Expert Analysis

• FDA Warning Letter Tightens Reins On 'Research Only' Labels

  

  A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

• Opinion

  Seafarer Detention Under Ship Pollution Law Must Have Limits

  

  The U.S. Coast Guard should reinstate limits on the number of days that foreign crew members may be forced to remain in the country while the U.S. Department of Justice investigates alleged violations of shipping pollution laws, in order to balance legitimate enforcement interests and seafarer welfare, say attorneys at Blank Rome.

• Perspectives

  Justices' Forfeiture Ruling Resolves Nonexistent Split

  

  The U.S. Supreme Court’s decision in McIntosh v. U.S., holding that a trial court’s failure to enter a preliminary criminal forfeiture order prior to sentencing doesn’t bar its entry later, is unusual in that it settles an issue on which the lower courts were not divided — but it may apply in certain forfeiture disputes, says Stefan Cassella at Asset Forfeiture Law.

• Behind Indiana's Broad New Healthcare Transactions Law

  

  The high materiality threshold in Indiana's recently passed healthcare transaction law, coupled with the inclusion of private equity in its definition of healthcare entities, makes it one of the broadest state review regulations to date, say attorneys at DLA Piper.

• What Cos. Are Reporting Under New SEC Cybersecurity Rule

  

  Four months after its effective date, 14 companies have made disclosures under the U.S. Securities and Exchange Commission's mandatory cybersecurity incident reporting rule, and some early trends are emerging, including a possible rush to file, say attorneys at Debevoise.

• Opinion

  SC's Courts Have It Wrong On Amazon Marketplace Sales Tax

  

  The South Carolina Supreme Court should step in and correct the misguided change in tax law effectuated by lower court rulings that found Amazon owes state sales tax for marketplace sales made prior to the U.S. Supreme Court’s Wayfair v. South Dakota decision in 2018, says Hayes Holderness at the University of Richmond.

• What's In OCC's Proposed Freedom Of Information Act Update

  

  In this article, Christine Docherty at Goodwin discusses the Office of the Comptroller of the Currency's proposed amendments to its regulations implementing the Freedom of Information Act, and how these changes might align with guidance from other regulators.

• Assigning Liability In Key Bridge Collapse May Be Challenging

  

  In the wake of a cargo ship's collision with Baltimore's Key Bridge last month, claimants may focus on the vessel's owners and the agencies responsible for the design and maintenance of the bridge — but allocating legal liability to either private or governmental entities may be difficult under applicable state and federal laws, says Clay Robbins at Wisner Baum.

• Highlights From The 2024 ABA Antitrust Spring Meeting

  

  U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.

• What FERC's Disclosure Demands Mean For Cos., Investors

  

  Two recent Federal Energy Regulatory Commission orders reflect the commission's increasingly meticulous approach to reviewing corporate structures in applications for approval of proposed consolidations, acquisitions or changes in control — putting the onus on the regulated community to track and comply with ever-more-burdensome disclosure requirements, say attorneys at Willkie.

• IRS Sings New Tune: Whistleblower Form Update Is Welcome

  

  In a significant reform at the Internal Revenue Service's Whistleblower Office, the recently introduced revisions to the Form 211 whistleblower award application use new technology and a more intuitive approach to streamline the process of reporting allegations of tax fraud committed by wealthy individuals and companies, says Benjamin Calitri at Kohn Kohn.

• Strategies For Challenging A Fla. Grand Jury Report's Release

  

  A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

• Macquarie Ruling Raises The Bar For Securities Fraud Claims

  

  The U.S. Supreme Court's decision last week in Macquarie Infrastructure v. Moab Partners — holding that a U.S. Securities and Exchange Commission rule does not forbid omissions in company disclosures unless they render other statements false — is a major setback for plaintiffs pursuing securities fraud claims against corporations, say attorneys at Skadden.

• Tenn. Law Protecting Artists From AI Raises Novel Issues

  

  Tennessee recently enacted a law that extends the right of publicity protection to individuals' voices in an attempt to control the proliferation of artificial intelligence in the music industry, presenting fascinating questions about the First Amendment, the fair use doctrine and more, say attorneys at Davis Wright.

• Consumer Privacy Takeaways From FTC Extraterritorial Action

  

  With what appears to be its first privacy-related consent agreement with a non-U.S. business, the Federal Trade Commission establishes that its reach is extraterritorial and that consumer internet browsing data is sensitive data, and there are lessons for any multinational business that handles consumer information, say Olivia Greer and Alexis Bello at Weil.