A woman who has suffered hair loss from Taxotere has filed a lawsuit against the chemotherapy drug’s maker.

Michelle C. was diagnosed with breast cancer in April 2013. She underwent chemotherapy treatment that included Taxotere from May 2013 to August of that year.

Unbeknownst to her or to her doctors, permanent hair loss from Taxotere was a possible side effect of the treatment. Michelle is suffering from permanent hair loss, also known as alopecia.

Taxotere is made and marketed by Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC, all of whom are defendants in this case.

Hair Loss from Taxotere Allegedly Concealed

The FDA approved Taxotere in May 1996 even though it was a more toxic drug than its main competitor, Taxol.

Because it was more toxic, the drug’s makers claimed that it was also superior for fighting breast cancer, which is not true.

The lawsuit states, “In marketing Taxotere, Defendants continually have made false claims of superior efficacy and omitted safety information.”

The FDA warned Aventis Pharmaceuticals North America to stop sending three direct-to-consumer print ads for Taxotere in November 2003 because the ads were misleading.

The FDA said the ads misled people because “they suggest that Taxotere is more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

In addition, the letter said the ads “do not discuss common side effects associated with Taxotere, including hair loss.”

By believing that Taxotere was more effective than alternative chemotherapies, women who relied upon this false information unknowingly exposed themselves to the risk of permanent hair loss from Taxotere for no good reason.

In 2009, the FDA said the promotional material for Taxotere “misleadingly suggest that Taxotere is superior to paclitaxel in the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and overstate the efficacy of Taxotere. FDA is unaware of substantial evidence to support these claims.”

Taxotere GEICAM 9805 Clinical Study Results Hidden

In May 2008, Taxotere released a press release regarding its efficacy based on results of a clinical study called GEICAM 9805.

What the defendants neglected to tell the public and health care providers was that in that study, hair loss from Taxotere “persisted into the follow-up period (10 years and five months was the median follow-up time) and was observed to be ongoing in 9.2 percent of the patients taking Taxotere.”

Interestingly, doctors, patients, and regulatory agencies in other countries such as Canada and the European Union were warned of the risks of permanent hair loss from Taxotere for years before such risks appeared in information published in the United States.

Consumers and health care providers were not informed of these risks until December 2015.

Michelle’s lawsuit says, “As a direct result of defendants’ wrongful and deceptive acts, users of Taxotere, including Plaintiff, were exposed to the risk of permanent” hair loss from Taxotere without warning.

As a result, Michelle and thousands of other women were “deprived of the opportunity to make an informed decision as to whether the benefits of using Taxotere over other comparable products was justified.”

The Taxotere Hair Loss Lawsuit is Case No. 17-cv-00998 in the U.S District Court for the Eastern District of Louisiana.