Policy & Compliance

  • April 14, 2026

    Doctors Hope Justices Maintain Shield Against Med Mal Suits

    A case headed to the U.S. Supreme Court next week could roll back a legal doctrine that physicians say is key to protecting them from frivolous medical malpractice suits filed by patients who've already lost in state court.

  • April 14, 2026

    7th Circ. Suggests High Court Ruling Supports Ark. PBM Rule

    The Seventh Circuit appeared reluctant Tuesday to revive a union fund's challenge to an Arkansas rule making health plans disclose pharmacy compensation and pay fees, with judges pointing to a 2020 U.S. Supreme Court ruling that permitted state cost regulations on pharmacy benefit managers.

  • 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.

Expert Analysis

  • Expect State Noncompete Reforms, FTC Scrutiny In 2026

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    Employer noncompete practices are facing intensified federal scrutiny and state reforms heading into 2026, with the Federal Trade Commission pivoting to case-by-case enforcement and states continuing to tighten the rules, especially in the healthcare sector, say attorneys at DLA Piper.

  • CMS 2027 Proposal Is Mixed Bag For Medicare Advantage

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    The Centers for Medicare and Medicaid Services' recent proposed rule for the Medicare Advantage and Part D programs gives small organizations reason for optimism, although certain elements may be inconsistent with the Centers' desire to enhance competition, says Christine Clements at Sheppard Mullin.

  • 3 Key Takeaways From Planned Rescheduling Of Cannabis

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    An executive order reviving cannabis rescheduling represents a monumental change for the industry and, while the substance will remain illegal at the federal level, introduces several benefits, including improving state-legal cannabis operators' tax treatment, lowering the industry's legal risk profile, and leaving state-regulated markets largely intact, say attorneys at Dentons.

  • 6 Issues That May Follow The 340B Rebate Pilot Challenge

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    Though the Health Resources and Services Administration withdrew a pending case to reconsider the controversial 340B rebate pilot program, a number of crucial considerations remain, including the likelihood of a rework and questions about what that rework might look like, say attorneys at Spencer Fane.

  • 2026 State AI Bills That Could Expand Liability, Insurance Risk

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    State bills legislating artificial intelligence that are expected to pass in 2026 will reshape the liability landscape for all companies incorporating AI solutions into their business operations, as any novel private rights of action authorized under AI-related statutes signal expanding exposures, say attorneys at Wiley.

  • How 11th Circ.'s Zafirov Decision Could Upend Qui Tam Cases

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    Oral argument before the Eleventh Circuit last month in U.S. ex rel. Zafirov v. Florida Medical Associates suggests that the court may affirm a lower court's opinion that the qui tam provisions of the False Claims Act are unconstitutional — which could wreak havoc on pending and future qui tam cases, say attorneys at Morgan Lewis.

  • Key Trends For Life Sciences Cos. To Watch In 2026

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    Following a year of drastic change at the U.S. Food and Drug Administration, two themes are likely to drive the coming year — a commitment to lowering the cost of drugs and an inherent tension between the priorities of the health agencies and the broader administration, say attorneys at Sheppard Mullin.

  • The Next Pressure Point In Digital Health: Informed Consent

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    Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.

  • 4 Trends Shaping Drug And Medical Device Law For 2026

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    2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.

  • Preparing For Congressional Investigations In A Midterm Year

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    2026 will be a consequential year for congressional oversight as the upcoming midterm elections may yield bolder investigations and more aggressive state attorneys general coalitions, so companies should consider adopting risk management measures to get ahead of potential changes, say attorneys at Morgan Lewis.

  • A Meaningful Shift In FDA's Biosimilarity Analysis

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    The U.S. Food and Drug Administration's potential pivot away from routinely requiring comparative efficacy studies for interchangeable biosimilar applications would not lower regulatory standards, but instead allow applicants to allocate resources toward establishing more probative evidence, says Theodore Thompson at Stinson.

  • Top 5 Antitrust Issues For In-House Counsel To Watch In 2026

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    With Trump administration enforcement policy having largely taken shape last year, antitrust issues that in-house counsel should have on the radar range from scrutiny of technology-assisted pricing to the return of merger remedies, say attorneys at Squire Patton.

  • 2025 Legal Milestones That Will Shape Psychedelics Sector

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    As 2025 draws to a close, psychedelic drug development stands at an inflection point, experiencing unprecedented momentum through recent sweeping regulatory changes and landmark clinical milestones, amid rapidly evolving regulatory expectations, say Odette Hauke at Odette Alina LLC and Kimberly Chew at Husch Blackwell.