The federal court overseeing thousands of Taxotere lawsuits involving the drug’s alleged potential to cause permanent hair loss has scheduled four bellwether trials, the first of which will begin in January 2019.
Bellwether trials are an important milestone in any large, complex litigation. These trials generally involve individual cases that are representative of others pending in a centralized court proceeding, such as the Taxotere multidistrict litigation. Verdicts in bellwether cases are intended to provide clues as to how other juries might rule in similar lawsuits.
Federally-filed Taxotere lawsuits have been centralized in a multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. According to an Order dated August 29th, the Court intends to convene bellwether trials on the following four dates in 2019:
Taxotere was approved by the U.S. Food & Drug Administration (FDA) in 1996 to treat breast cancer. Its approved uses have since been expanded to include several other malignancies, including head and neck cancer, gastric cancer, prostate cancer, and non-small cell lung cancer.
In December 2015, Taxotere’s U.S. labeling was altered to note that cases of permanent hair loss have been reported among patients treated with the medication. However, plaintiffs involved in the federal litigation contend that Sanofi-Aventis was aware of this risk for years, and note that the Taxotere label in several other countries actually included information on permanent alopecia long before the U.S. prescribing information was modified.
The complaints also cite several recently published studies that have suggested Taxotere could cause persistent alopecia, including the Sanofi-funded GEICAM 9805 clinical trial, which suggested that 9.2% of Taxotere patients experienced hair loss that lasted 10 years or longer. Plaintiffs also note that in 2006, a Denver-based oncologist reported that 6.3% of his Taxotere patients had experienced permanent alopecia.
“As a result of this undisclosed side effect, Plaintiffs have struggled to return to normalcy, even after surviving cancer because an integral element of their identities, their hair, never returned. Plaintiffs are stigmatized with the universal cancer signifier—baldness—long after they underwent cancer treatment, and their hair loss acts as a permanent reminder that they are cancer victims,” the litigation’s Master Long Form Complaint state. “This permanent change has altered Plaintiffs’ self-image, negatively impacted their relationships, and others’ perceptions of them, leading to social isolation and depression even long after fighting cancer.”