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Hikma v. Amarin, set for oral argument in the U.S. Supreme Court on Wednesday, has potential to affect not just generic drug label-based evidence in patent cases, but also how technology inducement cases are presented and proven, says attorney Abdul Abdullahi.
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The establishment this month of the National Fraud Enforcement Division within the U.S. Department of Justice is a significant reorganization that suggests an increase in enforcement activity involving federally funded programs but leaves a number of important questions unanswered, say attorneys at Crowell & Moring.
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A D.C. federal court's recent decision in Premier v. U.S. Department of Health limits the Health Resources and Services Administration's ability to enforce long-standing Section 340B interpretations through subregulatory guidance, leaving open core statutory questions about purchasing models, inventory classification and program oversight, says Martha Cramer at Hooper Lundy.
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Opinion
The U.S. Department of Justice's recent decision to delay compliance dates for regulations ensuring accessible government services online benefits no one, as it is long overdue for disabled Americans and doesn't lessen covered entities' legal obligations or litigation risk, say Mark Riccobono at the National Federation of the Blind and Eve Hill at Brown Goldstein.
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Series
Though they may seem to have little in common, officiating football has sharpened many of the same skills that define effective lawyering in management-side labor and employment: preparation, judgment, composure, credibility and ability to make difficult decisions in real time, says Josh Nadreau at Fisher Phillips.
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The Ninth Circuit's recent decision in Fresenius v. Bonta suggests that businesses have a First Amendment right to donate to certain charities, even if those donations are motivated by economic self-interest, potentially calling into question years of Anti-Kickback Statute proceedings against pharmaceutical manufacturers for making similar donations, says Jonah Knobler at Patterson Belknap.
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The Fifth Circuit's ruling in Bradford v. Sovereign Pest Control is a takedown of the Federal Communications Commission's prior express written consent regulation, and because Loper Bright empowers courts to disregard agency interpretations, Telephone Consumer Protection Act litigants now have an opportunity to challenge previously settled FCC regulations, orders and interpretations, say attorneys at Manatt.
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Series
Most law school graduates step into their first jobs without ever having drafted a complaint, answer, motion or other type of pleading, but that gap can be closed by understanding the strategy embedded in every filing, writing with clarity and purpose, and seeking feedback at every step, says Eric Yakaitis at Haug Barron.
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Several recent federal court decisions have perpetuated a split over what constitutes “control” of electronically stored information — with judges divided on whether the standard should turn on a party's legal right or practical ability to obtain the information, say attorneys at Sidley.
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The outlook for rural hospitals has grown more concerning, as recent policy and regulatory developments are decreasing hospital revenues and increasing the cost of uncompensated care, which may result in additional hospital closures, service reductions, or mergers and acquisitions, say Omur Celmanbet, Kristy Piccinini and Sabiha Quddus at FTI Consulting.
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Several pending cases target the issue of whether generative AI may appropriately replace human professional decision-making, and though each case is still in discovery, the decisions thus far provide insurers with guidance on how courts may view these claims, say attorneys at Simpson Thacher.
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As litigation becomes a de facto substitute for the regulation of major technology platforms, with plaintiffs advancing claims under product liability, public nuisance and consumer protection laws, among others, courts are evaluating how platform systems operate in practice based on large-scale operational data, say attorneys at Brattle.
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While a New York federal court’s recent ruling in U.S. v. Heppner suggests that some litigants’ communications with AI tools are discoverable, two other recent federal court decisions demonstrate that such interactions generally qualify for work-product protection under the Federal Rules of Civil Procedure, says Joshua Dunn at Brown Rudnick.
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In this month's bid protest roundup, Brian Doll at MoFo delves into three recent decisions from the Government Accountability Office about the evidentiary standards necessary to sustain a protest, discussions tailored to individual proposals, and misrepresentation claims involving factors irrelevant to the agency's decision.
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Series
My involvement in martial arts, specifically Isshin-ryu, which has principles rooted in the eight codes of karate, has been one of the most foundational in the development of my personality, and particularly my approach to challenges — including in my practice of law, says Kaitlyn Stone at Barnes & Thornburg.