Expert Analysis

• CMS Rule, DOJ Probes Deepen Gender Care Compliance Risk

  

  The Centers for Medicare & Medicaid Services' final rule restricting Medicaid funding for hospitals that provide gender-affirming care is likely to face immediate litigation, but the CMS rulemaking is already working alongside U.S. Department of Justice's enforcement campaign to create operational risk for providers, say attorneys at Arnall Golden.

• 5th Circ. Ruling Hints At Loper Bright's Effect On OSHA Suits

  

  The Fifth Circuit's recent decision in Exxon Mobil v. Occupational Safety and Health Review Commission relied on Loper Bright to narrow the scope of illnesses that employers must record, signaling that courts may continue to scrutinize agency assertions that deference is due, say attorneys at Ogletree.

• 2 Cases Shed Light On Invoking The 5th Before Congress

  

  Given the anticipated increase in congressional investigations following the midterm elections, those who anticipate being in Congress' spotlight can draw valuable Fifth Amendment lessons from the ongoing case involving Dr. Anthony Fauci's testimony and the D.C. Circuit’s recent ruling in de la Torre v. Cassidy, say attorneys at King & Spalding.

• Intersecting Investigation Risks Loom In Next Congress

  

  Taken together, two July D.C. Circuit decisions and a recent U.S. Department of Justice opinion on executive privilege may affect the procedural defenses and privilege protections available to targets of oversight in the upcoming Congress, and companies should begin preparing now, say attorneys at WilmerHale.

• Vanda Ruling Offers New Guide To Generic Labeling Disputes

  

  The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration is significant for its guidance on when generic-drug labeling remains sufficiently similar to brand labeling and when a difference requires a statutory exception, says Shashank Upadhye at Upadhye Tang.

• Attorneys Using AI May Have Ethical Duty To Redact Docs

  

  The trajectory of legal ethics guidance in recent years strongly suggests that as redaction technology becomes more accessible, the failure to use it when uploading highly confidential materials into artificial intelligence tools will become increasingly difficult to defend as reasonable, say attorneys at Lewis Brisbois.

• Cannabis, Psychedelics Boom Raises IP Hurdles

  

  Recent data regarding patent filing activity and litigation in the cannabis and psychedelics markets indicates that as commercial interest accelerates, the scope of publicly accessible prior art is also expanding, setting a higher bar for novelty and nonobviousness in patent applications, say attorneys at Sterne Kessler.

• 5 Practice Tips After DOJ's Healthcare Fraud Declination

  

  In light of the U.S. Department of Justice's decision to not prosecute Campus Eye Management under the agency's new corporate enforcement and voluntary self-disclosure policy, healthcare companies should keep several considerations in mind when weighing their risk and self-disclosure strategy, including the distinctions between reporting to the DOJ versus other government agencies, say attorneys at Haynes Boone.

• Bid Protest Spotlight: GAO Lessons For Small Biz Contractors

  

  In this month's bid protest roundup, Alissandra McCann at MoFo offers small business takeaways from three recent U.S. Government Accountability Office decisions about rule-of-two challenges, joint ventures maintaining service-disabled, veteran-owned small business certifications, and joint venture and teaming arrangement eligibility distinctions.

• State AI Safety Laws Raise New Liabilities For Healthcare Cos.

  

  Healthcare and life science companies using third-party artificial intelligence tools should pay particular attention to the changing state-level legal landscape, where the rollout of multiple AI safety laws is introducing both new compliance obligations and potential consumer protection liabilities, say attorneys at McDermott.

• Series

  Juggling And Unicycling Make Me A Better Lawyer

  

  Because I juggle (sometimes with fire) and ride the unicycle, friends and family used to joke that I should join the circus, but I pursued the practice of law instead and learned that my hobbies benefit my profession in several important ways, says Morgan Eddy at Smith Currie.

• 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.