Policy & Compliance

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

  • April 09, 2024

    Sanofi Sees End To 4,000 Suits Over Zantac

    The consequences of the demise of Roe rippled through state courts, big employers say they didn't get the generic-drug bargain they signed up for, and pharmaceutical giant Sanofi moved closer to resolving thousands of claims centering on the heartburn drug Zantac. Here, Law360 looks at the major healthcare litigation from the past week.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    3 Years In, 'No Surprises' Gets Mixed Reviews From Providers

    It's been more than three years since President Joe Biden signed federal "surprise" medical billing legislation. But after a rocky roll-out and several successful legal challenges, some are giving the No Surprises Act mixed reviews, including its particularly contentious independent dispute resolution process.

  • April 09, 2024

    Calif. Healthcare Attys Working Late Thanks To New Regs

    Attorneys working on healthcare deals in California are logging longer hours and getting less sleep as they grapple with new regulations that came into effect this month.

  • April 09, 2024

    Doctors 'On Notice': Liability And The Ariz. Abortion Decision

    The Arizona Supreme Court on Tuesday dropped a dense statutory examination concluding that an abortion ban passed before Arizona became a state had not been supplanted by a modern statute allowing abortions until 15 weeks of pregnancy. Law360 looks at how the court addressed doctor liability.

  • April 09, 2024

    Court Axes Subpoena Of Ex-Wife In 1st Abortion Death Suit

    The woman at the center of the nation's first abortion wrongful death suit since the landmark Dobbs decision need not produce info about how she allegedly obtained abortion-inducing drugs from two women, a Texas appeals court ruled Tuesday, saying doing so would violate the woman's Fifth Amendment right against self-incrimination.

  • April 09, 2024

    6th Circ. Ruling May Alter State Certificate Of Need Laws

    A Sixth Circuit finding that part of Kentucky's certificate of need law is unconstitutional shows that circuit courts are still figuring out how medical spending control statutes fit with modern U.S. Supreme Court case law.

  • April 09, 2024

    Idaho Abortion Ban Tees Up Battle On 'Trafficking' Restrictions

    As Idaho officials prepare to defend a near-total abortion ban at the U.S. Supreme Court this month, a state abortion "trafficking" statute is also heading for a federal court challenge that forecasts future constitutional battles over attempts to criminalize out-of-state travel.

  • April 09, 2024

    Tighter Limits On 'Junk' Insurance May Spur New Legal Fights

    The Biden administration's new rule limiting short-term insurance plans isn't likely to end debates over how strictly to regulate health coverage that falls outside Affordable Care Act protections.

  • April 09, 2024

    White House, Senate Dems Want $1.3B To Fight COVID Fraud

    The White House has been working with Senate Democrats on a $1.3 billion plan to expand the federal government's toolkit for going after pandemic fraudsters who took advantage of the influx of aid made available to different facets of the public during the COVID-19 pandemic.

  • April 09, 2024

    Life Sciences GCs On Tighter Regs, Outside Counsel Advice

    General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.

  • April 09, 2024

    Health Equity Advocates Notch Win with Dental Coverage Rule

    A new rule from the Department of Health and Human Services aimed at getting more adult dental care covered as an "essential" Affordable Care Act benefit promises to help close a critical healthcare equity gap.

  • April 09, 2024

    Ariz. High Court Restores Civil War-Era Abortion Ban

    The Arizona Supreme Court on Tuesday revived the state's nearly 160-year-old abortion ban, concluding that a far more recent law that had allowed abortion through 15 weeks of pregnancy did not replace the older prohibition.

  • April 09, 2024

    Crowell & Moring Hires Senior Health Atty From Capitol Hill

    Crowell & Moring LLP has hired a health care attorney from the U.S. House of Representatives who most recently served as a senior counsel in that body's Committee on Energy & Commerce, the firm announced Tuesday.

  • April 08, 2024

    Walmart Beats Investor Suit Over Opioid Probe Disclosures

    Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.

  • April 08, 2024

    Feds Say Philly Clinics Billed For 'Impossible' No. Of Visits

    The head psychiatrist at a group of Philadelphia mental health clinics allegedly billed Medicaid for enough "med check" patient visits that he would have exceeded the hours in a day if he had taken the state-mandated minimum of 15 minutes per patient, according to a federal False Claims Act suit filed Monday.

  • April 08, 2024

    High Court Creating DEI Headwinds, Colo. AG Says

    Colorado Attorney General Phil Weiser said Monday that the state's major losses last year in cases involving gay rights and prosecuting threatening speech were part of what he views as a trend at the U.S. Supreme Court of hampering efforts to increase diversity, equity and inclusion.

