Wednesday, October 20, 2010

Post-Levine Drug/Vaccine Preemption Cheat Sheet

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

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


  1. Smith v. Wyeth, 2009 WL 736208 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4697002, reconsideration denied, 2009 WL 425032) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5460) is pending in the Sixth Circuit.
  2. Morris v. Wyeth, 2009 WL 736200 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (582 F.Supp.2d 861, reconsideration denied, 642 F. Supp.2d 677) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5509) is pending in the Sixth Circuit
  3. Wilson v. Wyeth, Inc., 2009 WL 736198 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4696995, reconsideration denied, 2009 WL 425027) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5466) is pending in the Sixth Circuit
  4. In re Aredia & Zometa Products Liability Litigation, 2009 WL 2497229 (M.D. Tenn. Aug. 13, 2009), finding preemption of fraud-on-the-FDA allegation made in opposition to Michigan tort reform statute presumption of non-defectiveness from regulatory compliance.
  5. In re: Aredia & Zometa Products Liability Litigation, 352 Fed. Appx. 994 (6th Cir. Nov. 24, 2009), affirming preemption (see pre-Levine scorecard) of fraud-on-the-FDA exception to Michigan tort reform statute. Preemption applies to all claims alleging fraud on the FDA, including post-approval fraud and fraud asserted against an affirmative defense.
  6. LeFaivre v. KV Pharmaceutical Co., 2010 WL 59125 (E.D. Mo. Jan. 5, 2010), finding preemption under Buckman of economic-loss-only claim alleging that Metoprolol Succinate ER was "adulterated" and therefore unmerchantable under a state consumer protection statute. The adulteration claim was a disguised FDCA private right of action barred under Buckman. Levine involved a traditional state-law claim and did not affect the inability of state-law plaintiffs to sue over FDCA violations having no parallel in state law.
  7. Murphy v. Mylan, Inc., 2010 WL 2008797, slip op. (Utah Dist. Iron Co. May 10, 2010), finding Buckman preemption in case (specific drug not stated) involving statutory fraud-on-the-FDA exception to Utah statute barring punitive damages against manufacturers of FDA-approved drugs.
  8. Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. Aug. 11, 2010), finding failure to warn claim in in OTC Motrin case preempted with respect to failure to warn of SJS/TEN because the FDA rejected that warning in response to a petition. The FDA's rejection was "clear evidence" under Levine that would not permit the warning plaintiff advocated. Possible preemption of claim that OTC drug should have been sold by prescription only.
  9. Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011), finding consumer fraud claims preempted in Botox case where the allegations of illegal off-label promotion were nothing more than a private attempt to enforce the FDCA.
  10. Bruesewitz v. Wyeth LLC, 131 S.Ct. 1068 (U.S. Feb. 22, 2011), Vaccine Act expressly preempts all design defect claims against vaccine manufacturers.  Any other reading would render "unavoidable" as used in the Act meaningless.  No mention of any presumption against preemption.  Affirming 561 F.3d 233 (3d Cir. March 27, 2009).
  11. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. June 13, 2011), regulatory history of Effexor was "clear evidence" that, had the defendant submitted a stronger warning about adult suicide to the FDA, the FDA would have rejected it.  Plaintiff's failure to warn claim was preempted.
  12. Emerson v. Novartis Pharmaceuticals Corp., 446 Fed. Appx. 733 (6th Cir. Aug. 23, 2011), fraud on the FDA claims, made in pursuant to a statutory presumption of non-defectiveness by reason of FDA compliance, were preempted.
  13. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. Feb. 22, 2012), fraud on the FDA claims, made in pursuant to a statutory presumption (Texas) of non-defectiveness by reason of FDA compliance, were preempted.  Garcia's reasoning is more persuasive than DesianoAffirming 682 F. Supp.2d 662  (N.D.Tex. Jan. 27, 2010).
  14. Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. Sept. 6, 2012).  Reaffirming Garcia that Buckman preemption applies to fraud on the FDA statutory immunity exceptions and all other claims that attack the sufficiency of information submitted to the FDA.  "Compliance" refers to the aspects of the drug specified in the statute and not to fraud on the FDA-related non-compliance.  If "compliance" were broadly interpreted, then it would be preempted by Buckman for the same reasons as Garcia.  While Levine would preclude preemption of ordinary warning claims, the statute abolished those claims as a matter of state law.
  15. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL Docket No. 2226, slip op. (E.D. Ky. Oct. 10, 2012).  Mensing preemption bars warning-related claims in a branded drug case where the defendant had sold its NDA, and thus lost the ability to change warnings through the CBE process, before the plaintiff used its drug.manufacture the product that the plaintiff ingested.
  16. In re Fosamax Products Liability Litigation, ___ F. Supp.2d ___, 2013 WL 3270387 (D.N.J. June 27, 2013).  The FDA's rejection of a supplement submitted for pre-approval two days after the plaintiff suffered the injury that was the subject of the supplement was "clear evidence" that the FDA would have rejected a CBE submission concerning the same drug risk.  The substantive scientific standard for a warning was the same for both types of regulatory submissions.  The FDA had more information from more sources than any one manufacturer, and there was no evidence that any information was withheld.  Therefore, the plaintiff's warning claim was impliedly preempted under Levine.
  17. Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014).  Any change in the dosage of a drug is a "major change" requiring prior FDA approval.  Therefore, plaintiffs' class action consumer fraud claims based on "overfilling" are preempted because the dose in which the drug was marketed was approved by the FDA and was impossible to change immediately to comply with the plaintiffs' claimed state-law obligation.
  18. In re Fosamax Alendronate Sodium Products Liability Litigation, MDL No. 2243, 2014 U.S. Dist. Lexis 41111 (D.N.J. March 26, 2014).  The previous implied preemption "clear evidence" ruling in Fosamax (see above) is extended to other, similarly situated cases in the Fosamax MDL.
  19. Booker v. Johnson & Johnson, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-genericl drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Where state law demands an alternative design to avoid liability, that would require changing the composition of the drug, which is prohibited by federal law.  Therefore, the state-law claim is preempted.

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