re happy to oblige.

The first problem is where to start. Because, as we’ve discussed recently, express medical device preemption is different from (and somewhat more established than) the kind of preemption available to prescription drug manufacturers, the January 2006 FDA Final Rule isn’t the kind of watershed event for medical device preemption cases that it is for our prescription drug defense.

We’re going to be practical and not go back to Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which was the last true watershed event for device preemption. (Back when Beck and Herrmann were toiling in the Bone Screw fields together, they collected every device preemption decision known to man. The original list appears in the footnotes of Mark Herrmann & Geoffrey J. Ritts, “Preemption and Medical Devices: A Response to Adler and Mann,” 51 Food & Drug L.J. 1 (1996). Bexis’ book [we’ve decided that it’s “Beck and Herrmann” in the aggregate, but “Bexis” in the singular] again gathers the pre-Lohr device preemption cases, along with the post-Lohr cases through late 2006.) So, in this post, we’ve decided to go back only as far as the beginning of 2007.

So here’s our 2007 scorecard on medical device preemption although there are a couple of earlier cases that even Bexis didn’t know about until recently:

  1. Teplitsky v. Gershman, 2005 WL 4926167 (Cal. Super. Nov. 4, 2005), finding broad preemption with respect to a Class III pre-market approved (“PMA”) device (“CoreTherm”) used to treat benign prostrate growths. To our knowledge, Teplitsky was never appealed.
  2. Weston v. Kim’s Dollar Store, 2006 WL 4911566 (S.C. C.P. Nov. 28, 2006), finding broad preemption with respect to a Class III pre-market supplement approved device (non-corrective contact lenses). Since a distributor was sued on an independent basis, this does not appear to be an appealable final judgment.
  3. Dreyfus v. Advanced Medical Optics, Inc., 2007 WL 148437 (E.D. La. Jan. 12, 2007), finding “likely” broad preemption with respect to a Class III pre-market approved (“PMA”) device (implantable ocular lens), with “only the claim of manufacturing defect viable” after preemption. Id. at *1. This is not a final judgment, as the manufacturing defect claim escaped summary judgment on non-preemption related grounds.
  4. Tuttle v. CIBA Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007), finding preemption specifically with respect to a warning defect claim involving a 510k-cleared device (contact lens disinfectant). After Lohr, 510k preemption is rare, but the court found preemption because the FDA had issued something device specific – “a comprehensive Guidance Document which governs the form, content and requirements for [that device’s] labels.” Id. at *2. It’s a final judgment, but there are alternative causation grounds for summary judgment. The Westlaw docket does not indicate an appeal, but doesn’t appear to be complete.
  5. Alfred v. Mentor Corp., 2007 WL 708631 (W.D. Ky. Mar. 5, 2007), finding broad preemption with respect to a Class III pre-market approved (“PMA”) device (breast implants). Claims for manufacturing defect, non-FDA-related fraud, and the Kentucky Consumer Fraud Act excaped preemption, although it does not appear that the defendant claimed preemption against the consumer fraud claim. All the unpreempted claims failed for other reasons, so this is a final judgment. We are not aware of any appeal, and it may not have been, given that the plaintiff’s expert was excluded in a prior ruling.
  6. Mattingly v. Medtronic Inc., 486 F. Supp.2d 964 (E.D. Mo. 2007), finding broad preemption with respect to a Class III PMA device (an implantable cardiac defibrillator) against a claim that it short circuited. The court allowed plaintiff to pursue an unpreempted claim of failure to comply with unspecified FDA regulations. As it stands, there is no final order, and thus no appeal.
  7. Rattay v. Medtronic, Inc., 482 F. Supp.2d 746 (N.D.W. Va. 2007), finding relatively broad preemption with respect to a Class III PMA supplement device (a catheter). A claim for implied warranty escaped preemption. Rattay is the first post-Lohr PMA preemption case in the Fourth Circuit. There is no final order, and thus no appeal.
  8. Brown v. DePuy Spine, Inc., 22 Mass. L. Rptr. 425, 2007 WL 1089337 (Mass. Super. Apr. 9, 2007), finding no preemption with respect to an investigational (“IDE”) device (an artificial spinal disc), against a plaintiff who was a participant in a clinical trial. The plaintiff did not, however, bring traditional product liability claims, which the court indicated would have been preempted. Id. at *11. Instead, he “advance[d] claims based on. . .alleged departures from the standards set forth in the. . .IDE and PMA application.” Id. Those claims were held to be unpreempted violation claims. Also as to these claims, the court rejected an implied preemption claim based upon Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
  9. Thornburg v. Stryker Corp., 2007 WL 1742172 (Mag. S.D. Ind. June 12, 2007), adopted, 2007 WL 1959117 (S.D. Ind. July 3, 2007), finding broad preemption with respect to a Class III PMA device (hip prosthesis). Plaintiff did not assert a noncompliance claim. This is a final judgment, and we don’t know if there’s been an appeal.
