Dr. Gurpreet Walia Speaks to Law360 about the Supreme Court’s Generic Drug Liability Ruling
June 24, 2013
The U.S. Supreme Court recently ruled that users of generic drugs cannot bring state-law design defect claims against generics makers because the manufacturers cannot change a drug's design under federal law. Walia notes, "The decision reaffirms the fundamental principle of the Hatch-Waxman Act: Generic manufacturers must follow FDA requirements for pharmaceutical compositions and labels. A manufacturer of generic drugs cannot change a generic drug's design or labeling under federal law, and therefore should not be penalized for following federal law."