On November 16, FDA filed an amicus brief at the 6th Circuit's invitation in the consolidated appeals of Smith v. Wyeth, Inc. (Case No. 09-5460), Wilson v. Pliva, Inc. (Case No. 09-5466), and Morris v. Wyeth, Inc. (Case No. 09-5509). The issue on appeal is: "Whether federal law preempts a tort claim under state law that a generic drug approved by the Food and Drug Administration was inadequately labeled." FDA's position is that "failure-to-warn claims against manufacturers of generic drugs are not categorically preempted by federal law." Interestingly though, FDA filed a contrary amicus brief in 2006 for another case, Colacicco v. Apotex, advocating that state-law claims were preempted by federal law. However, FDA withdrew its opinion following the Supreme Court's decision in Wyeth v. Levine and after Obama's democratic administration took office.
The Wyeth cases concern the drug Reglan® (metoclopramide), which is indicated to relieve symptoms caused by slow stomach emptying in people who have diabetes. Plaintiffs assert that the drug was defective because the brand and generic drug manufacturers failed to adequately warn that long-term use of metaclopramide could result in tardive dyskinesia--a neurological disorder. The District Court dismissed the case, holding that plaintiffs' failure-to-warn claims were categorically preempted by federal law. The Court reasoned that generic drug manufacturers could not comply with Federal law--the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act in particular--if they were liable under state-law for failure-to-warn, because Federal law requires generic drugs to have identical labeling to the brand drugs.
FDA contends that the District Court's decision is therefore contrary to already-existing case law. For instance, the Supreme Court in Levine held that Federal Law does not pre-empt plaintiffs' claim that a drug or medical device manufacturer failed to give an adequate warning. However, the District Court distinguished Levine from the current case, because Levine involved a claim against a brand drug--not a generic drug--and, therefore, involved different regulatory provisions. Other court of appeals cases decided after Levine, held that Federal Law governing generic drugs does not preempt state law failure-to-warn cases against generic drugs. See Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009); Demahy v. Actavis, 593 F.3d 428 (5th Cir. 2010). FDA also opined that although federal law may proscribe remedies in failure-to-warn cases, these cases are categorically preempted, because failure of a generic drug company to petition the FDA to change a warning label could be an actionable negligence.