Sunday, September 23, 2007

Drug (and Vaccine) Preemption Scorecard

Don't be deceived by the date of this post! We update this scorecard regularly!

Folks keep asking us for the drug preemption scorecard: Since the FDA promulgated its "Preemption Preamble" in January 2006, how many decisions have accepted the preemption defense, and how many have courts rejected it?

It's not quite that easy. There are cases that squarely accept the defense; cases that reject it; cases that say the defense may be available, but doesn't apply on the facts before it; cases that address vaccine preemption, which is a different, but sometimes related, issue; and cases that apply preemption in ways that may or may not affect drug cases. (And then there's medical device preemption. We view that as an entirely separate ball of wax. We'll have more to say about that shortly.)

In the meantime, here's the list of cases -- originally through Friday, September 21, 2007, but we now update it whenever we learn of more cases -- that appear on our drug preemption scorecard. But don't ask for a precise win/loss tally in the drug preemption wars. The issue has become slightly more complicated than that.

  1. Zammit v. Shire US, Inc., 415 F. Supp. 2d 760 (E.D. Mich. 2006), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Adderall/heart attack case. No mention of FDA preemption preamble. We do not believe this case was appealed.
  2. Militrano v. Lederle Laboratories, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006), app. denied, 857 N.E.2d 1137 (N.Y. 2006), finding express preemption in Tetramune/neurological injuries case under Vaccine Act while affirming pre-preemption-preamble preemption decision (769 N.Y.S.2d 839 (N.Y. Sup. 2003)). No mention of FDA preemption preamble.
  3. Abramowitz v. Cephalon, Inc., 2006 WL 560639 (N.J. Super. Law Div. March 3, 2006), finding implied conflict preemption and relying on FDA preemption preamble in Actiq/tooth decay case. We believe this case settled.
  4. Peters v. Astrazeneca, LP, 417 F. Supp.2d 1051 (W.D. Wis. 2006), rejecting field and implied conflict preemption in omeprazole/loss of taste case. No mention of FDA preemption preamble. The defendant won the case on other grounds and the preemption ruling was not appealed.
  5. Laisure-Radke v. Par Pharmaceutical, Inc., 2006 WL 901657 (W.D. Wash. March 29, 2006), reconsid. denied (May 3, 2006), rejecting implied conflict preemption and mentioning (but not discussing) FDA preemption preamble in fluoxetine (generic Prozac)/suicide case. The defendant won the case on other grounds and the preemption ruling was not appealed.
  6. In re Diet Drugs Products Liabilty Litigation (Mingus), 2006 WL 1071545 (E.D. Pa. Apr. 21, 2006), rejecting implied conflict preemption under Buckman against exclusively non-warning claims in diet drug/primary pulmonary hypertension case. No mention of FDA preemption preamble. There was no final order to appeal.
  7. Coutu v. Tracy, 2006 WL 1314261 (R.I. Super. May 11, 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Propofol/liver-kidney failure case. There was no final judgment to appeal.
  8. Gourdine v. Crews, 2006 WL 5277412 (Md. Cir. June 28, 2006), finding implied conflict preemption and relying on FDA preemption preamble in insulin/hypoglycemia case. The order was appealable and affirmed on other grounds (no duty, the plaintiff was not the drug user), 935 A.2d 1146 (Md. App. 2007). The Maryland Court of Appeals (Maryland's highest court affirmed dismissal on non-preemption grounds, 955 A.2d 769 (Md. Sept. 4, 2008).
  9. Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006), finding implied conflict preemption and relying on FDA preemption preamble in paroxetine (generic Paxil)/suicide case. The FDA filed amicus briefs supporting preemption in this case. Colacicco has extensive appellate history (see below), with the decision ultimately vacated and remanded.
  10. Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zoloft-Effexor/suicide case. There was no final judgment to appeal, and the case has settled.
