preemption – Duane Morris Life Sciences Law

March 5, 2021March 5, 2021 by Duane Morris

Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices

The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices. The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.

To read the full text of this post by Duane Morris attorney Sharon O’Reilly, please visit the Duane Morris Products Liability Blog.

May 24, 2019 by Duane Morris

Supreme Court Rules That Judges, Not Juries, Must Decide Preemption of Failure-to-Warn Claims

On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”

View the full Alert on the Duane Morris LLP website.