A cancer diagnosis brings fear and uncertainty; the hair loss that has come to be recognized as a symbol of chemotherapy often amplifies the sense of loss of personal control that cancer brings.
Typically, chemo-related hair loss is temporary, but new lawsuits are being filed by users of Taxotere who have not regrown their hair years after treatment has been completed. Evidence suggests that Taxotere’s makers knew that permanent alopecia was one of the drug’s side effects but failed to disclose this information in the United States.
FDA hesitant to approve Taxotere
Lawsuits filed across the country, including in California, Illinois, and Ohio, point to Taxotere as the source of permanent hair loss. Taxotere is a type of drug known as Taxanes, which are derived from yew plants and used as chemotherapy agents. The French companies Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC, developed, manufactured, marketed, labeled, and distributed the drug in the U.S. under the name Winthrop U.S.
According to Taxotere lawsuits, Sanofi began clinical testing of the drug in 1990 but allegedly withheld critical data from patients and doctors in the United States. In 1994, the FDA denied approval because it found Taxotere more toxic than a competitor drug and recommended more studies of its side effects. The FDA approved the drug in 1996 for treating advanced or metastatic breast cancer after other chemo treatments have failed.
Sanofi allegedly undertook a campaign to promote off-label use of Taxotere and marketed it as more effective than competitor drugs. In 2009, the FDA took notice and issued a warning letter stating that those marketing materials misbranded the drug in violation of the law.
Research demonstrates permanent disfiguring hair loss
In the late 1990’s Sanofi sponsored a study called GEICAM 9805, which showed that 9.2% of Taxotere patients had persistent alopecia for up to a decade and sometimes longer. Sanofi allegedly withheld these results from decision-makers like doctors, healthcare providers, and patients in the US. Sanofi did provide information on Taxotere alopecia risks in Canada and the EU, however. The manufacturer was also put on notice in 2006, when a Denver-based oncologist noticed that his patients who took Taxotere were more likely to suffer persistent or permanent hair loss.
Taxotere alopecia lawsuits
Permanent baldness is a prospect some women might accept if there were not alternative treatments available that were just as effective. The makers of Taxotere are accused of overstating the effectiveness of the drug while misrepresenting the permanent nature of resulting hair loss.
The damages are physical, psychological, and even financial as victims can find it hard to find employment when suffering from hair loss. Lawsuits seek past and future medical expenses, compensation for psychological counseling and therapy expenses, past and future earnings, past and future loss and impairment of earning capacity, mental anguish, and loss of enjoyment.
The national product liability lawyers at Eisbrouch Marsh are currently reviewing Taxotere cases. Our aggressive and experienced attorneys have over 25 years of experience representing victims of dangerous drugs and defective devices.
If you have suffered persistent or permanent hair loss after taking Taxotere, contact Eisbrouch Marsh at 201-342-5545 to discuss your legal options.