Earlier this week, the 6th Circuit joined several of its sister courts in ruling that plaintiffs cannot maintain claims against either generic or brand-name manufacturers based on injuries allegedly caused by the consumption of generic drugs. The 6th Circuit panel held that the plaintiffs in seven lawsuits, who alleged that a generic version of digestion medication Reglan caused them to develop a neurological disorder, could not maintain claims against the brand-name manufacturer under the Tennessee Products Liability Act for injuries from products the brand-name manufacturer did not make. Additionally, the panel held that state law failure-to-warn claims were preempted by U.S. Food and Drug Administration (“FDA”) regulations that require generic drug labels to match the labels of their name-brand counterparts. U.S. Circuit Judge Ronald Lee Gilman, writing for the panel, stated “we feel compelled to affirm the judgment below in light of the controlling case law,” even if so holding precludes generic drug users of any claims against drug manufacturers.
This holding acknowledges the major victory defendants scored in the U.S. Supreme Court’s 2011 decision in Pliva v. Mensing, which held that state failure-to-warn claims were preempted by the federal requirement that generics labels be identical to brand name labels to get FDA approval. Plaintiffs, including those in the 6th Circuit cases, have tried to circumvent this ruling by arguing that the generic companies could have met their state law-based duty to warn by seeking approval for a labeling change or by sending “Dear Doctor” letters describing the health risks of a drug. But the 6th Circuit rejected these arguments, noting that “plaintiffs’ narrow reading of Mensing has been soundly rejected by all circuits to consider the argument.” Thus, another Circuit Court has reaffirmed the definitiveness of Mensing, solidifying its use by defendant drug manufacturers.