  11. In re Bextra & Celebrex Marketing Sales Practices & Products Liability Litigation, 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006), finding implied conflict preemption of failure to warn, but not false advertising, claims and relying on FDA preemption preamble in Bextra-Celebrex/cardiovascular risk MDL. There was no final judgment to appeal.
  12. Ackermann v. Wyeth Pharmaceuticals, 2006 WL 2591078 (Mag. E.D. Tex. Sept. 6, 2006), finding implied conflict preemption of failure to warn claims and relying on FDA preemption preamble in Effexor/suicide case. Opinion was withdrawn as moot in light of order granting complete summary judgment on other grounds, 2006 WL 3780913 (E.D. Tex. Dec. 20, 2006). The Fifth Circuit affirmed dismissal without reaching preemption. Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008).
  13. Conte v. Wyeth, Inc., 2006 WL 2692469 (Cal. Super. Sept. 14, 2006), and 2006 WL 3939262 (Cal. Super. Sept. 14, 2006), finding implied conflict preemption and relying on FDA preemption preamble in Metoclopramide/gastroesophageal reflux case). Affirmed in part and reversed on other (non-preemption) grounds, Conte v. Wyeth, Inc., 168 Cal. App.4th 89 (Cal. App. Nov. 7, 2008).
  14. McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zoloft/suicide case while denying reconsideration of, but certifying for interlocutory appeal, a pre-preemption-preamble preemption decision (2005 WL 3752269 (D.N.J. Dec. 29, 2005)). McNellis has extensive appellate history (see below, under Colacicco), with the decision ultimately vacated and remanded.
  15. Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (as amended Jan. 18, 2007) (2d Cir. Jan. 18, 2007), affirmed without opinion by equally divided court sub nom. Warner-Lambert Co. v. Kent, 128 S.Ct. 1168 (2008), reversing district court and rejecting implied conflict preemption of “fraud on the FDA” exception to state tort reform statute and rejecting FDA preemption preamble in Rezulin/diabetes case.
  16. Perry v. Novartis Pharmaceutical Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006), rejecting implied conflict preemption and distinguishing FDA preemption preamble in Elidel/lymphoma case. The FDA filed an amicus brief taking no position on preemption in this case. There was no final judgment to appeal. The defendant won the case on non-preemption grounds, Perry v. Novartis Pharmaceutical Corp., 564 F. Supp.2d 452 (E.D. Pa. July 9, 2008), and plaintiff did not appeal.
  17. Levine v. Wyeth, 944 A.2d 179 (Vt. Oct. 27, 2006) (affirming pre-preemption-preamble no preemption ruling, 2003 WL 25648135 (Vt. Super. Dec. 23, 2003)), cert. granted, No. 06-1249 (U.S. Jan. 18, 2008) (argued Nov. 3, 2008), rejecting implied conflict preemption and rejecting FDA preemption preamble in Phenergan/IV push case. Levine was affirmed by the Supreme Court, 129 S. Ct. 1187 (see last entry of this scorecard).
  18. Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp.2d 666 (E.D. Ky. 2006), rejecting implied conflict preemption, but relying on FDA preemption preamble in Elidel/lymphoma case. There was no final judgment to appeal.
  19. Brockert v. Wyeth Pharmaceuticals, 2007 WL 2077554 (Tex. Dist. Jan. 31, 2007), finding implied conflict preemption in Prempro/heart attack case). No mention of the FDA preemption preamble. Subsequent, post-Levine history is discussed in our new scorecard.
  20. In re Aredia & Zometa Products Liability Litigation, 2007 WL 649266 (M.D. Tenn. Feb. 27, 2007), rejecting "complete preemption," but suggesting that "ordinary" implied conflict preemption might apply and relying on FDA preemption preamble in Aredia-Zomenta/osteonecrosis case. Unappealable remand order.
  21. Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007), finding express preemption of design and warning claims, but not testing claims under Vaccine Act, and relying on FDA preemption preamble in Thimerosal/neurological injuries case. There was no final judgment to appeal. The remainder of the case was transferred to the Eastern District of Virgina (see separate entry).
