Yanise Germain v. Teva Pharmaceuticals, USA, Inc
2014 U.S. App. LEXIS 12111
| 6th Cir. | 2014

Background

  • Multidistrict litigation consolidating 68 personal-injury claims from users of propoxyphene (Darvocet/Darvon), mostly against generic manufacturers and some brand manufacturers. Plaintiffs allege defendants continued marketing despite risks outweighing benefits.
  • Regulatory context: brand NDAs require full FDA approval and may unilaterally change labels via CBE; generics use ANDAs and are subject to a “duty of sameness” with the reference listed drug (RLD).
  • FDA reviewed propoxyphene risks across decades; after advisory committee concerns, FDA required stronger warnings in 2009 and, after review of a Xanodyne study, requested market withdrawal in 2010. Plaintiffs ingested propoxyphene before withdrawal.
  • Supreme Court precedent: Wyeth v. Levine permits state failure-to-warn suits against brand manufacturers; PLIVA/Mensing and Bartlett limit or preempt state-law failure-to-warn and design-defect claims against generic manufacturers because of the duty-of-sameness and conflict preemption.
  • District court dismissed all claims; Sixth Circuit affirms in full except reverses dismissal for Dickerson (plaintiff alleging use of Lilly brand product), remanding that claim for further proceedings.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether generic wrongful-marketing/design-defect claims survive Mensing/Bartlett via a “parallel misbranding” theory Plaintiffs: Bartlett’s Footnote 4 carved out a parallel misbranding exception allowing state claims that mirror federal misbranding (new, scientific info not before FDA) Generics: Mensing/Bartlett preempt such state claims because generics cannot unilaterally change design/labeling; plaintiffs failed to plead the required "new information" Dismissed: Court assumes, arguendo, exception; Plaintiffs failed to plead mirror federal misbranding elements or new scientific information not before FDA, so claims fail.
Whether generic "failure-to-update" and "failure-to-communicate" (e.g., Dear Doctor letters) claims survive Plaintiffs: generics failed to timely adopt 2009 label changes or communicate risks to physicians Generics: such claims are preempted by duty-of-sameness (Mensing); complaints lack specific factual pleading (Iqbal) Dismissed: failure-to-update claims inadequately pleaded; failure-to-communicate claims preempted and/or forfeited as undeveloped.
Whether RLD designation converts a generic into a brand duty-bearer (e.g., liability like NDA-holder) Plaintiffs: Mylan’s RLD designation for certain strengths makes it liable like a brand Defendants/FDA: RLD status for bioequivalence does not change ANDA holder obligations; ANDA holders still subject to duty-of-sameness Dismissed: Court follows FDA and precedent — RLD designation does not convert an ANDA holder into an NDA/brand for unilateral label-change duties.
Whether brand manufacturers can be liable to consumers who ingested only generic equivalents based on misrepresentations to physicians Plaintiffs: brand manufacturers’ representations foreseeably influence physicians to prescribe generics; duty to downstream generic users exists Brands: under state product-liability doctrines and common law, liability requires product identification or no duty exists to users of another’s product Dismissed (majority): After Erie analysis across 22 states, the Sixth Circuit predicts state courts would either treat claims as product-liability claims (requiring product ID) or decline to recognize a duty; thus no liability. Exception: Dickerson sufficiently alleged brand (Lilly) use — remanded.

Key Cases Cited

  • United States v. Rutherford, 442 U.S. 544 (U.S. 1979) (FDA’s safety determination compares expected therapeutic gain to risks)
  • Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (state-law fraud-on-FDA claims impliedly preempted)
  • Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (MDA preemption of certain state-device claims)
  • Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (brand manufacturers can face state failure-to-warn claims because they can use CBE process)
  • PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (state failure-to-warn claims against generics preempted by federal duty-of-sameness)
  • Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (U.S. 2013) (reaffirmed Mensing; footnote noted, but did not apply, a possible parallel misbranding issue)
  • Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (pleading standard: plausibility requirement)
  • Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (antitrust pleading standard; factual enhancement requirement)
  • Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (failure-to-update claims against generics may not be preempted; governs pleading analysis)
  • Smith v. Wyeth, 657 F.3d 420 (6th Cir. 2011) (generic warranty and related claims preempted under Mensing)
  • Combs v. Int'l Ins. Co., 354 F.3d 568 (6th Cir. 2004) (in predicting state law, prefer narrower interpretation that reasonably restricts liability)
Read the full case