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 by 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), but no appellate decision ever occurred.
  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 allegeable 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 in action involving hip replacement prosthesis as to claims “based on theories that [defendant] failed to comply with federal requirements for manufacturing.”  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 warranty 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. Mitchell v. Howmedica Osteonics Corp., 2009 WL 10720098 (S.D. Ind. May 22, 2009). Motion to dismiss denied in action involving hip implant.  Following Hofts, above, 597 F. Supp.2d 830.
  35. 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 upon 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.
  36. 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 embolism 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.
  37. 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.
  38. 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.
  39. 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.
  40. 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.
  41. 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).
  42. 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.
  43. 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).
  44. 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 intervertebral disc.  No mention of any parallel claims.  No collateral estoppel by pre-Riegel decisions.
  45. 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.
  46. 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.
  47. 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.
  48. 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.
  49. 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.
  50. 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.
  51. 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.”
  52. Risavich v. Heart Rhythm Consultants, 2010 WL 9585790 (N.Y. Sup. Feb. 1, 2010).  Summary judgment granted against all claims in action involving an implantable 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.
  53. 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.
  54. 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.
  55. 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.
  56. 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.
  57. 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.
  58. 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.
  59. 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.
  60. 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.
  61. 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.
  62. 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).
  63. 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.
  64. 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.
  65. 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.
  66. 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).
  67. 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.
  68. 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.
  69. 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.
  70. 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.
  71. 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 system.”  No parallel violation claim alleged.
  72. 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).
  73. 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.
  74. 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.
  75. 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.
  76. 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.
  77. 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).
  78. 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.
  79. 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.
  80. 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.
  81. 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.
  82. 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.
  83. 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.
  84. 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.
  85. 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 granted, 2013 WL 801729, below.
  86. 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.
  87. 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.
  88. 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.
  89. 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.
  90. 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.
  91. 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.
  92. 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.
  93. 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.
  94. 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.
  95. 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.
  96. 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.
  97. 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).
  98. 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.
  99. 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.
  100. 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.
  101. 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).
  102. 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.
  103. 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.
  104. 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 granted, 2013 WL 801729, below.
  105. 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.
  106. 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.
  107. 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.
  108. 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.
  109. 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.
  110. 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.
  111. 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 negligence per se claims.
  112. 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.
  113. 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.
  114. 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.
  115. 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.
  116. 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
  117. 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.
  118. Haynes v. Cyberonics, Inc., 2011 WL  903238 (N.D. Ga. Sept. 6, 2011), summary judgment granted against 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.
  119. 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.
  120. 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.
  121. 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.
  122. 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.
  123. 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, below.
  124. 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.
  125. 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.
  126. 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.
  127. 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.
  128. 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 aspect 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).
  129. 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 misrepresentation 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.
  130. 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).
  131. 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.
  132. 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.
  133. 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).
  134. Wheeler v. Frank, 2012 WL 13229197 (Colo. Dist. April 14, 2012), motion in limine granted.  A recall does not give rise to an unpreempted claim.  Failure to report claims are akin to fraud on the FDA claims and therefore preempted.  Evidence of preempted claim is inadmissible.
  135. Wheeler v. Frank, 2012 WL 13222745 (Colo. Dist. April 14, 2012), summary judgment granted all claims.  No parallel claims alleged.
  136. 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.
  137. 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.
  138. Lowe v. Medtronic, Inc., 2012 WL 3656468, slip op. (C.D. Cal. May 9, 2012), motion to dismiss granted against all claims involving implantable defibrillator.  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.
  139. 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, below.  Most claims preempted, 17 F. Supp.3d 1275, below.
  140. 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.
  141. 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.
  142. 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.
  143. 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.
  144. 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.
  145. 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).
  146. 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.  FDA non-disclosure claims, both pre-approval and post-marketing failure to report, are preempted fraud-on-the-FDA claims, as they require proof of fraud against 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).
  147. 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.
  148. 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.
  149. 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.  Affirmed 2019 WL 2415049, below.
  150. 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),
  151. 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 on FDCA disclosure requirements are impliedly preempted.  Renewed motion granted, 944 F. Supp.2d 1193, below.
  152. 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).
  153. 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.
  154. 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 spinal 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, 17 F. Supp.3d 1275, below.
  155. 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, 2014 WL 5644699, below.
  156. 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.
  157. 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.
  158. 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).
  159. 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.
  160. 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.
  161. 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.
  162. 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.
  163. 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.
  164. 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, 784 F.3d 1335, below.
  165. 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 conduct of recall claim not preempted.  Failure to comply with PMA reporting requirements not preempted.  Subsequent order, 2013 WL 9874422, below.
  166. 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).
  167. 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 actions of sales representative fails to plausibly allege causation.
  168. 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.
  169. 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.
  170. 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 preempted 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.
  171. 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.
  172. 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, 552 F. Appx. 192, below.
  173. 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.
  174. 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.
  175. 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.
  176. 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.
  177. 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.
  178. 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.
  179. 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)
  180. 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.
  181. 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.
  182. 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, 2012 WL 5077401, above.
  183. 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.
  184. 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.
  185. 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.
  186. 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).
  187. 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.
  188. 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.
  189. 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.
  190. 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 warranty claim alleging false statements not constituting labeling would not be preempted, but is inadequately pleaded.  Subsequent order, 2014 WL 1364455, below.
  191. 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.
  192. 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.
  193. 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.
  194. 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 labels are expressly preempted.  Violation claims cannot be based on information provided to the FDA.
  195. 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.
  196. 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.
  197. 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, 101 A.3d 467, below.
  198. 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.
  199. 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.  Prior ruling, 989 F. Supp.2d 243, above.
  200. Kraushaar v. Coloplast 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.
  201. 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.
  202. 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.
  203. 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.
  204. 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.
  205. 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 F. Appx. 401 (9th Cir. Oct. 23, 2015), plaintiff should have been given a chance to plead parallel claims.  Subsequent decision, 2018 WL 9817168, aff’d, 940 F.3d 1106, below.
  206. 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.
  207. 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.  Warning claim based on failure to report adverse events is not preempted, but claim is dismissed with leave to amend for failure to plead causation.  Negligence claim alleging illegal off-label promotion is impliedly preempted as an FDCA violation claim.  Subsequent decision, 40 F. Supp.3d 1202, below.
  208. 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.
  209. 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.
  210. 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.
  211. 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 nexus, given an unexplained two-year gap between the time of the FDA inspection and the manufacture of plaintiff’s device.   The parallel 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.
  212. 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.
  213. 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.  Subsequent decision, 2014 WL 819392, below.
  214. 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).
  215. 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.
  216. 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.
  217. Ford v. Mentor Worldwide, LLC, 2013 WL 12420090 (E.D. La. Dec. 17, 2013), motion to dismiss granted against all claims in case involving an unidentified product.  Plaintiff did not oppose.
  218. 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.
  219. 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.
  220. 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.
  221. 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, above.
  222. Morris v. Rotolo, 2014 WL 12618659 (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 defendant violated unspecified regulations is insufficient.
  223. 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.
  224. 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.
  225. 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.
  226. 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.
  227. 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, 597 F. Appx. 226, below.
  228. 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.
  229. 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.
  230. 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.  Prior decision, 2013 WL 6172234, above.
  231. 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.
  232. 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.
  233. 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.
  234. 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 part, 863 N.W.2d 404, below.
  235. 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.
  236. 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.
  237. 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.
  238. 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).
  239. 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.  Express warranty based on voluntary statements about off-label uses are not preempted.  Design defect claims preempted.
  240. 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.
  241. 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.
  242. 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 part, 863 N.W.2d 404, below.
  243. 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 part, 863 N.W.2d 404, below.
  244. 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.
  245. 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.
  246. 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.  Dismissed, 92 F. Supp.3d 606, below.
  247. 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.
  248. 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.
  249. 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.
  250. 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.
  251. 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.  Prior decision, 914 F. Supp.2d 1290, above.
  252. 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. Fraudulent 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.  Prior order, 957 F. Supp.2d 1166, above.
  253. 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.
  254. 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.
  255. 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.  Prior decision, 981 F. Supp.2d 868, above.
  256. 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.
  257. 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.
  258. 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 parallel claim.  Failure to report adverse events alleged only an FDCA violation.
  259. 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.
  260. 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.
  261. 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.
  262. 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.
  263. 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.
  264. Mendez v. Shah, 28 F. Supp.3d 282 (D.N.J. June 27, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption does not depend on using all of the approved components.  Claims alleging false off-label promotion are not preempted.  Subsequent opinion, 94 F. Supp.3d 633, below.
  265. 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.
  266. 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.
  267. 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.
  268. 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.
  269. 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.  Dismissed, 63 F. Supp.3d 1050, below.
  270. 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.
  271. 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 preempted 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.
  272. 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.
  273. 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.
  274. 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.
  275. 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.
  276. Roberts v. Stryker Corp., 2014 WL 12911070 (W.D. Ky. Aug. 7, 2014), motion to dismiss granted in part and denied in part in action involving in action involving hip implant.  Some GMPs cited by plaintiffs are sufficiently specific in establishing a duty to support a parallel claim, others are too vague. Warning claims preempted because Kentucky does not recognize any failure to report claim.
  277. 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.
  278. 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.
  279. 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.
  280. 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.
  281. 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.
  282. 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.
  283. 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 parallel 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 TwIqballed.  Related negligence claims follow the defect allegations.
  284. 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.
  285. 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.
  286. 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.
  287. 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.
  288. 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.
  289. 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.
  290. 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.
  291. 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.
  292. 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)
  293. 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.  Prior decision, 32 F. Supp.3d 1026, above.
  294. 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).
  295. 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.
  296. 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.
  297. 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.
  298. 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.
  299. 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.
  300. 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.
  301. 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, below.
  302. 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.
  303. 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.
  304. 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)
  305. 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.
  306. 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.
  307. 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 liability claims based on sales rep conduct in the operating room are not preempted.
  308. 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.
  309. 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.
  310. 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.
  311. 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 & rejected in part, 2016 WL 3547932, below.
  312. 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 & reversed in part, 745 F. Appx. 714, below.
  313. 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.
  314. 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.  Subsequent decision, 142 F. Supp.3d 1262, below.
  315. 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.  Prior ruling, 13 F. Supp.3d 692, above.
  316. Mendez v. Shah, 94 F. Supp.3d 633 (D.N.J. March 30, 2015), motion to dismiss granted against all remaining claims in action involving bone growth device.  Manufacturing defect claim must identify allegedly violated FDA requirement.  Off-label warning claim preempted. Prior decision, 28 F. Supp.3d 282, above.
  317. 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.
  318. 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.
  319. 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. A recall is not a manufacturing defect.  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.  Dismissed, 2016 WL 5461900; affirmed in part & reversed in part, 885 F.3d 760, below.
  320. Morton v. Allergan, 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.
  321. 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.
  322. 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.
  323. 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.
  324. 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 parallel 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 promotion 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.
  325. 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.
  326. 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.
  327. 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.
  328. 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.
  329. Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586 (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.
  330. 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.
  331. 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.
  332. 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.
  333. 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.
  334. 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.
  335. 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.
  336. 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.
  337. 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.
  338. 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.”  Subsequent decision, 2016 WL 7011530, below.
  339. 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.
  340. 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.
  341. 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.
  342. 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.
  343. 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 reclassification 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.
  344. 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, 431 P.3d 571, below.
