Taxotere Risk of Permanent Hair Loss Withheld from Women and Doctors, Lawsuit Alleges

As more women learn about the link between Taxotere and permanent hair loss, a growing number of product liability lawsuits are being filed against the manufacturer of the breast cancer chemotherapy drug, alleging that patients and the medical community were not adequately warned that hair does not regrow for many women.

A complaint filed last week in the U.S. District Court for the Western District of Texas, raises similar claims to those presented in other cases filed by women throughout the U.S. in recent months who have experienced permanent hair loss after undergoing breast cancer treatment involving use of the controversial Sanofi-Aventis drug.

The lawsuit was filed by Alina S. Gorniak, alleging that breast cancer patients and the medical community have been provided false and misleading information about the Taxotere risk of permanent hair loss, depriving them of the opportunity to make an informed decision about whether to use the drug over other available chemotherapy drugs.

Gorniak indicates that she was diagnosed with infiltrating ductal carcinoma of the left breast in January 2013, and she was given Taxotere as part of chemotherapy before undergoing a surgical resection of her left breast. Although Sanofi-Aventis suggested that hair typically regrows following treatment with their drug, Gorniak claims that she has suffered permanent and disfiguring hair problems from Taxotere, known as alopecia, mirroring similar claims raised by other women who received the drug.

Taxotere (docetaxel) was approved by the FDA in May 1996, as a more potent version of another breast cancer treatment that was already on the market. Despite claims by the drug maker that Taxotere was superior to lower potency taxane-based drugs, Gorniak and other plaintiffs allege that it is actually no more effective than the earlier treatment options, yet carries a high risk that users may be left with permanent hair problems; a risk that is not associated with other breast cancer drugs.

“Defendants knew or should have known that the rate of permanent alopecia related to Taxotere was far greater than with other products available to treat the same condition as Defendants’ product,” the lawsuit states. “Before Defendants’ wrongful conduct resulted in thousands of women being exposed to the side effects of Taxotere, there were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia as does Taxotere.”

The lawsuit notes that Sanofi knew of the risks since the beginning of the 1990s. In addition, Gorniak and other women point to a 2005 study conducted by the drug maker, known as GEICAM 9805, which found that 9.2% of patients who took Taxotere suffered hair loss that lasted up to 10 years and five months, and in some cases longer. In 2006, a Denver oncologist also warned the manufacturer that 6.3% of his patients suffered long-term or permanent hair loss after Taxotere treatment.

The cases point out that while women may have accepted the Taxotere risk of permanent hair loss if no other treatment options were available, this was not the case, as similar drugs on the market at the time Taxotere was introduced provided the same treatment benefits without subjecting female users to the same risk of hair loss.

“Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women,” claims Gorniak in the complaint filed May 31. “Women who experience disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.”

Gorniak presents claims of negligence, design and manufacturing defects, failure to warn, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, violation of Texas consumer protection laws, and extreme and outrageous conduct.