title: Preemption of the "fraud on the FDA" exception to Michigan's tort immunity statute for drug manufacturers: reconsidering Garcia and Desiano after Levine.
abstract: In Buckman v. Plaintiff's Legal Committee, the Supreme Court of the United States held that "fraud on FDA" claims in medical device products liability actions were impliedly preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA). A Michigan statute that provides a complete regulatory compliance defense for drug manufacturers, absent a finding that the manufacturer defrauded or bribed the FDA. The Sixth Circuit found that the statute's fraud exception was preempted under Buckman, extending Buckman's holding to traditional products liability claims with circumstances involving fraud on the FDA. The Second Circuit reached the opposite conclusion in interpreting the same statute, confining Buckman to its narrow holding, preempting stand-alone fraud on the FDA claims while carving out a space for traditional state tort claims. The Supreme Court left the issue unresolved in its review of the Second Circuit, splitting 4-4. Since then, the great majority of courts have followed the Sixth Circuit's holding. This situation has created serious questions about the ability of Michigan citizens to obtain any relief in an action against a drug manufacturer. The Supreme Court recently refused to find blanket implied preemption for failure-to-warn claims involving prescription drugs in Wyeth v. Levine, holding that "common-law claims do not stand as an obstacle to the accomplishment of Congress's purposes in the FDCA." This holding casts serious doubt on the continued vitality of implied preemption in drug and device litigation, and could, and should, lead to a reexamination of the application of Buckman to traditional products liability claims against drug manufacturers from Michigan plaintiffs in circumstances that involve, inter alia, fraud on the FDA. The next time this application is considered, the court should allow plaintiffs to present evidence tending to show fraud on the FDA in rebutting the manufacturer's presumptive immunity under the Michigan immunity statute.
authors: Michigan State University College of Law, USA.
authors: Jason
authors: J
authors: Murdey
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies; D005607:Fraud / Q000331:legislation & jurisprudence*; D006801:Humans; D016365:Liability, Legal; D008824:Michigan; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*