Taxotere Side Effects Can Cause Permanent Baldness, Lawsuits Allege

Sanofi-Aventis faces a growing number of lawsuits involving allegations that the side effects of Taxotere, a breast cancer drug, may cause permanent hair loss or baldness. 

In one complaint (PDF) filed earlier this year in the U.S. District Court for the Northern District of Ohio, Hattie Carson alleges that the drug manufacturer failed to adequately warn patients and the medical community about the risk of permanent baldness from Taxotere, unlike most other cancer drugs, where hair loss is a temporary side effect.

Carson indicates that she was diagnosed with breast cancer in 2004, and underwent chemotherapy with Taxotere. However, she was later diagnosed with permanent alopecia, a disorder where the immune system begins attacking hair follicles, causing the hair to fall out and preventing its return.

Taxotere (docetaxel) is a cancer drug given with other chemotherapy drugs, which was approved by the FDA in May 1996 for the treatment of patients with locally advanced or metastatic breast cancer after prior chemotherapy attempts had failed.

“Although alopecia is a common side effect related to chemotherapy drugs, permanent alopecia is not,” the lawsuit states. “Defendants, through its publications and marketing material, misled Plaintiff, the public, and the medical community to believe that, as with other chemotherapy drugs that cause alopecia, patients’ hair would grow back.”

The lawsuit indicates that Sanofi-Aventis warned doctors and patients in other countries about the risks of permanent alopecia from Taxotere side effects, but failed to provide such warnings to their U.S. counterparts.

Carson’s was one of the first in what is expected to be a growing number of lawsuits over Taxotere that are likely to be filed in the coming months and years, alleging that Sanofi-Aventis failed to provide adequate warnings that Taxotere hair loss could be permanent.

The lawsuit indicates that such permanent hair loss from Taxotere is disfiguring, particularly for women, and that it caused her to suffer great mental anguish, economic damages and that the psychological damage was extensive enough that it caused a loss of work or inability to work. Her complaint also points out that exposure to Taxotere was unnecessary, and might have been avoided if she and her doctor had known the full risks.

“Although women might accept the possibility of permanent baldness as a result of the use of TAXOTERE if no other product were available to treat their cancer, this was not the case,” Carson notes in her complaint. “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 presents claims against Sanofi-Aventis for negligence, designing and manufacturing a defective drug, failure to warn, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and intentional infliction of emotional distress. She is seeking both compensatory and punitive damages, which are designed to punish the drug maker for their failure to warn.