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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 (device).
  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) (device).
  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 (device).
  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 (drug).
  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 (device).
  61. Johnson v. Moog, Inc., 2011 WL 719600 (E.D. Tex. Feb. 22, 2011).  All claims TwIqballed due to:  Pleading only that unknown “defendants” committed actions, failure to plead product identification (device).
  62. Llado-Carreno v. Guidant Corp., 2011 WL 705403 (S.D. Fla. Feb. 22, 2011).  All claims 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 (device).
  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 (device).
  64. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011). All claims TwIqballed due to:  failure to allege injury (drug).
  65. Bloom v. Depuy Orthopaedics, Inc., 2011 WL 1135753 (D. Md. March 25, 2011).  All claims 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 (device).
  66. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011).  Violation claims in 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 (device).
  67. Rhynes v. Stryker Corp., 2011 WL 2149095 (N.D. Cal. May 31, 2011).  Punitive damages claims TwIqballed due to:  failure to plead facts establishing heightened intent required for such damages (device).
  68. McFarland v. APP Pharmaceuticals, LLC, 2011 WL 2413797 (W.D. Wash. June 13, 2011).  All claims TwIqballed due to failure to identify the product’s manufacturer (drug and device).
  69. Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595 (W.D. Tex. June 23, 2011).  Product liability claims TwIqballed due to:  failure to allege defect or that the prescriber relied on inadequate warnings (drug).
  70. Singleton v. Eli Lilly Co., 2011 WL 2621067 (E.D. Cal. June 29, 2011).  All claims TwIqballed due to failure to identify the product’s manufacturer (drug).
  71. King v. Pfizer Pharmaceutical Co., 2011 WL 3157305 (D. Md. July 25, 2011).  FDCA violation claims TwIqballed for not involving the product plaintiff took (drug).
  72. O’Brien v. Intuitive Surgical, Inc., 2011 WL 3040479 (N.D. Ill. July 25, 2011).  All claims TwIqballed due to failure to plead causation (device).
  73. Rollins v. Wackenhut Services Inc., 802 F. Supp.2d 111 (D.D.C. Aug. 10, 2011).  All claims 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 (drug).
  74. Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, slip op. (D. Ariz. Aug. 11, 2011).  All claims 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 (drug).
  75. Tillman v. Taro Pharmaceutical Industries Ltd., 2011 WL 3704762 (N.D. Ill. Aug. 17, 2011).  All claims TwIqballed due to:   pleading only formulaic elements of claims.  The contents of the claimed express warranty are not alleged (generic drug).
  76. Salvio v. Amgen, Inc., 810 F. Supp.2d 745 (W.D. Pa. Aug. 18, 2011).  All claims 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 (drug).
  77. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011).  All claims 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 (device).
  78. Baldwin v. Zimmer, Inc., 2011 WL 3652411 (S.D. Ohio Aug. 19, 2011). All claims TwIqballed due to: failure to identify any specific defects or failures, and pleading only legal conclusions (device).
  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 (generic drug).
  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 (drug).
  81. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011).  Parallel violation claims TwIqballed due to failure to plead the nature of the violation (device).
  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 (device).
  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” (drug).
  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 (drug).
  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” (device).
  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 product defect (device).
  87. Esposito v. I-Flow Corp., 2011 WL 5041374 (E.D. Pa. Oct. 24, 2011).  All claims TwIqballed due to failure to plead facts concerning product identification (device).
  88. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011).  Violation claims TwIqballed due to failure to plead the nature of the violation (device).
  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 (device).
  90. Tierney v. AGA Medical Corp., 2011 WL 7400469 (D. Neb. Nov. 18, 2011).  Violation claims TwIqballed due to failure to plead the nature of the violation (device).
  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 product plaintiff took (drug).
  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 (device).
  93. Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085 (C.D. Cal. Dec. 12, 2011).  Violation claims TwIqballed due to failure to plead the nature of the violation (device).
  94. Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011).  All unpreempted claims TwIqballed due to: pleading only formulaic elements of claims (generic drug).
  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 (drug).
  96. Del Valle v. PLIVA, Inc., 2011 WL 7168620 (S.D. Tex. Dec. 21, 2011).  Unpreempted failure to update warning claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  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 (generic drug).
  98. Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143 (S.D. Ga. Jan. 19, 2012).  Unpreempted failure to update warning claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  99. In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. Jan. 30, 2012).  All unpreempted claims TwIqballed due to:   pleading only formulaic elements of claims (generic drug).
  100. Deese v. Immunex Corp., 2012 WL 463722 (S.D. Miss. Feb. 13, 2012).  All claims 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 (drug).
  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 (drug/biologic).
  102. Viserta v. St. Jude Medical, Inc., 2012 WL 667814 (D.S.C. Feb. 29, 2012).  Violation claims TwIqballed due to failure to plead the nature of the violation. Violation claims TwIqballed for failure to allege causation from the violation (device).
  103. Bowman v. Wyeth, LLC, 2012 WL 684116 (D. Minn. March 2, 2012).  Unpreempted failure to update claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  104. In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 718618(E.D. Ky. March 5, 2012).  Unpreempted failure to update claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  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 (drug).
  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 (device).
  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 (drug).
  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 claims TwIqballed due to:  failure to allege any specific manufacturing defect (device).
  110. Eckhardt v. Qualitest Pharmaceuticals Inc., 858 F. Supp.2d 792 (S.D. Tex. April 30, 2012).  Unpreempted claims TwIqballed due to:  failure to allege any specific manufacturing defect (generic drug).
