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.
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.
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.