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 […]
The Jury Has Spoken: Two Executives Convicted in Groundbreaking Consumer Product Safety Prosecution
Editor’s note: Authored by Daniel Grooms, Matt Howsare and Shawn Skolky, this article was originally published in Law360. In November 2023, a jury convicted two corporate executives of conspiracy and failure to report information about defective residential dehumidifiers, as required by the Consumer Product Safety Act.[1] The jury verdict in U.S. […]
SEC Announces FY23 Enforcement Results –Record-Breaking Whistleblower Awards, Focus on Individual Accountability, Self-Reporting, and Cooperation Credit
The Securities and Exchange Commission (SEC) recently announced its enforcement results for fiscal year 2023, which reported a total of 784 enforcement actions, up 3% from FY22. This includes 501 original (stand-alone) enforcement actions, an 8% increase from last year. The SEC also barred 133 individuals from serving as officers and […]
Marketing of Cryptoassets – UK’s Financial Conduct Authority Issues ‘Final Warning’
Regardless of whether you are in the UK, or the type of technology you use, companies marketing ‘qualifying cryptoassets’ to customers in the UK will need to comply with the financial promotions regime of the Financial Conduct Authority (FCA), the UK’s financial regulator. These measures will have a significant impact […]
Supreme Court Rules FCA Liability Turns on Subjective Belief, Not Objective Reasonableness
Key takeaways In a much-anticipated opinion released on June 1, 2023, the US Supreme Court held that the scienter element of the False Claims Act (FCA) turns on the defendant’s “knowledge and subjective beliefs” – not on “what an objectively reasonable person may have known or believed.” The unanimous decision […]