Policy & Compliance
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December 19, 2025
AstraZeneca Unit Ducks Patent Fraud, Not Sham Suit Claims
A Massachusetts federal judge spared AstraZeneca unit Alexion on Friday from half of a nonprofit insurer's proposed class action, finding the plaintiff too far removed from anticompetitive patent fraud that allegedly propped up blood disorder treatment Soliris, while preserving accusations that Alexion brought sham infringement allegations against would-be rivals.
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December 19, 2025
EEOC Sues Over Christian Nurse's Denied Vax Exemption
An Illinois-based hospital system bucked civil rights law when it denied a Christian nurse's request for an exemption to its COVID-19 vaccination policy and then fired her, the U.S. Equal Employment Opportunity Commission has told a federal court.
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December 19, 2025
Trump Admin Appeals Harvard Win In $2B Fund Freeze Case
The Trump administration will ask the First Circuit to overturn a federal judge's ruling that prevented the government from withholding $2.2 billion in federal grants from Harvard University over concerns about antisemitism on campus.
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December 18, 2025
Split 6th Circ. Blocks Michigan's Ban On Conversion Therapy
A split Sixth Circuit panel ordered an injunction on Michigan's conversion therapy ban, ruling the law likely places an unconstitutional restriction on the First Amendment rights of a Catholic charitable organization and a therapist whose faith-based psychotherapy practices fall under the ban.
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December 18, 2025
SF Must Reinstate Worker Fired For Violating COVID Vax Rule
A California federal judge ordered San Francisco to reinstate a 311 call center agent who was fired for violating a COVID-19 vaccination mandate after he sought an exemption based on his Muslim faith, ruling Thursday that the plaintiff has made a "prima facie case for religious discrimination."
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December 18, 2025
AstraZeneca Can't Block Colo. Law Over Drug Discount Rules
A Colorado federal judge rejected AstraZeneca's effort to block enforcement of a Colorado law surrounding federal 340B drug pricing that requires manufacturers to sell drugs at discounted prices to certain safety net healthcare facilities, ruling Wednesday the law isn't preempted by 340B drug pricing.
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December 18, 2025
HHS Proposes Hospital Ban On Gender Care For Minors
The Trump administration moved to block all hospitals that receive federal funding from providing gender-affirming care to minors and issued warning letters to a dozen companies Thursday as part of a sweeping push to halt the care nationwide, even in states with legal protections in place.
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December 17, 2025
Lighting Co. Strikes Deal In 401(k) Forfeiture, Tobacco Fee Suit
An automotive lighting company told an Illinois federal court Wednesday that it has settled an ex-worker's proposed class action claiming the business mismanaged forfeited 401(k) funds and failed to inform workers who used tobacco how to avoid paying an extra health plan fee.
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December 17, 2025
Braidwood Asks For Judgment In ACA Preventive Care Fight
Christian-owned, for-profit management company Braidwood Management Inc. asked a Texas federal judge Tuesday to end its challenge to an Affordable Care Act provision that requires coverage of lung cancer screenings and preexposure prophylaxis for HIV/AIDS, citing a U.S. Supreme Court finding upholding the provision.
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December 17, 2025
Doctors Not Harmed By CDC's Vaccine Guidance, Feds Say
The federal government argued Wednesday that doctors lack standing to challenge the overhaul of a key federal vaccine committee that has since downgraded the COVID-19 shot, saying healthcare providers haven't been harmed by the policy shifts.
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December 16, 2025
Ex-NIAID Director Claims Retaliation in Trump Admin Suit
The former director of the National Institute of Allergy and Infectious Diseases filed suit in Maryland federal court on Tuesday alleging Trump administration appointees violated her constitutional rights by illegally terminating her employment and that she cannot expect her claims to be fairly heard by the "undermined" U.S. Office of Special Counsel.
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December 16, 2025
DOD To Reevaluate Discharges Over COVID Vax Refusal
The U.S. Department of Defense said on Tuesday that Secretary of Defense Pete Hegseth ordered a reevaluation of the discharge status of service members who were involuntarily removed from the military after they refused to receive the COVID-19 vaccine.
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December 16, 2025
Vax Skeptics Cite High Court In New Challenge To NY Mandate
A vaccine skepticism advocacy group once tied to Secretary of Health and Human Services Robert F. Kennedy Jr. is revamping its fight against New York's school vaccination mandate, arguing recent activity by the U.S. Supreme Court necessitates a fresh analysis.
