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Ninth Circuit Ruling in FCA Case Predicated on 340B Pricing Violations Has Significant Implications for Pharma Manufacturers 

By Craig B. Bleifer, Michael J. Podberesky & Jessica L. Vaughn, Ph.D. on April 6, 2026
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On March 17, 2026, the U.S. Court of Appeals for the Ninth Circuit issued a significant opinion in United States ex rel. Adventist Health System of West v. AbbVie Inc., reversing the district court’s dismissal of a qui tam complaint brought under the False Claims Act (FCA) against four major drug manufacturers. The Ninth Circuit held that the FCA provides an independent mechanism for relators to bring claims alleging fraudulent drug pricing in violation of the Public Health Service Act’s Section 340B Program, even though Section 340B does not provide a private right of action.

Read on to learn more about the ruling and its important implications for pharmaceutical manufacturers participating in the Section 340B Program.

Photo of Craig B. Bleifer Craig B. Bleifer

Craig is a seasoned healthcare executive, previously serving as general counsel for two major pharmaceutical companies, Novo Nordisk and Daiichi Sankyo. With over 30 years as a corporate and life sciences lawyer, he provides counsel on legal, compliance, policy, and regulatory issues related…

Craig is a seasoned healthcare executive, previously serving as general counsel for two major pharmaceutical companies, Novo Nordisk and Daiichi Sankyo. With over 30 years as a corporate and life sciences lawyer, he provides counsel on legal, compliance, policy, and regulatory issues related to healthcare products and businesses. He provides strategic advice based on his practical real-world experiences, spanning discovery to commercialization.

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Photo of Michael J. Podberesky Michael J. Podberesky

Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-leader of the firm’s Healthcare Litigation and Enforcement Practice Group. Employing his…

Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-leader of the firm’s Healthcare Litigation and Enforcement Practice Group. Employing his extensive experience with False Claims Act cases in the healthcare and defense sectors, Michael represents clients confronting high-stakes government investigations and litigation arising from allegations of healthcare and procurement fraud and also counsels clients regarding compliance issues.

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Photo of Jessica L. Vaughn, Ph.D. Jessica L. Vaughn, Ph.D.

Jessica provides clients with legal and regulatory support to life sciences companies, focusing on pharmaceuticals, medical devices, cosmetics, food products and dietary supplements. With an advanced scientific degree in toxicology and experience as an in-house counsel at a global biotechnology company, Jessica provides…

Jessica provides clients with legal and regulatory support to life sciences companies, focusing on pharmaceuticals, medical devices, cosmetics, food products and dietary supplements. With an advanced scientific degree in toxicology and experience as an in-house counsel at a global biotechnology company, Jessica provides unique insight into pharmaceutical and medical device matters.

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  • Posted in:
    Banking, Finance and Securities
  • Blog:
    Subject to Inquiry
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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