Tag Archives: Wyeth v. Levine

Mutual v. Bartlett: A Line in the Sand on Side Effects

The Supreme Court ruled last Monday in the case of Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA. The majority, which included Justices Alito, Roberts, Scalia, Kennedy, and Thomas, concluded that federal regulation trumps state tort liability law, […]
Posted in FDA, Legal, Market Access, Marketing, Regulatory, Safety | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

Preemption Watch: You've Been Warned

The Supreme Court on Wednesday issued its decision in the much-watched case of Wyeth v. Levine—which many in pharma hoped would firmly establish FDA decisions as a bulwark against common-law liability suits in state courts. The decision, as you’ve no doubt heard already, went against Wyeth. Pharm Exec‘s coverage is here. The opinion is here. […]
Posted in Legal | Also tagged , , | 6 Comments
  • Categories

  • Meta