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December 16, 2025
Qui Tam Challenge At 11th Circuit: 4 Takeaways
An appellate panel weighed the constitutionality of the False Claim Act's whistleblower mechanism. Law360 Healthcare Authority has what you need to know about the closely watched hearing.
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December 16, 2025
Bazelon Center Dir. On Disabilities And Medicaid 'Barriers'
Law360 Healthcare Authority talks to Jennifer Mathis of the Bazelon Center for Mental Health Law about Medicaid, disability law and what states should do to stop people with impairments from being disenrolled improperly.
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December 16, 2025
Ex-Harvard Morgue Manager Gets 8 Years In Body Parts Case
Former Harvard Medical School morgue manager Cedric Lodge was sentenced Tuesday in Pennsylvania federal court to eight years in prison after pleading guilty earlier this year to trafficking body parts from donated cadavers.
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December 16, 2025
Hospital Owners Sue HHS Over Medicare Payment Rule
Allina Health System and other nonprofit hospital owners have sued the U.S. Department of Health and Human Services, telling a D.C. federal judge it unlawfully enacted a rule that will cause safety-net hospitals to lose out on billions of dollars of Medicare payments.
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December 16, 2025
FCA In 2025: Trump, A Qui Tam Clash And Whopping Penalties
From a 10-figure verdict to shifting Justice Department enforcement priorities, Law360 looks at the major FCA developments of the year.
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December 15, 2025
States Fight Sandoz Bid To Argue Duplication In Generics Row
Multiple attorneys general have told a Connecticut federal court that Sandoz Inc. and Fougera Pharmaceuticals Inc. can't claim the states' grievances over allegations of price fixing are duplicative of claims that were already settled, since there are some claims and forms of relief that only state plaintiffs can seek.
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December 15, 2025
DOJ Raises Accreditation Concerns In Vet School Case
The U.S. Department of Justice waded into a Tennessee veterinary school's antitrust case challenging the American Veterinary Medical Association's accreditation requirements, raising concerns about the risk posed by professional groups that play gatekeeping functions.
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December 15, 2025
NC Panel Says State's Hospital Law Is Constitutional
North Carolina's "certificate of need" law hasn't created a monopoly nor has it restricted an eye surgeon's right to earn a living, a state court panel ruled Friday, ending for now the surgeon's yearslong suit arguing the law is facially unconstitutional.
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December 15, 2025
Formula Suits An 'Undue Burden' On Cook County, Panel Says
An Illinois appellate court Friday agreed with Abbott Laboratories that 23 lawsuits alleging the company failed to warn of important risks associated with infant formulas and caused premature babies to develop necrotizing enterocolitis should not have been filed in Cook County, where the infants at the center of those cases were not born and have never lived.
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December 15, 2025
Connecticut 'Likely' To Settle Generic Drug Price Cap Dispute
A pharmaceutical industry trade group and the state of Connecticut have signaled their intent to settle a feud over the interpretation of the state's generic drug price cap law, and a federal judge gave them until Monday to say more about their plan.
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December 15, 2025
Yale Hospital Hit With $32M Baby Formula Death Verdict
A Connecticut judge has hit Yale University and Yale New Haven Hospital with a nearly $32 million verdict over the death of a premature baby, finding doctors failed to obtain either informed consent, or any consent, before feeding the infant a diet fortified by a product produced from cow's milk.
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December 15, 2025
Feds Deny Breaking Plea Deal With Ex-Morgue Manager
Prosecutors told a Pennsylvania federal judge Monday that they did not breach a plea deal between the government and Cedric Lodge by seeking a harsh sentence for the former head of Harvard University's morgue who admitted to theft and trafficking of human remains, claiming that Lodge's arguments to the contrary amounted to buyer's remorse.
Expert Analysis
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Noncompete Forecast Shows Tough Weather For Employers
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.
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Previewing State Efforts To Regulate Mental Health Chatbots
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.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
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.
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Texas Med Spas Must Prepare For 2 New State Laws
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.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
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.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
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.
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How Sweeping Budget Bill Shakes Up Health Industry
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.
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New DOJ Penalty Policy Could Spell Trouble For Cos.
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.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
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.
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What US Medicine Onshoring Means For Indian Life Sciences
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.
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FCA Working Group Reboot Signals EHR Compliance Risk
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.
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FDA's Hasty Policymaking Approach Faces APA Challenges
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.
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The Metamorphosis Of The Major Questions Doctrine
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.