Sixth Circuit Discourages False Claims Act Claims Based On Off-Label Promotion
On October 27, 2017, in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017) (Ibanez), the Sixth Circuit Court of Appeals affirmed the dismissal of a qui tam action under the False Claims Act (FCA) alleging that Bristol-Myers Squibb engaged in a nationwide scheme to promote off-label uses of its anti-psychotic drug Abilify. In its decision, the Sixth Circuit highlights the challenges for a relator asserting FCA claims based on off-label promotion in a manner that should be construed to discourage similar claims.
The FCA prohibits knowingly presenting, or causing to be presented, a false or fraudulent claim to the government for payment. According to the Sixth Circuit, because the claim is subject to the requirement under Rule 9(b) that fraud claims be plead with particularity, a relator must identify a specific claim that was actually submitted to the government. Not only that, a relator must specifically allege an entire causal chain including the improper promotion to a specific doctor, who prescribed the drug to a particular patient, who had the prescription filled at a pharmacy that submitted a claim for reimbursement to the government. The Sixth Circuit conceded that if a relator could allege each of these specific acts, it could proceed to discovery. But it also cited a recent Second Circuit decision in U.S. ex rel Polansky v. Pfizer, Inc., 822 F.3d 613 (2d Cir. 2016), that questioned the entire concept of a FCA claim based on truthful but off-label promotion.
Ibanez is but another sign of the trend against liability for off-label promotion. In a November 2, 2017 post, we wrote about a Seventh Circuit decision that barred third-party payors from asserting civil RICO claims against drug companies for off-label promotion practices, also in part due to the difficulty in establishing the long causal chain from promotion to reimbursement. The Second Circuit decision in Polansky follows a similar path. While drug companies should remain wary of enforcement by the FDA’s Office of Prescription Drug Promotion, enforcement by that agency is also down, with only three warning letters issued this year compared to 11 last year, continuing a steep decline over the last two decades.
Drug companies must continue to abide by drug-promotion rules. But at the same time, it appears there is a growing zone of comfort for companies to provide truthful information to physicians about studies that show benefits of a drug’s off-label use.