Federal Court Overseeing 7,500 Taxotere Alopecia Lawsuits Outlines Procedures for Product Identification

Published on February 2, 2018 by Sandy Liebhard

The manufacturers of Taxotere and other docetaxel chemotherapy medications continue to face a growing number of product liability lawsuits over their products’ alleged potential to cause permanent or persistent alopecia.

According to a Joint Status Report submitted by the parties on January 26th, 7,500 cases are now pending in the U.S. District Court, Eastern District of Louisiana, where all such federal claims have been centralized for the purpose of coordinated pretrial proceedings.

Plaintiffs Ordered to Produce Product Information

Per a Case Management Order dated January 12th, the Court has directed each Plaintiff to make a diligent, documented and good faith effort to:

  • Determine the facility, center, hospital, where they were infused with docetaxel
  • Determine the time frame when they were treated with docetaxel at such infusion facility
  • Request, order, and ultimately pay for medical records and other proof identifying the manufacturer of the docetaxel product(s) they received.

Plaintiffs in currently pending cases were directed to comply within 15 days of the Order’s entry. Others are to comply within 30 days of filing a Short Form Complaint with the Court.

Taxotere and Hair Loss

Taxotere was approved by the U.S. Food & Drug Administration (FDA) in 1996 to treat breast cancer, and is now indicated for the treatment of head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer. The first generic version of docetaxel was approved by the agency in 2012.

While hair loss is a typical side effect of chemotherapy, Taxotere lawsuit plaintiffs allege that alopecia associated with docetaxel is more likely to be permanent compared to other, equally as effective agents. Mention of permanent alopecia as a possible side effect was only added to Taxotere’s U.S. prescribing information in December 2015. However, plaintiffs point out that the European medical community was informed of the potential for permanent hair loss in 2005, while the Canadian Taxotere label underwent a similar modification in 2012.

Taxotere lawsuits also cite several recently-published studies, including a Sanofi-funded study called GEICAM 9805 , which suggested that 9.2% of docetaxel patients experienced hair loss that lasted 10 years or longer. In 2006, a Denver-based oncologist reported that 6.3% of his docetaxel patients had experienced permanent hair loss

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