  10. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation (Duron), 2007 WL 1725289 (D. Minn. June 12, 2007), finding no preemption with respect to a recalled Class III PMA supplement device (an implantable cardiac defibrillator) that had an increased risk of failure, but which was explanted before any failure. The court construed most of the plaintiff’s claims as unpreempted non-compliance claims, and also held that implied warranty claims were not preempted. Finally, the court rejected an implied preemption claim based upon Buckman. We suspect this case is part of the recent Guidant settlement.
  11. Von Essen v. C.R. Bard, Inc., 2007 WL 2086483 (D.N.J. June 18, 2007), is not really a preemption case, but involves “complete preemption” as a basis for “arising under” federal question jurisdiction (for any non-lawyers who are unaccountably still reading this, that’s a reason why the case could be heard by a federal, rather than a state, judge). In reaching its jurisdictional decision, the court took a narrow view of preemption under Buckman.
  12. Carson v. Depuy Spine, Inc., 2007 WL 1839324 (C.D. Cal. June 21, 2007), finding broad preemption with respect to a Class III PMA device (an artificial spinal disc). Plaintiffs did not assert a noncompliance claim. This was not a final judgment, there have been further developments post-Riegel. See our post-Riegel scorecard.
  13. Blunt v. Medtronic, Inc., 738 N.W.2d 143 (Wis. App. 2007), finding broad preemption with respect to a Class III PMA device (implantable cardiac defibrillator). We’ve blogged on this case before. There was a dissent, and we’ve been informed that the case is on appeal to the Wisconsin Supreme Court.
  14. Notmeyer v. Stryker Corp., 502 F. Supp. 2d 1051 (N.D. Cal. 2007), declining to find broad preemption with respect to a Class III PMA supplement device (hip prosthesis). It’s the first case in a while to following the post-Lohr minority view (Goodlin) that the PMA process is insufficiently “device specific” to be preemptive. Id. at *5-6. This is obviously not a final order, and after a petition for interlocutory appeal was denied the case settled.
  15. Cottengim v. Mentor Corp., 2007 WL 2782885 (E.D. Ky. Sep. 24, 2007), finding broad preemption with respect to a Class III PMA device (breast implant). Plaintifffs did not pursue a noncompliance claim. This is a final judgment, it might be on appeal, but there are non-preemption issues, such as exclusion of the plaintiff’s expert, involved in the case.
  16. Herbert v. Mentor Corp., 2007 WL 2893387 (D.N.J. Sep. 28, 2007), finding broad preemption with respect to a Class III PMA device (breast implant). Plaintifffs did not pursue a noncompliance claim. This is a final judgment. An express warranty claim would not be preempted, but plaintiffs did not plead such a claim, and any amendment would be futile.
  17. Wawrzynek v. Statprobe, Inc., 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007), finding no preemption of a fraud on the FDA claim with respect to contract research organization, where the FDA had successfully prosecuted the manufacturer (which settled a separate suit in this case) for fraud in connection with the study that the CRO carried out. The product was a Class III PMA device (ADCON-L) used to prevent formation of scar tissue after spinal surgery.
  18. Ehrhart v. Synthes (USA), 2007 WL 4591276 (D.N.J. Dec 28, 2007), finding no preemption of a possible fraud on the FDA claim with respect to a medical device (radial plates). The class is not stated, but is probably Class II. The court refused to find preemption on a motion to dismiss.
  19. Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039; 70 Cal. Rptr. 3d 566 (Cal. App. 4th Dist. 2008), finding broad preemption with respect to a Class III PMA device (heart valve). Plaintifffs did not pursue a noncompliance claim. The case is subject to further appellate review. An implied warranty claim was barred on state-law grounds (privity) and preemption not reached as to that claim. Further appeal is possible.
  20. Mathis v. E.I. DuPont de Nemours & Co,, C.A. No. 06-0825 (W.D. La. Jan. 16, 2008), finding broad preemption with respect to a “transitional device” (injectable vocal cord paste) that was approved as a drug by the FDA prior to 1976 and deemed to be a Class III PMA device following enactment of the Medical Device Amendments. This is a final judgment subject to appeal.
