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.

• 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.

• Perspectives

  Advocating For Disability Rights In Probation And Parole

  

  While the U.S. continues to over-police people with disabilities, defense attorneys can play a crucial role in ensuring that clients with disabilities who are on probation or parole have access to the accommodations they need and to which they are legally entitled, says Allison Frankel at the ACLU.

• 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.

• 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.

• Patent Lessons From 8 Federal Circuit Reversals In March

  

  A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

• First 10b5-1 Insider Trading Case Raises Compliance Issues

  

  The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.

• A Look At Ex Parte Seizures 8 Years Post-DTSA

  

  In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.

• Series

  Whitewater Kayaking Makes Me A Better Lawyer

  

  Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.

• AI In The Operating Room: Liability Issues For Device Makers

  

  As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.

• This Earth Day, Consider How Your Firm Can Go Greener

  

  As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.

• The Shifting Landscape Of Physician Disciplinary Proceedings

  

  Though hospitals have historically been able to terminate doctors' medical staff privileges without fear of court interference, recent case law has demonstrated that the tides are turning, especially when there is evidence of unlawful motivations, say Dylan Newton and Michael Horn at Archer & Greiner.

• Benzene Contamination Concerns: Drugmakers' Next Steps

  

  After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.

• Policy Misrepresentations Carry Insurance Rescission Risks

  

  The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.

• How DEI Programs Are Being Challenged In Court And Beyond

  

  In the wake of the U.S. Supreme Court's affirmative action decision last year declaring the consideration of race in university admissions unconstitutional, employers should keep abreast of recent litigation challenging diversity, equity and inclusion training programs, as well as legislation both supporting and opposing DEI initiatives in the workplace, say attorneys at Skadden.