It has been a little over two years since the Supreme Court issued its decision in Bauman v. AG Daimler, and, from our perspective, its impact has been significant, even earth shaking (no pun intended, and we have a San Francisco office and certainly would not make light of earthquakes).  We previously discussed Bauman’s impact on the analysis of personal jurisdiction on several occasions, in the context of notable decisions, good and bad (thank you, California), and in the hotly contested area of consent through registration to do business in a state, here.

Our breaking news is one of the biggest post-Bauman mass tort jurisdictional wins.  The Second Circuit held – in the context of asbestos mass tort litigation – that a company with “continuous and systematic” business in a state (Connecticut) can’t be sued by out-of-state litigation tourist plaintiffs over out-of-state asbestos exposure.   Brown v. Lockheed-Martin Corp., 814 F.3d 619, No. 14‐4083, slip op. (2d Cir. Feb. 18, 2016).  Having a major facility in the jurisdiction, and acquisition of a major in-state operating subsidiary, along with “significant” revenue wasn’t enough for the defendant to be “at home.”  Id. at 18-25.  Compared to the defendant’s total activities, there was nothing “exceptional.”  Id.
Continue Reading Breaking News – Bauman Trumps Jurisdiction By Consent in Second Circuit – and New Post-Bauman Cheat Sheet on General Personal Jurisdiction

Whenever we learn about the entry of a Lone Pine order, we take the opportunity to extoll the virtues of Lore v. Lone Pine Corp., 1986 WL 637507 (N.J. Sup. Ct. Nov. 18, 1986) in which a New Jersey state court judge ordered plaintiffs to offer proof connecting the defendant’s product to the plaintiff’s alleged injury.  And with the recent entry of another Lone Pine order in In re Fosamax Products Liability Litigation, 2012 U.S. Dist. LEXIS 166734 (S.D.N.Y. Nov. 20, 2012), we thought it made sense to start keeping track of these orders.  So, here you have our Lone Pine cheat sheet.  Like with our other cheat sheets, this is an attempt to collect all the favorable decisions entering or upholding Lone Pine orders and we’ll do our best to keep it updated (we’ve included toxic tort cases as well because they are helpful).

Although the specifics can vary, typically a Lone Pine order requires the plaintiff to prove that he or she was exposed to the defendant’s product, to identify the precise alleged injury resulting from the exposure, and to offer some sort of proof that the exposure caused the disease.  Huh?  Isn’t that part of plaintiffs’ burden in every products liability case?  Well, yes.  But as we all well know, in the context of a mass tort or multidistrict litigation (or a toxic tort) hundreds, maybe thousands, of plaintiffs’ cases sit idly on the court’s docket with virtually no case-specific discovery while millions of dollars of discovery directed to defendants goes on for years.  And that means meritless and frivolous cases (it’s no secret that with mass solicitation by plaintiffs’ lawyers many, many non-legitimate cases get filed) go along for the ride and are still hanging around when a mature mass tort moves toward remanding individual cases or settlement discussions begin.

So it can hardly come as a surprise that we favor a case management mechanism that puts plaintiffs to some level of proof early on in the proceedings.  “Early on” being a relative term as courts seem more willing to enter Lone Pine orders after a litigation has been around a while.  But, even after a few years of general discovery, a Lone Pine order is certainly better for defendants than collecting medical records, deposing plaintiffs and health care providers, retaining experts, deposing opposing experts, and drafting summary judgment motions in one case, let alone hundreds.  All to cause a court to dismiss a claim that was meritless or fraudulent from the start.

Lone Pine orders are permitted by the broad discretion given to federal courts by FRCP 16(c)(2)(L) to control mass torts and complex litigation.  State courts generally have their own discretion to employ such case management techniques.  Further, as alluded to above, Lone Pine orders “impose a minimal burden on plaintiffs, as it merely asks them to produce information they should already have.”  In re Fosamax Products Liability Litigation, 2012 U.S. Dist. LEXIS 166734 at *6.  The Fosamax court seemed particularly persuaded by the fact that the majority of cases set for trial and/or selected for discovery were dismissed:  “Plaintiffs’ habit of dismissing cases after both parties have expended time and money on case-specific discovery demonstrates that this MDL is ripe for a Lone Pine order.”  Id. at *7.  While a Lone Pine order is not always a slam dunk for the defense, there is certainly enough precedent to argue that entry is grounded in ample law.

  • Lore v. Lone Pine Corp., 1986 WL 637507 (N.J. Super. Nov. 18, 1986).
  • In re Love Canal Actions, 547 N.Y.S.2d 174, 176-78 (N.Y. Sup. 1989) (enforcing order requiring production of evidence of exposure, injury, and causation), aff’d as modified, 555 N.Y.S.2d 519 (N.Y.A.D. 1990) (affirmed except for ordering production of formal expert reports).
  • Eggar v. Burlington Northern Railroad Co., 1991 WL 315487, at *4 (D. Mont. Dec. 18, 1991) (granting summary judgment under prior case management order requiring plaintiffs to produce an medical expert’s affidavit “specify[ing], for each test plaintiff, the precise injuries, illnesses or conditions suffered by that plaintiff; the particular chemical or chemicals that, in the opinion of the physician, caused each injury, illness or condition; and the scientific and medical bases for the physician’s opinions.  It will not be sufficient for the affidavit to state a ‘laundry list’ of injuries and chemicals; each injury, illness or condition must be itemized and specifically linked to the chemical or chemicals believed to have caused that particular injury, condition or illness. Moreover, the statement of scientific and medical bases for the opinion shall include specific reference to the particular scientific and/or literature forming the basis for the opinion”), aff’d, 29 F.3d 499 (9th Cir. 1994)
  • Cottle v. Superior Court, 5 Cal. Rptr.2d 882, 886-92 (App. 1992) (upholding trial court order requiring plaintiffs to identify product, exposure, alleged injury and the identity of a medical expert who will support the plaintiff’s personal injury claim”).
  • Atwood v. Warner Electric Brake & Clutch Co, 605 N.E.2d 1032, 1036-38 (Ill. App. 2d 1992) (upholding trial court order requiring plaintiffs to produce case-specific medical reports and submit to defense expert medical examinations before the depositions of the plaintiffs were scheduled).
  • Able Supply Co. v. Moye, 898 S.W.2d 766, 771 (Tex. May 11, 1995) (granting mandamus compelling plaintiff to answer interrogatory demanding Lone Pine-type discovery:  “Please state the name and address of each and every doctor, physician or other medical practitioner who has attributed your alleged injury made the basis of this lawsuit to exposure to the defendants’ products, including the dates of treatment or examination of each such doctor, physician or other medical practitioner, and the name or identity of the product to which your alleged injury is attributed.”
  • Schelske v. Creative Nail Design, Inc., 933 P.2d 799, 802-05 (Mont. Jan. 2, 1997) (affirming district court’s dismissal of plaintiffs who failed to comply with trial court order requiring product identification; use and exposure; and causation linking product defect to an identifiable injury).
  • In re Orthopedic Bone Screw Products Liability Litigation, 1997 WL 303239, at *1-3 (E.D. Pa. Feb. 3, 1997) (entering order, invoking Rule 11, requiring “each plaintiff [to] identify and provide expert discovery with respect to at least one duly-qualified, medical expert on the issues of injury and causation.”  Setting various deadlines and subsidiary discovery requirements related to same).
  • Acuna v. Brown & Root, Inc., 1998 WL 35283824, at *5-6 (W.D. Tex. Sept. 30, 1998) (dismissing plfs who failed to comply with Lone Pine order requiring an expert report listing all injuries, illnesses or conditions suffered by the plaintiff that were caused by exposure to materials or substances from defendant’s operations, specifying what substances caused each injury, identifying the particular activity that was the source of the materials or substances, describing the exposures with specific dates, times, circumstances, incidents and dosages; and stating the scientific and medical bases for the expert’s opinions), aff’d, 200 F.3d 335 (5th Cir. 2000) (holding no abuse of discretion by trial court in entering Lone Pine orders; “the scheduling orders issued below essentially required that information which plaintiffs should have had before filing their claims pursuant to FRCP 11(b)(3)”).
  • In re Mohawk Rubber Co., 982 S.W.2d 494, 498 (Tex. App. Oct. 6, 1998) (granting mandamus compelling trial court to “set a timetable for discovery of facts showing a causal relationship between the defendants’ products and any harm to the plaintiffs”).
  • Adjemian v. American Smelting & Refining Co., 2002 WL 358829, at *1-6 (Tex. App. March 7, 2002) (affirming district court’s dismissal of plaintiffs who failed to comply with trial court order requiring production of information about the specific toxic substances to which they were exposed, the particular injuries that resulted from the exposure, and the medical evidence that supported each claimant’s case).
  • In re Baycol Litig., November Term, 2001, No. 0001, Order (Ct. Com. Pl. Phila. Co. Dec. 12, 2003) (entering Lone Pine order in Pennsylvania state court coordinated Baycol proceeding)
  • In re Baycol Prods. Liab. Litig., MDL No. 1431, 2004 WL 626866, at *1 (D. Minn. Mar. 18, 2004) (entering initial Lone Pine order, which was later amended, for numerous purposes including to “identify . . . the claims of those plaintiffs who have and those who do not have factually and legally sufficient support for their alleged claims and injuries or damages”).
  • Schneider National Carriers, Inc. v. Bates, 147 S.W.3d 264, 268 (Tex. Oct. 1, 2004) (affirming dismissal for violation of Lone Pine order requiring plaintiffs to specify (among other things) their dates of residence, specific complaints, and substances they contend were emitted from the defendants’ plants).
  • In re 1994 Exxon Chemical Plant Fire, 2005 WL 6252312, at *1-2 (M.D. La. April 7, 2005) (entering Lone Pine order requiring plaintiffs to produce evidence linking their alleged exposures to a particular substance with an identified injury.  Finding that if plaintiff is unable to comply “the court should be concerned with the viability of that plaintiff’s claims” and that the Lone Pine order “would reduce costs and save time.”).  See Steering Comm. v. Exxon Mobil Corp., 461 F.3d 598, 604 n.2 (5th Cir. 2006) (describing order).
  • In re: N.Y. Rezulin Prods. Liab. Litig., slip op., Master Index No. 752,000/00, Order (N.Y. Sup. Ct. N.Y. Co. Aug. 7, 2004) (entering Lone Pine order in New York state court coordinated Rezulin proceeding).
  • Bell v. Exxonmobil Corp., 2005 WL 497295, at *1, 3 (Tex. App. March 3, 2005) (affirming dismissal for failure to comply with Lone Pine order requiring each plaintiff to file an expert report detailing the manner and duration of the exposure the plaintiff had experienced, the chemicals to which the plaintiff was exposed, and, to a reasonable medical probability, the injury sustained because of that exposure. It also required expert affidavits detailing the location of the property damage claimed in the plaintiffs’ petition, the amount of economic injury, and the causative link between the chemical exposure and the damage.).
  • In re Rezulin Prods. Liab. Litig., MDL No. 1348, 2005 WL 1105067 (S.D.N.Y. May 9, 2005) (ordering plaintiffs to serve case-specific expert reports, failure to do so may result in sanction of dismissal with prejudice).  See 441 F. Supp.2d 567, 570 (dismissing plaintiffs whose reports were inadequate)
  • In re Silica Prods. Liability Litig., 398 F. Supp.2d 563, 576 (S.D. Tex. June 30, 2005) (entering Lone Pine type order requiring each plaintiff to submit specific information about his exposure to silica dust and detailed medical information concerning each alleged injury).
  • Baker v. Chevron USA, Inc., 2007 WL 315346, at *1 (S.D. Ohio Jan. 30, 2007) (dismissing plaintiffs who failed to comply with Lone Pine case management order requiring them to produce “an affidavit from a qualified expert or experts setting forth for each Plaintiff the specific illness allegedly sustained, the date the illness was diagnosed, the name and address of the medical provider who made the diagnosis, the toxic chemical which allegedly caused the illness, the alleged manner of exposure, and the date, duration, and dose of the exposure”).
  • Burns v. Universal Crop Protection Alliance, 2007 WL 2811533, at *2-3 (E.D. Ark. Sept. 25, 2007) (entering Lone Pine order in products liability action brought by 82 cotton farmers against five herbicide manufacturers, finding “a preliminary showing on causation is necessary for efficient case management”).
  • In re Vioxx Prods. Liab. Litig., 2007 WL 9653192 (E.D. La. Nov. 9, 2007) (Lone Pine order entered; plaintiffs must produce eight categories of documents, including exposure documentation and an expert report confirming injury and causation).  Enforced, see below.
  • In re Vioxx Prods. Liab. Litig., 557 F. Supp. 2d 741, 743-44 (E.D. La. 2008) (denying plaintiffs’ motion to stay Lone Pine order finding “it is not too much to ask a Plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury . . . Surely if Plaintiffs’ counsel believe that such claims have merit, they must have some basis for that belief; after all this time it is reasonable to require Plaintiffs to come forward and show the basis for their beliefs and show some kind of basic evidence of specific causation.”); dismissal of plaintiffs for failure to comply with Lone Pine order affirmed by 388 Fed.Appx. 391, 2010 WL 2802352 (5th Cir. Jul. 16, 2010).
  • In re Bextra and Celebrex Mktg. Sales Practices and Prod. Liab. Litig., MDL No. 1699, slip op., (N.D. Cal. Aug. 8, 2008) (Lone Pine order containing step-by-step enforcement enforcement procedures leading to dismissal for failure to comply).
  • Abbatiello v. Monsanto Co., 569 F. Supp.2d 351, 353-54 (S.D.N.Y. 2008) (in toxic tort action involving multiple parties, court denied plaintiffs’ request to stay previously entered Lone Pine order finding reason for “requiring early individual causation expert evidence, is to protect defendants and the Court from the burdens associated with potentially non-meritorious mass tort claims”).
  • Arias v. Dyncorp, 2008 WL 9887418, at *1-2 slip op. (D.D.C. Oct. 21, 2008) (entering Lone Pine order in toxic tort case involving herbicide exposure, requiring detailed exposure information, including map with location of each exposure event and submission of medical records as prerequisite to discovery).  Dismissal of noncompliant plaintiffs affirmed, 752 F.3d 1011, 1015-16  (D.C. Cir. 2014).
  • Wilcox v. Homestake Mining Co., 2008 WL 4697013, at *1 (D.N.M. Oct. 23, 2008) (dismissing plaintiffs for noncompliance with Lone Pine order requiring “expert affidavits which make a prima facie showing of harmful exposure and specific causation for each injury the particular Plaintiff claims was caused by the Defendants’ alleged contamination”), aff’d on other grounds, 619 F.3d 1165 (10th Cir. 2010) (Lone Pine noncompliance dismissals not appealed).
  • McManaway v. KBR, Inc., 265 F.R.D. 384, 385 (S.D. Ind. 2009) (entering Lone Pine order requiring plaintiffs to serve case-specific expert reports on exposure, injury and causation, but due to the early stage of the litigation “failure to address the causation issue will not be grounds for immediate dismissal” but may warrant awarding defense costs and fees if summary judgment later granted on that basis).
  • In re Asbestos Products Liability Litigation (No. VI), MDL No. 875, Admin. Order #12, slip op., at sec. 5 (E.D. Pa. Sept. 3, 2009) (current version of Asbestos MDL Lone Pine order, requires disclosure of expert reports supporting causation for both malignant and non-malignant cases, “objective and subjective” data on which reports are based must be “identified and descriptively set out within the report or opinion”).  Dismissals based on AO #12 affirmed, see below).
  • In re Avandia Mktg., Sales Practices and Prods. Liab. Litig., 2010 WL 4720335 (E.D.Pa. Nov. 15, 2010) (entering Lone Pine order court noted it was concerned by unsupported Plaintiff Fact Sheets and the need to “objectively identify which of the many thousand plaintiffs have injuries which can credibly be attributed to Avandia usage.”  Further, the order “merely requires information which plaintiffs and their counsel should have possessed before filing their claims: proof of Avanida usage, proof of injury, information about the nature of the injury, and the relation in time of the injury to the Avandia usage.”).  A second Lone Pine order was issued in Avandia on April 16, 2015 (PTO 236) requiring an expert report.  Dismissals based on Lone Pine orders affirmed see below).
  • Avila v. Willits Envtl. Remediation Trust, 633 F.3d 828, 833-34 (9th Cir. Jan. 27, 2011) (upholding entry of Lone Pine order “requir[ing] written statements setting forth “all facts” supporting non-resident and post–1988 resident plaintiffs’ claimed exposure, together with a written statement from an expert describing the condition for which recovery was sought, identifying the chemical to which the plaintiff was exposed, explaining the route of exposure, opining on causation, and setting forth the scientific and medical basis upon which the opinion was based as to exposure and causation,” and affirming dismissal of plaintiffs whose proffered expert report failed to satisfy Daubert).
  • Asarco LLC v. NL Industries, Inc., 2013 WL 943614, at *3 (E.D. Mo. March 11, 2013) (entering Lone Pine requiring plaintiff to provide evidence of:  (a) the identity of each hazardous substance, (b) general causation – whether any and each of these substances can cause the type(s) of environmental injuries that allegedly occurred, (c) the dose or other quantitative measurement of the concentration, timing, and duration of exposure, (d) the precise location of each exposure, (e) an identification, by way of reference to scientifically based studies, of the specific environmental harms that have allegedly occurred, (f) quantification of contamination to property attributable to each defendant’s operations, and (g) a conclusion that such harm was in fact caused by exposure from each separate defendant’s operations; order entered as alternative to total stay of litigation).
  • McMunn v. Babcox & Wilcox Babcock & Wilcox Power Generation Group, Inc., C.A. No. 2:1O-cv-OO1 43-DSC-RCM, slip op., (W.D. Pa. Jan. 25, 2012) (entering Lone Pine order requiring plaintiffs to identify within 90 days what they were exposed to, the source, the dose, the route of exposure, together with epidemiology and other scientific and medical evidence supportive of causation; forbidding terms such as “not limited to” or “without limitation”).  Order enforced:  McMunn v. Babcock & Wilcox Power Generation Group, Inc., 896 F. Supp.2d 347, 351-52 (W.D. Pa. 2012).
  • Baker v. Anschutz Exploration Corp., No. 11-Civ.-6119-CJS, slip op. (W.D.N.Y. Sept. 25, 2012) (entering Lone Pine order requiring plaintiffs to produce expert reports quantifying property contamination and alleged contaminants).  Order deemed complied with at Baker v. Anschutz Exploration Corp., 2013 WL 3282880, at *5 (W.D.N.Y. June 27, 2013).
  • In re Fosamax Products Liability Litigation, 2012 WL 5877418 (S.D.N.Y. Nov. 20, 2012) (entering Lone Pine order for particular alleged injuries to “target potentially spurious claims without imposing undue obligations upon other plaintiffs.”).
  • Asarco LLC v. NL Industries, Inc., 2013 WL 943614 (E.D. Mo. March 11, 2013) (court entered Lone Pine order requiring plaintiffs to “establish (a) the identity of each hazardous substance from each Defendant’s activities that resulted in exposure and which [plaintiff] claims has caused environmental injury, (b) whether any and each of these substances can cause the type(s) of environmental injuries [plaintiff] claims occurred and for which it seeks contribution (general causation), (c) the dose or other quantitative measurement of the concentration, timing, and duration of exposure, (d) the precise location of each exposure, (e) an identification, by way of reference to scientifically based studies, of the specific environmental harms that have allegedly occurred, (f) quantification of contamination to property attributable to each Defendant’s operations, and (g) a conclusion that such harm was in fact caused by exposure from each separate Defendant’s operations”).
  • In re Asbestos Products Liability Litigation (No. VI), 718 F.3d 236 (3d Cir. May 31, 2013) (Lone Pine order (AO 12) affirmed.  MDL court properly required all asbestos plaintiffs to “submit to the court a copy of the medical diagnosing report or opinion upon which the plaintiff now relies,” and “requir[e] a complete exposure history.”  Noncompliant plaintiffs were properly dismissed).
  • Miller v. Metrohealth Medical Center, 2014 WL 12589121 (N.D. Ohio March 31, 2014) (entering Lone Pine order requiring plaintiffs to “to provide an affidavit or signed report from a qualified expert as to what, if anything, was defective about [defendant’s] product and the causal connection” to the alleged injuries.
  • In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, 2014 WL 12692773, slip op. at 2, 5  (S.D. Ill. May 29, 2014) (Lone Pine order entered requiring non-settling plaintiffs to produce exposure documents and an expert report establishing exposure, injury, causation, and basis for causation opinion).
  • In re Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico, on April 20, 2010, MDL No. 2179, slip op. (E.D. La. July 17, 2014) (Lone Pine order entered against non-settling plaintiffs to produce:  (1) if clean-up workers, certain employment-related information; (2) a specific explanation of the circumstances of alleged exposure, including the pathway of exposure, the date(s), time(s), and location(s) of exposure, the duration of exposure, and which defendant is alleged to be responsible; (3) a specific description of the alleged injury, illness, or medical condition sustained; (4) the basis for the identification each defendant allegedly responsible for such exposure, including dates, times, locations, and acts/omissions; and (5) details and evidence regarding violations of federal government instruction, if any).  Enforced, In re Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico, on April 20, 2010, 2016 WL 614690 (E.D. La. Feb. 16, 2016).
  • Abner v. Hercules, Inc., 2014 WL 5817542 (S.D. Miss. Nov. 10, 2014) (entering Lone Pine order requiring plaintiffs to demonstrate a prima facie case that their property has been contaminated by the defendants’ conduct).
  • Modern Holdings, LLC v. Corning Inc., 2015 WL 64823744 (E.D. Ky. Oct. 27, 2015) (Lone Pine order entered requiring each plaintiff in environmental pollution case to submit an affidavit explaining (a) the specific illness sustained; (b) the date of diagnosis and information about the medical provider making the diagnosis; (c) the toxic chemical that allegedly caused the illness, with information about the manner, pathway, dates, duration, and dose of exposure; and (d) the scientific literature supporting a link between the plaintiff’s illness and the described chemical exposure).
  • In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 3281032, slip op. (N.D. Ill. June 10, 2016) (Lone Pine order requiring each plaintiff in bellwether trial track in medical device MDL to identify particular injury claims and provide a signed expert declaration regarding causation in the form attached to the order).
  • Trujillo v. Ametek, Inc., 2016 WL 3552029 (S.D. Cal. June 28, 2016) (Lone Pine order entered requiring case-specific expert reports that must include identity of substance exposed to, dose, route of exposure, relative risk, clinical value of early detection (this is a medical monitoring case), and scientific/medical bases for the above).
  • Gbarabe v. Chevron Corp., 2017 WL 956628 (N.D. Cal. March 13, 2017) (“causation evidence as to the named Plaintiffs comparable to Lone Pine” required to accompany class certification request).
  • In re Avandia Marketing, Sales Practices & Products Liability Litigation, 687 F. Appx. 210 (3d Cir. April 19, 2017).  (Lone Pine orders are “routine” and within the “wide latitude” afforded MDL courts in managing litigation.  Affirming dismissals with prejudice).
  • In re Testosterone Replacement Therapy Products Liability Litigation, 2018 WL 62588983 (N.D. Ill. June 11, 2018) (Lone Pine order requiring each remaining and new plaintiff against certain settling defendants to produce all medical and pharmacy records, and an expert report within 90 days.  Lone Pine orders are particularly appropriate after settlement).

After getting the latest favorable Facebook discovery decision in Largent v. Reed, and seeing that Largent cited to a recent New York case that we didn’t know about, we’ve come to the (probably belated) conclusion that the fast-developing area of e-discovery for defendants with respect to social media maintained by plaintiffs is worthy of a cheat sheet to keep up with the cases as they’ve come down.  So here it is – a compilation of all the favorable opinions we’re aware of concerning the right of defendants to take the offensive on e-discovery in personal injury cases, rather than merely having to grin and bear it on the receiving end.  As with our other posts of this nature, it’s in purely chronological order, and we’ll update it whenever we learn of additional case law, so if you on the right side of the “v.” win something, feel free to pass it along to us.

By the way, we’ve cited some Canadian cases as well, because, particularly early on, they’ve been cited several times on this side of the border.  The citation forms may look unusual to American lawyers, but we’ve tried them out.  This is how they appear on WL.

