A woman has filed a lawsuit against Sanofi Aventis alleging the company’s breast cancer chemotherapy drug Taxotere caused her to develop permanent hair loss, also known as permanent alopecia.

Plaintiff Tracy Q. filed the lawsuit in a Louisiana federal court stating that following her chemotherapy treatment, she experienced permanent hair loss from Taxotere.

She states she was not aware of this potential adverse side effect prior to using the chemotherapy drug, and would not have chosen to use it if she had known that she may never get her hair back.

Taxotere is a chemotherapy drug used to treat many types of cancer, including breast cancer. The manufacturers initially sought FDA in 1994, but the drug approval was rejected because it was more toxic than a related drug, Taxol, that was already FDA approved.

Ultimately, Taxotere became FDA approved in May 1996, with the label stating it was “indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.”

After initially receiving approval, Sanofi Aventis looked for additional FDA approval to grant the drug more indications for treatment.

“Based on self-sponsored clinical trials, Defendants claim superiority over other chemotherapy products approved to treat breast cancer,” the lawsuit states.

The claim goes on to state “Contrary to Defendants’ claims of superior efficacy, post-market surveillance has shown that the more potent and more toxic Taxotere does not in fact offer increased efficacy or benefits over other Tax liens, as Defendants have claimed and advertised” and purposefully hid the existence of such studies from the FDA, medical community and patients that refuted their claims.

Tracy states that her permanent hair loss from Taxotere and the permanent hair loss others have experienced was a direct result of improper actions taken by Sanofi Aventis.

“As a direct result of their aforementioned conduct, Defendants caused thousands of individuals to be exposed to increased frequency and more severe side effects, including, but not limited to, disfiguring permanent alopecia (hair loss).”

Most women who undergo chemotherapy for breast cancer treatment or for other cancer treatments understand that hair loss is part of the natural chemotherapy process. However, permanent hair loss from Taxotere was not expected, nor was it properly disclosed patients, Tracy states.

She states that other similar products were available on the market that were effective in treating cancer that did not subject chemotherapy patients to the risk of suffering disfigurement from permanent alopecia like Taxotere does.

Tracy also takes issue with Taxotere’s manufacturer warning patients and regulatory agencies in other countries of the risk of permanent hair loss from Taxotere while purposefully concealing such safety warnings from patients and physicians in the United States.

“As a direct result of Defendants’ failure to warn patients of the risk of disfiguring permanent alopecia in the United States, thousands of women, including Plaintiff, as well as their healthcare providers, were deprived of the opportunity to make an informed decision as to whether the benefits of Taxotere over other comparable products was justified,” the Taxotere lawsuit states.

Tracy is raising claims following her permanent hair loss from Taxotere including design defect, inadequate warning, breach of express warranty and breach of warranty in redhibition.

She is seeking damages for past, present and future medical and related expenses, physical injury and disability, physical pain and suffering, mental anguish and distress, loss of earnings, impairment to earning capacity, loss of enjoyment to life and other damages to be determined at trial.

The Permanent Hair Loss from Taxotere Lawsuit is Case No. 3:16-cv-01626, in the U.S. District Court for the Western District of Louisiana, Lafayette Division.