A California woman has filed a new lawsuit against Sanofi-Aventis, claiming that the company downplayed the link between Taxotere and permanent hair loss. The complaint, which is now pending in the U.S. District Court, Northern District of California, asserts that Sanofi’s alleged conduct caused thousands of patients to undergo chemotherapy with a medication that was far more toxic than its equally effective competitors.
Taxotere is a chemotherapy agent currently approved to treat breast cancer and a number of other cancers. Although temporary hair loss is a common with any chemotherapy, permanent alopecia is not. However, a growing number of Taxotere lawsuits plaintiffs claim to have suffered the permanent loss of their hair due to this medication. It was only this past December that the Taxotere label was updated to warn about the possibility of permanent baldness.
This newly- filed complaint charges that by the late 1990s, Sanofi was aware of a study showing that 9.2 percent of people treated with Taxotere lost their hair for more than 10 years, but withheld this information from U.S. consumers. While the drug’s labeling in a number of other countries did provide information about permanent alopecia, the U.S. label only provided a vague assurance that “hair generally grows back.”
The lawsuit also asserts that Sanofi wrongly marketed Taxotere as superior to other chemotherapy treatments. The plaintiff further charges that the company paid kickbacks to health care providers to persuade them to prescribe the drug for off-label uses
“Contrary to defendants’ claims of superior efficacy, post-market surveillance has shown that the more potent and more toxic Taxotere does not, in fact, offer increased efficacy or benefits over other taxanes, as defendants have claimed and advertised,” the complaint states. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted defendants’ claims.”
This case is just one of the most recent Taxotere lawsuits to be filed in the wake of the FDA’s hair loss warning. In January, an Ohio woman filed a similar complaint alleging that the permanent hair loss she experienced resulted in mental anguish and psychological damage so severe that she was unable to work.
According to a report from Law360.com, a former Sanofi employee has also filed a whistleblower lawsuit that accuses the company of engaging in a fraudulent marketing scheme and paying kickbacks in relation to Taxotere. That case is pending in the U.S. District Court, Eastern District of Pennsylvania.