Policy & Compliance

  • July 23, 2025

    Co., Lenders Hit With Suit Over Medical Spa Financing Scam

    A medical device manufacturer and several financing companies worked together to manipulate boutique clinics and medical spas into purchasing expensive cosmetic devices based on inflated revenue projections and false promises of marketing support, according to a proposed class action filed Monday in California federal court.

  • July 22, 2025

    FCA Draws Heavy Constitutional Fire After $1.6B J&J Verdict

    Reeling from a record fraud verdict tied to drug promotion practices, Johnson & Johnson is pursuing a sweeping constitutional challenge to the False Claims Act, and in filings this week at the Third Circuit, major industry allies rallied behind its views of whistleblower litigants usurping executive branch power.

  • July 22, 2025

    Healthcare In Court: NIH Grant Cuts, Flo Health Trial And More

    A First Circuit panel refused to hit pause on a Massachusetts federal judge's order voiding cuts by the National Institutes of Health to hundreds of grant programs. Meanwhile, in California, a jury trial kicked off over allegations of unlawful information sharing between menstrual app developer Flo Health Inc. and Meta Platforms. 

  • July 22, 2025

    Sandoz Loses 'Nonsense' Bid To Avoid DOJ Deal In AGs' Case

    A Connecticut federal judge has given dozens of state attorneys general a small but important win in a sprawling price-fixing litigation against generic-drug makers, applying previous admissions of criminal wrongdoing and flatly rejecting "ridiculous" efforts by Sandoz, Taro Pharmaceuticals and a former Sandoz official to avoid that application.

  • July 22, 2025

    Ohio Justices Accept AG's Bid To Limit Care For Trans Youths

    The Ohio Supreme Court on Tuesday agreed to review an appeals court's finding that portions of a state law restricting gender-affirming care for transgender youths are unconstitutional. 

  • July 22, 2025

    Employers, Plans Force Freeze Of Iowa's PBM Law

    A federal judge slapped a temporary hold on parts of an Iowa law that aims to limit pharmacy benefit managers' power to set drug prices, ruling that provisions barring discrimination against certain pharmacies and pushing cost-saving strategies are preempted by federal benefits law.

  • July 22, 2025

    4th Circ. Backs Medicaid Fraud Conviction, 17-Year Sentence

    A North Carolina lab owner lost his bid Tuesday to overturn his healthcare fraud conviction after the Fourth Circuit found evidence against him to be sufficient and the terms of his sentence reasonable.

  • July 22, 2025

    NC Hospital Says Dropped Malpractice Claim Dooms 2004 Suit

    A North Carolina hospital is asking state appellate judges to determine whether a hospital can face claims of negligently credentialing a doctor if the plaintiffs have dropped the underlying medical malpractice allegation against the physician.

  • July 22, 2025

    Medicaid Cuts To Raise Staffing Pressure On Nursing Homes

    Massive changes coming to Medicaid are expected to push more seniors reliant on state-supported services into nursing homes, adding pressure to a system already struggling with staffing and quality of care issues.

  • July 22, 2025

    Lawmakers Consider Case Of Would-Be Donor's 'Signs Of Life'

    The nation's organ transplant system is again under the microscope of federal lawmakers after a federal investigation found that a Kentucky organ procurement organization moved forward with the transplant process despite the patient showing "signs of life."

  • July 22, 2025

    Judge Blocks Some Planned Parenthood Cuts In Partial Ruling

    A Massachusetts federal judge partially blocked a measure passed by Congress this month stripping Medicaid funding from Planned Parenthood-affiliated facilities, but only as it applies to those that do not provide abortions or that receive minimal federal support.

  • July 22, 2025

    A Billing Code 'Ambiguity' Retrial: 3 Things To Know

    A Maryland doctor found guilty by a federal jury two years ago in a COVID-19 testing scheme, only to see his conviction thrown out, is once again facing a criminal trial. Law360 Healthcare Authority examines the restarted prosecution and talks to experts about what makes the case so unusual.

  • July 21, 2025

    Wash. Plastic Surgeon Can't Get $13M Jury Verdict Overturned

    A Washington appeals court panel refused on Monday to undo a $13 million jury verdict against a plastic surgeon in a medical malpractice case, rejecting the doctor's argument that the lower court wrongly allowed evidence of state regulators' unrelated disciplinary proceedings against her.

  • July 21, 2025

    Pa. Hospital Can Shield Some Docs In Birth Injury Suit

    A Pennsylvania state appeals panel won't force a hospital to turn over all of its internal reports in a suit by parents alleging that the hospital's negligence led to their son's injuries at birth, finding that the hospital sufficiently showed that two of the three contested files are privileged.

  • July 21, 2025

    States Say Noncitizen Benefit Restrictions Are Creating Chaos

    A coalition of 20 Democratic-led states and the District of Columbia sued the Trump administration on Monday for "upending" noncitizens' access to publicly funded programs like Head Start and food banks.

