Policy & Compliance

  • April 14, 2026

    Mich. AG Says PBMs Can't Duck Drug-Pricing Suit

    Two pharmacy benefit managers can't dodge an antitrust lawsuit accusing them of price-fixing reimbursement rates because Michigan has properly claimed an antitrust violation, state Attorney General Dana Nessel told a federal court, asking it to toss aside the PBMs' dismissal bid. 

  • April 14, 2026

    Vehicle Co. Inks $150K Deal To End Tobacco Fee Suit

    International Motors LLC, formerly Navistar, has agreed to pay $150,000 to resolve a suit claiming the company illegally charged workers an extra $600 a year if they used tobacco without giving them a proper avenue to dodge the fee, according to an Illinois federal court filing.

  • April 14, 2026

    Screening Time Deal Doesn't Bar Break Suit, Wash. Panel Says

    An eldercare company's class settlement over COVID-19 screening time doesn't bar a separate suit claiming the company failed to pay workers for missed meal breaks, a Washington state appeals court ruled, reviving the break claims.

  • April 13, 2026

    Ill. Judge Wants More Proof To Recalculate Kickback Damages

    An Illinois federal judge tasked with recalculating damages from a home health company's referral kickback scheme said Monday that she needs more complete and reliable evidence to help determine the appropriate amount, but allowed the government to continue offsetting Medicare payments as part of its judgment collection bid.

  • April 13, 2026

    Mylan Can't Revive Copaxone Antitrust Claims Against Teva

    A New Jersey federal judge sided Monday with a special master's recommendations to nix some of the parallel claims from Mylan and retailers like Walgreens accusing Teva of using regulatory deception, false advertising, improper rebates and more to delay generic competition to its Copaxone multiple sclerosis treatment.

  • April 13, 2026

    Abbott Urges Toss Of Relator, State Suits In FCA Recall Row

    Abbott Laboratories urged a Michigan federal court to throw out litigation brought by whistleblowers and a group of states over the 2022 infant formula shortage, saying their respective complaints lacked the details necessary to support claims that it defrauded numerous healthcare programs.

  • April 10, 2026

    Chest Binders Become Latest Front In Anti-Trans Litigation

    Chest binders — medical devices that can be used by individuals experiencing gender dysphoria or who want a more gender-neutral alternative to bras — have emerged as the newest target in an unfolding regulatory and legal climate that transgender advocates describe as an overtly partisan political attack against a type of product that the U.S. Food and Drug Administration has deemed the least risky.

  • April 10, 2026

    Wisconsin High Court OKs COVID Immunity For Hospitals

    A Wisconsin state appeals court erred when it held that a statute shielding healthcare providers from civil liability during the early months of the COVID-19 pandemic violated a woman's constitutional right to a jury, the state's highest court ruled unanimously Friday.

  • April 10, 2026

    Colo. Transport Co. Says Termination Lacked Due Process

    A medical transportation company that provided transportation services for Medicaid users in Denver asked a Colorado state judge to reverse a termination of its services from the state, claiming the statute used to issue the termination against the company is unconstitutional.

  • April 10, 2026

    Compass Group Workers Get Cert. For Tobacco Fee Suit

    Former employees for food service company Compass Group USA have secured class certification for their Missouri federal lawsuit claiming the company's $48 bi-weekly health insurance fee for tobacco using-workers violates federal law.

  • April 10, 2026

    Philip Morris Urges 11th Circ. To Affirm FDA Rule Toss

    Philip Morris urged the Eleventh Circuit to affirm a decision that struck down a U.S. Food and Drug Administration rule calling for graphic warnings on cigarette packaging, arguing a district court rightly found the FDA had not followed proper procedure when crafting the regulations.

  • April 10, 2026

    Drugmakers Can Intervene In Texas, Fla. Abortion Drug Suit

    A federal judge Friday allowed abortion medication manufacturers GenBioPro Inc. and Danco Laboratories to intervene in litigation brought by the states of Texas and Florida seeking to undo a slew of federal regulations concerning the abortion drug mifepristone.

  • April 10, 2026

    Elevance Can't Nix Suit Over GLP-1 Coverage For Sleep Apnea

    An Indiana federal judge declined to toss a proposed class action claiming Elevance Health Inc. illegally denied coverage for a GLP-1 weight loss medication that was prescribed to treat sleep apnea, ruling that the insurance company is the right party to answer to the allegations at play.

  • April 10, 2026

    Ill. Jury Adds $17M Punitive Award To Baby Formula Verdict

    Illinois jurors on Friday slapped another $17 million in punitive damages atop the $53 million they awarded the previous afternoon to four mothers who accused Abbott Laboratories of selling preterm infant formula that contributed to a serious and often fatal gut condition their babies developed.

  • April 09, 2026

    Yale Medical School Can't Nix Fraudulent Insemination Suit

    Yale can't escape a negligence suit by onetime patients alleging its former fertility doctor secretly inseminated them with his own sperm, after a Connecticut judge said that a letter from an anonymous doctor, which is mandated by law to support their claims, met the statutory requirements.

