The federal judge overseeing thousands of Taxotere lawsuits involving allegations of permanent hair loss will allow a former U.S. Food & Drug Administration (FDA) commissioner to testify for the plaintiff during the litigation’s first bellwether trial.
Sanofi-Aventis, the manufacturer of the cancer drug, had sought to prevent Dr. David Kessler’s appearance. But in an order dated September 4th, U.S. District Judge Jane Triche Milazzo ruled that his testimony would not confuse the jury.
Kessler is expected to address Sanofi’s regulatory obligations, and will likely assert that the company had “reasonable evidence of a causal relationship” between Taxotere and permanent hair loss.
Kessler served as FDA commissioner from 1990 until 1997. During his tenure, he worked to more fully exert the agency’s regulatory powers in the area of consumer protection.
Taxotere (docetaxel) is a chemotherapy agent used to treat breast cancer, head and neck cancer, gastric cancer, prostate cancer, and non-small cell lung cancer. While all chemo drugs cause temporary hair loss, more than 12,000 plaintiffs with claims pending in the Eastern District of Louisiana allege that hair loss associated with Taxotere is far more likely to be permanent.
The multidistrict litigation’s first bellwether trial is scheduled to begin on Monday, September 16th. As a test case, the verdict could provide valuable insight into how other juries might decide similar Taxotere lawsuits.
The FDA initially approved Taxotere to treat breast cancer in 1992, and expanded the drug’s approved indications in subsequent years. Mention of permanent hair loss wasn’t added to the medication’s U.S. label until December 2015. Up until that point, Taxotere plaintiffs claim that Sanofi’s advertising and marketing misleadingly reassured the U.S. public that Taxotere hair loss was merely temporary.
The complaints note that in 2006, a Denver-based oncologist reported that 6.3% of his Taxotere patients had experienced the permanent loss of hair. Four years later, a Sanofi-funded study called GEICAM 9805 found that 9.2% of Taxotere patients suffered hair loss that lasted 10 years or longer. According to a third study published by the Annals of Oncology in 2012, 19 of 20 women treated with Taxotere also experienced permanent alopecia.
Sanofi informed the European medical community of the potential for Taxotere permanent hair loss in 2005, and the drug’s Canadian Taxotere underwent a similar modification in 2012. Yet Sanofi waited three more years to updated the U.S. prescribing information, allegedly denying plaintiffs the opportunity to choose equally effective chemotherapy treatments that did not pose a similar risk.