November 10, 2015 — Law360 reports that diabetes drug-makers are shielded from failure-to-warn claims involving pancreatic cancer because the FDA would have rejected warning labels, a federal judge has ruled.
U.S. District Judge Anthony Battaglia granted defendants’ motion for summary judgment in an order (PDF) issued yesterday.
Earlier this year, the FDA completed a two-year review of DPP-4 inhibitor (gliptin) diabetes drugs and concluded that new warning labels were unnecessary. Plaintiffs’ attorneys argued that their claims should not be rejected just because the FDA was inadequately evaluating evidence and failing to act.
Concerns about the link between DPP-4 inhibitors and pancreatic cancer were sparked by a study published in the journal Diabetes. Researchers examined a small number of pancreatic tissue specimens and found evidence of pre-cancerous growths. In March 2013, the FDA issued a Safety Communication about the study and opened an investigation.
After European health officials called the study biased and methodologically limited, the FDA closed its investigation and concluded that no new warnings were needed.
The FDA’s decision essentially shoots down failure-to-warn claims in about 750 lawsuits centralized in California under Judge Battaglia, plus another 44 cases in other district courts. Some of the most popular drugs in the DPP-4 inhibitor class include Januvia (sitagliptin), Onglyza (saxagliptin), and Nesina (alogliptin).
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