Diabetes Drug MDL Ruling Helps Branded Cos. In Label Fights - Law360

Diabetes Drug MDL Ruling Helps Branded Cos. In Label Fights - Law360

By Sindhu Sundar

Law360, New York (November 16, 2015, 10:25 PM ET) -- A California federal court's decision for drugmakers in multidistrict litigation over their alleged failure to warn of their Type 2 diabetes drugs' potential to cause pancreas problems is among the first to clarify in detail that the U.S. Food and Drug Administration need not explicitly reject a heightened warning in order for branded-drug companies to beat labeling claims by injured patients.

U.S. District Judge Anthony J. Battaglia granted a summary judgment motion by defendants including Eli Lilly & Co. and Merck Sharp & Dohme Corp., finding the defendants had met the so-called "clear evidence" standard established by the U.S. Supreme Court's landmark 2009 ruling in Wyeth v. Levine.

Under that standard, branded-drug makers would have to show there is "clear evidence" that the FDA would not have approved a heightened safety warning in order to successfully argue that the plaintiffs' labeling claims are preempted by FDA oversight.

The high court's Levine decision established 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," Judge Battaglia noted in his opinion.

In that case, the court found there was no clear evidence that the FDA would have rejected the kind of labeling plaintiffs were seeking for the drug at issue in that case. But Judge Battaglia observed that although the Levine court found such an evidence standard applies, it did not say what qualifies as "clear evidence." Plaintiffs have argued in recent years, including in the diabetes drug MDL, that this standard is only met if the agency directly rejects a proposal to strengthen warnings.

Attorneys say Judge Battaglia's opinion, as one of the rare opinions since Levine that discussed in detail the FDA's own consideration of the drug risks alleged by the plaintiffs, is likely to influence other courts considering the issue.
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I think it's a very interesting, but misguided decision, because it couples the inaction of branded manufacturer with the inertia of the FDA to make a label change, to say that therefore a new label would be rejected," said Bill Curtis of the Curtis Law Group. "Even though there was no request [for a label change] by the manufacturer."

The case is In Re: Incretin Mimetics Products Liability Litigation, case number 3:13-md-02452, in the U.S. District Court for the Southern District of California.