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False Claims Act

Corporations and professionals are facing ever-increasing Government enforcement under the False Claims Act (FCA).

Since 2010, the Department of Justice (DOJ) has recovered over $45 billion through FCA actions, including a near-record $5.6 billion in 2021.  The majority of these cases originate as qui tam, or whistleblower, complaints brought by “Relators,” but DOJ is increasingly initiating FCA actions as well.  These actions often target the life sciences and healthcare industries, including pharmaceutical companies, drug manufacturers, healthcare providers, nursing homes, pharmacies, and managed care plans.  In addition to alleging the submission of false claims, these actions often allege violations of the Anti-Kickback Statute (AKS), and are increasingly coupled with actions by state attorneys general under state versions of the FCA and AKS.

How Orrick Can Help

Our FCA team combines deep knowledge of the statutes, regular appearances before the relevant agencies, an unsurpassed trial record and a focus on resolving matters effectively and efficiently.  We also understand the life sciences sector, with a practice that delivers comprehensive services to leading public and private entities in each vertical.

Our team comprises former federal prosecutors, including FCA civil enforcement attorneys, and experienced defense attorneys who have spent their careers handling all aspects of FCA matters.  We know first-hand federal agencies’ expectations and limitations in pursuing FCA investigations and appear before them regularly, including the DOJ, Department of Health and Human Services (HHS), federal agency and state Inspectors General (OIG), Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA), and state attorneys general.

We focus on creatively preempting, resolving, or curtailing Government action, but stand ready to aggressively litigate a case to the end.  We bring the perspective of seasoned trial attorneys to our efforts to prevail at each step in the process — convincing Government agencies to forego or cease action, winning dismissal through motion practice, or succeeding at trial.  

  • Substantive Industry Knowledge & Cross-Disciplinary Expertise

    Orrick has an industry leading life sciences practice, serving over 500 life science clients across all segments—biotech and pharma, digital health, research and laboratories, and medical devices and diagnostic tools.  Our biotechnology and pharmaceutical clients range from cutting edge start-ups to some of the largest pharmaceutical companies in the world.  Representing our life sciences clients in such matters as IPOs, M&A transactions and myriad litigation allows us to hit the ground running in defending against FCA claims that often fail to comprehend the complexity and nuance of the subject areas.  Likewise, we have substantial experience in the healthcare industry, including a range of health care providers and health systems, hospitals and clinical facilities, pharmacies and pharmacy benefit mangers (PBMs), and Medicare Advantage health plans. 

    We collaborate with Orrick’s market-leading practitioners in employment law, privacy and data innovation, and financial services to ensure our advice reflects a comprehensive view of risk. 

    Representative Engagements

    FCA Investigations

    • Major Health System – Defended multi-state health system in connection with FCA investigation into allegations that surgeons performed unnecessary surgeries and billed for services not rendered, ultimately negotiating favorable resolution for our client while the government continues to pursue a civil and criminal investigation against others.
    • Individual Physicians – Represented group of physicians in connection with multiparty FCA investigation connected with a leading academic medical center. Resolved the claims against our clients without any civil, criminal or administrative action being taken.
    • Skilled Nursing Home – in a qui tam FCA complaint, alleging violations of the Anti-Kickback Statute to pay physicians to refer patients, convinced DOJ not to intervene and the case was voluntarily dismissed.
    • Managed Care Plan – After years’ long investigation into upcoding allegations, successfully convinced DOJ not to pursue criminal charges or civil FCA claims against client.
    • Multinational Government Contractor – Negotiated resolution of DOJ and federal inspector general’s investigation into alleged FCA violations relating to performance under major government contracts in the Middle East and alleged improper relationships with foreign officials.
    • Pharmaceutical Company – Representing multinational pharmaceutical company in state and federal investigations into alleged Medicaid fraud.The Attorney General’s investigation was focused on alleged violations of the state’s FCA, fraudulent practices and anti-kickback statutes.Convinced DOJ not to intervene in case.
    • Industrial Manufacturer - Representing a German manufacturer in a “bet-the-company” FCA investigation by the DOJ and the Defense Criminal Investigative Service (DCIS) (an investigative arm of the Office of Department of Defense Inspector General) into performance under military contracts.

    FCA Litigation

    • Major Biopharmaceutical Company – Represented global biopharmaceutical leader in a qui tam action brought by former sales directors, who alleged the company’s speakership and advisory programs were used as kickbacks to increase sales of certain drugs. After extensive discovery and summary judgment briefing, the case was favorably resolved prior to trial.
    • Major Health Plan – Achieved a dismissal of federal FCA claims in a case where an ambulance provider filed a qui tam action against a leading national health plan for allegedly refusing to pay for services transporting its patients with certain conditions to and from required treatment and instead requiring another party to seek reimbursement for services from government payor.
    • Major Health Center - Represented a large community nonprofit health center, serving some of the state’s most vulnerable populations, against a federal qui tam action brought by a former employee.
    • Government Contractor - Represented government contractor, a joint venture of two industry leaders, in multibillion-dollar qui tam litigation alleging false claims resulting from fraud in the contracting process, violations of contract’s small business subcontracting requirements, and violations of multiple federal laws governing worker treatment.

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