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.

How SDNY US Atty Nom May Shape Enforcement Priorities

President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.

Improving Comms Between Trial Attys And Tech Witnesses

In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.

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.

Opinion

Congress Must Consider Accurate Data About Patent Thickets

If Congress revisits a controversial bill this year aimed at limiting the number of patents pharmaceutical manufacturers could assert, it must make sure to act based on accurate reports — such as a recent U.S. Patent and Trademark Office study that found no evidence of patent thicketing, says David Kappos at the Council for Innovation Promotion.

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.

Perspectives

Accountant-Owned Law Firms Could Blur Ethical Lines

KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.

The Post-Macquarie Securities Fraud-By-Omission Landscape

While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.