In Re: Fosamax Products Liability Litig.

E-Law Admin/ März 22, 2017/ Arzneimittelrecht Schweiz/ 0Kommentare

In Re: Fosamax Products Liability Litig., 14-1900

In consolidated personal-injury suits against a drug manufacturer, averring that the osteoporosis drug Fosamax caused plaintiffs to suffer serious thigh bone fractures, and bringing state-law tort claim alleging that defendant failed to add an adequate warning of the risk of thigh fractures to Fosamax’s FDA-approved drug label, the district court’s grant of summary judgment to defendants, based on the Supreme Court’s decision in Wyeth v. Levine, which holds that state-law failure-to-warn claims are preempted when there is ‘clear evidence’ that the FDA would not have approved the warning that a plaintiff claims was necessary, is vacated where: 1) preemption is an affirmative defense, and defendant has not carried its burden to prove that it is entitled to that defense as a matter of law; and 2) plaintiffs have produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures–or at the very least, to conclude that the odds of FDA rejection were less than highly probable.

Appellate Information

  • Argued
  • Submitted
  • Decided
  • Published 2017/03/22



  • United States Third Circuit


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