Wednesday, June 26, 2013

Supreme Court Rules in Bartlett Generic Drug Preemption Case; Says State-Law Design-Defect Claims That Turn on a Drug Warning’s Adequacy are Preempted

Tuesday, June 25, 2013

Source: FDA Law Blog

Posted: 24 Jun 2013 06:56 PM PDT

By Kurt R. Karst –

Shortly after 10:00 AM this morning (6/24), the generic drug industry let out a collective sigh of relief. It was at that time the U.S. Supreme Court issued its highly anticipated ruling in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142). In a big win for the generic drug industry, the Court, in a 5-4 decision penned by Justice Alito (and joined in by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas), held that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by the FDC Act and under the Court’s 2011 decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011). Jutice Breyer filed a dissenting opinion joined in by Justice Kagan. Justice Sotomayor filed a separate dissenting opinion joined in by Justice Ginsburg. The composition of Justices in the 5-4 Bartlett decision mirrors that of the 5-4 decision in PLIVA.

As we previously reported, the question presented to the Court was whether the U.S. Court of Appeals for the First Circuit erred when it ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic drug manufacturer stops selling its products.

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