Policy & Compliance

  • August 28, 2025

    DOJ Seeks Kroger Patient Data In Opioid FCA Probe

    The U.S. Department of Justice urged an Ohio federal court to order The Kroger Co. to turn over patient names and other health information the supermarket chain has redacted in responses to the government throughout a False Claims Act investigation into its opioid dispensing practices.

  • August 28, 2025

    Unions Urge Judgment Blocking DOGE's Agency Access

    Unions and advocacy groups asked a Washington, D.C., federal judge Thursday for a win before trial in their lawsuit claiming agencies unlawfully provided Elon Musk's Department of Government Efficiency access to sensitive data, saying the agencies departed from their usual data access procedures without explanation.

  • August 28, 2025

    AstraZeneca Challenges Colo. Law Over Drug Pricing Rules

    Pharmaceutical giant AstraZeneca told a Colorado federal judge Wednesday that a recently passed state law aiming to extend a federal drug discount program to certain pharmacies is preempted by the same law that created the program.

  • August 28, 2025

    J&J Unit Can't Shake $442M Loss In Catheter Antitrust Suit

    A California federal judge has refused to upend the $442 million trial loss of Johnson & Johnson's Biosense Webster health tech unit to Innovative Health, finding the jury was presented with sufficient evidence to fault Biosense for conditioning product support for its cardiac mapping systems on the purchase of cardiac catheters.

  • August 28, 2025

    Bid For DQ From FCA Suit Over AI Use 'Drastic,' Relator Says

    The unexpected disclosure that an expert witness misused artificial intelligence should not be enough to essentially doom a False Claims Act fraudulent billing suit, the case's relator told a Salt Lake City federal judge, arguing a sanctions bid brought by the anesthesiologist defendants is "grossly disproportional" to the error he already sought to rectify.

  • August 28, 2025

    Bradley Arant Taps Parker Hudson Healthcare Atty In Atlanta

    Bradley Arant Boult Cummings LLP announced Thursday that it continued its Atlanta growth with the addition of a new healthcare practice group partner from Parker Hudson Rainer & Dobbs LLP.

  • August 28, 2025

    SC Ends Sandoz, Novartis Price-Fixing Claims For $2.4M

    A Connecticut federal judge on Thursday approved South Carolina's request to dismiss its generic drug price-fixing claims from three multistate lawsuits against Sandoz Inc., Sandoz AG, Novartis AG and Fougera Pharmaceuticals Inc., four months after the parties filed a notice of settlement.

  • August 28, 2025

    Fed. Circ. Won't Upend Toss Of Flu Vaccine Injury Claim

    The Federal Circuit won't revive a man's vaccine injury claim after it was rejected by a special master at the U.S. Court of Federal Claims, finding the decision that his injuries were caused by a separate infection was not arbitrary or capricious.

  • August 27, 2025

    HHS Says CDC Head Has Been Fired. She Says Otherwise.

    Centers for Disease Control and Prevention director Susan Monarez said Wednesday that she's not resigning and also that she cannot be terminated except by the president himself, issuing a statement after CDC parent agency U.S. Department of Health and Human Services said she was "no longer director."

  • August 27, 2025

    DOJ Throws Lifeline To J&J At 3rd Circ. After $1.6B FCA Loss

    A district judge made multiple errors in an opinion and jury instructions underpinning a staggering False Claims Act verdict tied to Johnson & Johnson's drug marketing practices, and a fresh look is needed "under a correct view of the law," the U.S. Department of Justice told the Third Circuit on Wednesday.

  • August 27, 2025

    7th Circ. Denies Alcoa's Bid To Stay Health Benefits Injunction

    An aluminum manufacturer must comply with an injunction ordering it to reinstate union-represented retirees' healthcare benefits while it argues in court that it was allowed to transition them to health reimbursement accounts in 2021, the Seventh Circuit held, rejecting the company's request for the court to pause the injunction.

  • August 27, 2025

    CVS To Pay $12M To Settle Mass. Medicaid Overbilling Claims

    CVS Pharmacy Inc. will pay more than $12 million to settle allegations that it charged Massachusetts' Medicaid program higher prices than it offered to the public for the same drugs, the state attorney general announced Wednesday.

  • August 27, 2025

    6th Circ. Says Hospital Waived Arbitration In Pronoun Dispute

    The Sixth Circuit reversed an order Wednesday allowing a University of Michigan hospital to arbitrate an ex-worker's suit claiming she was fired out of religious bias for refusing to use preferred pronouns for certain LGBTQ patients, ruling the institution waited too long to invoke an arbitration pact.

  • August 27, 2025

    Scholars Tell High Court To Back Conversion Therapy Ban

    A group of health law experts told the U.S. Supreme Court that Colorado's conversion therapy ban doesn't violate healthcare providers' First Amendment rights, arguing that the law is consistent with states' and the federal government's ability to regulate healthcare.

  • August 27, 2025

    Boehringer Wins Another Zantac Cancer Trial In Ill.

