FCA Settlement Does Not Bar Third-Party Claims
Client Alert | 1 min read | 12.03.09
In Cell Therapeutics Inc. v. Lash Group Inc. (9th Cir. Nov. 18, 2009), the Ninth Circuit ruled that an FCA settlement entered into between a drug manufacturer and the government and relator did not preclude the drug manufacturer from bringing state common law claims against an expert in Medicare reimbursement protocol for having allegedly advised that the false Medicare billings were proper. Although a company found to have violated the FCA may not shift its FCA liability to a third party, the suit was not foreclosed because, first, "independent" claims for damages were asserted; and, second, a settlement agreement without an admission of FCA liability does not constitute a finding of FCA liability, which could preclude recovery against a third party.
Insights
Client Alert | 2 min read | 05.09.25
FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization
On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization.
Client Alert | 2 min read | 05.09.25
New SF-328 for Foreign Ownership, Control, and Influence Assessments Approved, Publication Imminent
Client Alert | 4 min read | 05.08.25
Client Alert | 4 min read | 05.07.25
