Expert Analysis

• Opinion

  FTC's Clinical Trial Requirement Threatens Food Claim Rules

  

  The Federal Trade Commission's general requirement for randomized controlled trials for most health-benefit claims, recently embraced by the National Advertising Review Board, lacks legal basis and endangers the existing statutory framework Congress created for marketing food and dietary supplements versus drugs, say attorneys at Keller & Heckman.

• Drawing A Line Between Settlement Pressure And Extortion

  

  U.S. v. Luo, pending in the U.S. District Court for the Southern District of New York, may force courts to address anew when settlement negotiations become criminal extortion, particularly in the age of easily fabricated digital evidence, says attorney Denis Kiely.

• Series

  Founding An Autism Academy Made Me A Better Lawyer

  

  Starting a nonprofit autism school with no building, no funding model and no guarantee that families would trust us taught me the importance of mission, patience and purpose — lessons that sharpened my practice and showed how meaningful work outside the office can make lawyers better, says Phillip Russell at Ogletree Deakins.

• Opinion

  Rule Of Law Requires Gov't Engagement With Bar, Not Retreat

  

  A federal agency's absence from national and local bar conferences, most recently illustrated by the U.S. Department of Justice's withdrawal from a New York City Bar Association white collar conference, disserves the bar, the government lawyers themselves and, ultimately, the administration of justice, says Muhammad Faridi at Linklaters.

• AG Watch: Oregon's Strategic Civil Enforcement Approach

  

  Oregon Attorney General Dan Rayfield’s recent antitrust litigation activity and proposed staffing increase are the latest in a series of structural and policy changes that signal that the state Department of Justice is taking a more aggressive approach to civil enforcement, says Keturah Taylor at Cozen O'Connor.

• How Nasdaq's 23/5 Rule Will Alter Public Offering Strategies

  

  The U.S. Securities and Exchange Commission's recent approval of Nasdaq's proposal to extend trading hours to 23 hours a day, five days a week, may reshape how certain public offerings are executed, particularly for confidentially marketed public offerings, say attorneys at Faegre Drinker.

• The Paradoxical Duty To Adopt AI When You Can't Bill For It

  

  Both billing for hours saved using artificial intelligence and preserving billable time by not adopting AI may violate rules of professional conduct, but until bar associations' ethics rules catch up to this emerging economic dilemma, firms must decide how to adjust fee structures themselves, says Ines Lassalle at Peyrot & Associates.

• Tips For Litigating Life Sciences Investigations At The ITC

  

  The International Trade Commission may soon become a significant battleground for life sciences companies as global intellectual property and trade disputes continue, increasing the importance of learning the ITC's unique considerations and litigation strategies, say attorneys at Crowell & Moring.

• Ch. 15 Ruling Is A Restructuring Blueprint For Cannabis Cos.

  

  The recent Cannabist Chapter 15 recognition order is arguably the most significant cannabis bankruptcy development in U.S. history, providing a concrete and tested road map by which such companies with foreign parent structures can access the protective machinery of U.S. bankruptcy law, say attorneys at Saul Ewing.

• Unsecured Synthetic Royalties May Be Returning

  

  Recent royalty monetization deals mark a notable shift in a market that had largely moved away from unsecured synthetic royalty structures after a multiyear freeze triggered by the Mallinckrodt bankruptcy decision in 2022, which exposed a legal risk inherent to the structure, says Peter Schwartz at Covington.

• Series

  Cow Horse Makes Me A Better Lawyer

  

  Moving an unwilling 800-pound cow while riding a horse at high speed is exhilarating, a little unhinged and, at least for me, a surprisingly effective training ground for litigation — both demand focus, preparation over rigid planning and the willingness to act despite fear, says Ashley Zitrin at Glenn Agre.

• Protecting AI-Driven Innovation In Life Sciences IP

  

  Recent developments, including the U.S. Patent and Trademark Office's evolving inventorship standards, and the impact of artificial intelligence on the "person of ordinary skill in the art" standard demand that life sciences companies elevate AI patent strategy to a top priority, says Sandra Haberny at Quinn Emanuel.

• What Prop 65 Listings For Welding Fumes, Drugs Mean For Cos.

  

  With California poised to add welding chemicals and three medications to its list of known carcinogens under Proposition 65, businesses must assess risks from nontraditional pharmaceutical dispensing, occupational and environmental exposures to welding operations, and downstream exposures from the manufacture of both types of substances, says Gregory Berlin at Alston & Bird.

• High Court's Hikma Decision Reshapes 'Skinny Label' Suits

  

  The U.S. Supreme Court's decision in Hikma v. Amarin marks a significant victory for generic drug manufacturers, but rather than putting an end to so-called skinny label inducement claims, it narrows and refocuses them, say attorneys at Sterne Kessler.

• Virginia's Cannabis Retail Veto Leaves Industry In Legal Limbo

  

  Virginia Gov. Abigail Spanberger's recent veto of legislation that would have established a regulated retail cannabis framework halts momentum built by the General Assembly, but it also sends important signals about what a future regulatory framework must address to survive, says Charles Slemp at Cozen.