  21. Jessen v. Mentor Corp., 2008 WL 142824 (Cal. App. Jan. 16, 2008), finding broad preemption with respect to a class III PMA supplement device (testicular prosthesis). There was no proof of noncompliance. Further appeal is possible.
  22. Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 324356 (Ark. Feb. 7, 2008), finding no preemption with respect to a class III PMA device (implantable hearing aid), following minority Goodlin reasoning. After Riegel, a motion to reconsider was granted, the decision was reversed, and preemption was affirmed. Despain v. Bradburn, ___ S.W.3d ___, 2008 WL 1067202 (Ark. April 10, 2008).
  23. Riegel v. Medtronic, Inc., ___ S. Ct. ___, 2008 WL 440744 (U.S. Feb. 20, 2008), providing definitive answer – there is broad preemption with respect to class III PMA devices (in this case a balloon catheter). Strict liability, negligence, and warranty actions that challenge the safety or effectiveness of a PMA device are preempted. A noncompliance claim was dismissed in the lower courts on state-law grounds and was not before the court.

That’s everything we know about medical device preemption cases since January 1, 2007. Again, if we’ve missed any cases, don’t be shy in telling us. Many of our readers, like us, follow this issue with interest – especially in light of the pending Supreme Court Riegel case and yesterday’s certiorari grant on the fraud on the FDA issue. We’d like to have a complete list available for those who care.

Don’t be deceived by the date of this post! We update this scorecard regularly!

Folks keep asking us for the drug preemption scorecard: Since the FDA promulgated its “Preemption Preamble” in January 2006, how many decisions have accepted the preemption defense, and how many have courts rejected it?

It’s not quite that easy. There are cases that squarely accept the defense; cases that reject it; cases that say the defense may be available, but doesn’t apply on the facts before it; cases that address vaccine preemption, which is a different, but sometimes related, issue; and cases that apply preemption in ways that may or may not affect drug cases. (And then there’s medical device preemption. We view that as an entirely separate ball of wax. We’ll have more to say about that shortly.)

In the meantime, here’s the list of cases — originally through Friday, September 21, 2007, but we now update it whenever we learn of more cases — that appear on our drug preemption scorecard. But don’t ask for a precise win/loss tally in the drug preemption wars. The issue has become slightly more complicated than that.

  1. Zammit v. Shire US, Inc., 415 F. Supp. 2d 760 (E.D. Mich. 2006), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Adderall/heart attack case. No mention of FDA preemption preamble. We do not believe this case was appealed.
  2. Militrano v. Lederle Laboratories, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006),app. denied, 857 N.E.2d 1137 (N.Y. 2006), finding express preemption in Tetramune/neurological injuries case under Vaccine Act while affirming pre-preemption-preamble preemption decision (769 N.Y.S.2d 839 (N.Y. Sup. 2003)). No mention of FDA preemption preamble.
  3. Abramowitz v. Cephalon, Inc., 2006 WL 560639 (N.J. Super. Law Div. March 3, 2006), finding implied conflict preemption and relying on FDA preemption preamble in Actiq/tooth decay case. We believe this case settled.
  4. Peters v. Astrazeneca, LP, 417 F. Supp.2d 1051 (W.D. Wis. 2006), rejecting field and implied conflict preemption in omeprazole/loss of taste case. No mention of FDA preemption preamble. The defendant won the case on other grounds and the preemption ruling was not appealed.
  5. Laisure-Radke v. Par Pharmaceutical, Inc., 2006 WL 901657 (W.D. Wash. March 29, 2006), reconsid. denied (May 3, 2006), rejecting implied conflict preemption and mentioning (but not discussing) FDA preemption preamble in fluoxetine (generic Prozac)/suicide case. The defendant won the case on other grounds and the preemption ruling was not appealed.
  6. In re Diet Drugs Products Liabilty Litigation (Mingus), 2006 WL 1071545 (E.D. Pa. Apr. 21, 2006), rejecting implied conflict preemption under Buckmanagainst exclusively non-warning claims in diet drug/primary pulmonary hypertension case. No mention of FDA preemption preamble. There was no final order to appeal.
  7. Coutu v. Tracy, 2006 WL 1314261 (R.I. Super. May 11, 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Propofol/liver-kidney failure case. There was no final judgment to appeal.
  8. Gourdine v. Crews, 2006 WL 5277412 (Md. Cir. June 28, 2006), finding implied conflict preemption and relying on FDA preemption preamble in insulin/hypoglycemia case. The order was appealable and affirmed on other grounds (no duty, the plaintiff was not the drug user), 935 A.2d 1146 (Md. App. 2007). The Maryland Court of Appeals (Maryland’s highest court affirmed dismissal on non-preemption grounds, 955 A.2d 769 (Md. Sept. 4, 2008).