  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 (device).
  112. Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697 (E.D. La. July 20, 2012).  All claims TwIqballed due to:  formulaic pleadings of all counts.  Express warranty claim TwIqballed due to failure to plead existence of any statement (generic drug).
  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 (drug).
  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 (drug).
  115. Lilak v. AstraZeneca 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 (drug).
  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 (device).
  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 (drug).
  118. Buckley v. DJO Surgical, 2012 WL 4849368 (S.D. Cal. Oct. 11, 2012).  Product liability claims TwIqballed due to:  failure to specify defect (device).
  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 (generic drug).
  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) (drug).
  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 (drug).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  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 (drug).
  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” (device)
  129. In re Pradaxa Products Liability Litigation, 2013 WL 3791509 (S.D. Ill. July 18, 2013).  Class action allegations TwIqballed due to formulaic pleadings (drug).
  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 product unmerchantable (drug).
  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 (drug).
  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 (device).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (device).
  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 (drug).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  146. Starks v. Coloplast Corp., 2014 WL 617130, slip op. (E.D. Pa. Feb. 18, 2014).  All unpreempted claims TwIqballed.  Parallel violation claim 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 (device).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (generic drug).
  158. Lirette v. Depuy Mitek LLC, 2014 WL 3341358, slip op. (W.D. La. July 7, 2014).  All claims TwIqballed due to formulaic pleadings (device).
  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 (drug).
  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 (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 (device).
  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 (drug).
  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 (device).
  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 (device).
  165. Lirette v. Depuy Mitek LLC, 2014 WL 5445777 (W.D. La. Oct. 20, 2014).  Manufacturing defect claim TwIqballed due to formulaic pleading (device).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  172. Mendez v. Shah, 94 F. Supp.3d 633 (D.N.J. March 30, 2015).  Express warranty TwIqballed due to formulaic pleadings (device).
  173. Morton v. Allergan, Inc.,  2015 WL 12839493 (D.N.J. April 2, 2015).  All unpreempted claims TwIqballed due to formulaic pleadings.  Express warranty claim did not state terms of warranty.  Manufacturing defect claims stated no facts (device).
  174. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. April 21, 2015).  Warranty claims TwIqballed due to formulaic pleadings (device).
  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 (device).
  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 (device).
  177. Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586 (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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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) (device).
  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 (drug).
  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 (device).
  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 (drug).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (device).
  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 (generic drug).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (drug).
  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 (device).
  197. Perry v. Boston Scientific Family, 2016 WL 10637082 (D. Minn. Dec. 1, 2016).  All claims TwIqballed due to conclusory pleadings (device).
  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 (device).
  199. House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017).  All claims TwIqballed due to:  formulaic pleadings (drug).
  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 (device).
  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) (device).
  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 (device).
  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 (device).
  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 (drug).
  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 (device).
  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 (device).
  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 (drug).
  208. Bigsby v. Davol, Inc., 2017 WL 2472274 (S.D. Ind. June 8, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  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 (device).
  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 (device).
  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 (device).
  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 (drug).
  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 (device).
  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.  Affirmed by 741 F. Appx. 624, below (device).
  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 (device).
  216. Cerniglia v. Zimmer, Inc., 2017 WL 4678201 (D.N.J. Oct. 17, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  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 (generic drug).
  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 (generic drug).
  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 (device).
  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 (device).
  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 (device).
  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 (device).
  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 (drug).
  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 (drug).
  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 (generic drug).
  226. Blanchard v. Merck & Co., 2018 WL 8244568 (M.D. Fla. May 21, 2018).  All claims TwIqballed due to failure to plead separate allegations against differently situated defendants (drug).
  227. 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 (drug).
  228. 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 (device).
  229. 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 (device).
  230. 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 (device).
  231. 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 (device).
  232. 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 (drug).
  233. Wright v. Howmedica Osteonics Corp., 741 F. Appx. 624 (11th Cir, July 5, 2018).  Dismissal of all claims being TwIqballed affirmed due to:  due to formulaic pleadings.  Complaint must state nature of defect.  Affirming 2017 WL 4555901, above (device).
  234. Murphy v. Boston Scientific Corp., 2018 WL 4870700 (Mag. M.D. La. July 12, 2018).  Parallel claims TwIqballed 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) (device).
  235. 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 (device).
  236. Bryant v. Thoratec Corp., 343 F. Supp.3d 594 (S.D. Miss. July 30, 2018).  Manufacturing defect claim TwIqballed due to:  due to formulaic pleadings.  No causal connection to plaintiff’s injury.  Allegation that discovery will establish nature of violations insufficient (device).
  237. Dendinger v. Covidien LP, 2018 WL 4462579 (E.D. La. Sept. 18, 2018).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  238. 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 (device).
  239. Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. Md. Nov. 15, 2019).  All claims TwIqballed due to failure to plead any facts establishing a parallel claim in a PMA preemption case.  Plaintiff given one last chance to plead a proper parallel claim (device).
  240. 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 (device).
  241. 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 (device).
  242. Calloway v. Coloplast Corp., 2019 WL 2169222 (Mag. W.D. La. Feb. 5, 2019), adopted, 2019 WL 2166539 (W.D. La. May 17, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Design claims must allege an alternative design.  Warning claims must allege what was not warned about, and causation through the physician under the learned intermediary rule.  Warranty claims must allege the language of the warranty (device).
