Appeals court overturns Sanofi victory in first Taxotere trial

Sanofi logo at the company’s headquarters during the annual earnings news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier

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(Reuters) – A federal appeals court on Thursday overturned a jury verdict for Sanofi-Aventis US in the first of thousands of lawsuits over its chemotherapy drug Taxotere to go to trial.

The 5th U.S. Circuit Court of Appeals says Sanofi “effectively smuggled inadmissible opinion evidence” into the 2019 trial of breast cancer survivor Barbara Earnest, in which it claimed that the company knew that Taxotere (docetaxel) could cause permanent hair loss but failed to notify her or her doctors.

The company’s “calculated and troubling final run” around the federal rules of evidence and the Supreme Court’s interpretation of them clearly prejudiced Earnest and warrants a new trial, Circuit Judge Cory Wilson wrote. for the panel of three judges.

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Sanofi and its appeal attorneys at DLA Piper (US) did not immediately respond to requests for comment. The company has long denied that Taxotere, which has been on the market since 1996, causes permanent hair loss, despite the US Food and Drug Administration requiring a label warning in 2015.

An attorney for Earnest, Dawn Barrios of Barrios, Kingsdorf & Casteix, said they were “grateful that the 5th Circuit unanimously agreed that the annulment was warranted.”

Earnest’s case, filed in 2016, is one of approximately 12,000 cases consolidated as multidistrict litigation before U.S. District Judge Jane Triche Milazzo in New Orleans. He was selected as an “indicator” or test case, and was the first to be judged. (A second landmark trial last year also resulted in a defense verdict, which is being appealed separately.)

At trial, Earnest’s evidence included the final report of a 10-year study Sanofi prepared for the FDA in 2010, which indicated “continued” hair loss in 4.2% of participants.

Sanofi called as witnesses two doctors, who said the risk of “permanent” hair loss was actually “extremely low”, about eight-tenths of 1%.

However, the revised figure comes from a new analysis of the 10-year study by Dr. Michael Kopreski, a former vice president of Sanofi testifying as a fact witness. Because he had never been approved as an expert, the trial court erred in allowing him to offer scientific advice, Wilson wrote for the court.

Sanofi’s second witness, Dr. John Glaspy of UCLA, was a suitably qualified expert, but neglected his duty to independently “validate or evaluate” Kopreski’s data, Wilson wrote.

Finally, Sanofi compounded the error with its “categorical” insistence that “the whole thing fails” because of Kopreski’s testimony, the court heard.

The case is Earnest v. Sanofi US Services et al, 5th US Circuit Court of Appeals, No. 20-30184.

For serious: Mr. Palmer Lambert of Gainsburgh, Benjamin, David, Meunier & Warshauer; Dawn Barrios de Barrios, Kingsdorf & Casteix; Christopher Coffin of Pendley, Baudin & Coffin and Andre Mura of Gibbs Law Group

For Sanofi: Ilana Eisenstein and Rachel Horton of DLA Piper

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