  9. Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006), finding implied conflict preemption and relying on FDA preemption preamble in paroxetine (generic Paxil)/suicide case. The FDA filed amicus briefs supporting preemption in this case. Colacicco has extensive appellate history (see below), with the decision ultimately vacated and remanded.
  10. Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zoloft-Effexor/suicide case. There was no final judgment to appeal, and the case has settled.
  11. In re Bextra & Celebrex Marketing Sales Practices & Products Liability Litigation, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006), finding implied conflict preemption of failure to warn, but not false advertising, claims and relying on FDA preemption preamble in Bextra-Celebrex/cardiovascular risk MDL. There was no final judgment to appeal.
  12. Ackermann v. Wyeth Pharmaceuticals, 2006 WL 2591078 (Mag. E.D. Tex. Sept. 6, 2006), finding implied conflict preemption of failure to warn claims and relying on FDA preemption preamble in Effexor/suicide case. Opinion was withdrawn as moot in light of order granting complete summary judgment on other grounds, 2006 WL 3780913 (E.D. Tex. Dec. 20, 2006). The Fifth Circuit affirmed dismissal without reaching preemption. Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008).
  13. Conte v. Wyeth, Inc., 2006 WL 2692469 (Cal. Super. Sept. 14, 2006), and 2006 WL 3939262 (Cal. Super. Sept. 14, 2006), finding implied conflict preemption and relying on FDA preemption preamble in Metoclopramide/gastroesophageal reflux case). Affirmed in part and reversed on other (non-preemption) grounds, Conte v. Wyeth, Inc., 168 Cal. App.4th 89 (Cal. App. Nov. 7, 2008).
  14. McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zoloft/suicide case while denying reconsideration of, but certifying for interlocutory appeal, a pre-preemption-preamble preemption decision (2005 WL 3752269 (D.N.J. Dec. 29, 2005)). McNellis has extensive appellate history (see below, under Colacicco), with the decision ultimately vacated and remanded.
  15. Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (as amended Jan. 18, 2007) (2d Cir. Jan. 18, 2007), affirmed without opinion by equally divided court sub nom. Warner-Lambert Co. v. Kent, 128 S.Ct. 1168 (2008), reversing district court and rejecting implied conflict preemption of “fraud on the FDA” exception to state tort reform statute and rejecting FDA preemption preamble in Rezulin/diabetes case.
  16. Perry v. Novartis Pharmaceutical Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006), rejecting implied conflict preemption and distinguishing FDA preemption preamble in Elidel/lymphoma case. The FDA filed an amicus brief taking no position on preemption in this case. There was no final judgment to appeal. The defendant won the case on non-preemption grounds, Perry v. Novartis Pharmaceutical Corp., 564 F. Supp.2d 452 (E.D. Pa. July 9, 2008), and plaintiff did not appeal.
  17. Levine v. Wyeth, 944 A.2d 179 (Vt. Oct. 27, 2006) (affirming pre-preemption-preamble no preemption ruling, 2003 WL 25648135 (Vt. Super. Dec. 23, 2003)), cert. granted, No. 06-1249 (U.S. Jan. 18, 2008) (argued Nov. 3, 2008), rejecting implied conflict preemption and rejecting FDA preemption preamble in Phenergan/IV push case. Levine was affirmed by the Supreme Court, 129 S. Ct. 1187 (see last entry of this scorecard).
  18. Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp.2d 666 (E.D. Ky. 2006), rejecting implied conflict preemption, but relying on FDA preemption preamble in Elidel/lymphoma case. There was no final judgment to appeal.
  19. Brockert v. Wyeth Pharmaceuticals, 2007 WL 2077554 (Tex. Dist. Jan. 31, 2007), finding implied conflict preemption in Prempro/heart attack case). No mention of the FDA preemption preamble. Subsequent, post-Levine history is discussed in our .
  20. In re Aredia & Zometa Products Liability Litigation, 2007 WL 649266 (M.D. Tenn. Feb. 27, 2007), rejecting “complete preemption,” but suggesting that “ordinary” implied conflict preemption might apply and relying on FDA preemption preamble in Aredia-Zomenta/osteonecrosis case. Unappealable remand order.
  21. Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007), finding express preemption of design and warning claims, but not testing claims under Vaccine Act, and relying on FDA preemption preamble in Thimerosal/neurological injuries case. There was no final judgment to appeal. The remainder of the case was transferred to the Eastern District of Virgina (see separate entry).