  1. Torres v. Lexington Insurance Co., 237 F.R.D. 533 (D.P.R. Aug. 14, 2006).  Plaintiff sanctioned for deleting several social media web pages with information contrary to her claims.  Defendant independently discovered the information and notified plaintiff to preserve it.  Two days later it was gone.  All claims for mental anguish, to which this evidence was relevant, are dismissed.
  2. Mackelprang v. Fidelity National Title Agency, Inc., 2007 WL 119149 (D. Nev. Jan. 9, 2007). Discovery of social media is allowable, to the extent relevant to the case, but discovery should come from the plaintiff, rather than directly from My Space.
  3. Dexter v. Dexter, 2007 WL 1532084 (Ohio App. May 25, 2007). Not a discovery case, but frequently cited.  Publicly available posts on MySpace were not entitled to any reasonable expectation of privacy.
  4. Murphy v. Perger, 2007 CarswellOnt 9439 (Ont. Super. Oct. 3, 2007) (Canada).  Discovery of plaintiff’s Facebook account authorized. Social media to which many people have access has no reasonable expectation of privacy.
  5. Beye v. Horizon Blue Cross Blue Shield, 2007 WL 7393489 (D.N.J. Dec. 14, 2007). Discovery of plaintiff’s Facebook and MySpace accounts authorized.  There is no reasonable expectation of privacy in information shared with others.
  6. Leduc v. Roman, 2009 CarswellOnt 843 (Ont. App. Feb. 20, 2009) (Canada).  Refusal to allow discovery of plaintiff’s Facebook account was an abuse of discretion.  Social media are not privileged, even if restricted as “private.”  A plaintiff must identify any relevant materials posted on Facebook, public or private.
  7. Moreno v. Hanford Sentinel, Inc., 91 Cal. Rptr.3d 858 (Cal. App. April 2, 2009).  Not a discovery case, but frequently cited.  A plaintiff cannot bring an invasion of privacy action concerning republication of information that he voluntarily posted on MySpace.  There can be no expectation of privacy in publicly posted information.
  8. Bishop v. Minichiello, 2009 CarswellBC 871 (B.C. April 7, 2009) (Canada).  Discovery of plaintiff’s hard drive was proper to determine how much time plaintiff spent on Facebook.
  9. Kent v. Laverdiere, 2009 CarswellOnt 1986 (Ont. Super. April 14, 2009) (Canada).  Discovery of plaintiff’s Facebook and MySpace accounts was proper.
  10. Ledbetter v. Wal-Mart Stores, Inc., 2009 WL 1067018 (D. Colo. April 21, 2009).  Subpoenas directly to Facebook, My Space, Inc., and Meetup.com were proper discovery of plaintiff’s accounts.
  11. Bass v. Miss Porter’s School, 2009 WL 3724968 (D. Conn. Oct. 27, 2009).  Discovery of plaintiff’s Facebook account was proper.  Plaintiff’s withholding of relevant information justified sanction of production of entire Facebook page.
  12. Romano v. Steelcase Inc., 907 N.Y.S.2d 650 (N.Y. Sup. Sept. 21, 2010).  Discovery of plaintiff’s Facebook and MySpace accounts authorized.  Social media are not privileged, even if restricted as “private.” Social media are discoverable, and have no reasonable expectation of privacy.
  13. McCann v. Harleysville Insurance Co., 910 N.Y.S.2d 614 (N.Y.A.D. Nov. 12, 2010).  While the defendant had yet to establish entitlement to discovery of any particular item, prospective refusal to allow any discovery of plaintiff’s Facebook account was an abuse of discretion.
  14. EEOC v. Simply Storage Management, LLC, 270 F.R.D. 430 (S.D. Ind. May 11, 2010).  Discovery of plaintiffs’ Facebook and MySpace accounts authorized.  Social media have no reasonable expectation of privacy.  Targeted social media discovery is not burdensome or oppressive.
  15. Barnes v. CUS Nashville, LLC, 2010 WL 2265668 (M.D. Tenn. June 3, 2010).  Discovery of plaintiff’s Facebook account authorized.  Due to plaintiff’s intransigence, the magistrate will “friend” plaintiff and review the account for discoverable information.
  16. McMillen v. Hummingbird Speedway, Inc., 2010 WL 4403285 (Pa. C.P. Jefferson Co. Sept. 9, 2010).  Discovery of plaintiff’s Facebook account authorized.  There is no “social network privilege.” Social media are discoverable, and access “should be freely granted.”
  17. Sparks v. Dubé, 2011 CarswellNB 80 ¶¶52-58 (N.B.Q.B. Feb. 4, 2011) (Canada).  Imposing litigation hold on plaintiff to prevent deletion of Facebook information.
  18. Zimmerman v. Weis Markets, Inc., 2011 WL 2065410 (Pa. C.P. Northumberland Co. May 19, 2011).  Discovery of plaintiff’s Facebook and MySpace accounts authorized.  No privilege exists for information posted in the non-public sections of social websites.  Social media have no reasonable expectation of privacy.
  19. Offenback v. LM Bowman, Inc., 2011 WL 2491371 (M.D. Pa. June 22, 2011).  Discovery of plaintiff’s Facebook account authorized. Social media are discoverable.  There is no need for judicial in camera review of social media before it is produced.
  20. Katiroll Co. v. Kati Roll and Platters, Inc., 2011 WL 3583408 (D.N.J. Aug. 3, 2011).  A party’s intentional destruction of Facebook evidence could constitute spoliation, but unintentional alterations do not.  Parties “control” their Facebook pages for purposes of discovery.
  21. Held v. Ferrellgas, Inc., 2011 WL 3896513 (D. Kan. Aug. 31, 2011).  Discovery of plaintiff’s Facebook and job search accounts authorized.  Targeted social media discovery is not burdensome or oppressive.
  22. Patterson v. Turner Construction Co., 931 N.Y.S.2d 311, 312 (N.Y. App. Div. 2011).  Affirming grant of Facebook discovery.  Social media are not privileged, even if restricted as “private.”
  23. Sourdiff v. Texas Roadhouse Holdings, LLC, 2011 WL 7560647 (Mag. N.D.N.Y. Oct. 24, 2011).  Discovery of plaintiff’s Facebook and MySpace accounts authorized.  Plaintiff’s counsel must review the sites’ content, including any deleted items, and turn over to the defendant all information related in any way to the plaintiff’s physical or emotional condition, injuries, damages, activity level, employment, or concerning this lawsuit.
  24. Largent v. Reed, 2011 WL 5632688, slip op. (Pa. C.P. Franklin Co. Nov. 8, 2011).  Discovery of plaintiff’s Facebook account authorized.  Social media are discoverable, and have no reasonable expectation of privacy. Social media are not privileged, even if access is restricted.  The Stored Communications Act does not apply to discovery from plaintiffs.  Targeted social media discovery is not burdensome or oppressive.
  25. In re Air Crash Near Clarence Center, New York, on February 12, 2009, 2011 WL 6370189 (W.D.N.Y. Dec. 20, 2011).  Where plaintiff’s domicile is an important contested issue, discovery will be allowed into all of plaintiff’s electronic communications for a five-year period prior to the accident, including social media, text messages, emails, and instant messages, relevant to the plaintiff’s domiciliary intentions.
  26. Davenport v. State Farm Mutual Automobile Insurance Co., 2012 WL 555759 (M.D. Fla. Feb. 21, 2012).  Discovery of plaintiff’s social media sites allowed.  Plaintiff must produce every photograph of the her that is posted on any social media site, whether or not she posted them (that is, including “tags”).  As a practical matter, the scope of production will be limited by the “custody and control” limits on discovery.
  27. Glazer v. Fireman’s Fund Insurance Co., 2012 WL 1197167 (S.D.N.Y. April 5, 2012).  Plaintiff must produce all her LivePerson social media accounts.  Pursuant to the Stored Communication Act the court may direct plaintiff to consent to disclosure if she wants to maintain this suit.  It makes more sense to require the plaintiff, rather than the online provider, make the production.  Since plaintiff has deleted relevant information that can be restored if she opens a new account, plaintiff is directed to open a new account.  Given the relevance of the excerpts provided to the court, all chats must be produced regardless of subject matter.  All chats during the plaintiff’s employment by the defendant must be produced.  If plaintiff claims any privilege, she must submit a privilege log.
  28. Loporcaro v. City of New York, 35 Misc.3d 1209(A), 950 N.Y.S.2d 723 (table), 2012 WL 1231021 (N.Y. Sup. April 9, 2012).  Plaintiff posted information on Facebook contradicting his claims, entitling defendants to full discovery.  A person creating a Facebook account may be found to have consented to the possibility that personal information might be shared with others, notwithstanding the privacy settings, as there is no guarantee that the pictures and information posted thereon, whether personal or not, will not be further broadcast and made available to other members of the public.
  29. Thompson v. Autoliv ASP, Inc., 2012 WL 2342928 (D. Nev. June 20, 2012).  Discovery of  plaintiff’s Facebook and other social networking sites allowed.  Redaction was inappropriate.  Relevance was established by public information obtained prior to formal discovery.  Plaintiff did not claim privilege so not entitled to in camera review.  All material after date of accident was potentially relevant to the injury/emotional distress claims and must be produced.
  30. Walter v. Walch, 2012 WL 6864400 (N.Y. Sup. July 2, 2012).  Defendants made a sufficient showing of particularity to be entitled to discovery from plaintiffs’ private Facebook pages.  Plaintiffs who place their physical and mental condition in controversy may not shield themselves from disclosure material which is necessary to the defense of the action.  Plaintiffs must provide authorizations.
  31. Trail v. Lesko, 2012 WL 2864004, slip op. (Pa. C.P. Allegheny Co. July 3, 2012).  I don’t usually put denials on cheat sheets, but this is Judge Wettick, and this decision is likely to become the standard in Pennsylvania.  Discovery of social media sites (plaintiff or defendant) is allowed unless “unreasonably intrusive.”  In order to be entitled to discovery, the moving party must show a reasonable likelihood of the site containing relevant evidence, not available elsewhere, that will have an impact on the outcome of the case.
  32. Robinson v. Jones Lang LaSalle Americas, Inc., 2012 WL 3763545 (D. Or. Aug. 29, 2012).  Where plaintiff has alleged severe emotional distress, defendant is entitled, for the relevant period, to social media discovery of any direct or indirect communications with current and former employee of defendant; plaintiff’s social media communications that reveal, refer, or relate to any significant emotions or emotion-stirring events allegedly caused by defendant’s conduct.  Defendant may challenge the production if it believes the production fails short.
  33. Cajamarca v. Regal Entertainment Group, 2012 WL 3782437 (E.D.N.Y. Aug. 31, 2012).  Monetary sanctions are appropriate against plaintiff’s counsel for failing to advise plaintiff not to delete relevant information from her computers.  The relevance of the deleted information, which was of a sexual nature, was patently clear.
  34. Mailhoit v. Home Depot U.S.A., Inc., 285 F.R.D. 566 (C.D. Cal. Sept. 7, 2012).  Social media is discoverable and not privileged, but must be particularized.  A particularized request for communications with specified employees of the defendant will be granted.  Vague requests will be denied.
  35. Howell v. Buckeye Ranch, Inc., 2012 WL 5265170 (S.D. Ohio Oct. 1, 2012).  Social media information is discoverable to the same extent as traditional material.  Defendants must make a particularized showing.  Plaintiff is on notice that defendants are seeking social media information and may not delete it.  Any deletions must be reported to the defendant, and plaintiff must endeavor to recover them.
  36. Simms v. Lewis, 2012 WL 6755098, slip op. (Pa. C.P. Oct. 10, 2012), pursuant to, 2012 WL 6888199 (Pa. C.P. July 3, 2012).   Discovery of plaintiff’s myYearbook account authorized.   Plaintiff’s the public posts indicated that the private pages are likely to contain relevant information.  No expectation of privacy exists.  Defendant will be granted discovery of plaintiff’s other social networking sites upon a similar preliminary showing.
  37. Bianco v. North Fork Bancorporation, Inc., 2012 WL 5199007 (N.Y. Sup. Oct. 10, 2012).  Given the plaintiff’s broad claims about alleged adverse impact on his life style and loss of enjoyment of life, defendant is entitled to Facebook discovery from plaintiff through the intermediary of a special master to whom the contents of plaintiff’s account will be produced.  The special master shall limit discovery to information that is calculated to lead to admissible evidence.
  38. In re White Tail Oilfield Services, L.L.C., 2012 WL 4857777 (E.D. La. Oct. 11, 2012).  Given claimant’s affidavit that he did not know how to download his own Facebook information, defendant will be given plaintiff’s download information, defendant will execute the download, and plaintiff must forward all downloaded information to defendant.
  39. EEOC v. Original Honeybaked Ham Co., 2012 WL 5430974 (D. Colo. Nov. 7, 2012).  Defendant in administrative class action is entitled to discovery from the plaintiff’s social media accounts.  The fact that information resides in cyberspace does not change its discoverability.  The claimants created these communications voluntarily.  Because a review of one claimant’s social media reveals much relevant information, there is valid reason to order discovery as to the other claimants in the class, particularly since other claimants posted to that claimant’s account.  All discovery will go through a special master to ensure that only discoverable information is ultimately produced to the other side.  Plaintiffs must produce all cell phones capable of text messaging and all social media access information to the special master for the time period at issue.  The cost of forensic evaluation of this electronic information will be shared jointly by defendant and plaintiffs.
  40. Mazzarella v. Mount Airy #1 LLC, 2012 WL 6000678, slip op. (Pa. C.P. Monroe Co. Nov. 7, 2012).  Discovery of unspecified social media is permitted.  No expectation of privacy exists.
  41. Reid v. Ingerman Smith LLP, 2012 WL 6720752 (E.D.N.Y. Dec. 27, 2012).  Social media is a source for relevant and discoverable information.  There is no justifiable expectation of privacy in social media, even if limited to “friends.”  Plaintiff can have no expectation that “friends” will keep her post private.  Defendants have made a sufficient showing from plaintiff’s publicly available Facebook pages that private pages are likely to contain evidence relevant to her emotional distress claims.  Posts about plaintiff’s social activities may be relevant to emotional distress allegations and also identify potential witnesses.  Completely irrelevant posts need not be produced.
  42. Keller v. National Farmers Union Property & Casualty Co., 2013 WL 27731 (D. Mont. Jan. 2, 2013).  Social media is not protected from discovery simply because it is marked “private.”  It is both discoverable and potentially admissible.  The requesting party must make some threshold showing of likely admissibility.  A non-specific request for a fishing expedition into a plaintiff’s social media will not be allowed.  Plaintiffs must list all social media to which they belong.  Defendant can renew with a showing of likely relevance.
  43. Allied Concrete Co. v. Lester, 736 S.E.2d 699 (Va. Jan. 10, 2013).  Plaintiff and his counsel was adequately sanctioned with costs, attorney fees, and an adverse inference instruction for intentionally spoliating the contents of his Facebook page while discovery was pending.  While the conduct was dishonest and unethical, there was ultimately no substantial prejudice as the information was recovered.  No new trial is required.
  44. German v. Micro Electronics, Inc., 2013 WL 143377 (S.D. Ohio Jan. 11, 2013).  Plaintiff engaged in significant social media use regarding her physical condition.  Plaintiff violated Rule 34 by failing to specify a production format for her social media production.  Cutting and pasting is not a form in which the information was ordinarily maintained.  The burden and expense to plaintiff does not outweigh production of the electronic information.  Plaintiff is not entitled to cost shifting.  Plaintiff is obligated by Rule 34 to undertake a review of her own online activity.  An offer to allow supply log-in credentials and passwords is not a valid alternative to production.  That proposal is rejected because it seeks to shift to the defendant the burden of sifting through plaintiff’s prolific on-line activities.  In light of plaintiff’s deceptive representations about discovery, defendant is entitled to an award of fees and costs.
  45. Scipione v. Advance Stores Co., 2013 WL 646405 (M.D. Fla. Feb. 21, 2013).  In slip and fall case, plaintiff is to produce all Facebook content since the accident that refers to the injury as well as recent Facebook photographs.
  46. Tejada v. Manhattan Plaza, Inc., 2013 WL 5396903 (N.Y. Sup. March 21, 2013).  Plaintiff’s counsel’s direction to plaintiff to not answer questions at her deposition regarding any social media accounts was unfounded and warranted reopening the deposition.
  47. Gatto v. United Air Lines, Inc., 2013 WL 1285285, slip op. (D.N.J. March 25, 2013).  After being ordered to authorize the defendant to access his Facebook account, plaintiff deactivated his account causing its contents to be lost.  By intentionally deactivating the account, plaintiff is guilty of spoliation.  Defendant is entitled to an adverse inference instruction to the jury regarding the destroyed electronic evidence.  Because plaintiff had a non-fraudulent excuse for his actions, monetary sanctions are denied.
  48. In re Christus Health Southeast Texas, 399 S.W.3d 343 (Tex. App. March 28, 2013).  Mandamus demanding discovery of social media in personal injury suit denied.  While the material was relevant and there is no expectation of privacy in social media, the request was unlimited in time and thus overbroad.
  49. Nieves v. 30 Ellwood Realty LLC, 966 N.Y.S.2d 808 (N.Y.A.D April 11, 2013). Defendant demonstrated that plaintiff’s Facebook profile contained photographs that were probative of the issue of the extent of her alleged injuries, and it is reasonable to believe that other portions of her Facebook records may contain further evidence relevant to that issue.  In camera review is appropriate.
  50. Perrone v. Rose City HMA, LLC, 2013 WL 4011633 (Pa. C.P. Lancaster Co. May 3, 2013).  Plaintiff ordered to submit to search of private Facebook account by agreed-upon neutral expert and to turn over all photos and emails relating to specific topics, including physical activity, relevant to the litigation.
  51. Giacchetto v. Patchogue-Medford Union Free School District, 293 F.R.D. 112 (E.D.N.Y. May 6, 2013).  While plaintiff’s emotional distress claim does not justify unfettered discovery of social media, defendant is entitled to all mentions of emotional distress plaintiff may have made as well as any postings on social networking websites that refer to an alternative potential source of emotional distress.  Postings or photographs on social networking websites that reflect physical capabilities inconsistent with a plaintiff’s claimed injury are also relevant.  Plaintiff’s counsel is to review for relevancy.  No third-party provider is necessary at this time.
  52. Kear v. Kohl’s Department Stores, Inc., 2013 WL 3088922 (D. Kan. June 18, 2013).  The nature of plaintiff’s claims support defendant’s discovery demand for Facebook and Twitter information subsequent to the date of her hire.  Plaintiff’s activity on social media sites may lead to relevant information.
  53. Pereira v. City of New York, 975 N.Y.S.2d 711, 2013 WL 3497615 (N.Y. Sup. June 19, 2013), 975 N.Y.S.2d 711 (table).  With pictures from the public section of plaintiff’s Facebook page defendant established activities inconsistent with plaintiff’s allegations.  With that showing, defendant is entitled to discovery of the rest of plaintiff’s social media sites.  Due to the likely presence of irrelevant material, in camera review is proper.
  54. Jennings v. TD Bank, 2013 WL 5957882 (N.Y. Sup. July 3, 2013).  Disclosure of the relevant contents of plaintiff’s private Facebook account is warranted.  Photographs on public, unblocked portions of plaintiff’s profile indicate activity inconsistent with her injury claims.  Plaintiff cannot shield disclosure material which is necessary to the defense of the action because she placed not only her physical condition but also her enjoyment of life and social activities.  Although plaintiff may utilize privacy settings on her account to restrict access, these postings are discoverable since there is no legitimate reasonable expectation of privacy.
  55. Higgins v. Koch Development Corp., 2013 WL 3366278 (S.D. Ind. July 5, 2013).  A court may compel production of a party’s Facebook information if the party seeking disclosure makes a threshold relevance showing.  Plaintiffs claim that they can no longer enjoy various activities indicate that such information is directly relevant.  Setting ones Facebook profile to “private” does not entitle a person to a greater expectation of privacy in the context of discovery in a civil action.  Tagging public photographs does not create an expectation of privacy that defeats discovery.
  56. Fox v. Transam Leasing, Inc., 2013 WL 5276111 (D. Kan. Sept. 18, 2013).  Defendant is entitled to plaintiffs’ Facebook and Twitter archives.  They have not established that their social media, if any, is totally lacking in relevant information.  Plaintiffs must produce any discussions about the defendants or about this law suit that is not subject to a legal privilege.
  57. Imanverdi v. Popovici, 971 N.Y.S.2d 911 (N.Y.A.D. Sept. 27, 2013).  Order compelling plaintiff to produce the contents of her Facebook page for in camera review affirmed.  Both the discovery order and the accompanying order requiring plaintiff to pay counsel fees were proper exercises of discretion.
  58. Marcum v. Graphic Packaging International, Inc., 2013 WL 6388650 (N.D. Ind. Dec. 6, 2013).  Given the nature of the Facebook post defendant offered to support its motion, plaintiff’s social media postings are likely to contain relevant evidence and therefore must be produced.
  59. D.O.H. v. Lake Central School Corp., 2014 WL 174675 (N.D. Ind. Jan. 15, 2014).  Because plaintiff placed his emotional state at issue, defendant was entitled to disclosure of social media records that relate to any emotion, feeling, or mental state, as well as communications that reveal, refer, or relate to events that could reasonably be expected to produce a significant emotion, feeling, or mental state.  To the extent plaintiff withholds anything, he must produce a privilege log.  See below for sanctions order.
  60. Painter v. Atwood, 2014 WL 1089694 (D. Nev. March 18, 2014).  Plaintiff and two of her witnesses deliberately deleted relevant text messages and comments from Facebook pages after she filed suit.  A an adverse inference instruction as a spoliation sanction is appropriate.
  61. Ogden v. All-State Career School, 299 F.R.D. 446 (W.D. Pa. April 23, 2014).  Discovery of social media activity is permitted where reasonably calculated to lead to admissible evidence.  Plaintiff must produce copies of all electronic communications belonging or attributable to him as a result of his affirmative actions that involved either the workplace conduct at issue or plaintiff’s emotional state of mind during the relevant period of employment.
  62. Hosch v. BAE Systems Information Solutions, Inc., 2014 WL 1681694 (E.D. Va. April 24, 2014).  Plaintiff’s False Claims Act action dismissed with prejudice due to his systematic spoliation of his electronic data from his cell phones, blackberry, and social media and refusal to turn over electronic devices for inspection.  Plaintiff had received a document preservation notice and other warnings.
  63. Stallings v. City of Johnston City, 2014 WL 2061669 (S.D. Ill. May 19, 2014).  Plaintiff may not redact names of participants in relevant social media conversations.  Plaintiff must produce hard copies of all relevant materials with names.  If defendant believes plaintiff has not been complete, plaintiff’s counsel will allow defense counsel to review plaintiff’s account online at plaintiff’s counsel’s office.
  64. Rowell v. NCO Financial Systems, Inc., 2014 WL 2154422 (Mag. D. Kan. May 22, 2014).  Plaintiff bears burden of establishing nondiscoverability of social media.  In debt collection lawsuit, plaintiff must all produce materials posted to social media relating to debts or financial obligations, the defendant, the facts or circumstances alleged in the complaint, or concerning this lawsuit.
  65. Chapman v. Hiland Operating, LLC, 2014 WL 2434775 (D.N.D. May 29, 2014).  Loss of consortium plaintiff who deactivated Facebook account on counsel’s advice ordered to reactivate it and provide discovery to defendant concerning spouse’s health, relationship, and activities and all references to incident at suit.
  66. Smith v. Hillshire Brands, 2014 WL 2804188 (D. Kan. June 20, 2014).  Plaintiffs must produce all social media content that mentions the defendant, and any content content that reveals plaintiff’s emotions or mental state, or content that refers to events that could reasonably be expected to produce in plaintiff a significant emotion or mental state.
  67. Stonebarger v. Union Pacific Corp., 2014 WL 2986892 (D. Kan. July 2, 2014).  Plaintiffs must produce private Facebook material that relates or refers to either their claims for damages for mental anguish, and defendants’ defenses to those claims.
  68. Doe v. Rutherford County, Board of Education,  2014 WL 4080159 (Mag. M.D. Tenn. Aug. 18, 2014).  Defendant satisfied evidentiary threshold for discovery of plaintiff’s private social media.  Publicly available information included material reasonably calculated to lead to relevant evidence and there was evidence that plaintiff was deleting information.
  69. Johnson v. SmithKline Beecham Corp., 55 F. Supp.3d 603 (E.D. Pa. Oct. 16, 2014).  Defendant entitled to discover plaintiffs’ product-related on-line and social media-related communications and research.  Plaintiffs’ obstruction and failure to comply required appointment of a discovery master.  Multiple examples of cases barred by the statute of limitations for decades were discovered.  Plaintiffs’ counsel conceded that sanctions were appropriate for failure to investigate cases before filing them and sought to withdraw.   Summary judgment granted on statute of limitations as a result of this discovery.
  70. Federico v. Lincoln Military Housing, LLC, 2014 WL 7447937 (E.D. Va. Dec. 31, 2014). Plaintiffs were extensive social media users. Defendant’s preservation letter should have led them to preserve their social media activity and be prepared to produce it. Plaintiffs were either poorly instructed or deliberately dilatory in their obligations to search for and produce responsive media. However, since most material was ultimately produced and was not of great importance, only monetary sanctions are appropriate.
  71. Nucci v. Target Corp., 162 So. 3d 146 (Fla. App. Jan. 7, 2015).  Affirming order compelling discovery.  Defendant entitled to discover photographs from plaintiff’s Facebook account for two years prior to her accident.  Social media are the same as “day in life” evidence.  There is no better portrayal of an individual’s life than those photographs the individual has chosen to share through social media.  Social media photographs are powerfully relevant.  That relevance is only enhanced by defendant’s surveillance indicating that plaintiff may be concealing her true condition.  Photographs posted on a social networking site are neither privileged nor protected by any right of privacy, regardless of any privacy settings the user may have established.  The inherent sharing of social media defeats any reasonable expectation of privacy.  The Stored Communications Act does not apply to users of social media.
  72. Crowe v. Marquette Transportation Co. Gulf-Inland, LLC, 2015 WL 254633 (E.D. La. Jan. 20, 2015). After lying about having social media accounts, plaintiff must produce the entire account. A cursory in camera review demonstrates the presence of considerable discoverable information. A deactivated Facebook account can easily be reactivated at any time, as plaintiff in fact did. Defendant is entitled to explore plaintiff’s deactivation and reactivation of the account.
  73. Gonet v. Private Island Entertainment, LLC, 2015 WL 505138 (N.Y. Sup. Feb. 3, 2015). Public Facebook conversations contradicting plaintiff’s allegations established a factual predicate warranting discovery of plaintiff’s social media accounts.
  74. D.O.H. v. Lake Central School Corp., 2015 WL 736419 (N.D. Ind. Feb. 20, 2015). Sanctions, including taxation of costs, imposed on plaintiff for violating social media discovery order (see above at 2014 WL 174675). Plaintiff must produce a log of all social networking information withheld for relevance or privilege reasons.
  75. Melissa “G” v. North Babylon Union Free School Dist., 6 N.Y.S.3d 445 (N.Y. Sup. March 18, 2015). Photographs from plaintiff’s public Facebook pages showed her engaged in recreational activities inconsistent with her claimed condition established a factual basis for discovery of private social media activities. Plaintiff’s counsel shall review all posts for relevance.
  76. Gonzalez v. City of New York, 16 N.Y.S.3d 792 (table), 2015 WL 2191363 (N.Y. Sup. May 4, 2015). Defendant established, from plaintiff’s public posts, a factual predicate to receive discovery of plaintiff’s social media accounts. The Court will inspect in camera copies of all status reports, e-mails, photographs, and videos posted on plaintiff’s social media sites since the date of the subject accident to determine their relevance.
  77. Tuzzolino v. Consolidated Edison Co., 2015 WL 2412374 (N.Y. Sup. May 21 2015). Plaintiff compelled to provide authorizations for full access to his Facebook account by presence of public Facebook pictures contrary to his claims.
  78. Johnson v. BAE Systems, Inc., 106 F. Supp.3d 179 (D.D.C. May 27, 2015). Plaintiff sanctioned for spoliation of social media records. Adverse inference, issue preclusion, and taxation of costs.
  79. Kaur v. New York City Health & Hospital Corp., 2015 WL 3792662 (N.Y. Sup. May 29, 2015). Posting of photographs and comments on a public social media site makes them fair game for discovery. Plaintiff shall provide the necessary authorizations.
  80. Spearin v. Linmar, L.P., 11 N.Y.S.3d 156 (N.Y. App. Div. June 15, 2015). Defendant entitled to discovery through in camera review of all plaintiff’s post-accident Facebook postings for identification of information relevant to his alleged injuries.
  81. Rivera v. A. L. Bazzini Co., 2015 WL 4993606 (N.Y. Sup. July 20, 2015). Plaintiff shall produce to defendant all business-related content contained on social media websites, and any deleted material. Any personal content shall be provided to the court for in camera review.
  82. Farley v. Callais & Sons LLC, 2015 WL 4730729 (Mag. E.D. La. Aug. 10, 2015). Plaintiff must turn over all social networking site information to her counsel, with completeness certified under oath. Plaintiff must produce to defendant all postings and photographs that involve: the accident, physical injuries or emotional distress caused by the accident and any treatment received, and potential alternative sources of physical injury or emotional distress. Plaintiff must also turn over all posts and photographs inconsistent with her claims or claimed injuries.
  83. A.D. v. C.A., 16 N.Y.S.3d 126 (N.Y. Sup. Aug. 13, 2015). In custody dispute, former spouse’s social media activity for the relevant period is discoverable to determine whether she spent as much time with the child as she claims during that period. She must take steps to produce printouts of Facebook postings depicting or describing her whereabouts. For in camera review, spouse shall swear to the completeness of the production and provide the court with access to her Facebook account.
  84. Peterson v. Northeastern Local School Dist., 2015 WL 5013360 (Mag. S.D. Ohio Aug. 25, 2015), adopted, 2015 WL 5793944 (S.D. Ohio Sept. 30, 2015). Plaintiff in employment action must produce Facebook postings, emails, voicemails, and texts from the time of the incident at suit.
  85. Facebook, Inc. v. Superior Court, 192 Cal. Rptr. 3d 443 (Cal. App. Sept. 8, 2015), review granted, 362 P.3d 430 (Cal. Dec. 16, 2015). Criminal subpoena for social media records does not violate Stored Communication Act.
  86. EEOC v. CollegeAmerica Denver, Inc., 2015 WL 5535192 (D. Colo. Sept. 21, 2015). Plaintiff required to produce social media postings of key witness about several topics for a specific time period. Evidence is relevant to consumer expectation and impeachment.
  87. Appler v. Mead Johnson & Co., 2015 WL 5615038 (S.D. Ind. Sept. 24, 2015). Except for certain specific categories, discovery of Facebook activity generated by plaintiff is generally reasonable. Social networking is neither privileged nor private. Plaintiff shall produce everything she posted on any social networking site regarding the defendant and its present or former employees. Plaintiff shall also produce her entire Facebook page, except for certain specified, largely financial, topics.
  88. Lucci v. Cabrera, 2015 WL 7455479 (N.Y. Sup. Nov. 12, 2015). Plaintiff’s posting of a Facebook photograph that contradicted his allegations concerning his physical condition provided the necessary factual predicate for discovery of plaintiff’s private social media activity.
  89. Fox v. Pittsburg State University, 2015 WL 7572301 (D. Kan. Nov. 24, 2015). Plaintiff’s activity on social media sites may lead to relevant information regarding Plaintiff’s claims. A five year time frame for production is reasonable. Responsive material encompasses social media postings indicating sources and/or instances of stress, anxiety, depression, loss of sleep, and/or embarrassment.
  90. Krayzel v. Roberts, 2015 WL 9320296 (Pa. Super. Dec. 22, 2015) (memorandum). Cross-examination of plaintiff with a social media statement indicating that he hoped to profit from litigation was proper.
  91. Impson v. Dixie Electric Membership Corp., 2015 WL 9413122 (M.D. La. Dec. 22, 2015). Plaintiff must produce social media postings and emails concerning the claimed accident and her damages and injuries. Social media is discoverable and privacy settings do not matter.
  92. Roberts v. Clark County School Dist., 312 F.R.D. 594 (D. Nev. Jan. 11, 2016). Plaintiff must identify all of the social media sites on which he has had an account from the event triggering the litigation to the present. Plaintiff’s counsel must review the account contents and produce anything referencing the litigation, the underlying events, plaintiff’s state of mind, emotional or physical responses to these events, and about his treatment by the defendant.
  93. Anderson v. Centraarchy Restaurant Management Co., 2016 WL 316851 (N.D. Ga. Jan. 26, 2016). Plaintiff held in contempt for avoiding social media discovery. Defendant entitled to reasonable attorney’s fees and expenses, and to redepose witnesses. Because the material has been produced, albeit belatedly, dismissal is not appropriate at this time.
  94. Silk v. Bowling Green State University, 2016 WL 2771165 (Ohio Ct. Cl. Jan. 28, 2016). Plaintiff’s social media activity is discoverable. Plaintiff may not unilaterally decide which posts are relevant and which are not. Admissibility will be determined later.
  95. Lewis v. Bellows Falls Congregation, Inc., 2016 WL 589867 (D. Vt. Feb. 11, 2016). Plaintiff’s social media is discoverable. Screen shots insufficient. Counsel shall review the entire account and produce relevant material, including:  (1) references to the defendants, sexual or other abuse, emotional distress, mental health, treatment, alternative potential stressors, emotions, feelings, and mental state; and (2) photographs or videos depicting plaintiff and her activities. Produced materials shall not be redacted.
  96. Rhone v. Schneider National Carriers, Inc., 2016 WL 1594453 (E.D. Mo. April 21, 2016). Plaintiff shall produce a complete list of her social media accounts during the requested time periods. Plaintiff shall provide a “Download Your Info” report from her Facebook account for the period after the date of the accident, given that defendant’s independent examination of public pages has uncovered relevant evidence.
  97. Gondola v. USMD PPM, LLC, 2016 WL 3031852 (N.D. Tex. May 27, 2016). Social networking is discoverable and not privileged. Defendant entitled to information, messages, and postings on social networking sites relevant to the claims and defenses to plaintiff’s wrongful termination claims.
  98. Waters v. Union Pacific Railroad Co., 2016 WL 3405173 (D. Kan. June 21, 2016). Defendant entitled to discovery of plaintiff’s social media account names as well as postings from the dates he missed work. Plaintiff put his emotional state at issue.
  99. Edwards v. City of Bossier City, 2016 WL 3951216 (Mag. W.D. La. July 20, 2016). Plaintiff must produce social media posts during the relevant period until the present that pertain to his alleged contact with the defendant and his subsequent loss of his job.
  100. Baxter v. Anderson, 2016 WL 4443178 (Mag. M.D. La. Aug. 19, 2016). Ordering plaintiff to identify every social networking website used or accessed since her accident, and where she posted photographs or other information, as well as usernames and the last date of access. Plaintiff must also produce all postings, including photographs, since the accident about the claims and defenses of the litigation, as well as postings about her alleged physical injuries and her physical capabilities.
  101. Zamora v. GC Services, LP, 2016 WL 8853096 (Mag. W.D. Tex. Aug. 19, 2016). Plaintiff ordered to respond to discovery demand for all social media postings, recordings, and text messages, that concern the factual allegations plaintiff is making in the lawsuit.
  102. McDonald v. Escape the Room Experience, LLC, 2016 WL 5793992 (Mag. S.D.N.Y. Sept. 21, 2016). Motion to compel granted ordering plaintiff to produce postings about plaintiff’s socializing, her attendance at parties or other social outings, and her participation in performances or other employment activities. Plaintiff’s production must include her complete postings, during the relevant time period, on any electronic social media or internet sites, including dating sites.
  103. Jacquelyn v. Macy’s Retail Holdings, Inc., 2016 WL 6246798 (Mag. S.D. Ga. Oct. 24, 2016). No threshold showing is necessary before a defendant can seek discovery of social media evidence. Such a rule would shield from discovery Facebook users who do not share information publicly. Where a plaintiff puts physical condition and quality of life at issue, Facebook postings reflecting physical capacity and inconsistent activities are relevant and discoverable. Plaintiffs must produce: (1) all photographs posted by plaintiffs or in which they are tagged; (2) all comments to those photographs; (3) all posts by plaintiffs relating to activities in which plaintiffs contend they could not participate due to the incident; and (4) any posts referencing their claimed injuries, damages, or loss of enjoyment of life since the incident.
  104. Scott v. United States Postal Service, 2016 WL 7440468 (Mag. M.D. La. Dec. 27, 2016). Where plaintiff has put her physical condition and activities at issue by filing a lawsuit, social media concerning those matters is discoverable. Defendant came forward with evidence that relevant social media existed. Plaintiff can also be required to identify all social media used since the accident and all postings related to any type of physical or athletic activities since the accident. To ensure completeness, plaintiff must retain historical data for all social media and review for responsive information. If such information is unavailable, plaintiff must describe the steps she took to locate and review responsive information.
  105. Brown v. City of Ferguson, 2017 WL 386544 (E.D. Mo. Jan. 27, 2017). Social media discovery is no different than any other discovery. Social media is neither privileged nor protected by a right of privacy. Plaintiffs must produce all social media content with any relevance to the case, for five years prior to the incident, including private messages sent through Facebook messenger.
  106. Shawe v. Elting, 157 A.3d 142 (Del. Feb. 13, 2017).  Plaintiff properly sanctioned for deliberate and reckless deleting email and text messages by being ordered not only to pay all expenses of recovery but also a percentage of defendant’s total counsel fees, due to the spoliation complicating the conduct of the litigation general.
  107. Gee v. Citizens Insurance Co., 2017 WL 694711 (Mich. App. Feb. 21, 2017) (unpublished). Affirming dismissal of plaintiff’s complaint as a sanction for deliberately deleting social media information to evade discovery.
  108. State v. Johnson, 538 S.W.3d 32 (Tenn. Crim. App. April 12, 2017). Although the Shared Communications Act prohibited criminal defendants from obtaining a witness’ social media content from social media platforms, the defendant had established good cause to obtain such evidence directly from the witnesses who were social media users.  They are not privileged.  The subpoenae to the witnesses were not oppressive.
  109. Lawrence v. Rocktenn CP LLC, 2017 WL 2951624 (Mag. W.D. La. April 19, 2017). Plaintiff must produce all text messages, photographs and videos that concern:  (1) plaintiff’s physical capabilities; (2) that allegations in the complaint; (3) emotional distress; (4) any decline in plaintiff’s marriage; (5) alternative causes of the injuries; and (f) plaintiff’s activities during the claimed period of disability.
  110. Gordon v. T.G.R. Logistics, Inc., 321 F.R.D. 410 (D. Wyo. May 10, 2017). Plaintiff required to produce all social media history about her significant emotional turmoil, any mental disability or ability, or significant events which reasonably could result in emotional distress. Plaintiff also required to produce all Facebook postings which reference the accident, its aftermath, and any of her claimed physical injuries. Plaintiff must produce Facebook history and photos which relate or show her level of activity after the accident. Pre-accident social media need not be produced without a showing of relevance.
  111. Matthews v. J & J Service Solutions, LLC, 2017 WL 2256963 (Mag. M.D. La. May 23, 2017). Plaintiff ordered to comply with document requests for all social media communications with defendant’s current or former employees and for archived Facebook material. Social media is discoverable.
  112. Flowers v. City of New York, 55 N.Y.S.3d 51 (N.Y. App. Div. June 20, 2017). Evidence from plaintiff’s public social media contradicted the plaintiff, thereby justifying discovery from plaintiff’s private social media accounts, including deleted material, relating to the same subject matter. Plaintiff shall provide a release to obtain material, including metadata, from the provider.
  113. Walker v. Carter, 2017 WL 3668585 (S.D.N.Y. July 12, 2017). Plaintiff sanctioned for failure to produce relevant text messages. Must pay defendant’s increased attorney’s fees.
  114. Ottoson v. SMBC Leasing & Finance, Inc., 268 F. Supp.3d 570 (S.D.N.Y. July 13, 2017). Plaintiff sanctioned for failure to preserve text messages and emails concerning the events at issue. The jury will be instructed on an adverse spoliation inference.
  115. Jones v. U.S. Border Patrol Agent Gerardo Hernandez, 2017 WL 3525259 (Mag. S.D. Cal. Aug. 16, 2017). Plaintiff must produce a GPS-based map generated by his fitness watch.
  116. Ehrenberg v. State Farm Mutual Automobile Insurance Co., 2017 WL 3582487 (Mag. E.D. La. Aug. 18, 2017). With respect to social media, plaintiffs must produce posts and photos: (1) relating to the accident, (2) relating to all physical injuries whether or not caused by the accident, (3) reflecting plaintiff’s physical activity, (4) relating to plaintiff’s emotional distress; (5) relating to alternative emotional stressors; (6) concerning plaintiff’s vacations.
  117. Calleros v. Rural Metro, Inc., 2017 WL 4391714 (Mag. S.D. Cal. Oct. 3, 2017). In class action over alleged deprivation of rest breaks, defendant is entitled to social media discovery of any activity plaintiffs engaged in while on company time.
  118. Forman v. Henkin, 93 N.E.3d 882 (N.Y. Feb. 13, 2018).  Private information is discoverable if relevant.  No special restrictions apply to discovery of social media.  A defendant’s discovery of plaintiff’s private media is not predicated on something existing on a plaintiff’s public social media.  Plaintiffs must respond to social media discovery requests tailored to the nature of the injuries claimed and other case-specific aspects.  Defendant entitled to any pictures of plaintiff’s lifestyle after the accident and to metadata on plaintiff’s typing ability.
  119. Kelter v Flanagan, 2018 WL 1439793 (Pa. C.P. Feb. 14, 2018).  Plaintiff required to disclose her Instagram account log-in information.  Plaintiff has chosen to use social media.  Other posts similar to those posts used at her deposition would be relevant

