Tag: FDA/FDCA
DOJ Targets Failure to Report Adverse Events: Lessons From the ExThera Enforcement Action
In March 2026, the US Department of Justice (DOJ) announced criminal charges against medical device company ExThera Medical Corporation and its former chief regulatory officer for allegedly concealing patient deaths associated with the company’s experimental blood filtration device. The case highlights a familiar, but often underappreciated, risk area for life […]
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson1 upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices […]
Proceed With Caution: Federal Courts of Appeal Uphold Criminal Convictions for Misbranding Violations Under FDCA
Voluntary compliance may be the backbone of the Federal Food, Drug, and Cosmetic Act (FDCA), but when the US government believes that a company is unwilling or unable to achieve compliance, it will seek to enforce the FDCA both civilly and criminally. Two recent cases reaffirm that the federal government […]
Parallel SEC, FDA Regulatory Enforcement: What Life Sciences Companies Should Know
Life sciences companies, take note: While parallel enforcement by the Securities and Exchange Commission (SEC) and the Food and Drug Administration (FDA) is not new, it appears to be gaining favor among regulators. Cooley partners Luke Cadigan and Sonia Nath recently co-authored an article in the Food and Drug Law […]
DOJ Previews Enforcement Policies Aimed at Clinical Trial Fraud
On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice.