Thursday, May 13, 2010

TwIqbal Cheat Sheet

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



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



The first of these is going to address Twombly/Iqbal pleading decisions in drug/device product liability cases (that means Rule 8, not Rule 9(b)).  For short we’re going to be calling that “TwIqbal” from now on.  That nifty little turn of a phrase is one of the things we learned at the recent PLAC spring conference.  So without further ado here’s our inaugural TwIqbal cheat sheet:
  1. In re Bausch & Lomb Inc., 2007 WL 3046682 (D.S.C. Oct. 11, 2007).  All claims TwIqballed (technically only "Twomblyed," since Iqbal wasn't decided yet) due to:  failure to plead facts concerning damages (device).
  2. Parker v. Howmedica Osteonics Corp., 2008 WL 141628 (D.N.J. Jan. 14, 2008).  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty (device).
  3. Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208 (E.D. Va. Feb. 12, 2008).  Gross negligence claim TwIqballed due to:  failure to plead any facts supporting the adjectives (vaccine).
  4. Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008).  All product liability claims TwIqballed due to:  unsubstantiated labels, and legal conclusions; failure to plead elements of strict liability, negligence, or warranty; and failure to distinguish between manufacturing, design, and warning defects (device).
  5. Stratford v. SmithKline Beecham Corp., 2008 WL 2491965 (S.D. Ohio June 17, 2008).  Statutory product liability claims TwIqballed due to:  failure to plead with reference to the proper sections of the statute.  Express warranty claim TwIqballed due to: failure to plead any facts establishing the nature of the warranty (drug).
  6. Wolicki-Gables v. Arrow International, Inc., 2008 WL 2773721 (M.D. Fla. June 17, 2008).  All product liability claims TwIqballed due to: failure to plead product identification (device).
  7. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008).  Negligence claim based upon conduct of sales representative TwIqballed due to:  failure to plead facts of representative’s negligent conduct or causation (device).
  8. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008).  Express warranty claim TwIqballed due to:  failure to specify the language that constituted the warranty (device).
  9. Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597 (11th Cir. July 29, 2008).  Warning claims TwIqballed due to:  failure to plead facts concerning how the warning to the prescribing physician was inadequate.  Negligence claims TwIqballed due to: failure to plead separate claims against separate defendants (device).
  10. Simmons v. Stryker Corp., 2008 WL 4936982 (D.N.J. Nov. 17, 2008).  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty (device).
  11. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009).  Manufacturing claims TwIqballed due to:  failure, in a preemption case, to plead how the defendant’s manufacturing process violated FDA regulations (device).
  12. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead how the defendant’s manufacturing process violated FDA regulations.  Express warranty claim TwIqballed due to:  failure to specify the language that constituted the warranty (device).
  13. Sherman v. Stryker Corp., 2009 WL 2241664 (C.D. Cal. March 30, 2009).  All product liability claims TwIqballed due to:  failure to plead facts concerning product identification (drug).
  14. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2009 WL 1921902 (D. Minn. July 1, 2009).  All claims TwIqballed due to:  vague and conclusory allegations that fail to establish standing (device).
  15. Pennsylvania Employees Benefit Trust Fund v. Astrazeneca Pharmaceuticals LP, 2009 WL 2231686 (M.D. Fla. July 20, 2009).  Express warranty claims TwIqballed due to:  failure to plead any facts supporting direct communication between plaintiff and defendant or proximate cause (drug).
  16. Frey v. Novartis Pharmaceuticals Corp., 642 F. Supp.2d 787 (S.D. Ohio July 23, 2009).  Design and manufacturing claims TwIqballed due to:  formulaic pleadings of defect and causation (drug).
  17. Lewis v. Abbott Laboratories, 2009 WL 2231701 (S.D.N.Y. July 24, 2009).  Design claim TwIqballed due to:  failure to plead facts establishing a feasible alternative design. Warning claims TwIqballed due to:  failure to plead inadequate warnings to doctors under the learned intermediary rule.  Manufacturing claims TwIqballed due to:  failure to plead a deviation from intended result.  Implied warranty claim TwIqballed due to:  failure to plead an actionable defect (drug).