It’s no secret that non-medical device preemption arguments haven’t been as successful after Wyeth v. Levine as they were before.  Here at the Drug and Device Law Blog, we like to provide information, but we also follow a defense Hippocratic Oath not to do harm by doing the other side’s research for them.  Our “scorecards” cover all decisions on both sides of an issue – but for us to keep a scorecard, the good guys (our clients) have to be doing well enough that we’re not in effect helping the other side.  That’s why we also have “cheat sheets” that include only those cases where our side wins.

Levine changed the landscape.  Thus after thinking long and hard about it, we’ve decided to “demote” non-device preemption from a scorecard to a cheat sheet.  So here’s our Post/Levine drug/vaccine cheat sheet.  Maybe, if we prevail in Bruesewitz, the landscape changes again and we’ll separate out vaccines.  Fingers crossed.

  1. Smith v. Wyeth, 2009 WL 736208 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4697002, reconsideration denied, 2009 WL 425032) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5460) is pending in the Sixth Circuit.
  2. Morris v. Wyeth, 2009 WL 736200 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (582 F.Supp.2d 861, reconsideration denied, 642 F. Supp.2d 677) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5509) is pending in the Sixth Circuit
  3. Wilson v. Wyeth, Inc., 2009 WL 736198 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4696995, reconsideration denied, 2009 WL 425027) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5466) is pending in the Sixth Circuit
  4. In re Aredia & Zometa Products Liability Litigation, 2009 WL 2497229 (M.D. Tenn. Aug. 13, 2009), finding preemption of fraud-on-the-FDA allegation made in opposition to Michigan tort reform statute presumption of non-defectiveness from regulatory compliance.
  5. In re: Aredia & Zometa Products Liability Litigation, 352 Fed. Appx. 994 (6th Cir. Nov. 24, 2009), affirming preemption (see pre-Levine scorecard) of fraud-on-the-FDA exception to Michigan tort reform statute. Preemption applies to all claims alleging fraud on the FDA, including post-approval fraud and fraud asserted against an affirmative defense.
  6. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 678 (N.D. Tex. Jan. 27, 2010), dictum stating that “clear evidence” supporting preemption would exist if plaintiffs were claiming only that two technical disease terms should have been used in OTC labeling, in light of regulatory history rejecting these terms.  Finding, however, that plaintiff’s claims were broader than that.  Reconsideration denied, 2010 WL 2484505 (N.D. Tex. June 17, 2010).  Affirmed on other grounds, 672 F.3d 372 (5th Cir. 2012).
  7. Murphy v. Mylan, Inc., 2010 WL 2008797 (Utah Dist. Iron Co. May 10, 2010), finding Buckman preemption in case (specific drug not stated) involving statutory fraud-on-the-FDA exception to Utah statute barring punitive damages against manufacturers of FDA-approved drugs.
  8. Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. Aug. 11, 2010), finding failure to warn claim in in OTC Motrin case preempted with respect to failure to warn of SJS/TEN because the FDA rejected that warning in response to a petition. The FDA’s rejection was “clear evidence” under Levine that would not permit the warning plaintiff advocated. Possible preemption of claim that OTC drug should have been sold by prescription only.
  9. Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011), finding consumer fraud claims preempted in Botox case where the allegations of illegal off-label promotion were nothing more than a private attempt to enforce the FDCA.
  10. Bruesewitz v. Wyeth LLC, 562 U.S. 223 (Feb. 22, 2011), Vaccine Act expressly preempts all design defect claims against vaccine manufacturers.  Any other reading would render “unavoidable” as used in the Act meaningless.  No mention of any presumption against preemption.  Affirming 561 F.3d 233 (3d Cir. March 27, 2009).
  11. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. June 13, 2011), regulatory history of Effexor was “clear evidence” that, had the defendant submitted a stronger warning about adult suicide to the FDA, the FDA would have rejected it.  Plaintiff’s failure to warn claim was preempted.
  12. Emerson v. Novartis Pharmaceuticals Corp., 446 Fed. Appx. 733 (6th Cir. Aug. 23, 2011), fraud on the FDA claims, made in pursuant to a statutory presumption of non-defectiveness by reason of FDA compliance, were preempted.
  13. In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012).  An authorized distributor of an innovator drug does not hold that drug’s New Drug Application and has no power to change that drug’s labeling.  Warning claims are preempted against those having no power to change the labeling unilaterally.
  14. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. Feb. 22, 2012), fraud on the FDA claims, made in pursuant to a statutory presumption (Texas) of non-defectiveness by reason of FDA compliance, were preempted.  Garcia‘s reasoning is more persuasive than DesianoAffirming 682 F. Supp.2d 662  (N.D.Tex. Jan. 27, 2010).
  15. Romero v. Wyeth LLC, 2012 WL 12547105 (E.D. Tex. May 30, 2012), fraud on the FDA claims, made in pursuant to a statutory presumption (Texas) of non-defectiveness by reason of FDA compliance, were preempted.
  16. Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. Sept. 6, 2012).  Reaffirming Garcia that Buckman preemption applies to fraud on the FDA statutory immunity exceptions and all other claims that attack the sufficiency of information submitted to the FDA.  “Compliance” refers to the aspects of the drug specified in the statute and not to fraud on the FDA-related non-compliance.  If “compliance” were broadly interpreted, then it would be preempted by Buckman for the same reasons as Garcia.  While Levine would preclude preemption of ordinary warning claims, the statute abolished those claims as a matter of state law.
  17. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 1831632, slip op. (E.D. Ky. Oct. 10, 2012).  Mensing preemption bars warning-related claims in a branded drug case where the defendant had sold its NDA, and thus lost the ability to change warnings through the CBE process, before the plaintiff used its drug manufacture the product that the plaintiff ingested.  Affirmed, see below.
  18. Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. Jan. 28, 2014).  Any change in the dosage of a drug is a “major change” requiring prior FDA approval.  Therefore, plaintiffs’ class action consumer fraud claims based on “overfilling” are preempted because the dose in which the drug was marketed was approved by the FDA and was impossible to change immediately to comply with the plaintiffs’ claimed state-law obligation.
  19. Amos v. Biogen Idec Inc., 28 F. Supp.3d 164 (W.D.N.Y. June 25, 2014).  Design defect claims against all prescription drugs are preempted as impossible under Bartlett.  Drug manufacturers cannot simultaneously comply with FDA requirements mandating the specific design of an approved drug and state law requirements mandating that the design be altered.  Subsequent ruling, see below.
  20. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. June 27, 2014).  Mensing preemption bars warning-related claims in a branded drug case after the defendant divested its NDA.  After divestiture a branded company has no power to change warnings and is no different than a generic manufacturer in that respect.
  21. DeBons v. Globus Medical, Inc., 2014 WL 12495351, slip op. (C.D. Cal. Aug. 8, 2014).  Buckman preempts all claims predicated on the defendant selling an “unapproved,” “not legal,” or not “safe and effective” medical device.  The claims are disguised FDCA enforcement and would not exist if the FDCA did not exist.  Incorporation of FDCA violations into California unfair practices statutes does not avoid Buckman and allow private FDCA enforcement in violation of federal law restricting enforcement to the government.  Affirmed, see below.
  22. Booker v. Johnson & Johnson, 54 F. Supp.3d 868 (N.D. Ohio Oct. 10, 2014).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-generic drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Where state law demands an alternative design to avoid liability, that would require changing the composition of the drug, which is prohibited by federal law.  Therefore, the state-law claim is preempted.
  23. Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680 (N.D. Ohio Jan. 5, 2015).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-generic drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Following BookerAffirmed 808 F.3d 281 (see below).
  24. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. Feb. 20, 2015).  A California consumer protection class action alleging misleading statements about the efficacy of an innovator/branded drug is entirely preempted under Levine/Mensing.  None of the efficacy-related label changes plaintiffs sought involved “newly acquired” information that the FDA had not already considered in its approval of the challenged indication, so they could have been accomplished through a CBE supplement.  Nor was the type of label change plaintiffs sought allowable through the CBE process.  The CBE process involves new safety-related information, and is not a way to second-guess FDA approval.  Because the CBE process is inapplicable, the label changes plaintiffs seek must be have FDA pre-approval, and are therefore preempted as impossible under Mensing.
  25. In re Depakote, 87 F. Supp.3d 916 (S.D. Ill. Feb. 20, 2015).  The defendant presented clear evidence that the FDA would not have included a developmental delay warning for Depakote at any time relevant to the plaintiff’s case.  Twice, after plaintiff’s use of the drug, the FDA refused attempts by the defendant to add such a warning, on the basis that the scientific support was insufficient.
  26. Shah v. Forest Laboratories, Inc., 2015 WL 3396813 (N.D. Ill. May 26, 2015).  Under Bartlett, state-law design defect claims against all prescription drugs are preempted.
  27. Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio Aug. 10, 2015).  The defendant presented clear evidence that the FDA would not have included a developmental delay warning for Depakote at any time relevant to the plaintiff’s case.  Twice, after plaintiff’s use of the drug, the FDA refused attempts by the defendant to add such a warning, on the basis that the scientific support was insufficient.  Because fraud on the FDA claims are preempted, plaintiff cannot try to undercut this evidence with fraud on the FDA claims.  Buckman preempts statutory fraud on the FDA punitive damages exception.  Affirmed, 680 F. Appx. 369 (6th Cir. Feb. 21, 2017).
  28. Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035 (S.D. Ohio Oct. 2, 2015).  Under Bartlett, state-law design defect claims against all prescription drugs are preempted.
  29. In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108 (S.D. Cal. Nov. 9, 2015).  Because the FDA specifically considered pancreatic cancer risk, publicly confirmed the adequacy of the challenged labeling, and has maintained its position that scientific evidence of a causal association between the drugs in question and the risk is indeterminate, there is clear evidence under Levine that the FDA would have rejected the warnings that plaintiffs demand.  Timing does not suggest gaps in the FDA’s consideration.  Actual submission and FDA rejection of a warning are not required.  All warning claims are preempted.  Buckman preempts attempts at claiming misreporting and underreporting to the FDA.  What the FDA chooses to consider in its evaluation cannot be second-guessed by litigants.  Note:  Buckman aspects were reversed without the appellate court reaching the Levine grounds:  In re Incretin-Based Therapies Products Liability Litigation, 2017 WL 6030735 (9th Cir. Dec. 6, 2017).
  30. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. Dec. 11, 2015).  Impossibility preemption under Bartlett applies where the alleged defect would have been a “major” change under FDA regulations, requiring FDA preapproval.  “Pre-approval” design claims are too speculative, since they require another design to have been approved, to have been used, and to have prevented injury.  Prior FDA approval of would have been necessary in any event.  A claim that a defendant should never have started selling its FDA-approved drug is preempted for the same reasons that stop-selling claims were preempted in BartlettAffirming 76 F. Supp.3d 680.
  31. Small v. Amgen, 2016 WL 4942078, slip op. (M.D. Fla. Jan. 25, 2016).  Judgment on the pleadings denied for factual determination of whether the formulation of the defendant’s biologic was capable of being redesigned and thus preempted under Bartlett.  It is likely that under Yates even if the biologic is capable of redesign, that any claim that the defendants should have changed that design before seeking FDA approval would likewise be preempted.
  32. Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296 (D. Conn. March 10, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving OTC drug.  The change in composition that plaintiff claims is required would be a “major change” requiring FDA preapproval.  On appeal at No. 16-1288 (2d Cir.).
  33. Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203 (D. Utah March 16, 2016).  FDA rejection, after plaintiff’s alleged injury, of citizen’s petition alleging same injury, was clear evidence that FDA would not allow the label change plaintiff demanded.  Further, the FDA continued to approve similar products with the labeling plaintiff challenged.  Pregnancy X label involving different risk was irrelevant.  Nonsensical to argue that any possible label strengthening, even if irrelevant to plaintiff’s case, precludes preemption.  Affirmed in part and reversed in part, see 855 F.3d 1091 below.
  34. Barcal v. EMD Serono, Inc., 2016 WL 1086028 (N.D. Ala. March 21, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving branded drug.  The design of any FDA approved drug cannot be changed without prior FDA approval, rendering compliance with both state and federal law impossible.
  35. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761 (D.S.C. May 6, 2016).  Impossibility preemption barred all claims not based on new information not previously submitted to FDA because CBE label changes can only be based on newly acquired information.  Information solely related to efficacy, not safety, also cannot be changed by CBE.  All labeling, but not advertising, claims about this information are preempted, because advertising can be changed outside of the CBE process.
  36. Seufert v. Merck Sharp & Dohme Corp., 187 F. Supp. 3d 1163 (S.D. Cal. May 11, 2016).  Clear evidence that FDA would not allow a warning change was established by FDA article in medical journal that alleged causal effect of branded drug was not supported by scientific evidence, and additional FDA actions.  FDA need not reject specific warning language before there can be preemption.  Lack of final FDA conclusion does not prevent preemption.  Buckman does not provide a basis for discovery of fraud on the FDA evidence in clear evidence cases.
  37. Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826 (W.D. Tenn. June 6, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving innovator drug.  A claim of design defect before approval is too attenuated and speculative as it depends on what the FDA might have done under different facts.
  38. Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351 (N.D. Ga. July 11, 2016).  Design defect claims against an innovator drug that would force changes in the drug’s composition are preempted because prior FDA approval would be required.  Preemption includes claims involving the pre-approval design.  Those are equivalent to stop-selling claims.  Warning claims against entities that do not hold the drug’s NDA are preempted because such entities have no power to change drug labeling.
  39. Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016).  Warning claim against innovator drug preempted.  FDA rejection of label change regarding same risk for lack of sufficient scientific support occurring after plaintiff’s final treatment was clear evidence that warning change was impossible in plaintiff’s case.  Distributor has no power to change labeling, so warning claims against it are preempted under Mensing.
  40. Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (D. Utah Aug. 5, 2016).  Warning claim against innovator drug preempted.  FDA rejection of label change regarding same risk for lack of sufficient scientific support occurring after plaintiff’s final treatment was clear evidence that warning change was impossible in plaintiff’s case.
  41. DeBons v. Globus Medical, Inc., 668 F. Appx. 258 (9th Cir. Aug. 16, 2016).  Preemption of all plaintiffs’ claims but one under Buckman affirmed (see, above for district court decision).  Private litigants cannot sue to enforce the FDCA.  Only a contract claim based on an alleged express representation that the product was FDA approved could survive preemption, but that claim was inadequately pleaded.
  42. Estes v. Lanx, Inc., 660 F. Appx. 260 (5th Cir. Aug. 16, 2016).  Fraudulent concealment claim based on manner in which the defendant submitted its 510(k) notifications to the FDA was preempted under Buckman.  Claims attacking the FDA clearance of a medical device are disguised FDCA enforcement.
  43. Elliott v. Sandoz, Inc., 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016).  Buckman preempts claims that the defendant failed to warn by not maintaining an adequate supply of FDA-mandated medication guides for distribution by others directly to patients.  The claims is private enforcement of the FDCA, since otherwise there is no duty to distribute medication guides.  On appeal at No. 16-16519 (11th Cir.).
  44. In re Zoloft Litigation, 2016 WL 4529213, slip op. (W. Va. Cir. Aug. 30, 2016).  Fraud on the FDA provision of Michigan product liability statute is preempted by Buckman.  Desiano is unpersuasive.
  45. In re: Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016).  Warning claims against a pharmacy dispensing a branded drug are preempted under Mensing/Bartlett because pharmacies, like drug distributors, cannot change FDA-approved warnings.
  46. In re Lipitor (Atorvastatin Calcium) Marketing Sales Practices & Products Liability Litigation, 2016 WL 7335738 (D.S.C. Nov. 7, 2016).  Warning claims against a distributor of a branded drug are clearly preempted under Mensing/Bartlett because drug distributors cannot change FDA-approved warnings.  Other claims involving the distributor’s own advertising, may not be preempted.
  47. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7644792 (D.S.C. Nov. 28, 2016).  Warning claims against a distributor of a branded drug are clearly preempted under Mensing/Bartlett because drug distributors cannot change FDA-approved warnings.  Other claims involving the distributor’s own advertising, may not be preempted.
  48. Utts v. Bristol-Myers Squibb Co., 226 F. Supp.3d 166 (S.D.N.Y. Dec. 23, 2016).  Warning and design claims against branded drug manufacturer preempted.  At the time of FDA approval, a manufacturer cannot change its design or label.  Thereafter it can unilaterally change labels if meeting CBE requirements.  Warning claims attacking warnings as first marketed are preempted.  Warning claims attacking clinical trial results submitted to the FDA do not involve new information subject to CBE and are preempted.  Pre-approval design claim preempted as speculative, and as a stop-selling claim.  Design claims cannot posit counterfactual FDA conduct.  Claims premised on failure to provide data to the FDA are preempted.
  49. McDaniel v. Upsher-Smith Pharmaceuticals, Inc., 229 F. Supp.3d 707 (W.D. Tenn. Jan. 26, 2017).  Failure to warn claims involving:  (1)  alleged failure to supply a medication guide to the plaintiff, and (2) off-label promotion are barred by Buckman as private attempts to enforce the FDCA.  On appeal at No. 17-5741 (6th Cir.).
  50. Rheinfrank v. Abbott Laboratories, Inc., 680 F. Appx. 369 (6th Cir. Feb. 21, 2017).  Two FDA rejections, for lack of sufficient supporting data, of the defendant’s attempts to strengthen its label with respect to the risk in question after to the plaintiff’s use of the drug established clear evidence that that the FDA would have rejected an attempt to change the label unilaterally by CBE.  Since the FDA considered the data insufficient in 2008, it would also have rejected a similar warning in 2003, with even less data available.  A formal procedure for considering the label change was not necessary – that would change clear evidence test from “would have” rejected to “did” reject.  Arguments based on asserted failure to conduct research were too speculative to defeat preemption.
  51. Risperdal & Invega Product Liability Cases, 2017 WL 4100102 (Cal. Super. March 16, 2017).  Preemption is a legal question.  CBE changes require “newly acquired evidence,” and cannot be based on evidence the FDA has already reviewed.  Denial of citizen’s petition is evidence of clear evidence the FDA would not allow label change.  Reconsideration denied, 2017 WL 4479317 (Cal. Super. July 24, 2017).
  52. Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. C.P. March 23, 2017).  Preliminary objections sustained. A cause of action for off-label promotion cannot exist in the absence of the FDCA.  It is not a state law cause of action, but only a private attempt to enforce the FDCA barred by BuckmanAffirmed, 2018 WL 2750560, below.
  53. Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. March 31, 2017).  Design defect claims against branded drugs are preempted by Bartlett.  Bartlett is not limited to generic drugs, and its preemption holding applies to all prescription drugs.
  54. Amos v. Biogen Idec, Inc., 249 F. Supp.3d 690 (W.D.N.Y. April 10, 2017).  Warning defect claims are preempted, both under Mensing/Bartlett and Levine “clear evidence.”  Only the FDA can order a change to a black box warning.  The FDA believed until after plaintiff’s injury that there was insufficient scientific evidence to justify the other warning plaintiff advocated.  Two “smoking gun” FDA rejections establish clear evidence.  Warning claims against a distributor that does not hold the New Drug Application for a drug are preempted, since such entities have no power to change labels under the FDCA.
  55. Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. May 2, 2017).  FDA denial of citizen’s petition for lack of evidence of the same risk of which plaintiff complains was clear evidence as a matter of law as to that risk.  FDA denial of citizen’s petitions applies the same scientific standard used for manufacturer submissions.  Denial of one is clear evidence as to the other.  We will not presume that the FDA violates its own regulations to treat citizen’s petitions more harshly.  Risk of taking the drug during pregnancy, which plaintiff did not do, is not preempted since the FDA proposed a different warning.  Whether state law bars warning claims based on risks the plaintiff did not encounter was waived.  Preemption of fraud, misrepresentation, and warranty claims must be considered independently on remand.  Affirming in part and reversing in part 155 F. Supp.3d 1203, above.
  56. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. May 8, 2017). All warning claims preempted where none of the information plaintiff relied upon was “newly acquired” so that the CBE exception to FDA warning pre-approval would apply.  Information is “newly acquired” when it was not submitted to the FDA during the approval process and revealed reveal risks the are of a “different type or greater severity or frequency” than information the FDA already had.  Federal law preempts all pre-FDA approval failure to warn and design defect claims for branded prescription medication.  Post-approval warning claims are preempted under Mensing/Bartlett if they require FDA pre-approval.  Defendant not required to give warning precluded by FDA.  Speculation is not newly acquired information.  Evidence consistent with existing labeling cannot be newly acquired information.  Whether information is “newly acquired” is a legal question amenable to a motion to dismiss.  Without any newly acquired information, plaintiffs never get to Levine‘s clear evidence standard.  Addition of a boxed warning would require FDA pre-approval.  Warranty claims that attack a manufacturer’s right to advertise an FDA approved drug are preempted.  An alleged breach of warranty that a drug is safe for its indicated use seeks to challenge the FDA’s decision to that effect and is preempted.  Fraud claims implicating disclosures to the FDA are preempted by Buckman.
  57. Trejo v. Johnson & Johnson, 13 Cal. App.5th 110, 220 Cal. Rptr.3d 127 (Cal. App. June 30, 2017).  OTC drug design defect and negligent design claims preempted under Bartlett.  Claims that the defendant should have sold a different compound than what the FDA approved are preempted.  The savings clause in §379r does not apply to implied preemption.  Plaintiff’s alternative design would have required FDA pre-approval to execute.  All stop selling claims are preempted.  Review denied (Cal. Oct. 11, 2017).
  58. In re Risperdal & Invega Product Liability Cases, 2017 WL 4479317 (Cal. Super. July 24, 2017).  Denying reconsideration of  2017 WL 4100102, above.  Fosamax was wrongly decided.  Preemption is a question of law for the court to decide.
  59. Fortner v. Bristol-Myers Squibb Co., 2017 WL 3193928 (S.D.N.Y. July 26, 2017).  Design and warning defect claims dismissed as preempted under Utts decisions.  Cannot avoid Utts by failing to plead the information examined in that case.  The absence of information only underscores lack of any newly acquired evidence that would allow resort to CBE exception.  Consumer protection claims preempted as involving same information as warning claims.  Appeal pending, No. 17-2689 (2d Cir.).
  60. Warren v. Boehringer Ingleheim Pharmaceuticals Inc., 2017 WL 3970666 (S.D. Ind. Sept. 8, 2017).  Mensing/Bartlett preemption is not limited to generic drugs.  Not every design defect claim necessarily involves a change that requires FDA pre-approval.  Preemption precludes any non-holder of the relevant new drug application from being liable for defects that it lacks the power to change.
  61. Cleary v. Biogen Inc., 2017 WL 4126240, slip op. (Mass. Super. Sept. 13, 2017).   Warning claim against innovator drug preempted.  FDA rejection of label change regarding same risk for lack of sufficient scientific support occurring after plaintiff’s final treatment was clear evidence that warning change was impossible in plaintiff’s case.  Distributor has no power to change labeling, so warning claims against it are preempted under Mensing.
  62. Markland v. Insys Therapeutics, Inc., 270 F. Supp.3d 1318 (M.D. Fla. Sept. 15, 2017).  Negligent marketing claim asserting off-label promotion preempted under Buckman as private FDCA enforcement.  Off-label preemption is a federal concept, and is a critical element of the claim.  No equivalent state-law cause of action exists.  Affirmed 2018 WL 6666385, below.
  63. Gustavsen v. Alcon Laboratories, Inc., 272 F. Supp.3d 241 (D. Mass. Sept. 29, 2017).  Consumer fraud Class action dismissed because changing dosage of eye drops would be a major change requiring FDA pre-approval.  Pre-approval design claim preempted as never start selling theory.  That defendants could have submitted different designs to FDA is irrelevant.  Affirmed 903 F.3d 1 below.
  64. Swanson v. Abbott Laboratories, 2017 WL 5903362 (S.D. Ohio Nov. 28, 2017).  Summary judgment granted on preemption.  The FDA’s four rejections of subsequent attempts to strength the drug label in the manner plaintiff sought, for reasons of inadequate supporting data, constituted clear evidence that the FDA would not have approved that change to the label at an even earlier time.  Defendant does not have a First Amendment right to add warnings rejected by the FDA.  Appeal pending No. 17-4311 (6th Cir.)
  65. Willis v. Abbott Laboratories, 2017 WL 5988215 (W.D. Ky. Dec. 1, 2017).  Partial summary judgment granted on preemption.  FDA rejection of proposed label changes are clear evidence supporting preemption.  Fraud and misrepresentation preempted to same extent as warnings.  Defendant does not have a First Amendment right to add warnings rejected by the FDA.  No question of fact for jury on this record.  Arguments based on asserted failure to conduct research were too speculative to defeat preemption.  Design defect claim preempted as requiring prior FDA review.  Contraindications to not implicate alternative design.
  66. Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630, slip op. (D. Neb. Dec. 12, 2017).  Motion to dismiss granted.  Plaintiff failed to plead that any information relevant to her warning claim was “newly acquired” after the product’s approval, so that it would qualify for the CBE exception to preemption.
  67. Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 849081 (M.D. Ga. Jan. 2, 2018).  Summary judgment granted against warning and design claims involving a dosage of the drug that the FDA refused to approve on several occasions.  A design defect claim that the drug should not have been sold until an antidote was also FDA approved is preempted as a stop-selling claim.
  68. In re Bard IVC Filters Products Liability Litigation, 2018 WL 1256768 (D. Ariz. March 12, 2018).  Yes, it’s really a 510(k) device case, but it’s very good on holding that FDCA-based negligence per se is preempted under Buckman as private FDCA enforcement.
  69. McGee v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 1399237 (N.D. Ala. March 20, 2018).  Allegations of pre-approval failure to communicate risk information to the FDA are fraud on the FDA claims preempted by Buckman.  As to post-approval claims, plaintiff failed to plead any newly acquired evidence that would bring the CBE exception into play, so that claim is dismissed without prejudice.
  70. Nelson v. Biogen Idec, Inc., 2018 WL 1960441 (D.N.J. April 26, 2018).  Summary judgment granted.  Warning defect claims are preempted by “clear evidence” satisfying Levine standard, even after Fosamax.  The FDA believed until after plaintiff’s injury that there was insufficient scientific evidence to justify the other warning plaintiff advocated.  Warning claims against a distributor that does not hold the New Drug Application for a drug are preempted, since such entities have no power to change labels under the FDCA.
  71. Patton v. Forest Laboratories, LLC, 2018 WL 5270476 (C.D. Cal. May 10, 2018).  Partial motion to dismiss granted.  Any claim that the warnings in a drug’s “highlights” section is preempted.  FDA regulations do not permit changes to highlights without prior FDA approval, requiring preemption.
  72. Caltagirone v. Cephalon, Inc., 190 A.3d 596 (Pa. Super. June 8, 2018).  Grant of preliminary objections affirmed.  All claims for negligence, misrepresentation, fraud, and consumer protection violations were explicitly premised on violation or disregard of the FDCA and FDA regulations, which cannot be privately enforced.  All claims preempted under Buckman.
  73. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. Aug. 22, 2018).  Denial of summary judgment reversed.  Warning claims were preempted as a matter of law.  Clear evidence, in the form of four prior FDA rejections of the same proposed warning, existed.  FDA rejection not based on position in label.  Preemption cannot be defeated by a claim that the defendant should have met further with the FDA.  That is a “take steps” argument barred by Mensing.   Between the FDA’s last rejection and plaintiff’s use of the drug, no newly acquired information existed to prevent preemption.  The FDA was aware of claimed shortcomings in submitted data.
  74. Plavix Products Liability Litigation, 2018 WL 4005859 (N.Y. Sup. Aug. 22, 2018).  Summary judgment granted.  No evidence that plaintiffs’ warning claims involve any newly acquired evidence.  Expert “design” opinion that drug’s risks outweigh its benefits and that it should not be sold preempted as a “stop selling” claim.
  75. Robinson v. Eli Lilly & Co., 2018 WL 4039703 (E.D. Ky. Aug. 23, 2018).  Motion to dismiss granted in part.  While preemption did not preclude a warning claim against a branded drug, design defect claims were preempted because it would be impossible to change the drug’s design without prior FDA approval.  Allegations of pre-approval design defect were also preempted.
  76. Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. Aug. 27, 2018).  Grant of motion to dismiss affirmed.  Alternation of drug dosage is a “major change” requiring prior FDA approval.  Impossibility preemption bars demands for changes that require prior FDA approval.  All changes described in 21 C.F.R. §314.70(b)(2)(i-viii) are “major” changes.   Affirming 272 F.Supp.3d 241, above.
  77. Patton v. Forest Laboratories, Inc., 2018 WL 5269239 (C.D. Cal. Sept. 19, 2018).  Motion to dismiss granted.  Plaintiff failed to plead any newly acquired evidence that would support an unpreempted claim seeking a label change.
  78. Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111 (N.D.N.Y. Sept. 21, 2018).  Motion for judgment as a matter of law granted.  Plaintiff’s claim that the defendant should have changed its warnings about an off-label use is preempted because prior FDA approval is required before such warnings can be added or changed.  Clear evidence is also present, since the FDA previously rejected warnings about pediatric use as promotional.  Nor was the risk of gynecomastia new information that would have supported a CBE-based label change.  Plaintiff’s expert’s opinion that unilateral off-label warning changes were allowed was ipse dixit and contrary to the plain language of the FDA’s regulations.  CBE-based unilateral warnings must also involve a “serious” hazard, which was not the FDA’s assessment of gynecomastia.  Serious risks, at the time in question, required either hospitalization or surgery to avoid hospitalization.  Preemption is decided as a matter of law.  Fraud on the FDA arguments are preempted.
  79. Markland v. Insys Therapeutics, Inc., ___ Fed. Appx. ___, 2018 WL 6666385 (11th Cir. Dec. 19, 2018).  Negligent marketing claim based on allegations of illegal off-label promotion is preempted under Buckman as an improper private attempt to enforce the FDCA.  Without the FDCA, there could be no such thing as off-label promotion.  Affirming 270 F. Supp.3d 1318, above.
  80. Marroquin v. Pfizer, Inc., 2019 WL 636845 (E.D. Cal. Feb. 14, 2019).  Motion to dismiss granted as to all claims.  Preemption extends to drug distributors, whether branded or generic.  The risk of confusion or being misled by differing labels would be even greater if a mere distributor could add additional warnings that it deems necessary or advisable.
  81. Maze v. Bayer Healthcare Pharmaceuticals Inc., 2019 WL 1062387 (E.D. Tenn. Mar. 6, 2019).  Motion to dismiss granted as to all claims.  Preemption of warning claims after Levine requires some allegation of “new” information existing after a drug’s initial FDA approval.  Information available to FDA at the time of approval cannot defeat preemption.  Where the defendant in fact warned of the risk at issue, plaintiff must allege some new information that could render the existing warning both inadequate under state law and falling within the CBE regulation to permit an immediate label change under federal law.  Plaintiff’s complaint contains no such allegations and is therefore preempted.

