Policy & Compliance

  • June 18, 2024

    Insurer Countersues In Penile Implant Coverage Dispute

    An insurer has no duty to defend or indemnify a urologist, his medical device company or his practice in a proposed class action over a penile enlargement implant and procedure, the company told a California federal court, saying the underlying suit doesn't seek bodily injury damages that would trigger coverage.

  • June 18, 2024

    Ex-Pharmacist Faces Rare Murder Trial In Meningitis Outbreak

    Twelve years after a deadly outbreak of fungal meningitis, an unusual legal question is set to be decided this fall: Was it murder?

  • June 18, 2024

    'Historic' Medicaid Disenrollment Sparks Suits Over Notice

    With millions of Americans losing healthcare coverage upon the expiration of COVID-era protections, two states are facing new legal challenges targeting allegedly flawed state notices.

  • June 17, 2024

    Teva, DOJ Signal Key Kickback Case May Fizzle At 1st Circ.

    A U.S. Department of Justice kickback case against Teva Pharmaceuticals — closely watched by False Claims Act lawyers because of its multibillion-dollar stakes and its link to a major circuit split — is poised for settlement, according to a new First Circuit filing ahead of eagerly awaited oral arguments.

  • June 17, 2024

    Teamsters Plan Says Health Network Has Monopoly In Conn.

    A Teamsters healthcare benefits plan and a Connecticut public transit provider have sued the healthcare network Hartford Healthcare Corp., accusing it of having a monopoly over healthcare in a half-dozen regions of the state.

  • June 17, 2024

    Pharmacy Groups Urge High Court To Hear Okla. PBM Case

    Pharmacy industry groups asked the U.S. Supreme Court to reverse a Tenth Circuit decision that overturned portions of an Oklahoma law regulating pharmacy benefit managers, saying these intermediaries have driven up costs for patients while raising their own bottom lines, and states should be allowed to keep them in check.

  • June 17, 2024

    Attys Accused Of Judge Shopping Must Turn Over Q&A Doc

    Attorneys accused of a coordinated effort to "judge shop" amid federal suits challenging an Alabama law banning certain medical procedures for transgender youth must supply a document the court believes displays the attorneys' preparations for a panel hearing in which one of the attorneys allegedly committed perjury.

  • June 14, 2024

    Janssen Hit With $150M Verdict In HIV Drug False Claims Suit

    A New Jersey federal jury hit Janssen with a $150 million False Claims Act verdict in a 12-year-old whistleblower suit, finding that the drugmaker violated the federal law as well as 27 related state FCA statutes by illegally profiting from the off-label marketing of two popular Janssen HIV medications.

  • June 14, 2024

    3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks

    The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.

  • June 13, 2024

    Justices Hand Abortion Advocates An Incomplete Win

    The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.

  • June 13, 2024

    Thomas Targets Group Standing In Mifepristone Ruling

    U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.

  • June 13, 2024

    Feds Get $4.6M In Deal Over Telehealth Billing Fraud Probe

    A multi-state network of behavioral health companies and their CEO have agreed to pay nearly $4.6 million to settle allegations that they submitted fraudulent claims for payment to Medicare and Connecticut's Medicaid program for telehealth services for nursing home residents, federal investigators said Thursday.

  • June 13, 2024

    Teva Wins Pause Of Order Ousting Patents From Orange Book

    A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.

  • June 13, 2024

    CVS Dodges Discovery Audit In Generic Drug Collusion Suit

    A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.

  • June 13, 2024

    Health Co. Execs Charged In $100M Adderall Sales Scheme

    Two California digital healthcare company executives were charged in a first-of-its-kind case Thursday with scheming to sell Adderall through deceptive advertising, allegedly bringing in $100 million in illicit profits.

  • June 13, 2024

    EU Makes First Ever Formal Pharma Price-Fixing Complaint

    European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.

  • June 13, 2024

    Abortion Medication Case Ends 'With A Whimper' At High Court

    A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.

  • June 12, 2024

    32 AGs Urge Justices Take Up Okla. PBM Law Fight

    Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.

  • June 12, 2024

    Sen. Dems Seek Criminal Penalties For PE Hospital 'Looters'

    A pair of Democratic senators are targeting private equity's role in the healthcare industry, introducing new legislation Tuesday that would give federal and state enforcers new tools to go after firms they say are "looting" hospital systems and other providers, including possibly jailing executives if patient deaths result.

  • June 11, 2024

    6th Circ. Judge Doubts Clinic's Standing To Block Bias Law

    During Sixth Circuit arguments Tuesday probing whether a Christian medical clinic can block Michigan from targeting it for refusing to facilitate gender transitions, one judge searched for evidence that the clinic is actually at risk of being prosecuted under the state's civil rights law.

  • June 11, 2024

    Doc-Patient Privilege, The Four Tops, And A Win For Humana

    Humana wins a round in a Medicare Advantage lawsuit. The high court takes up hospital "dish" payment case. A Motown legend sues a Michigan hospital. Law360 looks at those and other legal cases from the past week.

  • June 11, 2024

    Texas, Mont. Sue HHS Over ACA Trans Discrimination Rule

    Texas and Montana filed suit against the Biden administration seeking to halt its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, saying the new regulations infringe on states' autonomy and force them to violate their own laws.

  • June 11, 2024

    Judge Says Fla. Trans Medical Care Ban Is Unconstitutional

    A Florida federal judge on Tuesday declared that a state law banning gender-affirming care for transgender minors and restricting it for adults is unconstitutional because it was motivated by animus for a specific group of people and serves no legitimate state interest.

  • June 11, 2024

    Fast Appeal In Hospital Merger Row A Sign Of Determined FTC

    The Federal Trade Commission's quick appeal of its failed challenge to a North Carolina hospital merger suggests the agency remains committed to aggressive scrutiny of healthcare consolidation.

  • June 11, 2024

    High Court On Familiar Ground In Hospital Pay Row

    Two years ago, the U.S. Supreme Court decided a case about federal formula for calculating disproportionate share hospital payments — commonly called "dish" payments — under Medicare Part A. A similar case set for high court review puts the justices back on familiar ground.

Expert Analysis

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • AI In Health Law: The Top Guest Articles Of 2023

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    As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

  • AI Executive Order's Life Science, Healthcare Industry Effects

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    The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

  • HHS Advisory Highlights Free Product Inducement Risks

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    A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.

  • Attorneys' Busiest Times Can Be Business Opportunities

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    Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.

  • In The World Of Legal Ethics, 10 Trends To Note From 2023

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    Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

  • How Attorneys Can Be More Efficient This Holiday Season

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    Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

  • Top 10 Whistleblowing And Retaliation Events Of 2023

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    The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.