  345. 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.
  346. 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.
  347. 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.
  348. 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
  349. 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.
  350. 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.  Subsequent opinion, 2016 WL 4098608, below.
  351. 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.
  352. 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.
  353. 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.
  354. Day v. Howmedica Osteonics Corp., 2015 WL 13469348 (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.
  355. 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.
  356. 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.  Prior decision, 2015 WL 12803805, above.
  357. 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.
  358. 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.
  359. 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.
  360. 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.
  361. 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.
  362. 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.
  363. 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.
  364. 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.
  365. 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.
  366. 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, 2017 WL 697047, below.
  367. 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.
  368. 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.
  369. 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.
  370. 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.
  371. 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.
  372. 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.
  373. 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.
  374. 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.
  375. 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.
  376. 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.
  377. 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.
  378. 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.
  379. 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.
  380. 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.
  381. 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.
  382. 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.
  383. 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.
  384. 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.  Prior opinion, 2015 WL 7756063, above.
  385. 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.
  386. 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.
  387. 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.
  388. 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.
  389. 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.  Subsequent decision, 2016 WL 7098781; dismissed, 2017 WL 680725, below.
  390. 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.
  391. 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.
  392. 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.
  393. 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.
  394. 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).
  395. 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.
  396. 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, 2015 WL 1475368, above; affirmed in part and reversed in part, 885 F.3d 760, below.
  397. 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.
  398. 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.
  399. 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.  Prior decision, 2016 WL 4430855, above; dismissed, 2017 WL 680725, below.
  400. 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.
  401. 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, 874 F.3d 862, below.
  402. 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.
  403. 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.
  404. 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 & reversed in part, 881 F.3d 1309, below.
  405. 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.
  406. 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.
  407. 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.  Prior decisions, 2016 WL 4430855, 2016 WL 7098781, above.
  408. 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.  Prior decision 172 F. Supp.3d 804, above.
  409. 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.  Dismissed, 2017 WL 4574160, below.
  410. 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.
  411. 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.  Affirmed, 791 F. Appx. 679, below.
  412. 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).
  413. 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.
  414. 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.
  415. 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.
  416. 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.
  417. 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.
  418. 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.  Vacated on non-preemption grounds 918 F.3d 372 (4th Cir. 2019).
  419. 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.  Dismissed, 2017 WL 7411060, below.
  420. Perez v. Medtronic, Inc., 2017 WL 11610298 (D. Ariz. May 26, 2017), motion to dismiss granted in part and denied in part in action involving spinal pain pump.  Manufacturing defect claim not preempted.  Rejects GMP specificity argument.  Failure to report fails to plead causation.  Negligence per se impliedly preempted.
  421. 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.
  422. 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.
  423. 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.
  424. 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.
  425. 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.
  426. 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.  Subsequent opinions, 2018 WL 2448095, 2018 WL 6829122; affirmed, 804 F. Appx. 871, below.
  427. 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.  Subsequent opinion, 2019 WL 418843, below.
  428. 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.
  429. 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.
  430. 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.
  431. 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.
  432. 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.
  433. 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.  Prior decision, 2017 WL 825410, above.
  434. Williams v. St. Jude Medical, S.C., Inc., 2017 WL 11113322 (N.D. Ga. Oct. 19, 2017), motion to dismiss granted in part and denied in part in action involving pacemaker leads.  Manufacturing defect claims survive as parallel claims.  Warning, failure to report, and misrepresentation claims preempted.
  435. 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.
  436. 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.
  437. 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.  Affirmed, 786 F. Appx. 84 (9th Cir. Nov. 26, 2019).
  438. 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.
  439. 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.
  440. 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.
  441. 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.
  442. Perez v. Medtronic, Inc., 2017 WL 11610300 (D. Ariz. May 26, 2017), motion to dismiss denied in part in action involving spinal pain pump.  Manufacturing and failure to report not preempted under lax Stengel decision.
  443. 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.  Subsequent opinions, 2018 WL 2933609, and 2022 WL 17668486, below.
  444. Weber v. Allergan, Inc., 2018 WL 9817168 (D. Ariz. Jan. 25, 2018), summary judgment granted against all claims in action involving breast implants.  An FDA regulatory violation cannot be inferred from a device malfunction.  Affirmed, 940 F.3d 1106, below.
  445. 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.
  446. Godelia v. Doe, 881 F.3d 1309 (11th Cir. Feb. 8, 2018), affirming in part and reversing in part 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.
  447. 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.  Prior decision, 2015 WL 1475368; affirming in part and reversing in part, 211 F. Supp.3d 695, above.
  448. 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.
  449. 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.
  450. 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 in action involving infusion pump.  Manufacturing defect, failure to report, and warranty claims survive preemption.  Negligence, negligence per se, and consumer fraud claims preempted.
  451. 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.
  452. 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.
  453. 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.
  454. 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.  Dismissed, 517 F. Supp.3d 76 below; question law certified, 23 F.4th 29.
  455. 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.
  456. 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.  Affirmed 2019 WL 2415049, below.
  457. 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. Prior opinion, 2017 WL 4128976, above, subsequent opinion, 2018 WL 6829122, affirmed, 804 F. Appx. 871, below.
  458. Neils v. Steinberg, 76 N.Y.S.3d 921 (N.Y. Sup. June 5, 2018), motion to dismiss granted against all claims in action involving intraocular lens.  Express and implied warranty and negligence claims all would be in different from or in addition to FDA requirements.
  459. 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 opinion, 289 F. Supp.3d 877, above; subsequent opinion, 2022 WL 17668486, below.
  460. 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.
  461. 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.
  462. Besse v. Insightec, Ltd, 2018 WL 10703872 (Cal.Super. June 21, 2018), demurrer overruled in action involving ultrasound brain ablation device. The PMA status of the components plaintiff is suing over is not pleaded in the complaint and no judicial notice is established.
  463. 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.
  464. Murphy v. Boston Scientific Corp., 2018 WL 4870700 (Mag. M.D. La. July 12, 2018), motion to amend denied in action involving penile implant.  Preemption renders amendment futile.  A product development protocol is as preemptive as PMA.  Parallel claims insufficiently pleaded. Adopted on the merits 2018 WL 6046178 (M.D. La. Nov. 18, 2018), however plaintiff given a chance to amend.
  465. Reed v. St. Jude Medical, 2018 WL 4293146, 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.
  466. Bryant v. Thoratec Corp., 343 F. Supp.3d 594 (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.
  467. Ramkelawan v. Globus Medical, Inc., 2018 WL 8368675 (M.D. Fla. Aug. 8, 2018), motion to dismiss denied in action involving cervical artificial disc.  Manufacturing defect claims are parallel to GMP non-compliance and thus are parallel claims.  No other claim asserted.
  468. Jones v. Medtronic, Inc., 745 F. Appx. 714 (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.
  469. Gomez v. Bayer Corp., 2018 WL 10612946 (N.J. Super. L.D. Aug. 31, 2018), motion to dismiss granted against all claims in action involving implantable contraceptive.  Failure to warn is expressly preempted.  Failure to report and failure to train are impliedly preempted as not recognized under state law, and thus private FDCA enforcement.  Affirmed, 2020 WL 215897, below.
  470. 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.
  471. 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 claims except manufacturing defect.  Plaintiff allowed to infer both a manufacturing defect and an FDCA violation from the fact of an alleged malfunction.
  472. 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.
  473. 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.
  474. 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.  Subsequent opinion, 2018 WL 6694287, below.
  475. Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. Md. Nov. 15, 2019), motion to dismiss denied without prejudice in action involving heart valve assist device.  Plaintiff completely failed to plead any parallel claim, and will be given one more chance to do so.  Discovery is not necessary to plead a parallel claim.  Subsequent opinion, 2019 WL 6052702, below.
  476. Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. Dec. 18, 2018), reversal of grant of motion to dismiss reversed in action involving infusion pump.  Arizona does not 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.
  477. 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.
  478. 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.  Prior opinion, 2018 WL 5734664, above.
  479. 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.
  480. Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122slip 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.  Prior opinions, 2018 WL 2448095, 2018 WL 6829122, above; affirmed, 804 F. Appx. 871, below.
  481. ASEA/AFSCME Local 52 Health Benefits Trust v. St. Jude Medical, LLC, 2019 WL 318393 (D. Minn. Jan. 24, 2019), motion to dismiss granted against all claims in class action involving cardiac defibrillators.  Third party payors’ concealment allegations sought to add requirements or else sought private enforcement of the FDCA.  Failure to file adverse event reports or fraud on the FDA are all preempted.
  482. Freed v. St. Jude Medical, Inc., 2019 WL 418843 (D. Del. Feb. 1, 2019), motion to dismiss granted in part and denied in part in action involving neurostimulator.  Express and implied warranty claims preempted or inadequately pleaded.  Failure to report and negligent manufacturing claims survive preemption.  Prior opinion at 2017 WL 4102583.
  483. Calloway v. Coloplast Corp., 2019 WL 2169222 (Mag. W.D. La. Feb. 5, 2019), adopted, 2019 WL 2166539 (W.D. La. May 17, 2019), motion to dismiss granted against all claims in action involving penile implant.  No parallel claims alleged.
  484. White v. Medtronic, Inc., 2019 WL 13396132 (Mag. E.D. Mich. Feb. 20, 2019), adopted, 2019 WL 1330923 (E.D. Mich. March 25, 2019), motion to dismiss granted against all claims in class action involving bone growth device.  Off-label use does not affect preemption.  Riegel was an off-label case.  Off-label promotion claims are not parallel to recognized state-law cause of action.  Express and implied warranty claims preempted.  Fraud claim was disguised fraud on FDA claim.  Affirmed, 808 F. Appx. 290, below.
  485. Dillard v. Summerlin Hospital Medical Center, LLC,  2019 WL 1878211 (Nev. Dist. Feb. 21, 2019), summary judgment granted against all claims in action involving radiofrequency ablation device.  Device malfunction does not establish violation of FDA standards.
  486. Westerfield v. Corin Group, PLC, 2019 WL 1233634 (M.D. Fla. March 15, 2019), motion to dismiss granted against all claims in class action involving hip implant.  Design defect and failure to report claims preempted.
  487. Stampley v. Allergan USA, Inc., 2019 WL 1604201 (Mag. W.D. La. March 15, 2019), motion to dismiss granted against all claims in class action involving breast implant.  Plaintiff failed to connect her claims to the violation of any federal device requirement.  Adopted, 2019 WL 1601613 (W.D. La. April 15, 2019).
  488. Dunn v. Genzyme Corp., 2019 WL 10777691 (Mass. Super. April 16, 2019), motion to dismiss denied in case involving viscosupplement.  No requirement to plead FDA violations with specificity.  Reversed, 161 N.E.3d 390, below.
  489. McNeil-Williams v. Depuy Orthopaedics, Inc., 2019 WL 2339258 (E.D.N.C. May 29, 2019), motion to dismiss granted against all claims in case involving a knee implant.  Failure to update is not recognized as a state-law claim and therefore cannot be a parallel claim.  Rather it is a preempted private attempt to enforce the FDCA.  Warranty claim preempted as a warning claim.  Any attempt to challenge the integrity of FDA device approval would be preempted by Buckman.
  490. Soja v. Medtronic, Inc., 2019 WL 2391609 (E.D. Cal. June 6, 2019), motion to dismiss granted against all claims in class action involving pain pump.  Plaintiff alleged no parallel claims, and it is unclear what they could be.  Related decision, 2019 WL 2396540 – proper to take judicial notice of FDA website material.
