Expert Analysis

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Litigation Funding Could Create Ethics Issues For Attorneys

  

  A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.

• E-Discovery Quarterly: Recent Rulings On Dynamic Databases

  

  Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

• Prison Body Cams Raise Health Privacy Compliance Issues

  

  The increasing use of prison staff body cameras to enhance transparency and safety presents correctional healthcare partners with new risk management questions where they must carefully reconcile the benefits of surveillance with the imperative to protect patient privacy, say attorneys at Gordon Rees.

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  Building With Lego Makes Me A Better Lawyer

  

  Building with Lego has taught me to follow directions and adapt to unexpected challenges, and in pairing discipline with imagination, allows me to stay grounded while finding new ways to make complex deals come together, says Paul Levin at Venable.

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  Law School's Missed Lessons: Networking 101

  

  Cultivating a network isn't part of the law school curriculum, but learning the soft skills needed to do so may be the key to establishing a solid professional reputation, nurturing client relationships and building business, says Sharon Crane at Practising Law Institute.

• Defeating Estoppel-Based Claims In Legal Malpractice Actions

  

  State supreme court cases from recent years have addressed whether positions taken by attorneys in an underlying lawsuit can be used against them in a subsequent legal malpractice action, providing a foundation to defeat ex-clients’ estoppel claims, says Christopher Blazejewski at Sherin and Lodgen.

• How Cos. Can Prep For Tightened Calif. Data Breach Notices

  

  Amid California's recent enactment of S.B. 446, which significantly amends the state's data breach notification laws, companies should review and update their incident response plans by establishing processes to document and support any delayed notification, and ensure the notifications' accuracy, say Mark Krotoski and Alexandria Marx at Pillsbury.

• Employer Considerations After 11th Circ. Gender Care Ruling

  

  The Eleventh Circuit's en banc decision in Lange v. Houston County, Georgia, finding that a health plan did not violate Title VII by excluding coverage for gender-affirming care, shows that plans must be increasingly cognizant of federal and state liability as states pass varying mandates, say attorneys at Miller & Chevalier.

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  The Biz Court Digest: How It Works In Massachusetts

  

  Since its founding in 2000, the Massachusetts Business Litigation Session's expertise, procedural flexibility and litigant-friendly case management practices have contributed to the development of a robust body of commercial jurisprudence, say James Donnelly at Mirick O’Connell, Felicia Ellsworth at WilmerHale and Lisa Wood at Foley Hoag.

• How Healthcare Practices Can Prepare For ICE Visits

  

  Healthcare providers that may face encounters with immigration enforcement should familiarize themselves with compliance obligations beyond ensuring employment authorization, and mitigate risk by establishing clear policies and specific procedures that safeguard patient rights and manage staff interactions with agents, say attorneys at Roetzel & Andress.

• Adapting To Calif.'s Enhanced Regulation Of PE In Healthcare

  

  New California legislation enhances oversight on the role of private equity groups and hedge funds in healthcare transactions, featuring both a highly targeted nature and vague language that will require organizations to carefully evaluate existing practices, says Andrew Demetriou at Husch Blackwell.

• Why Appellees Should Write Their Answering Brief First

  

  Though counterintuitive, appellees should consider writing their answering briefs before they’ve ever seen their opponent’s opening brief, as this practice confers numerous benefits related to argument structure, time pressures and workflow, says Joshua Sohn at the U.S. Department of Justice.

• Navigating DEA Quotas: Key To Psychedelics Industry Growth

  

  As new compounds like DOI enter the Schedule I landscape, manufacturers who anticipate U.S. Drug Enforcement Administration quota regulations, and build quota management into their broader strategy, will be best equipped to meet the growing demand, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega.

• Federal Acquisition Rules Get Measured Makeover

  

  The Trump administration's promised overhaul of the Federal Acquisition Regulation is not a revolution in rules, but a meaningful recalibration of procurement practice that gives contracting officers more space to think, to tailor and to try, say attorneys at Mayer Brown.