On May 20, 2019, the United States Supreme Court decided Merck v. Albrecht (In re Fosamax), No. 17-290 (text version available here), destroying most of the arguments routinely used by drug companies to claim that plaintiffs’ cases are “preempted” and have to be dismissed. The law for people injured by branded prescription drugs is far better now than it was before Albrecht, and as a result, it is likely that far more victims will get to see their day in court.
After Albrecht, a branded prescription drug manufacturer can establish impossibility preemption — which happens when federal law makes it “impossible” for defendants to comply with state tort laws that enable victims to seek compensation — only if they can show:
- The manufacturer “fully informed” the FDA by providing both all “material” safety information and an “evaluation or analysis concerning the specific dangers” raised by the plaintiff; and,
- The FDA took action, “carrying the force of law,” to disapprove the warning proposed by the plaintiffs.
The Supreme Court’s analysis in Albrecht is far more narrow than any preemption argument ever proposed by drug manufacturers, and far more narrow than the “clear evidence” tests many lower courts have been using since Wyeth v. Levine, 555 U.S. 555 (2009). As the Supreme Court itself said, “a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.” Albrecht at *17.