Permanent Hair Loss Caused by Taxotere Breast Cancer Drug, Lawsuit Alleges

According to allegations raised in a recent product liability lawsuit filed against Sanofi-Aventis, inadequate warnings have been provided for patients and the medical community about the risk of permanent hair loss caused by Taxotere, a breast cancer drug that has been linked to reports of hair problems that continue long after the end of chemotherapy treatment.

The complaint (PDF) was filed earlier this month by Karen Detrixhe in the U.S. District Court for the District of Kansas, indicating that she has suffered permanent and disfiguring baldness from Taxotere, known as alopecia.

While hair loss is a known side effect of chemotherapy, Detrixhe indicates that permanent alopecia is not, and Sanofi-Aventis misleadingly suggested that hair grows back following treatment. The lawsuit alleges that the drug maker withheld information about reports of long-term hair loss associated with Taxotere, depriving Detrixhe and other women of the opportunity to choose a different breast cancer treatment that does not carry the same side effects.

Taxotere (docetaxel) was approved by the FDA in May 1996, as a more potent version of another breast cancer drug that was already on the market. Although Sanofi-Aventis has suggested that Taxotere is superior to lower potency taxane-based drugs, studies have found that it is no more effective and Taxotere side effects have been linked to problems with hair loss or thinning that may continue for years, or even decades, following treatment.

“Despite the fact that Defendants disclosed risks associated with Taxotere and permanent alopecia to patients and regulatory agencies in other countries, Defendants failed to either alert Plaintiff, the public, and the scientific community in the United States or perform further investigation into the safety of Taxotere regarding the side effect of disfiguring permanent alopecia,” the lawsuit states. “Defendants failed to update the warnings for Taxotere, and they failed to disclose the results of additional studies as Defendants learned new facts regarding the defects and risks of their product.”

The case is joins of a growing number of Taxotere hair loss lawsuits filed in recent months over permanent and disfiguring hair loss, alleging that safer alternative treatments were available that do not carry the same risks, yet Sanofi-Aventis pushed doctors to use Taxotere and withheld information about the risk of permanent hair loss.

Plaintiffs point to a study published in 2005, known as GEICAM 9805, which found that nearly 10% of patients who took Taxotere suffered permanent hair loss that continued for over 10 years after treatment. The manufacturers were aware of that study, as well as published of observations by a Denver-based oncologist in 2006, which indicated that more than 6% of his Taxotere patients suffered permanent hair loss.

Detrixhe 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, violation of Kansas consumer protection laws, and extreme and outrageous conduct. She is seeking both compensatory and punitive damages, which are designed to punish the drug maker for their failure to warn.