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Expert Analysis

• A Shifting Trend In FDA Form 483 Disclosure Obligations

  

  A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.

• Lessons From 7th Circ.'s Deleted Chat Sanctions Ruling

  

  The Seventh Circuit’s recent decision in Pable v. Chicago Transit Authority, affirming the dismissal of an ex-employee’s retaliation claims, highlights the importance of properly handling the preservation of ephemeral messages and clarifies key sanctions issues, says Philip Favro at Favro Law.

• Mitigating Employer Liability Risk Under Sex Assault Rule

  

  The American Law Institute's newly approved rule expands vicarious liability to employers for certain sexual assaults that employees commit, which could materially increase employers' exposure unless they strengthen safeguards around high-risk roles, say attorneys at Morgan Lewis.

• Breaking Down The Proposed Hemp Bill

  

  A proposed bill in the U.S. House of Representatives, recently approved by the House Appropriations Committee, contains a rider that would significantly change the definition of hemp and dramatically reshape the current hemp-derived product market, say attorneys at King & Spalding.

• Series

  Quilting Makes Me A Better Lawyer

  

  Turning intricate patterns of fabric and thread into quilts has taught me that craftsmanship, creative problem-solving and dedication to incremental progress are essential to creating something lasting that will help another person — just like in law, says Veronica McMillan at Kramon & Graham.

• Lessons Learned 3 Years After First CCPA Enforcement Action

  

  Three years after the first public enforcement action under the California Consumer Privacy Act, Attorney General Rob Bonta has pursued a steady stream of enforcement actions across industries, providing a clearer picture of how the law is being interpreted and enforced, says Tatum Andres at Kilpatrick.

• How To Prep For Potential Passage Of SAFER Banking Act

  

  The Secure and Fair Enforcement Regulation, or SAFER, Banking Act, could fundamentally reshape how financial institutions interact with cannabis businesses, so operators that move now to get their house in order will be best positioned to capitalize if and when change comes, says Alex Leonowicz at Howard & Howard.

• The Future Of Lab-Test Regs After FDA Rescinds Rule

  

  The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

• What 2 Profs Noticed As Transactional Law Students Used AI

  

  After a semester using generative artificial intelligence tools with students in an entrepreneurship law clinic, we came away with numerous observations about the opportunities and challenges such tools present to new transactional lawyers, say professors at Cornell Law School.

• Rebuttal

  BigLaw Settlements Should Not Spur Ethics Deregulation

  

  A recent Law360 op-ed argued that loosening law firm funding restrictions would make BigLaw firms less inclined to settle with the Trump administration, but deregulating legal financing ethics may well prove to be not merely ineffective, but counterproductive, says Laurel Kilgour at the American Economic Liberties Project.

• Opinion

  8th Circ. Should Reaffirm False Commercial Speech's Nature

  

  The Eighth Circuit in Goldfinch Laboratory v. Iowa Pathology Associates should assert that false commercial speech is not categorically immune from antitrust scrutiny, says Daniel Graulich at the Federal Trade Commission.

• Unpacking Ore. Law's Limits On PE Healthcare Investment

  

  A recent Oregon law imposes significant restrictions on nonphysicians owning or controlling medical practices, but newly enacted amendments provide some additional flexibility in certain ownership arrangements without scuttling the law's intent of addressing concerns about the rise of private equity investment in healthcare, say attorneys at Debevoise.

• 5 Ways Lawyers Can Earn Back The Public's Trust

  

  Amid salacious headlines about lawyers behaving badly and recent polls showing the public’s increasingly unfavorable view of attorneys, we must make meaningful changes to our culture to rebuild trust in the legal system, says Carl Taylor at Carl Taylor Law.

• Criminal Healthcare Fraud Takeaways From 4th Circ. Reversal

  

  After the Fourth Circuit reversed a doctor’s postconviction acquittal in U.S. v. Elfenbein last month, defense attorneys should consider three strategies when handling complex criminal healthcare matters, says Jonathan Porter at Husch Blackwell.

• Opinion

  Furtive Changes To Federal Health Data Threaten Admissibility

  

  A recent study showing that nearly 100 U.S. federal health datasets have been modified this year without any notation in official change logs should concern plaintiffs counsel, defense counsel and judges alike — because undermining data's integrity, authenticity and chain of custody threatens its admissibility in litigation, say attorneys at Kershaw Talley.