United States, ex rel. John King, et al. v. Solvay Pharmaceuticals, Incorporated

In this False Claims Act (FCA) case, petitioners allege that respondent Solvay Pharmaceuticals, Inc. caused the government to pay for three of its prescription drugs by unlawfully marketing those drugs for off-label indications. Petitioners had firsthand knowledge of Solvay’s multi-million dollar multi-year off-label promotion efforts, but not of specific claims for payment presented to the government. They disclosed what they knew to the government before suing. Through government subpoenas and discovery, petitioners obtained additional evidence that Solvay’s off-label marketing resulted in claims to the government. The lower courts granted summary judgment to Solvay. With respect to two drugs, the Fifth Circuit held that circumstantial evidence cannot prove that an off-label marketing campaign caused the submission of false claims. With respect to the third drug, the court held that the FCA’s public disclosure bar applied, and that petitioners could not qualify as “original sources” because their disclosure to the government did not connect the underlying frauds to false claims. The questions presented are:

1. Whether and when circumstantial evidence may be used to prove that a defendant’s illegal conduct caused another to submit false claims.

2. Whether a relator can qualify as an “original source” for purposes of the FCA’s public disclosure bar when the relator has knowledge of a fraudulent scheme, and good reason to believe that false claims were submitted to the government, but no direct knowledge of such claims.