In the last month, we’ve seen two more appellate decisions definitively rejecting the idea of some sort of separate cause of action – apart from warning or design defect – for “failure to test,” whatever that might be.  In the drug area, as we reported before, the Pennsylvania Superior Court thoroughly killed the concept in Lance v. Wyeth:

[Plaintiff] also maintains that her alleged her causes of action, including her claims for “unreasonable marketing” and “negligent failure to withdraw,” are sustainable because they are akin to a failure to inspect and/or test claim.  Citing Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 140-41 (3d. Cir.1973), [plaintiff] argues that a failure to test claim is valid cause of action. We disagree.

In Hoffman, the United States Court of Appeals for the Third Circuit applied Pennsylvania law and concluded that there was sufficient evidence for the jury to find that the manufacturer failed to adequately test its drug to discover potentially harmful side-effects.  485 F.2d at 140-41.  Regardless of the Hoffman decision, which is not binding upon this Court, Pennsylvania law has not recognized an independent tort for negligent failure to test.  In fact, we have held that “the claim for ‘negligent failure to test’ is not a viable cause of action recognized by our courts[.]” Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005).

If there is a duty to test and/or inspect in Pennsylvania, it does not exist as an independent cause of action, but rather, is subsumed within [plaintiff’s] other claims. . . . Therefore, even if there is a general duty to inspect and/or test under Pennsylvania law, it would be subsumed within [plaintiff’s] design defect claims and/or any potential failure to warn claim that [plaintiff] may have had. Because failure to test is not an independent cause of action in Pennsylvania, [plaintiff’s] arguments to the contrary fail.

2010 WL 2991597, at *7-8 (Pa. Super Aug. 2, 2010) (some citations omitted).

Then along comes the South Carolina Supreme Court, and (as we also mentioned before) it does a number on the purported duty to test in Branham v. Ford Motor Co.:

In addition, [defendant] asserts there is no separate “failure to test claim” apart from the duty to design and manufacture a product that is not defective and unreasonably dangerous. We agree, for if a product is not in a defective condition unreasonably dangerous to the user, an alleged failure to test cannot be the proximate cause of an injury. The failure to establish that the seatbelt sleeve was in a defective condition unreasonably dangerous to the user for purposes of the strict liability claim requires the dismissal of the companion negligence claim.

2010 WL 3219499, at *2 (S.C. Aug. 16, 2010).

Inspired by these two recent decisions – one in our pharma sandbox, and the other a more general product liability case – we’ve decided to make the non-existent duty to test the subject for our latest cheat sheet.  So that’s what the rest of this post is, a list of all the cases we could find where the misbegotten idea of some separate and independent duty to test has been rejected by a court.  No half-measures here.  To get on this list the court has to hold that there is no separate duty to test apart from well-established product liability claims for warning, design, or (maybe) manufacturing defect.

Continue Reading Duty To Test Cheat Sheet

We love being the bearers of glad tidings, especially when those glad tidings are cases rejecting the whacky theory espoused by Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) — i.e., that a brand-name manufacturer is possibly liable even where the manufacturer did not make the (generic) version of the product that allegedly injured the plaintiff. In fact, we hate Conte so much that we have a scorecard devoted to it. And now, we are happy to report that the scales have tipped even further against Conte.

We can’t provide detailed commentary because of our firm’s involvement in the Reglan/metoclopramide litigation, but two more recent cases have rejected the Conte “innovator liability” theory. In Craig v. Pfizer, Inc., 2010 U.S. Dist. LEXIS 64487 (W.D. La. May 26, 2010), and Mosley v. Wyeth, Inc., ___ F. Supp.2d ___, 2010 WL 2594000 (S.D. Ala. June 28, 2010), the courts rejected a host of warranty, fraud, and statutory claims brought against brand-name manufacturers of Reglan/metoclopramide. We’ve updated the scorecard to add these cases to the anti-Conte arsenal.

Last week we gave you our federal class action denial cheat sheet. This week we’re posting a similar list of class action denials from state courts.  It took some work, but we’ve been able to dig up certification denials from eleven different states.  If you’ve got others, send them along.

With the Class Action Fairness Act moving most class action litigation to federal court, there may not be very many new entries on this list.

As with the federal cases, we’ve only included decisions that deny certification of everything.  No split decisions on this list.

  1. Rosenfeld v. A.H. Robins Co., 407 N.Y.S.2d 196 (N.Y.A.D. July 3, 1978) (Dalkon Shield – personal injury).  Denial of statewide class certification affirmed.  No predominance due to plaintiff-specific variations.
  2. Morrissy v. Eli Lilly & Co., 394 N.E.2d 1369 (Ill. App. Sept. 18, 1979) (DES – increased risk of injury).  Denial of statewide class certification affirmed.  No predominance due to plaintiff-specific variations.
  3. Rose v. Medtronics, Inc., 166 Cal. Rptr. 16 (Cal. App. June 19, 1980) (pacemaker – personal injury).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations and differences in state law.
  4. Arthur v. Zearley, 895 S.W.2d 928 (Ark. April 10, 1995) (Orthoblock – personal injury).  Certification of single hospital class reversed.  No superiority due to plaintiff-specific variations.
  5. McCaster v. Becton Dickinson & Co., 1999 WL 34842201 (Ill. Cir. Jan. 11, 1999) (needles – personal injury).  Statewide class certification denied.  No predominance due to multiple products and plaintiff-specific variations, particularly affirmative defenses.
  6. Baker v. Wyeth-Ayerst Laboratories, 992 S.W.2d 797 (Ark. June 24, 1999) (fen-phen – personal injury, medical monitoring).  Denial of statewide class certification affirmed.  No predominance due to plaintiff-specific variations.  No issue certification.
  7. Becton Dickinson & Co. v. Usrey, 57 S.W.3d 488 (Tex. App. Aug. 16, 2001) (needles – economic loss).  Statewide class certification reversed.  No predominance due to plaintiff-specific variations.
  8. In re PPA Cases, 2002 WL 35071721, slip op. (Cal. Super. Aug. 23, 2002) (PPA  – economic loss).  Statewide class certification denied.  No substantial benefit since defendant voluntarily removed product from market and provided refunds.  Not ascertainable due to lack of purchase records.  No community of interest or typicality due to individualized damages and causation.  No adequacy due to abandonment of claims held by class members.
  9. Grant v. Becton Dickinson & Co., 2003 WL 21267787 (Ohio App. June 3, 2003) (needles – personal injury).  Statewide class certification reversed.  No commonality and typicality due to multiple products.  No predominance due to plaintiff-specific variations.  Class certification was reversed again on substantially the same grounds in Grant v. Becton Dickinson & Co., 2006 WL 2808164 (Ohio App. Sept. 21, 2006).
  10. Barnes v. Muscletech Research & Development, Inc., 2004 WL 5140060 (Fla. Cir. Nov. 12, 2004) (steroids – economic loss/consumer fraud).  Statewide class certification denied.  No commonality typicality, and adequacy due to conflicting theories.  No predominance, manageability, and superiority due to plaintiff-specific variations.
  11. Howland v. Purdue Pharma L.P., 821 N.E.2d 141 (Ohio Dec. 15, 2004) (Oxycontin – personal injury).  Certification of statewide class reversed.  No commonality or predominance due to plaintiff-specific variations, particularly learned intermediary.
  12. Johnson v. Abbott Laboratories, 2004 WL 3245947 (Ind. Cir. Dec. 31, 2004) (Oxycontin – personal injury).  Statewide class certification denied.  No proper class definition and no numerosity due to plaintiff-specific variations.  No commonality typicality, and predominance due to plaintiff-specific variations, particularly learned intermediary.  No adequacy.  No superiority.  No medical monitoring injunctive class due to monetary damages.
  13. Hurtado v. Purdue Pharma Co., 2005 WL 192351 (N.Y. Sup. Jan. 24, 2005) (unpublished, in table at 800 N.Y.S.2d 347) (Oxycontin – personal injury).  Statewide class certification reversed.  No commonality due to plaintiff-specific variations.  No typicality.
  14. Albertson v. Wyeth, Inc., 2005 WL 3782970 (Pa. C.P. May 3, 2005) (hormone replacement therapy – medical monitoring).  Statewide class certification denied.  No commonality and typicality due to plaintiff-specific variations, particularly causation.
  15. Johnson v. Ethicon, Inc., 2005 WL 3968820 (W. Va. Cir. May 17, 2005) (suture – personal injury).  Statewide class action decertified.  No proper class definition, no numerosity due to plaintiff-specific variations.  No commonality, typicality, adequacy, and predominance due to conflicting theories and plaintiff-specific variations, particularly causation.  No superiority.  No punitive damages class.
  16. Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla. App. Feb. 15, 2006) (hormone replacement therapy – medical monitoring).  Certification of statewide class reversed.  No commonality, typicality, and adequacy due to conflicting theories and plaintiff-specific variations.
  17. Arons v. Rite-Aid, 2005 WL 975462 (N.J. Super. Law Div. March 23, 2005) (counterfeit Lipitor – economic loss).  Nationwide class action denied.  No commonality and predominance due to plaintiff-specific variations.  No superiority due to multiple state laws.
  18. Dimich v. Med-Pro, Inc., 826 N.Y.S.2d 3 (N.Y.A.D. Nov 16, 2006) (counterfeit Lipitor – economic loss).  Denial of nationwide and statewide class certification affirmed.  No predominance due to plaintiff-specific variations.  Affirming: Dimich v. Med-Pro Inc., 2005 WL 5960153 (N.Y..Sup. Nov. 18, 2005), reargument denied, 2005 WL 6062132 (N.Y. Sup. Nov. 18, 2005).
  19. International Union of Operating Engineers Local No. 68 Welfare Fund v. Merck & Co., 929 A.2d 1076 (N.J. Sept. 6, 2007) (Vioxx – economic loss/consumer fraud).  Certification of nationwide class reversed.  No predominance due to plaintiff-specific variations, particularly causation.  No fraud on the market.  No superiority.
  20. Williams v . Nidek Co., 2009 WL 226024 (Cal. App. Feb. 2, 2009) (unpublished) (laser – economic loss).  Denial of certification of nationwide and state-wide classes affirmed.  No predominance due to plaintiff-specific variations.
  21. Kleinman v. Merck & Co., 2009 WL 699939 (N.J. Super. Law Div. March 17, 2009) (Vioxx – economic loss/consumer fraud).  Nationwide class certification denied.  No predominance and typicality due to plaintiff-specific variations, particularly causation.  No superiority.  Reconsideration denied, Kleinman v. Merck & Co., 2009 WL 2481925 (N.J. Super. Law Div. Aug. 13, 2009).
  22. In re Vioxx Class Cases, 103 Cal. Rptr.3d 83 (Cal. App. December 15, 2009) (Vioxx – economic loss/consumer fraud).  Denial of statewide class certification affirmed.  No typicality or predominance due to plaintiff-specific variations, particularly causation, materiality, and existence of injury.
  23. Clark v. Pfizer Inc., 990 A.2d 17 (Pa. Super. Jan 19, 2010) (Neurontin – economic loss).  Decertification of statewide class affirmed.  No commonality and typicality due to plaintiff-specific variations, particularly reliance and causation.  No fraud on the market.  Affirming, Clark v. Pfizer Inc., 2009 WL 1725953 (Pa. C.P. April 20, 2009).
  24. Judy v. Pfizer, Inc., 2010 WL 3001745, slip op. (Mo. Cir. St. Louis Co. July 27, 2010) (Neurontin – economic loss/consumer fraud).  Statewide class certification denied.  No proper class definition, and typicality, predominance, and superiority due to plaintiff-specific variations.
  25. Weiss v. Astrazeneca Pharmaceuticals, 2010 WL 3387220 (Cal. App. Aug. 30, 2010) (Nexium – economic loss/consumer fraud). Denial of statewide class certification affirmed.  No typicality or predominance due to plaintiff-specific variations, particularly causation, deception, materiality, and existence of injury.
  26. Merck & Co. v. Ratliff,  2012 WL 413522 (Ky. App. Feb. 10, 2012) (Vioxx – economic loss/consumer fraud).  Statewide class certification reversed as abuse of discretion.  No predominance due to plaintiff-specific variations, particularly causation, reliance and damages.  No fraud on the market.  The inequitable conduct element of unjust enrichment would require an individualized determination of risk/benefit for every user of the drug.  Note:  This decision was accepted for review by the Kentucky Supreme court and settled, so it no longer appears in Westlaw.
  27. Federman v. Qualitest, BC471059, slip op. (Cal. Super. L.A. Co. ??? 2012) (oral contraceptive – economic loss).  Statewide class certification denied.  Overly broad recalls should not be punished by class actions.  No numerosity due to lack of evidence of any significant number of actually defective products.  No commonality or typicality due to the plaintiff’s peculiar circumstances.

Almost from the day this blog was founded, we’ve been arguing that class actions have no place in prescription medical product liability litigation. We’ve put up several posts containing lists of cases to that effect – but none of them were complete (or purported to be).

One of the things that we’ve often thought about doing someday was putting together a truly comprehensive list of all the decisions denying class certification in prescription medical product liability litigation.  Well, today’s that day, at least as far as federal class action litigation (more important since the passage of the Class Action Fairness Act) is concerned.  This cheat sheet assembles all the failed Rule 23 class actions – and there’s a lot of them – in product liability actions involving prescription drugs, medical devices, and similar products.

This list only includes cases that deny class certification across the board.  We’re not including any opinions that deny even 90% of the claims sought to be certified, if they actually allow certification of any class action.  We’re picky that way.

For reasons we’ve discussed, we don’t expect plaintiffs’ repeated failure to succeed with these sorts of class actions to make them go away, given the (we think erroneous) effect that even bogus class actions can have on the statute of limitations in some jurisdictions.  Given that incentive, plaintiffs will keep trying and failing – and we’ll be updating this cheat sheet as needed.