  491. Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), summary judgment affirmed against all claims in action involving defibrillator.  Claimed parallel claims involving the PMA submission were factually incorrect.  What is a federal regulation and what violates that regulation are matters of law for the court to decide.  A malfunction does not preclude preemption.  Experts may not opine on issues of law.  Since preemption is an issue of law exclusion of plaintiff’s FDA expert was appropriate.  Affirming 2018 WL 2688420 and 2012 WL 12925029, above.
  492. Womack v. Nevro Corp., 2019 WL 2567982 (M.D. Fla. June 21, 2019), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Parallel claims must identify what FDA requirements were violated.  Alleged violation of unspecified requirements is insufficient.
  493. Jacob v. Mentor Worldwide, LLC, 389 F. Supp.3d 1024 (M.D. Fla. July 17, 2019), motion to dismiss granted against all claims in action involving breast implants.  All non-parallel claims preempted.  Failure to report parallel claim has no state-law counterpart, and is Buckman preempted.  Subsequent opinion, 2019 WL 6766574, below.
  494. Grubbs v. Medtronic, Inc., 2019 WL 3288263 (N.D. Ala. July 22, 2019), motion to dismiss granted in part and denied in part in action involving pain pump.  Warning claim, including failure to report, preempted.  Warranty claims escape preemption to the extent based on FDA violations.
  495. Jacob v. Mentor Worldwide, LLC, 393 F. Supp.3d 912 (C.D. Cal. Aug. 1, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  496. Vieira v. Mentor Worldwide, LLC, 392 F. Supp.3d 1117 (C.D. Cal. Aug. 1, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.  Affirmed 2021 WL 406628, below.
  497. Porter v. Depuy Orthopaedics, Inc., 2019 WL 3979656 (E.D. Va. Aug. 6, 2019), motion to dismiss granted against all claims in action involving knee implant.  Plaintiff failed to plead with any specificity what went wrong with the implant and how that was related to any regulatory violation.  A recall does not establish a causal violation.  Plaintiff’s claims are consistent with a compliant device causing injury.  No unpreempted express warranty claims because no statements exceeded the scope of FDA-approved statements.  Implied warranty of fitness for a particular purpose is necessarily preempted because the FDA approved the device’s intended use.
  498. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 401 F. Supp.3d 538 (D. Md. Aug. 14, 2018), motion to dismiss granted in part and denied in part in action involving hip implant.  In a hybrid PMA/510k device system, preemption bars non-parallel claims targeted against PMA components.  Holding applies to strict liability, negligence, warranty, misrepresentation-based, and recall claims.  False off-label promotion claims survive preemption.  Failure to conduct a post-marketing study is impliedly preempted as private FDCA enforcement.  Failure to update and duty to train claims are expressly preempted.  Negligence per se claims are not preempted.
  499. Sharp v. St. Jude Medical, S.C., Inc., 396 F. Supp.3d 1250 (N.D. Ga. Aug. 14, 2019), motion to dismiss granted against all claims in action involving implantable cardiac defibrillator.  Rejects Bausch “plaintiff needs discovery” rationale.  Plaintiff must plead facts to establish a parallel claim.  Laundry list of allegedly violated regulations failed to plead either how any violation occurred or causation.  Plaintiff failed to plead causation to avoid preemption of manufacturing defect claim.  Recall does not affect preemption.  Failure to report is a preempted fraud on the FDA claim.  Negligence per se is attempted private FDCA enforcement.  Reversed in part, 2020 WL 7647511, below.
  500. Sewell v. Mentor Worldwide, LLC, 2019 WL 4038219 (C.D. Cal. Aug. 27, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  501. Billetts v. Mentor Worldwide, LLC, 2019 WL 4038218 (C.D. Cal. Aug. 27, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  502. Titko v. Abbott Laboratories, 2019 WL 13214734 (D. Ariz. Aug. 28, 2019), motion to dismiss granted against all claims in action involving cardiac defibrillator.  All claims preempted.  Any attempted parallel claims were insufficiently pleaded.  Amended complaint dismissed 2019 WL 13197982, below.
  503. Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), motion to dismiss granted against all claims in action involving breast implants.  Negligent pharmacovigilance, failure to report, and several manufacturing defect claims impliedly preempted for lack of parallel state cause of action.  FDCA-based negligence per se not permitted.  Warning claim expressly preempted.  CBE FDA process is voluntary, not mandatory.  Manufacturing defect claims patterned on FDCA rather than common law are expressly and impliedly preempted.  Affirmed by, 985 F.3d 1272, below.
  504. Williams v. Mentor Worldwide LLC, 2019 WL 4750843 (N.D. Ohio Sept. 30, 2019), motion to dismiss granted against all claims in action involving breast implants.  No parallel claims alleged.
  505. Fuchs v. Allergan, Inc., 2019 Cal. Super. Lexis 52575 (Cal. Super. Oct. 2, 2019), motion to dismiss denied in action involving breast implants.  Without discovery it is premature to decide if plaintiff has pleaded parallel claims.
  506. Irizarry v. Abbott Laboratories, 2019 WL 5061127, slip op. (E.D. Pa. Oct. 8, 2019), motion to dismiss granted against all claims in action involving blood vessel closure device.  Parallel claims inadequately pleaded.  An appended affidavit is not a pleading.  Nature of any FDCA violation must be pleaded.  No discovery.  No parallel state-law claims identified.  Affirmed, 2020 WL 6441117, below.
  507. Freed v. St. Jude Medical, Inc., 2019 WL 5102643 (D. Del. Oct. 11, 2019), Motion to dismiss denied against remaining claims in action involving neurostimulator.  Arguments against manufacturing defect claims are temporarily waived.  Duty to report claim is adequately pleaded.
  508. Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. Oct. 11, 2019), affirming grant of motion to dismiss against all claims in action involving breast implants.  Statement about device performance in clinical trial was aspirational only and was not an FDA-approved standard.  To make it one was preempted as different from FDA regulation.  That the device malfunctioned was insufficient proof of violation of FDA regulations.  Direct proof of a violation is necessary.  Res ipsa loquitur can establish defect but not an FDA violation.  Affirming 2018 WL 9817168, above.  Cert. denied, 2020 WL 1326110 (U.S. March 23, 2020).
  509. Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678 (S.D. Miss. Nov. 8, 2019), motion to dismiss granted in part and denied in part in action involving gastric balloon.  All non-parallel claims preempted.  Manufacturing defect claim not preempted to the extent that it is based on GMP violations.  Design claim preempted.  Warning claim failed on state law grounds.  Express warranty claim based on statements not approved by FDA is not preempted.
  510. Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. Md. Nov. 15, 2019), motion to dismiss granted against all claims in action involving heart valve assist device.  Attempted parallel claim is conclusory.  Merely stating that the device generally violated some non-specific FDA “standards” is insufficient.  Device recall insufficient to establish an FDA violation.  Previous opinion, 2018 WL 6271055, above.
  511. Barone v. Bausch & Lomb, Inc., 2019 WL 9341358 (N.Y. Sup. Dec. 6, 2019), motion to dismiss denied.  The only claim being asserted, failure to report adverse events, was an unpreempted parallel claim.  Reversed, 141 N.Y.S.3d 808, below.
  512. Jacob v. Mentor Worldwide, LLC, 2019 WL 6766574 (M.D. Fla. Dec. 10, 2019), motion to dismiss amended complaint granted in action involving breast implants.  All plaintiff’s claims, particularly concerning warnings, were still preempted.  Informed consent was a disguised preempted warning claim.  Failure to maintain records claim impliedly preempted as private FDCA enforcement.  Prior opinion, 389 F. Supp.3d 1024, above.  Reversed in part, 2022 WL 2824908, below.
  513. Titko v. St. Jude Medical, LLC, 2019 WL 13197982 (D. Ariz. Dec. 13, 2019), motion to dismiss granted against all claims in action involving cardiac defibrillator.  No parallel claims pleaded.  Prior complaint dismissed, 2019 WL 13214734, above.
  514. Walls v. Medtronic, Inc., 2019 WL 6839942 (E.D. Pa. Dec. 16, 2019), motion to dismiss granted against all claims in action involving deep brain stimulators.  No parallel claims pleaded.  Post-sale duty to warn claim would be preempted if it went beyond FDA requirements.  Where plaintiff pleaded an intended use, an off-label promotion claim would not be viable.  Judicial notice proper of FDA documents establishing PMA.
  515. Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019), motion to dismiss granted against all claims in action involving breast implants.  No parallel claim pleaded.  FDCA duty to create procedures not “genuinely equivalent” to state-law warning claim.  Failure to report claims impliedly preempted.
  516. Bayer Corp. v. Leach, 139 N.E.3d 1127 (Ind. App. Dec. 31, 2019).  Partial denial of preemption judgment on the pleadings affirmed in action involving implantable contraceptive.  Parallel manufacturing defect claims escape preemption.  Both premised on federal GMP violation and within state statutory definition of manufacturing defect.  Vacated, and later decision, 2153 N.E.3d 1168, below.
  517. Green v. Medtronic, Inc., 2019 WL 7631397 (N.D. Ga. Dec. 31, 2019), motion to dismiss granted against all claims in action involving pain pump.  Manufacturing defect claim preempted where no violated regulation alleged.  Negligence per se dismissed under Buckman because claim cannot exist without FDCA.  Amendment allowed, 2020 WL 45777134; dismissed, 2020 WL 8225327, below.
  518. Bledsoe v. Medtronic, Inc., 2020 WL 43107 (N.D. Ind. Jan. 3, 2020), motion to dismiss granted in part and denied in part in action involving pain medication pump.  Duty to report runs only to FDA, so warning claims preempted.  Design defect preempted because it would second-guess FDA’s safety and effectiveness determination.  Under Bausch, a manufacturing defect claim escapes preemption even without the violated FDA requirement, or the violation, being specified.  Dismissed, 2022 WL 9395264 below.
  519. Gomez v. Bayer A.G., 2020 WL 215897, slip op. (N.J. Super. A.D. Jan. 14, 2020), grant of motion to dismiss affirmed against all claims affirmed in action involving implantable contraceptive.  Plaintiff failed to plead a parallel claim with respect to defendant’s warnings or as to any express warranty.  Failure to train and manufacturing defect claims did not allege any parallel claim.  Preemption requires stricter pleading requirements.  Affirming 2018 WL 10612946, above.
  520. Lawrence v. Medtronic, 791 F. Appx. 679 (9th Cir. Jan. 28, 2020), grant of motion to dismiss affirmed against all claims affirmed in action involving pain pump.  Parallel claims properly preempted for failure to identify violation of specific FDA regulation.  Failure to test explanted units properly preempted as “in addition to” FDA requirements that do not mandate any such tests.  Failure to report properly preempted for lack of causation and because all reports actually made.  Failure to report plaintiff’s own incident could not possibly be causal.  Affirming, 2017 WL 826963, above.
  521. White v. Medtronic, Inc., 808 F. Appx. 290 (6th Cir. Jan. 29, 2020), grant of motion to dismiss affirmed against all claims affirmed in action involving bone growth device.  Preemption applies when components of a PMA device are used separately off-label.  Affirming 2019 WL 13396132 above.
