Litigation partner and head of the firm’s Life Sciences group William Hoffman spoke with Law360 about a recent California federal court decision, which found that drugmakers were shielded from state law claims because the U.S. Food and Drug Administration would not have approved the changes to the product labels that the plaintiffs claimed were necessary.
In a multidistrict litigation against multiple drugmakers regarding their alleged failure to warn of their Type 2 diabetes drugs' potential to cause pancreas problems, Judge Anthony J. Battaglia found that defendants had met the so-called "clear evidence" standard established by the Supreme Court's landmark 2009 ruling in Wyeth v. Levine. The 2009 ruling mandated that branded-drug makers could be held liable to patients for potential labeling issues, finding that even though FDA oversees the pharmaceutical industry, manufacturers still have to maintain the adequacy of product labeling.
"This opinion gives a roadmap to other courts for the way they should handle this issue, and the way they should treat FDA regulatory actions as evidence bearing on the preemption questions," said Hoffman.
"There have been a range of decisions on this question since 2009, a range of decisions based on different records," he added. "This is probably the most thorough discussion of the question, and reflects what I think is the kind of considered analysis of a regulatory record that the Supreme Court contemplated in Levine."
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