Expert Analysis

• A Look At HHS' New Opinion On Patient Assistance Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

• How Ill. Ruling Could Influence Future Data Breach Cases

  

  The Illinois Supreme Court's recent decision in Petta v. Christie Business Holding, which was based solely on standing, establishes an important benchmark for the viability of Illinois-based lawsuits arising out of data security incidents that defendants can cite in future cases, say attorneys at Wilson Elser.

• Opinion

  Inconsistent Injury-In-Fact Rules Hinder Federal Practice

  

  A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.

• Virginia AI Bills Could Serve As Nationwide Model

  

  If signed into law, two Virginia bills focused on regulating the use of high-risk AI systems in the private and public sectors have the potential to influence similar legislation in other states, as well as the compliance strategies of companies operating in the commonwealth and across the U.S., say attorneys at Woods Rogers.

• 2 Anti-Kickback Developments Hold Lessons For Biopharma

  

  The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

• In-House Counsel Pointers For Preserving Atty-Client Privilege

  

  Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.

• Disability Ruling Guides On Cases With Uncertain Causation

  

  In Dime v. MetLife, a Washington federal court’s recent ruling in favor of a disability claimant instructs both claimants and insurers on the appropriate standard for establishing and making a disability determination when there is limited medical evidence explaining the disability’s cause, says Mark DeBofsky at DeBofsky Law.

• What's Next For State Regulation Of Hemp Cannabinoids

  

  Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.

• Series

  Collecting Rare Books Makes Me A Better Lawyer

  

  My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.

• Opinion

  New DOJ Leaders Should Curb Ill-Conceived Prosecutions

  

  First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.

• Tips For Pharma-Biotech Overlap Reporting In New HSR Form

  

  While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.

• Opinion

  Judge Should Not Have Been Reprimanded For Alito Essay

  

  Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Law of Duquesne University.

• A Look At Drug Price Negotiation Program's Ongoing Impact

  

  More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.

• Lights, Camera, Ethics? TV Lawyers Tend To Set Bad Example

  

  Though fictional movies and television shows portraying lawyers are fun to watch, Hollywood’s inaccurate depictions of legal ethics can desensitize attorneys to ethics violations and lead real-life clients to believe that good lawyers take a scorched-earth approach, says Nancy Rapoport at the University of Nevada, Las Vegas.

• Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?

  

  New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.