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# False Claims Act Off-Label Promotion Case Fails
- URL: https://www.fdaweb.com/false-claims-act-off-label-promotion-case-fails/
- Published: 2017-11-07T12:00:00.000Z
- Updated: 2026-09-14T23:00:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140066

The 6th Circuit Court of Appeals has upheld on a 2-1 vote a lower federal court’s dismissal of a whistleblower suit against Bristol-Myers Squibb that was based on allegations of off-label promotion. Attorney **Andrew Hull** (Hyman, Phelps & McNamara) [writes in his firm’s *FDA Law Blog*](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/11/sixth-circuit-affirms-dismissal-of-off-label-promotion-fca-case-for-lack-of-rule-9b-specificity.html?ref=fdaweb.com) that the court upheld dismissal of False Claims Act (FCA) conspiracy counts, saying that while alleged conduct involving off-label promotion to increase the number of drug prescriptions “may be condemnable” (if true), such an alleged plan “does not amount to conspiracy to violate the FCA.”

The court held that to adequately allege an FCA conspiracy, it is not enough for a whistleblower to show there was an agreement that made it likely there would be an FCA violation; rather, they must show that an agreement was made in order to violate the FCA.

The appeals court majority said the Rules of Civil Procedure 9(b) pleading standard is “awkward” and requires a specific representative example demonstrating three elements: 

- the doctor to whom the manufacturer improperly promoted the product must have prescribed the medication for an off-label use;
- the patient must have filled the prescription; and
- the filling pharmacy must have submitted a claim to the government for reimbursement of the prescription.

Hull says the dissenting appeals court judge said the whistleblower had pled with sufficient specificity in the third amended complaint “by identifying specific claims and supplementing those identifications with personal knowledge and statistical evidence.” He says the Rule 9(b) pleading standards vary by circuit and the “lack of a consistent standard among the circuits invites forum shopping by relators’ counsel and would benefit from Supreme Court review.”