  1. Ryan v. Eli Lilly & Co., 84 F.R.D. 230 (D.S.C. July 10, 1979) (DES – increased risk of injury).  Statewide class certification denied.  No predominance due to plaintiff-specific variations.
  2. McElhaney v. Eli Lilly & Co., 93 F.R.D. 875 (D.S.D. April 8, 1982) (DES – increased risk of injury).  Statewide class certification denied.  No properly defined class.  No typicality and predominance due to plaintiff-specific variations.  No adequacy.
  3. In Re Northern District of California, Dalkon Shield IUD Products Liability Litigation, 693 F.2d 847 (9th Cir. June 18, 1982) (Dalkon Shield – personal injury).  Nationwide punitive damages class certification reversed on mandamus.  Statewide class certification reversed on mandamus.  Limited fund certification rejected.  No typicality.  No predominance due to plaintiff-specific variations.  No superiority.
  4. Thompson v. Procter & Gamble Co., 1982 WL 114 (N.D. Cal. Dec. 8, 1982) (tampon – personal injury, increased risk of injury).  Nationwide class certification denied.  Mandatory class improper due to state law variations.  No predominance due to plaintiff-specific variations.
  5. Mertens v. Abbott Laboratories, 99 F.R.D. 38 (D.N.H. July 27, 1983) (DES – personal injury). Statewide class certification denied.  Mandatory class improper due to plaintiff-specific variations.  No predominance due to plaintiff-specific variations.  No superiority.
  6. Payton v. Abbott Laboratories, 100 F.R.D. 336 (D. Mass. July 30, 1983) (DES – increased risk of injury).  Statewide class decertified.  No predominance due to plaintiff-specific variations.  No superiority and manageability.
  7. In re Bendectin Products Liability Litigation, 749 F.2d 300 (6th Cir. Oct. 26, 1984) (Bendectin – personal injury).  Nationwide settlement class certification reversed on mandamus.  Limited fund certification rejected.
  8. Linkous v. Medtronic, Inc., 1985 WL 2602 (E.D. Pa. Sept. 4, 1985) (pacemaker – personal injury, medical monitoring, increased risk of injury).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations.  No superiority.  No issue certification as to punitive damages.
  9. In re Tetracycline Cases, 107 F.R.D. 719 (W.D. Mo. Oct. 1, 1985) (Tetracycline – personal injury).  Statewide class certification denied.  No issue certification due to lack of superiority and plaintiff-specific variations.
  10. Rall v. Medtronic, Inc., 1986 WL 22271 (D. Nev. Oct. 15, 1986) (pacemaker – personal injury, emotional distress from increased risk).  Nationwide class certification denied.  No commonality due to multiple products and plaintiff-specific variations.  No typicality due to plaintiff-specific variations.
  11. Raye v. Medtronic Corp., 696 F. Supp. 1273 (D. Minn. Oct. 19, 1988) (pacemaker – personal injury).  Nationwide class certification denied.  No predominance due to multiple state laws and plaintiff-specific variations.
  12. Mehornay v. Pfizer Inc., 1991 WL 540731 (C.D. Cal. June 3, 1991) (heart valve prosthesis – emotional distress from increased risk).  Nationwide class certification denied.  No typicality due to plaintiff-specific variations.  No predominance due to plaintiff-specific variations.  No superiority.
  13. Pasternak v. Upjohn Co., 1994 WL 16495152 (E.D.N.Y. Sept. 19, 1994) (Halcion – personal injury, emotional distress, economic loss).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations.  No typicality.
  14. In re Orthopedic Bone Screw Products Liability Litigation, 1995 WL 273597 (E.D. Pa. Feb. 22, 1995) (pedicle screws – personal injury, medical monitoring).  Nationwide class certification denied.  Limited fund certification rejected.  No predominance due to plaintiff-specific variations.
  15. Kurczi v. Eli Lilly & Co., 160 F.R.D. 667 (N.D. Ohio Feb. 27, 1995) (DES – personal injury).  Statewide class certification denied.  No commonality due to multiple defendants, multiple state laws, and plaintiff-specific variations.  No typicality.  No adequacy due to conflicts of interest.  No predominance due to plaintiff-specific variations.  No superiority.
  16. In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293 (7th Cir. March 16, 1995) (blood products – personal injury).  Nationwide class certification reversed on mandamus.  No manageability due to multiple state laws.  No issue certification due to Seventh Amendment jury trial right.
  17. Martin v. American Medical Systems, 1995 WL 680630 (S.D. Ind. Oct. 25, 1995) (penile implant – personal injury).  Nationwide class certification denied.  No typicality and adequacy due to plaintiff-specific variations, particularly varied injuries. No predominance due to plaintiff-specific variations.  No superiority.
  18. In re American Medical Systems, Inc., 75 F.3d 1069 (6th Cir. Feb. 15, 1996) (penile prosthesis – personal injury).  Nationwide class certification reversed on mandamus.  No commonality and predominance due to plaintiff-specific variations.  No typicality and adequacy.
  19. Harding v. Tambrands Inc., 165 F.R.D. 623 (D. Kan. March 15, 1996) (tampon – personal injury).  Nationwide class certification denied.  No predominance due to multiple products and multiple state laws.  No superiority.  No manageability due to multiple state laws.  No issue certification.  Reargument denied, Hayes v. Playtex Family Products Corp., 168 F.R.D. 292 (D. Kan. 1996).
  20. In re Norplant Contraceptive Products Liability Litigation, 168 F.R.D. 577 (E.D. Tex. Aug.. 5, 1996) (Norplant – personal injury).  Nationwide class certification denied.  No predominance and superiority due to immature tort.
  21. Valentino v. Carter-Wallace, Inc., 97 F.3d 1227 (9th Cir. Oct 7, 1996) (Felbatol – personal injury, increased risk of injury).  Nationwide settlement class certification reversed.  Inadequate consideration of predominance and superiority issues.
  22. Haley v. Medtronic, Inc., 169 F.R.D. 643 (C.D. Cal. Dec 12, 1996) (pacemaker lead – personal injury, fraud, medical monitoring).  Nationwide class certification denied.  No manageability due to multiple state laws, large number of plaintiffs, and plaintiff-specific variations.  No issue certification due to multiple state laws.  No medical monitoring injunctive class due to monetary damages.
  23. Kemp v. Medtronic Inc., 1998 WL 35161989 (S.D. Ohio Feb. 11, 1998) (pacemaker lead – personal injury).  Statewide class certification denied.  No predominance and superiority due to plaintiff-specific variations.  No manageability.
  24. Fisher v. Bristol-Myers Squibb Co., 181 F.R.D. 365 (N.D. Ill. May 28, 1998) (Stadol – personal injury, consumer fraud).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly causation.  No manageability due to multiple state laws.  No superiority.
  25. Woodell v. Proctor & Gamble Manufacturing Co., 1998 WL 686767 (N.D. Tex. Sept. 29, 1998) (Aleve – injunctive relief, personal injury).  Nationwide and statewide class certification denied.  Injunctive relief does not predominate.  No superiority due to plaintiff-specific variations.
  26. Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520 (N.D. Ill. Nov 18, 1998) (Stadol – personal injury, medical monitoring, consumer fraud/economic loss).  Nationwide class certification denied; addiction subclass denied.  No medical monitoring injunctive class due to monetary damages.  No predominance due to plaintiff-specific variations, particularly learned intermediary.  No manageability due to multiple state laws.
  27. Rosmer v. Pfizer, Inc., 2001 WL 34010613 (D.S.C. Mar 30, 2001) (Trovan – medical monitoring).  Nationwide class certification denied.  No adequacy due to South Carolina’s rejection of medical monitoring.
  28. Zinser v. Accufix Research Institute, Inc., 253 F.3d 1180 (9th Cir. June 15, 2001), amended, 273 F.3d 1266 (9th Cir. 2001) (pacemaker lead – personal injury, medical monitoring).  Denial of nationwide class certification affirmed.  No predominance due to multiple state laws and plaintiff-specific variations.  No superiority.  No manageability due to plaintiff-specific variations.  No medical monitoring subclass.  No medical monitoring injunctive class due to monetary damages
  29. Neely v. Ethicon, Inc., 2001 WL 1090204 (E.D. Tex. Aug. 15, 2001) (Vicryl suture – personal injury).  Nationwide class certification denied.  No issue certification due to Seventh Amendment jury trial right.  No predominance due to multiple state laws and plaintiff-specific variations.
  30. Block v. Abbott Laboratories, 2002 WL 485364 (N.D. Ill. March 29, 2002) (Total beta-hCG test kit – injunctive relief, consumer fraud).  Nationwide class certification denied.  No predominance due to multiple state laws and plaintiff-specific variations.  No adequacy due to lack of standing.
  31. In re Propulsid Products Liability Litigation, 208 F.R.D. 133 (E.D. La. June 4, 2002) (Propulsid – medical monitoring).  Nationwide class certification denied.  No medical monitoring injunctive class due to monetary damages.  No manageability due to multiple state laws.  No predominance due to plaintiff-specific variations.
  32. In re Phenylpropanolamine Products Liability Litigation, 208 F.R.D. 625 (W.D. Wash. June 5, 2002) (PPA – personal injury, increased risk of injury, emotional distress from increased risk).  Nationwide and statewide class certification denied.  No proper class definition due to plaintiff-specific variations.  No predominance due to multiple products and plaintiff-specific variations.  No limited fund or other mandatory class.
  33. Lewallen v. Medtronic USA, Inc., 2002 WL 31300899 (N.D. Cal. Aug. 28, 2002) (AneuRx stent – medical monitoring, fraud).  Nationwide class certification denied.  No medical monitoring injunctive class due to monetary damages.  No predominance due to plaintiff-specific variations and multiple state laws.  No superiority.
  34. In re Rezulin Products Liability Litigation, 210 F.R.D. 61 (S.D.N.Y. Sept. 12, 2002) (Rezulin – personal injury, economic loss, medical monitoring, fraud, restitution).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations particularly causation and reliance, and economic loss and multiple state laws.  No superiority.  No medical monitoring injunctive class due to monetary damages.  No medical monitoring subclass due to plaintiff-specific variations and multiple state laws.  Reconsideration denied, In re Rezulin Products Liability Litigation, 224 F.R.D. 346 (S.D.N.Y. 2004) (no medical monitoring injunctive class).
  35. Foister v. Purdue Pharma Co., 2002 WL 1008608 (E.D. Ky. Feb. 26, 2002) (Oxycontin – personal injury).  Nationwide class certification denied.  Improper class definition due to plaintiff-specific variations.  No numerosity.  No commonality, typicality, and adequacy due to plaintiff-specific variations.
  36. Gevedon v. Purdue Pharma Co., 212 F.R.D. 333 (E.D. Ky. Oct. 17, 2002) (Oxycontin –personal injury).  Statewide class certification denied.  Improper class definition due to plaintiff-specific variations.  No adequacy because class representatives not within class definition.  No numerosity.  No typicality and adequacy due to plaintiff-specific variations.
  37. In re Paxil Litigation, 212 F.R.D. 539 (C.D. Cal. Jan. 13, 2003) (Paxil – personal injury, medical monitoring, economic loss, fraud).  Multistate class certification denied.  No issue certification due to multiple state laws.  No proper class definition, manageability, typicality, and adequacy due to plaintiff-specific variations.  No predominance due to plaintiff-specific variations, particularly causation.  No superiority.  No injunctive or punitive damages subclasses.  No limited fund.
  38. In re Phenylpropanolamine (PPA) Products Liability Litigation, 214 F.R.D. 614 (W.D. Wash. Feb. 7, 2003) (PPA – economic loss).  Nationwide class certification denied.  No manageability due to proof of injury and multiple products.  No fluid recovery.  No superiority.
  39. Benner v. Becton Dickinson & Co., 214 F.R.D. 157 (S.D.N.Y. March 28, 2003) (needles – personal injury, emotional distress).  Statewide class certification denied.  No commonality and typicality due to multiple products.  No predominance due to plaintiff-specific variations.  No issue certification.  No superiority.
  40. In re Paxil Litigation, 218 F.R.D. 242 (C.D. Cal. Aug. 29, 2003) (Paxil – economic loss/consumer fraud).  Equitable and causation nationwide issue subclass certification denied.  No typicality and adequacy due to lack of cohesion.  No equitable subclass due to monetary damages.  No issue certification.
  41. In re Baycol Products Liability Litigation, 218 F.R.D. 197 (D. Minn. Sept. 17, 2003) (Baycol – personal injury, medical monitoring, economic loss).  Nationwide class certification denied.  No typicality due to plaintiff-specific variations.  No adequacy.  No predominance due to multiple state laws and plaintiff-specific variations.  No issue certification.  No superiority.  No medical monitoring class due to multiple state laws and plaintiff-specific variations.  No restitution class due to plaintiff-specific variations.  No punitive damages class.
  42. Perez v. Metabolife International, Inc., 218 F.R.D. 262 (S.D. Fla. Sept. 26, 2003) (ephedra – medical monitoring).  Nationwide and statewide medical monitoring class certification denied.  Improper class definition due to plaintiff-specific variations and multiple state laws.  No commonality, typicality, adequacy, predominance, and superiority due to plaintiff-specific variations.  No injunctive or other mandatory class.  No conditional certification.
  43. Wethington v. Purdue Pharma L.P., 218 F.R.D. 577 (S.D. Ohio Sept. 30, 2003) (Oxycontin – personal injury).  Multistate class certification denied.  No commonality due to plaintiff-specific variations, particularly learned intermediary.
  44. Harris v. Purdue Pharmaceuticals L.P., 218 F.R.D. 590 (S.D. Ohio Sept. 30, 2003) (Oxycontin – medical monitoring).  Nationwide class certification denied.  No commonality or cohesiveness due to plaintiff-specific variations, particularly learned intermediary.
  45. Campbell v. Purdue Pharma, L.P., 2004 WL 5840206, slip op. (E.D. Mo. June 25, 2004) (Oxycontin – personal injury, medical monitoring).  Statewide class certification denied.  No commonality, typicality, adequacy, predominance, and superiority due to plaintiff-specific variations.  No injunctive or other mandatory class.  No medical monitoring injunctive class due to monetary damages.
  46. Bostick v. St. Jude Medical, Inc., 2004 WL 3313614 (W.D. Tenn. Aug. 17, 2004) (Symmetry aortic connector – medical monitoring, personal injury).  Nationwide and statewide class certification denied.  No commonality due to multiple state laws.  No standing due to Tennessee’s rejection of medical monitoring.  No proper class definition, typicality and adequacy due to plaintiff-specific variations.
  47. Zehel-Miller v. AstraZeneca Pharmaceuticals, L.P., 223 F.R.D. 659 (M.D. Fla. Aug. 25, 2004) (Seroquel – medical monitoring, economic loss).  Nationwide class certification denied.  No medical monitoring injunctive class due to monetary damages.  No medical monitoring class due to multiple state laws and plaintiff-specific variations defeating cohesiveness.  No refund class due to multiple state laws and plaintiff-specific variations.
  48. In re Factor VIII or IX Concentrate Blood Products Litigation, 2005 WL 497782 (N.D. Ill. March 1, 2005) (blood products – personal injury, fraud).  Worldwide class certification denied.  No issue certification due to multiple state/national laws and undue settlement pressure.
  49. Foster v. St. Jude Medical, Inc., 229 F.R.D. 599 (D. Minn. July 26, 2005) (Symmetry bypass connector – medical monitoring).  Nationwide class certification denied.  No adequacy due to claim splitting.  No predominance due to multiple state laws.  No superiority due to improper class definition incorporating plaintiff-specific variations.  No injunctive medical monitoring class due to lack of cohesiveness.
  50. In re Prempro Products Liability Litigation, 230 F.R.D. 555 (E.D. Ark. Aug. 30, 2005) (hormone replacement therapy – medical monitoring, economic loss/consumer fraud).  Multistate class certification denied.  No manageability or superiority due to multiple state laws.  No predominance and cohesiveness due to multiple state laws and plaintiff-specific variations, particularly reliance.
  51. Dumas v. Albers Medical, Inc., 2005 WL 2172030 (W.D. Mo. Sept. 7, 2005) (counterfeit Lipitor – economic loss/consumer fraud/RICO).  Nationwide class action denied.  No predominance due to plaintiff-specific variations.  No manageability due to lack of proper class definition.  No fluid recovery.
  52. In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. Oct. 12, 2005) (Silzone heart valve – medical monitoring, economic loss/consumer fraud).  Certification of nationwide class reversed.  Failure to conduct choice of law analysis.  No medical monitoring class due to plaintiff-specific variations.
  53. Sweet v. Pfizer, 232 F.R.D. 360 (C.D. Cal. Nov. 15, 2005) (Mirapex – personal injury, loss of consortium, economic loss).  Nationwide and statewide class certification denied.  No typicality and superiority due to plaintiff-specific variations.  No adequacy due to counsel’s incompetence.  No predominance due to multiple state laws.  No mandatory class due to lack of cohesiveness.  No loss of consortium subclass.
  54. Sanders v. Johnson & Johnson, 2006 WL 1541033 (D.N.J. June 2, 2006) (Intergel adhesion prevention solution – personal injury, medical monitoring).  Nationwide class certification denied.  No predominance and cohesiveness due to multiple state laws and plaintiff-specific variations.
  55. In re Vioxx Products Liability Litigation, 239 F.R.D. 450 (E.D. La. Nov. 22, 2006) (Vioxx – personal injury).  Nationwide class certification denied.  No typicality, adequacy, predominance, and superiority due to multiple state laws and plaintiff-specific variations, particularly causation and damages.  No issue certification.
  56. Blain v. Smithkline Beecham Corp., 240 F.R.D. 179 (E.D. Pa. Jan. 25, 2007) (Paxil – personal injury).  Nationwide class certification denied.  No commonality, typicality, adequacy, and predominance due to plaintiff-specific variations.  No superiority.  No manageability due to multiple state laws.  No issue certification.
  57. Miller v. Janssen Pharmaceutica Products, L.P., 2007 WL 1295824 (S.D. Ill. May 1, 2007) (Duragesic patch – personal injury, economic loss/consumer fraud).  Nationwide class certification denied.  Improper class definition due to plaintiff-specific variations.  No predominance or manageability due to plaintiff-specific variations, particularly causation, damages, and reliance.
  58. In re Neurontin Marketing & Sale Practices Litigation, 244 F.R.D. 89 (D. Mass. Aug. 29, 2007) (Neurontin – economic loss/consumer fraud/RICO).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly learned intermediary and causation/reliance.  Improper class definition due to plaintiff-specific variations.
  59. In re Aredia & Zometa Products Liability Litigation, 2007 WL 3012972 (M.D. Tenn. Oct. 10, 2007) (Aredia/Zometa – medical monitoring).  Multistate certification denied.  Improper class definition due to plaintiff-specific variations.  No typicality and adequacy due to multiple state laws and plaintiff-specific variations.
  60. In re Fosamax Products Liability Litigation, 248 F.R.D. 389 (S.D.N.Y. Jan. 3, 2008) (Fosamax – medical monitoring).  Statewide certification denied.  Improper class definition due to plaintiff-specific variations.  No typicality and predominance due to plaintiff-specific variations.  No adequacy due to plaintiff-specific variations and claim splitting.  No superiority and manageability.
  61. Krueger v. Wyeth, Inc., 2008 WL 481956 (S.D. Cal. Feb. 19, 2008) (hormone replacement therapy – economic loss/consumer fraud).  Statewide certification denied.  No adequacy due to claim splitting.
  62. St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, 522 F.3d 836 (8th Cir. Apr. 9, 2008) (Silzone heart valve – economic loss/consumer fraud).  Nationwide class certification reversed.  No predominance due to plaintiff-specific variations, particularly reliance and causation.  No issue certification.
  63. In re Baycol Products Litigation, 265 F.R.D. 453 (D. Minn. Aug. 25, 2008) (Baycol – economic loss/consumer fraud).  Statewide certification denied.  No predominance due to plaintiff-specific variations, particularly causation.
  64. Ballew v. Matrixx Initiatives, Inc., 2008 WL 4831481 (E.D. Wash. Oct. 31, 2008) (Zicam – personal injury, economic loss/consumer fraud).  Statewide issue certification denied.  Single abstract question does not create commonality, typicality, adequacy, and predominance.  No mandatory class certification.  No injunctive class due to monetary damages.  No superiority.
  65. Thompson v. Bayer Corp., 2009 WL 362982 (E.D. Ark. Feb. 12, 2009) (Vitamins – economic loss/unjust enrichment).  Nationwide class certification denied.  No predominance and superiority due to multiple state laws.
  66. In re Neurontin Marketing, Sales Practices & Products Liability Litigation, 257 F.R.D. 315 (D. Mass. May 13, 2009) (Neurontin – economic loss/consumer fraud/RICO/unjust enrichment).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly causation and learned intermediary.  No fraud on the market.  Reconsideration denied, 2011 WL 1882870, slip op. (D. Mass. May 17, 2011).
  67. In re St. Jude Medical Inc. Silzone Heart Valves Products Liability Litigation, 2009 WL 1789376 (D. Minn. June 23, 2009) (Silzone heart valve – economic loss/consumer fraud/omissions).  Nationwide class allegations stricken.  No predominance due to plaintiff-specific variations, particularly causation and reliance.
  68. Thompson v. Bayer Corp., 2009 WL 2424352 (E.D. Ark. Aug. 6, 2009) (Vitamins – economic loss/unjust enrichment).  Statewide class certification denied.  No predominance due to plaintiff-specific variations, particularly reliance.
  69. Solo v. Bausch & Lomb Inc., 2009 WL 4287706 (D.S.C. Sept. 25, 2009) (contact lens solution – economic loss/consumer fraud/unjust enrichment).  Statewide class certification denied.  Improper class definition due to plaintiff-specific variations.
  70. In re Panacryl Sutures Products Liability Cases, 263 F.R.D. 312 (E.D.N.C. Nov. 13, 2009) (Panacryl absorbable sutures – personal injury).  Nationwide class certification denied.  No typicality and adequacy due to multiple state laws.  No predominance and superiority due to multiple state laws and plaintiff-specific variations.  No issue certification.  Reconsideration was denied at 2010 WL 3081389 (E.D.N.C. Aug. 1, 2010), again rejecting issue certification for multiple state-specific subclasses.
  71. In re Digitek Products Liability Litigation, 2010 WL 2102330 (S.D.W. Va. May 25, 2010) (Digitek – economic loss/consumer fraud).  Nationwide and statewide class certification denied.  No typicality and adequacy due to plaintiff-specific variations and multiple state laws.  No predominance due to plaintiff-specific variations.  No superiority.
  72. Sergeants Benevolent Assn. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, 2011 WL 824607, slip op. (E.D.N.Y. Feb. 16, 2011) (Ketek – economic loss/consumer fraud/RICO/unjust enrichment).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly causation and learned intermediary.
  73. In Re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Relevant Products Liability Litigation, 275 F.R.D. 270 (S.D. Ill. May 4, 2011) (Yasmin/Yaz – personal injury).  Nationwide class action allegation struck.  No predominance due to plaintiff-specific variations and multiple state laws.  No issue certification.
  74. Rader v. Teva Parenteral Medicines, Inc., 276 F.R.D. 524 (D. Nev. Oct. 5, 2011) (propofol – medical monitoring).  Class action of all persons allegedly exposed to pathogens at particular clinic denied.  No proper class definition due to plaintiff-specific variations.  No adequacy due to class representative’s bankruptcy and claim splitting.  No predominance due to multiple products and plaintiff-specific variations.
  75. In re Yasmin & Yaz Marketing, Sales Practices & Products Liability Litigation, 2012 WL 865041 (S.D. Ill. March 13, 2012) (Yasmin/Yaz – economic loss/consumer fraud).  No adequacy due to class representative’s close ties to plaintiff’s counsel.  No properly defined class.  No typicality or predominance to plaintiff-specific variations, particularly reliance, causation, and learned intermediary.
  76. Haggart v. Endogastric Solutions, Inc., 2012 WL 2513494 (W.D. Pa. June 28, 2012) (EsophyX – personal injury).  Nationwide class certification denied.  No typicality due to most procedures being successful.  No injunctive class due to monetary nature of relief and injunctive relief not benefiting class members.  No predominance or superiority due to plaintiff-specific variations.  Alternative class failed due to lack of proper class definition and lack of numerosity.
  77. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 291 F.R.D. 13 (D. Mass. Feb. 5, 2013) (Celexa – economic loss/consumer fraud).  Nationwide and statewide (California) class certification denied.  No superiority for nationwide classes due to multiple state laws.  No predominance in California statewide action due to plaintiff-specific variations.
  78. In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2014 WL 6684343 (E.D. Pa. Nov. 24, 2014) (Avandia– economic loss).  Nationwide class of Medicare Advantage Organizations suing under the Medicare Secondary Payer Act certification denied.  No commonality or predominance due to plaintiff-specific variations.  No superiority because insurers prefer to deal with subrogation issues on their own.  No typicality because the class representative has unusually large claims that allowed it to negotiate an unusually favorable deal for itself.
  79. Saavedra v. Eli Lilly & Co., 2014 WL 7338930, slip op. (C.D. Cal. Dec. 18 (2014) (Cymbalta – economic loss/consumer fraud).  Four-state (with subclasses) class certification denied.  No predominance because no valid class-wide method of calculating damages.  A “loss” not measured in price, but rather in subjective consumer value is not feasibly and efficiently calculated.  Plaintiffs advanced no damages model at all.  No predominance on issues of reliance and causation.  No superiority because damages calculations would be unmanageable.  No (c)(4) issue certification because it would not advance the litigation given all the individualized issues.
  80. In re Actiq Sales & Marketing Practices Litigation, 307 F.R.D. 150 (E.D. Pa. March 23, 2015) (Actiq – economic loss/unjust enrichment).  Nationwide class certification denied.  No predominance due to differences in state law of unjust enrichment.  TPP ability and desire to sue individually defeats superiority.
  81. Saavedra v. Eli Lilly & Co., 2015 WL 9916598, slip op. (C.D. Cal. July 21, 2015) (Cymbalta – economic loss/consumer fraud).  Two state-law (Massachusetts and New York) classes denied.  No predominance because right to minimum statutory damages requires proof of injury caused by deception.  Subjective product utility theory cannot establish damages.
  82. Shepherd v. Vintage Pharmaceuticals, LLC, 310 F.R.D. 691 (N.D. Ga. Nov. 4, 2015) (birth control pills – both personal injury and economic loss).  Nationwide class action involving four subclasses denied.  No ascertainability because determining who is in the class is at best difficult and at worse impossible beyond self-identifying plaintiffs.  No typicality due to differences in claimed injury.  No predominance because of individualized medical (for personal injury) and causation/injury (economic loss) reasons.  No predominance also for variations in state law of negligence, consumer fraud, and wrongful conception.  Damages are also individualized.
  83. Sergeants Benevolent Ass’n Health & Welfare Fund v. Sanofi-Aventis United States LLP, 806 F.3d 71 (2d Cir. Nov. 13, 2015) (Ketek – economic loss/RICO).  Nationwide RICO class certification denied.  Absent extreme circumstances (drug too dangerous for any use), individualized prescriber decisions to prescribe preclude proof of TPP economic losses by statistical proof.  Prescriber decisions preclude proof of causation by statistical proof, therefore individualized issues predominate.
  84. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 315 F.R.D. 116 (D. Mass. June 2, 2016) (Celexa/Lexapro – economic loss/RICO).  Nationwide and Minnesota statewide RICO third-party payor class certification denied.  Causation is an individualized issue that precludes certification.  Doctors use individual judgment in prescribing drugs.  Correlation between fraudulent promotions and fraudulently induced sales is an invalid assumption.  Damages depend on an individualized assessment of efficacy in each patient.  The statute of limitations is an individualized defense.  Affirmed 915 F.3d 1, below.
  85. Center City Periodontists, P.C. v. Dentsply International, Inc., 321 F.R.D. 193 (E.D. Pa. July 24, 2017)  (Cavitron device – economic loss).  Two-state express warranty only class certification denied.  Plaintiffs’ warranty and damages experts fail Daubert. Whether express warranty exists doesn’t require expert testimony.  No typicality where representative plaintiff purchased device under the table, did not read supposed warranty, and knew about the risk.  No adequacy due to statute of limitations problems, and being personal friends of class counsel.  Numerosity not proven.  Individual reliance, causation, and damages issues defeat predominance.  Lack of predominance means lack of superiority.  No ascertainability because membership in class depends not on purchase, but particular ways of using, of the device.
  86. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 325 F.R.D. 529 (D. Mass. Aug. 15, 2017) (Celexa/Lexapro – economic loss/RICO).  Nationwide RICO classes/subclasses and Washington state consumer class denied.  No predominance for but for causation, injury, damages, or the statute of limitations.  No superiority.  Certification of liability issue classes inappropriate because numerous related issues require individual analysis.  No predominance on causation for state consumer protection class.
  87. Barraza v. C.R. Bard Inc., 322 F.R.D. 369 (D. Ariz. Sept. 11, 2017) (IVC filters – medical monitoring).  Multiple single state classes denied.  No predominance or typicality due to multiple devices with differences in design and warnings over time, plaintiff-specific affirmative defenses, necessity of additional monitoring, and whether monitoring beyond what ordinary medical care would require.  Not all class members had surgery in state of residence, so choice of law issues also defeat predominance.  Whether or not the requested relief is “equitable,” it is not “injunctive,” but rather a demand to play money, thus Rule 23(b)(2) cannot apply, nor are the proposed classes cohesive.
  88. Andren v. Alere, Inc., 2017 WL 6509550 (S.D. Cal. Dec. 20, 2017) (home blood testing strips – economic loss.  Nationwide and multiple single state classes denied.  Due process does not allow application of law of state of principal place of business to all plaintiffs.  State consumer protection laws and unjust enrichment vary significantly.  Learned intermediary issues preclude predominance of single state class actions.  Manifestation, privity, and other issues preclude predominance of warranty claims.  Statute of limitations is also major individualized issue.
  89. In re Testosterone Replacement Therapy Products Liability Litigation, 2018 WL 3586182 (N.D. Ill. July 26, 2018) (testosterone supplements).  Nationwide and multiple single state classes denied.  No adequacy because of particularized defenses bases on class representative’s own negligence.  No predominance due to individualized representation and reliance issues.
  90. Fenwick v. Ranbaxy Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2018 WL 5994473 (D.N.J. Nov. 13, 2018) (Atorvastatin – economic loss).  Nationwide class denied.  Class of end users of pharmaceuticals allegedly adulterated by the defendant manufacturer could not be be reliably ascertained because it was not possible to trace those pills after intermediate sellers mixed them with with non-defective pills made by others.  Plaintiffs’ expert conceded end users could not be individually identified with his methodology.  No predominance due to differences in state warranty and unjust enrichment law.
  91. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 915 F.3d 1 (1st Cir. 2019) (Celexa/Lexapro – economic loss/RICO). Class action properly barred by statute of limitations.  No class action tolling available based on any previous class action.  Affirming 315 F.R.D. 116, above.

A lot of things about that recent Gadolinium opinion ticked us off.  But one of the lowest of many low points was when the court ruled a causation opinion based upon FDA adverse event reports (“AERs”) was admissible in a civil trial because the FDA used AERs to assess causation administratively.  In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334, at *9-11 (N.D. Ohio May 4, 2010).  Never mind that the FDA’s administrative standards (and agency standards generally) are a far cry  from those used in civil litigation.

Anyway, as we pointed out in the Gadolinium post, a lot of other courts have taken a more sensible – not to mention scientifically valid – approach to AERs and have excluded them, or opinions based upon them, from evidence.  Heck, even Gadolinium wouldn’t let the plaintiffs’ experts base their opinions “based on AERs alone.”  2010 WL 1796334, at *11.  For this reason we’ve decided to make exclusions of AERs from evidence (on grounds other than notice) our latest “cheat sheet.”

Before get to the cases, however, we’ll also supply links to some relevant FDA documents.

(1) the FDA’s 1996 Annual Adverse Experience Drug Report, in which the agency states that AERs “may not be used to calculate incidences or estimates of drug risk”;

(2) the FDA’s 2003 Pharmaceutical Safety Assessments Analysis, which characterized causation assessments based upon AERs as “dubious,” “inefficient,” and “low quality”;

(3) the FDA’s 2005 Guidance for Industry Good Pharmacovigilance Practices & Pharmacoepidemiologic Assessment, which discusses the “reporting biases” underreporting issues plaguing AERs.

(4) the FDA’s current website description of its adverse event reporting system, discussing the “limitations” of AERs and how they “cannot be used to calculate the incidence of an adverse event in the U.S. population.”

(5) the Department of Justice’s recent amicus brief in Bruesewitz v. Wyeth in which it states that even the stricter regime of “voluntary” adverse vaccine event reporting “alone” isn’t enough to establish anything scientific.  Br. at 21-22.

(6) the FDA’s current website description of its MAUDE system of medical device reporting, which acknowledges “limitations,” such as “potential submission of incomplete, inaccurate, untimely, unverified or biased data,” and that “the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.”

Here goes.  It’s the usual format: a list of cases, similar to our scorecards, but only including those cases we would consider citing in support of a motion to exclude.  Like the scorecards, this cheat sheet will be updated periodically.