  22. Kelly v. Wyeth, 2007 WL 1302589 (Mass. Super. April 12, 2007), cross-motions for reconsideration denied, 2007 WL 3407466 (Mass. Super. Oct. 23, 2007), rejecting implied conflict preemption and rejecting/distinguishing FDA preemption preamble in Reglan/generic metoclopramide/akathisia case. There was no final judgment to appeal.
  23. Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 U.S. Dist. Lexis 44718 (D. Ala. April 24, 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in cephalexin (generic Keflex)/Stevens-Johnson-Syndrome case. There was no final judgment to appeal.
  24. Ledbetter v. Merck & Co., 2007 WL 1181991 (Tex. Dist. April 20, 2007), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Vioxx/heart attack case. No mention of the FDA preemption preamble. The appeal has been dismissed at the plaintiff's request. See Ledbetter v. Merck & Co., 2008 WL 2066580 (Tex. App. May 15, 2008) (unpublished).
  25. Prohias v. Pfizer, Inc., 490 F. Supp.2d 1228 (S.D. Fla. 2007), finding implied conflict preemption of claims after July, 2004, but not before, and relying upon FDA preemption preamble in Lipitor/false advertising case. There was no final judgment to appeal.
  26. In re Zyprexa Products Liability Litigation, 489 F. Supp.2d 230 (E.D.N.Y. 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Zyprexa/side effects (weight gain, hyperglycemia, and diabetes) MDL. There was no final judgment to appeal.
  27. Prohias v. AstraZeneca Pharmacerticals, L.P., 958 So.2d 1054 (Fla. App. 2007) (affirming, 2006 WL 4634292 (Fla. Cir. Oct. 2006)), finding implied conflict preemption in Nexium/false advertising case. A further appeal was denied by the Florida Supreme Court, 969 So.2d 1014.
  28. Giles v. Wyeth, Inc., 500 F. Supp.2d 1063 (S.D. Ill. 2007), rejecting implied conflict preemption in Effexor/suicide case. No mention of the FDA preemption preamble. The defendant won the case on other grounds and the preemption ruling was not appealed.
  29. Deutsch v. Wyeth, Inc., 2007 WL 2060072 (N.J. Super. Law Div. June 22, 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Prempro/breast cancer case. There was no final judgment to appeal.
  30. In re Vioxx Products Liability Litigation, 501 F. Supp.2d 776 (E.D. La. 2007), rejecting implied conflict preemption and rejecting FDA preemption preamble in Vioxx/heart attack MDL. There was no final judgment to appeal, and the MDL has largely settled.
  31. In re Baycol Products Liability Litigation, 495 F. Supp.2d 977 (D. Minn. 2007), applying implied conflict preemption to exclude expert testimony offered to support allegations of “fraud on the FDA” in Baycol/muscle-kidney damage MDL. No mention of FDA preemption preamble. There was no final judgment to appeal.
  32. Price v. Cook, 2007 WL 2154766 (W. Va. Cir. July 9, 2007), finding implied conflict preemption and relying on prior FDA amicus briefs (but not mentioning FDA preemption preamble) in Zoloft/suicide attempt case. We believe this case has settled.
  33. Sarli v. Mylan Bertek Pharmaceuticals, Inc., 2007 WL 2111577 (M.D.N.C. July 19, 2007), rejecting implied conflict preemption but relying on FDA preemption preamble in Amnesteem/unspecified personal injury case. There was no final judgment to appeal, and the case has settled.
  34. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 499 F.3d 239 (3d Cir. 2007), affirming district finding of implied conflict preemption in Nexium/false advertising case. No mention of FDA preemption preamble. A motion for panel rehearing and rehearing en banc was denied on September 19, 2007. After Wyeth v. Levine, the Supreme Court vacated the Third Circuit's opinion and remanded the case. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 129 S. Ct. 1578 (March 9, 2009). On May 5, 2009, the Third Circuit remanded the case to the District of Delaware.
