Labor & Employment Law Daily Wrap Up, WHISTLEBLOWERS—7th Cir.: AbbVie salesperson cannot revive FCA claim concerning off-label prescription sales push, (Sep 4, 2025)

By Todd Harrison, J.D.

Although AbbVie may have risked violating the FDA’s regulations about off-label marketing, the would-be whistleblower’s claims were “wholly unrelated to the FCA.”

Affirming a district court’s grant of AbbVie’s motion to dismiss an employee’s claim for whistleblower retaliation, the Seventh Circuit determined that the employee had failed to put AbbVie on notice that he was blowing the whistle on fraud concerning the company’s sales push for the off-label use of one of its drugs. The employee complained only of regulatory, not fraudulent, violations in his internal communications with the company. Thus, AbbVie had no reason to think his concerns implicated the False Claims Act (Lewis v. AbbVie Inc., No. 24-3121 (7th Cir. Sept. 3, 2025)).

Off-label. Medical providers can prescribe a drug for either its FDA approved use on the label or its unapproved off-label use. The Food, Drug, and Cosmetic Act (FDCA) generally prohibits pharmaceutical companies such as AbbVie from promoting off-label uses to the public or medical providers. In addition, Medicare and Medicaid do not reimburse off-label prescriptions unless one of three medical compendia have sanctioned the use.

Sales push. According to the employee in this case, after the FDA approved AbbVie’s drug Vraylar for bipolar depression treatment, the company began aggressively peddling the drug to providers for off-label uses, primarily as a treatment for substance abuse and major depression disorder. The campaign appeared to pay off, as Vraylar sales increased 88 percent in the first three fiscal quarters after AbbVie began the sales push, and revenue from Vraylar sales increased 70 percent in the second quarter of 2020 alone.

Complaints. Despite the ongoing success of the sales initiative, the employee faced resistance when he refused to push Vraylar’s off-label use. He complained to his supervisor and HR about the campaign, and emailed HR in the summer of 2020 that he was worried about being “noncompliant” when pitching Vraylar as an off-label treatment and his concerns surrounding corporate policy. However, he never framed his internal grievances as related to defrauding the government through the off-label campaign. Instead, he complained of regulatory risks. As a result of his complaints, he allegedly lost an opportunity for promotion and received excessive work.

Lawsuit. In November 2020, the employee brought a False Claims Act qui tam action against AbbVie, alleging the company violated the FCA by: (1) causing the government to pay fraudulent insurance claims in violation of 31 U.S.C. §3729; and (2) retaliating against him for whistleblowing in violation of 31 U.S.C. §3730(h). The government investigated for four years before deciding not to intervene.

AbbVie filed a motion to dismiss, and the employee dropped his Section 3729 allegation, leaving only his whistleblower retaliation claim. AbbVie again moved to dismiss for failure to state a claim, a motion the district court granted after finding the employee’s theory of fraud against the government was not objectively reasonable. This appeal followed.

Notice. Although the employee abandoned his Section 3729 fraud claim, the viability of his fraud theory was still relevant to understanding the court’s disposition. In order to advance a fraud claim, the employee needed to put AbbVie on notice that he reasonably suspected AbbVie was defrauding the government. Here, the employee argued that AbbVie caused providers to present false claims to the government because they prescribed Vraylar for an off-label use at AbbVie’s insistence, to at least one government-insured patient, and submitted a claim for reimbursement.

Regardless of the employee’s theory of fraud, no facts suggested that AbbVie was “on notice” of these concerns, said the court. Merely informing an employer that it is not complying with a statutory or regulatory requirement is not sufficient to put an employer on notice, explained the court, which is exactly what the employee did here when he complained about being noncompliant with corporate policy. Not once did he suggest that he feared defrauding the government, the court observed.

Chain of causation. “In the typical FCA fraud case where an employee whistle blows on the firm directly submitting false claims, satisfying notice is practically co-extensive with the protected conduct element,” said the court. However, the longer the chain of causation, the less related protected conduct and notice become.

Here, AbbVie purportedly caused third parties to defraud the government by subscribing to a marketing pitch. Such a marketing scheme does not imply any of the employee’s alleged fraud concerns on its face, explained the court. Thus, an individual complaining about the campaign is not plausibly conveying a connection to the FCA or unlawful claims for government payment. Instead, the employee’s complaints suggested that AbbVie may have been running afoul of FDA regulations concerning off-label marketing, an assertion that is “wholly unrelated to the FCA.”

There was nothing in the employee’s communications that would steer AbbVie to understand that he was suggesting that the company was engaged in fraud in violation of the FCA, concluded the court, affirming the lower court’s dismissal of his claim.

The case is No. 24-3121.

Judge: Kolar, J.

Attorneys: Peter D. Hamann (Pfeifer, Morgan & Stesiak) for Jeffrey Lewis. John Robert Maley (Barnes & Thornburg) for AbbVie Inc. fka Allergan.

Companies: AbbVie Inc.; Allergan

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