  1. Wolf v. Procter & Gamble Co., 555 F. Supp. 613 (D.N.J. Dec. 22, 1982) (tampon).  Excluding AERs from evidence. AERs are inadmissible hearsay. Pre-Daubert case.
  2. Richardson v. Richardson-Merrell, Inc., 649 F. Supp. 799 (D.D.C. Dec. 19, 1986) (Bendectin).  Excluding AERs from evidence and as a basis for expert opinion.  AERs “are neither exceptions to the hearsay rule nor data reasonably relied upon by experts in the field of making determinations of causality.” Richardson was affirmed on other grounds.  Richardson v. Richardson-Merrell, Inc., 857 F.2d 823 (D.C. Cir. 1988). Pre-Daubert case.
  3. Hagaman v. Merrell Dow Pharmaceuticals, 1987 WL 342949 (D. Kan. June 26, 1987) (Bendectin).  Excluding AERs from evidence.  AERs “are often incomplete, in that they often do not indicate whether other drugs are being taken, or whether other drugs might have caused the reported health problem.”  Many “have been prompted by contemplated or existing litigation.”  Pre-Daubert case.
  4. Martinkovic v. Bangash, 1987 WL 28400 (N.D. Ill. Dec. 18, 1987) (DTP vaccine).  AERs excluded as evidence of causation, although admissible for purposes of notice.  “[A]necdotal reports of alleged adverse reactions are not admissible to prove the truth of the matter” and are hearsay for that purpose.  Pre-Daubert case.
  5. Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 788 P.2d 1293 (Idaho June 8, 1989) (Bendectin).  Affirming exclusion of AERs from evidence.  AERs “are anecdotal in nature and should not form the basis for any conclusions, expert or otherwise” and are inadmissible hearsay.  Pre-Daubert case.
  6. Peters v. Johnson & Johnson Products, Inc., 783 S.W.2d 442 (Mo. App. Jan. 23, 1990) (tampon).  Affirming exclusion of AERs from evidence.  AERs are inadmissible hearsay as “unsolicited letters and unsubstantiated reports from alleged . . . users do not stand as to their trustworthiness.”  Pre-Daubert case.
  7. DeLuca v. Merrell Dow Pharmaceuticals, Inc., 791 F. Supp. 1042 (D.N.J. April 29, 1992) (Bendectin).  Excluding expert opinion based upon AERs.  AERs “are unreliable for determining causation” because they “ADRs have inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions.”  They are “not of a type of data that are reasonably relied upon by experts . . . to make a determination of [a] causal relationship.”  DeLuca was affirmed without opinion: 6 F.3d 778 (3d Cir. 1993).  Pre-Daubert case.
  8. Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441 (D.V.I. March 3, 1994) (Primatine).  Excluding expert opinion based upon “[a]necdotal reports of the claimed adverse experiences” and AERs “filed with manufacturers or regulatory authorities.”  “[S]uch data represent anecdotal information of chance associations, do not purport to assess cause and effect and have no epidemiological significance.”  Pre-Daubert case.
  9. Sprague v. Upjohn Co., CA No. 91-40035-NMG (D. Mass. May 13, 1994) (Halcion).  Excluding expert opinion based upon AERs. AERs are “not a scientifically valid or accepted methodology for making a determination of causation or relative drug safety.”  Pre-Daubert case.  We don’t have a copy of this opinion, but would like one.
  10. Casey v. Ohio Medical Products, 877 F. Supp. 1380 (N.D. Cal. Feb. 28, 1995) (Halothane).  Excluding expert report based upon a study that was based upon foreign AERs.  The foreign AERs “simply describe reported phenomena without comparison to the rate at which the phenomena occur,” “do not isolate and exclude potentially alternative causes,” and “do not investigate or explain the mechanism of causation.”
  11. Reynolds v. Warthan, 896 S.W.2d 823 (Tex. App. March 17, 1995) (Kwell).  Affirming exclusion of AERs from evidence on grounds of danger of jury confusion.  AERs “did not establish a causal link between [the product] and the reported symptoms; rather, they created a suspicion without any medical proof.”  “[S]ubmission of [an AER] does not necessarily constitute an admission that the drug caused the adverse reaction.”
  12. Haggerty v. Upjohn Co., 950 F. Supp. 1160 (S.D. Fla. Dec. 6, 1996) (Halcion).  Excluding expert opinion based upon AERs and “anecdotal case reports appearing in medical literature.”  Due to the “the inherent bias in the” AERs, they “cannot be relied upon to form causation opinions.”  Haggerty was affirmed without opinion: 158 F.3d 588 (11th Cir. 1998).
  13. Lopez v. Wyeth-Ayerst Laboratories, 1996 WL 784566 (N.D. Cal. Dec. 13, 1996) (non-swine flu vaccine).  Excluding expert report based upon “case reports,” which were probably AERs, absent evidence that the reports “isolate and exclude other potential causes.”  Lopez was affirmed in a non-precedential opinion.  Lopez v. Wyeth-Ayerst Laboratories, Inc., 1998 WL 81296 (9th Cir. 1998) (“anecdotal reports . . . do not attempt to isolate causes and are not intended to reach conclusions as to causation”) (in table at 139 F.3d 905).
  14. Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. Dec. 18, 1996) (breast implants).  Excluding expert opinion based upon “case reports or collections of case reports” which sound like AERs.  “[C]ase reports and case studies are universally regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls.”
  15. In re Norplant Contraceptive Products Liability Litigation, 1997 WL 80527 (E.D. Tex. Feb. 19, 1997) (Norplant).  AERs excluded from evidence on the basis of jury confusion and waste of time.  AERs are only “marginally probative” because “the FDA requires [defendant] to submit all adverse events reported to it without regard to whether there is any proven causal connection.”
  16. Saari v. Merck & Co., 961 F. Supp. 387 (N.D.N.Y. March 11, 1997) (hepatitis B vaccine).  AER about plaintiff’s case excluded from evidence.  It was “was simply a report of what plaintiff told [the reporting doctor] about what she believed was her reaction to the vaccine.”  Reporting physician could not testify since in the AER he “neither confirmed nor den[ied] that there is any [causal] relationship.”
  17. Golod v. La Roche, 964 F. Supp. 841 (S.D.N.Y. May 20, 1997) (Tegison).  AERs excluded from evidence of causation, although admissible for purposes of notice.  “[T]he reports may not be sufficiently reliable or relevant to be admissible on the issue of causation, [but] are relevant to [defendant’s] awareness.”
  18. Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d. 706 (Tex. July 9, 1997) (Bendectin).  Reversing admission of expert opinion based on “case reports” (which in other Bendectin cases included AERs).  “[P]hysicians following scientific methodology” would not “rely on case reports to determine whether a substance is harmful.”  “[A]necdotal . . . evidence accomplishes no more than a false appearance of direct and actual knowledge of a causal relationship.”
  19. Willert v. Ortho Pharmaceutical Corp., 995 F. Supp. 979 (D. Minn. Feb. 25, 1998) (Floxin).  Excluding expert opinion based on “case reports” (which might be AERs) and other “anecdotal” evidence.  “[T]hey simply describe reported phenomena without comparison to the rate at which the phenomena occur,” “do not isolate and exclude potentially alternative causes,” and “do not investigate or explain the mechanism of causation.”
  20. In re Breast Implant Litigation, 11 F. Supp.2d 1217 (D. Colo. June 3, 1998) (breast implants).  Technically this case shouldn’t be here because it doesn’t involve FDA AERs, but other anecdotal evidence (an expert’s individual clinical experience).  But it comes up so often – and cites several AER cases – that we’re including it.  “[C]ase reports. and case studies universally are regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls.”
  21. Allison v. McGhan Medical Corp., 184 F.3d 1300 (11th Cir. Aug. 18, 1999) (breast implants).  Affirming exclusion of expert opinion based on “case reports” (which might be AERs).  “Case reports and case studies are universally regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls.”
  22. Revels v. Novartis Pharmaceuticals Corp., 1999 WL 644732 (Tex. App. Aug. 26 1999) (non-precedential), review denied (Tex. June 29, 2000) (Parlodel).  Affirming exclusion of expert opinion based upon AERs.  “[A] study of case reports alone is a scientifically invalid manner in which to form an expert opinion.”
  23. Brumbaugh v. Sandoz Pharmaceuticals Corp., 77 F. Supp. 2d 1153 (D. Mont. Sept. 27, 1999) (Parlodel).  Excluding expert opinion based upon AERs.  AERs “do not demonstrate a causal link but instead represent coincidence.”  Their “most significant analytical defect is that they don’t isolate and investigate the effects of alternative causation.”
  24. Linnen v. A.H. Robins Co., 2000 WL 16769 (Mass. Super. Dec. 14, 1999) (Phentermine).  Excluding expert opinion based on “between ten and twenty case reports” that sound like AERs.  “[C]ase reports alone are not considered reliable scientific evidence of causation.”
  25. Nelson v. American Home Products Corp., 92 F. Supp.2d 954 (W.D. Mo. March 24, 2000) (Cordarone).  Excluding expert opinion based upon AERs and possibly other case reports.  AERs “do not demonstrate a causal link sufficient for admission to a finder of fact in court.”
  26. Robinson v. Astra Pharmaceutical Products, Inc., 765 So.2d 378 (La. App. March 31, 2000) (Citanest).  AERs were “wholly irrelevant” because they were not substantially similar to the plaintiff’s situation.
  27. In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Products Liability Litigation, 2001 WL 454586 (E.D. Pa. Feb. 1, 2001) (fen-phen).  Excluding expert opinion based upon AERs.  AERs “are universally recognized as insufficient and unreliable evidence of causation.”
  28. Glastetter v. Novartis Pharmaceuticals Corp., 252 F.3d 986 (8th Cir. June 8, 2001) (Parlodel).  Affirming exclusion of expert opinion based upon AERs.  Mere “case reports” suffer from numerous flaws and are “not scientifically valid proof of causation.”  The trial court opinion is at Glastetter v. Novartis Pharmaceuticals Corp., 107 F. Supp.2d 1015 (E.D. Mo. 2000).
  29. Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1046 (S.D. Ill. Sept. 12, 2001) (Parlodel).  Excluding expert opinion based upon AERs and published case reports.  AERs “make little attempt to isolate or exclude possible alternative causes, lack adequate controls, and lack any real analysis.”
  30. Cloud v. Pfizer, Inc., 198 F. Supp. 2d 1118 (D. Ariz. Nov. 21, 2001) (Zoloft).  Excluding expert opinion based upon AERs and “retrospective case reports.”  Such items “are merely compilations of occurrences, and have been rejected as reliable scientific evidence supporting an expert opinion.”
  31. Hollander v. Sandoz Pharmaceuticals Corp., 289 F.3d 1193 (10th Cir. May 10, 2002) (Parlodel).  Affirming exclusion of expert opinion based upon AERs and other case reports.  AERs “contain only limited information” and are “unreliable evidence of causation.”  The trial court opinion is at Hollander v. Sandoz Pharmaceuticals Corp., 95 F. Supp.2d 1230 (W.D. Okla. 2000) (“case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation”).
  32. Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194 (11th Cir. June 24, 2002) (Parlodel).  Affirming exclusion of expert opinion based upon AERs.  Such case reports “are merely accounts of medical events” and “reflect only reported data, not scientific methodology.”  They do “not by themselves provide reliable proof of causation.”  The trial court opinion is at Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp.2d 1347 (N.D. Ga. 2001) (case reports “cannot establish general causation”).
  33. Newton v. Roche Laboratories, Inc., 243 F. Supp.2d 672 (W.D. Tex. Dec. 5, 2002) (Accutane).  Excluding expert opinion based upon AERs.  “[M]any other courts have soundly rejected case reports as an acceptable basis for causation.”
  34. Soldo v. Sandoz Pharmaceuticals Corp., 244 F. Supp.2d 434 (W.D. Pa. Jan. 13, 2003) (Parlodel).  Excluding expert opinion based upon AERs.  AERs “do not demonstrate a causal link but instead represent coincidence.  Case reports and ADEs are compilations of occurrences, and have been rejected as reliable scientific evidence supporting expert opinion so as to meet the requirements set forth in Daubert.”
  35. Dunn v. Sandoz Pharmaceuticals Corp., 275 F. Supp. 2d 672 (M.D.N.C. Aug. 4, 2003) (Parlodel).  Excluding expert opinion based upon AERs.  AERs “are not controlled studies, and they cannot be verified through peer review.  [AERs] often do not include information about the patient’s medical history, family medical history, use of other medications or drugs, or other information that would be necessary to determine whether causation between the use of the drug and the reported adverse effect can be established. [AERs] are not scientific proof of causation.”
  36. Swallow v. Emergency Medicine of Idaho, P.A., 67 P.3d 68 (Idaho April 2, 2003) (Cipro).  Excluding expert opinion based upon AERs. AERs are “based solely upon the temporal relationship between the administration of [the drug] and the adverse . . . event.”  “There was no showing as to what percentage of . . . patients are represented by these ten events, nor . . . that these ten events were statistically significant.  In other words, there is no showing that [the AERs are] a greater incidence of such events than would be expected to occur by chance.”
  37. Freeman v. Hoffman-Laroche, Inc., 2004 WL 5382304 (Neb. Dist. March 18, 2004) (Accutane).  Further discovery of AER files denied.  AERs “do[] not constitute valid scientific proof of medical causation and therefore, has little relevance in a product liability case.”
  38. Skibniewski v. American Home Products Corp., 2004 WL 5628157 (W.D. Mo. April 1, 2004) (fen-phen).  AERs excluded from evidence.  AERs “cannot be used to establish causation,” and “are hearsay and do not fall within an exception.”
  39. In re Meridia Products Liability Litigation, 328 F. Supp.2d 791 (N.D. Ohio July 7, 2004) (Meridia).  Excluding expert opinion on comparative drug risk based upon AERs.  AERs “do not screen out alternative causes for the adverse event and often lack analysis,” are “not scientifically valid proof of causation” and are “irrelevant to establish a material issue of fact.”
  40. McClain v. Metabolife International, Inc., 401 F.3d 1233 (11th Cir. March 2, 2005) (ephedrine).  Reversing admission of expert opinion based upon AERs.  AERs “reflect complaints called in by product consumers without any medical controls or scientific assessment.”  “Uncontrolled anecdotal information offers one of the least reliable sources to justify opinions about both general and individual causation.”
  41. Ryman v. Sec’y of Dep’t of Health & Human Services, 65 Fed. Cl. 35 (2005) (hepatitis B vaccine).   Affirming a trier of fact’s rejection of expert causation testimony.  Finding “several difficulties” with reliance upon adverse event reports:  “First, the reports can be filed by anyone.  Second, the quantity and quality of information obtained in the reports is often insufficient to make an informed decision as to whether a causal link exists between the vaccination and the injury.   Third, the reports may be biased towards pre-existing notions of adverse events.  Fourth, the respondent’s expert . . .  testified that VAERS reports ‘offer very little information regarding causality.’”
  42. Heckstall v. Pincus, 797 N.Y.S.2d 445 (N.Y.A.D. June 16, 2005) (Bupropion).  Excluding expert opinion based upon AERs.  AERs are “unverified listings and reporting of adverse reactions . . . [and] “are not generally accepted in the scientific community on questions of causation.”
  43. Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440 (D.N.J. Dec. 13, 2005) (Lotronex).  Excluding AERs from evidence.  AERs are not FDA conclusions and thus have no guarantees of genuineness. AERs “may not be sufficiently reliable or relevant to be admissible on the issue of causation.”
  44. Pauley v. Bayer Corp., 2006 WL 463866 (Pa. C.P. Jan. 26, 2006) (Baycol).  Excluding AERs from evidence.  AERs are “not the product of laboratory research or any type of controlled study,” but “merely the compilation of experiential reports.”  They “are not proof of the data they contain, and do not directly bear upon the adequacy of label warnings.”  Pauley was affirmed in a non-citable memorandum opinion. Pauley v. Bayer Corp., 2009 WL 1654592 (Pa. Super. June 12, 2009) (“the court’s limitation on the use of the AERs data at trial was appropriate, because it was anecdotal, not scientific”) (in table at 981 A.2d 331).
  45. Leathers v. Pfizer, Inc., 233 F.R.D. 687, 694 (N.D. Ga. March 10, 2006) (Lipitor).  Excluding expert opinion based upon AERs.  AERs “reflect only reported data, not scientific methodology . . . with little or no patient history, description or course of treatment, or reasoning to exclude other possible causes.”
  46. Ervin v. Johnson & Johnson, Inc., 2006 WL 1529582 (S.D. Ind. May 30, 2006) (Remicade).  Excluding expert opinion based upon AERs. AERs “do little more than establish a temporal association between an exposure to a drug and a particular occurrence.”  Ervin was affirmed:  Ervin v. Johnson & Johnson, Inc., 492 F.3d 901 (7th Cir. 2007), without any specific discussion of AERs.
  47. Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006) (Itrel implantable neurological electrical pulse generator).  Affirming exclusion of expert opinion based upon MDRs.  An inference of defect cannot be drawn from the number of complaints.  MDRs “invite rank speculation and are not demonstrably relevant to the failure of the individual unit.”
  48. Dellinger v. Pfizer Inc., 2006 WL 2057654 (W.D.N.C. July 19, 2006) (Neurontin).  Excluding expert opinion based upon AERs.  AERs “are not scientific proof of causation.”  “[M]any courts have recognized that adverse drug reaction case reports and other regulatory reports fail to test a causal hypothesis and therefore cannot support a causation opinion.”
  49. Sutherland v. Matrixx Initiatives, Inc., 2006 WL 6617000 (N.D. Ala. Nov. 7, 2006) (Zicam). Excluding expert opinion based upon “case reports,” which may not have been FDA-reported AERs.  “[A]s is always true of case reports, there are inherent methodological concerns about their significance.”  “Anecdotal hearsay cannot fill the gap.”
  50. Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp.2d 1316 (M.D. Ala. Dec. 27, 2006) (Zicam).  Excluding expert opinion based upon AERs.  AERs are “are even less persuasive than case reports” because they are “[u]ncontrolled anecdotal information.”
  51. Salden v. Matrixx Initiatives, Inc., 2007 WL 850239 (E.D. Mich. March 16, 2007) (Zicam). Excluding expert opinion based upon a “case report,” not an FDA-submitted AER, as “merely an anecdotal observation” lacking “confirmatory research.”
  52. Wyatt v. Matrixx Initiatives, Inc., 2007 WL 7238402 (N.D. Ala. March 30, 2007) (Zicam). Excluding expert opinion based upon “case reports,” probably not true AERs, as “anecdotal evidence, not evidence that has been vigorously tested using scientific methodology.”
  53. In re: Accutane Products Liability Litigation, 2007 WL 1288354 (M.D. Fla. May 2, 2007) (Accutane).  Excluding AERs from evidence. AERs “reflect[] nothing more than an assessment of a possible relationship, not an actual relationship.”
  54. Goldstein v. Centocor, 2007 WL 7428597 (S.D. Fla. May 14, 2007) (Remicade).  Excluding AERs from evidence.  MedWatch reports are hearsay.  They are not business records because their submission is purely voluntary.  Nor are they reliable because voluntary reporting is subject to various biases.  They are not adoptive admissions, because a reporting manufacturer does not vouch for their truth.  AERs are “uncontrolled anecdotal information” not sufficient to base an expert opinion, and their prejudice outweighs their probative value because they give a one-sided view of risks with no corresponding admission of beneficial uses of the drug.
  55. In re: Accutane Products Liability Litigation, 511 F. Supp.2d 1288 (M.D. Fla. June 15, 2007) (Accutane).  Excluding expert opinion based upon AERs and case reports.  “The reports are unreliable as proof of causation because, in general, the events were not observed in such a way as to rule out coincidence or other potential causes.”
  56. In re Baycol Products Litigation, 532 F. Supp.2d 1029 (D. Minn. July 16, 2007) (Baycol).  Excluding expert opinion on comparative drug risk based upon AERs.  “[T]he limitations inherent in AER data” preclude any rate of error analysis and “no evidence has been submitted to demonstrate that such an analysis is generally accepted.”
  57. In re Viagra Products Liability Litigation, 572 F. Supp.2d 1071 (D. Minn. 2008) (Viagra).  Excluding expert opinion based upon 10 case reports and one rechallenge.  “The difficulty with case reports is distinguishing between association and causation.”  One rechallenge among millions of prescriptions is a “paucity.”
  58. Rose v. Matrixx Initiatives, Inc., 2009 WL 902311 (W.D. Tenn. March 31, 2009) (Zicam).  Excluding expert opinion based upon ten “case reports,” which are not technically AERs.  The reports are “mere accoun[ts] of medical events,” “reflect[] only reported data, not scientific methodology,” and while they “may bolster true toxicological data, they are not, standing alone, sufficient to establish general causation.”
  59. Gibson v. Sanofi-Aventis U.S., LLC, 2009 WL 3490454 (W. D. Ky. Oct. 27, 2009) (Ambien).  Excluding expert opinion based upon “a collection of case reports,” which sound like AERs, as “wholly inadequate.”
  60. Ranes v. Adams Laboratories, Inc., 778 N.W.2d 677 (Iowa Feb. 5, 2010) (PPA). Affirming exclusion of expert opinion based upon AERs and published case reports.  “[C]ase reports are merely accounts of medical events. They reflect only reported data, not scientific methodology.”  “[T]he methodology used by the expert becomes suspect when it is only supported by case reports of limited use to the medical field.”
  61. Smith v. Pfizer Inc., 2010 WL 1754443 (M.D. Tenn. April 30, 2010) (Neurontin). Excluding AERs from evidence.  AERs are not probative of causation as they have “inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions.”
  62. Hendrix  v. Evenflo Co., Inc., 609 F.3d 1183 (11th Cir. June 22, 2010) (child restraint system).  Affirming exclusion of expert testimony.  “Case studies and clinical experience, used alone and not merely to bolster other evidence, are also insufficient to show general causation.”
  63. Kilpatrick v. Berg, Inc., 613 F.3d 1329 (11th Cir. Aug. 12, 2010) (pain pump).  Affirming that case study was an unreliable basis for expert testimony because it did not contain statistical analysis and did not draw medically valid conclusions.  The excluded expert “acknowledged that case reports . . . are ‘way down at the very bottom as far as medical strength of an article’ and cannot establish medical causation,” because of a “multitude of factors that could have caused” the alleged injuries.
  64. Toni’s Alpacas, Inc. v. Evans, 2010 WL 3730382 (D. Colo. Sept. 16, 2010) (fiber supplement).  Rejecting anecdotal reports as foundation for proof of causation, since they do not isolate and exclude alternative causes and lack controls.
  65. In re Zicam Cold Remedy Marketing, Sales Practices, & Products Liability Litigation., 2011 WL 798898 (D. Ariz. Feb. 24, 2011) (Zicam).  The FDA’s “AERs data and the agency’s reports are not admissible bases” for expert causation opinions.  Such reports “reflect complaints called in by product consumers without any medical controls or scientific assessment,” and are “uncontrolled anecdotal information [which] is not the foundation of a reliable causation methodology.”
  66. In re Denture Cream Products Liability Litigation 795 F. Supp.2d 1345 (S.D. Fla. June 13, 2011) (Fixodent).  Expert testimony on general causation was unreliable because there was “no evidence that Plaintiffs’ experts or the case reports they rely on [were] systematic in considering other plausible hypotheses and excluding background risk.”  AERs are “unreliable, as a general matter,” due to “inconsistencies in case definition,” which “limit[ed] the evidentiary value of the case reports to support an inference of causation.”
  67. In re Aredia & Zometa Products Liability Litigation, 483 F. Appx. 182 (6th Cir. June 5, 2012) (bisphosphonate drugs).  Affirming grant of summary judgment.  Expert testimony was properly excluded as unreliable because general causation expert admitted that he could not “establish causation [based on 2] case reports, but simply a ‘very close association.’”
  68. Rhodes v. Bayer Healthcare Pharmaceutical, Inc., 2013 WL 1289050 (W.D. La. Mar. 26, 2013) (Avelox).  Granting Daubert motion to exclude expert testimony because “reliance on adverse event reports is also unimpressive, as such reports do not demonstrate the requisite degree of reliability.”
  69. Klein v. TAP Pharmaceutical Products, Inc., 518 F. Appx. 583 (9th Cir. May 14, 2013) (Lupron).  Affirming exclusion of adverse event reports, as they “were hearsay reports of uncertain reliability, lacking information relevant to causation.”
  70. Trainer v. Sec’y of Health & Human Services, 2013 WL 4505803 (Fed. Cl. July 24, 2013) (hepatitis A vaccine).  Finding “no causal link” between” the product and the alleged harm where the claimant attempted to rely on case reports and anecdotal evidence because “there are too many unknown variables that make such raw information inherently unreliable.”
  71. Berman v. Stryker Corp., No. 11 C 1309, 2013 WL 5348324 (N.D. Ill. Sept. 24, 2013) (prosthetic knee).  Reliance on Manufacturer and User Facility Device Experience (“MAUDE”) medical device adverse event reports alone was inappropriate basis to infer causation are because “such reports can contain inaccurate and non-validated data,” and “[d]enominator data are missing which makes evaluation of the incidence or prevalence of reported events impossible.”
  72. DeGidio v. Centocor Ortho Biotech, Inc., 3 F. Supp.3d 674 (N.D. Ohio Mar. 11, 2014) (Remicade).  Excluding expert testimony under Daubert, where there was “no question that plaintiffs’’ experts based their general-causation opinions solely on case reports” because “[c]ase reports make little attempt to screen out alternative causes for a patient’s condition,”  and simply describe phenomena without comparison to background rates, either “in the general population or in a defined control group; do not isolate and exclude potentially alternative causes; and do not investigate or explain the mechanism of causation.
  73. Wirt v. Sec’y of Health & Human Services, No. 11–118V S, 2014 WL 1911421 (Fed. Cl. Apr. 18, 2014) (HPV vaccine).  Adverse event data alone, “without the opinion of a medical expert and/or medical records showing a causal connection between vaccination and injury, is not proof of a causal connection,” and is insufficient to establish that a product caused a particular disease.
  74. Schenone v. Zimmer, Inc., 2014 WL 12619911 (M.D. Fla. Aug. 27, 2014) (hip implant).  ADEs excluded as insufficiently similar other incidents and unduly prejudicial.
  75. Chapman v. Procter & Gamble Distributors, LLC, 766 F.3d 1296 (11th Cir. Sept. 11, 2014) (Fixodent).   Affirming exclusion of causation testimony because reliance on “generalized case reports, hypotheses, and animal studies are insufficient proof of general causation,” because such information “could mislead the jury by causing it to consider testimony that was insufficient by recognized primary methodologies to prove using [denture cream] causes myelopathy.”
  76. In re Incretin Mimetics Products Liability Litigation, 2014 WL 4987877 (S.D. Cal. Oct. 6, 2014).  (Incretin-based diabetes drugs).  Denying generalized discovery of AER databases.  AERs lack medical controls and scientific assessment,  and are too unreliable to justify the expense of production as relevant to causation.
  77. In re Denture Cream Products Liability Litigation, 2015 WL 392021 (S.D. Fla. Jan. 28, 2015) (Fixodent).  Case studies are not a reliable basis for an expert opinion on causation.
  78. In re Byetta Cases, 2015 WL 7184655, slip op. (Cal. Super. Nov. 13, 2015) (Byetta).  ADEs are unvalidated, and even plaintiff lawyers can submit them.  They are not particularly useful to establish causation.
  79. In re Mirena IUD Products Liability Litigation, 202 F. Supp.3d 304 (S.D.N.Y. Aug. 26, 2016) (Mirena).  Case reports are not reliable evidence of causation.  Affirmed 713 F. Appx. 11 (2d Cir. Oct. 24, 2017).
  80. Hale v. Bayer Corp., 2017 WL 1425944 (S.D. Ill. April 21, 2017) (Aleve).  ADEs are too unreliable to serve as the basis of an expert opinion.
  81. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. May 8, 2017) (Eliquis).  ADEs do not require causation.  An adverse event, standing alone, says nothing about causation.  FDA voluntary reporting does not collect systematic data.  Reporting rates say little about actual incidence of risk.
  82. In re Mirena Ius Levonorgestrel-Related Products Liability Litigation (No. II), 341 F. Supp.3d 213 (S.D.N.Y. Oct. 24, 2018) (Mirena).  Adverse event reports cannot establish causation.  primarily serve a more limited function, as a tool to generate hypotheses.  Precedent has hesitated to base causation or even an epidemiological association on adverse event data.  Collections of adverse event reports are often inherently skewed by the reporting impulses of those, including lawyers, who choose to make reports.

We’re inaugurating a new feature today.  It’s sort of half way between our scorecards, which we keep up to date (as best we’re able) with both favorable and adverse decisions on a particular subject, and our usual defense-side cheerleading that hails defense wins and excoriates our losses.

What we’re going to start is something we call “cheat sheets.” These will be lists of cases, similar to scorecards.  We intend to update them like we do with the scorecards.  Only, in accordance with our general philosophy that we don’t believe in doing the other side’s research for them, these will only include cases that have pro-defense outcomes on the particular issue.  This will allow us to extend our scorecard research tool (which we use ourselves, quite often) to more subject areas.