  • April 09, 2026

    Irish Mallinckrodt Unit Stuck In Drug Price-Fixing Suit

    An Irish entity of drugmaker Mallinckrodt waited too long to seek dismissal of a price-fixing lawsuit brought by states based on a lack of personal jurisdiction or proper service, a Connecticut federal judge has ruled, finding that the company first raised that argument more than five years after the complaint was filed.

  • April 09, 2026

    Cigna 401(k) Suit Won't Wait For Intel Supreme Court Decision

    A Pennsylvania federal court turned down Cigna's bid to stay a proposed class action alleging the insurance company misspent forfeitures from its employee 401(k) plan and offered an underperforming investment fund while the U.S. Supreme Court considers a 401(k) suit against Intel, finding the request unjustified.

  • April 09, 2026

    Abbott Hit With $53M Verdict Over Baby Formula Harms

    A Cook County jury on Thursday awarded a total of $53 million in damages to four mothers claiming Abbott Laboratories' preterm baby formula contributed to their babies' development of a serious and often fatal gut condition, in the first of such claims to go to trial in Illinois.

  • April 09, 2026

    Nonprofit Insurer Wants To Seek AstraZeneca Claims Revival

    EmblemHealth asked a Massachusetts federal judge to let it seek First Circuit intervention against a decision that cut in half its proposed class action accusing AstraZeneca unit Alexion of using sham patents to protect blood disorder treatment Soliris from biosimilar rivals.

  • April 09, 2026

    Philly Injection Site Row Judge Rejects Nonprofit's 'Ploy'

    A Pennsylvania federal judge on Thursday called the addition of overdose prevention nonprofit Safehouse's president as a counterclaim plaintiff in the government's suit to stop it from launching a safe-injection site in Philadelphia a "ploy" to add another to the ranks of those claiming the government infringed the group's religious freedom.

  • April 09, 2026

    US Again Urges High Court To Back Drug Price Program

    The administration of President Donald Trump again urged the Supreme Court not to hear a challenge to the Medicare drug price negotiation program, arguing against a constitutional challenge brought by Boehringer Ingelheim that drug companies aren't forced to accept lower prices because they can choose not to participate. 

  • April 08, 2026

    Ed. Dept. Says It's Not Required To Fund $1B In Youth Grants

    The U.S. Department of Education denied accusations by 16 U.S. states that it is flouting a court order to restore nearly $1 billion in K–12 mental health grants, arguing in a Western District of Washington filing that the order required officials to re-review the grants, not actually provide full funding.

  • April 08, 2026

    AbbVie Says 340B Program Defines 'Patient' Too Broadly

    Federally funded healthcare providers in the 340B Drug Pricing Program are using an "overly broad" interpretation of the word "patient" based on government guidelines, and it's leading to them abusing 340B discounts, AbbVie claimed in a lawsuit filed against two federal health agencies Wednesday.

  • April 08, 2026

    3M Settles Ex-Worker's COVID Vax Firing Suit

    A former 3M Co. employee who claimed the company's COVID-19 vaccination mandate policy was "unnecessary" and "draconian" has settled his more than 3-year-old suit over his firing, according to a court filing.

  • April 08, 2026

    AstraZeneca Wants 25 Opt-Ins Axed From Pay Bias Suit

    More than two dozen women refused to take part in required discovery and should be removed from a collective action accusing AstraZeneca of paying female pharmaceutical sales representatives less than men, the company told an Illinois federal court.

Expert Analysis

  • HHS Plan To Cut Immigrant Benefits Spurs Provider Questions

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    A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.

  • Noncompete Forecast Shows Tough Weather For Employers

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    Several new state noncompete laws signal rough conditions for employers, particularly in the healthcare sector, so employers must account for employees' geographic circumstances as they cannot rely solely on choice-of-law clauses, say lawyers at McDermott.

  • Previewing State Efforts To Regulate Mental Health Chatbots

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    New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.

  • How DOJ's New Data Security Rules Leave HIPAA In The Dust

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    The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

  • Texas Med Spas Must Prepare For 2 New State Laws

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    Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.

  • DOJ-HHS Collab Crystallizes Focus On Health Enforcement

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    The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.

  • How The Healthline Privacy Settlement Redefines Ad Tech Use

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    The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

  • How Sweeping Budget Bill Shakes Up Health Industry

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    With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.

  • New DOJ Penalty Policy Could Spell Trouble For Cos.

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    In light of the U.S. Department of Justice’s recently published guidance making victim relief a core condition of coordinated resolution crediting, companies facing parallel investigations must carefully calibrate their negotiation strategies to minimize the risk of duplicative penalties, say attorneys at Debevoise.

  • A Look At Key 5th Circ. White Collar Rulings So Far This Year

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    In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.

  • What US Medicine Onshoring Means For Indian Life Sciences

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    Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.

  • 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.