  • April 08, 2024

    La. Drug Caps Conflict With Federal Law, AbbVie Says

    Drugmaker AbbVie is asking a Louisiana federal judge to grant its summary judgment motion and block new state-level pharmaceutical caps for the federal 340B drug discount program, calling the state's competing summary judgment motion arguments "legally and factually wrong."

  • April 05, 2024

    Ind. Can't Undo Abortion Law Injunction In Jewish Org's Case

    An Indiana law banning most abortions in the state remains blocked for certain people with sincerely held religious beliefs, after a state appeals court largely upheld — in a sometimes sharply worded opinion — a preliminary injunction issued in a lawsuit brought by a Jewish reproductive rights group and other individual plaintiffs.

  • April 05, 2024

    Target, Major Employers Raise New Drug Price-Fixing Claims

    Target Corp., Lowe's Cos. Inc. and American Airlines Inc. are among major employers that lodged new price-fixing claims in Pennsylvania federal court against dozens of pharmaceutical companies, accusing them of orchestrating illegal agreements to allocate customers and markets and fix the prices of hundreds of generic drugs for more than a decade.

  • April 05, 2024

    'Take The Win,' Judge Tells Texas In HHS Abortion Pill Suit

    Texas' lawsuit challenging the Biden administration's guidance to require pharmacies to dispense abortion medication is moot following revised U.S. Department of Health and Human Services guidance clarifying that access to the drug isn't for abortion purposes, a federal judge ruled Friday, saying the state "should take the win."

  • April 05, 2024

    Abbott Settles TM Suit Over Gray Market Diabetes Test Strips

    Abbott Laboratories told a New York federal judge Friday that the company has settled what remains of its trademark litigation campaign against makers of gray market diabetes test strips that has been going on since 2015.

  • April 05, 2024

    Judge Lourie's Dissent Revives Debate Over FDA Safe Harbor

    U.S. Circuit Judge Alan Lourie has urged the Federal Circuit to reconsider its precedent over a safe harbor that allows infringement when companies are developing products regulated by the U.S. Food and Drug Administration, and many attorneys agreed with him that the appeals court has been improperly expanding the safe harbor for decades.

Expert Analysis

  • A Closer Look At Proposed HHS Research Misconduct Rule

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    The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

  • Handling Religious Objections To Abortion-Related Job Duties

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    While health care and pharmacy employee religious exemption requests concerning abortion-related procedures or drugs are not new, recent cases demonstrate why employer accommodation considerations should factor in the Title VII standard set forth by the U.S. Supreme Court’s 2023 Groff v. DeJoy ruling, as well as applicable federal, state and local laws, say attorneys at Epstein Becker.

  • Why Hemp-Synthesized Intoxicants Need Uniform Regs

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    State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.

  • Attorneys, Law Schools Must Adapt To New Era Of Evidence

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    Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.

  • The Self-Funded Plan's Guide To Gender-Affirming Coverage

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    Self-funded group health plans face complicated legal risks when determining whether to cover gender-affirming health benefits for their transgender participants, so plan sponsors should carefully weigh how federal nondiscrimination laws and state penalties for providing care for trans minors could affect their decision to offer coverage, say Tim Kennedy and Anne Tyler Hall at Hall Benefits Law.

  • ESG Around The World: The UK

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    Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.

  • 3 Tips For Defending Against Data Breach Litigation

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    As cyberattacks become more prevalent, companies responding to data breaches must consider several strategies to better position themselves in the event of litigation even during their preliminary investigations and breach notifications, say attorneys at Davis Wright.

  • Tips For Litigating Against Pro Se Parties In Complex Disputes

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    Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.

  • Air Ambulance Ch. 11s Show Dispute Program Must Resume

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    Air Methods’ recent bankruptcy filing highlights the urgent need to reopen the No Surprises Act’s independent dispute resolution program for air ambulances, whose shutdown benefits insurance companies and hurts providers, says Adam Schramek at Norton Rose.

  • Pro Bono Work Is Powerful Self-Help For Attorneys

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    Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.

  • Playing In A Rock Cover Band Makes Me A Better Lawyer

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    Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.

  • The Pop Culture Docket: Judge Espinosa On 'Lincoln Lawyer'

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    The murder trials in Netflix’s “The Lincoln Lawyer” illustrate the stark contrast between the ethical high ground that fosters and maintains the criminal justice system's integrity, and the ethical abyss that can undermine it, with an important reminder for all legal practitioners, say Judge Adam Espinosa and Andrew Howard at the Colorado 2nd Judicial District Court.

  • Calif. GHG Disclosure Law Will Affect Companies Worldwide

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    California's Climate Corporate Data Accountability Act, which will require comprehensive greenhouse gas emissions disclosures from large companies operating in the state, will mean compliance challenges for a wide range of industries, nationally and globally, as the law's requirements will ultimately trickle out and down, say attorneys at Brownstein Hyatt.