Thirty-three cases that had been filed federally across the U.S. against pharmaceutical company Sanofi SA were consolidated this month into a multidistrict litigation (MDL) in Louisiana district court, according to Law360. The drug maker is accused of marketing its chemotherapy drug Taxotere as superior to similar competing drugs, while concealing that the drug caused permanent hair loss.
Law360 quotes from one of the suits filed by Ami Dodson in California saying that Sonafi SA began misrepresenting the safety and effectiveness of Taxotere as early as 1996, the year that the drug was approved for use by the Food and Drug Administration (FDA). The complaint alleges that the company trained employees to promote the drug’s off-label use. The lawsuit alleges that Sanofi SA then paid kickbacks to health care providers who prescribed Taxotere off-label and as a result Taxatore’s sales jumped from $424 million in 2000 to $1.4 billion in 2004.
While physicians can prescribe drugs off-label for uses for which they are not approved by the FDA, it is illegal for drug manufacturers to market drugs for unapproved uses. Pharmaceutical companies who engage in this activity are prosecuted by the Department of Justice.
The increase in sales is also allegedly as a result of marketing based on self-sponsored clinical trials where Sanofi ignored the results of other studies that found competing drugs were more effective for certain patients. According to the lawsuit, one such study, published in the New England Journal of Medicine in 2008, resulted in a warning letter to Sanofi and its affiliates from the FDA in 2009 for continuing to claim Taxatore’s “superior efficacy” in their marketing.
“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,” Dodson said, according to Law360. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted defendants’ claims.
“Although women might accept the possibility of permanent baldness as a result of the use of Taxotere if no other product were available to treat their cancer, this was not the case,” Dodson said of the rare chemotherapy side-effect of permanent instead of temporary hair loss. “There were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia.”