  243. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. March 26, 2019).  In a warning case, plaintiff must plead the “newly acquired evidence” on which the claim for a different warning rests, or the warning claim will be preempted (drug).
  244. Kennedy v. Covidien, LP, 2019 WL 1429979 (S.D.N.Y. March 29, 2019).  All claims TwIqballed.  Design claims must plead an alternative design, and not never using product.  Manufacturing defect claims cannot be mislabeled design claims.  Warning claim must allege how the warnings were inadequate or insufficient.  Express and implied warranty claims TwIqballed due to formulaic pleadings.  Unjust enrichment claims fail for not alleging a defective product (device).
  245. Nowell v. Medtronic, Inc., 372 F. Supp.3d 1166 (D.N.M. March 29, 2019).  All claims TwIqballed due to:  failure to plead causation.  Product liability claims TwIqballed due to failure to plead defect, alternative design, or causation.  Warning claims TwIqballed due to failure to plead that the surgeon would have acted differently or that a different warning would have prevented injury. Warranty claims TwIqballed due to failure to plead lack of merchantability.  Punitive damages claim merely recites the legal standard (device).  Affirmed 2021 WL 4979300 (10th Cir. Oct. 27, 2021) (non-TwIqbal grounds).
  246. Peniston v. Medtronic, Inc., 2019 WL 1894745 (D.N.J. April 29, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  The complaint provides almost no factual allegations whatsoever (device).
  247. In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2019 WL 2137427 (E.D. Pa. May 2, 2019).  All claims in all MDL complaints TwIqballed due to:  boilerplate pleading leading to “allegations that are absurd on their face as to every plaintiff” (vaccine).
  248. Aguilar v. B Braun Medical Inc., 2019 WL 2173777 (M.D. Fla. May 20, 2019).  All claims in all MDL complaints TwIqballed due to:  “shotgun” pleading.  Plaintiff may not lump together allegations against different defendants.  Plaintiffs may not incorporate multiple counts by reference (device).
  249. Cantwell v. De La Garza, 2019 WL 2166541 (W.D. Okla. May 17, 2019).   All claims, including implied warranty of fitness, TwIqballed due to:  due to formulaic pleadings.  FDCA-based negligence per se requires pleading of specific particular statute or regulation that provides the duty allegedly violated (device).
  250. Grzanecki v. Smith & Nephew, Inc., 2019 WL 2297452 (N.D. Ill. May 30, 2019).  All claims TwIqballed due to:  due to formulaic pleadings. Manufacturing defect clam must plead how the product deviated from specifications.  Design defect must plead nature of defect and causation.  Warning defect must plead how warning is defective and causation under the learned intermediary rule (device).
  251. Carpenter v. Boston Scientific Corp., 2019 WL 3322091 (N.D. Tex. July 24, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Design defect claims must plead an alternative feasible design.  Manufacturing defect claims must plead a deviation from the manufacturer’s intended design in the particular product, not a defect of the entire product line.  Warning defect cases must plead how the warnings are inadequate and that they were received by the plaintiff’s treating physician (device).
  252. Jacob v. Mentor Worldwide, LLC, 393 F. Supp.3d 912 (C.D. Cal. Aug. 1, 2019).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead any actual adverse events that were not reported. Manufacturing claims failed to specify the violated regulation, how any regulation was violated, or causation (device).  Affirmed, 847 Fed. Appx. 373, below.
  253. Vieira v. Mentor Worldwide, LLC, 392 F. Supp.3d 1117 (C.D. Cal. Aug. 1, 2019).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead any actual adverse events that were not reported. Manufacturing claims failed to specify the violated regulation, how any regulation was violated, or causation (device).  Affirmed, 845 Fed. Appx. 503, below.
  254. Dubroc v. Bristol Myers Squibb, 2019 WL 3756469 (M.D. La. Aug. 8, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Design defect claims must plead an alternative feasible design.  Warning claims must allege how the learned intermediary would have acted differently with an adequate warning.  Express warranty claims must allege the terms of the warranty and how it became the basis of the bargain (reliance) (device).
  255. Heaton v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 4060097 (S.D. Ind. Aug. 28, 2019).  All claims TwIqballed due to:  due to formulaic pleadings (drug).
  256. Green v. Covidien LP, 2019 WL 4142480 (S.D.N.Y. Aug. 30, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff’s complaint made allegations about the wrong product.  An alternative design must be pleaded to establish a design defect.  Manufacturing defect claims must plead how the product deviated from the intended result.  Pleading injury is a non sequitur.  Injury as circumstantial evidence of malfunction is defeated by the injury being warned about.  A warning claim cannot be pleaded solely with respect to injuries that were actually warned of (device).
  257. Cavanaugh v. Medtronic, PLC, 2019 WL 6768107 (D. Md. Sept. 25, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Alleging malfunction alone does not state a plausible claim under any theory (device).
  258. Meredith v. Medtronic, Inc., 2019 WL 6330677 (S.D. Iowa Oct. 25, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff must plead the elements of a product liability action under the Iowa statute.  Design defect claims must allege how the required alternative design would have prevented injury.  Manufacturing defect claims must plead a deviation from the intended result.  Warning claims must allege what warnings were given and how they were insufficient (device).
  259. Hindermyer v. B. Braun Medical, Inc., 419 F. Supp.3d 809 (D.N.J. Oct. 30, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff must plead the elements of a product liability action under the NJ statute.  Design defect requires pleading a feasible alternative design.  Manufacturing defect claims must plead a deviation from the intended result.  Warning claim must plead a failure to warn about a risk the the plaintiff actually suffered.  Warning defect and express warranty claims must pertain to risks the plaintiff actually suffered (device).