  18. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, plead an FDCA violation involving the plaintiff’s device, anything beyond formulaic conclusions, or facts supporting proximate cause.
  19. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009).  Express warranty claim TwIqballed due to:  failure to plead facts establishing any express statement (device).
  20. Ivory v. Pfizer Inc., 2009 WL 3230611 (W.D. La. Sept. 30, 2009).  Design claim TwIqballed due to:  failure to plead facts establishing a feasible alternative design (drug).
  21. Dittman v. DJO, LLC, 2009 WL 3246128 (D. Colo. Oct. 5, 2009).  All claims TwIqballed due to:  failure to plead product identification (drug).
  22. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009).  Parallel violation claim TwIqballed due to:  failure to plead any supporting facts (device).
  23. Gilmore v. DJO, Inc., 663 F. Supp.2d 856 (D. Ariz. Oct. 15, 2009).  All claims TwIqballed due to:  failure to plead any facts, and failure to specify what products were at issue (device).
  24. Mohr v. Targeted Genetics, Inc., 2009 WL 4021153 (C.D. Ill. Nov. 18, 2009).  Strict liability and wrongful death claims TwIqballed in experimental drug case due to:  failure to plead any specific facts beyond bare legal conclusions (drug).
  25. Combs v. Stryker Corp., 2009 WL 4929110 (E.D. Cal. Dec. 14, 2009).  All claims TwIqballed due to:  failure to plead product identification (drug).
  26. 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).
  27. 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).
  28. 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).
  29. 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).
  30. 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).
  31. Haskins v. Zimmer Holdings, Inc., 2010 WL 342552 (D. Vt. Jan. 29, 2010).  Product liability claims TwIqballed due to: failure to plead product identification (drug).
  32. 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).
  33. 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).
  34. 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).
  35. Mitchell v. Proctor & Gamble, 2010 WL 728222 (S.D. Ohio March 1, 2010).  Product liability claims TwIqballed due to:  failure to plead causation (drug)
  36. 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).
  37. 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).
  38. 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).
  39. 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).
  40. 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).
  41. 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).
  42. 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).
  43. 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).
  44. 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).
  45. 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).
  46. 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).
  47. 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).
  48. 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).
  49. 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.
  50. In re Actimmune Marketing Litigation, 2010 WL 3463491 (N.D. Cal. Sept. 1, 2010).  California consuer fraud claims TwIqballed due to:   formulaic pleading of reliance by prescribing physicians.  Missouri consuer fraud claims TwIqballed due to:   failure to plead reliance upon illegal activity (drug).
  51. 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).
  52. 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).
  53. 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).
  54. 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).
  55. 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).
  56. 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).
  57. 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).
  58. 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).
  59. 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.
  60. Johnson v. Moog, Inc., 2011 WL 719600 (E.D. Tex. Feb. 22, 2011).  All claims in medical device case TwIqballed due to:  Pleading only that unknown "defendants" committed actions, failure to plead product identification.
  61. Llado-Carreno v. Guidant Corp., 2011 WL 705403 (S.D. Fla. Feb. 22, 2011).  All claims in medical device case TwIqballed due to:  failure to plead more than "boilerplate" violation and failure to plead causation. Plaintiff failed to plead any injury because his device had not failed and no physical harm is claimed.   Warranty claims did not allege what warranty was.
  62. 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.
  63. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011). All claims in prescription drug case TwIqballed due to:  failure to allege injury.
  64. Bloom v. Depuy Orthopaedics, Inc., 2011 WL 1135753 (D. Md. March 25, 2011).  All claims in medical device case TwIqballed due to:  failure to plead anything more than a malfunction, failure to plead which of several components was defective, whether the defect was in design or manufacture, or how a non-defective product would have worked differently.  A failure to obtain approval claim did not allege what should have been approved and how.  Warranty claims did not allege what warranty was.
  65. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011).  Violation claims in PMA device case TwIqballed due to:  failure to plead violation of device-specific GMP regulation, and failure to plead causation.  Neither a particular regulation nor the nature of the violation was pleaded.
