Expert Analysis

• Key Takeaways From FDA Final Rule On Lab-Developed Tests

  

  Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

• Bankruptcy Courts Have Contempt Power, Del. Case Reminds

  

  A Delaware bankruptcy court recently held Camshaft Capital and its principal in contempt, serving as a reminder to bankruptcy practitioners and anyone else that appears before a bankruptcy judge that there are serious consequences for failing to comply with court orders, say Daniel Lowenthal and Kimberly Black at Patterson Belknap.

• Measuring Early Impact Of Rule 702 Changes On Patent Cases

  

  Since Federal Rule of Evidence 702 was amended to clarify the standards for admitting expert witness testimony five months ago, emerging trends in patent cases suggest that it may be easier to limit or exclude expert testimony, and hold key practice takeaways for attorneys, say Manuel Velez and Nan Zhang at Mayer Brown.

• Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures

  

  The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.

• 8 Legal Issues Influencing Investors In The Creator Economy

  

  The rapidly expanding digital creator economy — funding for which more than doubled in the U.S. in the first quarter — comes with its own set of unique legal issues investors must carefully consider before diving in, say Louis Lehot and Alan Pate at Foley & Lardner.

• Key Antitrust Class Certification Questions Remain Unclear

  

  The U.S. Supreme Court, by recently rejecting certiorari in Visa v. National ATM, turned down the opportunity to clarify how to analyze disputed evidence bearing on the certification of antitrust class actions, leaving the applicable standards unclear instead of resolving this split of authority, says Jonathan Berman at Jones Day.

• Action Steps To Address New Restrictions On Outbound Data

  

  Companies should immediately assess all their data-based operations so they can consider strategies to effectively mitigate new compliance risks brought on by recently implemented transaction restrictions, including a Justice Department proposal and landmark data legislation, say attorneys at Wiley.

• E-Discovery Quarterly: Recent Rulings On Text Message Data

  

  Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.

• CFPB Reality Check: Video Game Cash Is Still Money

  

  The Consumer Financial Protection Bureau's recent report examining payments within online video games indicates that financial services offered within the game marketplace are quickly evolving to the point where they are indistinguishable from traditional financial services subject to regulation, say attorneys at Sheppard Mullin.

• How Copyright Office AI Standards Depart From Precedent

  

  The U.S. Copyright Office's recent departure from decades of precedent for technology-assisted works, and express refusal to grant protection to artificial intelligence-assisted works, may change as the dust settles around ancillary copyright issues for AI currently pending in litigation, says Kristine Craig at Hanson Bridgett.

• IP Considerations For Companies In Carbon Capture Sector

  

  As companies collaborate to commercialize carbon capture technologies amid massive government investment under the Infrastructure Investment and Jobs Act, a coherent intellectual property strategy is more important than ever, including proactively addressing and resolving questions about ownership of the technology, say Ashley Kennedy and James De Vellis at Foley & Lardner.

• Keeping Up With Class Actions: A New Era Of Higher Stakes

  

  Corporate defendants saw unprecedented settlement numbers across all areas of class action litigation in 2022 and 2023, and this year has kept pace so far, with three settlements that stand out for the nature of the claims and for their high dollar amounts, says Gerald Maatman at Duane Morris.

• Does Expert Testimony Aid Preliminary IPR Responses?

  

  Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

• Are Concessions In FDA's Lab-Developed Tests Rule Enough?

  

  Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

• 8 Questions To Ask Before Final CISA Breach Reporting Rule

  

  The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.