  260. Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. Md. Nov. 15, 2019).  Parallel violation claim TwIqballed in PMA preemption case due to:  due to formulaic pleadings.  Merely stating that the device generally violated some non-specific FDA “standards” is insufficient.  A recall alone does not plead an FDA violation, or causation (device).
  261. Allo v. Allergan USA, Inc., 2020 WL 32439 (E.D. La. Jan. 2, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Manufacturing defect claim must allege what standards were deviated from and the nature of the deviation.  Warning claim must allege how the warning was inadequate.  Express warranty claim must allege the language of the warranty and how it was breached.  Redhibition claim must allege must allege the relevant industry standards and how the product did not comply (device).
  262. Marshall v. Smith & Nephew, Inc., 2020 WL 362803 (D. Minn. Jan. 22, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Where preemption is possible, a claim is not plausible and must be dismissed where it does not allege the  FDA classification and relevant approval process of the device.  Plaintiff must also allege his condition, the outcome for which his implant was intended, other potential factors leading to his symptoms and revision surgery, and causation.  Warning claim must allege defendant’s knowledge of the risk, what warnings were or should have been issued (by and to whom), and how such a hypothetical warning would have changed the course of events (device).
  263. Oliver v. Covidien LP, 2020 WL 564957 (E.D. La. Feb. 5, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning causation, requires pleaded facts that a proper warning would have changed the prescriber’s decision to use the product.  Design defect requires pleading a safer alternative design.  Express warranty claims must identify the warranty.  Manufacturing defect claims must allege the relevant product standard and the nature of the deviation from it (device).
  264. Boris v. Atrium Medical Corp., 2020 WL 589440 (S.D.N.Y. Feb. 6, 2020), Cosh v. Atrium Medical Corp., 2020 WL 583826 (S.D.N.Y. Feb. 6, 2020), and Bustamante v. Atrium Medical Corp., 2020 WL 583745 (S.D.N.Y. Feb. 6, 2020).  Three identical opinions for TwIqbal purposes.  All claims TwIqballed due to:  due to formulaic pleadings.  Design claim must plead alternative design.  Where injuries are common, circumstantial proof unavailable and plaintiff must specify the manufacturing defect.  Warning claim must specify the inadequate warning language.  Negligent misrepresentation, consumer protection, and express warranty claims fails to plead either the false statements or reliance.  Implied warranty must plead facts why product is not reasonably fit for its intended purpose.  Remaining claims fall with the others (device).
  265. Taylor v. Medtronic, Inc., 2020 WL 886118 (N.D.N.Y. Feb. 24, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning claim must allege how the warning was inadequate and causation.  Design defect requires pleading a feasible alternative design not avoiding use of product altogether.  Manufacturing defect claims must plead a deviation from the intended result.  Express warranty claim must allege the language of the warranty.  Implied warranty fails where no valid product defect is pleaded (device).  Reversed on non-TwIqbal grounds, 15 F.4th 148 (2d Cir. Sept. 30, 2021)
  266. Bartlett v. Pfizer, Inc., 2020 WL 896751 (W.D. Ky. Feb. 24, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff fails to plead causation (drug).
  267. Saltis v. Nuvasive, Inc., 2020 WL 4689787 (D. Vt. March 13, 2020).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  268. Fischer v. Boston Scientific Corp., 2020 WL 2300138 (C.D. Cal. March 25, 2020).  All claims dismissed.  Warning claim TwIqballed due to:  failure to identify the implanting physician was, the warning the physician received, how those warnings were inadequate, and what injuries resulted (device).
  269. Green v. W. L. Gore & Associates, Inc., 2020 WL 1666790 (D. Idaho April 3, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Neither defect nor causation are properly pleaded.  An alleged recall is not tied to plaintiff’s case.  Nature of warning’s alleged inadequacy is not pleaded (device).
  270. Burgess v. Pfizer, Inc., 2020 WL 1812010 (E.D.N.C. April 9, 2020).  Warning (only claim brought) TwIqballed due to:  failure to allege newly acquired information sufficient to avoid preemption.  Warning claims also require pleading that defendant knew or should have known of dangers not included in its warning label, and that the warning label played any role in the prescriber’s decision to prescribe, plaintiff’s decision to take it, and that a different label plausibly would have changed these decisions (drug).
  271. Cofresi v. Medtronic, Inc., 450 F. Supp.3d 759 (W.D. Tex. March 30, 2020).  All claims TwIqballed.  Design defect must state an alternative design that is not a different product.  Manufacturing claim challenged the design, not a unit-specific defect.  Warning claim must state how the warning was inadequate and “must identify what [the] surgeon was warned or what the surgeon reviewed in order to allege” causation.  Punitive damages and gross negligent claims are conclusory.  Loss of consortium must plead a marriage at the time of product use.  Express warranty is totally conclusory (device).
  272. Kahler v. Merck Sharp & Dohme Corp., 2020 WL 2745667 (W.D. Wash. May 27, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Unclear what type of defect plaintiff alleged.  As to warnings, plaintiff failed to plead that the product was not reasonably safe or causation (vaccine).
