Expert Analysis

• FDA Closeout Letter Suggests Relaxing Stance On Wearables

  

  The U.S. Food and Drug Administration's recent decision not to pursue enforcement action against Whoop's wearable blood pressure tracker, read together with guidance released earlier this year, suggests a softer shift in the FDA's approach to regulating wearables, say attorneys at Arnold & Porter.

• Justices' Hikma Reasoning May Extend Well Beyond Pharma

  

  The active steps framework announced by the U.S. Supreme Court in its Hikma v. Amarin decision, finding that Amarin failed to plausibly allege inducement of infringement, has the potential to reshape how courts evaluate inducement claims across patent, copyright and other doctrines, say attorneys at BCLP.

• Teva MDL Loss Shows DPAs Can Return To Haunt Civil Suits

  

  Teva’s recent partial summary judgment loss in antitrust multidistrict litigation reinforces the importance of carefully scrutinizing any statement of facts a company admits to in a deferred prosecution agreement, and illustrates the potential costs of resolving a criminal investigation this way, say attorneys at Sheppard.

• 11th Circ. FCA Qui Tam Revival Queues Up Next Challenges

  

  Though the Eleventh Circuit on Sept. 1 upheld the constitutionality of the False Claims Act's qui tam provision, it will probably face continued litigation since the appellate court declined to rule on other constitutional challenges and the decision will likely be petitioned to the U.S. Supreme Court, say attorneys at Sheppard.

• Prepping Health Businesses For Sale In A Data-Driven Market

  

  In a thinner market for healthcare transactions, with both regulators and buyers using artificial intelligence to inspect data in great detail, the margin for error in sellers' financials and legal diligence has narrowed, requiring more proactive compliance efforts, says Cody Dumas at FBFK Law.

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  Ballet Makes Me A Better Lawyer

  

  A lifetime of learning and performing ballet taught me that success — whether in dance or practicing law — comes only through hours of thorough preparation, boundless energy and relentless effort, says Sharon Katz-Pearlman at Greenberg Traurig.

• Rejection Of NLRB Successor Bar Renews An Employer Tool

  

  Although the D.C. Circuit's recent ruling in Hospital Menonita v. National Labor Relations Board does not allow purchasers to disregard incumbent unions, employers acquiring a unionized business have regained a tool to challenge a union's majority support, say attorneys at Bass Berry.

• NY Ethics Opinion Warns Attys On Qui Tam Deception

  

  A recent New York State Bar Association ethics opinion cautions that counsel representing whistleblowers may not induce, supervise or facilitate a client's deceptive prefiling investigations, creating a potential vulnerability for qui tam complaints built on questionable evidence-gathering methods, say attorneys at Sidley.

• DOJ Fraud Declination Highlights Self-Disclosure Tradeoffs

  

  As exemplified by the U.S. Department of Justice's declination of charges against Campus Eye Management under its new corporate enforcement policy, self-disclosure can be an attractive option for healthcare companies navigating criminal exposure, but should be weighed against potential costs, say attorneys at Morgan Lewis.

• Insurer Spoliation Ruling Flags Continuing Duty To Preserve

  

  An Illinois federal court’s recent decision to impose spoliation sanctions on the insurer in H.D. Smith v. Cincinnati Insurance provides practical guidance for navigating long-tail coverage litigation, underscoring the importance of evaluating preservation obligations in light of the full life cycle of a dispute, say attorneys at Morgan Lewis.

• What DOJ Fraud Division Rule Resolves, And What It Doesn't

  

  The U.S. Department of Justice’s recently published final rule answers many outstanding questions about the newly created National Fraud Enforcement Division, but overlapping mandates could result in parallel investigations and diverging viewpoints between multiple sets of prosecutors, say attorneys at Gibson Dunn.

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  Taekwondo Makes Me A Better Lawyer

  

  Taekwondo has taught me to recognize when to fight for a position and when to focus on finding a solution, and that the best outcomes are often achieved by solving problems — all of which has improved my work as a bankruptcy lawyer, mediator and Subchapter V trustee, says Amy Denton Mayer at Berger Singerman.

• Youth Center Investigation Shows Rising Governance Scrutiny

  

  A recent New Hampshire attorney general report following its investigation into the state's Sununu Youth Services Center shows how organizations serving vulnerable populations can face scrutiny of their governance, safety practices and preparedness, even when investigators find no abuse, say attorneys at Morgan Lewis.

• Target's ERISA Win Doesn't Ax Tobacco Surcharge Questions

  

  Though a Minnesota federal court's recent dismissal of a putative class action challenging Target's tobacco surcharge wellness program offers employers a defense road map, courts' differing conclusions about the Employee Retirement Income Security Act versus U.S. Department of Labor requirements leave the legal landscape unsettled, say attorneys at McGuireWoods.

• How 'Most Favored Nation' Regime Affects Biopharma Deals

  

  As M&A activity surges in the biopharma space, companies will need to account for the Trump administration's most-favored-nation pricing proposals — durable in concept, if unsettled in detail — when drafting deals, say attorneys at Gibson Dunn.