Policy & Compliance

  • December 15, 2025

    Formula Suits An 'Undue Burden' On Cook County, Panel Says

    An Illinois appellate court Friday agreed with Abbott Laboratories that 23 lawsuits alleging the company failed to warn of important risks associated with infant formulas and caused premature babies to develop necrotizing enterocolitis should not have been filed in Cook County, where the infants at the center of those cases were not born and have never lived.

  • December 15, 2025

    Connecticut 'Likely' To Settle Generic Drug Price Cap Dispute

    A pharmaceutical industry trade group and the state of Connecticut have signaled their intent to settle a feud over the interpretation of the state's generic drug price cap law, and a federal judge gave them until Monday to say more about their plan.

  • December 15, 2025

    Yale Hospital Hit With $32M Baby Formula Death Verdict

    A Connecticut judge has hit Yale University and Yale New Haven Hospital with a nearly $32 million verdict over the death of a premature baby, finding doctors failed to obtain either informed consent, or any consent, before feeding the infant a diet fortified by a product produced from cow's milk.

  • December 15, 2025

    Feds Deny Breaking Plea Deal With Ex-Morgue Manager

    Prosecutors told a Pennsylvania federal judge Monday that they did not breach a plea deal between the government and Cedric Lodge by seeking a harsh sentence for the former head of Harvard University's morgue who admitted to theft and trafficking of human remains, claiming that Lodge's arguments to the contrary amounted to buyer's remorse.

  • December 15, 2025

    High Court Won't Review Doctor 'Upcoding' Acquittal Decision

    The U.S. Supreme Court said Monday that it won't review a decision allowing a retrial of a Maryland doctor who was initially found guilty of a COVID-19 testing scheme but then secured an acquittal.

  • December 12, 2025

    Ore. Justices Rule Docs Can Be Liable For Nonpatient Deaths

    Oregon's highest court ruled that medical professionals can be held liable if their negligence results in a nonpatient's death, settling a split between a trial and appeals court in a case over a cyclist struck and killed by a driver under the influence of prescription drugs.

  • December 12, 2025

    Court Nixes NY Nursing Home's Win In COVID Immunity Suit

    It was premature for a trial court to find that a liability statute protected a Bronx-based nursing home from a suit over a patient's death, a New York appellate court ruled Thursday, concluding further fact inquiry is needed in the case. 

  • December 12, 2025

    Sherwin-Williams Flicks Tobacco Fee Suit To Arbitration

    An Ohio federal judge refused Friday to toss a proposed class action from two Sherwin-Williams ex-workers who alleged an employee health plan tobacco surcharge violated nondiscrimination provisions in federal benefits law, finding while one claim could proceed in court, the dispute should first head to arbitration.

  • December 12, 2025

    11th Circ. Scrutinizes Qui Tam History In FCA Challenge

    The Eleventh Circuit Friday weighed both the history of whistleblower laws going back to the nation's founding and recent U.S. Supreme Court commentary on qui tam litigation in a closely watched challenge to the False Claims Act.

  • December 11, 2025

    Trial Record Backs Gender-Affirming Care, Ohio Justices Told

    A group of transgender youths and their families urged Ohio's highest court to affirm their win overturning state restrictions on gender-affirming care, arguing undisputed evidence at trial backed their arguments on the safety and effectiveness of the treatment.

  • December 11, 2025

    6th Circ. Panel Shows No Leanings On PBM Jurisdiction Fight

    A Sixth Circuit appeals panel gave few hints Thursday on whether it would send back to state court a lawsuit from Ohio alleging that pharmacy benefit managers were driving up prescription prices through rebate schemes. 

  • December 10, 2025

    Florida, Texas Sue FDA Over Abortion Drug Approval

    The states of Florida and Texas again took aim at the U.S. Food and Drug Administration's approval of abortion medication mifepristone, saying in a Tuesday suit that the agency flouted federal law in greenlighting the drug and signing off on several generic versions.

  • December 10, 2025

    Teva Pulls 200 Patents From Orange Book Amid FTC Probe

    The Federal Trade Commission said Wednesday an investigation it conducted into Teva Pharmaceuticals prompted the company to remove over 200 patents from the U.S. Food and Drug Administration's Orange Book.

  • December 10, 2025

    Courts Let Military Ban Trans, HIV-Positive Troops For Now

    Two federal appellate courts have cleared the federal government to enforce a pair of controversial policies restricting transgender and HIV-positive people from serving in the military, with each lifting trial court blockades on the rules while litigation challenging them plays out.

  • December 10, 2025

    Nursing Home Owners Defrauded Medicaid For Years, NJ Says

    The owners of two New Jersey nursing homes diverted nearly $100 million in Medicaid funds to themselves while intentionally understaffing the facilities and neglecting the residents, according to a state comptroller report released Wednesday that called for more scrutiny of for-profit residential care facility operators.

  • December 10, 2025

    Med Delivery Co. Fired Workers For Pay Complaints, Suit Says

    A pharmaceutical delivery company misclassified drivers as independent contractors even though it controlled nearly every aspect of their work and fired 12 named drivers at once for speaking up about it, according to a proposed class action filed in Kentucky federal court.