  273. Batiste v. Stryker Corp., 2020 WL 3451690 (M.D. La. June 24, 2020) (applying Louisiana law).  All claims TwIqballed due to:  due to formulaic pleadings.  Manufacturing defect must plead some deviation from a manufacturer specification.  Design defect must plead an alternative design. Warning defect must plead what the nature of the defect is and how it caused injury.  Express warranty claim must allege how that alleged warranty was false (device).
  274. Miles v. Boston Scientific Corp., 2020 WL 3871329 (S.D. Tex. July 9, 2020).  Warning claims TwIqballed due to failure to identify the warning her doctor received, to allege how it was inadequate, and to allege how any failure caused injury (device).
  275. Castillo v. Boston Scientific Corp., 2020 WL 5608510 (S.D. Tex. Sept. 18, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Complaint is virtually the same as others.  Design defect claims must plead a safer alternative design, not just a feasible one.  Warning defect must plead the warning, its inadequacy, and how an adequate warning would have changed the learned intermediary’s conduct to prevent injury.  Manufacturing defect requires a deviation from the manufacturer’s intended result (device).
  276. Adams v. Medtronic, Inc., 2020 WL 5868113 (E.D. Tex. Oct. 1, 2020).  All claims TwIqballed due to:  due to formulaic pleadings. Design defect must plead an alternative design, not an alternative product.  Manufacturing defect must plead what the deviation from intended product is.  Warning claim must allege causation under the learned intermediary rule.  Implied warranty claim must plead notice.  Express warranty claim must plead what the warranty is and reliance (device).
  277. Krulewich v. Covidien, LP,  498 F. Supp.3d 566 (S.D.N.Y. Oct. 9, 2020) and Dunham v. Covidien LP, 2020 WL 5995102 (S.D.N.Y. Oct. 9, 2020).  Substantively identical opinions.  All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect does not allege any specific deviation from specifications, or exclude alternative causes sufficiently to allege the defect circumstantially.  Design defect fails to allege causation.  Warning claim does not allege how existing warnings are insufficient, or how adequate warnings would have caused a change in treatment.  Express warranty fails to state the warranty (device).
  278. Baca v. Johnson & Johnson, 2020 WL 6450294 (D. Ariz. Nov. 2, 2020).  Standard pelvic mesh complaint TwIqballed in its entirety due to:  formulaic pleadings.  No deviation to support manufacturing defect.  Warning claim does not plead causation under the learned intermediary rule.  General design defect allegations fail to allege causation as to this plaintiff’s injury.  Causation likewise not alleged as to other theories.  Express warranty not identified.  Punitive damages claim does not allege compliance with state statutory limits.
  279. Teal v. Argon Medical Devices, 2020 U.S. Dist. Lexis 226437 (E.D. Mich. Dec. 3, 2020).  All claims TwIqballed due to:  lumping differently situated defendants together.
  280. Gergenti v. Ethicon, Inc., 2020 U.S. Dist. LEXIS 242633 (M.D. Fla. Dec. 28, 2020).  All claims TwIqballed due to inclusion of allegations about irrelevant products that the plaintiff never used.  Complaint was an improper “shotgun” pleading.
  281. In re Zantac Ranitidine Products Liability Litigation, 2020 WL 7866674 (S.D. Fla. Dec. 31, 2020).  All claims TwIqballed due to indiscriminate use of incorporation by reference and lumping differently situated defendants together.  Complaints were improper “shotgun” pleadings.
  282. Yarbrough v. Stryker Corp., 2021 WL 27291 (D. Or. Jan. 4, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Plaintiff failed to allege which of the four components of the device was defective or violated a duty of care.  Injury does not equal defect.
  283. Hernandez v. Johnson & Johnson, 2021 WL 320612 (E.D. Wash. Jan. 8, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Design and warning claims failed to allege causation.  Manufacturing defect claim failed to allege an design deviation or other manufacturing flaw.  Express warranty claim failed to allege what the warranty was.
  284. Vieira v. Mentor Worldwide, LLC, 845 Fed. Appx. 503 (9th Cir. Feb. 5, 2021) (C.D. Cal. Aug. 1, 2019).  Parallel violation claims TwIqballed due to:  speculative allegations that studies never undertaken would have generated actual adverse events that would not have been reported. Manufacturing claims failed to identify any violated regulation (device).  Affirming, 392 F. Supp.3d 1117, above.
  285. Nunn v. Mentor Worldwide, LLC, 847 Fed. Appx. 373 (9th Cir. Feb. 5, 2021) (C.D. Cal. Aug. 1, 2019).  Parallel violation claims TwIqballed due to:  speculative allegations that studies never undertaken would have generated actual adverse events that would not have been reported. Manufacturing claims failed to identify any violated regulation (device).  Affirming, 393 F. Supp.3d 912, above.
  286. McCormick v. Caldera Medical, Inc., 2021 U.S. Dist. Lexis 25232 (S.D. Ohio Feb. 10, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Plaintiff failed to identify the allegedly injurious product.
  287. Morris v. Sun Pharma Global, 2021 WL 687247 (C.D. Cal. Feb. 19, 2021).  All unpreempted claims TwIqballed in generic drug case due to:  formulaic pleadings.  Manufacturing defect claim fails to state how the product deviated from the intended result.
  288. Dolan v. Boston Scientific Corp., 2021 WL 698777 (D. Minn. Feb. 23, 2021).  All claims TwIqballed due to:  formulaic pleadings.  More than “direct and proximate” is required to plead causation.  Prior MDL involving defendant does not justify failure to plead plaintiff-specific facts. Must plead warning causation under learned intermediary rule.  Warranty claim must plead notice.