  22. Kelly v. Wyeth, 2007 WL 1302589 (Mass. Super. April 12, 2007), cross-motions for reconsideration denied, 2007 WL 3407466 (Mass. Super. Oct. 23, 2007), rejecting implied conflict preemption and rejecting/distinguishing FDA preemption preamble in Reglan/generic metoclopramide/akathisia case. There was no final judgment to appeal.
  23. Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 U.S. Dist. Lexis 44718 (D. Ala. April 24, 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in cephalexin (generic Keflex)/Stevens-Johnson-Syndrome case. There was no final judgment to appeal.
  24. Ledbetter v. Merck & Co., 2007 WL 1181991 (Tex. Dist. April 20, 2007), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Vioxx/heart attack case. No mention of the FDA preemption preamble. The appeal has been dismissed at the plaintiff’s request. See Ledbetter v. Merck & Co., 2008 WL 2066580 (Tex. App. May 15, 2008) (unpublished).
  25. Prohias v. Pfizer, Inc., 490 F. Supp.2d 1228 (S.D. Fla. 2007), finding implied conflict preemption of claims after July, 2004, but not before, and relying upon FDA preemption preamble in Lipitor/false advertising case. There was no final judgment to appeal.
  26. In re Zyprexa Products Liability Litigation, 489 F. Supp.2d 230 (E.D.N.Y. 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zyprexa/side effects (weight gain, hyperglycemia, and diabetes) MDL. There was no final judgment to appeal.
  27. Prohias v. AstraZeneca Pharmacerticals, L.P., 958 So.2d 1054 (Fla. App. 2007) (affirming, 2006 WL 4634292 (Fla. Cir. Oct. 2006)), finding implied conflict preemption in Nexium/false advertising case. A further appeal was denied by the Florida Supreme Court, 969 So.2d 1014.
  28. Giles v. Wyeth, Inc., 500 F. Supp.2d 1063 (S.D. Ill. 2007), rejecting implied conflict preemption in Effexor/suicide case. No mention of the FDA preemption preamble. The defendant won the case on other grounds and the preemption ruling was not appealed.
  29. Deutsch v. Wyeth, Inc., 2007 WL 2060072 (N.J. Super. Law Div. June 22, 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Prempro/breast cancer case. There was no final judgment to appeal.
  30. In re Vioxx Products Liability Litigation, 501 F. Supp.2d 776 (E.D. La. 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Vioxx/heart attack MDL. There was no final judgment to appeal, and the MDL has largely settled.
  31. In re Baycol Products Liability Litigation, 495 F. Supp.2d 977 (D. Minn. 2007), applying implied conflict preemption to exclude expert testimony offered to support allegations of “fraud on the FDA” in Baycol/muscle-kidney damage MDL. No mention of FDA preemption preamble. There was no final judgment to appeal.
  32. Price v. Cook, 2007 WL 2154766 (W. Va. Cir. July 9, 2007), finding implied conflict preemption and relying on prior FDA amicus briefs (but not mentioning FDA preemption preamble) in Zoloft/suicide attempt case. We believe this case has settled.
  33. Sarli v. Mylan Bertek Pharmaceuticals, Inc., 2007 WL 2111577 (M.D.N.C. July 19, 2007), rejecting implied conflict preemption but relying on FDA preemption preamble in Amnesteem/unspecified personal injury case. There was no final judgment to appeal, and the case has settled.
  34. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 499 F.3d 239 (3d Cir. 2007), affirming district finding of implied conflict preemption in Nexium/false advertising case. No mention of FDA preemption preamble. A motion for panel rehearing and rehearing en banc was denied on September 19, 2007. After Wyeth v. Levine, the Supreme Court vacated the Third Circuit’s opinion and remanded the case. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 129 S. Ct. 1578 (March 9, 2009). On May 5, 2009, the Third Circuit the case to the District of Delaware.
  35. Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430 (E.D. Pa. 2007), finding express preemption under Vaccine Act in Tri-Immunol DPT vaccine/seizure-developmental delay case. No mention of FDA preemption preamble. There is a final judgment. The Third Circuit affirmed, 2009 WL 792468, see entry in our New Drug and Vaccine Preemption Scorecard.
  36. Strong v. American Cyanamid Co., 261 S.W.3d 493 (Mo. App. E.D. Aug. 28, 2007), rejecting express or implied conflict preemption in Orimune vaccine/polio case. No mention of FDA preemption preamble. Review (“transfer”) was first rejected, then acceptef, and then rejected again by the Missouri Supreme Court, with the end result that the appellate decision was reinstated on Oct. 6, 2008.