  • July 21, 2025

    Trump Admin's Harvard Cuts Vex Judge: 'Staggering To Me'

    A Massachusetts federal judge said Monday that the Trump administration has not presented evidence that Harvard has failed to address antisemitism on its campus and expressed bewilderment at the government's legal justifications for cutting $2.2 billion in funding.

  • July 21, 2025

    Hartford Unit Must Cover Drug Test Co. In False Results Suit

    A Hartford unit must cover a drug testing company in a suit over false positive tests, a Virginia federal court ruled, finding that the suit was not related to a prior proposed class action filed during another insurer's coverage period.

  • July 18, 2025

    Law360 Names 2025's Top Attorneys Under 40

    Law360 is pleased to announce the Rising Stars of 2025, our list of more than 150 attorneys under 40 whose legal accomplishments belie their age.

  • July 18, 2025

    Kaiser's $11M Class Meal Break Deal Gets Final OK In Wash.

    A Washington state judge gave the final green light on Friday to a nearly $11 million class deal to end claims that Kaiser Permanente shortchanged Evergreen State employees who worked through their meal breaks, while also awarding class counsel $3.6 million in legal fees from the settlement fund.

  • July 18, 2025

    Investor Sues Biotech Capricor After Product's FDA Denial

    Biotechnology company Capricor Therapeutics Inc. faces a proposed investor class action alleging it misrepresented its lead product candidate's approval prospects before the U.S. Food and Drug Administration.

  • July 18, 2025

    Judge Advised Against State AG Intervention In Sandoz Deal

    A special master on Friday advised a Pennsylvania federal court to deny a bid by California and other state attorneys general to intervene in a $275 million settlement resolving generic-drug price-fixing claims against Sandoz, finding they lacked standing to represent the interests of consumers.

  • July 18, 2025

    Judge Questions Basis For Planned Parenthood Funding Cuts

    A Massachusetts federal judge on Friday pressed the government for any plausible rationale, besides retaliation, for a provision in Congress' budget reconciliation that will prevent Planned Parenthood and its affiliates from receiving Medicaid reimbursements if any one of them offers abortion services.

  • July 18, 2025

    Pillsbury Atty Fights Sanctions In Nurse Wage-Fixing Case

    A partner with Pillsbury Winthrop Shaw Pittman LLP told a Nevada federal court he should not be sanctioned for using a poor choice of words when communicating with the government about the availability of an expert witness during a wage-fixing and wire fraud trial.

  • July 17, 2025

    21 States Fight ACA Rule They Say Guts Health Coverage

    A 21-state coalition led by the attorneys general of California, Massachusetts and New Jersey sued the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services on Thursday, challenging a new Trump administration rule they say unlawfully undermines access to healthcare under the Affordable Care Act.

  • July 17, 2025

    Senators Float 'Patent Thicket' Bill To Limit Generic Litigation

    A bill floated in the U.S. Senate would limit the use of so-called patent thickets that are asserted by major pharmaceutical companies in litigation to restrict generic competition.

Expert Analysis

  • FCA Working Group Reboot Signals EHR Compliance Risk

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    The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.

  • FDA's Hasty Policymaking Approach Faces APA Challenges

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    Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

  • The Metamorphosis Of The Major Questions Doctrine

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    The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

  • A Rapidly Evolving Landscape For Noncompetes In Healthcare

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    A wave of new state laws regulating noncompete agreements in the healthcare sector, varying in scope, approach and enforceability, are shaped by several factors unique to the industry and are likely to distort the market, say attorneys at Seyfarth.

  • Arguing The 8th Amendment For Reduction In FCA Penalties

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    While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.

  • $95M Caremark Verdict Should Put PBMs On Notice

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    A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.

  • DOJ Actions Signal Rising Enforcement Risk For Health Cos.

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    The U.S. Department of Justice's announcement of a new False Claims Act working group, together with the largest healthcare fraud takedown in history, underscore the importance of sophisticated compliance programs that align with the DOJ's data-driven approach, say attorneys at Debevoise.

  • Spotlight On Medicare Marketing Practices Enforcement Trend

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    Recent U.S. Department of Justice actions, including its recent Medicare kickback allegations in Shea v. eHealth, demonstrate increasing enforcement scrutiny on Medicare Advantage marketing practices, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Erica Hitchings at the Whistleblower Law Collaborative.

  • Federal Regs Order May Spell Harsher FDCA Enforcement

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    A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

  • What High Court's Tenn. Trans Care Ruling Means Nationally

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    The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

  • High Court ACA Ruling May Harm Preventative Care

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    The U.S. Supreme Court's decision in Kennedy v. Braidwood last week, ruling that the U.S. Department of Health and Human Services secretary has authority over an Affordable Care Act preventive care task force, risks harming the credibility of the task force and could open the door to politicians dictating clinical recommendations, says Michael Kolber at Manatt.

  • Rising Enforcement Stakes For Pharma Telehealth Platforms

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    Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

  • 3 Judicial Approaches To Applying Loper Bright, 1 Year Later

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    In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.