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Expert Analysis

• FCA Working Group Reboot Signals EHR Compliance Risk

  

  The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.

• Litigation Inspiration: How To Respond After A Loss

  

  Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.

• 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.

• 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.

• 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.

• 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.

• 9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

  

  Two Ninth Circuit decisions last week provide a welcome development in clarifying the line between laboratories' legal marketing efforts and undue influence that violates the Eliminating Kickbacks in Recovery Act, and offer useful guidance for labs seeking to mitigate enforcement risk, says Joshua Robbins at Buchalter.

• $95M Caremark Verdict Should Put PBMs On Notice

  

  A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.

• Series

  Playing Mah-Jongg Makes Me A Better Mediator

  

  Mah-jongg rewards patience, pattern recognition, adaptability and keen observation, all skills that are invaluable to my role as a mediator, and to all mediating parties, says Marina Corodemus.

• Series

  Law School's Missed Lessons: Navigating Client Trauma

  

  Law schools don't train students to handle repeated exposure to clients' traumatic experiences, but for litigators practicing in areas like civil rights and personal injury, success depends on the ability to view cases clinically and to recognize when you may need to seek help, says Katie Bennett at Robins Kaplan.

• Opinion

  4 Former Justices Would Likely Frown On Litigation Funding

  

  As courts increasingly confront cases involving hidden litigation finance contracts, the jurisprudence of four former U.S. Supreme Court justices establishes a constitutional framework that risks erosion by undisclosed financial interests, says Roland Eisenhuth at the American Property Casualty Insurance Association.

• DOJ Actions Signal Rising Enforcement Risk For Health Cos.

  

  The U.S. Department of Justice's announcement of a new False Claims Act working group, together with the largest healthcare fraud takedown in history, underscore the importance of sophisticated compliance programs that align with the DOJ's data-driven approach, say attorneys at Debevoise.

• How Attys Can Use AI To Surface Narratives In E-Discovery

  

  E-discovery has reached a turning point where document review is no longer just about procedural tasks like identifying relevance and redacting privilege — rather, generative artificial intelligence tools now allow attorneys to draw connections, extract meaning and tell a coherent story, says Rose Jones at Hilgers Graben.

• How McKesson Ruling Will Inform Interpretations Of The TCPA

  

  Amid the U.S. Supreme Court's ruling in McLaughlin Chiropractic Associates v. McKesson, we can expect to see both plaintiffs and defendants utilizing the decision to revisit the Federal Communications Commission's past Telephone Consumer Protection Act interpretations and decisions they did not like, says Jason McElroy at Saul Ewing.