  35. Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430 (E.D. Pa. 2007), finding express preemption under Vaccine Act in Tri-Immunol DPT vaccine/seizure-developmental delay case. No mention of FDA preemption preamble. There is a final judgment. The Third Circuit affirmed, 2009 WL 792468, see entry in our New Drug and Vaccine Preemption Scorecard.
  36. Strong v. American Cyanamid Co., 261 S.W.3d 493 (Mo. App. E.D. Aug. 28, 2007), rejecting express or implied conflict preemption in Orimune vaccine/polio case. No mention of FDA preemption preamble. Review ("transfer") was first rejected, then acceptef, and then rejected again by the Missouri Supreme Court, with the end result that the appellate decision was reinstated on Oct. 6, 2008.
  37. Dunson v. McNeil-PPC, Inc., 2007 WL 3052315 (Pa. C.P. Sept. 12, 2007), finding no implied conflict preemption and distinguishing FDA preemption preamble in over-the-counter Infant Tylernol/liver failure-death case. On appeal, j.n.o.v. was entered against plaintiffs on non-preemption grounds. Dunson v. McNeil-PPC, Inc., 2009 WL 1178651 (Pa. Super. April 24, 2009). Further appeal is possible.
  38. In re Seroquel Products Liability Litigation, 2007 WL 4117201 (M.D. Fla. Nov. 6, 2007), denying without prejudice implied conflict preemption motion for judgment on the pleadings until after discovery in Seroquel/diabetes cases. Merits not reached.
  39. [Intentionally omitted (Nov. 19, 2007). Another adverse, unpublished case. A federal trial court, in a one-page, three-sentence order, rejects a conflict preemption argument raised by a generic drug manufacturer. This one is too short to ever make the reporters, but we note here that it exists.]
  40. [Intentionally omitted (Nov. 29, 2007). This is another unpublished case that the reporters have not yet picked up, and we're not here to spread the word. A federal trial court rejected both an implied conflict preemption and a fraud-on-the-FDA statutory exception preemption argument raised by a generic drug manufacturer. If we see this reported somewhere, we'll provide the cite. Until then, just be aware that it exists.]
  41. Dobbs v. Wyeth Pharmaceuticals, 530 F. Supp.2d 1275 (W.D. Okla. 2008), finding implied conflict preemption and relying on FDA preemption preamble in Effexor/suicide case. While this is a partial summary ruling, a Rule 54(c) appeal has been taken. Post-Levine, the Tenth Circuit vacated and remanded, as discussed in our new scorecard.
    O'Neal v. SmithKline Beecham Corp., 551 F. Supp.2d 993 (E.D. Cal. Jan. 30, 2008), finding implied conflict preemption in Paxil/pediatric suicide case. Summary judgment is granted against all claims, therefore the order is appealable. Reconsideration was denied. 2008 WL 1721891. The case has setttled.
  42. Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208 (E.D. Va. Feb. 12, 2008), finding implied conflict preemption of failure to warn claims and impliedly (the court does not use the word "preemption," but that's what the argument is) finding implied preemption of design defect claims in immune globulin case. The order denied a motion to amend and is not final judgment. No appeal was taken from entry of final judgment. This case is related to Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289 (E.D. Pa. 2007), which is also on this list.
  43. Miller v. SmithKline Beecham Corp., 2008 WL 510449 (N.D. Okla. Feb. 15, 2008), finding implied conflict preemption in Paxil/suicide case. Summary judgment is granted against all claims.  Post-Levine, the Tenth Circuit vacated and remanded, as discussed in our new scorecard.
  44. Longs v. Wyeth, 536 F.Supp. 2d 843 (N.D. Ohio Feb. 28, 2008), finding implied conflict preemption of some claims, those alleging that the drug should never have been approved or that no warning could be adequate, as well as fraud on the FDA, in a Redux/primary pulmonary hypertension case. Summary judgment was granded against all remaining claims on other grounds, therefore the order is appealable. Subsequent, post-Levine history is discussed in our new scorecard.
