Pharmaceutical

More than 1,000 suits in Taxotere MDL

bald woman Taxotere Pixabay image 315x210 More than 1,000 suits in Taxotere MDLIn October last year, the MDL-2740 Taxotere (docetaxel) Products Liability Litigation was formed when 33 lawsuits that had been filed federally against drugmaker Sanofi SA were consolidated in the Eastern District of Louisiana under Judge Kurt D. Engelhardt.

Now just a little more than seven months later, the number of suits in the multidistrict litigation (MDL) has grown to 1,006 as of the May 15 update from the Judicial Panel on Multidistrict Litigation (JPML).

All of the suits in the MDL allege that chemotherapy drug docetaxel can cause permanent hair loss when other competing drugs do not carry this risk and that American consumers were warned of this side effect much too late despite drugmakers’ knowledge of it — a decade after patients outside the U.S. were warned.

The suits allege that Sanofi in particular was aware as early as the 1990s from results of their own clinical trials of the side effect of alopecia with 9.2 percent of study participants who completed chemotherapy with Taxotere, Adriamcycin, and Cyclophosphamide (TAC) reporting persistent hair loss over a 10-year follow-up period. The drug was approved for use by the Food and Drug Administration (FDA) in 1996 to treat certain types of breast cancer. It is now approved to treat breast, lung, prostate, stomach, and head and neck cancer.

Law360 quotes from one of the suits filed by Ami Dodson in California saying that Sanofi has been misrepresenting the safety and effectiveness of Taxotere since the nineties, making false claims of superior efficacy to other drugs on the market based on self-sponsored clinical trials and concealing the existence of studies that refuted their claims. The suit also accuses the pharmaceutical company of during the early 2000s dramatically increasing sales of Taxotere by illegally promoting off-label use and providing kickbacks to health care providers, meanwhile concealing the risk of permanent alopecia and merely including the vague labeling that “hair generally grows back” after completing chemotherapy. It wasn’t until 2015 that the U.S. label was changed to include permanent hair loss as a potential side effect.

MDLs are created by the federal court system to help manage these types of complex product liability suits, in this case establishing liaison counsel for the plaintiffs and defense and a Plaintiffs’ Steering Committee to expedite the discovery process. The MDL will hold bellwether trials, which are designed to be representative of the whole and predictive of how future trials might play out. Judge Engelhardt has also established settlement committees with attorneys meeting regularly toward the pursuit of potential resolution.

Sources:
United States Judicial Panel on Multidistrict Litigation
Righting Injustice
Law360