On May 20, 2019, the U.S. Supreme Court held that the judge, not the jury, must decide whether state-law failure-to-warn claims are preempted by federal law on the ground that there is “clear evidence” that the U.S. Food and Drug Administration (FDA) would not have approved the warning that state law requires.
Litigation resulting from failure to warn consumers of the side effects of prescription drugs is growing exponentially. The decision of the United States Supreme Court in Merck Sharp & Dohme Corp. v. Albrecht may make it more difficult for injured parties to prevail on claims that they were not adequately warned about those side effects.
The issue with state v. FDA drug labeling
The FDA has the last word on prescription drug labeling. The agency must approve the text of labels that accompany prescription drugs, including any warnings about potential side effects. In exercising that authority, the FDA may decline to include certain side effects on the product’s warning label. That can lead to problems for manufacturers when they are sued under state product liability laws.
For example, state laws may require that certain side effects be listed on a particular prescription drug label, while the FDA has no such requirement. A drug manufacturer will be faced with both state law requirements and FDA regulations. So what is a manufacturer to do? In the past, a manufacturer sued for failing to warn about a side effect had to convince the finder of fact – usually a jury – that despite any effort the FDA would not have permitted it to do so.
Pre-emption before Merck: appellate courts side with plaintiffs
Such was the state of the law when the U.S. Supreme Court was asked to decide Merck Sharpe & Dohme v. Albrecht, a case which originated as an MDL in the District of New Jersey. At issue in the lower court was whether patients were adequately warned that the osteoporosis drug Fosamax might cause severe thigh bone fractures. In the district court, Merck successfully claimed that these claims were pre-empted by federal law because, in accord with Wyeth v. Levine, 555 U.S. 555 (2009), there was “clear evidence” that the FDA would not have approved the warning that the plaintiffs claimed was necessary.
That decision was reversed by the Third Circuit Court of Appeals, relying upon Wyeth to hold that Merck had not demonstrated that there was “clear evidence” that the FDA would not have approved the warning. The decision was widely seen as a victory for plaintiffs seeking to hold pharmaceutical manufacturers liable.
Pre-emption after Merck: SCOTUS sides with drug manufacturers
Manufacturers and plaintiffs both had a great deal at stake when the case was appealed to the Supreme Court. Industry groups such as The Pharmaceutical Research and Manufacturers of America, the US Chamber of Commerce, and The Product Liability counsel submitted amicus briefs urging reversal. Ultimately, the Supreme Court reversed the Third Circuit.
Highlights of the SCOTUS decision in Merck
The Supreme Court unanimously held that it is up to the judge, and not the jury, to determine whether the “clear evidence” standard has been met. The Court also clarified Wyeth’s “clear evidence” standard, finding that “clear evidence”:
“is evidence that shows the court that the drug manufacturer 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 a change to the drug’s label to include that warning.”
The Third Circuit treated the preemption question as one of fact, not law, and did not have an opportunity to consider fully the “clear-evidence” requirement as explained in the Court’s opinion. Therefore, the Court vacated the judgment and remanded the case for further proceedings. The Merck decision presents plaintiffs’ attorneys looking to prosecute cases involving pharmaceutical side effects with an additional hurdle to success. Read the entire Order.
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