A growing number of cancer patients who allegedly experienced permanent hair loss following chemotherapy with generic Taxotere have joined the federal multidistrict litigation currently underway in the U.S. District Court, Eastern District of Louisiana. Court records indicate that the consolidated proceeding now includes eight generic defendants in addition to Sanofi-Aventis, the French company that markets the name-brand version of docetaxel.
All pending generic lawsuits involve versions of docetaxel brought to market under section 505(b)(2) of the Food, Drug and Cosmetic Act, which was created to prevent unnecessary duplication of studies already performed on a previously approved medication. Plaintiffs pursuing these claims allege that generic manufacturers were aware of their products’ potential to cause permanent hair loss via a study called GEICAM 9805, which suggested that many patients treated with docetaxel experienced persistent alopecia for more than 10 years. Results of the study were published in the Annals of Oncology in 2007, as well as the New England Journal of Medicine in 2010.
Last December, U.S. District Judge Kurt D. Engelhardt of the Eastern District of Louisiana wrote to the U.S. Judicial Panel on Multidistrict Litigation (JPML), asking that it clarify whether the scope of the consolidated Taxotere proceeding should include generic drug lawsuits. JPML Chair Judge Sarah S. Vance affirmed responded in the affirmative.
“The Panel’s order, as reflected in the title of the MDL, was intended to include cases against non-Sanofi/generic manufacturers of docetaxel that allege common issues,” Judge Vance wrote in a letter dated January 4th. “In addition, since the MDL was formed, we have reviewed potential tag alongs that named generic manufacturers and concluded that they shared sufficient factual questions (allegations of a common injury after taking the drug) with MDL 2740 to warrant placing them on Conditional Transfer Orders.”
The multidistrict litigation has since grown to include at 1,006 product liability claims, all of which were filed on behalf of individuals who allegedly suffered permanent or persistent alopecia following treatment with Taxotere or generic brands of docetaxel. While hair loss is not unusual with chemotherapy, Taxotere lawsuit plaintiffs charge that docetaxel-induced alopecia is far more likely to be permanent compared to hair loss associated with other, equally effective medications.
Taxotere was brought to market by Sanofi-Aventis in 1996, while the first generic brand was approved in 2001. In December 2015, the U.S. labeling for these products was updated to note that permanent hair loss had been reported in patients treated with docetaxel. However, plaintiffs involved in the U.S. litigation charge that the potential for Taxotere to cause permanent alopecia was reported to regulators and patients in Europe as early as 2005, while the Canadian label underwent a similar modification in 2012. Meanwhile, the U.S. prescribing information only included a vaguely worded and insufficient statement that “hair generally grows back.”