  522. Allo v. Allergan USA, Inc., 2020 WL 814855 (E.D. La. Feb. 19, 2020), motion to dismiss granted in part and denied in part in action involving breast implants.  Manufacturing defect and redhibition claims based on product not meeting FDA thickness standards are permissible parallel claims.  All other claims preempted.
  523. Lewis v. Abbott Laboratories, Inc., 2020 WL 825428 (M.D. Fla. Feb. 24, 2020), motion to dismiss denied in action involving a defibrillator.  Plaintiff only brought unpreempted manufacturing defect claims.  Fraud dismissed for failure to allege any false statement.
  524. Doe v. Bausch & Lomb, Inc., 443 F. Supp.3d 259 (D. Conn. March 11, 2020), motion to dismiss granted against all claims in action involving intraocular lens.  All warning-related claims expressly preempted, including consumer fraud.  Failure to report claim impliedly preempted as private FDCA enforcement.  Reversed in part, 2022 WL 3146797, below.
  525. Saltis v. Nuvasive, Inc., 2020 WL 4689787 (D. Vt. March 13, 2020), motion to dismiss granted against all claims in action involving pedicle screws.  No FDCA violations pleaded.
  526. Hayes v. Endologix, Inc., 449 F. Supp.3d 676 (E.D. Ky. March. 26, 2020), motion to dismiss granted in part and denied in part in action involving aortic aneurysm graft.  FDCA-based negligence per se had no state-law analog and could not be parallel claims.  Remaining claims were sufficiently specific to avoid preemption.
  527. Webb v. Mentor Worldwide LLC, 453 F. Supp.3d 550 (N.D.N.Y. April, 7, 2020), motion to dismiss granted against all claims in action involving breast implants.  References to vague GMPs and a warning letter involving a different product do not plead a manufacturing defect.  Nothing suggests that this unit was any different from any other.  Warning, design and implied warranty claims preempted.  No express warranty pleaded.
  528. Carter v. Medtronic, Inc., 2020 WL 2319729 (S.D. Ohio May 11, 2020), summary judgment granted against all claims in action involving pain pump.  Manufacturing defect claim fails because res ipsa loquitur cannot establish a regulatory violation.
  529. Ebrahimi v. Mentor Worldwide LLC, 804 F. Appx. 871 (9th Cir. May 15, 2020), dismissal of all claims affirmed in action involving breast implant.  Manufacturing defect preempted.  Plaintiff’s injury was not proof that defendant must have violated some GMP.  Defendant’s data sheet did not create any design specification.  Prior opinions, 2017 WL 4128976, 2018 WL 2448095, 2018 WL 6829122, above.
  530. Green v. Medtronic, Inc., 2020 WL 4577713 (N.D. Ga. May 1, 2020), motion to amend allowed in part and denied in part in action involving a pain pump.  Manufacturing defect claim patterned after FDA warning letter not preempted on the pleadings.  Negligence per se, including little FDCA act, impliedly preempted.  Express warranty not breached, and otherwise preempted.  Prior decision, 2019 WL 7631397, above.
  531. Diodato v. Mentor Worldwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), motion to dismiss granted against all claims in action involving breast implants.  A device malfunction is insufficient to infer that the defendant violated FDA regulations.  No particular deviation from any identified FDA manufacturing regulation is alleged.  Same for warning and design claims.
  532. Sullivan v. Boston Scientific Corp., 2020 WL 4558303 (Mag. N.D. Fla. June 23, 2020), adopted, 2020 WL 4430392 (N.D. Fla. July 31, 2020), motion to dismiss granted against all claims in action involving spinal cord stimulator.  No parallel claims alleged.
  533. English v. Bayer Corp., 468 F. Supp.3d 573 (W.D.N.Y. June 25, 2020), motion to dismiss granted against all claims in action involving implantable contraceptive.  Failure to train expressly and impliedly preempted.  Failure to report expressly preempted because no parallel state claim exists.  On appeal, No. 20-2137 (2d Cir.)
  534. D’Addario v. Johnson & Johnson, 2020 WL 3546750 (D.N.J. June 30, 2020), motion to dismiss granted against all claims in action involving breast implants.  Manufacturing claim failed to tie the alleged defect to violation of any FDA regulation.  Warning claim either challenged approved warnings or asserted fraud on the FDA.
  535. Arnold v. Biotronik, Inc., 2020 WL 13804742 (Ariz. Super. June 30, 2020), motion to dismiss denied in action involving an implantable cardioverter-defibrillator.  Plaintiff questions whether the device is PMA, vague pleading of violation allowed.
  536. Humphrey v. Dexcom, Inc., 2020 Cal. Super. Lexis 33653 (Cal. Super. July 17, 2020), demurrer granted in part and denied in part in action involving glucose monitor.  Manufacturing defect and failure to report survive given California lax pleading standards.  Warning claim not based on reporting dismissed.
  537. James v. Medtronic, 2020 WL 13310413 (Cal. Super. July 23, 2020), partial demurrer granted in action involving spinal stimulator.  All claims not based on FDCA violations are preempted.  Subsequent dismissal, 2022 WL 6238373, below.
  538. Bayer Corp. v. Leach, 153 N.E.3d 1168 (Ind. App. Aug. 19, 2020), denial of motion to dismiss affirmed in part and reversed in part in action involving implantable contraceptive.  Negligence per se is impliedly preempted.  Plaintiff cannot, on a failure to report theory or otherwise, require a defendant to make a labeling change that is voluntary under FDA regulation.  Fraud claims based on false statements outside FDA-approved warnings survives on the pleadings.  Manufacturing defect claim not impliedly preempted.  Allegation of negligent conduct of FDA-mandated physician training, or voluntarily self-assumed additional training, is not preempted.  Express warranty claims are voluntarily assumed and not preempted.  Prior decision, 139 N.E.3d 1127, above.
  539. Hill v. Abbott Laboratories, 2020 WL 4820243 (D.S.C. Aug. 19, 2020), motion to amend allowed in part and denied in part in action involving an implantable cardiac defibrillator.  Recall does not establish an FDCA violation, but allows one to be pleaded.  Express and implied warranty and unjust enrichment expressly preempted.  Manufacturing defect and related warning/misrepresentation claims not preempted.
  540. Cleeton v. SIU Healthcare, Inc., 2020 WL 5875947 (Ill. Cir. Aug. 21, 2020), summary judgment granted against all claims in action involving pain pump.  Defendant’s warnings and delivery of same complied with all FDA requirements.  FDA does not require separate delivery of warnings.  Affirmed, 2021 WL 3399851, below.
  541. Coghill v. Bayer Corp., 2020 U.S. Dist. Lexis 154092 (E.D. Ky. Aug. 25, 2020), motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Only claims plaintiff conceded were dismissed.  As to everything else, the record was too unclear to make an affirmative ruling on preemption.
  542. Podoll v. Koch, 2020 WL 13220526 (Colo. Dist. Aug. 25, 2020), motion to dismiss granted against all claims in action involving hip resurfacing system.  Conclusory negligence per se violation allegations are preempted as private FDCA enforcement.  Consumer protection claim varies from federal standards and is preempted.  A distributor has not power or duty to make any changes to a medical device.
  543. Noel v. Bayer Corp., 481 F. Supp.3d 1111 (D. Mont. Aug. 26, 2020), motion to dismiss granted against all claims in action involving implantable contraceptive.  Alleged adulteration could not have caused plaintiff’s injury and thus was not an unpreempted manufacturing defect claim.  Plaintiff cannot invalidate FDA approval.  Claim of duty to submit CBE supplement preempted.  Reporting claims preempted as either beyond what FDA requires or not supported by state law.  Express warranty claims attacking FDA-approved statements are preempted.  Duty to train claims must plead violation of FDCA training duties.  Overpromotion, pharmacovigilence, and consumer fraud claims all preempted.
  544. Conley v. St. Jude Medical, LLC, 482 F. Supp.3d 268  (M.D. Pa. Aug. 28, 2020), motion to dismiss granted against all claims in action involving nerve root stimulator.  Parallel claims cannot be asserted by alleging violations of vague CGMPs.  Express warranty not preempted but inadequately pleaded.  Failure to report and manufacturing defect are preempted.
  545. Wigginton v. Hologic, Inc.,  2020 WL 13093771 (M.D. Fla. Sept. 3, 2020), motion to dismiss granted against all claims in action involving digital mammography system.  Plaintiff failed to plead any parallel claims.  No discovery allowed on motion to dismiss.
  546. Hill v. Bayer Corp., 485 F. Supp.3d 843 (E.D. Mich. Sept. 8, 2020), motion to dismiss granted against all claims in action involving implantable contraceptive.  No parallel state law claim for failure to report adverse events to the FDA.  Failure to train preempted to the extent it exceeds FDA requirements, and causation not pleaded to the extent it does not.  Express warranty preempted as to statements approved by FDA.  Reconsideration denied, 2020 WL 5903892 (E.D. Mich. Oct. 5, 2020).
  547. Pratt v. Bayer Corp., 2020 WL 5749956 (D. Conn. Sept. 25, 2020), motion to dismiss granted against all claims in action involving implantable contraceptive.  Failure to report impliedly preempted as private FDCA enforcement.  Failure to train claim was parallel to Good Samaritan liability, but causation not pleaded.  Other training and warning claims expressly preempted.
  548. Santoro v. Endologix, Inc., 2020 WL 6295077 (Mag. D. Or. Oct. 6, 2020), adopted, 2020 WL 6287473 (D. Or. Oct. 27, 2020) & Lakey v. Endologix, Inc., 2020 WL 6295080 (Mag. D. Or. Oct. 6, 2020), adopted, 2020 WL 6287472 (D. Or. Oct. 27, 2020) (identical opinions), motion to dismiss denied in action involving aortic graft.  Applies presumption against preemption.  FDCA duty to file annual reports to doctors paralleled state law warning and fraud liability.  Initial disguised recall violated state and federal law.  Manufacturing and design defect claims based on alleged improper use of supplement to change device materials not preempted.  GMPs need not be specific.  PMA was conditional on following FDA regulations.  Negligence per se not impliedly preempted.
  549. Dietz v. Allergan, Inc., 2020 WL 6220125, slip op. (Ill. Cir. Oct. 8, 2020), motion to dismiss granted against all claims in action involving breast implants.  All plaintiff’s claims, including failure to report, challenge the suitability and propriety of FDA-approved processes and procedures.  Warning letters issued years after plaintiff’s implant are not relevant.  To the extent not expressly preempted, the claims are impliedly preempted as private FDA enforcement.
  550. Frey v. Bayer Corp., 499 F. Supp.3d 1283 (M.D. Ga. Oct. 9, 2020), motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Failure to report impliedly preempted as private FDCA enforcement.  Negligent manufacturing claim based on malfunction of product not preempted.  Numerous alleged express warranties preempted as attacking FDA-approved language.  Express warranty claim relating to negligent manufacturing claim not preempted.
  551. Mories v. Boston Scientific Corp., 494 F. Supp.3d 461 (S.D. Ohio Oct. 14, 2020), motion to dismiss granted in part and denied in part in action involving spinal cord stimulator.  Design and manufacturing defect claims generally alleging nonconformity with PMA requirements escape preemption.  No obligation to plead specific violations.  Similarly vague violation-based warning and warranty claims escape preemption.  Failure to report and negligent handling claims preempted as private FDA enforcement in the absent of any state-law duty.
