Expert Analysis

• 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.

• High Court's Expert Ruling May Help Health Fraud Defendants

  

  The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.

• Patent Lessons From 5 Federal Circuit Reversals In June

  

  A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

• 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.

• 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.

• Contract Disputes Recap: Preserving Payment Rights

  

  Stephanie Magnell and Zachary Jacobson at Seyfarth examine three recent decisions that together illustrate the importance of keeping accurate records and adhering to contractual procedures to avoid inadvertently waiving contractual rights to cost reimbursements or nonroutine payments.

• 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.

• 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.

• 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.

• Bid Protest Spotlight: Standing, Prejudice, Conflicts

  

  In this month's bid protest roundup, Caitlin Crujido at MoFo examines three recent decisions from the U.S. Government Accountability Office concerning whether a would-be protestor was an interested party with standing, whether an agency adequately investigated potential procurement violations and whether a proposed firewall sufficiently addressed an impaired objectivity organizational conflict of interest.