2nd Circuit upholds dismissal of Lipitor diabetes lawsuit

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(Reuters) - A federal appeals court has refused to revive a lawsuit accusing Pfizer Inc of failing to warn that its cholesterol drug Lipitor could cause diabetes, agreeing with a lower court judge that the plaintiffs' state law claims were preempted by federal law.

The unsigned summary order from a 2nd U.S. Circuit Court of Appeals panel Wednesday said only that the decision was based on "substantially the reasons stated by the District Court."

Senior Circuit Judge Pierre Leval, Circuit Judge Raymond Lohier and Judge Gary Katzmann of the Court of International Trade, sitting by designation, had heard arguments in the case last month.

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Keith Altman, a lawyer for the plaintiffs, did not immediately respond to a request for comment.

Pfizer, which was represented by Mark Cheffo of Dechert, referred a request for comment to Viatris Inc, which has owned Lipitor since it was formed through the merger of Mylan NV and Pfizer's Upjohn division in November. Viatris did not immediately respond to a request for comment.

The 2019 lawsuit is one of many that have been filed around the country alleging that Lipitor can cause diabetes, though most of those cases were consolidated in a multidistrict litigation and dismissed in 2017 after plaintiffs' experts were excluded.

The plaintiffs in the 2nd Circuit case - patients who took Lipitor and their spouses – focused on about 6,000 so-called adverse-event reports Pfizer submitted to the FDA of patients being diagnosed with diabetes after taking Lipitor. Such events must legally be reported, whether or not a drugmaker believes they are related to the drug.

They said that Pfizer failed to warn of diabetes risk because they were required not merely to submit adverse event reports, but to analyze them.

U.S. District Judge William Pauley dismissed the case, finding that the claims were preempted by the federal Food, Drug and Cosmetic Act because Pfizer could not change the Food and Drug Administration-approved label without the agency's permission.

He said preemption could only be overcome if Pfizer had new information linking Lipitor to diabetes that it failed to report, but that the adverse event reports did not qualify.

Altman argued on appeal last month that there was a question of fact as to whether Pfizer should have told the FDA that Lipitor can cause diabetes, which would have allowed it to change its label.

Cheffo said the plaintiffs failed to support the claimed link, noting that diabetes is a frequent comorbidity with high cholesterol and calling the lawsuit a "fishing expedition."

Courts have held that most state law failure-to-warn claims over drugs with FDA-approved labels are preempted.

The case is Gayle v. Pfizer Inc, 2nd U.S. Circuit Court of Appeals, No. 20-1383.

For plaintiffs: Keith Altman of The Law Office of Keith Altman

For Pfizer: Mark Cheffo of Dechert

READ MORE: 2nd Circuit urged to revive claims that Lipitor caused diabetes

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.