Product liability actions are proliferating in federal courts across the country, charging that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not.
The emerging litigation is ripe for a motion to consolidate them into a federal multi-district litigation docket, because complaints involving Taxotere (Docetaxel) have been filed in multiple jurisdictions, including US District Courts in Illinois, North Carolina, Florida, Mississippi, Kansas, Louisiana and Colorado.
In one case Magistrate Judge Michael Watanabe has scheduled a planning conference on June 30 in US District Court in Denver, Colorado. The case is Melissa Leith v. Sanofi, Case No. 16-cv-00741-MJW.
Mass Tort Nexus has compiled a Taxotere Lawsuit Emerging Litigation Briefcase for subscribers with 120 sub folders and documents as of June 2016.
Warnings overseas, but not in the US
Thousands of women of never got the chance to make an informed decision about their cancer treatment because the words “permanent alopecia” or “permanent hair loss” did not appear in any Taxotere information available in the U.S. — even though Sanofi had provided such information to doctors and patients in other countries.
As a direct result of defendants’ fraudulent marketing scheme, the defendants dramatically increased revenue on sales of Docetaxel from $424 million in 2000 to $1.4 billion in 2004.
The best-developed action is Kally Gahan v. Sanofi. The “Sanofi defendants” include:
- Sanofi S.A. headquartered in Paris, France
- Aventis Pharma S.A. headquartered in Antony, France
- Sanofi-Aventis US, Inc. headquartered in Bridgewater, NJ
- Sanofi-Aventis U.S. LLC headquartered in Bridgewater, NJ
- Sanofi US Services Inc. Winthrop US (a subsidiary of Sanofi-Aventis US) headquartered in Bridgewater, NJ.
The product liability action is Case No. 1:16-cv-03038, filed on May 26, 2016 in US District Court in Colorado.
The Gahan case also alleges breach of warranty, fraudulent misrepresentation, fraudulent concealment and violation of the Colorado Consumer Protection Act. The plaintiff suffered damages including medical expenses, psychological counseling and therapy expenses, loss of earnings, impairment of earning capacity, permanent disfigurement mental anguish severe and debilitating emotional distress and increased risk of future harm.
Negligence and failure to warn
Allegations are that the defendants were negligent in the designing, researching, supplying, manufacturing, promoting, packaging, distributing, testing, advertising, warning, marketing, and selling of Taxotere in that they:
- Failed to use due care in designing and manufacturing Taxotere so as to avoid the risks to individuals when Taxotere was used for the treatment of breast cancer.
- Failed to accompany their product with proper and/or accurate warnings.
- Failed to warn the plaintiff, physicians and the public of the severity and duration of adverse effects.
- Failed to conduct adequate testing, including pre-clinical and clinical testing and post-marketing surveillance, to determine the safety, dangers, and risks associated with Taxotere.
The FDA approved Taxotere on May 14, 1996 for“the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.” It was designed as an increased potency Taxane. This increased potency resulted in increased toxicity, which can be directly related to increased adverse events. The most likely reason defendants designed the increased potency Taxane was to enable the manufacturers to get a patent (and the concurrent market advantage) on a product that in fact was not novel but instead only more dangerous.
Kickbacks and Off-Label Sales
A Qui Tam lawsuit was also filed against Sanofi-Aventis and its affiliates in the US District Court for the Eastern District of Pennsylvania by a former employee accusing Sanofi-Aventis and its affiliates of engaging in a fraudulent marketing scheme, paying kickbacks, and providing other unlawful incentives to entice physicians to use Taxotere. See U.S. ex rel. Gohil v. Sanofi-Aventis U.S. Inc., Civil Action No. 02-2964 (E.D. Pa. 2015).
Beginning in 1996, Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC launched a marketing scheme that promoted Taxoterefor off-label uses not approved by the FDA. The scheme took two forms:
First, defendants trained and directed their employees to misrepresent the safety and effectiveness of the off-label use of Taxotere to expand the market for Taxotere in unapproved settings.
Second, defendants paid healthcare providers illegal kickbacks in the form of sham grants, speaking fees, travel, entertainment, sports and concert tickets, preceptorship fees, and free reimbursement assistance to incentivize healthcare providers to prescribe Taxotere.