Over the past two months, the number of lawsuits against Taxotere maker Sanofi-Aventis has nearly tripled, going from 260 to more than 700. This comes in the wake of the consolidation of all federal lawsuits into multi-district litigation (MDL) before the Honorable Judge Kurt D. Engelhart in U.S. District Court for the Eastern District of Louisiana last fall. The relatively sudden increase in litigation strongly suggests that many more lawsuits will be filed in the coming months by plaintiffs alleging that their permanent hair loss was caused by Taxotere.
However, this is not the only legal issue the French pharmaceutical company faces. According to a whistleblower who filed a qui tam suit in 2002, Sanofi Aventis ordered its sales staff to misrepresent the product's safety and efficacy to potential customers. According to former Aventis sales representative Yoash Gohil, it was part of a fraudulent scheme to promote Taxotere for off-label purposes – in violation of FDA regulations. Further allegations state that the company offered illegal kickbacks to physicians in the form of phony research grants, inflated “speaking fees” and other payments in order to provide incentives to recommend the product to their patients. According to the complaint:
“Aventis’ fraudulent marketing scheme allegedly caused a substantial number of health care providers to submit claims for reimbursement to governmental medical reimbursement systems for the use of Taxotere, which would not have otherwise been paid had the government reimbursement programs known of Aventis’ fraudulent marketing scheme.”
In response, Aventis attorneys filed a motion for partial judgment and asked that the case be dismissed. The defense argued that the statute of limitations on some of Gohil's claims (which date back to 1996) had expired.
Judge Lawrence Stengel denied the request on grounds that Aventis had received “fair warning” when the initial amended claims were filed. The defense then used an argument that is being used by an increasing number of corporate criminals these days. Counsel claimed that some of Gohil's claims were based in fact, and that “commercial speech” is protected under the First Amendment. This request was also denied, since Gohil alleges that said speech involving off-label use was in fact false and misleading – and therefore, not protected under the First Amendment. In his decision, Judge Stengel wrote that the “question is better answered by a jury.”
The case, United States ex rel. Gohil v. Aventis, Inc. will go forward as scheduled.