November 10, 2015 — A federal judge in California has shot down state law failure-to-warn claims involving pancreatic side effects of several diabetes drugs, Law360 reports.
In an order (PDF) granting defendants’ motion for summary judgement, U.S. District Judge Anthony J. Battaglia found that the FDA would have rejected warning labels about pancreatic cancer even if drug-makers had wanted to add them.
The FDA investigated the link between DPP-4 inhibitor (gliptin) diabetes drugs and pancreatic cancer after a study that examined pancreatic tissue specimens found evidence of pre-cancerous growths.
The agency issued a Safety Communication about the study in March 2013, but decided that a new warning label wasn’t needed.
Earlier this year, European health officials said the study “had a number of methodological limitations and potential sources of bias.” Soon afterward, the FDA closed its investigation.
That decision essentially preempts any failure-to-warn claims under state law, according to Judge Battaglia. Therefore, drug-makers Merck & Co., Eli Lilly & Co., Novo Nordisk, and Amylin Pharmaceuticals had no duty to warn patients or doctors about the potential risk.
Plaintiffs argued that lawsuits should not be preempted because the FDA was inadequately evaluating evidence and failing to act.
About 750 lawsuits involving diabetes drugs like Januvia (sitagliptin), Onglyza (saxagliptin),and Nesina (alogliptin) have been centralized in California district court since August 2013. Another 44 cases are pending in other federal courts around the nation.
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