Product Liability

This summary also appears under Litigation


Issues: Whether the plaintiffs' personal injury claims based on "wrongful marketing" brought against defendant-generic drug manufacturers were preempted by federal law; Food, Drug, & Cosmetic Act (FDCA)(21 USC § 301 et seq.); PLIVA, Inc. v. Mensing; Fulgenzi v. PLIVA, Inc.; Whether a state "parallel misbranding" claim escapes preemption; Mutual Pharm. Co. v. Bartlett; Whether the plaintiffs sufficiently pleaded the parallel-branding issue; Ashcroft v. Iqbal; 21 USC § 352(j); Whether the plaintiffs sufficiently pleaded failure to warn claims; Whether the warranty, fraud, and misrepresentation claims were preempted; Smith v. Wyeth; Statutory negligence claims; Buckman Co. v. Plaintiffs' Legal Comm.; Misrepresentation claims against the "Brand Manufacturers"; Foster v. American Home Prods. Corp. (4th Cir.); Whether the plaintiffs' misrepresentation claims were actually for "product liability" under the tort law of each state; Erie R.R. Co. v. Tompkins; MCL 600.2945(h); Abel v. Eli Lilly & Co.; Buczkowski v. McKay; Combs v. International Ins. Co.; United States Food & Drug Administration (FDA)

Court: U.S. Court of Appeals Sixth Circuit

Case Name: Germain v. Teva Pharm., USA, Inc.

e-Journal Number: 57507

Judge(s): Suhrheinrich, Rogers, and Sutton


In this multidistrict litigation consolidating personal injury claims against both generic and brand-name manufacturers related to the use of the drug propoxyphene (brand-name Darvocet or Darvon), the court affirmed the district court's dismissal of plaintiffs' wrongful marketing, failure-to-warn, and other claims brought against generic manufacturers of the drug. It also affirmed the dismissal of their misrepresentation claims against the brand manufacturers, except in the case of one plaintiff, where the court held that the complaint adequately alleged use of brand name drugs and alleged that use of the drugs caused the plaintiff's husband's heart problems, which led to his death. The plaintiffs argued that their claims against the generic manufacturers were not preempted, citing a footnote in Bartlett which they claimed created a preemption exception for the "'parallel misbranding' theory of generic drug manufacturer liability." The court declined to decide whether a preemption "exception for 'parallel misbranding' claims actually exists[,]" finding the inquiry to be "whether Plaintiffs' wrongful marketing claims recast in light of the 'parallel misbranding' exception alleged sufficient facts in order to survive a motion to dismiss." They failed "to identify specific wrongful marketing claims from the states at issue that parallel . . . a federal misbranding claim under" § 352(j). Assuming "that the states at issue have mirror image state law claims, Plaintiffs cannot state such a claim because they do not point to 'new and scientifically significant information' that the Generic Manufacturers possessed that was not before the FDA." Their "failure to warn" claim based on the Generic Manufacturers' alleged failure to inform the prescribing physicians about propoxyphene's risks was also inadequately pleaded under Iqbal. The claims for warranty breach, fraud, and misrepresentation were preempted in accordance with Mensing and Bartlett. Their statutory negligence claim was preempted under Buckman because there is no private right to enforce the FDCA. The district court dismissed plaintiffs' misrepresentation/product liability claims against the Brand Manufacturers, reasoning that, in the 22 states implicated, including Michigan, "it is settled law that the plaintiff must assert that the defendant's product caused the plaintiff's injury" - the "product identification requirement." Most of the plaintiffs "did not ingest the Brand Manufacturers' drugs," they ingested "generic" drugs. Courts have rejected the premise that "'[a] name brand manufacturer's statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer's drug.'" The court's Erie analysis determined that "the Michigan Supreme Court would decline to recognize that brand manufacturers owe generic consumers a duty of care that could give rise to liability. Thus, the district court did not err in dismissing Plaintiffs' claims against the Brand Manufacturers that arise under Michigan law."


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