Expert Analysis

• How To Engage With Gov't's Direct-To-Consumer Drug Policy

  

  The U.S. Department of Health and Human Services' recent request for industry input on manufacturers' direct-to-consumer drug sales reflects the government's caution in this arena, and allows stakeholders a rare opportunity to help shape policy, says Mary Kohler at Kohler Health Law.

• Opinion

  It's Time To Clarify California's Elder Abuse Act

  

  As California's elderly population soars, the Golden State's high court and Legislature must provide needed clarification about the scope of the Elder Abuse Act, to resolve the inconsistencies and ambiguities that have impeded the law's ability to remedy elder abuse, neglect and abandonment, say attorneys at Horvitz & Levy.

• Series

  Podcasting Makes Me A Better Lawyer

  

  Podcasting has changed how I ask questions and connect with people, sharpening my ability to listen without interrupting or prejudging, and bringing me closer to what law is meant to be: a human profession grounded in understanding, judgment and trust, says Donna DiMaggio Berger at Becker.

• When Fraud Involvement Disqualifies FCA Whistleblowers

  

  A Massachusetts federal court's recent dismissal of a False Claims Act relator in U.S. ex rel. Perry v. First Psychiatric Planners provides instructive insight into when whistleblowers may be denied their share of settlement proceeds, even if their involvement in the underlying fraud is a step removed, say attorneys at Holland & Knight.

• Job Shift Accommodation Ruling Clarifies 'Essential Function'

  

  In Siebrecht v. Mercy Health-Iowa, the Eighth Circuit's recent denial of a disabled worker's shift exemption request shows that the essential function of a job can encompass more than core job requirements and include things like scheduling flexibility, says Kim Kirn at Miles Mediation & Arbitration.

• Opinion

  Fed. Circ. Must Bury Design Patent Doctrinal Zombies

  

  After recently finding noninfringement in Range of Motion Products v. Armaid, the Federal Circuit must rehear the case to confront two troublesome doctrines of design patent law claim construction — feature filtration and claim verbalization — that have lingered for decades and intensified in recent years, say attorneys at McAndrews Held.

• H-1B Registration Tips For New Wage-Weighted Selection

  

  Practitioners participating in this year’s H-1B visa registration, currently underway, must understand that under the new wage-weighted selection process that replaced the random lottery, the crucial first step is choosing the correct standard occupational classification, says Jimmy Lai at Lai & Turner.

• Lessons From Justices' Split On Major Questions Doctrine

  

  The justices' varied opinions in Learning Resources v. Trump, which held the International Emergency Economy Powers Act did not confer the power to impose tariffs, offer a meaningful window into the U.S. Supreme Court's perspective on the major questions doctrine that will likely shape lower courts' approach to executive action challenges, say attorneys at Venable.

• Drug Wholesaler's DPA Shows Imperfect Efforts Still Count

  

  Atlantic Biologicals’ recent deferred prosecution agreement with federal prosecutors for allegedly distributing controlled substances to pill mill pharmacies demonstrates that even subpar cooperation, when combined with genuine remediation and strategic advocacy, can yield outcomes that protect a company's long-term interests, says Jonathan Porter at Husch Blackwell.

• Key Takeaways As HRSA Aims To Revive 340B Rebate Pilot

  

  The U.S. Department of Health and Human Services' recent request for feedback on the 340B Rebate Model Pilot Program demonstrates that it intends to correct the model's procedural defects, which is positive news for participating manufacturers, but a setback for covered entities, say attorneys at Manatt.

• Why Mukherji Won't End USCIS' EB-1A Two-Step

  

  A Nebraska federal court's recent decision in Mukherji v. Miller seemed to vindicate longstanding complaints about the U.S. Citizenship and Immigration Services' controversial two-step adjudication process, declaring the framework unlawful — but Mukherji is unlikely to be the death blow that immigration practitioners have hoped for, says Jun Li at Reid & Wise.

• Unique Issues Facing Brand-Compounder Patent Litigation

  

  Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounders and branded pharmaceuticals companies would be positioned in patent litigation as compared to generics companies, which would require strategies different from those that would be used in traditional Hatch-Waxman Act litigation, say attorneys at Morgan Lewis.

• Series

  Volunteering With Scouts Makes Me A Better Lawyer

  

  Serving as an assistant scoutmaster for my son’s troop reaffirmed several skills and principles crucial to lawyering — from the importance of disconnecting to the value of morality, says Michael Warren at McManis Faulkner.

• Series

  Law School's Missed Lessons: In Court, It's About Storytelling

  

  Law school provides doctrine, cases and hypotheticals, but when lawyers step into the courtroom, they must learn the importance of clarity, credibility, memorability and preparation — in other words, how to tell simple, effective stories, say Nicholas Steverson and Danielle Trujillo at Wheeler Trigg, and Lisa DeCaro at Courtroom Performance.

• Pros And Cons Of FDA's Push For Nonprescription Drugs

  

  The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.