  289. Reddick v. Medtronic, Inc., 2021 WL 798294 (E.D. La. March 2, 2021).  All non-preempted claims TwIqballed due to:  formulaic pleadings.  Incorporation by reference does not allege alternative designs where the devices are different.  Res ipsa is evidentiary and may not be used to satisfy a plaintiff’s pleading burden.  Affirmed, 2022 WL 7154942022 WL 715494, below.
  290. Spencer v. Bristol-Myers Squibb Co., 2021 U.S. Dist. Lexis 42727 (W.D. Okla. March 8, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Warning claim must that, if the prescribing physician was properly informed the of the product’s risks the physician would not have prescribed it to the plaintiff.
  291. Sparks v. Medtronic, Inc., , 2021 U.S. Dist. Lexis 72459 (M.D. Fla. April 15, 2021).  All claims TwIqballed due to:  failure to plead defect.  That a product malfunctioned does not plead a defect.  Plaintiff failed to exclude other causes to qualify for res ipsa.
  292. Frei v. Taro Pharmaceutical U.S.A., Inc., ___ F. Appx. ___, 2021 WL 1541141 (2d Cir. April 20, 2021).  All claims TwIqballed due to:  failure to plead how defendant did anything wrong.  No allegation that defendant violated FDA medication guide regulation or had any duty to correct materials prepared by others.  No failure to report alleged; broad statistical allegation insufficient.
  293. Celino v. Biotronik, Inc., 2021 WL 1699847 (E.D. La. April 29, 2021).  All unpreempted claims TwIqballed due to:  formulaic pleadings.  Manufacturing claim does not distinguish between several devices or components.  Design claim does not plead an alternative design.  Warning claim fails to plead learned intermediary causation.  Warranty claim does not plead the warranty or basis of bargain.  Complaint full of typos misidentifying defendant and product.  Contract claim conclusory.
  294. Carter v. Ethicon, Inc., 2021 WL 1893749 (W.D. Wash. May 11, 2021).  All product liability claims TwIqballed due to:  formulaic pleadings.
  295. Stich v. Smith & Nephew, Inc.,  2021 U.S. Dist. Lexis 94923 (D.N.J. May 19, 2021).  All product liability claims TwIqballed due to:  formulaic pleadings.  Design defect requires a plaintiff to plead what the alleged defect is.  Manufacturing defect requires pleading a deviation from manufacturer specifications.  Express warranty must allege the actual language and source of the warranty. Punitive damages must plead facts to support the required mental state.
  296. Koublani v. Cochlear Limited, 2021 WL 2577068 (E.D.N.Y. June 23, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Design defect requires a plaintiff to plead the alleged defect and alternative design.  Manufacturing defect requires pleading of the nature of the defect and how it failed to follow the manufacturer’s specifications.  No malfunction theory where plaintiff also sues health care providers.  Express warranty requires reliance.  Implied warranty requires a defect at sale.  Warning claim must identify some deficiency in the warnings.
  297. McGrain v. C.R. Bard, Inc., 2021 WL 3288601 (E.D. Pa. July 30, 2021).  All otherwise viable claims TwIqballed due to:  formulaic pleadings.  Negligent manufacturing requires alleging what went wrong during the manufacturing process.  No res ipsa pleading.  Negligent design allegations must address product design and the availability of safer, feasible alternative.  Warning claims must allege the risk at issue and the content of the warnings defendants should have provided.  Express warranty must state the source of the alleged warranty and the specific statements.  Misrepresentation claims must be more than “dressed up” warning claims.
  298. Christian v. Altaire Pharmaceuticals, Inc., 2021 U.S. App. Lexis 23751 (6th Cir. Aug. 10, 2021).  Dismissal of all claims as Twiqballed affirmed.  Plaintiff relied solely on a recall to show defect and misrepresented the reasons for the recall.  Proper to take judicial notice of the recall announcement.
  299. Bergman v. Johnson & Johnson,  2021 U.S. Dist. Lexis 152758 (D. Minn. Aug. 13, 2021).  All moved-against claims TwIqballed in pelvic mesh case due to:  formulaic pleadings.
  300. Harrison v. Medtronic, Inc., 2021 U.S. Dist. Lexis 178827 (N.D. Tex. Sept. 20, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect must state how the product deviated from what was intended.   How warning was insufficient must be plead, as well as how the prescriber would have changed the course treatment with a proper warning.  Alternate design is essential to a design defect.  A device “without the defects” is not sufficient pleading of an alternative design.  Negligence and implied warranty claims fail for same reasons.  Warranty also requires pleading of notice.
  301. Lewis v. Abbott Laboratories, 2021 WL 4448920 (M.D. La. Sept. 28, 2021).  All unpreempted claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect must state how the product deviated from what was intended.  Warning claims must state how the warning was defective and how the defect was causal.  Express warranty claims must allege what the warranty is (device).
  302. Parker v. Medtronic Sofamor Danek USA, Inc., 2021 WL 4751185 (N.D. Ohio Oct. 12, 2021).   All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect must state how the product deviated from what was intended.  Design defect claims require more than a device failure.  Warning/warranty claims must identify the allegedly incorrect information.  Punitive damages claim likewise pleads no facts (device).
  303. Naquin v. Medtronic, Inc., 2021 WL 4848838 (5th Cir. Oct. 18, 2021).  Affirming TwIqballing of parallel claims.  Plaintiff failed to provide details how a violation of federal regulations produced a manufacturing or design defect or how a specific defect caused his alleged harms.  Plaintiff failed to reproduce any specific warranty or to specify its precise source (device).
