Expert Analysis

• Are Concessions In FDA's Lab-Developed Tests Rule Enough?

  

  Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

• 8 Questions To Ask Before Final CISA Breach Reporting Rule

  

  The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

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  Swimming Makes Me A Better Lawyer

  

  Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

• Mid-2024 FCA Enforcement And Litigation Trends To Watch

  

  Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

• A Recipe For Growth Equity Investing In A Slow M&A Market

  

  Carl Marcellino at Ropes & Gray discusses the factors bolstering appetite for growth equity fundraising in a depressed M&A market, and walks through the deal terms and other ingredients that set growth equity transactions apart from bread-and-butter venture capital investing.

• What 100 Federal Cases Suggest About Changes To Chevron

  

  With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

• Notable Q1 Updates In Insurance Class Actions

  

  Mark Johnson and Mathew Drocton at BakerHostetler discuss notable insurance class action decisions from the first quarter of the year ranging from salvage vehicle titling to rate discrimination based on premium-setting software.

• New Federal Bill Would Drastically Alter Privacy Landscape

  

  While the recently introduced American Privacy Rights Act would eliminate the burdensome patchwork of state regulations, the proposed federal privacy law would also significantly expand compliance obligations and liability exposure for companies, especially those that rely on artificial intelligence or biometric technologies, says David Oberly at Baker Donelson.

• The Fed. Circ. In April: Hurdles Remain For Generics

  

  The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.

• Tylenol MDL Highlights Expert Admissibility Headaches

  

  A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.

• PE-Healthcare Mergers Should Prepare For Challenges

  

  State and federal regulators are increasingly imposing new requirements on healthcare transactions involving private equity partners, with mergers that would have drawn little scrutiny a few years ago now requiring a multijurisdictional risk analysis during the deal formation process, say attorneys at Stinson.

• Don't Use The Same Template For Every Client Alert

  

  As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.

• Online Portal Helps Fortify Feds' Unfair Health Practices Fight

  

  The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

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  Walking With My Dog Makes Me A Better Lawyer

  

  Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.

• Think Like A Lawyer: Follow The Iron Rule Of Trial Logic

  

  Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.