The first of these is going to address Twombly/Iqbal pleading decisions in drug/device product liability cases (that means Rule 8, not Rule 9(b)).  For short we’re going to be calling that “TwIqbal” from now on.  That nifty little turn of a phrase is one of the things we learned at the recent PLAC spring conference.  So without further ado here’s our inaugural TwIqbal cheat sheet:

  1. In re Bausch & Lomb Inc., 2007 WL 3046682 (D.S.C. Oct. 11, 2007).  All claims TwIqballed (technically only “Twomblyed,” since Iqbal wasn’t decided yet) due to:  failure to plead facts concerning damages (device).
  2. Parker v. Howmedica Osteonics Corp., 2008 WL 141628 (D.N.J. Jan. 14, 2008).  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty (device).
  3. Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208 (E.D. Va. Feb. 12, 2008).  Gross negligence claim TwIqballed due to:  failure to plead any facts supporting the adjectives (vaccine).
  4. Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008).  All product liability claims TwIqballed due to:  unsubstantiated labels, and legal conclusions; failure to plead elements of strict liability, negligence, or warranty; and failure to distinguish between manufacturing, design, and warning defects (device).
  5. Stratford v. SmithKline Beecham Corp., 2008 WL 2491965 (S.D. Ohio June 17, 2008).  Statutory product liability claims TwIqballed due to:  failure to plead with reference to the proper sections of the statute.  Express warranty claim TwIqballed due to: failure to plead any facts establishing the nature of the warranty (drug).
  6. Wolicki-Gables v. Arrow International, Inc., 2008 WL 2773721 (M.D. Fla. June 17, 2008).  All product liability claims TwIqballed due to: failure to plead product identification (device).
  7. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008).  Negligence claim based upon conduct of sales representative TwIqballed due to:  failure to plead facts of representative’s negligent conduct or causation (device).
  8. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008).  Express warranty claim TwIqballed due to:  failure to specify the language that constituted the warranty (device).
  9. Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597 (11th Cir. July 29, 2008).  Warning claims TwIqballed due to:  failure to plead facts concerning how the warning to the prescribing physician was inadequate.  Negligence claims TwIqballed due to: failure to plead separate claims against separate defendants (device).
  10. Simmons v. Stryker Corp., 2008 WL 4936982 (D.N.J. Nov. 17, 2008).  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty (device).
  11. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009).  Manufacturing claims TwIqballed due to:  failure, in a preemption case, to plead how the defendant’s manufacturing process violated FDA regulations (device).
  12. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead how the defendant’s manufacturing process violated FDA regulations.  Express warranty claim TwIqballed due to:  failure to specify the language that constituted the warranty (device).
  13. Sherman v. Stryker Corp., 2009 WL 2241664 (C.D. Cal. March 30, 2009).  All product liability claims TwIqballed due to:  failure to plead facts concerning product identification (drug).
  14. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2009 WL 1921902 (D. Minn. July 1, 2009).  All claims TwIqballed due to:  vague and conclusory allegations that fail to establish standing (device).
  15. Pennsylvania Employees Benefit Trust Fund v. Astrazeneca Pharmaceuticals LP, 2009 WL 2231686 (M.D. Fla. July 20, 2009).  Express warranty claims TwIqballed due to:  failure to plead any facts supporting direct communication between plaintiff and defendant or proximate cause (drug).
  16. Frey v. Novartis Pharmaceuticals Corp., 642 F. Supp.2d 787 (S.D. Ohio July 23, 2009).  Design and manufacturing claims TwIqballed due to:  formulaic pleadings of defect and causation (drug).
  17. Lewis v. Abbott Laboratories, 2009 WL 2231701 (S.D.N.Y. July 24, 2009).  Design claim TwIqballed due to:  failure to plead facts establishing a feasible alternative design. Warning claims TwIqballed due to:  failure to plead inadequate warnings to doctors under the learned intermediary rule.  Manufacturing claims TwIqballed due to:  failure to plead a deviation from intended result.  Implied warranty claim TwIqballed due to:  failure to plead an actionable defect (drug).
  18. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, plead an FDCA violation involving the plaintiff’s device, anything beyond formulaic conclusions, or facts supporting proximate cause.
  19. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009).  Express warranty claim TwIqballed due to:  failure to plead facts establishing any express statement (device).
  20. Ivory v. Pfizer Inc., 2009 WL 3230611 (W.D. La. Sept. 30, 2009).  Design claim TwIqballed due to:  failure to plead facts establishing a feasible alternative design (drug).
  21. Dittman v. DJO, LLC, 2009 WL 3246128 (D. Colo. Oct. 5, 2009).  All claims TwIqballed due to:  failure to plead product identification (drug).
  22. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009).  Parallel violation claim TwIqballed due to:  failure to plead any supporting facts (device).
  23. Gilmore v. DJO, Inc., 663 F. Supp.2d 856 (D. Ariz. Oct. 15, 2009).  All claims TwIqballed due to:  failure to plead any facts, and failure to specify what products were at issue (device).
  24. Mohr v. Targeted Genetics, Inc., 2009 WL 4021153 (C.D. Ill. Nov. 18, 2009).  Strict liability and wrongful death claims TwIqballed in experimental drug case due to:  failure to plead any specific facts beyond bare legal conclusions (drug).
  25. Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009).  “Information and belief” allegations TwIqballed where facts were public information.  Affirmed on other grounds 631 F.3d 777 (5th Cir. 2011)
  26. Combs v. Stryker Corp., 2009 WL 4929110 (E.D. Cal. Dec. 14, 2009).  All claims TwIqballed due to:  failure to plead product identification (drug).
  27. Gomez v. Pfizer, Inc., 675 F. Supp.2d 1159 (S.D. Fla. Dec. 21, 2009).  Negligence claims TwIqballed due to:  failure to plead individualized allegations against multiple defendants.  Strict liability claims TwIqballed due to:  failure to plead individualized allegations against multiple defendants, failure to plead anything more than bare legal conclusions, and failure to plead what category of defect is claimed (drug).
  28. Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. Dec. 28, 2009).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead more than unsupported violations of general FDA regulations, and failure to plead causation (device).
  29. Gonzalez v. Bristol-Myers Squibb Co., 2009 WL 5216984 (D.N.J. Dec. 30, 2009).  Negligent misrepresentation claim TwIqballed due to: failure to plead anything beyond conclusory allegations (drug).
  30. Wendell v. Johnson & Johnson, 2010 WL 271423 (N.D. Cal. Jan. 20, 2010).  Negligence, negligence per se, strict liability, wrongful death, and express and implied warranty claims TwIqballed due to:  failure to plead anything beyond the conclusory legal elements (drug).
  31. Krywokulski v. Ethicon, Inc., 2010 WL 326166 (M.D. Fla. Jan. 21, 2010).  Negligence claim TwIqballed due to:  failure to plead facts establishing a duty, and failure to plead facts separately as to each defendant (device).
  32. Haskins v. Zimmer Holdings, Inc., 2010 WL 342552 (D. Vt. Jan. 29, 2010).  Product liability claims TwIqballed due to: failure to plead product identification.
  33. Washington v. Wyeth, Inc., 2010 WL 450351 (W.D. La. Feb. 8, 2010).  Product liability claims TwIqballed due to:  failure to plead product identification (drug).
  34. In re Heparin, 2010 WL 547322 (N.D. Ohio Feb. 9, 2010).  Product liability claims TwIqballed due to:  failure to plead facts establishing proximate cause (drug).
  35. Timmons v. Linvatec Corp., 263 F.R.D. 582 (C.D. Cal. Feb. 9, 2010).  Product liability claims TwIqballed due to:  failure to plead product identification (drug).
  36. Mitchell v. Proctor & Gamble, 2010 WL 728222 (S.D. Ohio March 1, 2010).  Product liability claims TwIqballed due to:  failure to plead causation (drug)
  37. Heisner v. Genzyme Corp., 2010 WL 894054 (N.D. Ill. March 8, 2010).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead anything more than formulaic allegations.  Negligence per se claim TwIqballed due to: failure, in a preemption case, to plead any facts establishing causation (device).
  38. Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. March 15, 2010).  Redhibition claim TwIqballed due to:  failure, in a preemption case, to plead a parallel FDCA violation claim or causation (device).
  39. Adams v. I-Flow Corp., 2010 WL 1339948 (C.D. Cal. March 30, 2010).  All claims TwIqballed due to:  failure to plead facts concerning product identification (drug and device).
  40. Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead how the alleged FDCA violations caused injury (device).
  41. In re Fosamax Products Liability Litigation, 2010 WL 1654156 (S.D.N.Y. April 9, 2010).  All product liability claims TwIqballed due to:  failure to plead facts concerning product identification (drug).
  42. Tyler v. Bristol-Meyer Squibb, 2010 WL 1664967 (D. Neb. April 23, 2010).  Warning claims TwIqballed due to:  failure to plead inadequate warnings to doctors under the learned intermediary rule (drug).
  43. Peterson v. Breg, Inc., 2010 WL 2044248 (D. Ariz. April 29, 2010).  All claims TwIqballed due to: failure to plead product identification (drug and device).
  44. Daughtery v. I-Flow, Inc., 2010 WL 2034835 (N.D. Tex. April 29, 2010).  All claims TwIqballed (although TwIqbal not cited) due to:  failure to plead sufficient causal link to establish standing (drug and device).
  45. Dean v. DJO, LLC, 2010 WL 1999295 (D. Or. May 17, 2010) & Flint v. DJO, LLC, 2010 WL 1999302 (D. Or. May 17, 2010).  Two identical opinions.  Civil conspiracy claims based upon alleged FDCA violations TwIqballed due to:  an agreement to “sell” a product and “make a profit” was insufficient because there was no allegation that the purpose of the agreement was to cause harm to the plaintiff.  Leave to amend was denied as futile (device).
  46. In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2010 WL 2346624 (D.N.J. June 9, 2010).  RICO allegations that third party payers were injured by off-label promotion TwIqballed due to:   failure to plead that drugs were actually ineffective or unsafe, as opposed to unproven; failure plausibly to allege fairly traceable direct injury necessary for standing.  Mere volume of purchases is insufficient to state that plaintiff must have been injured by statistical prevalence of off-label use.  Specific purchases must be connected to specific acts.  Tortious interference claim inadequately pleaded (drug).
  47. In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2010 WL 2464746 (D.N.J. June 9, 2010).  Consumer fraud claim TwIqballed due to:   failure to plead any nexus between the alleged misconduct and the plaintiff’s prescriber.  Incorporation by reference of allegations made in other proceedings does not suffice, where plaintiff has not pleaded injury to himself (drug).
  48. Kester v. Zimmer Holdings, 2010 WL 2696467 (W.D. Pa. June 16, 2010), second motion granted, 2101 WL 4103553 (W.D. Pa. Oct. 18, 2010).  Negligence claims TwIqballed due to:  failure to plead facts concerning product identification or the applicability of the discovery rule tolling the statute of limitations.  Express warranty claim TwIqballed due to: failure to plead any facts establishing the nature of the warranty (drug).
  49. Steen v. Medtronic, Inc., 2010 WL 2573455 (N.D. Tex. June 25, 2010).  Strict liability, negligence, and warranty claims TwIqballed due to:  failure to support legal conclusions with factual allegations.  Res ipsa was not plausibly pleaded because the plaintiff’s surgeon, not the defendant, allegedly implanted the product that later dislodged (device).
  50. Vice v. Sgalrato Medical, Inc., 2010 WL 2942652, slip op. (W.D. La. July 21, 2010).  Plaintiff’s pleading of the discovery rule/fraudulent concealment as a defense to the statute of limitations TwIqballed due to:  failure to support legal conclusions with factual allegations.
  51. In re Actimmune Marketing Litigation, 2010 WL 3463491 (N.D. Cal. Sept. 1, 2010).  California consumer fraud claims TwIqballed due to:   formulaic pleading of reliance by prescribing physicians.  Missouri consumer fraud claims TwIqballed due to:   failure to plead reliance upon illegal activity (drug).
  52. Bass v. Stryker Corp., 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010).  Parallel violation claims in PMA device case TwIqballed due to:  unelaborated allegations that make no attempt to relate the alleged violations to the PMA or the product.  Plaintiff failed to plead what regulation the defendant violated (device).
  53. Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010).  Parallel violation claims in PMA device case TwIqballed due to:  failure to plead “device-specific” violation or a “cognizable link” to the plaintiff’s injuries.  Express warranty claim TwIqballed due to failure to plead the warranty or how it was breached (device).
  54. Forslund v. Stryker Corp., 2010 WL 3905854 (D. Minn. Sept. 30, 2010).  All product liability claims in medical device case TwIqballed due to failure to plead defect (device).
  55. Maness v. Boston Scientific, 751 F. Supp.2d 962 (E.D. Tenn. Nov. 4, 2010).  Product liability claims against non-PMA medical device TwIqballed for failure to plead facts establishing:  (1) the product was defective and/or unreasonably dangerous, (2) the defect existed at the time the product left the manufacturer’s control, and (3) the plaintiff’s injury was proximately caused by the defective product.  Pleading injury from a product is not enough, nor is merely pleading the legal conclusion “defective.”  Plaintiff must plead a specific problem with the product.  Pleading a recall is insufficient without facts tying it to the plaintiff’s injuries.  TwIqbal applies to complaints filed in state court and removed to federal court (device).
  56. Bishoff v. Medtronic, Inc., 2010 WL 4852650, slip op. (N.D.W. Va. Nov. 22, 2010).   Parallel violation claims in PMA device case TwIqballed due to:  failure to plead “how or why” there was noncompliance with FDA regulations.  Express warranty claim TwIqballed due to no allegations establishing that the defendant had warranted that its “product met safety standards exceeding the requirements of the PMA process” (device).
  57. Adams v. Stryker Pain Pump Corp., 2010 WL 4909564, slip op. (D. Minn. Dec. 1, 2010).  All claims TwIqballed despite “liberal construction” of pro se prisoner complaint.  Strict liability:  no facts pleaded why device was unreasonably dangerous for its intended use.  Failure to warn:  no facts pleaded (1) that defendant promoted the device for the intended use in question, (2) no facts pleaded that the defendant gave a warning to plaintiff’s surgeon, (3) no facts pleaded that the defendant had reason to know its device was dangerous for the intended use (device).
  58. Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. Jan. 25, 2011) .  TwIqbal dismissal affirmed.  In a manufacturing defect claim involving PMA preemption, plaintiffs must plead how the manufacturing process failed, how it deviated from FDA specifications, and the the causal connection between the violation and the plaintiff.  Affirming Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009) (device).
  59. Rojas v. Qualitest Pharmaceuticals Inc., 2011 WL 334671 (E.D. La. Jan. 28, 2011).  All claims in prescription drug case TwIqballed due to failure to plead product identification (drug).
  60. Cohen v. Guidant Corp., 2011 WL 637472, slip op. (C.D. Cal. Feb. 15, 2011).  Violation claims in PMA device case TwIqballed due to:  failure to plead more than “boilerplate” violation and failure to plead causation.  Plaintiff failed to plead any injury because his device had not failed.
  61. Johnson v. Moog, Inc., 2011 WL 719600 (E.D. Tex. Feb. 22, 2011).  All claims in medical device case TwIqballed due to:  Pleading only that unknown “defendants” committed actions, failure to plead product identification.
  62. Llado-Carreno v. Guidant Corp., 2011 WL 705403 (S.D. Fla. Feb. 22, 2011).  All claims in medical device case TwIqballed due to:  failure to plead more than “boilerplate” violation and failure to plead causation. Plaintiff failed to plead any injury because his device had not failed and no physical harm is claimed.   Warranty claims did not allege what warranty was.
  63. Nimtz v. Cepin, 2011 WL 831182 (S.D. Cal. Mar. 3, 2011), dismissed with prejudice, 2011 WL 2160181 (S.D. Cal. June 1, 2011).  Manufacturing, design, and warning claims TwIqballed due to:  failure to plead more than “legal conclusions” concerning the elements of the causes of action.  There is no allegation how the product was inadequately designed or manufactured.  To state a plausible claim for failure to warn, a complaint should at least identify which danger was not warned against, that the danger was substantial, that the danger was not readily recognizable to an ordinary consumer, that the manufacturer knew or should have reasonably known of the danger, and causation.
  64. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011). All claims in prescription drug case TwIqballed due to:  failure to allege injury.
  65. Bloom v. Depuy Orthopaedics, Inc., 2011 WL 1135753 (D. Md. March 25, 2011).  All claims in medical device case TwIqballed due to:  failure to plead anything more than a malfunction, failure to plead which of several components was defective, whether the defect was in design or manufacture, or how a non-defective product would have worked differently.  A failure to obtain approval claim did not allege what should have been approved and how.  Warranty claims did not allege what warranty was.
  66. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011).  Violation claims in PMA device case TwIqballed due to:  failure to plead violation of device-specific GMP regulation, and failure to plead causation.  Neither a particular regulation nor the nature of the violation was pleaded.
  67. Rhynes v. Stryker Corp., 2011 WL 2149095 (N.D. Cal. May 31, 2011).  Punitive damages claims in PMA device case TwIqballed due to:  failure to plead facts establishing heightened intent required for such damages.
  68. McFarland v. APP Pharmaceuticals, LLC, 2011 WL 2413797 (W.D. Wash. June 13, 2011).  All claims in prescription drug/medical device case TwIqballed due to failure to identify the product’s manufacturer.
  69. Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595 (W.D. Tex. June 23, 2011).  Product liability claims in prescription drug case TwIqballed due to:  failure to allege defect or that the prescriber relied on inadequate warnings.
  70. Singleton v. Eli Lilly Co., 2011 WL 2621067 (E.D. Cal. June 29, 2011).  All claims in prescription drug case TwIqballed due to failure to identify the product’s manufacturer.
  71. King v. Pfizer Pharmaceutical Co., 2011 WL 3157305 (D. Md. July 25, 2011).  FDCA violation claims in prescription drug case TwIqballed for not involving the product plaintiff took.
  72. O’Brien v. Intuitive Surgical, Inc., 2011 WL 3040479 (N.D. Ill. July 25, 2011).  All claims in medical device case TwIqballed due to failure to plead causation.
  73. Rollins v. Wackenhut Services Inc., 802 F. Supp.2d 111 (D.D.C. Aug. 10, 2011).  All claims in prescription drug case TwIqballed due to:  failure to plead more than “legal conclusions” concerning the elements of the causes of action.  The plaintiff’s own allegations defeat a suicide warning claim.  Plaintiff pleaded no facts to bring a comment k case.
  74. Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, slip op. (D. Ariz. Aug. 11, 2011).  All claims in prescription drug case TwIqballed due to:   the failure of plaintiff’s “generic boilerplate” allegation to tie the defendants’ conduct to the plaintiff.  No allegations of prescribing physician reliance.  No allegations how the warning was inadequate.
  75. Tillman v. Taro Pharmaceutical Industries Ltd., 2011 WL 3704762 (N.D. Ill. Aug. 17, 2011).  All claims in prescription generic drug case TwIqballed due to:   pleading only formulaic elements of claims.  The contents of the claimed express warranty are not alleged.
  76. Salvio v. Amgen, Inc., 810 F. Supp.2d 745 (W.D. Pa. Aug. 18, 2011).  All claims in prescription drug case TwIqballed due to:  failure to plead more than “legal conclusions” concerning the elements of the causes of action.  The judicially noticed package insert eliminates any possible warning claim.  Failure to plead alternative design eliminates any possible design claim.  Claims for strict liability, warranty, testing and marketing not recognized by state law dismissed.
  77. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011).  All claims in PMA medical device case TwIqballed due to: failure to plead more than “conclusory statements and formulaic recitations.” Parallel violation claims TwIqballed for failure to specify what was violated, how it was violated, or how the violation allegedly injured plaintiff.
  78. Baldwin v. Zimmer, Inc., 2011 WL 3652411 (S.D. Ohio Aug. 19, 2011). All claims in PMA medical device case TwIqballed due to: failure to identify any specific defects or failures, and pleading only legal conclusions.
  79. Henderson v. Sun Pharmaceuticals Industries, Ltd., 809 F. Supp.2d 1373 (N.D. Ga. Aug. 22, 2011).  All claims  TwIqballed due to:  failure to identify the defendant that manufactured the product, and failure to allege FDCA violations that involved the plaintiff’s product.
  80. Patterson v. Novartis Pharmaceuticals Corp., 451 Fed. Appx. 495 (6th Cir. Aug. 23, 2011). Product identification allegation TwIqballed due to: use of “and/or” to create ambiguity concerning the product used.
  81. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011).  Parallel violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  82. Younker v. Ohio State University Medical Center, 2011 WL 4558922 (S.D. Ohio Sept. 29, 2011).  All product liability claims TwIqballed due to failure to allege any specific product defect.
  83. Cardenas v. Abbott Laboratories, 2011 WL 4808166, slip op. (N.D. Ill. Oct. 7, 2011).  All claims TwIqballed due to failure to allege any facts about plaintiffs beyond their state of residence and that they took the drug “several times.”
  84. Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011).  “Information and belief” allegations TwIqballed due to the allegations not being within the defendant’s sole knowledge.  Reliance on a study TwIqballed due to the plaintiff not having the same characteristics as the study subjects.  Warning defect claim TwIqballed due to failure to plead any facts (other than on information and belief) that an adequate warning would have changed the plaintiff’s prescriber’s treatment.
  85. Currier v. Stryker Corp., 2011 WL 4898501 (E.D. Cal. Oct. 13, 2011).  Manufacturing claim TwIqballed due to failure to allege how device deviated from intended design.  Implied warranty claim TwIqballed due to vague allegations concerning “defendants.”
  86. Hammonds v. Boston Scientific, Inc., 2011 WL 4978369 (W.D. Okla. Oct. 19, 2011).  All claims TwIqballed due to failure to allege that a defect existed in the plaintiff’s device.
  87. Esposito v. I-Flow Corp., 2011 WL 5041374 (E.D. Pa. Oct. 24, 2011).  All claims in pain pump case TwIqballed due to failure to plead facts concerning product identification.
  88. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  89. Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420 (W.D. Pa. Nov. 10, 2011).  Express warranty claim TwIqballed due to:  failure to plead the warranty or how it became part of the basis of the bargain.
  90. Tierney v. AGA Medical Corp., 2011 WL 7400469 (D. Neb. Nov. 18, 2011).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  91. In re Fosamax Products Liability Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011).  Manufacturing defect claim TwIqballed due to:  failure to plead nature of the defect.  Violation claim TwIqballed due to:  failure to link violation to drug plaintiff took.
  92. Callaway v. American Medical Systems, Inc., 2011 WL 7724268 (W.D. La. Dec. 8, 2011).  All claims TwIqballed due to:  Failure to allege that the defendant manufactured the product, failure to describe any particular defect, and failure to how the undefined defect caused injury.
  93. Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085 (C.D. Cal. Dec. 12, 2011).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  94. Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011).  All unpreempted claims in generic prescription drug case TwIqballed due to: pleading only formulaic elements of claims.
  95. Polk v. KV Pharmaceutical Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011).  All claims TwIqballed due to failure to plead any injury.
  96. Del Valle v. PLIVA, Inc., 2011 WL 7168620 (S.D. Tex. Dec. 21, 2011).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  97. Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862 (D. Md. Dec. 30, 2011).  Possibly unpreempted claim claim for failure to use alternative means of communication due to failure to allege causation under the learned intermediary rule.  Implied warranty claims TwIqballed due to failure to plead any facts.
  98. Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143 (S.D. Ga. Jan. 19, 2012).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  99. In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. Jan. 30, 2012).  All unpreempted claims in generic prescription drug case TwIqballed due to:   pleading only formulaic elements of claims.
  100. Deese v. Immunex Corp., 2012 WL 463722 (S.D. Miss. Feb. 13, 2012).  All claims in prescription drug case TwIqballed due to:   pleading only formulaic elements of claims.  Warning claims TwIqballed due to failure to allege causation under the learned intermediary rule.  Express warranty claim TwIqballed due to: failure to plead the warranty or how it became part of the basis of the bargain.
  101. Salvio v. Amgen, Inc., 2012 WL 517446 (W.D. Pa. Feb. 15, 2012). Package inserts mentioned in the complaint may be judicially noticed. In negligent failure to warn claim, a plaintiff must plead facts indicating that the physician did not receive the package insert. A design defect claim must plead an alternative design, not an alternative product.
  102. Viserta v. St. Jude Medical, Inc., 2012 WL 667814 (D.S.C. Feb. 29, 2012).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation. Violation claims TwIqballed for failure to allege causation from the violation.
  103. Bowman v. Wyeth, LLC, 2012 WL 684116 (D. Minn. March 2, 2012).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  104. In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 718618(E.D. Ky. March 5, 2012).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  105. Bartlett v. Pfizer, Inc., 2012 WL 718782 (D.R.I. March 5, 2012).  All claims TwIqballed due to failure to allege causation.  Violation claims TwIqballed for failure to allege causation from the violation.
  106. Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. March 14, 2012).  Negligence and res ipsa loquitur claims TwIqballed because they are too vague to establish what standard of care was breached.  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.  Broad references to federal regulations are insufficient to establish the duty element of a negligence state law claim which would parallel a violation of federal law.  Plaintiff must allege what regulations are violated and how.  Pleading res ipsa loquitur requires plaintiff to rule out other causes of injury, including medical malpractice.  Rejecting Hofts.  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty or how it became part of the basis of the bargain.
  107. Reed v. Pfizer Inc., 839 F. Supp.2d 571 (E.D.N.Y. March 14, 2012).  Package inserts mentioned in the complaint may be judicially noticed.  Warning claims TwIqballed due to failure to plead what the warning was or how it was inadequate, particularly since the precise risk was in fact warned of.  Design claims TwIqballed due to failure to plead any alternative design.  Manufacturing and express and implied warranty claims TwIqballed due to failure to allege any specific product defect.
  108. Metz v. Wyeth LLC, 872 F. Supp.2d 1335 (M.D. Fla. March 28, 2012).  Negligence per se claim TwIqballed due to:  failure to identify the allegedly violated regulation or that the violation was causal (drug).
  109. Cooley v. Medtronic, Inc., 2012 WL 1380265 (E.D. Ky. April 20, 2012).  Unpreempted medical device claims TwIqballed due to:  failure to allege any specific manufacturing defect.
  110. Eckhardt v. Qualitest Pharmaceuticals Inc., 858 F. Supp.2d 792(S.D. Tex. April 30, 2012).  Unpreempted generic drug claims TwIqballed due to:  failure to allege any specific manufacturing defect.
  111. Hammarlund v. Stryker Corp., 2012 WL 12868486 (S.D. Cal. July 16, 2012). Violation claims TwIqballed for failure to allege causation from the violation.
  112. Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697 (E.D. La. July 20, 2012).  Generic drug claims TwIqballed due to:  formulaic pleadings of all counts.  Express warranty claim TwIqballed due to failure to plead existence of any statement.
  113. Lilak v. Glaxosmithkline, LLC, 2012 WL 4443961 (D. Colo. July 23, 2012).  Negligence per se claims TwIqballed due to:  failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff.
  114. Lilak v. GlaxoSmithKline, LLC, 2012 WL 4478972 (D. Colo. July 23, 2012). Negligence per se claims TwIqballed due to: failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff.
  115. Lilak v. Astrazenca Pharmaceutical-US, Inc., 2012 WL 4444347 (D. Colo. July 23, 2012). Negligence per se claims TwIqballed due to: failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff.
  116. Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012).  Violation claims TwIqballed for failure to allege the violation or causation from the violation.
  117. In re Prempro Products Liability Litigation, 2012 WL 3985752 (E.D. Ark. Sept.11, 2012).  TwIqbal requires that claims of off-label promotion who, what, when, and where of the claimed promotion.  How the plaintiff’s doctor relied on the promotion so as to affect the plaintiff must be pleaded specifically.  Boilerplate reliance allegations will be dismissed.
  118. Buckley v. DJO Surgical, 2012 WL 4849368 (S.D. Cal. Oct. 11, 2012).  Product liability claims TwIqballed due to:  failure to specify defect.
  119. Bowdrie v. Sun Pharmaceutical Industries Ltd., 2012 WL 5465994, (E.D.N.Y. Nov. 9, 2012).  Strict liability, warranty, negligence per se, and fraud claims TwIqballed due to:  failure to allege a factual basis for allegations of FDCA violations.
  120. Rollins v. Wackenhut Services, Inc., 703 F.3d 122 (D.C. Cir. Dec. 28, 2012).  Design and manufacturing defect claims TwIqballed due to: formulaic pleadings.  Warning defect claim TwIqballed due to:  the risk at issue having a black box warning.  Off-label promotion and other allegations TwIqballed due to:  lack of relevance to this plaintiff’s claims.  TwIqbal applies to judgments on the pleadings under Rule 12(c).
  121. Harris v. Eli Lilly & Co., 2012 WL 6732725 (N.D. Ohio Dec. 28, 2012).  Express warranty claim TwIqballed due to failure to plead existence of the representation or how it was relied upon.  Boilerplate allegations of falsity and reliance must be disregarded.
  122. Aaron v. Novartis Pharmaceutical Corp., 2013 WL 790009, slip op. (W.D. Ky. March 4, 2013).  All claims TwIqballed due to:  formulaic pleadings.
  123. Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808 (S.D. Tex. March 12, 2013).  All claims TwIqballed due to: formulaic pleadings.  Warning claims TwIqballed due to:  failure to plead facts establishing warning causation under the learned intermediary rule and failure to plead facts establishing an exception to the Texas presumption of adequate warnings due to FDA approval.  Warranty claims are TwIqballed due to:  failure to state the warranty.
  124. Watson v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 1558328, slip op. (E.D. La. April 11, 2013).  All actual LPLA claims TwIqballed due to:   formulaic pleadings.  Neither the nature of the defect or causation is pleaded.  As to warnings, plaintiff also failed to plead having the conditions allegedly not warned about.
  125. Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013).  Manufacturing defect claim based on circumstantial malfunction TwIqballed due to failure to allege how alternative causes are ruled out.  Design defect claim TwIqballed due to failure to allege substantial risk or alternative design.  Alleging a recall is insufficient to allege a design defect.  Warning claim TwIqballed due to failure to allege how the warning was defective and how the physician relied on the defect.  Implied warranty claim TwIqballed due to failure to allege defect as previously described.  Express warranty claims are TwIqballed due to failure to state the warranty.  Other claims TwIqballed due to:   formulaic pleadings.
  126. Knoppel v. St. Jude Medical, Inc., 2013 WL 3803612 (C.D. Cal. May 7, 2013).  All claims TwIqballed due to failure to specify product defects or state how they caused injury.  Warranty claim TwIqballed due to failure to allege privity.
