Policy & Compliance

  • February 11, 2025

    Novo Nordisk Mostly Escapes Insulin Pen Contamination Suit

    Novo Nordisk has, for now, beaten much of a Connecticut-based hospital's federal lawsuit seeking to hold it financially responsible for the $1 million settlement the hospital paid to patients potentially exposed to blood-borne infections after the medical staff used the pharma company's product.

  • February 11, 2025

    Colo. Justices Mull Statute's Silence In Med Mal Cap Debate

    The Colorado Supreme Court on Tuesday pressed a doctor on why it should cap a patient's prefiling interest in a medical malpractice case when lawmakers didn't clearly state whether an exception to a damages cap applies.

  • February 11, 2025

    Federal Healthcare Attys Look For Exits Amid Trump Upheaval

    Amid President Donald Trump's aggressive moves to slash the federal workforce, government healthcare attorneys are job hunting in the private sector en masse as they look to get ahead of potential layoffs and beat the crowd out the door.

  • February 11, 2025

    Split 3rd Circ. Keeps Merck Vaccine Antitrust Panel Immunity

    The full Third Circuit refused to reconsider a ruling that immunized Merck & Co. from antitrust claims over submissions it made to federal regulators for its mumps vaccine, over the objection of a trio of appellate judges.

  • February 11, 2025

    Former HHS Drug Pricing Atty Returns To Covington

    Covington & Burling LLP said Tuesday a former partner who most recently served at the U.S. Department of Health and Human Services working on drug pricing negotiation programs will return to the firm's healthcare and life sciences practice groups in Washington, D.C. 

  • February 11, 2025

    Insurer Says $641M Deal Over Tainted Flint Water Not Covered

    An insurer told a Michigan federal court Tuesday that it shouldn't have to pay any part of a $641 million settlement reached by a Flint, Michigan, medical center on behalf of patients who supposedly suffered from legionella and lead exposure because of unclean drinking water in the facility.

  • February 11, 2025

    Abortion Bans, State Shield Laws Tee Up Extradition Conflict

    The decision by Louisiana officials to bring a criminal case against a New York doctor for providing abortion medications online has set the stage for a new battle over states' duties to hand over defendants accused of fleeing justice in another state.

  • February 11, 2025

    A 'Disaster For Science': Universities Sue Over NIH Grant Cap

    Research universities and higher education organizations on Tuesday requested an order from a Massachusetts federal court to halt the Trump administration from capping indirect costs for grants from the National Institutes of Health, one day after a separate Bay State federal judge paused the change from taking effect in a case brought by a group of state attorneys general.

  • February 11, 2025

    Chiropractors As Expert Medical Witnesses: 3 Cases To Know

    A recent Michigan appellate decision builds on a growing volume of case law addressing when chiropractors can weigh in as medical experts in court. Law360 looks at that decision and others that have shaped the standard for expert testimony from chiropractors.

  • February 11, 2025

    CVS, Aetna Escape Testing Lab's $20.6M Unpaid Invoices Suit

    A Connecticut federal judge threw out a testing laboratory's lawsuit seeking $20.6 million in unpaid invoices from Aetna Inc. and its owner CVS Health Corp., saying the complaint lacked detail and left the companies "guessing" which allegations corresponded to which claims.

  • February 11, 2025

    DC Judge Orders Restoration Of Public Health Webpages

    A D.C. federal judge on Tuesday ordered federal agencies to revive public health webpages and datasets taken offline as part of the Trump administration's effort to root out references to "gender ideology."

  • February 10, 2025

    DC Judge Questions Abrupt Removal Of Public Health Info

    A D.C. federal judge said he was wrestling with some "circular" arguments offered by the government on Monday as he weighed whether to order the restoration of public health web pages and datasets that had been taken down by the Trump administration.

  • February 10, 2025

    UnitedHealth Says Fed Suit Imperils Deal's Many Benefits

    UnitedHealth Group and home health and hospice giant Amedisys Inc. responded to the U.S. Department of Justice's merger challenge Friday by telling a Maryland federal judge that the government is taking quotes out of context, focusing on "artificially narrow geographic markets" and misjudging market realities.