  552. Sullivan v. Boston Scientific Corp., 2020 WL 7212604 (N.D. Fla. Oct. 20, 2020), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Plaintiff failed to plead a violation of any specific, pertinent federal regulation.  Adopted 2020 WL 7186748 (N.D. Fla. Dec. 7, 2020).
  553. Irizarry v. Abbott Laboratories, 833 F. Appx. 947 (3d Cir. Nov. 3, 2020), grant of motion to dismiss against all claims affirmed in action involving blood vessel closure device.  Parallel claims must plead specific claims of PMA violations.  An expert affidavit is not a pleading under Rule 12.  No discovery.   Affirming, 2019 WL 5061127, above.
  554. Hogg-Johnson v. Merz North America, 2020 WL 6826420 (S.D. Cal. Nov. 18, 2020), motion to dismiss granted against all claims in action involving dermal filler.  Judicial notice taken of FDA PMA.  Warning and negligence preempted.  No parallel claim pleaded.
  555. Smith v. Zoll Medical Corp., 505 F. Supp.3d 787 (W.D. Tenn. Dec. 8, 2020), motion to dismiss granted in part and denied in part in action involving wearable defibrillator.  Manufacturing defect claim based on improper product repair was parallel and not preempted, but claims attacking manufacturing specifications are preempted.  All non-manufacturing warning, design, warranty, and misrepresentation theories preempted.
  556. Cooksey v. Medtronic, Inc., 2020 WL 10090793 (N.D. Ga. Dec. 16, 2020), motion to dismiss granted in part and denied in part in action involving pain pump.  Manufacturing defect claims tracking FDA warning letters not preempted.  Other claims dismissed on non-preemption grounds.
  557. Naquin v. Medtronic, Inc., 2020 WL 7060150 (E.D. La. Dec. 2, 2020), motion to dismiss granted in part and denied in part in action involving defibrillator and components.  Warning, design, and express warranty claims against six PMA components expressly preempted.  Parallel claim allegations fail to allege any particular FDCA violation or causation.  Res ipsa cannot show a violation.  Contract claim can be repleaded.  Affirmed, 2021 WL 4848838, below
  558. Sharp v. St. Jude Medical, S.C., Inc., 838 F. Appx. 462 (11th Cir. Dec. 23, 2020), grant of motion to dismiss reversed in part in action involving defibrillator.  Manufacturing defect claim escaped preemption.  Device recall was circumstantial evidence of defect and conclusory allegation of regulatory violation sufficed.
  559. Green v. Medtronic, Inc., 2020 WL 8225327 (N.D. Ga. Dec. 23, 2020), summary judgment granted against all claims in action involving pain pump.  Defendant’s traceability cards negated allegations of manufacturing defect, and plaintiff failed to come forward with any evidence contradicting them, establishing that plaintiff could not prove her case.  Prior decisions, 2019 WL 7631397, 2020 WL 4577713, above.
  560. Brooks v. Mentor Worldwide, LLC, 985 F.3d 1272 (10th Cir. Jan. 26, 2021), dismissal of all claims affirmed in action involving breast implants.  Treating §337(a) as a preemption clause.  Negligence per se expressly and impliedly preempted.  Neither Kansas nor Missouri allow FDCA-based negligence per se.  Warning claims to plaintiff and doctors expressly preempted.  Failure to report to FDA impliedly preempted.  Manufacturing defect not properly pleaded.  Affirming, 2019 WL 4628264, above.
  561. Dunn v. Genzyme Corp., 161 N.E.3d 390 (Mass. Jan. 29, 2021), denial of motion to dismiss reversed in action involving viscosupplement.  While there is no peculiarly stringent pleading standard for parallel claims in PMA medical device cases, none of plaintiff’s claims is sufficiently pleaded to satisfy ordinary pleading standards.  Reversing, 2019 WL 10777691, above.
  562. Nunn v. Mentor Worldwide, LLC, 847 F. Appx. 373 (9th Cir. Feb. 3, 2021), grant of motion to dismiss against all claims affirmed in action involving breast implants.  Failure to conduct post-approval studies impliedly preempted as private FDCA enforcement.  Failure to report speculative without actual non-reporting.  Manufacturing defect preempted for failure to identify a particular violated FDA requirement.  Res ipsa insufficient.
  563. Billetts v. Mentor Worldwide, LLC, 847 F. Appx. 377 (9th Cir. Feb. 5, 2021), grant of motion to dismiss against all claims affirmed in action involving breast implants.  Failure to conduct post-approval studies impliedly preempted as private FDCA enforcement.  Failure to report speculative without actual non-reporting.  Manufacturing defect preempted for failure to identify a particular violated FDA requirement.  Res ipsa insufficient.
  564. Sewell v. Mentor Worldwide, LLC, 847 F. Appx. 380 (9th Cir. Feb. 5, 2021), grant of motion to dismiss against all claims affirmed in action involving breast implants.  Failure to conduct post-approval studies impliedly preempted as private FDCA enforcement.  Failure to report speculative without actual non-reporting.  Manufacturing defect preempted for failure to identify a particular violated FDA requirement.  Res ipsa insufficient.
  565. Vieira v. Mentor Worldwide, LLC, 845 F. Appx. 503 (9th Cir. Feb. 5, 2021), grant of motion to dismiss against all claims affirmed in action involving breast implants.  Failure to conduct post-approval studies impliedly preempted as private FDCA enforcement.  Failure to report speculative without actual non-reporting.  Manufacturing defect preempted for failure to identify a particular violated FDA requirement.  Res ipsa insufficient.  Affirming, 392 F. Supp.3d 1117, above.
  566. Barone v. Bausch & Lomb, Inc., 141 N.Y.S.3d 808 (N.Y. App. Div. Feb. 5, 2021), denial of motion to dismiss all claims reversed.  Failure to report claims are not the same as failure to warn and are thus preempted. Reversing, 2019 WL 9341358, above.
  567. Plourde v. Sorin Group USA, Inc., 517 F. Supp.3d 76 (D. Mass. Feb. 5, 2021), summary judgment granted against all remaining claims in action involving porcine heart valve.  Massachusetts does not recognize any cause of action for failure to report adverse events to the FDA.  Failure to report claim cannot be parallel and is expressly preempted.  Same result for consumer fraud claim.  Prior decision, 2018 WL 1542361, above; state law question certified, 23 F.4th 29.
  568. Green v. Bayer Corp., 522 F. Supp.3d 492 (E.D. Ark. Feb. 22, 2021), motion to dismiss granted against all claims in action involving implantable contraceptive.  Negligent training might escape preemption under a Restatement §324A theory, but is inadequately pleaded.  Failure to report impliedly and expressly preempted.  Express warranty preempted because no non-FDA statement pleaded.  Manufacturing related claims preempted and insufficiently pleaded.  Warning related claims expressly preempted.
  569. Hawkins v. Abbott Diabetes Care Sales Corp., 2021 WL 795860 (E.D. La. March 2, 2021), motion to dismiss granted against all claims in action involving glucose monitoring device.  Judicial notice taken of the PMA.  Plaintiff did not oppose preemption on the merits.
  570. Reddick v. Medtronic, Inc., 2021 WL 798294 (E.D. La. March 2, 2021), motion to dismiss granted against all claims in action involving implantable cardiac defibrillator.  Recalls of different products or of the same product for unrelated problems do not establish a parallel manufacturing defect claim.  Off label use-based claims preempted because any state restrictions on such use are different from federal law allowing such use.  Design and warning allegations of FDCA violations too vague.  Plaintiff failed to allege the terms of any express warranty going beyond FDA-approved labeling.  On appeal, No. 21-30169 (5th Cir.)
  571. Lowery, v. Sanofi-Aventis LLC, 535 F. Supp.3d 1157 (N.D. Ala. March 9, 2021), summary judgment granted against all claims in action involving injection based pain prevention device.  Eleventh Circuit does not limit parallel claims to violations of specific FDA regulations.  While parallel claims can be based on violations of non-specific GMPs, plaintiff must still allege specific facts establishing what the violation is and how it caused injury.  Plaintiff cannot establish a parallel claim, including an adulteration claim, based solely on GMPs applicable to drugs.  To apply drug GMPs to medical devices would be “in addition to” the applicable FDA requirements.  A parallel negligence per se claim cannot be based on violations of FDA guidance documents because they lack force of law.  Speculative violation claims cannot defeat preemption.  While defendant could have done more testing, it was not required to do so, therefore express preemption.  Express and implied warranty also preempted.
  572. Brumfield v. Medtronic, Inc., 2021 WL 933869 (S.D. W. Va. March 11, 2021), motion to dismiss granted in part and denied in part in action involving spinal pain pump.  Manufacturing defect claim based on CGMP violation not preempted.  Any claim not based on a violation would be preempted.
  573. Pappas v. Medtronic Inc., 2021 WL 977165 (D. Ariz. March 16, 2021), motion to dismiss granted against all claims in action involving pain pump.  Plaintiff failed to allege any causal parallel claim.  Allegations about unrelated warning letters and recalls regarding devices plaintiff did not use, defects plaintiff did not allege, and complications plaintiff did not experienced are insufficient.
  574. In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. March 19, 2021), motion to dismiss granted in part and denied in part in action involving breast implants.  All claims attacking language in labeling, including misbranding, are expressly preempted.  State law cannot make discretionary CBE label updates mandatory.  Failure to report claims not preempted as parallel claims, or as private FDCA enforcement, in states that allow reporting claims as a matter of state law.  Most states do not recognize reporting claims.  Manufacturing defect claims, as pleaded, are non-preempted parallel claims of CGMP violations.  Plaintiffs have alleged specific CGMP violations that can serve as a basis for adulteration claims, and can have discovery to establish that products did not comply with FDA or defendant’s standards.  FDCA-based negligence per se is not impliedly preempted, but is not recognized by many states. Post-PMA claims against reclassified devices are expressly preempted.  Negligent warning claim for failure to conduct post-marketing studies required by PMA are preempted.  No parallel state-law duty exists.  Implied warranty claims raising same parallel reporting or manufacturing claims are not preempted.  Express warranty, misrepresentation, and consumer fraud claims based on specifically identified non-labeling information from defendant are not preempted.
  575. Kline v. Mentor Worldwide, LLC, 2021 WL 1173279 (E.D. Cal. March 29, 2021), motion to dismiss granted against all claims in action involving breast implants.  Failure to report claims expressly preempted except as to reporting to FDA.  FDA-based reporting claims and manufacturing defect claims insufficiently pleaded.  No particular unreported adverse events pleaded that could support causation as to plaintiff.  Only violations of general CGMPs by use of unknown materials pleaded.
  576. Ramljak v. Boston Scientific Corp., 2021 WL 1209025 (N.D. Ill. March 31, 2021), motion to dismiss denied in action involving penile implant.  Plaintiff pleaded a deviation from specifications, so a non-preempted parallel manufacturing defect claim existed.  Violated regulations need not be specific, but regardless plaintiff pleaded a specific deviation from intended result.  FDA enforcement activity not required.
  577. Edwards v. Thoratec LLC, 532 F. Supp.3d 786 (D. Minn. March 31, 2021), motion to dismiss denied in action involving ventricular assist system.  Defendant admitted deviation from specifications, so a non-preempted parallel manufacturing defect claim existed.
  578. D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. March 31, 2021), motion to dismiss granted against all claims in action involving breast implants.  Manufacturing based claims really involved a concealed design-based claim.  Warning claims based on failure to report and failure to complete studies preempted and inadequately pleaded.  Warranty and misrepresentation claims that the device should not have been marketed as “safe” conflict with FDA approval and are preempted.