    An Illinois state court jury sided with Boehringer Ingelheim on Wednesday in a man's lawsuit claiming over-the-counter Zantac use contributed to his colorectal cancer development, adding another tally on the German drugmaker's list of victories over similar accusations.

  • August 26, 2025

    Split 9th Circ. Upholds Oregon Pharmaceutical Reporting Law

    A split Ninth Circuit panel on Tuesday vacated a lower court's order blocking an Oregon law requiring drug manufacturers to report information related to certain prescription drugs to the state, ruling that the law is indeed constitutional under both the First and Fifth amendments.

  • August 26, 2025

    DC Circ. Backs HHS In Low-Income Patient Payment Dispute

    The D.C. Circuit has delivered a blow to a group of hospitals in a recent decision finding they had challenged a key component of their Medicare reimbursements too early, despite hospital associations' warnings that such a ruling could slow healthcare providers' ability to seek review and "ultimately harm" patients.

  • August 26, 2025

    Mich. AG Lambasts UMich For Halting Trans Youth Care

    Michigan's attorney general publicly warned the University of Michigan Tuesday that her office was "considering all of our options" after the university's hospital system said it would cease providing gender-affirming care to minors under pressure from the Trump administration. 

  • August 26, 2025

    Maine Medicaid Cuts, Medicare Radiation Ruling And More

    A Maine federal court turned down a family planning organization's request to temporarily block a congressional mandate withdrawing Medicaid funds to abortion providers. In South Carolina, Planned Parenthood filed a new complaint challenging a state policy kicking the provider out of the state's Medicaid program for providing abortions. 

  • August 26, 2025

    Doctors Press 5th Circ. To Reverse Surprise Billing Ruling

    Three physician trade associations urged the full Fifth Circuit to reverse a panel's ruling on how qualifying payments are calculated under the No Surprises Act, writing that the current decision harms underserved communities by narrowing provider networks.

  • August 26, 2025

    Cigna Strikes ERISA Ghost Network Suit Settlement Deal

    Cigna Health and Life Insurance Co. has agreed to settle a proposed class action alleging the health plan administrator violated federal benefits law by advertising providers as in-network who were out-of-network to participants in employer-sponsored health benefit plans that Cigna administered, according to filings in Illinois federal court.

  • August 26, 2025

    Frier Levitt Adds FDA Regulation Specialist Duo

    New Jersey-based national healthcare law boutique Frier Levitt added a partner and senior counsel pair from a life science law boutique this week to expand its expertise in Food and Drug Administration regulation and compliance and the cannabis and hemp industries.

  • August 26, 2025

    TikTok Takes State's Addictive App Case To NC Top Court

    TikTok and its Chinese parent company are taking the state of North Carolina's lawsuit accusing it of intentionally designing the app to addict young users to the state's highest court after a Business Court judge rejected their early exit bid.

  • August 26, 2025

    Foley Hoag Adds Healthcare Co-Leader From Manatt

    Foley Hoag LLP has hired the former president and CEO of the National Hospice and Palliative Care Organization as the new co-chair of its healthcare department.

  • August 25, 2025

    DOJ Wants $10.5M From Convicted Nursing Exec For Fraud

    U.S. Department of Justice prosecutors asked a Nevada federal judge Friday for a $10.5 million preliminary forfeiture order against a nurse staffing executive convicted of wage-fixing, an amount that matches what he was paid for his staffing company after deceiving the buyer into thinking there was no criminal antitrust investigation.

Expert Analysis

  • 10 Noteworthy CFPB Developments From 2024

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    In a banner year for consumer finance regulation, the Consumer Financial Protection Bureau made significant strides in its efforts to rein in Big Tech and nonbank financial firms, including via rules regarding open banking, credit card late fees, and buy now, pay later products, say attorneys at Wiley.

  • The Future Of GLP-1 Policy After Drug Shortage Ends

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    If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

  • Top 10 Whistleblowing And Retaliation Events Of 2024

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    From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.

  • How White Collar Defense Attys Can Use Summary Witnesses

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    Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.

  • Nutraceutical Patent Insights As Market Heats Up

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    Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.

  • How White Collar Attys Can Use Mythic Archetypes At Trial

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    A careful reading of a classic screenwriting guide shows that fairy tales and white collar trials actually have a lot in common, and defense attorneys would do well to tell a hero’s journey at trial, relying on universal character archetypes to connect with the jury, says Jack Sharman at Lightfoot Franklin.

  • What 2024 Election Means For Drugs, Medicare And Medicaid

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    With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.

  • Justices Mull Sex-Based Classification In Trans Law Case

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    After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.

  • Key Takeaways From FDA's Latest Social Media Warnings

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    The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.

  • Rank-And-File DOJ Attorneys Will Keep Calm And Carry On

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    Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.

  • Unpacking Arguments From High Court's Rural Hospital Case

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    During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.

  • Health Policy Predictions For Trump's Second Administration

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    As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.