The federal judicial system uses multidistrict litigation (MDL) to manage large numbers of complex lawsuits related to each other by transferring those cases to one federal judge for pre-trial discovery in advance of trial.
In October 2016 the US Judicial Panel on Multidistrict Litigation ordered that 33 Taxotere lawsuits be transferred to the US District Court, Eastern District of Louisiana. By January of this year, the number of MDL cases had swelled to 776.
According to the 2016 MDL order, the original 33 lawsuits shared "common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients. . . Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere."
Taxotere (docetaxel), which the FDA approved in 1996, is administered intravenously and used to treat breast cancer, non-small lung cancer and prostate cancer. Taxotere's possible side effects can include low blood cell count, allergic reactions, fluid retention, gastrointestinal problems and hair loss.
An earlier patient leaflet for Taxotere patients stated that "Once you have completed all your treatment, hair generally grows back." However, in December 2015 the FDA updated its safety information on Taxotere (docetaxel) to include the adverse reaction of hair loss: "Permanent cases of alopecia have been reported."
Now the Taxotere patient leaflet includes that updated information: "In most cases normal hair growth should return," states Sanofi's current Taxotere prescribing information. "In some cases (frequency not known) permanent hair loss has been observed."
As the multidistrict litigation moves forward in Louisiana, hundreds of plaintiffs on those lawsuits allege that their hair never grew back after receiving Taxotere during cancer treatment. Meanwhile, the court has directed plaintiffs' counsel to submit a master complaint and short form complaint to the court by March 31, 2017.
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On Feb. 14, US District Judge Kurt Engelhardt issued an order approving the 30-page fact sheet that plaintiffs will use going forward with their lawsuits against Sanofi S.A., the manufacturer of Taxotere.
The court has also appointed representatives of the plaintiffs and defendants to settlement committees, which will continue to collaborate on a framework for potential resolution of cases.
The next general status conference for those committees will be on March, 17, 2017.