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Kaye Scholer Secures Seventh Circuit Generic Preemption Win

February 3, 2016

Kaye Scholer litigators achieved a significant win for Vintage Pharmaceuticals, LLC d/b/a Qualitest Pharmaceuticals (“Qualitest”), when the 7th Circuit Court of Appeals affirmed dismissal of a generic prescription product liability case on preemption grounds under the Supreme Court’s decisions in PLIVA, Inc. v. Mensing and Mutual Pharm. Co., Inc. v. Bartlett. This is the first time that the 7th Circuit has considered the extent to which product liability claims against generic prescription drug manufacturers are preempted by federal law since Mensing and Bartlett.

In Houston v. USA, plaintiff alleged a variety of state-law claims against Qualitest, including failure to warn, defective design, negligence, consumer fraud, breach of warranty and battery. Through each of the claims, plaintiff alleged that Qualitest should have labeled or designed the drug differently. The district court dismissed all claims with prejudice and the 7th Circuit affirmed.

The 7th Circuit held that all of plaintiff’s claims are preempted by the “ongoing duty of sameness” that is imposed on generic drug manufacturers to ensure that the design and label of a generic drug are the same as its brand-name counterpart. As the Court observed, “[w]ithout a different label or design, the only way that Qualitest could avoid liability would be to exit (or never have entered) the generic market.” But because “market exit is precisely the outcome that the duty of sameness and Mensing’s preemption principle are designed to prevent,” the claims were preempted.

In addition, the Court rejected plaintiff’s argument that Mensing and Bartlett did not apply because his claims arose after the passage of the Food and Drug Administration Amendments Act of 2007. The Court noted that the amendments still forbid a generic drug-maker from violating the duty of sameness without FDA permission.

Litigation partner Angela R. Vicari and associate Daniel Meyers helped secure this success for Qualitest.

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