  45. White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023 (W.D. Mich. March 6, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in a Paxil pediatric suicide case. The case has settled.
  46. Collins v. Smithkline Beecham Corp., 2008 WL 744070 (Pa. C.P. March 11, 2008), finding no implied conflict preemption in Paxil/suicide case, refusing to judicially notice FDA final rule. There is no appealable order.
  47. Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768 (W.D.N.C. March 25, 2008), finding implied conflict preemption of some claims, including all warning-related claims, as well as fraud on the FDA, and relying on FDA preemption preamble in a Lotensin birth defect case. The order is not appealable. The case has been dismissed with prejudice.
  48. In re Aredia & Zometa Products Liability Litigation, 2008 WL 913087 (M.D. Tenn. Apr. 2, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in Aredia/Zomenta MDL litigation. An appeal is pending in the Sixth Circuit (No. 08-5573, and others).
  49. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008), finding broad implied conflict preemption and giving some deference to the FDA preemption preamble in two consolidated SSRI suicide cases (one, Colacicco, involving paroxetine (generic Paxil), and the other, McNellis, involving Zoloft. The FDA filed amicus briefs supporting preemption in this case. Rehearing has been denied. After Wyeth v. Levine, the Supreme Court vacated the Colacicco opinion and remanded the case to the Third Circuit. Colacicco v. Apotex, Inc., 129 S. Ct. 1578 (March 9, 2009). On April 22, 2009, the Third Circuit remanded both cases (Colacicco and McNellis) to the respective District Courts.
  50. Mason v. Smithkline Beecham Corp., 546 F. Supp.2d 618 (C.D. Ill. April 23, 2008), finding implied conflict preemption and relying on FDA preemption preamble in Paxil/suicide case. The Seventh Circuit reversed after Levine, as discussed in our new scorecard.
  51. McDarby v. Merck & Co., 949 A.2d 223 (N.J. Super. A.D. May 29, 2008), finding no implied conflict preemption in Vioxx/heart attack case; rejecting reliance on FDA preemption preamble; finding implied conflict preemption of “fraud on the FDA” exception for punitive damages in state tort reform statute. On May 7, 2009, the New Jersey Supreme Court dismissed an a pending appeal as improvidently granted. No. 62,856.
  52. Gaeta v. Perrigo Pharmaceuticals, Inc., 562 F. Supp.2d 1091 (N.D. Cal. June 13, 2008), finding preemption in the context of an over-the-counter, generic drug, and giving Chevron deference to the Preemption Preamble. The order is final, but there will be no appeal.
  53. Mensing v. Wyeth et al., 562 F. Supp.2d 1056 (D. Minn. June 17, 2008), finding conflict preemption of failure to warn claims in generic Reglan case. The Eighth Circuit reversed after Levine, as discussed in our new scorecard.
  54. Tucker v. SmithKline Beecham Corp., 596 F. Supp.2d 1225 (S.D. Ind. July 18, 2008) (S.D. Ind. Sept. 19, 2007), finding no implied conflict preemption and declining to rely on the FDA preemption preamble in a Paxil/suicide case. This is a reconsideration of an earlier opinion, at 2007 WL 2726259, that had recognized preemption. A second motion for reconsideration, or for interlocutory appeal, is pending.
  55. In re Celexa & Lexapro Products Liability Litigation, 2008 WL 2906713 (E.D. Mo. July 24, 2008), postponing decision of a motion seeking implied conflict preemption in generic SSRI/suicide case due to pendency of Levine. Obviously, there is no appealable order.
  56. In re Aredia & Zometa Products Liability Litigation, 2008 WL 2944910 (M.D. Tenn. July 25, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute in several Aredia/Zometa cancer cases. No mention of the FDA preemption preamble. These orders were not appealed.
