Expert Analysis

• What Pharma Cos. Must Know About FDA Off-Label Guidance

  

  The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.

• It's Time To Prescribe Frameworks For AI-Driven Health Care

  

  As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.

• Opinion

  Air Ambulance Ch. 11s Show Dispute Program Must Resume

  

  Air Methods’ recent bankruptcy filing highlights the urgent need to reopen the No Surprises Act’s independent dispute resolution program for air ambulances, whose shutdown benefits insurance companies and hurts providers, says Adam Schramek at Norton Rose.

• Preparing For Higher Health Transaction Standards In Calif.

  

  The California Office of Health Care Affordability's revised draft regulations on the reporting of health care transactions incorporate useful improvements to the regulatory scheme, but also contain provisions that may cause concerns for parties contemplating covered transactions, says Andrew Demetriou at Husch Blackwell.

• How Ill. Supreme Court Could Shape Statutory Violation Cases

  

  In Fausett v. Walgreens, the Illinois Supreme Court will take up the question of whether a violation of the Fair and Accurate Credit Transactions Act satisfies the injury-in-fact requirement, and any outcome could significantly change the litigation landscape in Illinois, say Donald Patrick Eckler and Joshua Zhao at Freeman Mathis.

• Class Action Defense: Don't Give Up On Bristol-Myers Squibb

  

  Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.

• Pro Bono Work Is Powerful Self-Help For Attorneys

  

  Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.

• FDA Proposals Clarify Rules For Devices With Predicates

  

  As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.

• State Regs Sow Discord Between Cannabis, Hemp Industries

  

  Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.

• Series

  Playing In A Rock Cover Band Makes Me A Better Lawyer

  

  Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.

• How Int'l Regulatory Collabs Can Expedite Pharma Approvals

  

  Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.

• Series

  The Pop Culture Docket: Judge Espinosa On 'Lincoln Lawyer'

  

  The murder trials in Netflix’s “The Lincoln Lawyer” illustrate the stark contrast between the ethical high ground that fosters and maintains the criminal justice system's integrity, and the ethical abyss that can undermine it, with an important reminder for all legal practitioners, say Judge Adam Espinosa and Andrew Howard at the Colorado 2nd Judicial District Court.

• Calif. GHG Disclosure Law Will Affect Companies Worldwide

  

  California's Climate Corporate Data Accountability Act, which will require comprehensive greenhouse gas emissions disclosures from large companies operating in the state, will mean compliance challenges for a wide range of industries, nationally and globally, as the law's requirements will ultimately trickle out and down, say attorneys at Brownstein Hyatt.

• Questions Linger After FDA's Lab-Developed Tests Proposal

  

  The U.S. Food and Drug Administration's recently proposed rule regarding its plan to regulate lab-developed tests is light on details, leaving many fundamental questions about the agency's authority and ability to execute its plans, say attorneys at Covington.

• Lessons For Biosimilar And Biologic Antitrust Litigation

  

  Aaron Marks at Cohen Milstein considers emerging ways in which biosimilar markets differ from traditional small-molecule drug markets, and recommends how pharmaceutical antitrust litigators can account for these market dynamics in biosimilar-delay cases.