  304. Fussell v. Johnson & Johnson, 2021 WL 5907702 (E.D. La. Dec. 14, 2021).  All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect claim must plead the relevant manufacturer’s specifications and how the product deviated from it.  An express warranty claim must plead how the warranty induced the plaintiff to use the product.  Redhibition claims based on personal injury are not viable (device).
  305. Bond v. Johnson & Johnson, 2021 WL 6050178 (D.N.J. Dec. 21, 2021).  All otherwise surviving claims TwIqballed due to:  formulaic pleadings.  Pleading causation must distinguish between risks of surgery generally and product-specific risks.  Plaintiffs fail to cite any study supporting their risk allegations.  Manufacturing defect claims must must plead a deviation from the relevant manufacturer’s specifications.  Warning claims must plead that exact language alleged to be defective and causation.  Warranty claims must plead notice (device).
  306. Cunningham v. Abbott Vascular, Inc., 2022 WL 2387903 (Mag. D. Mass. March 1, 2022).  All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect claim must plead a deviation from the product’s intended design.  Design defect claim must plead an alternative design.  Warning claim must plead inadequate warnings to the plaintiff’s doctors.  Plaintiff pleaded none of the five elements of implied warranty.  Express warranty claim failed to allege the terms of the warranty (device).
  307. Reddick v. Medtronic, Inc., 2022 WL 715494 (5th Cir. March 9, 2022).  Affirming TwIqballing of all non-preempted claims due to:  formulaic pleadings.  Information and belief pleading is insufficient.  Recall did not involve this product.  Res ipsa cannot cure defective pleadings.  Breach of warranty must be pleaded with particularity.  The terms and source of the warranty was not pleaded (device).  Affirming, 2021 WL 798294, above.
  308. Flores v. Merck & Co., 2022 WL 798374 (D. Nev. March 16, 2022).  All otherwise surviving claims TwIqballed due to:  prolix and convoluted allegations.  TwIqbal can be violated both when a pleading says too little and when a pleading says too much.  Complaint contains many allegations having nothing to do with this plaintiff.  Warning claims are formulaic and vague.  Manufacturing defect claim is internally contradictory (vaccine).
  309. Fussy v. RTI Surgical, 2022 WL 1122615 (E.D. Cal. April 13, 2022).  All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect claims must identify and explain how the product either deviated from either the defendant’s intended design or other identical products.  Design defect claims must identify what aspect of the product’s design made it defective.  Warning claims must allege facts sufficient to show that defendant did not warn plaintiff’s doctors of the product risks or that the warning was inadequate,” and must allege causation from the lack of adequate warnings (device).
  310. Richardson v. Tandem Diabetes Care, Inc., 2022 WL 1571205 (W.D. La. May 18, 2022).  All claims TwIqballed due to:  formulaic pleadings.  Manufacturing defect claim fails to identify any deviation from intended design.  Design claim fails to identify either the defect or any alternative design (device).
  311. Greenwood v. Arthrex, Inc., 2022 WL 2117763 (W.D.N.Y. June 13, 2022).  All claims TwIqballed due to:  formulaic pleadings.  Plaintiff failed to allege what component of a medical device deviated from properly manufactured parts.  Mere malfunction does not allege a design defect.  Allegation of recall not related to this defendant’s component part.  Terms of express warranty not pleaded (device).
  312. Garcia v. Sanofi Pasteur Inc., 2022 U.S. Dist. Lexis 134330 (E.D. Cal. July 28, 2022). All claims concerning two defendants’ vaccines TwIqballed due to:  formulaic pleadings. Warning and negligence claims are entirely without factual content.  Federal, not California, law applies (vaccine).
  313. Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. June 22, 2022).  Warning claim TwIqballed due to:  failure to allege that the warning influenced the prescribing physician.  Plaintiff also failed to allege any newly acquired information necessary to avoid preemption (drug).
  314. Bennett v. Teva Pharmaceuticals USA, Inc., 2022 WL 4093739 (3d Cir. Sept. 7, 2022).  All claims intended to evade generic preemption TwIqballed due to conclusory pleading.  Medication guide claim failed to plead any FDCA violation.  Failure-to-report claim only made assumptions and failed to plead any actual failure to report.  Failure to correct off-label misrepresentation claim failed to plead any actual misrepresentation or a factual basis for any duty to correct.  Amendment properly denied (generic drug).
  315. McGuire v. Abbott Laboratories, Inc., 2022 WL 4295402 (E.D. Tex. Sept. 15, 2022).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, plead any specific defect, facts establishing an FDCA violation, what the violation was, or causation.   Res ipsa loquitur cannot support a parallel claim (device).
  316. Richardson v. Tandem Diabetes Care, Inc., 2023 U.S. Dist. Lexis 38279 (W.D. La. March 7, 2023).   All claims TwIqballed due to:  formulaic pleadings.  That the product was “reconditioned” does not plead a design defect.  No alternative design pleaded, nor that an alternative design had a better risk/benefit ratio.  No manufacturing claim because reconditioning a product is not a deviation from its intended design.
  317. Estate of Comatov v. Medtronic, Inc., 2023 WL 2922830 (C.D. Cal. March 16, 2023).  Parallel violation claims TwIqballed due to: conclusory pleading.  Laundry list of allegedly violated regulations insufficient.  Failure to report implausible since FDA sent out safety notice.
