Expert Analysis

• 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.

• AI May Help Patent Applicants With Functional Claiming

  

  The U.S. Supreme Court recently set what many patent practitioners consider too high a bar for functional claims, but artificial intelligence could alter functionality analysis — conferring predictability that alleviates courts' concerns that practicing the claims requires undue experimentation, say Brian Nolan and Ying-Zi Yang at Mayer Brown.

• 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.

• How Executives' Deposition Standards Can Differ

  

  The recent Trustees of Purdue University v. Wolfspeed Inc. decision granting a motion on a protective order for a high-level witness shows how courts can vary in the application of the apex doctrine and analysis under Rule 26 of the Federal Rule of Civil Procedure, say Genevieve Halpenny and John Cook at Barclay Damon.

• 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.

• Balancing Justice And Accountability In Opioid Bankruptcies

  

  As Rite Aid joins other pharmaceutical companies in pursuing bankruptcy following the onslaught of state and federal litigation related to the opioid epidemic, courts and the country will have to reconcile the ideals of economic justice and accountability against the U.S. Constitution’s promise of a fresh start through bankruptcy, says Monique Hayes at DGIM Law.

• How To Navigate The FTC's New Private Equity Frontier

  

  The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

• Opinion

  Newman Suspension Shows Need For Judicial Reform

  

  The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

• An Overview Of Congress' Proposed Drug Shortage Solutions

  

  Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

• Considerations And Calculations For DOJ Clawback Program

  

  The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.