Taxotere Bellwether Lawsuit Cleared To Proceed Before Jury, But Trial Date Postponed Due to COVID-19

The U.S. District Judge presiding over all federal Taxotere hair loss lawsuits has rejected a motion for summary judgment filed in a bellwether case previously selected for trial, clearing the case to go before a jury, but the trial originally scheduled to begin in February has been continued due to the on-going coronavirus pandemic.

Sanofi-Aventis currently faces more than 12,000 product liability claims brought by women nationwide, each involving similar allegations that the drug maker failed to adequately warn that users of the breast cancer treatment may suffer permanent hair loss that is not associated with other, equally effective drugs.

While hair loss is a normal side effect of chemotherapy, the lawsuits claim that Sanofi-Aventis provided false and misleading information about the hair loss risk with Taxotere, suggesting hair would regrow following treatment. However, plaintiffs indicate they could have avoided the permanent problems by using a less toxic breast cancer treatment if proper warnings had been provided.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, all lawsuits filed in U.S. District Courts nationwide are centralized as part of a multidistrict litigation (MDL) in the Eastern District of Louisiana, where U.S. District Judge Jane Triche Milazzo has been presiding over coordinated discovery and a series of early “bellwether” trials designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

After a first bellwether trial ended in a defense verdict in September 2019, and a second trial set to begin earlier this year was dismissed on statute of limitations grounds, a case filed by Elizabeth Kahn was scheduled for trial to begin on February 1, 2021.

In a series a pretrial decisions issued late last week, Judge Milazzo denied the defendants’ motion for summary judgment (PDF) based on the affirmative defense of preemption, rejecting the argument that federal law precluded Sanofi from revising the Taxotere warning label.

“The evidence shows that the FDA learned from third-party sources, rather than from Sanofi, about the risk of permanent alopecia. Then, upon review of the information Sanofi initially provided, the FDA asked Sanofi for more information,” Judge Milazzo wrote. “All of this suggests that Sanofi was sitting on its hands rather than making an ‘earnest attempt’ to keep the FDA informed of the possible need for a stronger warning.”

The decision clears the way for Kahn’s case to proceed before a jury. However, in a separate case management order (PDF) issued on December 21, Judge Milazzo announced the trial date slated for February 1 has been continued, and that a new trial date will be selected in a future case management order.

While the outcome of the Kahn trial, and the other two remaining bellwether cases that are yet to be scheduled, will not have a binding effect on the claims brought by other women, they will be closely watched by parties involved in the litigation and will likely have a big influence on any eventual Taxotere settlement negotiations, which would be necessary for the drug maker to avoid thousands of separate trial dates in U.S. District Courts nationwide in the coming years.