  57. In re Fosamax Products Liability Litigation, 2008 WL 2940560 (S.D.N.Y. July 29, 2008), finding no "impossibility" of a successful claim by reason of implied conflict preemption in fraudulent joinder context in Fosamax/osteonecrosis. No mention of the FDA preemption preamble. The case was remanded to state court.
  58. Depriest v. Astrazeneca Pharmaceuticals L.P., 2008 WL 3243562 (Ark. Cir. July 31, 2008), finding conflict preemption of all claims in economic loss consumer fraud claim involving promotion of Nexium. No mention of preamble. This is an appealable order.
  59. Masterson v. Apotex Corp., 2008 WL 3262690 (S.D. Fla. Aug. 7, 2008), finding conflict preemption of failure to warn claims in generic paxil (birth defects, not suicide) case. Manufacturing defect claims escaped preemption, so the order is not appealable.
  60. Valerio v. SmithKline Beecham Corp., 2008 WL 3286976 (S.D. Fla. Aug. 7, 2008) (companion case to Masterson -- same product, alleged injury, date of order, judge, holding, and reasoning, but different plaintiff).
  61. Bolin v. SmithKline Beecham Corp., 2008 WL 3286973 (S.D. Fla. Aug. 7, 2008) (another companion case to Masterson -- same product, alleged injury, date of order, judge, holding, and reasoning, but different plaintiff).
  62. Wright v. Aventis-Pasteur, Inc., 2008 WL 4144386 (Pa. C.P. Philadelphia Co. Aug. 27, 2008), finding express preemption under Vaccine Act in Thimerosal case against several vaccine manufacturers. No mention of FDA preemption preamble. An appeal (No. 336 EDA 2008) is pending in the Pennsylvania Superior Court.
  63. Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008), finding no conflict preemption of failure to warn claims in Paxil/teen suicide case. Giving FDA preamble some deference. An interlocutory appeal was granted by the District Court, 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008), but denied by the Third Circuit on December 30, 2008 (No. 08-8060).
  64. McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr. 3d 810 (Cal. App. 5th Dist. Sept. 25, 2008), finding no conflict preemption of failure to warn claims in generic Reglan (metoclopramide) tardive dyskinesia case, mentioning but neither following nor rejecting FDA preemption preamble. The California Supreme Court denied review on Jan. 14, 2009.
  65. Mills v. Warner-Lambert Co., 581 F. Supp.2d 772 (E.D. Tex. Sept. 30, 2008), finding express preemption of pure economic loss claims involving monograph (OTC) lice treatments. This is a final judgment, and there has been no appeal.
  66. American Home Products Corp. v. Ferrari, 668 S.E.2d 236 (Ga. Oct. 6, 2008), affirming intermediate appellate court ruling (650 S.E.2d 585) and rejecting express preemption under Vaccine Act in Thimerosal/neurological injury case. No mention of FDA preemption preamble. There is a certiorari petition (No. 08-1120) pending before the United States Supreme Court.
  67. Knipe v. SmithKline Beecham Corp., 2008 WL 4442635 (E.D. Pa. Sept. 30, 2008), no preemption of failure to warn claims as disguised fraud-on-the-FDA claims in Paxil/teen suicide case, but finding implied conflict preemption of “fraud on the FDA” exception for punitive damages in state tort reform statute. The preemption Preamble was not mentioned. There is no appealable order. The court has granted an interlocutory appeal concerning a related preemption issue, 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008), but denied by the Third Circuit on December 30, 2008 (No. 08-8060).
  68. Morris v. Wyeth, Inc., 582 F. Supp.2d 861 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 WL 424590 (W.D. Ky. Feb. 20, 2009), slip op. finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
  69. Smith v. Wyeth, Inc., 2008 WL 4696995 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 13250 (W.D. Ky. Feb. 20, 2009), finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
  70. Wilson v. Wyeth, Inc., 2008 WL 4697002 (W.D. Ky. Oct. 24, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 13273 (W.D. Ky. Feb. 20, 2009), finding conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Does not mention preemption preamble, but relies on recent FDA statements regarding generic drugs. Subsequent, post-Levine history is discussed in our new scorecard.