  66. Rhynes v. Stryker Corp., 2011 WL 2149095 (N.D. Cal. May 31, 2011).  Punitive damages claims in PMA device case TwIqballed due to:  failure to plead facts establishing heightened intent required for such damages.
  67. McFarland v. APP Pharmaceuticals, LLC, 2011 WL 2413797 (W.D. Wash. June 13, 2011).  All claims in prescription drug/medical device case TwIqballed due to failure to identify the product's manufacturer.
  68. Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595 (W.D. Tex. June 23, 2011).  Product liability claims in prescription drug case TwIqballed due to:  failure to allege defect or that the prescriber relied on inadequate warnings.
  69. Singleton v. Eli Lilly Co., 2011 WL 2621067 (E.D. Cal. June 29, 2011).  All claims in prescription drug case TwIqballed due to failure to identify the product's manufacturer.
  70. King v. Pfizer Pharmaceutical Co., 2011 WL 3157305 (D. Md. July 25, 2011).  FDCA violation claims in prescription drug case TwIqballed for not involving the product plaintiff took.
  71. O’Brien v. Intuitive Surgical, Inc., 2011 WL 3040479 (N.D. Ill. July 25, 2011).  All claims in medical device case TwIqballed due to failure to plead causation.
  72. Rollins v. Wackenhut Services Inc., 802 F. Supp.2d 111 (D.D.C. Aug. 10, 2011).  All claims in prescription drug case TwIqballed due to:  failure to plead more than "legal conclusions" concerning the elements of the causes of action.  The plaintiff's own allegations defeat a suicide warning claim.  Plaintiff pleaded no facts to bring a comment k case.
  73. Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, slip op. (D. Ariz., Aug. 11, 2011).  All claims in prescription drug case TwIqballed due to:   the failure of plaintiff's "generic boilerplate" allegation to tie the defendants' conduct to the plaintiff.  No allegations of prescribing physician reliance.  No allegations how the warning was inadequate.
  74. Tillman v. Taro Pharmaceutical Industries Ltd., 2011 WL 3704762 (N.D. Ill. Aug. 17, 2011).  All claims in prescription generic drug case TwIqballed due to:   pleading only formulaic elements of claims.  The contents of the claimed express warranty are not alleged.
  75. Salvio v. Amgen, Inc.810 F. Supp.2d 745 (W.D. Pa. Aug. 18, 2011).  All claims in prescription drug case TwIqballed due to:  failure to plead more than "legal conclusions" concerning the elements of the causes of action.  The judicially noticed package insert eliminates any possible warning claim.  Failure to plead alternative design eliminates any possible design claim.  Claims for strict liability, warranty, testing and marketing not recognized by state law dismissed.
  76. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011). All claims in PMA medical device case TwIqballed due to: failure to plead more than "conclusory statements and formulaic recitations." Parallel violation claims TwIqballed for failure to specify what was violated, how it was violated, or how the violation allegedly injured plaintiff.
  77. Baldwin v. Zimmer, Inc., 2011 WL 3652411 (S.D. Ohio Aug. 19, 2011). All claims in PMA medical device case TwIqballed due to: failure to identify any specific defects or failures, and pleading only legal conclusions.
  78. 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.
  79. 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.
  80. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011).  Parallel violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  81. 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.
  82. 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."
  83. 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.
  84. 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."
  85. Hammonds v. Boston Scientific, Inc., 2011 WL 4978369 (W.D. Okla. Oct. 19, 2011).  All claims TwIqballed due to failure to allege that a defect existed in the plaintiff's device.
  86. Esposito v. I-Flow Corp., 2011 WL 5041374 (E.D. Pa. Oct. 24, 2011).  All claims in pain pump case TwIqballed due to failure to plead facts concerning product identification.
  87. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  88. 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.
  89. Tierney v. AGA Medical Corp., 2011 WL 7400469 (D. Neb. Nov. 18, 2011).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  90. In re Fosamax Products Liability Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011).  Manufacturing defect claim TwIqballed due to:  failure to plead nature of the defect.  Violation claim TwIqballed due to:  failure to link violation to drug plaintiff took.
  91. 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.