  37. Dunson v. McNeil-PPC, Inc., 2007 WL 3052315 (Pa. C.P. Sept. 12, 2007), finding no implied conflict preemption and distinguishing FDA preemption preamble in over-the-counter Infant Tylernol/liver failure-death case. On appeal, j.n.o.v. was entered against plaintiffs on non-preemption grounds. Dunson v. McNeil-PPC, Inc., 2009 WL 1178651 (Pa. Super. April 24, 2009). Further appeal is possible.
  38. In re Seroquel Products Liability Litigation, 2007 WL 4117201 (M.D. Fla. Nov. 6, 2007), denying without prejudice implied conflict preemption motion for judgment on the pleadings until after discovery in Seroquel/diabetes cases. Merits not reached.
  39. [Intentionally omitted (Nov. 19, 2007). Another adverse, unpublished case. A federal trial court, in a one-page, three-sentence order, rejects a conflict preemption argument raised by a generic drug manufacturer. This one is too short to ever make the reporters, but we note here that it exists.]
  40. [Intentionally omitted (Nov. 29, 2007). This is another unpublished case that the reporters have not yet picked up, and we’re not here to spread the word. A federal trial court rejected both an implied conflict preemption and a fraud-on-the-FDA statutory exception preemption argument raised by a generic drug manufacturer. If we see this reported somewhere, we’ll provide the cite. Until then, just be aware that it exists.]
  41. Dobbs v. Wyeth Pharmaceuticals, 530 F. Supp.2d 1275 (W.D. Okla. 2008), finding implied conflict preemption and relying on FDA preemption preamble in Effexor/suicide case. While this is a partial summary ruling, a Rule 54(c) appeal has been taken. Post-Levine, the Tenth Circuit vacated and remanded, as discussed in our new scorecard.
  42. O’Neal v. SmithKline Beecham Corp., 551 F. Supp.2d 993 (E.D. Cal. Jan. 30, 2008), finding implied conflict preemption in Paxil/pediatric suicide case. Summary judgment is granted against all claims, therefore the order is appealable. Reconsideration was denied. 2008 WL 1721891. The case has setttled.
  43. Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208 (E.D. Va. Feb. 12, 2008), finding implied conflict preemption of failure to warn claims and impliedly (the court does not use the word “preemption,” but that’s what the argument is) finding implied preemption of design defect claims in immune globulin case. The order denied a motion to amend and is not final judgment. No appeal was taken from entry of final judgment. This case is related to Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007), which is also on this list.
  44. Miller v. SmithKline Beecham Corp., 2008 WL 510449 (N.D. Okla. Feb. 15, 2008), finding implied conflict preemption in Paxil/suicide case. Summary judgment is granted against all claims.  Post-Levine, the Tenth Circuit vacated and remanded, as discussed in our new scorecard.
  45. Longs v. Wyeth, 536 F.Supp. 2d 843 (N.D. Ohio Feb. 28, 2008), finding implied conflict preemption of some claims, those alleging that the drug should never have been approved or that no warning could be adequate, as well as fraud on the FDA, in a Redux/primary pulmonary hypertension case. Summary judgment was granded against all remaining claims on other grounds, therefore the order is appealable. Subsequent, post-Levine history is discussed in our new scorecard.
  46. White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023 (W.D. Mich. March 6, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in a Paxil pediatric suicide case. The case has settled.
  47. Collins v. Smithkline Beecham Corp., 2008 WL 744070 (Pa. C.P. March 11, 2008), finding no implied conflict preemption in Paxil/suicide case, refusing to judicially notice FDA final rule. There is no appealable order.
  48. Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768 (W.D.N.C. March 25, 2008), finding implied conflict preemption of some claims, including all warning-related claims, as well as fraud on the FDA, and relying on FDA preemption preamble in a Lotensin birth defect case. The order is not appealable. The case has been dismissed with prejudice.
  49. In re Aredia & Zometa Products Liability Litigation, 2008 WL 913087 (M.D. Tenn. Apr. 2, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Aredia/Zomenta MDL litigation. An appeal is pending in the Sixth Circuit (No. 08-5573, and others).
  50. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008), finding broad implied conflict preemption and giving some deference to the FDA preemption preamble in two consolidated SSRI suicide cases (one, Colacicco, involving paroxetine (generic Paxil), and the other, McNellis, involving Zoloft. The FDA filed amicus briefs supporting preemption in this case. Rehearing has been denied. After Wyeth v. Levine, the Supreme Court vacated the Colacicco opinion and remanded the case to the Third Circuit. Colacicco v. Apotex, Inc., 129 S. Ct. 1578 (March 9, 2009). On April 22, 2009, the Third Circuit remanded both cases (Colacicco and McNellis) to the respective District Courts.
