In an already rapidly growing multidistrict litigation (MDL), in January the Judicial Panel on Multidistrict Litigation (JPML) clarified that generic as well as name-brand Taxotere was intended to be included in the litigation. “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,” the panel wrote in a letter to U.S. District Judge Kurt D. Engelhardt answering his question concerning the scope of the MDL.
These common issues are primarily that the chemotherapy drug allegedly causes permanent alopecia, or hair loss. Docetaxel, sold under the brand name Taxotere, is used to treat breast, lung, prostate, stomach, and head and neck cancer. According to the Daily Hornet, most of the lawsuits are filed by women with breast cancer who did not regrow their hair after being treated with the drug.
When the MDL was created and the lawsuits were consolidated in the Eastern District of Louisiana in October there were 33 cases. In mid-December the MDL included 267 lawsuits, and, according to the JPML, this February there were 755, nearly tripling in just two months. With more tag-alongs that named generic manufacturers being transferred in, this number will only continue to grow.
The lawsuits accuse Sanofi-Aventis and other manufacturers of docetaxel of designing a defective drug.
“Sanofi-Aventis’s own clinical trials in the 1990s found that 9.2 percent of women with breast cancer who completed chemotherapy with Taxotere, Adriamcycin, and Cyclophosphamide (TAC) reported hair loss that persisted during the 10-year follow-up period,” reports the Daily Hornet.
Drugmakers are also accused of failing to warn patients of this potential risk. Sanofi-Aventis, aware of this side effect, warned patients outside of the U.S. as early as 2005, but the safety label in the U.S. was not updated to include permanent hair loss as a side effect until 2015. Patients had been told “hair generally grows back” after completing chemotherapy. Doctors and patients alike were left wondering at the cause when some suffered permanent hair loss and many are only now because of the litigation realizing why after chemotherapy their hair never grew back.
“The number of lawsuits has skyrocketed as more people who did not re-grow their hair after chemotherapy learn that permanent alopecia is a possible side effect of Taxotere,” said the Daily Hornet.