  92. Erickson v. Boston Scientific Corp., ___ F. Supp.2d ___, 2011 WL 7036060 (C.D. Cal. Dec. 12, 2011).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.
  93. Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011).  All unpreempted claims in generic prescription drug case TwIqballed due to: pleading only formulaic elements of claims.
  94. Polk v. KV Pharmaceutical Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011).  All claims TwIqballed due to failure to plead any injury.
  95. Del Valle v. PLIVA, Inc., 2011 WL 7168620 (S.D. Tex. Dec. 21, 2011).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  96. Grinage v. Mylan Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2011 WL 6951962 (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.
  97. Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143 (S.D. Ga. Jan. 19, 2012).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  98. In re Pamidronate Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 272889 (E.D.N.Y. Jan. 30, 2012).  All unpreempted claims in generic prescription drug case TwIqballed due to:   pleading only formulaic elements of claims.
  99. Deese v. Immunex Corp., 2012 WL 463722 (S.D. Miss. Feb. 13, 2012).  All claims in prescription drug case TwIqballed due to:   pleading only formulaic elements of claims.  Warning claims TwIqballed due to failure to allege causation under the learned intermediary rule.  Express warranty claim TwIqballed due to: failure to plead the warranty or how it became part of the basis of the bargain.
  100. 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.
  101. Viserta v. St. Jude Medical, Inc., 2012 WL 667814 (D.S.C. Feb. 29, 2012).  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation. Violation claims TwIqballed for failure to allege causation from the violation.
  102. Bowman v. Wyeth, LLC, 2012 WL 684116 (D. Minn. March 2, 2012).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  103. In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 718618, at *4 (E.D. Ky. March 5, 2012).  Unpreempted failure to update generic warning claims TwIqballed due to failure to plead facts supporting the allegations.
  104. 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.
  105. Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719 (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.
  106. Reed v. Pfizer Inc., ___ F. Supp.2d ___, 2012 WL 859729 (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.
  107. Metz v. Wyeth LLC, ___ F. Supp.2d ___, 2012 WL 1058870 (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).
  108. Cooley v. Medtronic, Inc., 2012 WL 1380265 (E.D. Ky. April 20, 2012).  Unpreempted medical device claims TwIqballed due to:  failure to allege any specific manufacturing defect.
  109. Eckhardt v. Qualitest Pharmaceuticals Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012).  Unpreempted generic drug claims TwIqballed due to:  failure to allege any specific manufacturing defect.
  110. Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697 (E.D. La. July 20, 2012).  Generic drug claims TwIqballed due to:  formulaic pleadings of all counts.  Express warranty claim TwIqballed due to failure to plead existence of any statement.
  111. 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.
  112. 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.
  113. Lilak v. Astrazenca Pharmaceutical-US, Inc., 2012 WL 4444347 (D. Colo. July 23, 2012). Negligence per se claims TwIqballed due to: failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff.
  114. 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.
  115. Buckley v. DJO Surgical, 2012 U.S. Dist Lexis 146856 (S.D. Cal. Oct. 11, 2012).  Product liability claims TwIqballed due to:  failure to specify defect.
  116. 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.
  117. Rollins v. Wackenhut Services, Inc., 2012 U.S. App. LEXIS 26549 (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).
  118. 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.
  119. Aaron v. Novartis Pharmaceutical Corp., C.A. No. 1:12CV-00203-JHM, slip op. (W.D. Ky. March 4, 2013).  All claims TwIqballed due to:  formulaic pleadings.
  120. Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 2013 U.S. Dist. Lexis 33585 (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 warings due to FDA approval.  Warranty claims are TwIqballed due to:  failure to state the warranty.
  121. Watson v. Bayer Healthcare Pharmaceuticals, Inc., C.A. No. 13-212, Sec. F, 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.
  122. Goldin v. Smith & Nephew, Inc., 2013 U.S. Dist. Lexis 58811 (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.
  123. 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.
  124. 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.
  125. Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. Lexis 171021 (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."
  126. In re Pradaxa Products Liability Litigation, 2013 U.S. Dist. Lexis 100726 (S.D. Ill. July 18, 2013).  Class action allegations TwIqballed due to formulaic pleadings.
