A Mississippi woman has filed a Taxotere lawsuit against the makers of Taxotere, a chemotherapy medication used to treat breast cancer, alleging that the drug caused chemotherapy hair loss.

While many chemotherapy treatments can cause temporary hair loss, Taxotere side effects can allegedly cause permanent chemotherapy hair loss, also known as alopecia.

The permanent loss of hair – on the head, eyebrows, eyelashes, and body – are particularly distressing and disfiguring to women such as the plaintiff.

Plaintiff Florine C. accuses Taxotere’s manufacturer, French corporation Sanofi S.A., of allegedly marketing Taxotere in a way that not only downplayed the risks of permanent alopecia, but overstated the drug’s superiority over competitive treatment options.

Background on Taxotere

Chemotherapy drugs can shrink the size of cancer tumors, stop tumors from growing, kill cancer cells that have spread to other body parts and decrease the incidence of cancer recurrence.

Taxotare belongs to a family of chemotherapy drugs called taxanes, which basically prevent cancer cells from replicating. Taxol is another chemotherapy drug in the taxane family.

Rhone-Poulenc Rorer S.A., predecessor of pharmaceutical company Aventis Pharma S.A., submitted Taxotere for FDA approval in 1994. The FDA initially rejected Taxotere on the grounds it was more toxic than Taxol and that more studies of Taxotere’s side effects were necessary.

Two years later, in May 1996, the FDA approved Taxotere, but only for treating locally advanced or metastatic breast caner after previous chemotherapy treatments proved unsuccessful.

Eventually, the FDA approved Taxotere for other indications. At that point, Florine’s lawsuit alleges, Taxotere’s manufacturers claimed their drug was more effective than other chemotherapy options for treating breast cancer.

The Taxotere Marketing Machine

The FDA has chastised Sanofi and its subsidiaries for making false claims of superior performance and for omitting important safety information, including the possibility of Taxotere side effects such as permanent chemotherapy hair loss.

In November 2003, the FDA warned Aventis to stop sending three direct-to-consumer print advertisements for Taxotere, saying the ads “suggest that Taxotere is more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

In 2008, the New England Journal of Medicine published a study that showed that Taxol combined with other chemotherapy drugs was more effective than Taxotere in reaching disease-free status and the overall survival of women with breast cancer.

The study, Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer, compared the efficacy of docetaxel (Taxotere) and paclitaxel (Taxol) with doxorubicin and cyclophosphamide in the adjuvant treatment of breast cancer. Adjuvant therapy is applied after the initial treatment for cancer as a means to suppress secondary tumor growth.

This study prompted the FDA to issue another letter in April 2009, stating that marketing material for Taxotere continued to boast unsubstantiated superiority claims and overstatements of efficacy.

Chemotherapy Hair Loss Risks Omitted from Ads

The FDA also stated that the same ads that made false claims of Taxotere’s superiority failed to mention the drug’s risks. The FDA’s November 2003 letter says the Taxotere advertisements do not discuss chemotherapy hair loss, permanent or otherwise, or other common side effects.

In fact, doctors treating their patients for breast cancer were also unaware of the possibility of Taxotere side effects, including permanent chemotherapy hair loss.

The Taxotere Chemotherapy Hair Loss Lawsuit is Case No. 3:16-cv-404, in the U.S. District Court for the Southern District of Mississippi, Jackson Division.