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SAN DIEGO — (Mealey’s) The California federal judge overseeing the incretin mimetic multidistrict litigation on Nov. 9 granted summary judgment to five makers or promoters of the diabetes drugs, finding clear evidence that the Food and Drug Administration would have rejected a new warning about the risk of pancreatic cancer from the drugs (In Re: Incretin-Based Therapies Products Liability Litigation, MDL Docket No. 2452, S.D. Calif.).
(Incretin mimetic opinion available. Document #28-151112-015Z.)
The summary judgment ruling applies to all cases in the MDL. As of Oct. 15, the Judicial Panel on Multidistrict Litigation listed 749 pending MDL cases.
“Defendants have demonstrated by clear evidence that the FDA would have rejected a reference to pancreatic cancer in the product labeling during the time in which Plaintiffs’ claims accrued,” U.S. Judge Anthony J. Battaglia of the Southern District of California held. “Plaintiffs’ challenges to the FDA’s conclusions regarding pancreatic cancer risk are insufficient to overcome preemption in light of the extensive regulatory history of the drugs at issue.
“The evidence establishes the FDA has reviewed the risk specific to Plaintiffs’ claims and, after considering the totality of available scientific data, concluded a warning or other reference to that risk is unsubstantiated,” Judge Battaglia continued.
All Time Periods Covered
The judge said his preemption order applied to plaintiffs’ claims that accrued before Oct. 15, when the record closed on the preemption motion. “Finding no significant temporal gaps between the FDA’s conclusions regarding pancreatic cancer risk and the dates Plaintiffs’ claims accrued, the Court finds such claims preempted.”
Judge Battaglia said that while the “most compelling example of clear evidence the FDA would have rejected a pancreatic cancer label change occurred in 2014, the record supports the conclusion that a label change would have been rejected at any earlier date, when presumably less scientific data existed, and less extensive research by the FDA had been conducted. This is particularly true as the FDA’s earliest conclusions regarding pancreatic cancer risk as presented in the record occurred in 2009.”
“Thus, the affirmative defense of preemption operates to bar Plaintiffs’ claims which accrued prior to the close of the record,” the judge said.
The MDL was created in 2013 after medical literature suggested a link between incretin mimetics and pancreatitis or pancreatic cancer.
Drugs, Defendants At Issue
The drugs at issue are: Januvia brand sitagliptin and Janumet, a combination of Januvia and metformin, made by Merck Sharpe & Dohme Corp.; Byetta brand exenatide, made by Amylin Pharmaceuticals LLC and co-promoted by AstraZeneca; Victoza brand liraglutide, made by Novo Nordisk Inc.; and Tradjenta brand linagliptin, made by Eli Lilly and Co. The drugs are glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors and are sometimes described as incretin mimetics.
The drugs are prescribed to people with type 2 diabetes to help control blood glucose levels.
The defendants twice moved for preemption summary judgment, arguing that it would be impossible for them to comply with federal labeling requirements and state tort law, given the FDA’s opinions regarding a causal association between the drugs and pancreatic cancer. They noted that the agency in February 2014 issued an assessment of pancreatic safety in the New England Journal of Medicine, rejected a citizen petition requesting the withdrawal of Victoza and issued a September 2014 conclusion that a causation association with pancreatic cancer was indeterminate.
The plaintiffs countered that the FDA did not expressly reject a label reference to pancreatic cancer and, therefore, under U.S. Supreme Court case law, there is no “clear evidence” that the agency would have rejected such a warning.
FDA’s Actions Key
Judge Battaglia said the FDA’s inaction after all its reviews “supports the conclusion that the FDA does not consider available scientific evidence of a causal association sufficient to warrant inclusion in the labeling.”
Contrary to the plaintiffs’ argument that the FDA had to reject a pancreatic cancer warning, the judge said the law requires only that the agency would have rejected a new warning.
Merck is represented by Douglas R. Marvin, F. Lane Heard III, Ana C. Reyes and Paul E. Boehm of Williams & Connolly in Washington, D.C., and Vickie E. Turner of Wilson Turner Kosmo in San Diego. Lilly is represented by Nina M. Gussack, Aline Fairweather and Kenneth J. King of Pepper Hamilton in Philadelphia.
Novo Nordisk is represented by Loren H. Brown, Heidi Levine and Raymond M. Williams of DLA Piper in New York. Amylin is represented by Richard B. Goetz and Amy J. Laurendeau of O’Melveny & Myers in Los Angeles.
The plaintiffs are represented by Michael K. Johnson of Johnson Becker in Minneapolis; Ryan L. Thompson of Watts Guerra in San Antonio; Louis M. Bograd of the Center for Constitutional Litigation in Washington; Hunter J. Shkolnik of Napoli Shkolnik in New York; Tor A. Hoerman of Tor Hoerman Law in Edwardsville, Ill.; and Max Kennerly of the Beasley Firm in Philadelphia.
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