Assessing the Fallout from a Thermonuclear FCA Verdict

Host Jonathan Porter welcomes Tynan Kugler, Principal with PYA, P.C., and Mara Smith Kouba, legal counsel with Bristol Myers Squibb, to discuss a recent False Claims Act trial verdict from a New Jersey federal court. United States ex re Penelow et al. v. Janssen Products, LP was decided on June 13, 2024, resulting in potential damage awards of over $1 billion. The case is awaiting appeal.

Our discussion centers on the financial relationships that life sciences companies have with physicians and the potential risks inherent in those relationships. We dissect the Penelow case and the legal theories at play from both the relator and defense perspectives, including how they concern the use of a speaker network program and the ‘one-purpose’ theory of the Anti-Kickback Statute. We then pivot to what the Penelow verdict means for compliance programs and risk management practices.

Jonathan Porter Biography

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Jonathan focuses on white collar criminal defense, federal investigations brought under the False Claims Act, and litigation against the government and whistleblowers, where he uses his experience as a former federal prosecutor to guide clients in sensitive and enterprise-threatening litigation. At the Department of Justice, Jonathan earned a reputation as a top white collar prosecutor and trial lawyer and was a key member of multiple international healthcare fraud takedowns and high-profile financial crime prosecution teams. He serves as a vice chair of the American Health Law Association’s Fraud and Abuse Practice Group and teaches white collar crime as an adjunct professor of law at Mercer University School of Law.

Tynan Kugler Biography

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Tynan is a Principal with PYA, P.C., a Certified Valuation Analyst (CVA), and a frequent speaker on valuations and related topics for various healthcare organizations. Her experience includes performing fair market value compensation analyses and valuations of medical practices and ancillary service lines for a variety of physician and hospital transactions. Additionally, her experience includes valuations specific to the life sciences industry, including key opinion leader (KOL) compensation and fee-for-service arrangements. Tynan also conducts provider needs analyses and strategic market assessments. She has more than two decades of healthcare consulting experience, and prior to rejoining PYA in 2007, spent several years assisting community hospitals/healthcare systems, academic medical centers, and physician groups with strategic planning related to the development of coordinated, comprehensive cancer programs. 

Mara Smith Kouba Biography

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Mara Smith Kouba, JD, MBA, MHA, is an attorney at Bristol Myers Squibb where she provides legal support for the company’s worldwide cardiovascular brand teams. She has spent her career developing an expertise in health and life sciences law. She is also an adjunct professor at Drexel University’s Kline School of Law, teaching courses on risk assessment and management and currently serves as the Vice Chair of Education for the American Health Law Association’s Life Sciences Practice Group, is on the Kline School of Law’s Health Law Program Advisory Board, and is a board member for the Come to Believe Network.