  127. Batchelor v. Pfizer, Inc., 2013 U.S. Dist. Lexis 103974 (N.D. Ala. July 25, 2013).  All claims TwIqballed due to:   to formulaic pleadings and failure to plead nature of injury and when plaintiff took the drug.  Warning claim TwIqballed due to failure to plead inadequacy as to treating physician and how warnings were inadequate.  Negligence claim TwIqballed due to failure to plead duty violated.  Negligence per se claim TwIqballed due to failure to identify what provision violated and how.  Warranty claim TwIqballed due to failure to plead what made drug unmerchantable.
  128. 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.
  129. 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.
  130. Scianneaux v. St. Jude Medical, S.C., ___ F. Supp.2d ___, 2013 WL 4417455, slip op. (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 clais 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.
  131. Kennedy v. Pfizer, Inc., 2013 U.S. Dist. Lexis 123292 (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.
  132. 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.
  133. Bradley v. Baxter Healthcare Corp., 2013 U.S. Dist. Lexis 158935 (Mag. W.D.N.C. Oct. 18, 2013).  All unpreempted claims TwIqballed due to: failure to allege what FDCA violations were violated.
  134. Bergstresser v. Bristol-Myers Squibb Co., 2013 U.S. Dist. Lexis 169138 (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.
  135. 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.
  136. Witt v. Howmedica Osteonics Corp., 2013 U.S. Dist. Lexis 181203 (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.
  137. Wells v. Allergan, Inc., C.A. No. 6:12-3509-TMC, 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.
  138. 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.
  139. Hawkins v. Medtronic, Inc., No. 1:13-cv-00499, 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.
  140. 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.
  141. Starks v. Coloplast Corp., C.A. No. 13-3872, slip op. (E.D. Pa. Feb. 18, 2014).  All unpreempted claims TwIqballed.  Parallel violation claim in PMA preemption case TwIqballed as boilerplate.  Express warranty claims TwIqballed due to failure to plead the warranty, how it was made, how it became part of the basis of the bargain, or how it was directed to plaintiff.  Contract claims TwIqballed due to failure to plead how a sales brochure was a contract.
  142. Kitchen v. Biomet, Inc., 2014 U.S. Dist. Lexis 21672 (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.
  143. Plumlee v. Pfizer, Inc., 2014 U.S. Dist. Lexis 23172 (N.D. Cal.  Feb. 21, 2014).  Allegations of delayed discovery TwIqballed.  Case dismissed on statute of limitations grounds.
  144. 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.
  145. Burkett v. Smith & Nephew, No. CV 12-4895 (LDW) (ARL), 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.
  146. Dilley v. C.R. Bard, Inc., 2014 U.S. Dist. Lexis 47066 (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.
  147. Vasquez v. Gloucester County, 2014 U.S. Dist. Lexis 55218 (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.
  148. Williamston v. Medtronic, Inc., 2014 U.S. Dist. Lexis 68083 (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.
  149. Miller v. Pfizer Inc., No. 4:13-cv-01687, 2014 U.S. Dist. Lexis 70297 (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 inadequzate were properly before the court on a motion for judgment on the pleadings under the incorporation by reference doctrine.
  150. Smith v. Medtronic, Inc., No. 5:13-cv-00451-EEF-MLH, 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.
  151. Arnold v. Alphatec Spine, 2014 U.S. Dist. Lexis 87079 (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.
  152. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al., slip op. (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. 
  153. Lirette v. Depuy Mitek LLC, C.A. No. 2:13-cv-2892, slip op. (W.D. La. July 7, 2014).  All claims TwIqballed due to formulaic pleadings.
  154. Dimieri v. Medicis Pharmaceuticals Corp., 2014 U.S. Dist. Lexis 95409 (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.
  155. McElroy v. Amylin Pharmaceuticals, Inc., ___ F. Appx. ___, 2014 WL 3843832 (6th Cir. Aug. 5, 2014).  All claims TwIqballed due to failure to plead causation of plaintiff's injuries by the drug.
  156. Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014).  Unpreempted express warranty claim TwIqballed due to foormulaic pleadings.
  157. Kennedy v. Pfizer, Inc., C.A. No. 13-3132, 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.

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