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Expert Analysis

• FDA's Hasty Policymaking Approach Faces APA Challenges

  

  Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

• DOJ Crypto Enforcement Is Shifting To Target Willfulness

  

  Three pending criminal prosecutions could be an indication of how the U.S. Department of Justice's recent digital assets memo is shaping enforcement of the area, and show a growing focus on executives who knowingly allow their platforms to be used for criminal conduct involving sanctions offenses, say attorneys at Gibson Dunn.

• Legal Considerations Around Ibogaine As Addiction Therapy

  

  Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.

• Unpacking DOJ's Suit Against Maryland Federal Bench

  

  Political hoopla aside, the Trump administration’s suit naming the Maryland federal district court and all of its judges, which challenges a standing order that delays deportation upon the filing of a habeas petition, raises valid questions about both the validity of the order and the DOJ’s approach, says Steven Gordon at Holland & Knight.

• What Calif. Insurance Ruling Means For Smoke Damage Limits

  

  As California continues to grapple with an increasing number of wildfire claims, a state court's recent Aliff v. California FAIR Plan decision serves as a clear directive to insurers that policy language that narrows the scope of fire coverage below the California Insurance Code's minimum standards is impermissible, say attorneys at Wood Smith.

• Wash. Law Highlights Debate Over Unemployment For Strikers

  

  A new Washington state law that will allow strikers to receive unemployment benefits during work stoppages raises questions about whether such laws subsidize disruptions to the economy or whether they are preempted by federal labor law, says Daniel Johns at Cozen O'Connor.

• Why SEC Abandoned Microcap Convertible Debt Crackdown

  

  The U.S. Securities and Exchange Commission has recently dismissed several cases targeting microcap convertible debt lenders, a significant disavowal of what was a controversial enforcement initiative under the Biden administration and a message that the new administration will focus on clear fraud, say attorneys at O'Melveny.

• Justices' Resentencing Ruling Fortifies First Step Act Tools

  

  The U.S. Supreme Court’s recent Hewitt v. U.S. ruling clarifies that resentencing after vacatur must reflect the law in effect at the time of the new sentencing, ultimately strengthening the strategic tools available to defense attorneys under the First Step Act, says Benson Varghese at Varghese Summersett.

• The Metamorphosis Of The Major Questions Doctrine

  

  The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

• A Rapidly Evolving Landscape For Noncompetes In Healthcare

  

  A wave of new state laws regulating noncompete agreements in the healthcare sector, varying in scope, approach and enforceability, are shaped by several factors unique to the industry and are likely to distort the market, say attorneys at Seyfarth.

• New PTAB Denial Processes Grow More And More Confusing

  

  Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.

• Arguing The 8th Amendment For Reduction In FCA Penalties

  

  While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.

• GENIUS Act Creates 'Commodity' Uncertainty For Stablecoins

  

  Half a century ago, Congress made trading in onion futures on commodity exchanges unlawful, and payment stablecoins could soon face a similarly unstable fate in the markets as the GENIUS Act heads to the president's desk for signature, says Peter Malyshev at Cadwalader.

• EU Space Act Could Stifle US Commercial Operators

  

  The EU Space Act, proposed last month, has the potential to raise global standards for safety and sustainability in space, but the U.S. and EU need to harmonize their regulatory approaches to avoid imposing regulatory burdens that undermine commercial innovation and agility, say Jessica Noble and Adriane Mandakunis at Aegis Space Law.

• Cos. Face Convergence Of Anti-Terrorism Act, FCPA Risks

  

  Recent moves by the U.S. Department of Justice to classify cartels and transnational criminal organizations as terrorist groups, and to use a range of statutes including the Foreign Corrupt Practices Act to pursue these types of targets, mean that companies operating in certain jurisdictions are now subject to overlapping exposure, say attorneys at Miller & Chevalier.