January 23, 2017 — A federal judge has refused to dismiss a whistleblower lawsuit over “off-label” promotion of the chemotherapy drug Taxotere.
The whistleblower says Sanofi-Aventis paid kickbacks to incentivize doctors to prescribe Taxotere, which more than tripled sales of the drug in four years — $424 million in 2000 to $1.4 billion by 2004.
The long-running lawsuit was filed by Yoash Gohil, a sales representative who worked for Aventis from 1982 until his resignation in 2002. In a Qui Tam lawsuit filed in 2001, Gohil accused his former employer of a “fraudulent marketing scheme.”
Sanofi-Aventis tried to dismiss the whistleblower lawsuit, claiming the statute-of-limitations had expired. The French drug-maker also claimed that the U.S. Constitution protects “off-label” promotion as free speech under the First Amendment.
U.S. District Judge Lawrence Stengel rejected both of these defenses in a memorandum (PDF) issued on January 7. Off-label promotion might be protected free speech, but only if it was truthful and not misleading — and a jury should answer that question after more fact-finding.
The lawsuit accuses Aventis of training sales representatives to market Taxotere for unapproved uses, downplay the risk of side effects, and provide kickbacks to doctors between 1996 and 2004.
Gohil says those kickbacks to doctors included “sham unrestricted grants” and fees for speaking fees, travel, entertainment, sports, concert tickets, free samples, and free reimbursement assistance.
Sanofi-Aventis is currently facing over 700 lawsuits from people who suffered permanent hair loss after being prescribed Taxotere with other chemotherapy drugs. Lawyers say the company knew about the risk for more than a decade before updating warning labels in the U.S.
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