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 […]
DOJ Announces New Safe Harbor Policy for Voluntary Self-Disclosure in M&A
The Department of Justice continues to make clear that one of its principal corporate enforcement priorities is encouraging companies to voluntarily self-disclose misconduct. To that end, the DOJ recently announced its decision to decline to prosecute Lifecore Biomedical, a pharmaceutical and medical device manufacturer, despite evidence that employees of Lifecore’s […]
When Are Redactions Reasonable?
The long-running investigation by the Serious Fraud Office (SFO) into Eurasian Natural Resources Corporation (ENRC) has provided several points of instructive guidance during its lifetime – and that trend looks set to continue. The most recent matter before the High Court[1] examined certain redactions the SFO made to a report it […]
Are You Really Prepared to Prevent Fraud?
In a landmark day for regulatory authorities in the United Kingdom, the Economic Crime and Corporate Transparency Act came into force on 26 October 2023. The act will have a material impact on the manner in which the authorities combat money laundering, fraud and other economic crimes within the jurisdiction. […]
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 […]
Are Courts Reining in Causation and Remuneration in False Claims Act and Anti-Kickback Cases?
In US ex rel. Martin v. Hathaway, the US Court of Appeals for the Sixth Circuit joined the US Court of Appeals for the Eighth Circuit in requiring False Claims Act (FCA) plaintiffs to establish a direct causal relationship between alleged kickbacks and specific healthcare claims. This decision widens an […]
Failing to Prepare is Preparing to Fail: UK Government Proposes ‘Failure to Prevent Fraud’ Corporate Criminal Offence
Economic crime has risen to such a level in the United Kingdom that UK Finance, a trade association for the UK banking and financial services sector, considers financial fraud to be a ‘national security threat’. More than £750 million was stolen from banking customers by fraudsters in the first half […]