The court found the relator did not allege specific reimbursement requests or facts linking challenged promotional statements to government payments.
A Maryland federal district court dismissed a qui tam action alleging that the marketers of the probiotic VSL#3 violated the False Claims Act (FCA) and numerous analogous state statutes by promoting the product through allegedly misleading statements about its formulation and clinical support. The court held that the relator failed to plead with particularity that false claims were actually presented to government health care programs or that the defendants caused such claims to be submitted. The court also dismissed related state law claims based on the same alleged conduct (U.S. ex rel. De Simone v. VSL Pharmaceuticals, Inc., No. 23-cv-00700-LKG (D. Md. Sept. 2, 2026)).
Background. The inventor of a probiotic formulation, proceeding on behalf of the U.S. and numerous states, alleged that VSL Pharmaceuticals, Inc., Leadiant Biosciences, Inc., and Alfasigma USA, Inc. engaged in a scheme to market VSL#3 as the same probiotic formulation that had previously been supported by clinical studies, despite alleged changes to the product. He contended that the defendants' marketing caused physicians to prescribe VSL#3 and led to reimbursement claims paid by Medicare, Medicaid, the Department of Veterans Affairs, and other government health care programs. The government declined to intervene.
Alleged marketing scheme. According to the...
The court found the relator did not allege specific reimbursement requests or facts linking challenged promotional statements to government payments. A Maryland federal district court dismissed a ...