A Missouri woman suffering from female alopecia has joined multidistrict litigation against drug manufacturer Sanofi and several other defendants over allegations of negligence and fraud.

Plaintiff Linda M. filed a complaint on Jan. 16, 2019, alleging that Sanofi and its co-defendants were aware of the risks of permanent hair loss stemming from the use of the cancer chemotherapy drug Taxotere (docetaxel).

The lawsuit says that Sanofi deliberately failed to make this risk clear to doctors and their patients. Her lawsuit is one of the hundreds that have been consolidated in a Louisiana federal court, all of which state that Sanofi deliberately failed in its duty to warn patients about the possibility of permanent, disfiguring hair loss.

What Is Taxotere?

Taxotere is the brand name for docetaxel, a synthetic form of a compound known as paclitaxel. It is a chemotherapy drug used primarily for the treatment of breast cancer; other indications include non-small lung cancer as well as cancers of the head and neck, stomach and prostate. Its mechanism of action is to prevent mitosis (cell division) by disabling the “microtubules” that maintain cell structure.

Paclitaxel is a natural extract taken from the bark of the Pacific Yew tree, first identified in 1971. It was eventually approved by the FDA in 1993, and marketed by Bristol-Meyer Squibb (BSM) under the brand name Taxol.

In an attempt to compete with BSM for market share, French pharmaceutical firm Sanofi created its synthetic version, docetaxel, in the mid-1980s and received FDA approval in 1996. Docetaxel’s active ingredient has twice the strength of Taxol, and is therefore more toxic. This toxicity reportedly results in the permanent destruction of hair follicles, which in turn causes permanent alopecia.

Plaintiffs Say Warnings Were Inadequate

Lawsuits against Sanofi say that the company failed to adequately warn patients and doctors about the extreme toxicity of Taxotere. Plaintiffs say that package labeling in the U.S. contained vague statements about possible hair loss but claimed that hair “generally regrows” after treatment is over.

Significantly, Sanofi did issue warnings about the risk of permanent female alopecia on its packages of Taxotere sold in the European Union and Canada in 2005. However, this acknowledgment did not appear in the U.S. product information until 2015. Furthermore, internal studies performed by Sanofi in 2005 showed the risk of permanent hair loss was around 3 percent (later independent studies showed it as being closer to 6 percent).

The Impact of Permanent Female Alopecia

Some believe that plaintiffs like Linda M. should simply be grateful that the medication cured their cancer. These people fail to understand the significance of hair in many cultures and the long-term psychological damage that can result from female alopecia in terms of self-esteem as well as the perceptions of others.

A 2005 study originally appearing in the British Medical Journal found that victims of alopecia suffer “high levels of anxiety and depression” and experience “lower self-esteem, poorer quality of life, and poorer body image.”

Linda’s Female Alopecia Lawsuit is part of MDL No. 2:16-md-02740-KDE-MBN, MDL No. 2740, U.S. District Court for the Eastern District of Louisiana.