Expert Analysis

• Vanda Ruling Opens Door For Contesting FDA Drug Denials

  

  The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration creates new opportunities and considerations for drug companies navigating the FDA approval process, establishing that litigation is an option when the FDA refuses to hold a hearing, say attorneys at Polsinelli.

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  Law School's Missed Lessons: Mastering Time Management

  

  Law students typically have weeks or months to prepare for any given deadline, but the unpredictability of practicing in the real world means that lawyers must become time-management pros, ready to adapt to scheduling conflicts and unexpected assignments at any given moment, says David Thomas at Honigman.

• Courts Keep Upping Standing Ante In ERISA Healthcare Suits

  

  As Article III standing becomes increasingly important in litigation brought by employer-sponsored health plan members under the Employee Retirement Income Security Act, several recent cases suggest that courts are taking a more scrutinizing approach to the standing inquiry in both class actions and individual matters, say attorneys at Crowell & Moring.

• Calif. Bill May Shake Up Healthcare Investment Landscape

  

  If signed by the governor, newly passed California legislation would significantly expand the Office of Health Care Affordability's oversight of private equity and hedge fund investments in healthcare companies and management services organizations, and raise several questions about companies' data confidentiality and filing burdens, say attorneys at Ropes & Gray.

• How Hyperlinks Are Changing E-Discovery Responsibilities

  

  A recent e-discovery dispute over hyperlinked data in Hubbard v. Crow shows how courts have increasingly broadened the definition of control to account for cloud-based evidence, and why organizations must rethink preservation practices to avoid spoliation risks, says Bree Murphy at Exterro.

• Pharma Copay Programs Raise Complex Economic Questions

  

  The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.

• State False Claims Acts Can Help Curb Opioid Fund Fraud

  

  State versions of the federal False Claims Act can play an important role in policing the misuse of opioid settlement funds, taking a cue from the U.S. Department of Justice’s handling of federal fraud cases involving pandemic relief funds, says Kenneth Levine at Stone & Magnanini.

• 'Occurrence' Lessons From Policyholder's COVID Ruling Win

  

  The Minnesota Court of Appeals recently handed policyholders an important win in Life Time v. Zurich American Insurance, reversing a trial court ruling that had capped coverage under a communicable disease endorsement at a single occurrence, showing the importance of fact-specific inquiry, say attorneys at Hunton.

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  Writing Musicals Makes Me A Better Lawyer

  

  My experiences with writing musicals and practicing law have shown that the building blocks for both endeavors are one and the same, because drama is necessary for the law to exist, says Addison O’Donnell at LOIS Law.

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  Adapting To Private Practice: From Va. AUSA To Mid-Law

  

  Returning to the firm where I began my career after seven years as an assistant U.S. attorney in Virginia has been complex, nuanced and rewarding, and I’ve learned that the pursuit of justice remains the constant, even as the mindset and client change, says Kristin Johnson at Woods Rogers.

• Transmission Security Has A Critical Role In Healthcare

  

  In light of the U.S. Department of Health and Human Services' Office of Civil Rights' continuing enforcement initiative focusing on businesses' accurate and thorough security risk assessments under the Health Insurance Portability and Accountability Act, covered entities should not neglect the importance of transmission security, says John Howard at Clark Hill.

• Rebutting Price Impact In Securities Class Actions

  

  Defendants litigating securities cases historically faced long odds in defeating class certification, but that paradigm has recently begun to shift, with recent cases ushering in a more searching analysis of price impact and changing the evidence courts can consider at the class certification stage, say attorneys at Katten.

• 7 Document Review Concepts New Attorneys Need To Know

  

  For new associates joining firms this fall, stepping into the world of e-discovery can feel like learning a new language, but understanding a handful of fundamentals — from coding layouts to metadata — can help attorneys become fluent in document review, says Ann Motl at Bowman and Brooke.

• FTC Actions Highlight New Noncompete Enforcement Strategy

  

  Several recent noncompete-related actions from the Federal Trade Commission — including its recent dismissal of cases appealing the vacatur of a Biden-era noncompete ban — reflect the commission's shift toward case-by-case enforcement, while confirming that the agency intends to remain active in policing such agreements, say attorneys at Debevoise.

• Ruling On Labor Peace Law Marks Shift For Cannabis Cos.

  

  Currently on appeal to the Ninth Circuit, an Oregon federal court’s novel decision in Casala v. Kotek, invalidating a state law that requires labor peace agreements as a condition of cannabis business licensure, marks the potential for compliance uncertainty for all cannabis employers in states with labor peace mandates, say attorneys at Sheppard Mullin.