Category: Case Insights

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 […]

A Sword and A Shield: How SCOTUS Expert Testimony Rulings May Benefit Corporate Defendants

The US Supreme Court decided several criminal procedure cases during the 2023 – 2024 term – including Diaz v. United States, 144 S. Ct. 1727 (2024) and Smith v. Arizona, 144 S. Ct. 1785 (2024) – which have relevance and strategic value to corporate defense, despite being facially outside the […]

Federal Court Dismisses Bulk of SEC’s Complaint Against SolarWinds in Cyberattack Case

On July 18, 2024, US District Judge Paul Engelmayer of the Southern District of New York issued a detailed 107-page opinion and order dismissing most of the US Securities and Exchange Commission (SEC) case against SolarWinds and its chief information security officer (CISO). The SEC’s amended complaint alleged that SolarWinds and its […]

Fatal Flaws in SEC’s Amended Complaint Against SolarWinds

In March 2024, a coalition of more than 50 cybersecurity leaders and organizations called for dismissal of an amended complaint by the Securities and Exchange Commission (SEC) against SolarWinds and its chief information security officer (CISO), Tim Brown. Amici from the business community and the software industry, as well as […]

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 […]

Featured in Law360: Landmark Product Safety Prosecution May Signal Sea Change

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 (CPSA).  The jury verdict in U.S. v. Chu is the first-ever criminal conviction of corporate executives for failure to report under the […]

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. […]

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 […]

Bloomberg LP v. ZXC: Privacy Triumphs

The UK Supreme Court has handed down its highly anticipated judgment in the matter of Bloomberg LP v. ZXC [2022] UKSC 5. As we explained in our 16 February 2022 Cooley blog, the case highlighted the tension between the privacy interests of individuals under investigation who have not been charged with a crime and […]