Alopecia—hair loss—is a common side effect of chemotherapy. Permanent alopecia is not. Typically, a chemotherapy patient’s hair will fully regrow within 6 months of the end of treatment. In very rare circumstances (less than 1%), however, the intense drug regimen can permanently damage hair follicles, resulting in permanent baldness. But a new wave of lawsuits alleges that a very popular chemotherapy drug for breast cancer—Taxotere—has been causing permanent alopecia at a rate ten times that seen in other chemotherapy drugs. The lawsuits also allege Taxotere’s manufacturer knew of this risk and failed to advise doctors or patients of that fact.
Two of the most popular chemotherapy drugs for breast cancer patients are Taxol (owned by the American company, Bristol-Myers Squibb) and Taxotere (owned by the French company, Sanofi-Aventis). Both drugs emanate from the bark of the yew tree, but Taxotere is 2.5 times as cytotoxic (poisonous to cell growth) as is Taxol.
Both drugs were approved by the FDA for chemotherapy use in breast cancer patients in the 1990s. Concerns over the toxicity of Taxotere, however, limited its approval for treatment of women “with locally advanced or metastatic breast cancer after failure of prior chemotherapy.” This prevented Taxotere from becoming a “first-line treatment” option for breast cancer patients, thereby greatly limiting the market of potential customers. It is here that existing litigation alleges the French company Sanofi-Aventis began to engage in nefarious activity designed to boost its sales at the risk of injuring unsuspecting cancer patients.
In May of 2002, Sanofi-Aventis began marketing Taxotere to oncologists as a “first-line treatment” option for breast cancer despite the FDA’s previous limitation. In publicly available documents which can be viewed at www.fda.gov, the agency reprimanded the pharmaceutical giant for false advertising.
[w]ith minimal survival benefits in patients with newly-diagnosed [cancer], and the potential for increased toxicity with its use, Taxotere as a single agent was not indicated as first-line therapy and certainly was not “at the center of more strategies every day” as claimed in your sales aid. Therefore, Aventis’ false or misleading promotion in the sales aid may compromise patient survival and safety.
Duly chastised, Aventis assured the agency that all such marketing materials would be destroyed.
Sanofi-Aventis changed its marketing strategy, however, only to market directly to breast cancer patients themselves. The company crafted a circulation wrap for “People” magazine that featured the queen piece with the ominous slogan “THE NEXT MOVE MAY BE THE KEY TO SURVIVAL.” The advertisement was also featured in “Cure” and “Coping” magazines—publications specifically for cancer patients and their families. On November 12, 2003, the FDA issued a warning letter to Aventis separate and apart from its previous reprimand in 2002: “[w]e are concerned that you continued to promote Taxotere in a similar manner to consumers in popular consumer magazines.”
Your claim also implies to patients that if they do not add Taxotere to their treatment, they will not survive. This is misleading, given that there are other treatments available for breast cancer and lung cancer with proven survival benefits.
Meanwhile, clinical studies continued to confirm that Taxotere showed no medical benefit beyond that offered by its less-toxic competitor, Taxol. In April of 2008, a study of 4,950 breast cancer patients published in the New England Journal of Medicine “found no significant differences in survival between the groups treated with [Taxol] and those treated with [Taxotere]…”. At the same time, a European study funded in part by Sanofi-Aventis revealed that 9.2% of Taxotere patients continued to suffer from permanent baldness 10 years after their initial treatment. No such risk has been associated with Taxol.
But the pharmaceutical company declined to warn doctors or cancer patients of this substantial risk of permanent scarring.
The healthcare community, however, was beginning to catch on. In 2010, an article appeared in the Journal of the American Academy of Dermatology analyzing the existing body of literature on chemotherapy-related permanent alopecia. The article recognized that “[w]hy some patients develop permanent, rather than temporary, alopecia following chemotherapy is unknown,” but went on to state that the evidence in this particular case study “suggests that [Taxotere] is the implicated agent.” Two years later, a group of French doctors conducted a prospective study of 20 patients receiving Taxotere chemotherapy. After six months of recovery, all of the patients showed signs of permanent alopecia.
On December 11, 2015, Aventis finally changed the Taxotere warning label and package insert to contain the following phrase: “Cases of permanent alopecia have been reported.” Ten days later, the litigation dam burst with the first American lawsuit being filed in the District of Colorado. By October of 2016, 100 additional cases were filed throughout the United States and the Judicial Panel on Multidistrict Litigation ordered the establishment of an MDL proceeding in the Southern District of Louisiana. There are currently 859 cases pending in the MDL and more are being added each week.
The number of victims of Taxotere-induced permanent alopecia is unknown. But as noted above, this was a billion-dollar drug in the United States, alone. Taxotere patients certainly number in the tens of thousands. With nearly a thousand lawsuits already pending, the likelihood appears high that there will be thousands more.
Our law firm is investigating cases involving Taxotere and permanent baldness across the Southeast. If you would like to speak to a South Carolina personal injury lawyer at Chappell, Smith & Arden about a potential case, please call us at 1 (800) 531-9780 or contact us online.