  579. Engle v. Medtronic, Inc., 2021 WL 1318322 (W.D. Ky. April 8, 2021), motion to dismiss granted against all claims in action involving spinal pain pump.  Allowing generalized pleading of CGMP violations.  While legal, off-label use is different from what FDA labeling requires, so claims arising from a doctor’s off-label use are preempted.  A recall does not automatically give rise to unpreempted claims, but determination of the alleged recalls are not causal will wait until after discovery.
  580. Kilmer v. Medtronic USA, Inc., 2021 WL 1405198 (E.D. Cal. April 13, 2021), motion to dismiss granted in part and denied in part in action involving spinal pain pump.  Manufacturing defect claim based on skipped step causing malfunctioning software not preempted. Allegations based on FDA warning letter sufficiently specific.  Failure to report claims escape preemption but are insufficiently pleaded.  An express warranty beyond FDA-approved language is not preempted.
  581. Celino v. Biotronik, Inc., 536 F. Supp.3d 89 (E.D. La. April 29, 2021), motion to dismiss granted in part and denied in part in action involving implantable defibrillator.  All FDA approvals judicially noticed, as regulatory status is a question of law.  Laundry list of FDA regulations lacked any causal connection to plaintiff’s injuries.  Conclusory manufacturing claim fails to distinguish between multiple products.  Warranty claim does not allege any statement not FDA approved.  Other claims TwIqballed.
  582. In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 2021 WL 2396579 (New Jersey Super. Law Div. May 4, 2021), motion to dismiss granted in part and denied in part in action involving breast implants.  All claims attacking language in labeling, including misbranding, are expressly preempted.  State law cannot make discretionary CBE label updates mandatory.  Stand alone failure to report claims preempted, but failure to report can be asserted under exceptions to the NJ compliance defense.  Manufacturing defect claims, as pleaded, are non-preempted parallel claims of CGMP violations.  Negligent warning claim for failure to conduct post-marketing studies required by PMA are preempted.  No parallel state-law duty exists.  Implied warranty claims raising same parallel reporting or manufacturing claims are not preempted.  Express warranty, misrepresentation, and consumer fraud claims based on specifically identified non-labeling information from defendant are not preempted.
  583. Reynolds v. Medtronic, Inc., 2021 WL 1854968 (S.D. Ohio May 10, 2021), motion to dismiss granted in part and denied in part in action involving spinal pain pump.  Judicial notice taken of FDA approvals.  Manufacturing defect claim based on device coming apart is parallel and survives preemption.  Warning and implied warranty claims preempted.  Failure to report preempted.  Pleading unspecified FDCA deviations not permitted.
  584. Bernasek v. Gatz, 2021 WL 2152968 (Fla. Cir. May 20, 2021), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Claims for failure to report, failure to update warnings, and failure to conduct risk analyses all impliedly preempted as involving solely federal duties.
  585. Estate of Ravizza v. Abbott Laboratories, 2021 Cal. Super. Lexis 121761 (Cal. Super. May 25, 2021), demurrer denied in action involving implantable defibrillator.  Failure to report and negligence per se are unpreempted parallel claims.
  586. Sims v. Medtronic, Inc., 2021 WL 2291014 (N.D. Tex. June 4, 2021), motion to dismiss granted against all claims in action involving pain pump.  An alleged recall does not establish defect or causation.
  587. Goodwin v. Medtronic, Inc., 2021 WL 7448501 (E.D. Tex. June 4, 2021), motion to dismiss denied in action involving pain pump.  All plaintiff’s claims are based on recall and other alleged FDCA violations.
  588. Koublani v. Cochlear Limited, 2021 WL 2577068 (E.D.N.Y. June 23, 2021), motion to dismiss denied in action involving accessory to cochlear implant.  Record was too uncertain to establish PMA status of a device “accessory.”  While the rationale used for “components” may apply, that would require taking inferences in favor of the movant.
  589. Lloyd v. Medtronic, Inc., 2021 WL 2822882 (S.D. Ill. July 7, 2021), motion to dismiss granted in part and denied in part in action involving pain pump.  Manufacturing defect claims based on recalls, survive.  Other claims dismissed.
  590. Castaneda v. Saint Francis Medical Center, 2021 WL 2823160 (E.D. Mo. July 7, 2021), motion to dismiss granted in part and denied in part in action involving implanted reflux management device.  Manufacturing defect claim based on recall sufficiently pleaded.  No warning or design claim.  Negligence per se impliedly preempted as adopting FDCA standard.
  591. Hastings v. Cochlear Ltd., 2021 WL 6805628 (D. Ariz. July 23, 2021), motion to dismiss granted in part and denied in part in action involving cochlear implant.  Manufacturing defect claim preempted.  Warning defect claim preempted, except for failure to warn the FDA.
  592. Cleeton v. SIU Healthcare, Inc., 189 N.E.3d 1085 (Ill. App. Aug. 3, 2021), affirming grant of summary judgment against all claims in action involving pain pump.  Warning claim demanding separate resupply of part of labeling preempted as “in addition to” FDA requirements.   Affirming, 2020 WL 5875947, above.
  593. Sherrod v. Smith & Nephew, 2021 WL 9583260 (Tenn. Cir. Aug. 10, 2021), motion to dismiss granted against all claims in action involving PMA component of total hip implant.  Off-label use does not reduce preemption.  All claims concerning a PMA component in a hybrid construct are preempted.  Parallel claims lacked any state-law predicate and were private FDCA enforcement.
  594. In re Smith & Nephew Birmingham HIP Resurfacing (BHR) HIP Implant Products Liability Litigation, 2021 WL 3617419 (D. Md. Aug. 13, 2021), summary judgment granted against all claims in action involving total hip implant.  Failure to train and misbranding claims preempted.
  595. In re Smith & Nephew Birmingham HIP Resurfacing (BHR) HIP Implant Products Liability Litigation, 2021 WL 11561427 (D. Md. Aug. 19, 2021), summary judgment granted against all claims in action involving total hip implant.  Failure to warn, negligent misrepresentation claims about information approved by FDA, failure to train, and misbranding preempted.
  596. Somerville v. Medtronic, Inc., 2021 WL 5926029 (C.D. Cal. Aug. 19, 2021), motion to dismiss granted against all claims in action involving pain pump.  Manufacturing defect and failure to report claims survive preemption, but are barred by the statute of limitations and by failure to allege any actual unreported events.
  597. Barnes v. Medtronic, Inc., 2021 WL 3742436 (N.D. Ga. Aug. 24, 2021), motion to dismiss granted in part and denied in part in action involving pain pump.  Manufacturing defect and implied warranty claims based on recalls, survive.  Other claims dismissed.
  598. Cline v. Medtronic, Inc., 2021 WL 3860194 (S.D. Ohio Aug. 30, 2021), motion to dismiss granted against all claims in action involving pain pump. Manufacturing claims fail to plead causal FDCA violations.  Warning and warranty claim preempted.  Failure to report not a parallel claim.  Pleading unspecified FDCA deviations not permitted.
  599. Centeno v. Krieff,  2021 WL 3884060 (N.Y. Sup. Aug. 30, 2021), motion to dismiss denied in action involving spinal cord stimulator.  While all product liability claims would be preempted, plaintiff only asserts unpreempted negligence claims based on conduct of manufacturer’s representative at the time of plaintiff’s surgery.
  600. Groeschen v. Ciba Corp., 2021 WL 12193089 (Ohio C.P. Sept. 17, 2021), motion to dismiss granted for device manufacturers, in action involving contact lenses.  No parallel claims pleaded.  Second dismissal, below, 2024 WL 488424.
  601. Ward v. Zoll Lifevest Holdings LLC, 2021 WL 7907066 (D.D.C. Sept. 20, 2021), motion to dismiss granted in part and denied in part in action involving anti-arrhythmia vest.  Design and warning claims preempted.  Unspecific manufacturing defect claim allowed on pleadings.  Express warranty claim allowed to the extent defendant allegedly went beyond what FDA requires.  If warranty claim contradicts the device PMA it will be preempted.  Failure to report claim preempted.
  602. Kiser v. Terumo Medical Corp., 2021 WL 4356044 (E.D. Tenn. Sept. 23, 2021), motion to dismiss denied in action involving vascular closure device.  Plaintiff only brought a manufacturing claim, which was unpreempted.  Rejecting specificity in pleading violation.
  603. McKenzie v. Abbott Laboratories, 563 F. Supp.3d 512 (M.D. La. Sept. 24, 2021), motion to dismiss granted in part and denied in part in action involving left ventricular assist device.  Manufacturing defect claim not expressly or impliedly preempted, although design claims in the guise of manufacturing claims would be.  Reporting and express warranty claims inadequately pleaded.
  604. Lewis v. Abbott Laboratories, 2021 WL 4448920 (M.D. La. Sept. 28, 2021), motion to dismiss granted against all claims in action involving heart valve.  Plaintiff failed to plead any parallel claims.  Judicial notice taken of FDA PMA.  Discovery denied.
  605. Kaemmlein v. Abbott Laboratories, 564 F. Supp.3d 58 (E.D.N.Y. Sept. 29, 2021), motion to dismiss denied in action involving heart valve.  Given a recall and FDA findings of violations, claims for warning and manufacturing defect, negligence, implied warranty, and fraud are parallel claims.
  606. Naquin v. Medtronic, Inc., 2021 WL 4848838 (5th Cir. Oct. 18, 2021), grant of motion to dismiss affirmed in action involving defibrillator.  Warning and design claims expressly preempted.  Parallel and express warranty claims inadequately pleaded.  Affirming, 2020 WL 7060150, above.
  607. Muoio v. Livanova Holding USA, Inc., 2021 WL 5410507 (D. Mass. Oct. 15, 2021), motion to dismiss granted against all claims in action involving heart valve.  Pre-PMA claims preempted as fraud on the FDA.  Warning claims expressly preempted.  State law recognizes no parallel duty to report claims.
  608. Mikos v. Abbott Laboratories, 2021 WL 5416534 (D. Md. Nov. 18, 2021), motion to dismiss granted in part and denied in part in action involving spine stimulator.  Any reference to FDCA violations, no matter how vague, suffices to plead a parallel claim.  Negligence and negligence per se claims survive preemption as parallel  claims.  Strict liability, express and implied warranty, and negligent misrepresentation  claims expressly preempted.  FDCA imposes no duty to warn the public about adverse events.  PMA gives defendant the right to describe its device as “safe.”
  609. Allergan Implant Cases, 2021 WL 12190293 (Cal. Super. Nov. 23, 2021), demurrer sustained in part and overruled in part in action involving breast implants.  Duty to file a supplemental PMA claim not preempted.  Plaintiffs can base manufacturing defect claims on violations of general FDA regulations.  Whether a manufacturing defect claim is really a design claim cannot be determined on demurrer.  Negligent infliction of emotional distress is derivative of plaintiffs’ unpreempted warning claim.  Consumer fraud claims based on fraud on the FDA are preempted, but claims based on statements to consumers are not.  Express warranty claims are not imposed by state law, but rather by contract, and are not preempted.  Implied warranty claims based on FDA regulatory violations are not preempted.
