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Expert Analysis

• What US Medicine Onshoring Means For Indian Life Sciences

  

  Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.

• How US Cos. Should Prep For Brazil's Int'l Data Transfer Rules

  

  Brazil's National Data Protection Authority's new rules concerning the processing and storing of Brazilians' personal data carry significant reputational risks for the e-commerce, financial services, education and health sectors, so U.S. companies with business in Brazil should prepare ahead of the Aug. 23 compliance date, says Juliane Chaves Ferreira at Guimarães & Vieira de Mello.

• APA Relief May Blunt Justices' Universal Injunction Ruling

  

  The Administrative Procedure Act’s avenue for universal preliminary relief seems to hold the most promise for neutralizing the U.S. Supreme Court’s decision in Trump v. CASA to limit federal district courts' nationally applicable orders, say attorneys at Crowell.

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  Law School's Missed Lessons: Skillful Persuasion

  

  In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.

• A Look At Trump 2.0 Antitrust Enforcement So Far

  

  The first six months of President Donald Trump's second administration were marked by aggressive antitrust enforcement tempered by traditional structural remedies for mergers, but other unprecedented actions, like the firing of Federal Trade Commission Democrats, will likely stoke heated discussion ahead, says Richard Dagen at Axinn.

• 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.

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  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.