  318. McGuire v. Abbott Laboratories, Inc., 2023 U.S. Dist. Lexis 77682 (E.D. Tex. May 3, 2023).  Parallel violation claims TwIqballed due to: conclusory pleading.  Failure to report claim fails to plead what was not reported, how that would have changed any warning, or how a changed warning would have been causal.  Manufacturing defect claim failed to plead the nature of the defect, how it deviated from any FDA requirement, or causation.  Misrepresentation and warranty claims failed to plead any false statement.
  319. Asby v. Medtronic, Inc., 2023 U.S. Dist. Lexis 87496 (E.D.N.C. May 18, 2023).  All claims TwIqballed due to:  vague and inconsistent pleadings. Design claim failed to identify any alternative design, to plead the statutory risk/benefit factors, or to provide any consistent FDA-related theory.  Warning, express warranty, and consumer protection claims all failed to allege that the surgeon read or relied on defendant’s warnings.  Implied warranty of fitness claim fails to plead any peculiar purpose beyond the product’s ordinary use.  Express warranty claim also fails to state any actual warranty language.
  320. LaTouche v. Merck & Co., 2023 WL 3604655 (D.N.J. May 22, 2023).  All claims TwIqballed due to:  conclusory pleading.  Warning claim failed to allege how a different warning would have affected the prescriber’s treatment.  Design claim failed to allege alternative design.
  321. Neto v. Bristol-Myers Squibb, 2023 WL 3689533 (D. Conn. May 26, 2023).  All claims TwIqballed due to:  conclusory pleading.  Design defect claim must plead the nature of the defect.  Warning claim must plead what the warning was, why it was inadequate, and how a different warning could have made a difference in the prescriber’s treatment under the learned intermediary rule.
  322. Short v. Pfizer, Inc., 2023 U.S. Dist. Lexis 100250 (E.D. Pa. June 8, 2023).  All claims TwIqballed due to:  conclusory pleading.  Warning claims must plead causation.  Warranty claims must plead the existence of a warranty, breach, and causation.  Risk of future cancer is speculative.  Warning claims must plead that a different warning would have affected a physician’s decision to prescribe the medication.
  323. Tripolskiy v. Boston Scientific Corp., 2023 WL 5440783 (C.D. Cal. June 23, 2023).  Parallel violation claims TwIqballed due to: conclusory pleading.
  324. Williams v. Boston Scientific Corp., 2023 U.S. Dist. Lexis 220371 (N.D. Ohio Dec. 11, 2023).  All claims TwIqballed due to:  conclusory pleading.  Design claims must state the nature of the defect, not just that the product injured the plaintiff.  Manufacturing claims must state how the product was incorrectly manufactured.  Warning claims must identify the inadequate warning and state how an adequate warning would have influenced the prescriber.
  325. Holloway v. Abbvie, Inc., 2024 WL 477523 (M.D. La. Feb. 7, 2024).  All claims TwIqballed due to: conclusory pleading.  Warning claim failed to state that a different warning would have changed the prescriber’s prescription decision.  Manufacturing defect claim failed to plead a unit-specific defect.  Design claim failed to plead both the nature of the defect and that an alternative design existed.  Express warranty claim failed to plead the warranty.  Merely that the product would be “safe,” is insufficient.
  326. Nazzal v. Wyeth, 2024 U.S. Dist. Lexis 49890 (C.D. Cal. March 19, 2024).  All claims TwIqballed due to:  conclusory pleading.  A warning claim must plead how or why the warning was inadequate, or what an adequate warning might look like. Plaintiff also failed to plead that if prescribing physician had been warned, he would not have prescribed the drug.  Warranty claims fail to plead both what the prescriber was, or was not told and reliance.
  327. Pacheco v. Johnson & Johnson, 2024 WL 1641777 (M.D. Ga. April 15, 2024).  All claims TwIqballed due to:  shotgun pleading.  Alleged defects are not causally tied to this plaintiff’s claimed injuries.  The learned intermediary prescriber is barely mentioned.  Marketing is not linked to the plaintiff or the plaintiff’s surgeon.  Underpleaded causation is rife throughout the complaint.  A “common facts” section is inadequate, and not tethered to the rest of the complaint.  Broad incorporation of all prior paragraphs does not count.  The defendants are lumped together despite being parent and subsidiary, with the actual product manufacturer never pleaded.  That litigation about this product has been widespread does not relieve this plaintiff from adequately pleading this case.
  328. Hawkins v. Kaiser Foundation Health Plan, 2024 WL 2894771 (D. Or. June 10, 2024).  All product liability claims TwIqballed due to:  conclusory pleading.  Allegation of a bare product failure, without identifying which component failed, or how is insufficient.  Nor are any facts alleged to establish that defendant had knowledge of the claimed risk so that it could have warned about it.  Nor does plaintiff allege what warnings were provided for the device or how the warnings were inadequate.  Nor does plaintiff that her surgeon would have performed the procedure any  differently with an adequate warning.
  329. Cordle v. Enovis Corp., 2024 WL 4254082 (E.D. Ky. Sept. 20, 2024).  All remaining claims TwIqballed due to:  conclusory and collective pleading.  Plaintiff’s amended complaint improperly made all relevant allegations against all of the defendants as a group, which failed to identify the manufacturer of the medical device, an essential element of any product liability claim.  The complaint also failed to identify the nature of the defect or to allege causation.