  127. Kwasniewski v. Sanofi-Aventis U.S., LLC, 2013 WL 2558283 (D. Nev. June 8, 2013).  All claims TwIqballed due to:   failure to plead causation.  Warning claim TwIqballed due to failure to allege what the warnings were, who received them, and how the warning was inadequate.
  128. Bertini v. Smith & Nephew, Inc., 2013 WL 6332684 (E.D.N.Y. July 15, 2013).  All claims TwIqballed due to: to formulaic pleadings.  The nature of the defect is not stated.  Merely pleading a recall without defect or causation allegations is insufficient.  No alternative design pleaded. Rejecting loose Bausch pleading standard.  Negligence allegations came “from some form book.”
  129. In re Pradaxa Products Liability Litigation, 2013 WL 3791509 (S.D. Ill. July 18, 2013).  Class action allegations TwIqballed due to formulaic pleadings.
  130. Batchelor v. Pfizer, Inc., 2013 WL 3873242 (N.D. Ala. July 25, 2013).  All claims TwIqballed due to:   to formulaic pleadings and failure to plead nature of injury and when plaintiff took the drug.  Warning claim TwIqballed due to failure to plead inadequacy as to treating physician and how warnings were inadequate.  Negligence claim TwIqballed due to failure to plead duty violated.  Negligence per se claim TwIqballed due to failure to identify what provision violated and how.  Warranty claim TwIqballed due to failure to plead what made drug unmerchantable.
  131. Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013).  Most claims (those not dismissed on the merits) TwIqballed due to:  formulaic pleadings that fail to specify the defect and lumping defendants together.  Negligence per se claims TwIqballed due to failure to identify the enactment violated.
  132. Marsar v. Smith & Nephew, 950 F. Supp.2d 1228 (M.D. Fla. Aug.14, 2013).  All claims TwIqballed due to:   indiscriminate incorporation by reference; lumping differently situated defendants together; and repetitive and irrelevant and redundant factual allegations.  Design defect claim TwIqballed due to lack of description of defect.  Negligence claim TwIqballed due to no facts how defendant knew or should have known of defect.  Warranty claim TwIqballed due to formulaic pleadings.
  133. Scianneaux v. St. Jude Medical, S.C., 961 F. Supp.2d 808 (E.D. La. Aug. 19, 2013).  All claims TwIqballed due to:   formulaic pleadings.  All claims except express warranty TwIqballed due to failure to plead claims under exclusive product liability statute.  FDCA violation claims TwIqballed due to failure to plead what regulation was violated and how.  A recall does not establish a violation.  Warranty claims TwIqballed due to failure to plead what the warranty was and how it was violated.
  134. Kennedy v. Pfizer, Inc., 2013 WL 4590331 (W.D. La. Aug. 28, 2013).  Manufacturing defect claim TwIqballed due to failure to state how the product was not what the manufacturer intended to make.  Design defect claim TwIqballed due to failure to plead how the product was defective or caused injury.  Warning defect claim TwIqballed due to failure to plead the defect, causation, or who prescribed the product.  Express warranty claim TwIqballed due to failure to plead what was false about the defendant’s promotion.
  135. Bueno v. St. Jude Medical Inc., 2013 WL 12142536 (C.D. Cal. Sept. 24, 2013).  All parallel claims TwIqballed due to:  failure to plead the nature  of the injury so that causation by the violation could be evaluated.
  136. McPhee v DePuy Orthopedics, Inc., 2013 WL 5462762, slip op. (W.D. Pa. Sept. 30, 2013).  All unpreempted claims TwIqballed due to:  failure to allege what FDCA violations were violated, or how, and failure to plead what the express warranty was and how it was violated.
  137. Bradley v. Baxter Healthcare Corp.,  2013 WL 5952060 (W.D.N.C. Nov. 6, 2013).  All unpreempted claims TwIqballed due to: failure to allege what FDCA violations were violated.
  138. Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489 (M.D. Pa. Dec. 2, 2013).  Warning claims TwIqballed due to failure to plead causation.  No facts support an allegation that a different warning would have affected the prescriber’s conduct so as to alter the result.
  139. Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395, (S.D.N.Y. Dec. 3, 2013).  Strict liability design claims fail to plead any alternative design.  Alleging that the defendant “could have manufactured a different product altogether . . . does not itself make out a plausible claim of a design defect.”  Negligence and warranty design claims TwIqballed due to formulaic pleadings.  Pleading a recall does not plead a defect.
  140. Christison v. Biogen Idec, Inc., 2013 WL 6834371 (D. Utah Dec. 26, 2013).  Warning claims TwIqballed due to formulaic pleadings.  Plaintiff must plead what information made the warnings inadequate at the time the drug was taken and how adequate warnings would have affected the prescriber’s decision.
  141. Witt v. Howmedica Osteonics Corp., 2013 WL 6858395 (S.D. Fla. Dec. 30, 2013).  All claims TwIqballed as “shotgun” pleadings due to indiscriminate incorporation by reference.  Design defect claim TwIqballed due to failure to plead what component of a “complex” product was defective and how.  Warning defect claim TwIqballed due to failure to address the product’s warnings.  Negligence claim TwIqballed due to formulaic pleadings and failure to plead facts about alleged lapses of due care.
  142. Wells v. Allergan, Inc., 2014 WL 117773, slip op. (D.S.C. Jan. 13 2014).  Parallel violation claim in PMA preemption case TwIqballed due to failure to plead the particular defect, the regulation violated, or causation as to any claimed FDCA violation.
  143. Poll v. Stryker Sustainability Solutions, Inc., 2014 WL 199150 (D. Ariz. Jan. 17, 2014), post-Stengel warning claim asserting failure to submit adverse events to the FDA TwIqballed due to failure to identify the unreported information or the nature of the adverse events, or to identify any FDA action supporting the non-reporting allegations.
  144. Hawkins v. Medtronic, Inc., 2014 WL 346622, slip op. (E.D. Cal. Jan. 30, 2014).  Failure to report claims TwIqballed due to failure to plead causation.  There is no showing the timing of late reports influenced the plaintiff’s treatment.  Violation claims TwIqballed due to failure to identify the enactments violated.
  145. Kashani-Matts v. Medtronic, Inc., 2014 WL 819392 (C.D. Cal. Feb. 14, 2014).  Parallel claims in PMA medical device preemption case TwIqballed due to: failure to plead any supporting facts.
  146. Starks v. Coloplast Corp., 2014 WL 617130, slip op. (E.D. Pa. Feb. 18, 2014).  All unpreempted claims TwIqballed.  Parallel violation claim in PMA preemption case TwIqballed as boilerplate.  Express warranty claims TwIqballed due to failure to plead the warranty, how it was made, how it became part of the basis of the bargain, or how it was directed to plaintiff.  Contract claims TwIqballed due to failure to plead how a sales brochure was a contract.
  147. Kitchen v. Biomet, Inc.,  2014 WL 694226 (E.D. Ky. Feb. 21, 2014).  All unpreempted claims TwIqballed. Parallel violation claim in PMA preemption case TwIqballed because nature of the claimed violation was not specified.
  148. Plumlee v. Pfizer, Inc., 2014 WL 695024 (N.D. Cal. Feb. 21, 2014).  Allegations of delayed discovery TwIqballed.  Case dismissed on statute of limitations grounds.
  149. Swisher v. Stryker Corp., 2014 WL 1153716 (W.D. Okla. March 14, 2014). Negligence per se allegation asserted as parallel claim in PMA preemption case TwIqballed due to failure to state how FDA regulations were violated and how the violations caused injury.
  150. Burkett v. Smith & Nephew GMBH, 2014 WL 1315315, slip op. (E.D.N.Y. March 31, 2014).  Parallel violation claims in PMA preemption case TwIqballed due to failure to state what FDA regulations were violated and how the violations caused injury.
  151. Dilley v. C.R. Bard, Inc., 2014 WL 1338877 (C.D. Cal. April 3, 2014).  Manufacturing defect claims TwIqballed due to formulaic pleadings.  Warning defect claims TwIqballed due to failure to identify the allegedly defective warnings.
  152. Vasquez v. Gloucester County, 2014 WL 1599499 (D.N.J. April 21, 2014).  Design defect claims TwIqballed due to failure to plead an alternative design.  Punitive damages claim TwIqballed due to failure to plead any New Jersey exception that would allow a claim against an FDA-approved product.
  153. Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014).  Parallel violation claims in PMA preemption case TwIqballed due to failure to state how the alleged violation corresponded to any state-law defect and for failure to plead causation.  Plaintiffs not entitled to discovery until TwIqbal is satisfied.
  154. Miller v. Pfizer, Inc., 2014 WL 2155020 (N.D. Ala. May 22, 2014).  All claims TwIqballed due to failure to plead how the defendant’s warnings were inadequate.  Although not attached to the complaint, drug warnings alleged to be inadequate were properly before the court on a motion for judgment on the pleadings under the incorporation by reference doctrine.
  155. Smith v. Medtronic, Inc., 2014 WL 2547813, slip op. (W.D. La. June 4, 2014).  Parallel violation claims in PMA preemption case TwIqballed due to conclusory allegations.  Plaintiff failed to plead how the defendant promoted the product off-label to her physician or how such promotion caused her injuries.
  156. Arnold v. Alphatec Spine, 2014 WL 2896838 (S.D. Ohio June 26, 2014).  TwIqballed due to Allegations against all defendants TwIqballed due to failure to plead allegations against different defendants separately.  All claims TwIqballed due to conclusory assertions and the rambling, disorganized, and undecipherable nature of the complaint.  Particularity is not the same as prolixity.
  157. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. June 27, 2014).  A parallel misbranding claim requires pleading of the new and scientifically significant information in the hands of the defendant that was not before the FDA.  Allegations based on “information and belief” TwIqballed due to a plaintiff’s belief not providing a plausible basis for anything.
  158. Lirette v. Depuy Mitek LLC, 2014 WL 3341358, slip op. (W.D. La. July 7, 2014).  All claims TwIqballed due to formulaic pleadings.
  159. Dimieri v. Medicis Pharmaceuticals Corp., 2014 WL 3417364 (M.D. Fla. July 14, 2014).   All claims TwIqballed due to formulaic pleadings. Warning defect claims TwIqballed due to failure to plead physician involvement required by learned intermediary rule.
  160. McElroy v. Amylin Pharmaceuticals, Inc., 573 F. Appx. 545 (6th Cir. Aug. 5, 2014).  All claims TwIqballed due to failure to plead causation of plaintiff’s injuries by the drug.
  161. Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014).  Unpreempted express warranty claim TwIqballed due to formulaic pleadings.
  162. Kennedy v. Pfizer, Inc., 2014 WL 4093065, slip op. (W.D. La. Aug. 15, 2014).  All claims TwIqballed due to formulaic pleadings.  Manufacturing defect claim did not allege how product deviated from specifications.  Design defect claim did not allege alternative design or how risks outweighed benefits.  Warning defect claim did not allege causation under learned intermediary rule.  Express warranty claim did not allege the warranty.
  163. Carlson v. Medtronic Inc., 2014 WL 11514911 (S.D. Miss. Aug. 28, 2014).  Possibly unpreempted manufacturing defect claim TwIqballed due to vagueness. Complaint did not identify allegedly violated regulation, state how the product deviated from FDA requirements, or allege how the violation caused plaintiff’s injury.
  164. Rodman v. Stryker Sales Corp., 2014 WL 5002095 (S.D.N.Y. Oct. 7, 2014).  All claims TwIqballed due to failure to plead defect or causation.  “Including but not limited to” does not plead a specific defect.  Pleading a remote in time recall does not plead defect.  Affirmed 604 F. Appx. 81 (2d Cir. May 21, 2015) – plaintiff failed adequately to allege how his device was defective and how any defect caused his injuries.
  165. Lirette v. Depuy Mitek LLC, 2014 WL 5445777 (W.D. La. Oct. 20, 2014).  Manufacturing defect claim TwIqballed due to formulaic pleading.
  166. Lindler v. Mentor Worldwide LLC, 2014 WL 6390307, slip op. (D.S.C. Oct. 23, 2014).  Express warranty claim TwIqballed due to formulaic pleading.
  167. Mallory v. Biomet, Inc., 2014 WL 6890740 (M.D. Ala. Dec. 4, 2014).  All claims TwIqballed due to formulaic pleadings.  A broken device without more does not state a claim.
  168. Becker v. Smith & Nephew, 2015 WL 268857 (D.N.J. Jan. 20, 2015).  All claims barred as formulaic pleadings failing to establish the elements of product liability claims under the NJ product liability statute.  Manufacturing defect must plead deviation from intended result.  Design defect must specify defect and address risk utility factors.  Warning claim must state nature of inadequate warning, that the risk was known to exist and was not obvious, and causation.  The warranty language for an express warranty is not pleaded.  Dismissed a second time, 2015 WL 4647982 (D.N.J. Aug. 5, 2015), violation claims TwIqballed due to failure to specify violated enactments; express warranty TwIqballed due to formulaic pleadings.
  169. Shells v. X-Spine Systems, Inc., 2015 WL 736981 (W.D. Okla. Feb. 20, 2015).   All claims TwIqballed due to formulaic pleadings.  The complaint does not even allege what the medical device is or who manufactured it.  “Probably” is not enough.  The nature of the alleged defect is not specified.
  170. Lonon v. Globus Medical, Inc., 2015 WL 1032861 (S.D. Ga. March 9, 2015).  All claims TwIqballed due to formulaic “shotgun” pleading.  The type and model of the product must be identified.  How the product was defective is not pleaded.  The type of warranty is not specified.
  171. Jackson v. St. Jude Medical Neuromodulation Division, 2015 WL 1456650, slip op. (M.D. Fla. March 30, 2015).  All claims, including purported “parallel” claims in PMA preemption case TwIqballed due to formulaic pleadings.
  172. Mendez v. Shah, 94 F. Supp.3d 633 (D.N.J. March 30, 2015).  Express warranty TwIqballed due to formulaic pleadings.
  173. Morton v. Allergan, Inc.,  2015 WL 12839493 (D.N.J. April 2, 2015).  All unpreempted claims involving PMA medical device TwIqballed due to formulaic pleadings.  Express warranty claim did not state terms of warranty.  Manufacturing defect claims stated no facts.
  174. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. April 21, 2015).  Warranty claims TwIqballed due to formulaic pleadings.
  175. Williams v. CIBA Vision Corp., 2015 WL 1903429 (S.D. Miss. April 27, 2015).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, plead an FDCA violation other than with formulaic conclusions.   Plaintiff’s unsupported “belief” is insufficient.
  176. Mercado v.  Bayer Healthcare Pharmaceuticals, Inc., 2015 WL 3545238, slip op. (N.D. Ill. June 5, 2015).  All claims, including express warranty, TwIqballed due to formulaic pleadings.
  177. Clements v. Sanofi-Aventis, U.S., Inc., 2015 WL 3648911 (D.N.J. June 11, 2015).  Parallel violation claims TwIqballed due to failure to specify the violation or causation.  Express warranty claims TwIqballed due to formulaic pleadings, including failure to state what the alleged warranty said.
  178. Doe v. AstraZeneca Pharmaceuticals, LP, 2015 WL 4661814, slip op. (E.D. La. Aug. 5, 2015).  All non-preempted claims TwIqballed due to formulaic pleadings.  Warning claims must plead the specific adverse effect allegedly not adequately warned of and why the warning was inadequate.  Express warranty must plead the specific promise or representation and how the product failed to conform.  John Doe complaints are not allowed.
  179. Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015).  Parallel violation claims TwIqballed due to:  failure to plead factual basis for claims of violation of GMPs, and lack of support by any FDA action.  Warranty claims also inadequately pleaded.
  180. Blair v. Medtronic, Inc., 2015 WL 5728050 (N.D. Cal. Sept. 30, 2015).   All claims TwIqballed due to formulaic pleadings.  Form state-court complaint was “epitome” of “threadbare” pleading barred under Rule 8.
  181. Nevolas v. Boston Scientific Corp., 2016 WL 347721 (W.D. Okla. Jan. 28, 2016).  Parallel violation claims TwIqballed due to:  vague pleading of violations of multiple, generally-applicable FDA regulations.  Confidentially of PMAs does not excuse conclusory pleading.  Dismissed with prejudice for same flaws after amendment, 2016 WL 1532259 (W.D. Okla. April 15, 2016).  On appeal at NO. 16-6127 (10th Cir.).
  182. Tsavaris v. Pfizer, Inc., 2016 WL 375008 (S.D. Fla. Feb. 1, 2016).  Design defect claim TwIqballed due to formulaic pleadings.  Warning claim TwIqballed due to failure to plead what was in the existing warning and why that was inadequate or exactly how the warning should have been rewritten.  Plaintiff failed to plead how dual compliance with state and federal law was possible to avoid preemption.
  183. Ellis v. Smith & Nephew, Inc., 2016 WL 7319397 (D.S.C. Feb. 16, 2016).  Parallel violation claims TwIqballed due to: failure to plead the nature of the violation or causation.  Express warranty claim TwIqballed due to formulaic pleadings.  Plaintiff not entitled to discovery.
  184. Guidry v. Janssen Pharmaceuticals, 2016 WL 633673 (E.D. La. Feb. 17, 2016).  All claims TwIqballed due to formulaic pleadings.  No facts support a deviation for a manufacturing defect.  Nature of design defect and how it could have been cured not pleaded.  No allegation how warning was inadequate.  No allegation that plaintiff suffered the condition mentioned in an FDA safety announcement.  No allegation of reliance or causation as to warranty.
  185. Felger v. Smith & Nephew, Inc., 2016 WL 8673054 (D. Alaska March 4, 2016).  Parallel violation claims TwIqballed due to:  formulaic pleadings that fail to identify what regulations were violated or whether adverse events were, in fact, not reported.
  186. Brazil v. Janssen Research & Development LLC, 249 F. Supp.3d 1321 (N.D. Ga. March 24, 2016).  All claims TwIqballed due to formulaic pleadings and lumping all defendants together.  Lumping all defendants together also precluded any allegations from supporting personal jurisdiction over any of the defendants.
  187. Schmidt v. Boston Scientific Corp., 2016 WL 1274824 (N.D. Ohio March 31, 2016).  Parallel violation claims TwIqballed due to:  failure to identify any allegedly violated regulations.
  188. Weddle v. Smith & Nephew, Inc., 2016 WL 1407634 (N.D. Ill. April 11, 2016).  All claims TwIqballed due to:  product identification – failure to identify which of three manufacturer’s implanted products failed.
  189. Yosowitz v. Covidien LP, 182 F. Supp.3d 683 (S.D. Tex. April 23, 2016).    Parallel violation claims TwIqballed due to:  failure to identify the allegedly violated regulations, describe the violations, or plead how they were causal.
  190. Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).  Unpreempted failure-to-update claims TwIqballed due to:  lumping differently situated “defendants” together in overly broad causation allegations.
  191. Adams v. Stryker Orthopaedics, 2016 WL 2993213 (S.D.N.Y. May 23, 2016).  All claims TwIqballed due to:  failure to allege the product problem claimed to make it defective, whether a defect affected the device the plaintiff received or how a defect caused plaintiff’s injuries.
  192. Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp. 3d 826 (W.D. Tenn. June 6, 2016).  All claims TwIqballed due to:  formulaic pleadings.  Description of how drug works does not plead defect.
  193. Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. June 30, 2016).  “Information and belief” allegations TwIqballed where facts were within plaintiff’s control.  Express warranty claims TwIqballed due to failure to plead the specific promise or representation.  Parallel violation claims TwIqballed due to failure to plead causation from FDA actions.
  194. Chiasson v. Medtronic Inc., 2016 WL 4191837 (E.D. La. Aug. 9, 2016).  Parallel violation claims TwIqballed due to:  due to formulaic pleadings.  Because of the potential for preemption, courts require greater specificity in pleading parallel claims.
  195. Morrison v. Hoffmann-La Roche, Inc., 2016 WL 5678546 (E.D.N.Y. Sept. 29, 2016).  Allegations in briefs but not in the complaint are ignored.  All claims TwIqballed due to:   lumping differently situated defendants together and formulaic pleadings.  Design claims must allege alternative design.  Manufacturing claims must allege deviation from intended result.  Negligence requires allegation of duty.  Express warranty must specify the warranty.
  196. Moore v. C.R. Bard, Inc., 217 F. Supp.3d 990 (E.D. Tenn. Nov. 14, 2016).  All claims TwIqballed due to conclusory pleadings.  Product liability claims must plead what was wrong with the product and how it caused the plaintiff’s injury.  The composition of the product is insufficient.  That injury followed implantation is insufficient.  Manufacturing defect claims must allege the error in production.  Allegations cannot lump differently situated defendants together.
  197. Perry v. Boston Scientific Family, 2016 WL 10637082 (D. Minn. Dec. 1, 2016).  All claims TwIqballed due to conclusory pleadings.
  198. Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016).  Parallel violation claims, including failure to report, TwIqballed due to failure to plead causation from FDA actions.
  199. House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017).  All claims TwIqballed due to:  formulaic pleadings.
  200. Cure v. Intuitive Surgical, Inc., 2017 WL 498727, slip op. (N.D. Ga. Jan. 31, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.
  201. Mikesell v. St. Jude Medical, Inc., 2017 WL 9565366 (Mag. N.D. Ind. Feb. 2, 2017).  Parallel violation claims TwIqballed due to conclusory pleadings.  Adopted 2017 WL 655862 (N.D. Ind. Feb. 17, 2017).
  202. Lawrence v. Medtronic, 2017 WL 826963 (C.D. Cal. Feb. 27, 2017).  Parallel violation claims TwIqballed due to conclusory pleadings.  Parallel claims, including failure to report, must plead the actual violation and causation.
  203. Agee v. Alphatec Spine, Inc., 2017 WL 5706002 (S.D. Ohio March 27, 2017), aff’d, 711 F. Appx. 791 (6th Cir. Feb. 22, 2018).  All claims TwIqballed due to:  prolix and confusing pleadings that make it difficult to formulate a responsive pleading.
  204. Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. March 31, 2017).  Common-law warning claims TwIqballed due to conclusory pleadings.  Plaintiffs failed to plead contents of warnings, inadequacy, timing of use of drug, timing of injuries, warning causation, injury, or injury causation.  Express warranty claims TwIqballed due to failure to state the warranty.
  205. Webb v. Stryker Corp., 2017 WL 1406899 (W.D. Pa. April 20, 2017).  Negligent design and manufacturing claims TwIqballed due to:  due to conclusory pleadings – failure to specify which component was defective or how manufacturing process went wrong.  Failure to allege causation – claimed propensity to loosen could not have caused infection.
  206. Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  Belated facts stated in briefing did not substitute for proper pleading.
  207. Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504 (E.D. La. June 1, 2017).   All claims TwIqballed due to:  due to formulaic pleadings.  Manufacturing claims must identify a deviation from the defendant’s specifications and plead causation.  Warning claims must identify risks not disclosed to the prescribing doctor, and how the omission was causal.  Express warranty claims must identify the warranty, state how it was untrue, and include facts indicating reliance.
  208. Bigsby v. Davol Inc., 2017 WL 2472274 (S.D. Ind. June 8, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.
  209. Jeffries v. Boston Scientific Corp., 2017 WL 2645723 (D. Md. June 20, 2017).  All claims TwIqballed due to failure to allege causation.  Design, manufacturing, and implied warranty claims TwIqballed due to failure to allege a defect.  Warning claims TwIqballed due to failure to allege what warnings were defective and how.
  210. Golden v. Brown, 2017 WL 3272368 (Colo. Dist. June 27, 2017).  Colorado follows TwIqbal.  All claims TwIqballed due to failure to allege product identification.  Recall-based claims TwIqballed due to failure to allege that plaintiff had the recalled product.  Parallel violation claims TwIqballed due to failure to allege what regulations were violated.  Failure to report claims TwIqballed due to failure to allege what was not reported or causation.  Express and implied warranty claims TwIqballed due to formulaic pleadings.
  211. Freed v. St. Jude Medical, Inc.,  2017 WL 4102583 (D. Del. Sept. 15, 2017).   Parallel violation claims TwIqballed due to conclusory pleadings.  No specific violations alleged.  No basis for alleging “adulterated” device.  Documents attached to briefs cannot be considered.
  212. Sich v. Pfizer Pharmaceutical, 2017 WL 4407930 (D.N.J. October 4, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  Neither the nature of any defect nor the terms of any warranty are alleged.
  213. Griffin v. Medtronic, Inc., 2017 WL 4417821 (N.D. Ill. Oct. 5, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  Complaint lacked any description of defect or causation, including prescriber causation under learned intermediary rule.  “[T]he allegations of undisclosed warnings are too vague to establish that [defendant] failed to disclose anything to [plaintiff’s] doctors that they did not already know.”  Warranty claims required the warranty language and how product was unmerchantable.
  214. Wright v. Howmedica Osteonics Corp., 2017 WL 4555901 (M.D. Fla. Oct. 12, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  A recall does not equal a defect.  Warning claims must plead causation.  On appeal at No. 17-15685.
  215. Martin v. Medtronic, Inc., 2017 WL 4574160 (E.D. Cal. Oct. 13, 2017).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead an FDCA violation involving the plaintiff’s device, and failure to allege any adverse events that were not reported.  Express warranty claims fail to plead the terms of the warranty or reliance.
  216. Cerniglia v. Zimmer, Inc., 2017 WL 4678201 (D.N.J. Oct. 17, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.
  217. Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630, slip op. (D. Neb. Dec. 12, 2017).  Warning claim (the sole claim remaining) TwIqballed due to:  failure, in a preemption case, to plead any facts establishing that information relevant to the claim was “newly acquired” after the product’s approval, so that it would qualify for the CBE exception to preemption.
  218. Owen v. Dr. Reddy’s Laboratories, 2017 WL 6820197 (W.D.N.C. Dec. 13, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.
  219. Douse v. Boston Scientific Corp., 2017 WL 9672522, slip op. (M.D. Fla. Dec. 18, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.
  220. Smith v. Medtronic, Inc., 2018 WL 921986 (D. Kan. Jan. 12, 2018).  Recall based claim TwIqballed due to failure to plead that the recall applied to the plaintiff’s product.
  221. McGuire v. NorthBay Medical Center, 2018 WL 453736 (E.D. Cal. Jan. 16, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Defendant joined in obviously irrelevant claims.  No pleading of specific product, nature of defect, causation, or nature of warranty.
  222. Black v. Covidien, PLC, 2018 WL 573569 (W.D.N.Y. Jan. 26, 2018).  All claims TwIqballed due to:  formulaic pleadings.  Causation not adequately alleged as to design or warning defects.
  223. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 928237 (W.D. Pa. Feb. 15, 2018).  All claims TwIqballed due to:  formulaic pleadings.  Description of how drug works does not plead defect.  Roles of each defendant not pleaded.  How and why the product was defective not pleaded.  Alternative design and causation not pleaded.
  224. McGee v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 1399237 (N.D. Ala. March 20, 2018).  All claims TwIqballed due to:  formulaic pleadings.  Much of the complaint simply “spews legal conclusions.”  Warning claim, in order to avoid preemption, must plead what newly acquired information was not warned of.
  225. Tutwiler v. Sandoz, Inc., 726 Fed. Appx. 753 (11th Cir. April 9, 2018).  Dismissal affirmed because warning claim TwIqballed due to failure to plead causation under the learned intermediary rule.  Plaintiff must plead, in more than a conclusory fashion, why an adequate warning would have caused the treating physician not to prescribe the drug.
  226. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 2447788 (W.D. Pa. May 31, 2018).  All claims TwIqballed due to:  formulaic pleadings.  What new information the defendant learned that should have changed the warning not pleaded.  Nor what a revised warning should have said, nor causation.  No alternative design pleaded, only different products.
  227. Oden v. Boston Scientific Corp., 330 F. Supp.3d 877 (E.D.N.Y. June 4, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Design claims must plead nature of defect and a feasible alternative design.  A different product cannot be an alternative design.  Manufacturing defect claim must allege what deviated from specifications.  Warning claim failed to identify how or why the warnings were inadequate.  Plaintiff’s actual injuries not alleged so cannot be matched against warnings.  Prescriber-specific facts must be alleged to establish causation by inadequate warning.  Language, reliance, and breach of express warranty must be alleged.  Implied warranty fails when defect claims fail.  Particular purpose warranty must plead a particular purpose other than the product’s ordinary purpose.  Causation not pleaded for consumer protection claim.
  228. Weaver v. Ethicon, Inc., 737 F. Appx. 315 (9th Cir. June 12, 2018).  Affirming all claims being TwIqballed.  Manufacturing defect claim TwIqballed due to failure to plead use of recalled product or nature of defect.  Failure to report TwIqballed due to failure to plead a causal failure to report.  Prescriber had access to one allegedly unreported incident and used the product anyway, and the plaintiff’s own incident could not possibly be causal.
  229. Pellegrin v. C.R. Bard, 2018 WL 3046570 (E.D. La. June 20, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning claim must plead causation, including that the prescriber would not have prescribed.  Design claims must plead nature of defect and a feasible alternative design.
  230. Quashie v. Olympus America, Inc., 315 F. Supp.3d 1329 (N.D. Ga. June 19, 2018).  All claims TwIqballed due to failure to plead separate allegations against differently situated defendants.
  231. Proffitt v. Bristol-Myers Squibb Co., 2018 WL 3318893, slip op. (S.D.W. Va. July 5, 2018).  Warning claims TwIqballed due to failure to plead how the warnings were inadequate or what an alternative should say.
  232. Murphy v. Boston Scientific Corp., 2018 WL 4870700 (Mag. M.D. La. July 12, 2018).  Parallel claims in PMA device case claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff failed to plead any specific defect that violated any particular FDA requirement and failed to plead causation.  Express warranty also not pleaded.  Adopted as to TwIqbal issues; rejected on not giving plaintiff a chance to amend, 2018 WL 6046178 (M.D. La. Nov. 19, 2018).
  233. Quintana v. B. Braun Medical, Inc., 2018 WL 3559091 (S.D.N.Y. July 24, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Design claims must plead nature of defect and cannot rest on res ipsa.  Warning claim must state how warning was inadequate and how it affected prescriber’s conduct in a causal fashion.  Express warranty must plead reliance and a product defect.  Learned intermediary precludes reliance needed for negligent misrepresentation.  Consumer fraud failed to plead reliance or causation.
  234. Bryant v. Thoratec Corp., 343 F. Supp.3d 594 (S.D. Miss. July 30, 2018).  Manufacturing defect claim in PMA preemption case TwIqballed due to:  due to formulaic pleadings.  No causal connection to plaintiff’s injury.  Allegation that discovery will establish nature of violations insufficient.
  235. Dendinger v. Covidien LP, 2018 WL 4462579 (E.D. La. Sept. 18, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.
  236. Tears v. Boston Scientific Corp., 344 F. Supp.3d 500 (S.D.N.Y. Sept. 29, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Design defect claims must identify a defect and an alternative design.  Manufacturing defect claims must identify how the product diverged from the defendant’s intended result.  A warning claim mist indicate how the warning was inadequate when the warning mentions that risk that the plaintiff encountered.  Express warranty claim failed to allege how the statements advanced as warranties were not true.  Implied warranty claims were same as strict liability.  No particular purpose different from the device’s intended use was alleged.
  237. Broge v. ALN International, Inc., 2018 WL 6308194 (N.D. Cal. Dec. 3, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning claim must allege risk known at time of manufacture and prescriber causation under learned intermediary rule.  Manufacturing defect claim must allege deviation from specifications.  A general reference to every conceivable form of communication cannot plead negligent misrepresentation.  No pleading that warranty was breached.
  238. Knoles v. Teva Pharmaceuticals United States, 2019 WL 295258 (N.D. Cal. Jan. 23, 2019).  All claims TwIqballed due to failure to plead any facts establishing product identification.  Lumping defendants together and use of “and/or” pleading is improper.