Expert Analysis

• Justices' Intent Witness Ruling May Be Useful For Defense Bar

  

  At first glance, the U.S. Supreme Court’s recent Diaz v. U.S. decision, allowing experts to testify to the mental state of criminal defendants in federal court, gives prosecutors a new tool, but creative white collar defense counsel may be able to use the same tool to their own advantage, say Jack Sharman and Rachel Bragg at Lightfoot Franklin.

• Eye On Compliance: New Pregnancy And Nursing Protections

  

  With New York rolling out paid lactation breaks and extra leave for prenatal care, and recent federal legislative developments enhancing protection for pregnant and nursing workers, employers required to offer these complex new accommodations should take several steps to mitigate their compliance risks, says Madjeen Garcon-Bonneau at Wilson Elser.

• How To Grow Marketing, Biz Dev Teams In A Tight Market

  

  Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.

• FTC Focus: Private Equity Investments In Healthcare

  

  As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.

• Jarkesy's Impact On SEC Enforcement Will Be Modest

  

  Though the U.S. Supreme Court’s recent U.S. Securities and Exchange Commission v. Jarkesy decision found that fraud defendants have a constitutional right to a jury trial, the ruling will have muted impact on the agency’s enforcement because it’s already bringing most of its cases in federal court, say Jeremiah Williams and Alyssa Fixsen at Ropes & Gray.

• Opinion

  Data Breach Reporting Requirements Must Change In AI Age

  

  Outdated data breach reporting laws are inadequate to protect consumers in the age of artificial intelligence, as AI’s ability to determine relationships coupled with its improvements to deepfake technology mean that the very definitions used in breach reporting laws are no longer sufficient, says Collin Walke at Hall Estill.

• Unpacking HHS' Opinion On Cell Therapy Refund Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

• New FARA Letters Offer Insight Into DOJ's Approach

  

  The U.S. Department of Justice's recently released batch of 15 advisory opinions from the Foreign Agents Registration Act Unit provides important guidance on FARA registration triggers and exemptions, underscoring the breadth of FARA's scope, says Tessa Capeloto at Wiley.

• Series

  Rock Climbing Makes Me A Better Lawyer

  

  Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.

• How 5 States' Deal Notification Laws Are Guiding Healthcare

  

  Healthcare transaction notification laws at various stages of implementation in California, Illinois, Indiana, Oregon and Washington are shaping sector mergers and acquisitions, with significant transparency, continuity of care and compliance implications as providers tackle complex regulatory requirements, says Melesa Freerks at DLA Piper.

• Think Like A Lawyer: Dance The Legal Standard Two-Step

  

  From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.

• Recent Settlement Shows 'China Initiative' Has Life After Death

  

  Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.

• Takeaways From Tossed Deal In Visa, Mastercard Class Action

  

  Given the rejection of a proposed deal in the long-running merchant antitrust class action against Visa and Mastercard in New York federal court, sweetening the proposed settlement pot likely will not be an option, leaving few possible outcomes including splitting the class and allowing opt-outs, say attorneys at Davis Wright.

• DOJ Innovasis Settlement Offers Lessons On Self-Disclosure

  

  The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.

• How Orange Book Antitrust Scrutiny Is Intensifying

  

  Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.