Policy & Compliance

  • 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.

  • April 05, 2024

    Mich. Plaintiffs Bar Prepares For Growth After Policy Shifts

    After decades of the deck stacked against them, Michigan's plaintiffs attorneys are poised to take advantage of a more hospitable environment for personal injury cases and pharmaceutical class actions, though experts caution the learning curve will be steep.

Expert Analysis

  • What Marijuana Status Change Would Mean For Industry

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    If the Drug Enforcement Administration accepts the U.S. Department of Health and Human Services’ recent recommendation to change marijuana’s classification under federal law, it would be a significant regulatory shift that could foster many industry benefits — but questions, risks and uncertainties at both the state and federal levels would remain, say attorneys at Neal Gerber.

  • Top 4 Antitrust Enforcement Issues In Health Care Today

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    The Federal Trade Commission's recent lawsuit against U.S. Anesthesia Partners exemplifies antitrust enforcement authorities' efforts to aggressively reshape the health care industry, ranging from new proposed rules to withdrawals of previous guidance, say attorneys at Fried Frank.

  • Calif. Climate Disclosure Bills Promise Challenges For Cos.

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    Two novel climate disclosure bills recently passed by the California Legislature will pose challenges for many businesses — especially private companies that are less familiar with climate-related reporting obligations — and will require investments of significant time and effort in processes, procedures and personnel, say John Rousakis and Chris Bowman at O'Melveny.

  • Maximizing Law Firm Profitability In Uncertain Times

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    As threats of an economic downturn loom, firms can boost profits by embracing the power of bottom-line management and creating an ecosystem where strategic financial oversight and robust timekeeping practices meet evolved client relations, says Shireen Hilal at Maior Strategic Consulting.

  • 5th Circ. Ruling Reminds Attys That CBP Can Search Devices

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    The Fifth Circuit’s recent Malik v. Department of Homeland Security decision adds to the chorus of federal courts holding that border agents don’t need a warrant to search travelers’ electronic devices, so attorneys should consider certain special precautions to secure privileged information when reentering the U.S., says Jennifer Freel at Jackson Walker.

  • ESG Around The World: European Union

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    As the EU makes ESG regulation a priority, companies — both those based in the EU and others just doing business there — need to keep abreast of myriad new legislation that has either already taken effect or will in the near future, as noncompliance could result in fines, damages and director liability, say attorneys at Steptoe & Johnson.

  • Avoiding The Ethical Pitfalls Of Crowdfunded Legal Fees

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    The crowdfunding of legal fees has become increasingly common, providing a new way for people to afford legal services, but attorneys who accept crowdsourced funds must remember several key ethical obligations to mitigate their risks, say Hilary Gerzhoy and Julienne Pasichow at HWG.

  • 4 Pharma Industry Arguments Against CMS Drug Pricing Plan

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    The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.

  • Issues Ahead As Psychedelic Medicine Faces Pivotal Moment

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    Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.

  • An Overview Of 6 PBM Bills Moving Through Congress

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    As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

  • 10th Circ. ERISA Ruling Is Promising For Self-Funded Plans

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    Though some recent appellate decisions have seemingly narrowed application of Employee Retirement Income Security Act preemption, which generally helps protect self-funded health plans from state regulation, the Tenth Circuit's decision in PCMA v. Mulready takes a big step toward reaffirming preemption, say attorneys at Bass Berry.

  • What Large Language Models Mean For Document Review

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    Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.

  • Checking In On How SuperValu Has Altered FCA Litigation

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    Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.