  • December 10, 2025

    Feds Seek 10 Years For Ex-Harvard Morgue Manager

    Federal prosecutors in Pennsylvania have recommended that the court impose a 10-year prison sentence for former Harvard Medical School morgue manager Cedric Lodge following his admission to stealing and selling body parts from cadavers donated to the school for scientific research.

  • December 09, 2025

    Fla. AG Targets Pediatric Org. In Gender-Affirming Care Suit

    The office of Florida Attorney General James Uthmeier sued the American Academy for Pediatrics along with the World Professional Association for Transgender Health and the Endocrine Society in Florida state court Tuesday for allegedly misleading the public about the safety of gender-affirming care for minors.

  • December 09, 2025

    Meet The Attys For Humana In Price-Fixing MDL Set For Trial

    Attorneys from Lowey Dannenberg PC and Schneider Wallace Cottrell Kim LLP are teaming up to represent insurance giant Humana in the first bellwether case set for trial in multidistrict litigation accusing pharmaceutical companies of fixing generic drug prices.

  • December 09, 2025

    Lax Enforcement Spurs Suits Over Insurers' 'Ghost' Networks

    More patients are alleging that what are known as insurers' ghost networks — directories full of unreachable providers — deny them access to mental health care. Their counsel say scarce enforcement is just one of the problems.

  • December 09, 2025

    Vax Critic Atty Wants To 'Depoliticize' Shots

    Attorney Aaron Siri, who specializes in vaccine cases and has close ties to Health and Human Services Secretary Robert F. Kennedy Jr., sparked concerns after he spoke at a highly publicized Centers for Disease Control and Prevention vaccine meeting. Siri told Law360 he doesn’t see a conflict between his litigation work and his advocacy.

  • December 09, 2025

    Conn. Seems Open To Limits On Drug Price Cap Enforcement

    The state of Connecticut suggested Tuesday that drug sales to the state were not the same as drug sales "in this state" as defined by state law, a stance drug manufacturers promised to leverage in their efforts to block an impending drug price cap.

  • December 09, 2025

    4th Circ. Probes Limit Of HIV-Positive Military Hopefuls' Suit

    A federal appellate judge on Tuesday repeatedly pressed an attorney representing people who were denied admission to the U.S. military due to an HIV diagnosis, asking him to explain why his argument wouldn't force the U.S. Department of Defense to accept anyone with a medically controlled, chronic condition.

  • December 09, 2025

    FCA Bar Eager To Scrutinize 11th Circ. Qui Tam Debate

    An Eleventh Circuit panel this week will help decide the fate of the qui tam provisions of the False Claims Act. The FCA bar is watching closely a case with potentially massive ramifications for federal fraud enforcement.

  • December 09, 2025

    Mistrial Declared In Fla. Opioid Case Against Pharmacies

    A Florida state judge declared a mistrial following a hung jury after two weeks of deliberations in a lawsuit brought by hospitals alleging that Walmart, Walgreens and CVS pharmacies negligently doled out painkillers and contributed to the opioid crisis. 

Expert Analysis

  • Unpacking Ore. Law's Limits On PE Healthcare Investment

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    A recent Oregon law imposes significant restrictions on nonphysicians owning or controlling medical practices, but newly enacted amendments provide some additional flexibility in certain ownership arrangements without scuttling the law's intent of addressing concerns about the rise of private equity investment in healthcare, say attorneys at Debevoise.

  • Criminal Healthcare Fraud Takeaways From 4th Circ. Reversal

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    After the Fourth Circuit reversed a doctor’s postconviction acquittal in U.S. v. Elfenbein last month, defense attorneys should consider three strategies when handling complex criminal healthcare matters, says Jonathan Porter at Husch Blackwell.

  • AG Watch: Texas Embraces The MAHA Movement

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    Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.

  • How States Are Regulating Health Insurers' AI Usage

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    The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.

  • HHS Plan To Cut Immigrant Benefits Spurs Provider Questions

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    A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.

  • Noncompete Forecast Shows Tough Weather For Employers

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    Several new state noncompete laws signal rough conditions for employers, particularly in the healthcare sector, so employers must account for employees' geographic circumstances as they cannot rely solely on choice-of-law clauses, say lawyers at McDermott.

  • Previewing State Efforts To Regulate Mental Health Chatbots

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    New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.

  • How DOJ's New Data Security Rules Leave HIPAA In The Dust

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    The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

  • Texas Med Spas Must Prepare For 2 New State Laws

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    Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.

  • DOJ-HHS Collab Crystallizes Focus On Health Enforcement

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    The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.

  • How The Healthline Privacy Settlement Redefines Ad Tech Use

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    The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

  • How Sweeping Budget Bill Shakes Up Health Industry

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    With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.

  • New DOJ Penalty Policy Could Spell Trouble For Cos.

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    In light of the U.S. Department of Justice’s recently published guidance making victim relief a core condition of coordinated resolution crediting, companies facing parallel investigations must carefully calibrate their negotiation strategies to minimize the risk of duplicative penalties, say attorneys at Debevoise.