  610. Arnold v. Lanier, 154 N.Y.S.3d 844 (N.Y. App. Div. Dec. 1, 2021).  Dismissal of all claims partially reversed.  All product liability claims properly dismissed.  Negligence claims against defendant’s personnel attending plaintiff’s surgery not preempted.
  611. Sundaramurthy v. Abbott Vascular, Inc., 2021 WL 7542704  (D. Mass. Dec. 6, 2021), motion to dismiss granted against all claims in action involving a drug eluting stent.  Humanitarian device exemption device subject to PMA preemption.  No parallel claim pleaded.   Subsequent decisions, 594 F. Supp.3d 117, and 2023 WL 2311661, below.
  612. Poozhikala v. Medtronic, Inc., 2022 WL 610276 (C.D. Cal. Jan. 31, 2022), motion to dismiss granted against all claims in action involving implantable defibrillator.  No presumption against preemption.  All warning-related claims, including fraud and express warranty, preempted, except for failure to report, which is inadequately pleaded.  Alleged statement by representative not tied to any FDCA violation.  Failure to recall preempted.  Design defect and implied warranty preempted.  Dismissed, 2022 WL 1076173, below.
  613. Hawkins v. Bayer Corp., 2022 WL 2761379 (Mag. W.D. Tex. Feb. 1, 2022), adopted, 2022 WL 2718541 (W.D. Tex. Feb. 23, 2022), motion to dismiss granted against all claims in action involving implantable contraceptive device.  Design and warning claims plainly preempted. Fraud and warranty claims preempted because they challenged only FDA-approved statements.  Failure-to-report claims impliedly preempted because no parallel state-law claim.  Manufacturing claims preempted because no causal link to vague CGMP violation allegations.
  614. Feeser v. Medtronic, Inc., 2022 WL 378143 (D.S.C. Feb. 8, 2022), motion to dismiss granted in part and denied in part in action involving a pacemaker.  Only a manufacturing defect claim that the product was made without an FDA-required coating survives.
  615. Cunningham v. Abbott Vascular, Inc., 2022 WL 2387903 (Mag. D. Mass. March 1, 2022), motion to dismiss granted against all claims in action involving drug eluting stent.  Taking judicial notice of FDA documents.  No parallel claims pleaded so all claims preempted.
  616. Reddick v. Medtronic, Inc., 2022 WL 715494 (5th Cir. March 9, 2022).  Affirming dismissal of all claims in action involving implantable cardiac defibrillator.  All four claims allowed under the Louisiana statute are preempted.  No parallel claim pleaded.  Affirming, 2021 WL 798294, above.
  617. Sundaramurthy v. Abbott Vascular, Inc., 594 F. Supp.3d 117 (D. Mass. March 18, 2022), motion to dismiss granted in part and denied in part in action involving a drug eluting stent.  Manufacturing defect based on GMP allegations claim stated parallel claim.  Warning, design, and express/implied warranty claims all preempted.  Prior decision, 2021 WL 7542704, above, reconsideration denied, 2023 WL 2311661, below.
  618. Poozhikala v. Medtronic, Inc., 2022 WL 1076173 (C.D. Cal. April 7, 2022), motion to dismiss granted against all claims in action involving implantable defibrillator.  A laundry list of allegedly violated FDA  regulations, with no factual support, does not establish either a manufacturing defect or failure to report.  Defect does not establish an FDCA violation.  Express warranty beyond FDA requirements not pleaded.  Prior decision, 2022 WL 610276, above.
  619. Pietrowski-Valdez v. Smith & Nephew, 2022 WL 2103125 (Cal. Super. April 28, 2022), summary judgment granted in part in action involving hip implant component.  Off-label use does not defeat preemption and did not create a new device.  All product liability and negligence claims dismissed.  Parallel fraud and misrepresentation involving sales representative not preempted.
  620. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 603 F. Supp.3d 222 (D. Md. May 17, 2022), summary judgment granted on all remaining claims in action involving hip implant.  Warning claims are preempted or non-causal.  Negligence per se and duty to train claims preempted.  On appeal, No. 22-1677 (4th Cir.).
  621. Froman v. Coopersurgical, Inc., 2022 WL 2657117 (N.D. Ala. July 8, 2022), motion to dismiss granted in action involving contraceptive surgical clips.  The duty to report adverse events is owed to the FDA, not to individual device consumers, and are therefore impliedly preempted as private FDCA enforcement.  Other than the reporting duty, no other FDCA violations are alleged, so the claims are also expressly preempted, as no parallel violation is pleaded.
  622. Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329 (11th Cir. July 20, 2022), grant of motion to dismiss reversed in part in action involving breast implants.  Manufacturing defect claims are sufficiently pleaded as parallel claims.  Pro se plaintiffs can plead non-device specific boilerplate and survive.  No requirement to plead a specific FDCA violation.   Prior decision, 2019 WL 6766574, above.
  623. Hunt v. Medtronic USA, Inc., 627 F. Supp.3d 1188 (W.D. Wash. July 29, 2022), motion to dismiss granted in part and denied in part in action involving spinal cord stimulator.  Misrepresentation and contract claims based on plaintiff not receiving the type of device promised were not safety liability claims and not preempted.
  624. Grimes v. Rush Oak Park Hospital, Inc., 2022 WL 20437029 (Ill. Cir. Aug. 4, 2022), motion to dismiss granted against all claims in action involving spine stimulator.  No parallel claims alleged.  Plaintiff not entitled to discovery.
  625. Glover v. Bausch & Lomb, Inc., 43 F.4th 304 (2d Cir. Aug. 8, 2022), grant of motion to dismiss reversed in part.  State law action for failure to report is a non-preempted parallel claim.  Reversing, 443 F. Supp.3d 259, above.
  626. Estate of Comatov v. Kiankhooy, 2022 WL 16575450 (Cal. Super. Aug. 11, 2022), demurrer granted against all claims in action involving a pacemaker.  Complaint does not articulate how any claims are parallel.
  627. Tchakerian v. Heartbeat Cardiovascular Medical Group, 2022 WL 20815248 (Cal. Super. Aug. 15, 2022), demurrer granted against all claims in action involving mechanical heart pump.  Complaint does not contain any allegations that the defendant violated the FDCA in any way.
  628. Holland v. Abbott Laboratories, Inc., 626 F. Supp.3d 1256 (M.D. Fla. Sept. 7, 2022), motion to dismiss granted against all claims in action involving neurostimulator.  Parallel claim fails because no particular FDCA violation is alleged or FDA regulation identified.
  629. McGuire v. Abbott Laboratories, Inc., 2022 WL 4295402 (E.D. Tex. Sept. 15, 2022), motion to dismiss granted against all claims in action involving implantable cardioverter-defibrillator.  Plaintiff’s claims are too conclusory to be considered parallel.  Res ipsa loquitur is not a basis for parallel claims.  Subsequent dismissal, 2023 U.S. Dist. Lexis 77682.
  630. James v. Medtronic, 2022 WL 6238373 (Cal. Super. Sept. 16, 2022), summary judgment granted in part and denied in part in action involving spinal cord stimulator.  All claims involving the condition of the product were preempted.  Only claims involving the actions of sales representatives survived.  Prior dismissal, 2020 WL 13310413, above.
  631. Garcia v. Bayer Essure, Inc., 635 F. Supp.3d 1026 (D.N.M. Sept. 28, 2022), motion to dismiss granted against all claims in action involving implantable contraceptive.  No anti-preemption presumption.  Design and warning claims not parallel.  No mandatory duty to update labeling.  Failure to report claims impliedly preempted, both as not parallel and as a form of fraud on the FDA.  Manufacturing defect claims fail to allege that plaintiff was injured by any alleged regulatory violation.  Violation claims must be causal.  Subsequent decision at 2023 WL 4235670, below.
  632. Bledsoe v. Medtronic, Inc., 635 F. Supp.3d 654 (N.D. Ind. Oct. 13, 2022), summary judgment granted against all remaining claims in action involving pain medication pump.  Plaintiff failed to specify any FDCA regulatory violation that caused the injury, thereby failing to establish a parallel manufacturing defect claim.  Dismissal denied, 2020 WL 43107, above.
  633. Manopella-Fletcher v. Bayer, Inc., 2022 WL 14813742 (E.D.N.Y. Oct. 26, 2022), motion to dismiss granted against all claims in action involving implantable contraceptive.  Unopposed motion.
  634. Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), motion to dismiss granted against all claims in action involving implantable contraceptive.  PMA is not conditional on FDCA compliance.  Warning and misrepresentation claims preempted where no deviation from FDA-approved labeling is specified.  Failure to report claims are conclusory.
  635. Neve v. Endologix, Inc., 2022 WL 17098835 (E.D. Tenn. Nov. 21, 2022), motion to dismiss granted in part and denied in part in action involving aneurism repair device.  Negligence per se claim preempted.  Parallel claims sufficiently pleaded to state a claim.
  636. Gravitt v. Mentor Worldwide, LLC, 646 F. Supp.3d 962 (N.D. Ill. Dec. 14, 2022), summary judgment granted on all claims in action involving breast implants.  All claims other than failure to report preempted.  As to failure to report, plaintiff failed to prove either a violation or causation.   Prior opinions, 289 F. Supp.3d 877 and 2018 WL 2933609, above.
  637. Ortiz v. Bayer Corp., 2022 WL 17817726 (Mag. E.D.N.Y. Dec. 13, 2022), motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Duty to train claim expressly preempted since plaintiffs seek more training than FDA required.  Also impliedly preempted because no parallel state law training-based claim.  Manufacturing defect claims survives preemption, since specific defects are alleged.  Express warranty is expressly preempted.
  638. Blevins-Ellington v. CooperSurgical, Inc., 2023 WL 2111346 (N.D. Ga. Jan. 17, 2023), motion to dismiss denied in action involving contraceptive surgical clips.  Manufacturing defect and failure to report claims were parallel and escaped express preemption.  Implied preemption not considered for procedural reasons.
  639. D’Addario v. Johnson & Johnson, 2023 WL 239395 (D.N.J. Jan. 18, 2023), motion to dismiss granted in part and denied in part in action involving breast implants.  Strict and negligent manufacturing defect claims based on GMP violations were not preempted, nor are implied warranty claims based on the same manufacturing allegations.  Negligent misrepresentation claim preempted because the FDCA does not require disclosure of claimed GMP violations in labeling.  A claim that the FDA-required labeling was not in fact included with the device states is not preempted.
  640. Tice v. Boston Scientific Corp., 2023 WL 360983 (N.D. Ohio Jan. 23, 2023), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Plaintiff pleaded no parallel claims.  Claim that defendant should have conducted additional studies is preempted.
  641. Watters v. CooperSurgical, Inc., 2023 WL 1982347 (E.D.N.C. Feb. 13, 2023), motion to dismiss granted against all claims in action involving contraceptive surgical clips.  Failure to report claims “squarely” preempted because there is no parallel state tort duty.  Failure to report claims are a form of fraud on the FDA since they claim that the FDA would have done something different with the reported information.  All other claims expressly preempted.  Plaintiff must identify what regulations were violated.
  642. Bergdoll v. CooperSurgical, Inc., 2023 WL 2167417 (W.D. Mo. Feb. 22, 2023), motion to dismiss denied in action involving contraceptive surgical clips.  Unspecified parallel claims preclude dismissal.  Refuses to undertake any analysis on the pleadings.
