The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) has allowed claims involving generic docetaxel, a chemotherapy drug, to be included in the Taxotere MDL now underway in the Eastern District of Louisiana.
Judge Sarah S. Vance, Chair of the JPMDL, stated in a letter that the consolidated litigation does include lawsuits against both name-brand and generic forms of the drug.
The panel’s letter was in response to District Judge Kurt D. Engelhardt, who wrote to the panel for clarification in December. Judge Engelhardt is overseeing 1,006 lawsuits filed in 2740, IN RE: Taxotere (Docetaxel) Products Liability Litigation.
Half of cases against generics
Taxotere, manufactured by Sanofi, lost its patent protection in late 2010. Half of the cases in the MDL involve generic and quasi-generic manufacturers, whose products obtained FDA approval under 21 USC Sec. 505(b)(2) and not through the more traditional generic approval under 21 USC Sec. 505(j).
The plaintiffs charge that they experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy.
It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”
Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.