A recent survivor of breast cancer is taking on the makers of chemotherapy drug Taxotere for allegedly failing to provide adequate warnings about the drug’s side effects.

Plaintiff Stephanie W. says that following a May 2014 lumpectomy, she underwent chemotherapy from July through September of that year.

She says her  treatment included the chemotherapy drug Taxotere, a drug made by defendant Sanofi and its associated companies.

Following that chemotherapy, she says she developed permanent hair loss, known as alopecia. She attributes that hair loss to the Taxotere she was treated with.

Taxotere, also known under its generic name docetaxel, is one of a class of chemotherapy drugs known as taxanes.

It was developed by a predecessor of the current defendant companies. After an initial denial of FDA approval in 1994, Taxotere was approved for U.S. use in 1996.

Chemotherapy Drug Taxotere and Permanent Hair Loss

Stephanie notes that while hair loss is common among chemotherapy patients, it’s not common for that hair loss to be permanent.

She says Sanofi held on to clinical evidence of the link between Taxotere and permanent hair loss, failing to publicize it when they should have.

A study known as the GEICAM study examined the efficacy of Taxotere.

While Sanofi promoted the study’s results addressing Taxotere’s efficiency, Stephanie says the company neglected to publicize the finding that alopecia persisted in more than 9 percent of the study’s patients for a median follow-up time of 10 years and 5 months.

Stephanie says that before she began chemotherapy, neither she nor her treating physicians were aware of the risk of permanent alopecia associated with chemotherapy drug Taxotere.

She says other chemotherapy drugs are available that are at least as effective as Taxotere but that don’t present the same risk of permanent alopecia.

But because of the lack of an adequate warning, patients don’t get the opportunity to make an informed decision as to whether the benefits of chemotherapy drug Taxotere are worth the risks.

The defendants allegedly made things worse for her by issuing promotional materials that overstated the efficacy of Taxotere compared to its competitors.

Stephanie says these alleged overstatements got the attention of the FDA, who sent Sanofi a letter in 2003 telling the company that three of its direct-to-consumer print ads were misleading because they “suggest that Taxotere is more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

The FDA sent another letter in 2009, again warning Sanofi that its promotional material for chemotherapy drug Taxotere made unsubstantiated claims of superiority and efficacy.

The agency said the ads in question had overstated Taxotere’s efficacy in comparison to Taxol, addressed in the letter by its generic name paclitaxel.

As a result of those overstatements, Stephanie says, she was exposed to the risk of alopecia without getting the benefit of the greater efficacy she was led to expect.

Stephanie’s Taxotere lawsuit raises claims for negligence, fraud, and failure to warn.

She seeks an award of damages including compensatory damages to cover her own current and future harm, and punitive damages to deter Sanofi from continuing their allegedly unlawful conduct.

The Taxotere Lawsuit is Case No. 1:16-cv-09288 in the U.S. District Court for the Northern District of Illinois.