Policy & Compliance

  • August 06, 2025

    States Urge Justices To Back Med Mal Laws In Federal Court

    Tennessee and 26 other states on Wednesday urged the U.S. Supreme Court to hold that state statutes requiring an expert affidavit in all medical malpractice suits may be applied in federal court, arguing that overriding these laws under federal procedure rules would undermine state authority.

  • August 06, 2025

    Compelling ERISA Arbitration No Sure Thing, 9th Circ. Shows

    The Ninth Circuit aligned with several other federal appeals courts when it recently struck down a clause in a food service company's employee health plan that barred class or representative actions, marking the latest in a series of setbacks for employers looking to push federal benefits suits into solo arbitration.

  • August 06, 2025

    Texas Hospital Should Face Retirement Plan Suit, Judge Says

    A Houston hospital shouldn't dodge a proposed class action claiming it failed to remove a J.P. Morgan fund from its $2.8 billion employee retirement plan despite the investment option's consistent underperformance, a Texas federal magistrate judge recommended Wednesday, saying the allegations are solid enough to stay in court.

  • August 06, 2025

    Spinal Implant Co. CEO Avoids Prison After Plea Deal

    The founder and CEO of Massachusetts medical device maker SpineFrontier was sentenced Wednesday to a year of supervised release, the first six months on home confinement, for directing employees to mislead the government about the nature of payments to a surgeon who was using the company's products.

  • August 06, 2025

    State AGs Want Final OK For $39M Apotex Price-Fixing Deal

    Nearly every state attorney general in the country has asked a Connecticut federal judge to give final approval to a $39.1 million deal to settle claims that drugmaker Apotex Corp. schemed with others to fix prices and allocate markets for generic drugs, noting that the Florida-based company has already made the payment.

  • August 05, 2025

    Crowell Lands 16 Reed Smith Health Partners Across 4 Cities

    Crowell & Moring LLP announced Wednesday that it is expanding its healthcare practice with dozens of attorneys from Reed Smith LLP, including 16 healthcare litigation partners based in Chicago, Los Angeles, San Francisco and Dallas, where the firm is launching a new shop with a former Reed Smith lawyer at the helm.

  • August 05, 2025

    Wash. Judge Questions Injunctions' Scope In Head Start Case

    A Washington federal judge asked attorneys Tuesday to explain how the U.S. Supreme Court's decision concerning nationwide injunctions might impact efforts by a group of Head Start associations to halt federal directives restricting noncitizen access to the program and use of funds for diversity initiatives.

  • August 05, 2025

    OptumRx Urges Panel To DQ Motley Rice In LA Opioid Suit

    OptumRx told a California appellate panel Tuesday that Motley Rice should be disqualified from representing Los Angeles County in a lawsuit alleging it colluded with drugmakers to fuel the opioid crisis, saying the firm violated state law by using confidential information obtained in the case in other lawsuits it's handling against Optum.

  • August 05, 2025

    Key Opioid Theory Actually Irrelevant, Drug Cos. Tell 4th Circ.

    With federal judges in West Virginia suddenly split over the central legal theory in opioid litigation, major drug distributors are insisting the theory actually doesn't matter, telling the Fourth Circuit it can uphold their triumph in a landmark trial without even touching the hot-button issue.

  • August 05, 2025

    Law, Medical School Orgs Face Application Fee Antitrust Suits

    The Law School Admission Council and the Association of American Medical Colleges have each been hit with a proposed class action in Pennsylvania and D.C. federal courts, respectively, by candidates who said the nonprofits conspired with their member schools to charge excessive application fees that have been fixed at the same price regardless of the school.

  • August 05, 2025

    Ex-USPTO Heads, Judges Oppose Anti-Patent Thicket Bill

    A pro-innovation group composed of former U.S. Patent and Trademark Office officials and former Federal Circuit judges on Tuesday asked Congress to oppose a bill introduced last month that would limit so-called patent thickets used by pharmaceutical companies to restrict the production of generic counterparts to their drugs.

  • August 05, 2025

    UBH Patients Score Partial Win In Mental Health Claims Fight

    A California federal judge handed a partial win Tuesday to a class of participants in employee health benefit plans who sought coverage for mental health and substance use disorder treatments from United Behavioral Health, holding the company's overly restrictive guidelines breached fiduciary duties under federal benefits law.

  • August 05, 2025

    A Free Exercise 'Blueprint' In Colo. Abortion Reversal Order

    A Colorado federal judge's decision to allow medication abortion "reversals" on free exercise grounds could serve as a model for other lawsuits meant to legitimize a practice that is outside the standard practice of medicine.

  • August 05, 2025

    Meet FDA Chief Counsel Sean Keveney

    The new top attorney at the U.S. Food and Drug Administration, described as a "tremendous technical lawyer," rose through the ranks as a federal prosecutor before helping lead President Donald Trump's confrontation with elite universities this year.

  • August 05, 2025

    'Shocked' By Eye-Watering Fines, Fed. Judges Redo FCA Math

    District courts handling big-dollar False Claims Act cases are increasingly wrestling with the Eighth Amendment ban on excessive fines as more defendants go to trial and face whopping jury verdicts. An order last month in a New York case reducing an FCA penalty was the third of its kind in 18 months.