  51. Mason v. Smithkline Beecham Corp., 546 F. Supp.2d 618 (C.D. Ill. April 23, 2008), finding implied conflict preemption and relying on FDA preemption preamble in Paxil/suicide case. The Seventh Circuit reversed after Levine, as discussed in our new scorecard.
  52. McDarby v. Merck & Co., 949 A.2d 223 (N.J. Super. A.D. May 29, 2008), finding no implied conflict preemption in Vioxx/heart attack case; rejecting reliance on FDA preemption preamble; finding implied conflict preemption of “fraud on the FDA” exception for punitive damages in state tort reform statute. On May 7, 2009, the New Jersey Supreme Court dismissed an a pending appeal as improvidently granted. No. 62,856.
  53. Gaeta v. Perrigo Pharmaceuticals, Inc., 562 F. Supp.2d 1091 (N.D. Cal. June 13, 2008), finding preemption in the context of an over-the-counter, generic drug, and giving Chevron deference to the Preemption Preamble. The order is final, but there will be no appeal.
  54. Mensing v. Wyeth et al., 562 F. Supp.2d 1056 (D. Minn. June 17, 2008), finding conflict preemption of failure to warn claims in generic Reglan case. The Eighth Circuit reversed after Levine, as discussed in our new scorecard.
  55. Tucker v. SmithKline Beecham Corp., 596 F. Supp.2d 1225 (S.D. Ind. July 18, 2008) (S.D. Ind. Sept. 19, 2007), finding no implied conflict preemption and declining to rely on the FDA preemption preamble in a Paxil/suicide case. This is a reconsideration of an earlier opinion, at 2007 WL 2726259, that had recognized preemption. A second motion for reconsideration, or for interlocutory appeal, is pending.
  56. In re Celexa & Lexapro Products Liability Litigation, 2008 WL 2906713 (E.D. Mo. July 24, 2008), postponing decision of a motion seeking implied conflict preemption in generic SSRI/suicide case due to pendency of Levine. Obviously, there is no appealable order.
  57. In re Aredia & Zometa Products Liability Litigation, 2008 WL 2944910 (M.D. Tenn. July 25, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in several Aredia/Zometa cancer cases. No mention of the FDA preemption preamble. These orders were not appealed.
  58. In re Fosamax Products Liability Litigation, 2008 WL 2940560 (S.D.N.Y. July 29, 2008), finding no “impossibility” of a successful claim by reason of implied conflict preemption in fraudulent joinder context in Fosamax/osteonecrosis. No mention of the FDA preemption preamble. The case was remanded to state court.
  59. Depriest v. Astrazeneca Pharmaceuticals L.P., 2008 WL 3243562 (Ark. Cir. July 31, 2008), finding conflict preemption of all claims in economic loss consumer fraud claim involving promotion of Nexium. No mention of preamble. This is an appealable order.
  60. Masterson v. Apotex Corp., 2008 WL 3262690 (S.D. Fla. Aug. 7, 2008), finding conflict preemption of failure to warn claims in generic paxil (birth defects, not suicide) case. Manufacturing defect claims escaped preemption, so the order is not appealable.
  61. Valerio v. SmithKline Beecham Corp., 2008 WL 3286976 (S.D. Fla. Aug. 7, 2008) (companion case to Masterson — same product, alleged injury, date of order, judge, holding, and reasoning, but different plaintiff).
  62. Bolin v. SmithKline Beecham Corp., 2008 WL 3286973 (S.D. Fla. Aug. 7, 2008) (another companion case to Masterson — same product, alleged injury, date of order, judge, holding, and reasoning, but different plaintiff).
  63. Wright v. Aventis-Pasteur, Inc., 2008 WL 4144386 (Pa. C.P. Philadelphia Co. Aug. 27, 2008), finding express preemption under Vaccine Act in Thimerosal case against several vaccine manufacturers. No mention of FDA preemption preamble. An appeal (No. 336 EDA 2008) is pending in the Pennsylvania Superior Court.
  64. Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008), finding no conflict preemption of failure to warn claims in Paxil/teen suicide case. Giving FDA preamble some deference. An interlocutory appeal was granted by the District Court, 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008), but denied by the Third Circuit on December 30, 2008 (No. 08-8060).
