Facing more than 12,000 product liability lawsuits brought by women who indicate they have been left with permanent hair loss from Taxotere, Sanofi-Aventis has obtained a defense verdict in the first “bellwether” trial to go before a jury over failure to warn about the risk.

The Taxotere trial involved claims presented in a complaint (PDF) filed by Barbara Earnest in December 2016, which was selected as an early “bellwether” case, because it raises allegations and claims similar to those presented by women nationwide who received the breast cancer drug.

Earnest indicated she was diagnosed with breast cancer in April 2011 and underwent chemotherapy, which included the use of Taxotere, from June 2011 through August 2011. Like many chemotherapy patients, she lost her hair, but unlike most, hers did not come back; a characteristic she and other plaintiffs allege is an unwarned of side effect with Taxotere.

In complaints filed throughout the federal court system, Earnest and other plaintiffs allege that the drug maker knew about the hair loss risk associated with Taxotere, and provided false and misleading information that suggested hair would regrow. However, exposure to Taxotere has been linked to reports of thinning or balding that continues long after treatments are over, and similar problems are not associated with other, equally effective, breast cancer treatments.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, the lawsuit filed by Earnest and other women are centralized before U.S. District Judge Jane Triche Milazzo in the Eastern District of Louisiana, as part of a federal Multidistrict Litigation, or MDL.

As part of the coordinated proceedings in the Taxotere MDL, Judge Milazzo established a “bellwether” process for Taxotere trials, selecting a small group of representative cases that will go before juries, to help the parties gauge the relative strengths and weaknesses of their positions.

Following a trial before a federal court in Louisiana, a New Orleans jury returned a defense verdict in favor of Sanofi-Aventis late last week.

Four other bellwether trials are slated to follow next year.

While the outcomes of these early trial dates will not be binding on the thousands of other women pursuing cases, they are being closely watched and may have an influence on 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.

Tags: Alopecia, Breast Cancer, Chemotherapy, Hair Loss, Sanofi-Aventis, Taxotere