Life Sciences

Expert Analysis

• A Holistic Approach To Compliance For Cannabis Cos.

  

  Effectively running a multistate cannabis business requires a dedicated commitment to developing and maintaining a robust regulatory enterprise risk management system involving legal compliance, finance, operations and technology, says Gary Kaminsky of Acreage Holdings.

• 3 Lessons From A Crypto Mock Trial

  

  We recently hatched a plan to test whether litigators could get blockchain ledger entries into evidence under the existing Federal Rules of Evidence, and we found a federal judge willing to help us, say attorneys Justin Steffen, Andrew Hinkes, Lisa Braganca, Christopher Veatch, Kashan Pathan and Jimmie Zhang.

• Arizona High Court Puts Stengel Claims In Doubt

  

  In its recent rejection of the Ninth Circuit’s key 2013 holding in Stengel v. Medtronic, the Arizona Supreme Court gave new hope to defendants arguing that state law failure-to-warn claims are preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act, say Colleen McElroy and Brendan Krasinski of DLA Piper LLP.

• HHS Is Embracing A Broader Vision Of Health Care

  

  In the last month, divisions of the U.S. Department of Health and Human Services have taken three separate actions that collectively reflect continuing interest in facilitating high-value care delivery that goes far beyond traditional models, say attorneys at Ropes & Gray LLP.

• Explainability: Where AI And Liability Meet

  

  There is a commercial imperative to illuminate the mystery of artificial intelligence. Doctors are hard-pressed to rely on machine recommendations that contradict their own medical judgment without a clear explanation, and banks cannot rely on lending algorithms that may be discriminating against classes of borrowers through hidden variables, says Danny Tobey of DLA Piper LLP.

• Q&A

  A Chat With McDermott COO John Yoshimura

  

  In this monthly series, Amanda Brady of Major Lindsey & Africa interviews management from top law firms about the increasingly competitive business environment. Here we feature John Yoshimura, chief operating officer at McDermott Will & Emery LLP.

• Opinion

  The Problem With 'Optimal' Diversity

  

  Organizations should seek to avoid discrimination, but they should also be wary of the idea that diverse teams function better than nondiverse teams, because this reasoning lacks evidence and can lead to a slippery slope, says J.B. Heaton of J.B. Heaton Research LLC.

• Opinion

  Gov't Opioid Suits Hide Attorneys' Personal Interests

  

  Personal injury lawyers have set their sights on America’s pharmaceutical companies and opioid distributors, which they blame for a national health crisis. The cases these lawyers initiate may bear the names of states and municipalities, but are driven by law firms' pursuit of huge contingency fees, says Sherman Joyce of the American Tort Reform Association.

• A First Look At New HHS Prescription Drug Safe Harbors

  

  The U.S. Department of Health and Human Services' recent proposal to update the prescription drug discount safe harbor does not directly affect the price-setting activities of pharmaceutical manufacturers, but instead appears designed to affect prices indirectly by increasing transparency, say attorneys with Ropes & Gray LLP.

• Reasons To Limit Inventor Testimony In Hatch-Waxman Cases

  

  Inventor testimony inevitably forms a part of every generic drug company’s case in a Paragraph IV obviousness challenge under the Hatch-Waxman Act. This is odd because recent cases demonstrate that inventor testimony can damage a generic defendant’s case, says Michael Hogan of Caesar Rivise PC.