Third Circuit Clarifies Next Steps in Fosamax Decision


On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+ lawsuits pending regarding the medication Fosamax in Merck Sharpe & Dohme v. Albrecht. As previously discussed on this blog in May 2019, the United States Supreme Court held that the issue of federal preemption is one to be decided by the court and not a jury, while somewhat clarifying the “clear evidence” standard governing the analysis.

After the high court’s decision, it was unclear whether the Third Circuit would remand the cases to the district court for application of the Supreme Court’s guidance or decide the issue – a legal one, after all, as just declared by the Supreme Court – itself de novo. Following supplemental briefing by the parties, with a November 25, 2019, Order, the Third Circuit elected the former procedure, kicking these cases back to the district court on remand:

[W]e conclude and hereby order that these cases shall be remanded to the District Court in order to allow that court to determine in the first instance whether the plaintiffs’ state law claims are preempted by federal law under the standards described by the Supreme Court in its opinion. On remand, the District Court is instructed to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether such agency actions are sufficient to give rise to preemption.

Few courts have applied the “clear evidence” standard since the Supreme Court’s decision in Albrecht earlier this year. On remand, the district court may be one of the first courts to take a crack at applying the Albrecht recitation of the “clear evidence” standard in deciding a question of federal preemption.

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