Unless the defendant Sanofi-Aventis reaches a global settlement, the first “bellwether” cases in current mass litigation over the chemotherapy drug Taxotere (docetaxel) will go before a jury starting in May 2019.
These Taxotere cases are part of multi-district litigation (MDL) that were granted mass tort status in 2017 and consolidated before U.S. District Judge Jane T. Milazzo of the Eastern District of Louisiana. The bellwether trials were originally scheduled to go to trial last month; however, due to numerous issues over the past year, these have been postponed in order to give both parties additional time to present evidence as well as an opportunity for the defendants to settle with over 10,000 plaintiffs.
The MDL in Louisiana is also being coordinated with over 350 additional cases that were granted mass tort status before the New Jersey Supreme Court in August of last year. In addition to Sanofi-Aventis, which first developed the drug, named defendants include Accord Healthcare, Sandoz, Hospira Worldwide, Pfizer, Actavis, and Sun Pharmaceuticals, all of which sold or distributed the medication under a license or in generic form.
Taxotere was first approved by the FDA in 1996 for the treatment of breast cancer. Since that time, it has also been used for patients with cancer of the head and neck, stomach, colon, kidneys, prostate, and ovaries. As a cytotoxic chemotherapeutic agent, Taxotere is designed to kill off cancer cells by preventing them from reproducing. Unfortunately, this cytotoxic effect extends to healthy cells as well, including those of hair follicles. Hair loss is a common side effect of chemotherapy; however, for the majority of patients, hair growth resumes within a few months after the course of treatment has been completed.
This has not been the case with Taxotere. Plaintiffs who have been treated with this medication claim their hair loss is permanent, and that the drug companies involved with its manufacture and sale failed to issue adequate warnings to that effect. Docetaxel is essentially a synthetic version of a type of drug known as paclitaxel, an extract of the bark of the Pacific Yew tree (taxus brevfolia). Unlike the natural extract, however, docetaxel is much stronger. Drug companies also charge substantially more for the synthetic version. As of 2015, the cost for a vial of docetaxel was over $85 USD, whereas a vial of paclitaxel was under $14, according to the International Medical Products Price Guide.
Package warnings said that hair loss was one of the possible side effects, but added that “hair generally regrows” after treatment. In 2009, Sanofi-Aventis got in trouble for making exaggerated claims of superior efficacy, which the FDA said were “unsubstantiated.” Last year, it was revealed that Sanofi-Aventis had also issued a warning about permanent alopecia (hair loss) in Canada and the European Union in 2005. However, that warning was not given to U.S. doctors and patients until 2015.
A total of nine bellwether cases are scheduled to go to trial this year, after which both sides should have a clearer idea of how future litigation will play out – and whether the defendants will seek to settle remaining cases or continue to litigate.