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Pharmaceuticals / Regulatory Affairs / Postmarket Safety / Commercial Operations

Appeals Court Tosses Generic Reglan Case

Dec. 5, 2013

A federal appeals court Monday agreed to dismiss seven personal injury lawsuits brought by patients that took the generic version of Reglan (metoclopramide), admitting the plaintiffs were caught in a catch-22 that prevents liability claims against generic or brand-name manufacturers.

The U.S. Appeals Court for the Sixth Circuit upheld a lower court’s decision that brand-name manufacturers couldn’t be held liable under state law for injuries from products they didn’t make; and generic drugmakers cannot be held liable because the Supreme Court’s decision in Pliva v. Mensing ruled 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.

“Although we feel compelled to affirm the judgment below in light of the controlling case law, we cannot help but note the basic unfairness of this result,” the Sixth Circuit’s opinion said. "[The plaintiffs are] caught in a classic ‘catch-22,’ barred from all claims against the generic manufacturers whose drugs they ingested and from all claims against the brand-name manufacturers.”

The Sixth Circuit court’s ruling comes down just weeks after the FDA proposed a rule to give generic drugmakers the ability to revise product labeling in response to safety issues prior to agency approval or changes being initiated by the brand counterpart — making the federal preemption defense obsolete.

The seven consolidated cases are among many others filed nationwide alleging that the plaintiffs developed a serious neurological disorder known as tardive dyskinesia as a result of taking metoclopramide. — Melissa Winn

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