In mid-September, a Minnesota resident filed a product liability lawsuits alleging that she suffered permanent hair loss due to the side effects of the drug Taxotere, a chemotherapy drug prescribed to her for treatment of breast cancer.
While chemotherapy drugs are known to frequently cause hair loss, the loss is usually temporary. Taxotere has been accused of causing permanent and irreversible hair loss by a growing number of patients.
Taxotere lawsuit filed over long-term hair loss
The complaint by the woman, Angela Thomas, was filed in the U.S. District Court for the District of Minnesota. It alleges that the information given to both patients and healthcare providers by Taxotere manufacturer Sanofi-Aventis was false and misleading. The drug label allegedly indicated that hair loss was reversible, and that any lost hair would grow back after chemotherapy was over. The suit further states that Sanofi-Aventis either knew or should have known that the hair problems associated with the drug were permanent, and that these permanent side effects did not exist with other available treatments.
Angela Thomas developed stage IIB breast cancer. Her treatment included a double mastectomy. In 2009, she started chemotherapy treatment that included Taxotere.
In the suit, Thomas says that she is still suffering from disfiguring hair problems related to Taxotere. According to the lawsuit, Sanofi-Aventis’s marketing materials and other publications, given to both medical personnel and patients, suggests that the only hair loss issues related to Taxotere are temporary, a condition known as alopecia.
A manufacturer-sponsored study, GEICAM 9805, reported in 2005 that more than 9% of patients administered Taxotere had hair loss that persisted for 10 years or longer.
Studies in 2005 indicated that 10% of Taxotere-treated patients experienced hair loss that continued up to 10 years and five months after therapy. In some cases, it persisted for a longer period of time. Despite the study results, claims the suit, the manufacturer used the more general warning “hair generally grows back” on Taxotere’s label. Other studies have indicated that Taxotere treatment results in permanent hair loss in from 6% to 16% of patients who take it.
There is no known antidote or reversal agent currently available for hair loss resulting from chemotherapy treatment.
Taxotere and permanent hair loss in women
Taxotere (docetaxel) is a taxane-based drug for breast cancer. It was launched in 1996 by Sanofi-Aventis as a more potent version of alternative chemotherapy drugs which were then on the market. Sanofi-Aventis marketed the drug as a better alternative to treatment options then available, like Taxol.
The suit alleges that other treatments were available. The complaint states “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. 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].”
Many experts point out that hair loss is devastating for patients. As the chief medical officer of BreastCancer.org, Maria Weiss MD, observes, “There are studies that show that for many women, losing their hair is worse than losing a breast. That’s because you can conceal the loss of a breast, but hair loss is so obvious and apparent.”
Move to consolidate Taxotere lawsuits
Thomas’s case joins a number of similar suits asserting claims about Sanofi-Aventis’s failure to make known the potential side effects of the drug. The company is accused of placing consumer safety second to continued profits from Taxotere.
In some other countries, Sanofi-Aventis updated Taxotere information to include warnings about the alopecia risk, but this information was never provided to U.S. patients and their physicians.
This July, in a move looking to consolidate all Taxotere lawsuits pending in the federal court system, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML). The motion seeks centralized management before one judge as part of a Multidistrict Litigation (MDL). Such a move is desired to decrease duplicative discovery, eliminate any potential of conflicting pretrial rulings and be of optimal convenience to witnesses, parties and the courts.
On September 29, the JPML is scheduled to hear oral arguments on the MDL motion in Washington, D.C.
In many cases where individual claims are centralized before a single judge for coordinated discovery and pretrial proceedings, a subset group of claims will be chosen for early “bellwether” trials. The bellwether trails are designed to indicate how juries respond to evidence and expert testimony that is very likely to occur frequently in the litigation process.
The outcome of bellwether trials is never binding on other cases. However, bellwethers may help the parties reach settlements with the makers of Taxotere for women who suffer from hair loss issues that are permanent.
Taxotere hair loss attorneys
The national product liability lawyers at Bonsignore are experts in litigation concerning negligence on the part of pharmaceutical companies and medical device manufacturers. We are currently offering free case reviews to victims of permanent hair loss from Taxotere.
If you are contemplating filing a lawsuit against the makers and distributors of Taxotere, please put our expertise to work for you. We will review your case at no charge and then discuss the legal recourse available.
Taxotere hair loss resources
- U.S. Food and Drug Administration, Taxotere (docetaxel) injection concentrate, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm212079.htm
- Cancer Survivors Network, Permanent hair loss taxotere, http://csn.cancer.org/node/193088
- CBS MoneyWatch, Sanofi’s Latest Challenge: Women Who Say Its Chemotherapy Left Them Permanently Bald, http://www.cbsnews.com/news/sanofis-latest-challenge-women-who-say-its-chemotherapy-left-them-permanently-bald/