Taxotere Permanent Alopecia Lawsuits Move Forward with Issuance of New Pretrial Orders
New Pretrial Orders have been filed by the federal court overseeing hundreds of product liability claims involving the chemotherapy drug Taxotere and its alleged potential to cause permanent alopecia.
Pretrial Order No. 49, filed in the U.S. District Court, Eastern District of Louisiana on July 6th, adopts a protocol for the production of electronically stored information (ESI).
The protocol addresses the scope of ESI discovery, search methodology, timing of discovery, format of production and other matters.
It also directs each of the parties to designate a liaison to coordinate all ESI requests and responses.
Pretrial Order No. 50 was also issued on July 6th and adopts a Protective Order that sets forth guidelines governing the disclosure of certain confidential information, including.
- Information prohibited from disclosure by law
- Information that reveals trade secrets
- Research, technical, commercial or financial information that the party has maintained as confidential
- Medical and protected health information (“PHI”) concerning any individual
- Personal identifying information
- Income tax returns (including attached schedules and forms), W-2 forms and 1099 forms
- Personnel or employment records of a person who is not a party to the case
Taxotere Lawsuit Allegations
Court records indicate that more than 1,100 Taxotere lawsuits are currently undergoing coordinated pretrial proceedings in the Eastern District of Louisiana.
All federally-filed hair loss claims involving the cancer drug were transferred to Louisiana last October, after the U.S. Judicial Panel on Multidistrict Litigation determined that the growing docket would benefit from consolidation.
Taxotere was brought to market by Sanofi-Aventis in 1996, and was initially approved to treat breast cancer. Its approved indications have since been expanded to several other cancers. It wasn’t until December 2015, however, that the U.S. Taxotere label was updated to include mention of permanent hair loss as a potential side effect.
Alopecia often accompanies chemotherapy. However, plaintiffs in Taxotere lawsuits charge that it is far more likely to cause permanent hair loss compared to other, equally effective chemotherapy agents.
Among other things, they note that doctors and patients were informed of the potential for permanent hair loss in 2005, while the Canadian label underwent a similar modification in 2012. By contrast, the U.S. prescribing information only included a vaguely worded and insufficient statement that “hair generally grows back.”
Taxotere and Permanent Hair Loss
According to Taxotere lawsuits, permanent alopecia associated with its use results in baldness, as well as the loss of eyelashes, eyebrows and pubic hair. Plaintiffs claim that Sanofi-Aventis has long been aware of this potential side effect, and cite several studies that have suggested a link between Taxotere and persistent hair loss, including:
- The GEICAM 9805 clinical trial – funded by Sanofi – suggested that 9.2% of Taxotere patients suffered hair loss that lasted 10 years or longer.
- In 2006, a Denver-based oncologist reported that 6.3% of his Taxotere patients had experienced permanent alopecia.
- A 2012 study published in the Annals of Oncology followed 20 Taxotere patients, 19 of whom had permanent hair loss, including the loss of their eyebrows and eyelashes. The authors of the paper cautioned that “physicians and patients should be aware of this new distressing side-effect.”