About a week ago, the Surpreme Court issued its opinion on Merck Sharpe & Dohme v. Albrecht, the latest decision in the Court's line of cases on pre-emption as a defense in cases for injuries caused by lack of adequate warnings regarding prescription drugs.
According to the summary and analysis of the opinion in the SCotUS blog, the opinion offers "clarity on the procedure for deciding pre-emption defenses, but little additional elucidation on the contours of those defenses."
You should read the full article (here), which explains that "[a] decade ago in Wyeth v. Levine, the court held that to succeed with the impossibility pre-emption defense, defendants had to produce “clear evidence” that the FDA would have prohibited an additional warning. Yesterday’s opinion in Albrecht attempted to clarify Wyeth’s application by explaining abstractly that the “clear evidence” standard contemplates an irreconcilable conflict between federal and state law, rather than a heightened standard of evidentiary proof."
The court held that judges, rather than juries, should decide whether FDA actions pre-empt state tort suits alleging failure to warn consumers of adverse effects. This is a strategic win for drug manufacturers, clarifying that their go-to defense of “impossibility preemption” – the claim that federal regulation would have prohibited the additional warnings plaintiffs allege state tort law required – can be decided on motions before the case reaches a jury.
Jurist has a short summary here.
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