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.

• Biosolid Contaminants Spawn Litigation, Regulation Risks

  

  While nutrient-rich biosolids — aka sewage sludge — can be an attractive fertilizer, pending legislation and litigation spurred by the risk of contamination with per- and polyfluoroalkyl substances and other pollutants should put stakeholders in this industry on guard, say attorneys at K&L Gates.

• When Misconduct Can Trigger Bank Industry Employment Ban

  

  The Federal Reserve Board recently settled an enforcement action in which a former employee of a Wyoming bank was banned from banking for conduct she allegedly committed at an entity unrelated to the bank, raising questions about the scope of regulatory enforcement authority, says Travis Nelson at Polsinelli.

• Filing Clarifies FTC, DOJ's Passive Investment Stance

  

  The antitrust agencies' statement of interest filed in Texas v. Blackrock clarifies that certain forms of corporate governance engagement are permissible under the "solely for investment" exemption, a move that offers guidance for passive investors but also signals new scrutiny of coordinated engagement, say attorneys at Stinson.

• 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.

• Opinion

  Aviation Watch: Liability Lessons From 737 Max Blowout

  

  The National Transportation Safety Board's recently released report on the 2024 door plug blowout on board a Boeing 737 Max airliner helps illuminate how a company's strategic mistakes can lead to flawed decision-making and supply chain oversight failures, ultimately increasing regulatory and legal exposure, says Alan Hoffman, a retired attorney and aviation expert.

• 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.

• Genius Act Sets Stablecoin Standards — Without Regulation E

  

  While the Genius Act expressly requires payment stablecoin issuers to be treated as financial institutions for purposes of the Bank Secrecy Act, it is notably silent as to whether they are to be treated as such under the Electronic Fund Transfer Act, as implemented by Regulation E, says Tom Witherspoon at Stinson.

• Divest Order Shows How Security Fears Extend CFIUS Scope

  

  A recent White House order forcing a Chinese company to divest its 2020 acquisition of a U.S. audiovisual supplier demonstrates the Committee on Foreign Investment in the United States’ growing power to sink foreign transactions over national security concerns — and the enormous risks to U.S. companies from such reviews, say attorneys at Bass Berry.

• Art Market Must Prepare For More AML Scrutiny

  

  Calls for art market regulation continue to grow, as evidenced by a recently introduced bill that would subject it to the Bank Secrecy Act’s anti-money laundering requirements, so participants should consider adopting basic, risk-based controls, says Jane Levine at The ArtRisk Group.

• 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.

• 2 Appellate Rulings Offer Clickwrap Enforcement Road Map

  

  Two recent decisions from the Fourth and Eleventh Circuits in cases involving Experian signal that federal appellate courts are recognizing clickwrap agreements' power in spite of their simplicity, and offer practical advice on how companies can sufficiently demonstrate notice and assent when attempting to enforce contractual terms, says Brian Willett at Saul Ewing.

• How Tariffs Can Affect Event Studies In Securities Litigation

  

  When the control period is calm and the event window is stormy — often the case with breaking political or economic developments, like President Donald Trump's recent tariff announcements — traditional event study methodology can increase the risk of misleading conclusions in securities litigation, say economic consultants at NERA.

• 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.