Expert Analysis

• Opinion

  New CMS Medical Device Pathway May Have Limited Effect

  

  The Centers for Medicare & Medicaid Services' new pathway for giving Medicare beneficiaries earlier access to certain medical devices bears similarities to previous programs that did not advance coverage significantly, and thus may only benefit certain manufacturers, say attorneys at King & Spalding.

• A Road Map To Modernizing Clinical Lab Regulations

  

  The Centers for Medicare & Medicaid Services' recent request for comments on potential changes to the Clinical Laboratory Improvement Amendments provides an early indication of where CLIA is headed, and the operational, compliance, reimbursement and enforcement issues those changes will create, says Jose Vela at Clark Hill.

• How GCs Can Assess The Risks Of Emerging AI Laws

  

  Amid a swirl of momentous legislative activity aimed at regulating artificial intelligence, general counsel must return to first principles when determining whether new laws will apply and whether the company’s use could cause regulators to subject it to additional regulation, say attorneys at WilmerHale.

• Ch. 11 Ruling Offers A Drafting Guide For 3rd-Party Releases

  

  A recent Puerto Rico bankruptcy court decision in Grupo Hima San Pablo has provided important guidance and a concrete playbook for drafting consensual third-party releases following the U.S. Supreme Court's 2024 decision in Harrington v. Purdue Pharma, say attorneys at Eversheds Sutherland.

• Harvard Morgue Deal Shows Stakes Of Good Faith Immunity

  

  Harvard's recent $53 million payment to settle lawsuits concerning body part thefts from its medical school morgue spotlights the state’s Uniform Anatomical Gift Act, which only extends good faith immunity to anatomical donation stakeholders if certain conditions are met, says Christina Strong at Dilworth Paxson.

• 2nd Circ. Tylenol MDL Ruling Clarifies Court Gatekeeper Role

  

  The Second Circuit’s recent decision in multidistrict litigation over alleged links between Tylenol and developmental disorders, holding that the trial court improperly excluded expert witnesses, preserves meaningful judicial gatekeeping while making clear that judges may not resolve legitimate scientific disputes themselves, say attorneys at Lowenstein Sandler.

• Series

  Law School's Missed Lessons: Cultivating Good Judgment

  

  Law schools generally overlook the role that solid judgment skills play in real-world practice, but attorneys can bridge the gap by strengthening their abilities to assess a case’s strengths and weaknesses, develop and execute effective strategies, and provide clear recommendations to clients, says Manny Caixeiro at Venable.

• 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.