Policy & Compliance

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.

• 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.

• 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.

• 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.

• 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.

• Where DOJ's Fraud Priorities Memo May Actually Matter

  

  The U.S. Department of Justice’s recently released memo outlining priorities for its newly created fraud division will shape how cases are identified, staffed and sequenced, meaning white collar defense work must begin earlier, say David Tarras at Tarras Defense and Trevor Jones at Dynamis.

• DOJ Healthcare Declination Offers Self-Disclosure Checklist

  

  The U.S. Department of Justice's declination of criminal charges against Campus Eye Management signals that its new self-disclosure policy provides a real path for healthcare companies to avoid criminal exposure, but that path is paved with speed, transparency and operational remediation, says Jonathan Porter at Husch Blackwell.

• Correctional Healthcare Requires Clearer Legal Standards

  

  As the correctional healthcare industry increasingly faces financial instability due to litigation, the U.S. Bureau of Prisons should develop clear standards for constitutionally adequate care for incarcerated patients, says Susanne Moore at Blackstone Trial Group.