Taxotere Permanent Hair Loss Risk Withheld by Drug Maker, Lawsuit Alleges

In a product liability lawsuit filed last week against Sanofi-Aventis, an Illinois woman alleges that the drug maker withheld information and warnings about the permanent hair loss risk with Taxotere, a breast cancer drug that is the subject of a growing number of similar claims brought by women nationwide. 

The complaint (PDF) was filed by Theresa Wysocki in the U.S. District Court for the Northern District of Illinois on July 7, indicating that she has experienced continuing hair problems, known as alopecia, long after receiving Taxotere as part of her chemotherapy treatments between September 2014 and January 2015.

While allopecia is a common side effect of chemotherapy, it is usually temporary, and Wysocki indicates that Sanofi-Aventis provided false and misleading information that suggested hair would regrow following Taxotere treatments. However, the lawsuit suggests that the drug makers withheld information about the a large number of women who were left with disfiguring and long-term hair problems.

Taxotere (docetaxel) is a high potency taxane-based cancer drug, which was introduced by Sanofi-Aventis in 1996, claiming that it was superior to existing low potency taxanes, such as Taxol. However, Wysocki and other plaintiffs who are pursuing by Taxotere hair loss lawsuits allege that the drug is no more effective than earlier treatments, yet carries a risk of permanent alopecia that is not found with Taxol.

“There were already products on the market at least as effective as Taxotere that did not subject users to the same risk of permanent alopecia, but users of Taxotere were not presented with the opportunity to make an informed choice as to whether the benefits of Taxotere were worth its associated risks,” the lawsuit states. “Defendants engaged in a pattern of deception by overstating the benefits of Taxotere as compared to other alternatives while simultaneously failing to warn of the risk of permanent alopecia.”

The lawsuit notes that the manufacturers failed to disclose information about the link between Taxotere and permanent hair loss, providing false and misleading information that suggested hair would regrow following use of the breast cancer drug. However, in several other countries, Taxotere warnings include information about the permanent hair loss risk. Those same warnings were not provided to users and medical providers in the United States.

As early as 2005, studies have found that women face a substantial risk of permanent hair loss with Taxotere, including findings that indicate one out of every 10 patients treated with Taxotere suffered hair loss that lasted up to 10 years and five months following chemotherapy, and in some cases longer.

Wysocki’s lawsuit presents claims of negligence, failure to warn, and fraud. She seeks both compensatory and punitive damages.