  • February 10, 2025

    Harvard Immunity For Body Part Thefts 'Gnaws' At Justice

    A judge on Massachusetts' highest court said Monday it's "problematic" that a state law could shield Harvard Medical School from liability in a suit by family members of people whose remains were allegedly sold off in parts by a rogue mortician.

  • February 10, 2025

    UnitedHealthcare Fined $3.4M In NC Over Billing Shortfalls

    UnitedHealthcare of North Carolina Inc. and its insurance affiliate got fined $3.4 million by the Tar Heel State's insurance regulator for failing to follow its own policies for negotiating with out-of-network providers to keep extra costs off of its policyholders.

  • February 10, 2025

    Mass. Judge Temporarily Blocks NIH Funding Cuts

    A Massachusetts federal judge issued a temporary hold Monday on a Trump administration plan to slash grant funding provided by the National Institutes of Health after 22 states sued to block the cuts.

  • February 10, 2025

    Trump Admin Violating Order To Unfreeze Funds, Judge Says

    A Rhode Island federal judge ruled Monday the Trump administration is not complying with the court's temporary restraining order barring a freeze on funding for federal grants and programs, ordering the administration to immediately restore the frozen funds.

  • February 07, 2025

    70 Depo-Provera Suits Joined In Florida's Northern District

    The U.S. Judicial Panel on Multidistrict Litigation on Friday consolidated more than 70 consumer lawsuits claiming that Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive drug Depo-Provera in the Northern District of Florida.

  • February 07, 2025

    CFPB's Medical Debt Rule Halted For 90 Days By Texas Judge

    A Texas federal judge has issued a 90-day halt on an approaching effective day for a Consumer Financial Protection Bureau rule banning medical debt from credit reports, a day after the agency's new leadership said it needed time to consider the rule trade groups have sued to end.

  • February 07, 2025

    Trump Drops High Court Opposition To Transgender Care Ban

    The federal government on Friday changed course in a U.S. Supreme Court case challenging a Tennessee ban on transgender care for minors, telling the court that the Trump administration's position is that the statute does not deny equal protection on the basis of sex.

  • February 07, 2025

    Under The Radar: Bankruptcy News You May Have Missed

    A onetime financial adviser to UpHealth is opposing the debtor's Chapter 11 plan, Hearthside Food Solutions' official committee of unsecured creditors has balked at the company's executive bonus proposal in bankruptcy, and one-time investors in defunct real estate investment firm RealtyShares willingly dismissed a suit against the firm's former directors, litigation that had outlived the firm's Chapter 7 by more than a year.

  • February 07, 2025

    Chicago Hospital Network Inks $850K Retirement Suit Deal

    A Chicago-area hospital system will pay $850,000 to settle an ex-worker's proposed class action alleging it violated federal benefits law by failing to leverage the size of its $1.8 billion employee retirement plan to lower recordkeeping fees, according to filings Friday in Illinois federal court.

  • February 07, 2025

    Wash. AG Sues To Block 'Hateful' Trump Transgender Edict

    Washington, Minnesota and Oregon, along with three unnamed doctors, seek to block President Donald Trump's order targeting transgender youth and their medical providers, arguing in a complaint filed Friday in Seattle federal court that the Trump edict is unconstitutional, discriminates against transgender people and interferes with lifesaving healthcare.

  • February 06, 2025

    Doctors Org. Wants Health Agency Website Info Restored

    An advocacy organization representing physicians asked a Washington, D.C., federal judge Thursday to require federal agencies to restore public-health related web pages and data that were taken down after the Office of Personnel Management directed the agencies to root out references to "gender ideology" on their websites.

  • February 06, 2025

    6th Circ. Uncertain If Health Plan Administrator Is A Fiduciary

    A yacht-maker urged the Sixth Circuit on Thursday to revive its lawsuit accusing Blue Cross Blue Shield of Michigan of overpaying employee health plan claims so it could profit off of savings recovered later, but faced tough questions about whether plan administrator BCBSM was a fiduciary under federal benefits law.

Expert Analysis

  • 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.

  • Takeaways From FDA's Updated Confirmatory Trial Guidance

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    The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.