A Louisiana woman alleges she could have avoided permanent baldness were it not for an unlawful Taxotere marketing scheme.
Plaintiff Annette W. was diagnosed with breast cancer in October 2006. She underwent four rounds of chemotherapy with Taxotere between April and June 2007.
Neither she nor her treating physicians were aware of any increased risk of permanent baldness, or alopecia, resulting from treatment with Taxotere, she says.
But after her Taxotere treatment, she says, she suffered from disfiguring permanent alopecia that she alleges was caused by Taxotere.
Annette claims defendant Sanofi-Aventis never bothered to warn doctors or patients about the risks associated with Taxotere, even though the company was in possession of study results showing a notably high incidence of permanent alopecia among Taxotere patients.
She says that a study from the late 1990s known as the GEICAM 9805 study, sponsored by Sanofi-Aventis, revealed that over 9 percent of the patients studies still had hair loss as much as 10 years and 5 months following cessation of treatment – and in some cases even longer.
Instead of alerting the public to these risks, Annette alleges, Sanofi-Aventis kept hammering home the message that Taxotere was no more likely than any other chemotherapy drug to result in permanent hair loss.
By failing to apprise patients of these risks, Sanofi-Aventis denied them the opportunity to make informed decisions about their health care, the Taxotere lawsuit claims. Other chemotherapy drugs are on the market that do not present as much of a risk of permanent baldness, Annette says.
Had she known about the risk of permanent hair loss associated with Taxotere, she says, she could have elected to avoid that risk by choosing a different chemotherapy drug.
Whistleblower Alleges Unlawful Taxotere Marketing Scheme
Annette also says that in 2015, a whistleblower claim alleged that Sanofi-Aventis had been marketing Taxotere in violation of federal law for years.
The whistleblower alleged that since as far back as 1996, Sanofi-Aventis had promoted Taxotere for off-label uses that had not been approved by the FDA.
While individual doctors may prescribe drugs for off-label uses on a case-by-case basis, it’s unlawful for drug companies like Sanofi-Aventis to promote their drugs for any use other than what the FDA has approved.
As part of the alleged Taxotere marketing scheme, Sanofi-Aventis employees allegedly were instructed to misrepresent the safety and effectiveness of Taxotere in the interest of promoting it for these off-label uses.
Sanofi-Aventis also was accused of paying kickbacks to healthcare providers in exchange for prescribing Taxotere for off-label uses.
Kickbacks took the form of “sham grants, speaking fees, travel, entertainment, sports and concert tickets, preceptorship fees, and free reimbursement assistance,” according to Annette’s Taxotere lawsuit.
According to Annette, this Taxotere marketing schemedrove sales of the drug up from $424 million in 2000 to $1.4 billion in 2004.
Annette is now raising claims against Sanofi-Aventis for design defect, inadequate warning, and breaches of express warranty and of warranty in redhibition.
The Taxotere Marketing Scheme Lawsuit is Case No. 2:16-cv-16062 in the U.S. District Court for the Eastern District of Louisiana.
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