Sanofi Aventis Can’t Invoke the First Amendment to Escape FCA Liability

United States ex rel. Gohil v. Aventis, Inc. is a long-running False Claims Act suit filed in the Eastern District of Pennsylvania by an ex-sales specialist against his former employer, behemoth pharmaceutical company, Sanofi Aventis.  Relator Yoash Gohil filed this qui tam suit in 2002 alleging that his former employer engaged in a fraudulent marketing scheme to promote off-label the chemo-therapy drug, Taxotere.

The Relator alleges that Aventis trained and directed its sales force to misrepresent the safety and effectiveness of the chemotherapy agent in order to expand the market share for Taxotere beyond its FDA approval as a “second line treatment.”  A second line treatment is one that is approved for limited use only after the failure of a prior treatment.  Relator also alleges that Aventis had engaged in a kickback scheme that included sham grants, exorbitant speaking fees, and excessive preceptorship fees paid to physicians in order to incentivize them to prescribe Taxotere.

Aventis moved for a partial judgment on the pleadings and raised two grounds for dismissal.  First, Aventis argued that some of the claims (those from 1996 to 2000) were barred by the statute of limitations.  Federal District Court Judge Lawrence Stengel rejected this argument finding that the pharmaceutical company was given fair notice of the claims when the First and Second Amended Complaints were filed.  The Court accepted Relator’s argument that all of the new claims “related back” to the claims laid out in his original complaint.

Second, Aventis argued that some of Relator’s claims were precluded by the First Amendment.  This argument has been made with increasing frequency by the pharmaceutical industry in trial and appellate courts throughout the United States.  Aventis argued that First Amendment protections extend to commercial speech and that parts of Relator’s claims were based on truthful, non-misleading speech regarding Taxotere.  Judge Stengel rejected this argument as well, finding that Relator’s Complaint had asserted that the off-label promotion was false and/or misleading.  Ultimately, the dispute over the whether the speech was false or misleading is material to the outcome of the case.  Judge Stengel held that the First Amendment issue was not ripe for disposition and denied the motion for partial summary judgment.  He wrote, “This question is better answered by a jury.”

United States ex rel. Gohil v. Aventis, Inc., No. 02-2964, 2017 U.S. Dist. LEXIS 3236 (E.D. Pa. Jan. 9, 2017)