A woman from Louisiana is suing the Sanofi-Aventis companies, alleging she suffered permanent hair loss after chemotherapy treatment with Taxotere.

Plaintiff Alma W. says she was diagnosed with stage 3 cancer in her right breast in 2010.

In April of that year, she says, she began the first of six rounds of chemotherapy using the drug Taxotere, manufactured by defendant Sanofi-Aventis.

Neither Alma nor her treating physicians were ever made aware of the risk of permanent hair loss from chemotherapy treatment associated with Taxotere, she claims.

Had she been made aware of that risk, she says, she never would have taken Taxotere.

Taxotere, or docetaxel, is a chemotherapy drug used to treat various forms of cancer. It sees a particular amount of use in the treatment of breast cancer. It’s one of a class of plant-derived chemotherapy drugs known as taxanes.

Attributing Permanent Hair Loss from Chemotherapy Treatment to Taxotere

While it’s common for chemotherapy patients to experience some hair loss, permanent hair loss from chemotherapy is an extraordinary side effect, Alma claims.

She cites a study of Taxotere’s side effects known as the GEICAM 9805 study, in which 9.2 percent of patients ended up with persistent alopecia, or hair loss, lasting as long as 10 years and 5 months.

She also says that in 2006, an oncologist in Denver reported that 6.3 percent of his patients treated with Taxotere had permanent disfiguring hair loss lasting for years after cessation of Taxotere treatment.

Alma argues that a patient might reasonably accept the risk of permanent hair loss from chemotherapy if there were no other alternative available.

But in fact, she says there are other drugs on the market that are at least as effective as Taxotere without the same risk of disfiguring permanent alopecia.

Since Taxotere was first approved by the FDA in 1996, Sanofi’s labeling for the drug did not address the risk of disfiguring baldness until a label change was issued in December 2015, Alma contends.

Even then, she claims, the new warning label did not fully address the actual risks of permanent hair loss from chemotherapy treatment with Taxotere.

Alma says that Taxotere was purposely designed to have increased toxicity – not for any therapeutic purpose but only so that it would be more eligible for a patent.

But “post market surveillance has shown that the more potent and more toxic TAXOTERE® does not in fact offer increased efficacy or benefits over other Taxanes, as Defendants have claimed and advertised,” according to Alma.

Alma cites a few studies from 2007 and 2008 that found Taxotere was not more effective than other taxanes. She says that despite the results of these studies, Sanofi continued to advertise Taxotere as being more effective than competitor drugs.

These allegedly false and misleading statements ultimately earned Sanofi a letter from the FDA warning the company that its advertising materials for Taxotere constituted a misbranding of the drug in violation of the Federal Food, Drug, and Cosmetic Act.

Alma’s Taxotere lawsuit raises claims under the Louisiana Products Liability Act for defective design, inadequate warning, and breach of warranty. She seeks an award of damages, plus court costs, attorney’s fees, and applicable interest.

The Taxotere Chemotherapy Treatment Lawsuit is Case No. 2:16-cv-12706 in the U.S. District Court for the Eastern District of Louisiana.