Will High Court Provide Clarity On ‘Clear Evidence’?

The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held liable for state-law failure-to-warn claims even though federal law regulates the contents of its drug’s label.

Lower courts have struggled to apply Levine’s “clear evidence” standard, and the Third Circuit, in In re: Fosamax, arguably gutted it altogether. Merck & Co for a writ of certiorari in In re: Fosamax is pending before the Supreme Court, where it awaits the views of the Solicitor General. If the Supreme Court grants certiorari, it could signal that In re: Fosamax will be overturned and lower courts (as well as branded manufacturers) will finally receive guidance on Levine’s “clear evidence” standard.

Please see our full article as published on Law360.