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Protecting against FCA exposure

The False Claims Act (FCA) remains a key US government enforcement tool – recovering billions of dollars annually through whistleblower claims, Department of Justice (DOJ) investigations, and settlements across industries.

DLA Piper helps companies navigate this evolving landscape with a dual focus: defending against high-stakes litigation and delivering proactive compliance strategies aimed at reducing exposure.

Dedicated coverage for FCA issues

The FCA is more than a fraud statute. It is a powerful enforcement tool that shapes compliance across industries. Our White Collar team works closely with practices across the firm, including Government Contracts, Data Privacy, and National Security and Global Trade, to manage FCA exposure with confidence.

Strategic FCA and qui tam defense

Whistleblowers can file qui tam lawsuits under the FCA on behalf of the government and are financially incentivized to do so, often triggering costly investigations and litigation. Government intervention in a FCA case can greatly increase legal and financial exposure for businesses, making it critical to minimize risk through strong compliance measures and early detection of potential issues.

We have a strong track record of persuading the US government to dismiss whistleblower-led fraud cases that conflict with federal priorities. In matters where the government declines to intervene, we draw on our appellate experience and fact development capabilities to pursue favorable outcomes, including summary judgment. Our strategies are designed to meet the demands of any FCA matter.


The firm is well-prepared to handle complex and sophisticated False Claims Act matters.

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Awards and recognition

Experience

  • Represented Adamas Pharmaceuticals in an FCA lawsuit involving allegations that patents had been acquired and used to wrongfully block generic medicines from entering the market, causing Medicare and Medicaid to overpay for branded drugs by more than US$2 billion. DOJ declined to intervene, and we moved to dismiss the complaint at the district court under the FCA’s public disclosure bar. The Ninth Circuit remanded the case on interlocutory appeal, and the district court ultimately dismissed the case with prejudice.

  • Represented a global pharmaceutical company in an off-label promotion and DOJ FCA investigation. Settled favorably for the client following a multi-year investigation, including large-scale productions and lengthy government presentations.

  • Represented a global retailer and its chief executive officer in a DOJ-intervened FCA litigation alleging a fraudulent scheme to evade US customs duties, a matter in which had DOJ intervened. After an investigation, we presented various arguments in mitigation and negotiated a resolution for a fraction of the financial penalty originally sought by the DOJ.

  • Represented a global financial services company in a FCA litigation alleging a scheme to defrauded the US government by submitting applications for fishing licenses that falsely certified the vessels were US-owned. Achieved dismissal with prejudice and we are representing the client on appeal in the Second Circuit.

  • Represented BioMatrix in a DOJ investigation based on a sealed qui tam FCA case asserting violations of federal and state anti-kickback statutes. We convinced DOJ not to intervene in the case and the relator voluntarily dismissed the complaint.

  • Represented Biz2Credit in civil and criminal investigations involving alleged violations of the FCA, Federal Trade Commission Act, and COVID-19 Consumer Protection Act in connection with Paycheck Protection Program loans. We negotiated a favorable resolution with the FTC in which the client did not admit to any wrongdoing and reduced the monetary demand from $380 million to $33 million.

  • Represented a pharmaceutical company in an industry-wide DOJ investigation concerning possible violations of the Anti-Kickback Statute based on donations to patient-assistance charities and a parallel inquiry concerning the sales and marketing of two multiple sclerosis products. Settled favorably with DOJ concerning the donations issue and convinced DOJ to walk away from its parallel sales and marketing inquiry.

  • Represented a US contractor in the negotiation and settlement of a relator’s FCA case concerning the award and performance of a defense contract. The FCA allegations were based on the same operative facts as a criminal case being pursued by DOJ, so we pushed for and achieved a favorable global settlement of the FCA and criminal cases, including non-prosecution agreements.

  • Represented a medical device manufacturer in an internal and government investigations of alleged false claims to federal healthcare programs. We convinced DOJ not to intervene in the underlying qui tam action; relator dismissed the case voluntarily.

  • Representing a biotechnology company in a FCA case alleging violations of the FCA and AKS through marketing practices and product support services related to a chemotherapy drug offered to patients

  • Represented Christiana Care Hospital System against allegations of violations of the Stark Law and AKS). Achieved partial summary judgment and then favorably settled the remainder of the case.

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