Expert Analysis

• What's New In FDA's Updated Data Monitoring Guidance

  

  The U.S. Food and Drug Administration's new guidance on the use of data monitoring committees in clinical trials is set to replace the agency's 2006 guidance on the topic, with notable updates including stronger language indicating a more stringent stance against financial conflicts of interest and adaptation to recent changes in DMC structure, say attorneys at Hogan Lovells.

• Opinion

  Suits Against Insulin Pricing Are Driven By Rebate Addiction

  

  A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

• Conn. Data Privacy Enforcement Takeaways For Cos.

  

  In light of the Connecticut attorney general's recently released report on its enforcement of the Connecticut Data Privacy Act, which focuses on companies' privacy policies, protections of sensitive data and more, businesses can expect increased enforcement scrutiny — especially in areas that are the subject of consumer complaints, say Paul Pittman and Abdul Hafiz at White & Case.

• Lessons For D&O Policyholders From Pharma Co. Ruling

  

  A California federal court's recent decision in AmTrust v. 180 Life Sciences, requiring insurers to advance defense costs for a potentially covered claim, provides a valuable road map for directors and officers insurance policyholders, rebutting the common presumption that a D&O insurer's duty to advance costs is more limited than under other policies, say attorneys at Pasich.

• How Firms Can Ensure Associate Gender Parity Lasts

  

  Among associates, women now outnumber men for the first time, but progress toward gender equality at the top of the legal profession remains glacially slow, and firms must implement time-tested solutions to ensure associates’ gender parity lasts throughout their careers, say Kelly Culhane and Nicole Joseph at Culhane Meadows.

• 7 Common Myths About Lateral Partner Moves

  

  As lateral recruiting remains a key factor for law firm growth, partners considering a lateral move should be aware of a few commonly held myths — some of which contain a kernel of truth, and some of which are flat out wrong, says Dave Maurer at Major Lindsey.

• When Physician Retirement Arrangements May Be Legal

  

  A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.

• Series

  Cheering In The NFL Makes Me A Better Lawyer

  

  Balancing my time between a BigLaw career and my role as an NFL cheerleader has taught me that pursuing your passions outside of work is not a distraction, but rather an opportunity to harness important skills that can positively affect how you approach work and view success in your career, says Rachel Schuster at Sheppard Mullin.

• Keeping Up With Class Actions: Data Breach Litigation In Flux

  

  In this monthly look at notable class action decisions, Gerald Maatman at Duane Morris examines a recent mixed-bag data breach ruling from an Illinois federal court — in the context of case law developments over the last year — which illustrates the range of issues confronting litigants going forward.

• Args In APA Case Amplify Justices' Focus On Agency Power

  

  In arguments last week in Corner Post v. Federal Reserve, the U.S. Supreme Court justices paid particular importance to the possible ripple effects of their decision, which will address when a facial challenge to long-standing federal rules under the Administrative Procedure Act first accrues and could thus unleash a flood of new lawsuits, say attorneys at Snell & Wilmer.

• Series

  ESG Around The World: Gulf Cooperation Council

  

  The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.

• Navigating ACA Reporting Nuances As Deadlines Loom

  

  Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.

• Inside The PTAB's Seagen Cancer Drug Patent Decision

  

  The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.

• A Cautionary Tale On Hospital-Physician Alignment Structures

  

  A $345 million settlement between the U.S. Department of Justice and Community Health Network highlights how quickly hospital and physician alignment relationships can violate legal restrictions on such dealings, and the onerous financial penalties that can ensue, say Robert Threlkeld and Elliott Coward at Morris Manning.

• 6 Pointers For Attys To Build Trust, Credibility On Social Media

  

  In an era of information overload, attorneys can use social media strategically — from making infographics to leveraging targeted advertising — to cut through the noise and establish a reputation among current and potential clients, says Marly Broudie at SocialEyes Communications.