  71. Demahy v. Wyeth, Inc., 586 F. Supp.2d 642 (E.D. La. Oct. 27, 2008), finding no conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Fraud on the FDA claims are preempted. Mention preemption preamble only in a footnote, and gives it no deference, refuses to give deference to recent FDA statements regarding generic drugs. The District Court granted leave to take an interlocutory appeal, the Fifth Circuit accepted, and affirmed, as discussed in our new scorecard.
  72. Grange v. Mylan Laboratories, Inc., 2008 WL 4813311 (D. Utah Oct. 31, 2008), finding implied conflict preemption of “fraud on the FDA” exception to state tort reform statute concerning punitive damages in fentamyl/wrongful death case. No mention of the FDA preemption preamble. There is no appealable order.
  73. In re Aredia and Zometa Prods. Liab. Litig., MDL No. 1760, 3:06-MD-1760 (M.D. Tenn. Nov. 25, 2008) (order is undated, but we believe it was entered on November 25), following earlier rulings in the Aredia and Zometa MDL and holding, in a two-page order, that the claims of Texas plaintiffs are barred by Tex. Civ. Prac. & Rem. Code Sec. 82.007(a) and, implicitly, that the fraud-on-the-FDA exception to that immunity is preempted under Buckman. "[P]laintiffs have reserved the right to seek appellate review of these rulings when they become appealable."
  74. Kunnemann v. Janssen Pharmaceutica Products, L.P., 2008 WL 5101116 (N.D. Ill. Dec. 2, 2008), finding no implied conflict preemption in duragesic patch/fentamyl case. Brief discussion is unclear whether drug or device preemption is claimed, we assume drug from the cited cases. No mention of FDA preemption preamble. There is no final order. The case has settled.
  75. Merck & Co. v. Garza, 277 S.W.3d 430 (Tex. App. Dec. 10, 2008), finding no implied conflict preemption and rejecting FDA preemption preamble in Vioxx/heart attack case. The court vacated the verdict in its entirety on other grounds, and a further appeal the the Texas Supreme Court is pending.
  76. Kellogg v. Wyeth, No. 07-82, 2008 WL 5272715 (D. Vt. Dec. 17, 2008), finding no conflict preemption of failure to warn claims in generic reglan tardive dyskinesia case. Distinguishing FDA preemption preamble from generic drug preemption. There is no final order. Subsequent, post-Levine history is discussed in our new scorecard.
  77. Wyeth v. Levine, 129 S. Ct. 1187 (U.S. Mar. 4, 2009), finding no conflict preemption of failure to warn claims in Phenergan amputation case. Finding FDA preemption preamble entitled to no deference. The litigation is concluded as to preemption.
If we've missed any cases, please do let us know. Many of our readers, like us, follow this issue with interest. We'd like to have a complete list available for those who care.

2 comments:

Anonymous said...

Bruesewitz is on appeal to the 3rd Cir., is fully briefed, and will be orally argued in September

Anonymous said...

The reason the Courts dismiss the prescription drug cases and product Libility litigations is in 1962 Congress omitted product liability for defective prescription drugs and Medical Devises. The Congress placed a shield of protection on prescription drug manufacturing companies. They are immune to prosecution, 18 Senators who are on the oversight committees in the legislative body of our government and who have served on the Health and Human Services Committees are responsible for preempting the law that protects the drug companies. Read the FDCA ACT of 1962 as proof of the action you can see Congress omitted the Law. There is NO Federal Law or State Law anywhere in the United States that provides a remedy for anyone who is injured or killed by a defective prescription drug or a medical devise. Congress preempted it...