  643. Sundaramurthy v. Abbott Vascular, Inc., 2023 WL 2311661 (D. Mass. March 1, 2023), reconsideration of order dismissing all claims denied in action involving a drug eluting stent.  Warning, and implied and express warranty claims all preempted.  Prior decisions, 594 F. Supp.3d 117, and 2021 WL 7542704, above.
  644. Morris v. Medtronic, Inc., 2023 WL 2387497 (E.D. Mo. March 7, 2023), partial motion to dismiss granted in part and denied in part in action involving ventricular assist device.  As long as one negligence theory is not preempted, negligence will not be dismissed.  Negligence per se claim based on state little FDCA act not impliedly preempted because the state statute is not identical to the FDCA.  Implied warranty preempted.
  645. Richardson v. Tandem Diabetes Care, Inc., 2023 WL 2393692 (W.D. La. March 7, 2023), motion to dismiss granted against all claims in action involving a reconditioned insulin pump.  No parallel claims pleaded.  That the pump was reconditioned is not an FDCA violation.
  646. Harris v. Medtronic Inc., 2023 WL 2478913 (D. Ariz. March 13, 2023), motion to dismiss granted against all claims in action involving pacemaker.  Adulteration is insufficient to state a parallel manufacturing defect claim, when no particular FDCA violation is alleged.  Arizona does not recognize FDA-based failure to report claims.
  647. Estate of Comatov v. Medtronic, Inc., 2023 WL 2922830 (C.D. Cal. March 16, 2023), motion to dismiss granted against all claims in action involving pacemaker.  Warning claim preempted.  Parallel claims insufficiently pleaded.  Failure to report implausible, since the complaint alleged that the FDA sent out a warning.
  648. Mack v. CooperSurgical, Inc., 2023 WL 2653365 (M.D. Ala. March 27, 2023), motion to dismiss denied in action involving contraceptive surgical clips.  Manufacturing defect claim was parallel and escaped express preemption.  Construing failure to report claim as involving warnings to plaintiff and not to FDA.
  649. Briggs v. Endologix, Inc., 2023 WL 2716592 (Mag. S.D. Tex. March 30, 2023), adopted, 2023 WL 3059156 (S.D. Tex. April 24, 2023), motion to dismiss granted against all claims in action involving aneurysm repair graft.  Warning claim preempted.  Submissions of PMA supplements and CBE label changes are voluntary, not mandatory.  Claimed CGMP violations not causally related to plaintiff’s injuries.
  650. Boyd v. Allergan PLC, 2023 WL 2869476 (D. Or. April 10, 2023), motion to dismiss granted against all claims in action involving breast implants.  All non-parallel claims are preempted and no parallel claims are pleaded with sufficient specificity.  Plaintiff failed to allege which PMA specification or regulatory requirement was violated.  Product warnings contradicted what facts were alleged.
  651. McGuire v. Abbott Laboratories, Inc., 2023 WL 3262033 (E.D. Tex. May 3, 2023), motion to dismiss granted against all claims in action involving implantable cardioverter-defibrillator.  No parallel claim properly pleaded.  Prior dismissal, 2022 WL 4295402.
  652. Strontzer v. Johnson & Johnson, 2023 WL 3580951 (D.N.J. May 22, 2023), motion to dismiss granted in part and denied in part in action involving breast implants.  Manufacturing and warning (failure to report under CT law) defect claims are parallel and avoid preemption.  Negligent misrepresentation challenges FDA approved labeling and is preempted.
  653. Ford v. St. Jude Medical, LLC, 2023 WL 3918744 (Mag. M.D. Pa. June 7, 2023), motion to dismiss granted in part and denied in part in action involving pacemaker lead.  All claims except express warranty are preempted.  Express warranty claim based on alleged affirmative oral statement by unidentified manufacturer’s representative to plaintiff is not preempted.
  654. Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), motion to dismiss granted against all claims in action involving insulin pump. Strict liability, implied warranty, and negligence claims expressly preempted.  Alleging a recall is not the same as alleging an FDCA violation.  Failure to report claim impliedly preempted as private FDCA enforcement.  Express warranty claims are based on safety allegations and are thus preempted.
  655. Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), motion to dismiss granted against all claims in action involving insulin pump.  Claims based on negligence, manufacturing and design defects, strict liability, breach of warranty, failure to warn, and state consumer fraud statutes are preempted.  A recall does not permit an inference of an FDCA violation.
  656. Otis v. Thoratec LLC, 2023 WL 5431631 (Fla. Cir. June 16, 2023), motion to dismiss granted against all claims in action involving left ventricular assist device.  A broad reference to FDA CGMPs as a whole is insufficient to plead a parallel claim.
  657. Tripolskiy v. Boston Scientific Corp., 2023 WL 5440783 (C.D. Cal. June 23, 2023), motion to dismiss granted against all claims in part in action involving implantable defibrillator.  All plaintiff’s violation claims are conclusory and plead neither what regulation was violated nor how.  Subsequent dismissal, 2023 WL 5440785, below.
  658. Garcia v. Bayer Essure, Inc., 2023 WL 4235670 (D.N.M. June 28, 2023), motion to dismiss granted against all claims in action involving contraceptive device.  CGMPs are are insufficiently specific for their generally pleaded violation to state an unpreempted parallel claim.  Only the FDA can enforce reporting duties so failure to report claim is impliedly preempted.  Failure to train claim cannot be a parallel claim because no equivalent state law claim exists.  Prior decision, 2022 WL 4536240 above.
  659. Gurule v. Boston Scientific Corp., 2023 WL 5509070 (Cal. Super. July 18, 2023), demurrer sustained against all claims in action involving penile implant. Warning claims both different from FDA label and based entirely on FDCA rather than California law.  No failure to report claim pleaded.
  660. Arnold v. Coopersurgical, Inc., __ F. Supp.3d ___, 2023 WL 4552154 (S.D. Ohio July 10, 2023), motion to dismiss granted in part and denied in part in action involving contraceptive surgical clips.  Design defect claim based on claims of failure to report was preempted as a disguised fraud on the FDA claim.  Manufacturing claim failed to allege any FDCA violation and was preempted.  Warning claim based on later discovered information did not seek warnings beyond those permitted by the FDA.
  661. Tillet v. CooperSurgical, Inc., 2023 WL 4704091 (W.D.N.Y. July 24, 2023), motion to dismiss granted against all claims in action involving surgical clips. Design claim preempted for challenging FDA safety conclusions.  Manufacturing claim inadequately pleaded.  Failure to report expressly preempted as different from state-law failure to warn.  The FDA is not a state-law learned intermediary, and passive FDA reporting is different from what NY sophisticated purchaser doctrine requires.  Attacks on quality of FDA reporting is impliedly preempted. Negligence claim no different than product defect claims.  Consumer fraud claim preempted because all statements to physicians or patients were FDA-approved.  Other statements made to the FDA or to investors are not consumer oriented.  Attacks on statements made to the FDA are preempted by Buckman.  An informed consent form concerned the medical procedure, not the product, and did not originate with the defendant manufacturer.
  662. McGee v. Johnson & Johnson, ___ F. Supp.3d ___, 2023 WL 4765454 (W.D. Pa. July 26, 2023), motion to dismiss granted in part and denied in part in action involving breast implants.  Manufacturing defect not preempted.  Failure to report claims not recognized under state law and therefore cannot support a parallel claim.
  663. Farson v. Coopersurgical, Inc., 2023 WL 5002818 (N.D. Ohio Aug. 4, 2023), motion to dismiss granted against all claims in part in action involving contraceptive surgical clips. Design and warning claims expressly preempted.  Failure to report claim presented as negligence per se impliedly preempted because a claimed FDCA violation is a critical element.
  664. Tripolskiy v. Boston Scientific Corp., 2023 WL 5440785 (C.D. Cal. Aug. 18, 2023), motion to dismiss granted against all claims in part in action involving implantable defibrillator.  A recall does not establish an FDA regulatory violation.  Prior dismissal, 2023 WL 5440783, above.
  665. Armstrong v. ABC Corp., 2023 WL 6063806 (W.D. La. Aug. 21, 2023), motion to dismiss granted in part and denied in part in action involving implantable cardioverter-defibrillator.  Manufacturing defect claims supported by a recall are non-preempted parallel claims.  Design and warning claims preempted.  Failure to report claims are “analogous” to warning claims and thus not preempted.  Express warranty claim is inadequately pleaded and might be preempted.
  666. Skinner v. Small Bone Innovations Inc., 2023 U.S. Dist. Lexis 173787 (D. Ariz. Sept. 28, 2023), motion to dismiss granted against all claims in part in action involving total ankle replacement.  No presumption against preemption exists in express preemption cases.  FDA PMA documents are judicially noticed.  Design and manufacturing defect and negligence claims expressly preempted.
  667. Wilson v. CooperSurgical, Inc., 2023 WL 6216933 (S.D. Ill. Sept. 25, 2023), motion to dismiss denied in action involving contraceptive surgical clips. Preemption is an affirmative defense and should not be allowed on a motion to dismiss.  Since, much of the basis for compliance or violation of federal requirements is confidential, plaintiff doesn’t have to plead a parallel claim with any degree of specificity until after discovery.
  668. Manor v. Puckett, 2023 Ohio Misc. Lexis 1654 (Ct. Com. Pl. Oct. 6, 2023), motion to dismiss granted, but on non-preemption (failure to plead causation) grounds.  Manufacturing defect claim stated parallel claim. Non-specific violation claim was sufficient to plead the claim.
  669. Regwan v. Abbott Laboratories, Inc., 2023 WL 8818748 (Cal. App. Dec. 21, 2023) (unpublished), grant of demurrer against all claims affirmed.  Plaintiff cannot demand warnings different from what the FDA approved by asserting a negligent undertaking duty against a manufacturer’s representative who was present for the surgery.  The representative’s claimed duty was still different from the approved label, and would have allowed liability despite the manufacturer’s FDCA compliance.
  670. Sheinfeld v. B. Braun Medical, Inc., 2024 WL 635483 (Mag. S.D.N.Y. Feb. 1, 2024), motion to dismiss granted against all claims in action involving artificial spinal disc.  Conclusory and circular defect arguments do not establish a parallel violation claim.  Res ipsa is not a parallel claim.  Warning defect claim differed from FDA requirements and failed to plead causation.
  671. Groeschen v. Alcon Laboratories, Inc., 2024 WL 488424 (Ohio C.P. Feb. 2, 2024), motion to dismiss granted against all claims in action involving contact lenses.  Only parallel claims can survive preemption, but plaintiffs fail to plead either any device-specific FDA requirement that defendant violated or any specific parallel state-law duty.  Earlier dismissal, above at 2021 WL 12193089.
  672. Wilhite v. Medtronic, Inc., 2024 WL 968867 (Mag. N.D. Ala. March 6, 2024), motion to dismiss granted against all claims in action involving a defibrillator.  Pleading a laundry list of 24 boilerplate and conclusory FDA violations cannot support a parallel claim, resulting in express preemption of design and manufacturing claims.  Claims of failure to report to doctors or patients expressly preempted.  Since there is no state-law duty to report adverse events to the government, this claim is impliedly preempted as private FDCA enforcement.
  673. Franks v. Coopersurgical, Inc., 2024 WL 1109055 (D.R.I. March 14, 2024), motion to dismiss granted in part and denied in part in action involving contraceptive surgical clips.  Manufacturing and design claims preempted due to lack of allegations that these aspects of the product did not meet FDA requirements.  Warning claim based on failure to report allegations not preempted.