Wednesday, May 22, 2019
Yesterday, in Merck Sharpe & Dohme v. Albrecht, the Court held that judges, not juries, should decide whether FDA actions preempt state tort suit alleging failure to warn. The opinion explained that Wyeth v. Levine's "clear evidence" standard contemplates an irreconcilable conflict between federal and state law, rather than a heightened standard of evidentiary proof:
This point of procedural clarity has enormous strategic value for products-liability defendants because it confirms that courts may conclusively rule on the pre-emption defense as early as a pre-answer motion, though the factual complexity of FDA communications likely will push the issue in many drug-pre-emption cases to summary judgment.
Elizabeth McCuskey at SCOTUSblog has details.