  • August 05, 2025

    Law Profs Urge 11th Circ. To Toss Judge-Shopping Sanctions

    A group of seven law school professors is urging the Eleventh Circuit to toss a sanctions ruling against three attorneys for judge shopping, arguing that federal law does not forbid the practice and citing the "potentially chilling effect the order will have on counsel, especially those involved in pro bono representation."

  • August 05, 2025

    Teva Settles Claims Over Delayed Generic Asthma Inhalers

    Teva Pharmaceuticals has settled a 2023 lawsuit by a coalition of union healthcare funds accusing the company of thwarting the introduction of a generic version of its QVAR inhalers to the market, according to a filing in Massachusetts federal court.

  • August 05, 2025

    Epstein Becker Adds NJ Health Duo From Wilentz Goldman

    Epstein Becker Green has added two attorneys from New Jersey firm Wilentz Goldman & Spitzer PA to bolster its healthcare and life sciences practice, including one it is welcoming back to the firm.

  • August 05, 2025

    Medicaid Cuts May Worsen Incarceration-Linked Death Risks

    A new public health investigation reveals an association between incarceration and elevated risk of early death, not only for people who have been behind bars but for entire communities. Experts caution that impending disinvestment in Medicaid could worsen outcomes in vulnerable populations.

  • August 05, 2025

    A Texas 'Pressure Test' For State Abortion Shield Laws

    A first-of-its-kind federal suit filed in Texas against a California doctor who prescribed abortion pills to the plaintiff's girlfriend promises to "pressure test" reproductive care shield laws in states where abortion remains legal.

  • August 04, 2025

    Feds Get 2nd Crack At Regeneron FCA Case After Key Ruling

    The government may pursue an alternate theory of its False Claims Act kickback case against Regeneron Pharmaceuticals Inc. and try again for a pretrial win after a First Circuit ruling created a "critical shift" in the law, a Massachusetts federal judge said Monday.

  • August 04, 2025

    Holland & Knight Adds King & Spalding Health Pro In Houston

    Holland & Knight LLP announced Monday that it has made a valuable addition to its healthcare team with a partner in Houston who came aboard after 17 years with King & Spalding LLP.

  • August 04, 2025

    Religious Carveout Sinks Nurse's Vax Bias Suit, 8th Circ. Says

    The Eighth Circuit refused to reinstate a religious discrimination suit from a nurse who said a Catholic hospital unlawfully fired her for rejecting its COVID-19 vaccination mandate, ruling the institution is shielded from liability under Title VII's exception for religious organizations.

  • August 01, 2025

    AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care

    The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.

  • August 01, 2025

    States Urge High Court To Keep NIH Grant Funds Flowing

    A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.

Expert Analysis

  • 2 Anti-Kickback Developments Hold Lessons For Biopharma

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    The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

  • Tips For Pharma-Biotech Overlap Reporting In New HSR Form

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    While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.

  • A Look At Drug Price Negotiation Program's Ongoing Impact

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    More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.

  • Preparing For A Possible End To The Subminimum Wage

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    The U.S. Department of Labor's proposed rule to end the subminimum wage for employees with disabilities may significantly affect the community-based rehabilitation and training programs that employ these workers, so certified programs should be especially vigilant about compliance during this period of evaluation and scrutiny, say attorneys at Jackson Lewis.

  • Drug Pricing Policy Trends To Expect In 2025 And Beyond

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    Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.

  • Top 10 Healthcare And Life Sciences Issues To Watch In 2025

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    Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.

  • 4 Keys To Litigating In An Active Regulatory Environment

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    For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.

  • How Views On Healthcare Price Transparency Are Changing

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    Regulators' attitudes toward price transparency regulation have shifted over the past several years in ways that may seem contradictory, and research into detailed rate information published by hospitals and health plans has yielded mixed results, says Matthew List at Charles River Associates.

  • EEOC Wearable Tech Guidance Highlights Monitoring Scrutiny

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    The U.S. Equal Employment Opportunity Commission's recent fact sheet on wearable technologies cautions against potential issues with federal anti-discrimination laws and demonstrates growing concern from regulators and legislators about intrusive technologies in the workplace, say attorneys at Littler.

  • Navigating The Potential End Of GLP-1 Drug Shortages

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    The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.

  • Politicized OIGs Could Target Federal Employees, Contractors

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    After President Donald Trump fired nearly 20 inspectors general last week, it’s worth exploring how the administration could use Offices of Inspectors General to target federal employees and contractors, why it would be difficult to fight this effort, and one possible bulwark against the politicization of these watchdogs, says Sara Kropf at Kropf Moseley.

  • Takeaways From DOJ Fraud Section's 2024 Year In Review

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    Attorneys at Paul Weiss highlight notable developments in the U.S. Department of Justice Fraud Section’s recently released annual report, and discuss what the second Trump administration could mean for enforcement in the year to come.

  • IVF Suits Highlight Need For Better Legal Frameworks

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    The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.