  65. McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr. 3d 810 (Cal. App. 5th Dist. Sept. 25, 2008), finding no conflict preemption of failure to warn claims in generic Reglan (metoclopramide) tardive dyskinesia case, mentioning but neither following nor rejecting FDA preemption preamble. The California Supreme Court denied review on Jan. 14, 2009.
  66. Mills v. Warner-Lambert Co., 581 F. Supp.2d 772 (E.D. Tex. Sept. 30, 2008), finding express preemption of pure economic loss claims involving monograph (OTC) lice treatments. This is a final judgment, and there has been no appeal.
  67. American Home Products Corp. v. Ferrari, 668 S.E.2d 236 (Ga. Oct. 6, 2008), affirming intermediate appellate court ruling (650 S.E.2d 585) and rejecting express preemption under Vaccine Act in Thimerosal/neurological injury case. No mention of FDA preemption preamble. There is a certiorari petition (No. 08-1120) pending before the United States Supreme Court.
  68. Knipe v. SmithKline Beecham Corp., 2008 WL 4442635 (E.D. Pa. Sept. 30, 2008), no preemption of failure to warn claims as disguised fraud-on-the-FDA claims in Paxil/teen suicide case, but finding implied conflict preemption of “fraud on the FDA” exception for punitive damages in state tort reform statute. The preemption Preamble was not mentioned. There is no appealable order. The court has granted an interlocutory appeal concerning a related preemption issue, 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008), but denied by the Third Circuit on December 30, 2008 (No. 08-8060).
  69. Morris v. Wyeth, Inc., 582 F. Supp.2d 861 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 WL 424590 (W.D. Ky. Feb. 20, 2009), slip op. finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
  70. Smith v. Wyeth, Inc., 2008 WL 4696995 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 13250 (W.D. Ky. Feb. 20, 2009), finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
  71. Wilson v. Wyeth, Inc., 2008 WL 4697002 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 13273 (W.D. Ky. Feb. 20, 2009), finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
  72. Demahy v. Wyeth, Inc., 586 F. Supp.2d 642 (E.D. La. Oct. 27, 2008), finding no conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Fraud on the FDA claims are preempted. Mention preemption preamble only in a footnote, and gives it no deference, refuses to give deference to recent FDA statements regarding generic drugs. The District Court granted leave to take an interlocutory appeal, the Fifth Circuit accepted, and affirmed, as discussed in our new scorecard.
  73. Grange v. Mylan Laboratories, Inc., 2008 WL 4813311 (D. Utah Oct. 31, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute concerning punitive damages in fentamyl/wrongful death case. No mention of the FDA preemption preamble. There is no appealable order.
  74. In re Aredia and Zometa Prods. Liab. Litig., MDL No. 1760, 3:06-MD-1760 (M.D. Tenn. Nov. 25, 2008) (order is undated, but we believe it was entered on November 25), following earlier rulings in the Aredia and Zometa MDL and holding, in a two-page order, that the claims of Texas plaintiffs are barred by Tex. Civ. Prac. & Rem. Code Sec. 82.007(a) and, implicitly, that the fraud-on-the-FDA exception to that immunity is preempted underBuckman. “[P]laintiffs have reserved the right to seek appellate review of these rulings when they become appealable.”
  75. Kunnemann v. Janssen Pharmaceutica Products, L.P., 2008 WL 5101116 (N.D. Ill. Dec. 2, 2008), finding no implied conflict preemption in duragesic patch/fentamyl case. Brief discussion is unclear whether drug or device preemption is claimed, we assume drug from the cited cases. No mention of FDA preemption preamble. There is no final order. The case has settled.
  76. Merck & Co. v. Garza, 277 S.W.3d 430 (Tex. App. Dec. 10, 2008), finding no implied conflict preemption and rejecting FDA preemption preamble in Vioxx/heart attack case. The court vacated the verdict in its entirety on other grounds, and a further appeal the the Texas Supreme Court is pending.
  77. Kellogg v. Wyeth, No. 07-82, 2008 WL 5272715 (D. Vt. Dec. 17, 2008), finding no conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Distinguishing FDA preemption preamble from generic drug preemption. There is no final order. Subsequent, post-Levine history is discussed in our new scorecard.
  78. Wyeth v. Levine, 129 S. Ct. 1187 (U.S. Mar. 4, 2009), finding no conflict preemption of failure to warn claims in Phenergan amputation case. Finding FDA preemption preamble entitled to no deference. The litigation is concluded as to preemption.

If we’ve missed any cases, please do let us know. Many of our readers, like us, follow this issue with interest. We’d like to have a complete list available for those who care.