03 August 2022

DOJ Renews Interest in Fraud-on-the-FDA Theory

Over the past decade, whistleblowers have attempted to expand the long-established fraudulent inducement theory of FCA liability into a novel fraud-on-the-FDA theory of FCA liability.  DOJ embraced the theory during the Obama administration, but its enthusiasm became muted during the Trump administration.  DOJ now appears to have once again revisited its position, and DOJ’s renewed interest in supporting the viability of this theory may further encourage relators to advance these arguments in court, and may even preview DOJ’s willingness to intervene and litigate such a case.  In a recent Law360 article entitled DOJ’s Fraud-On-The-FDA Liability Theory is Problematic, Sidley lawyers Jaime Jones, Brenna Jenny, and Krystalyn Weaver discuss the weaknesses in DOJ’s theory of liability, the latest caselaw developments, and how life sciences companies can mitigate enforcement risk.

A copy of the article is available here.

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