Policy & Compliance

  • May 02, 2024

    Endo Judge Hopes Criminal Sentence Warns Opioid Makers

    A Michigan federal judge said Thursday she hoped Endo's criminal sentence for falsely advertising a pain medication as "abuse deterrent" would itself be a deterrent for other opioid makers, as she accepted the company's recent $200 million settlement deal with federal prosecutors. 

  • May 02, 2024

    Feds Call Out Gilead's Efforts To Revise HIV Drug IP Judgment

    The U.S. Department of Justice has asked a Delaware federal judge to reject Gilead Sciences' motion to modify a judgment finding that two medications in its HIV prevention regimen directly infringe voided patents owned by the government, arguing that the pharmaceutical company's attempt to rewrite the judgment is "unnecessary as well as improper."

  • May 02, 2024

    Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.

    Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.

  • May 02, 2024

    Biden Announces $3B To Fund Lead Pipe Replacement

    The Biden administration is distributing $3 billion to states so they can replace lead water pipes that pose a health risk to those who rely on them for drinking water, as part of the larger goal to remove all lead service lines nationwide.

  • May 02, 2024

    State Legislators Urge Feds To Change Cannabis' Status

    A coalition of state lawmakers on Thursday urged the heads of the U.S. Department of Justice and its drug enforcement agency to prioritize changing cannabis' status as a highly restricted drug.

  • May 01, 2024

    Sens. Slam UnitedHealth's Security Lapses, Breach Response

    UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.

  • May 01, 2024

    Ariz. AG Warns Repeal Of 1864 Abortion Ban May Be Too Late

    Legislation narrowly adopted Wednesday to repeal Arizona's 1864 abortion law won't be enough on its own to keep the near-total ban from taking effect this summer, the state attorney general warned, because the bill lacks an emergency clause.

  • May 01, 2024

    J&J Unit Cuts Deal To End Cancer Drug Trade Secret Fight

    A New Jersey federal judge has signed off on a consent judgment that permanently bars Chinese drugmaker Jiangsu Hengrui Pharmaceuticals Co. from misappropriating Johnson and Johnson's pharmaceutical subsidiary Janssen's trade secrets for its popular chemotherapy drug Yondelis.

  • May 01, 2024

    5th Circ. Judge Skeptical Of Medicare Drug 'Price-Setting'

    A Fifth Circuit judge on Wednesday sharply criticized the Biden administration's Medicare drug pricing program, characterizing it as government "price-setting" and questioning "what possible procompetitive justification" there can be for penalizing companies that don't participate.

  • April 30, 2024

    Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue

    The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.

  • April 30, 2024

    Judge Strikes Parts Of NC Law Restricting Abortion Drug

    A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.

  • April 30, 2024

    BCBS Says Federal Drug Law Preempts NM Medical Weed Row

    A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.

  • April 30, 2024

    Aetna Resists State Court Remand In Provider Payment Suit

    A lawsuit alleging Aetna units have underpaid emergency healthcare workers' benefit claims should be heard in an Ohio federal court, the insurer said in opposing a remand to the state level, based in part on the argument that two of the corporate defendants don't belong in the case.

  • April 30, 2024

    Biden Rocks Healthcare Space With Rule After Rule

    Using federal agencies as its instrument, the Biden administration pumped out numerous healthcare and life sciences rules in the past week, ranging from addressing discrimination in healthcare to requiring health apps to report data breaches to consumers.

  • April 30, 2024

    FTC Continues To Target 'Junk' Drug Patents

    Federal trade officials told a series of pharmaceutical companies — including the makers of the controversial diabetes and weight loss drug Ozempic — that they may have listed faulty patents in a key register of a federal drug database.

  • April 30, 2024

    High Court's Conscience Concerns Offer Docs Little Guidance

    At oral arguments in both abortion cases to reach the nation's top court this term, justices parried with the federal government over the knotty topic of doctors raising a personal objection to providing an abortion to a patient suffering a medical crisis.

  • April 30, 2024

    'Global' Budgets May Fix Hospital Spending. Will States Try It?

    An ambitious experiment is underway that could shake up healthcare spending by moving providers away from a traditional fee-for-service model in favor of "global" hospital budgets. But with deadlines looming, the voluntary, "total cost of care" model can't deliver without state buy-in.

  • April 30, 2024

    6th Circ. Weighs Merits, Procedure In NLRB Severance Case

    The Sixth Circuit grappled Tuesday with a hospital's challenge to the National Labor Relations Board's ruling that it unlawfully offered severance agreements that muzzled workers, with one judge questioning how the agreements interfered with workers' rights and another whether the hospital was even entitled to oppose the new standard.

  • April 30, 2024

    New Staffing Minimums Rattle Nursing Home Industry

    A new Biden administration rule that sets minimum staffing standards for nursing homes could reshape the industry, intensifying the competition to hire nurses and exposing the facilities to new litigation and financial risks, healthcare attorneys say.

  • April 30, 2024

    Tougher Privacy Rule Won't End Abortion Data Fight

    Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.

  • April 30, 2024

    Texas, Washington Spar In Rare Interstate Gender Care Clash

    An investigation launched by the Texas attorney general into medical care 1,700 miles away in Washington triggered an unusual burst of litigation and a settlement, illustrating a potential new front in the legal fight over transgender rights.

  • April 29, 2024

    ReNew Health To Pay $7M To Settle COVID-19 FCA Claims

    ReNew Health Group LLC has agreed to pay the federal government and California $7 million to settle whistleblower allegations that the healthcare provider misused a COVID-19 waiver intended to free up hospital beds by submitting fraudulent claims for nursing home residents, the U.S. Department of Justice announced Friday.

  • April 29, 2024

    Pfizer Inks $25M Deal Ending Leftover Effexor Antitrust Claims

    A proposed class of indirect buyers have asked a New Jersey federal judge to greenlight a $25.5 million settlement to end allegations that Pfizer unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant Effexor XR.

  • April 29, 2024

    Judge Rejects 2 Challenges To Medicare Drug Price Talks

    A New Jersey federal judge on Monday shot down a pair of challenges to the Medicare drug price negotiations, extending a string of court victories for the Biden administration as it defends the talks as entirely voluntary.

  • April 29, 2024

    9th Circ. Scraps Trans Law Opinion After High Court Ruling

    The Ninth Circuit on Monday scrapped its 2023 opinion blocking an Idaho law that would have banned transgender women from competing in sports following the U.S. Supreme Court's recent decision allowing enforcement of another Idaho law permitting a ban on gender-affirming care for minors, explaining that a revised opinion is needed.

Expert Analysis

  • 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.

  • Children's Book Writing Makes Me A Better Lawyer

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    Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.

  • The State Of CFPB Focus On Credit Reporting Of Medical Debt

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    An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.

  • FDA's Recent Litigation Records Are Strong, But Imperfect

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    The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.