Win for copy drugmakers as US Supreme Court rules for generics in Bartlett pre-emption Case

In what must be seen as a major victory for the generic drug industry in the USA, the US Supreme Court, in a five to four 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 SCt. 2567 (2011).

Justice 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 five-four Bartlett decision mirrors that of the 5-4 decision in PLIVA, writes Kurt Karst on the FDA Law Blog.

The Supreme Court thus says that generic drug manufacturers cannot be sued in state court for a drug’s design defects if federal officials approved the brand-name version the generic drug copied.