Permanent chemotherapy hair loss is at the center of a lawsuit filed by a woman who endured Taxotere treatments.

Plaintiff Linda C. has filed a permanent chemotherapy hair loss suit against Sanofi-Aventis because she has suffered “permanent hair loss, emotional distress, humiliation, sleeplessness, anxiety, and other personal injuries” after receiving Taxotere chemotherapy treatments from Dec. 23, 2009 through Feb. 5, 2010.

Plaintiff Says Taxotere Promoted with False Claims of Superiority

Taxotere was approved by the FDA in May 1996 “for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy,” according to the drug’s label.

Sanofi-Aventis sought further FDA approval for other indications for Taxotere. The company brought forth evidence from self-sponsored clinical trials that purportedly showed Taxotere was superior over competing chemo products approved to combat breast cancer.

According to the complaint, Sanofi-Aventis claimed “superior efficacy over the lower potency Taxane product paclitaxel (Taxol), which was the primary competitor product to Taxotere.”

Linda says post market results have shown that although Taxotere is more potent and toxic, it is not more effective than other chemotherapy Taxane medications. Sanofi-Aventis is accused of concealing studies that refuted its claims of superiority from the FDA, the medical community and patients.

A look at clinical studies comparing the Taxanes’ effectiveness was published in the August 2007 journal Cancer Treatment Review. That analysis “concluded that no significant differences were found in the efficacy and outcomes obtained with Taxotere or Taxol.”

In spite of the such studies, Sanofi-Aventis “continued to make false and misleading statements promoting the ‘superior efficacy’ of Taxotere over the competing product,” says the complaint.

The FDA issued a warning letter to Sanofi-Aventis in 2009 telling the company to stop reprinting Taxotere’s unsubstantiated claims of superiority and to refrain from overstating the drug’s efficacy.

Plaintiff: Marketing Scheme Exposed More Women to Risks of Permanent Chemotherapy Hair Loss

Sanofi-Aventis allegedly ran a two-part marketing scheme beginning in 1996. According to the complaint, the drug company “trained and directed their employees to misrepresent the safety and effectiveness of the off-label use of Taxotere to expand the market for Taxotere in unapproved settings.”

Secondly, Taxotere’s makers “paid healthcare providers illegal kickbacks in the form of sham grants, speaking fees, travel, entertainment, sports and concert tickets, preceptorship fees, and free reimbursement assistance to incentivize healthcare providers to prescribe Taxotere for off-label uses.”

Their efforts saw Taxotere revenue rise from $424 million in 2000 to $1.4 billion in 2014.

The permanent chemotherapy hair loss lawsuit alleges that due to the marketing scheme, Sanofi-Aventis “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).”

Even though temporary hair loss is often a side effect of chemotherapy treatments, permanent hair loss is rare.

Sanofi-Aventis is accused of knowing the rate of permanent chemotherapy hair loss related to Taxotere was far greater than the rate with other competing products.

This higher probability of permanent alopecia was not disclosed to the U.S. medical community or the public by Sanofi-Aventis until December 2015.

The Permanent Chemotherapy Hair Loss Lawsuit is Case No. 2:17-cv-03698-KDE-MBN in the U.S. District Court for the Eastern District of Louisiana.