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Taxotere Chemotherapy Lawsuit Alleges Permanent Hair Loss Warnings Withheld

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A product liability lawsuit filed by yet another breast cancer survivor alleges that women and the medical community were not adequately warned about the potential side effects of Taxotere, a chemotherapy drug that has been linked to reports of permanent and disfiguring hair loss, known as alopecia. 

In a complaint (PDF) filed late last month in the U.S. District Court for the Northern District of Texas, Kimberly Free indicates that Sanofi-Aventis placed their desire for profits before consumer safety by promoting Taxotere without adequate warnings about the hair-loss risks, despite the availability of other breast cancer treatments that have not been linked to the same problems.

Free indicates that she underwent Taxotere chemotherapy from October 2012 through February 2013, for treatment of breast cancer. Since the completion of the chemotherapy treatment, Free indicates that she continues to suffer “disfiguring permanent alopecia” more than three years later.

While hair loss is a known side effect of chemotherapy, Free indicates that permanent alopecia is not, and Sanofi-Aventis misleadingly suggested that hair grows back following treatment. The lawsuit alleges that the drug maker knew about reports of long-term hair loss associated with Taxotere, yet withheld the information, depriving Free 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.

“Contrary to Defendants’ claims of superior efficacy, post market surveillance has shown that the more potent and more toxic Taxotere does not in fact offer increased efficacy or benefits over other Taxanes, as Defendants have claimed and advertised,” the lawsuit states. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted Defendants’ claims.”

The case is joins of a growing number of Taxotere hair loss lawsuits filed in recent months over chemotherapy hair loss that has continued for years, or even decades, after treatment. The complaints allege that safer alternative treatments were available, which do not carry the same risks, yet Sanofi-Aventis pushed doctors to use Taxotere and withheld information about the risk of permanent hair loss.

Free and other 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.

“Although women might accept the possibility of permanent baldness as the result of the use of Taxotere if no other product were available to treat their cancer, this was not the case,” according to the lawsuit filed by Free. “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 efffective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia as does Taxotere.”

Free presents claims of negligence, manufacturing and design defects, failure to warn, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, strict product liability, fraud and deceit, extreme and outrageous conduct, and violation of the Texas Consumer Protection Act.

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