Taxotere (docetaxel) is a cancer drug used in association with chemotherapy. And while temporary hair loss is not uncommon in association with chemotherapy, it shouldn’t necessarily be permanent.
A growing number of Docetaxel hair loss plaintiffs are asserting that permanent hair loss is, indeed the case – and that Taxotere manufacturer Sanofi SA has for years been engaged in a cover-up scheme to withhold information pertaining to permanent hair loss from consumers in order to protect growing profit margins.
Plaintiff Ami Dodson, who hails from California, alleges just that. To wit, Dodson asserts that Sanofi SA’s misrepresentation extends all the way back to 1996, the year during which the US Food and Drug Administration (FDA) gave its regulatory blessing to Sanofi for Taxotere.
Dodson doesn’t stop at alleging Sanofi merely promoted Taxotere for off-label use, together with the payment of kickbacks to doctors and healthcare providers to prescribe Taxotere off-label. The plaintiff also accuses Sanofi of specifically training their employees to purposefully misrepresent the safety and effectiveness of taxotere.
“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. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted defendants’ claims.”
Sanofi SA, which is based in France, is reported to have received a warning letter from the FDA in 2009 with respect to its allegedly unsavory practices.
The case is Dodson v. Sanofi SA, et al., Case No. 3:16-cv-01251, in the US District Court for the Northern District of California. No fewer than 33 taxotere hair loss lawsuits pending in 16 districts have been centralized in Louisiana for pre-trial determinations.
Plaintiffs assert that one study from 2008 and published in the New England Journal of Medicine came to the conclusion that a competing drug was more effective for certain patients. However, it has been alleged that Sanofi downplayed the superior performance of the competing drug in favor of promoting Taxotere as having “superior efficacy” when, in fact it does not, or so it has been alleged.
That allegation is mirrored in Canada, where at least one cancer doctor is aware that not all cancer doctors shared the true risks of taxotere alopecia (hair loss) with their patients. According to a report in The Globe and Mail (03/16/11) Canadian oncologist Hughes Bourgeois habitually gives his cancer patients a choice: 4 cycles of Taxotere with a higher risk of hair loss, v. 12 cycles of the cancer drug Taxol, with a minimal risk for hair loss.
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In the report, Dr. Bourgeois noted that most of his patients chose Taxol, with its longer treatment period but with less of a risk for permanent hair loss. Taxol, he said, is equally effective as Taxotere for treatment of breast cancer. Bourgeois noted that Taxol cost less than Taxotere with similar efficacy, but with less risk for permanent hair loss.
Cancer patient Cynthia MacGregor, of Montreal, wishes she had gone the Taxol route, instead of Taxotere. MacGregor not only suffered permanent Docetaxel hair loss, her hair loss was absolutely total: The Globe and Mailreported in 2011 that she was left completely hairless.
No hair at all – not even a single eyebrow.
“It’s devastating,” she said, in comments published in The Globe and Mail. “With no hair, there is no going back to normal.”
MacGregor reported her Docetaxel side effects to Health Canada at the time. It is not known if she pursued legal action against Sanofi-Aventis Canada Inc.