Expert Analysis

• 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.

• What To Know As Children's Privacy Law Rapidly Evolves

  

  If your business hasn't been paying attention to growing state and federal efforts to protect children online, now is the time to start — there is no sign of this regulation slowing down, and more aggressive enforcement actions are to be expected in the coming year, says Susan Rohol at Willkie Farr.

• Weight-Loss Drugs May Spur Next Major Mass Tort

  

  With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.

• Opinion

  OFAC Sanctions Deserve To Be Challenged Post-Chevron

  

  The U.S. Supreme Court's Loper Bright decision opens the door to challenges against the Office of Foreign Assets Control's sanctions regime, the unintended consequences of which raise serious questions about the wisdom of what appears to be a scorched-earth approach, says Solomon Shinerock at Lewis Baach.

• Tips For Lenders Offering Texas Home Equity Lines Of Credit

  

  As interest in home equity lines of credit increases, lenders seeking to utilize such products in Texas must be aware of state-specific requirements and limitations that can make it challenging to originate open-end lines of credit on homestead property, says Tye McWhorter at Polunsky Beitel.

• Behind The Delay Of Final HSR Premerger Filing Rules

  

  Erin Toomey at Epiq discusses the wait for the final version of the revised Hart-Scott-Rodino premerger filing requirements that were first introduced in June 2023, the factors that might be behind the delay, and how to plan for the potential data-focused rule change

• Opinion

  After Jarkesy, IRS Must Course-Correct On Captive Insurance

  

  The U.S. Supreme Court’s recent Securities and Exchange Commission v. Jarkesy decision has profound implications for other agencies, including the IRS, which must stop ignoring due process and curtailing congressional intent in its policing of captive insurance arrangements, says Peter Dawson at the 831(b) Institute.