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TwIqbal Cheat Sheet

By James M. Beck and Mark Herrmann

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.
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).  Parallel violation claim TwIqballed due to:  overuse of ?information and belief? pleading (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. 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, ___ F. Supp.2d ___, 2010 WL 996523 (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).

Full post as published by Drug and Device Law on May 13, 2010 (boomark / email).