Taxotere Hair Loss: a Look Back at 2016

Washington, DCThe close of another year affords an opportunity to look back and review the various events that characterized the legal implications of Taxotere hair loss over the past year.

Taxotere, which is generically known as Docetaxel, was granted approval by the US Food and Drug Administration (FDA) in 1996. Sanofi, Aventis Pharma SA in France and Sanofi-Aventis US LLC in this country promoted Taxotere as an effective chemotherapy drug for cancer patients. The primary message for Taxotere was that patients could reduce the number of chemotherapy treatments – and therefore the overall timeframe of their treatment regimen – through the use of Taxotere over other, more common chemotherapy drugs.

Many women embraced the opportunity to reduce the number of treatments with a drug that afforded increased potency with no more grievous side effects than other drugs currently on the market. Hair loss is a common byproduct of chemotherapy; however it is normally not permanent. For most cancer patients, hair grows back following treatment.

With Taxotere, plaintiffs report, this was not always the case. Taxotere alopecia (hair loss) has been alleged to be permanent.

One of the first Docetaxel side effects lawsuits was filed by plaintiff Ami Dodson (Dodson v. Sanofi SA, et al., Case No. 3:16-cv-01251, in the US District Court for the Northern District of California), who alleged in her claim that defendants engaged in an extended scheme to increase usage of Taxotere dating back to when Docetaxel was first approved in 1996. Dodson claimed that Sanofi employees were coached to misrepresent the safety and effectiveness of Taxotere, and withheld information from the US market with regard to Docetaxel hair loss that was widely distributed in other countries, or so it was alleged.

The lawsuit also referenced a qui tam lawsuit filed by a former employee who alleged illegal and inappropriate marketing.

“Defendants [preyed] on one of the most vulnerable groups of individual’s at the most difficult time in their lives,” Dodson said, in her lawsuit. “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”

In addition to referencing a warning letter sent by the FDA to Sanofi in 2009 with regard to the pharmaceutical’s marketing practices, Dodson alleged the defendant was aware, in the late 1990’s, of a study showing that 9.2 percent of Taxotere patients lost their hair for more than ten years, yet continued to withhold this from the public and instead, provided vague references that “hair generally grows back,” or so the lawsuit alleged.

In October, the US Judicial Panel on Multidistrict Litigation issued an order for consolidation of all Taxotere lawsuits involving permanent hair loss in US District Court, Eastern District of Louisiana (In Re: Taxotere (Docetaxel) Products Liability Litigation - MDL No. 2740). The latest event in the file is a Pretrial Order issued November 30 pertaining to the filing of requests for summons and return of same.

Thus, Taxotere hair loss litigation is moving forward.

It was a year ago, in December 2015, that the FDA requested an update to the Taxotere product label to include Taxotere alopecia as a potential side effect – some 19 years after the approval of Taxotere for the US market.