Policy & Compliance
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August 05, 2025
Crowell Lands 16 Reed Smith Health Partners Across 4 Cities
Crowell & Moring LLP announced Wednesday that it is expanding its healthcare practice with dozens of attorneys from Reed Smith LLP, including 16 healthcare litigation partners based in Chicago, Los Angeles, San Francisco and Dallas, where the firm is launching a new shop with a former Reed Smith lawyer at the helm.
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August 05, 2025
Wash. Judge Questions Injunctions' Scope In Head Start Case
A Washington federal judge asked attorneys Tuesday to explain how the U.S. Supreme Court's decision concerning nationwide injunctions might impact efforts by a group of Head Start associations to halt federal directives restricting noncitizen access to the program and use of funds for diversity initiatives.
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August 05, 2025
OptumRx Urges Panel To DQ Motley Rice In LA Opioid Suit
OptumRx told a California appellate panel Tuesday that Motley Rice should be disqualified from representing Los Angeles County in a lawsuit alleging it colluded with drugmakers to fuel the opioid crisis, saying the firm violated state law by using confidential information obtained in the case in other lawsuits it's handling against Optum.
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August 05, 2025
Key Opioid Theory Actually Irrelevant, Drug Cos. Tell 4th Circ.
With federal judges in West Virginia suddenly split over the central legal theory in opioid litigation, major drug distributors are insisting the theory actually doesn't matter, telling the Fourth Circuit it can uphold their triumph in a landmark trial without even touching the hot-button issue.
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August 05, 2025
Law, Medical School Orgs Face Application Fee Antitrust Suits
The Law School Admission Council and the Association of American Medical Colleges have each been hit with a proposed class action in Pennsylvania and D.C. federal courts, respectively, by candidates who said the nonprofits conspired with their member schools to charge excessive application fees that have been fixed at the same price regardless of the school.
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August 05, 2025
Ex-USPTO Heads, Judges Oppose Anti-Patent Thicket Bill
A pro-innovation group composed of former U.S. Patent and Trademark Office officials and former Federal Circuit judges on Tuesday asked Congress to oppose a bill introduced last month that would limit so-called patent thickets used by pharmaceutical companies to restrict the production of generic counterparts to their drugs.
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August 05, 2025
UBH Patients Score Partial Win In Mental Health Claims Fight
A California federal judge handed a partial win Tuesday to a class of participants in employee health benefit plans who sought coverage for mental health and substance use disorder treatments from United Behavioral Health, holding the company's overly restrictive guidelines breached fiduciary duties under federal benefits law.
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August 05, 2025
A Free Exercise 'Blueprint' In Colo. Abortion Reversal Order
A Colorado federal judge's decision to allow medication abortion "reversals" on free exercise grounds could serve as a model for other lawsuits meant to legitimize a practice that is outside the standard practice of medicine.
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August 05, 2025
Meet FDA Chief Counsel Sean Keveney
The new top attorney at the U.S. Food and Drug Administration, described as a "tremendous technical lawyer," rose through the ranks as a federal prosecutor before helping lead President Donald Trump's confrontation with elite universities this year.
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August 05, 2025
Law Profs Urge 11th Circ. To Toss Judge-Shopping Sanctions
A group of seven law school professors is urging the Eleventh Circuit to toss a sanctions ruling against three attorneys for judge shopping, arguing that federal law does not forbid the practice and citing the "potentially chilling effect the order will have on counsel, especially those involved in pro bono representation."
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August 05, 2025
Teva Settles Claims Over Delayed Generic Asthma Inhalers
Teva Pharmaceuticals has settled a 2023 lawsuit by a coalition of union healthcare funds accusing the company of thwarting the introduction of a generic version of its QVAR inhalers to the market, according to a filing in Massachusetts federal court.
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August 05, 2025
Epstein Becker Adds NJ Health Duo From Wilentz Goldman
Epstein Becker Green has added two attorneys from New Jersey firm Wilentz Goldman & Spitzer PA to bolster its healthcare and life sciences practice, including one it is welcoming back to the firm.
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August 05, 2025
Medicaid Cuts May Worsen Incarceration-Linked Death Risks
A new public health investigation reveals an association between incarceration and elevated risk of early death, not only for people who have been behind bars but for entire communities. Experts caution that impending disinvestment in Medicaid could worsen outcomes in vulnerable populations.
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August 05, 2025
A Texas 'Pressure Test' For State Abortion Shield Laws
A first-of-its-kind federal suit filed in Texas against a California doctor who prescribed abortion pills to the plaintiff's girlfriend promises to "pressure test" reproductive care shield laws in states where abortion remains legal.
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August 04, 2025
Feds Get 2nd Crack At Regeneron FCA Case After Key Ruling
The government may pursue an alternate theory of its False Claims Act kickback case against Regeneron Pharmaceuticals Inc. and try again for a pretrial win after a First Circuit ruling created a "critical shift" in the law, a Massachusetts federal judge said Monday.
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August 04, 2025
Holland & Knight Adds King & Spalding Health Pro In Houston
Holland & Knight LLP announced Monday that it has made a valuable addition to its healthcare team with a partner in Houston who came aboard after 17 years with King & Spalding LLP.
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August 04, 2025
Religious Carveout Sinks Nurse's Vax Bias Suit, 8th Circ. Says
The Eighth Circuit refused to reinstate a religious discrimination suit from a nurse who said a Catholic hospital unlawfully fired her for rejecting its COVID-19 vaccination mandate, ruling the institution is shielded from liability under Title VII's exception for religious organizations.
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August 01, 2025
AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care
The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.
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August 01, 2025
States Urge High Court To Keep NIH Grant Funds Flowing
A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.
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August 01, 2025
Indiana Health Care Co. Fudged Workers' Time, Suit Claims
An Indiana health care network falsified employees' time sheets to avoid paying their overtime, a financial counselor claimed in a proposed class and collective action in federal court.
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August 01, 2025
NC Legislation Highlights Of The 1st Half Of 2025
The North Carolina General Assembly has pushed through another round of hurricane relief aid to help the western swath of the state while lawmakers remain in talks to repeal a long-standing healthcare law that critics say hampers competition. Here are five North Carolina bills from the year's first half that saw the governor's stamp of approval or remain up for debate.
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August 01, 2025
J&J Unit's Catheter Rival Scores Injunction After $442M Win
A California federal judge will block Johnson & Johnson's Biosense Webster from refusing clinical support for its Carto cardio mapping systems from hospitals that use competitors' cardiac catheters, requiring the company to institute nondiscriminatory pricing for its services at hospitals regardless of which products they use.
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July 31, 2025
Justices Told State Med Mal Laws Fly In Federal Court
A Delaware federal court must apply a state statute requiring an expert affidavit in all medical malpractice suits, a hospital defendant told the U.S. Supreme Court, as key aspects of the Delaware law and similar statutes in 28 other states "should not be checked at the federal courthouse doors."
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July 31, 2025
EEOC Says Hospital Wrong To Fire Worker Allergic To Vaccine
A hospital violated federal disability law when it fired a worker in its insurance department who didn't get the COVID-19 vaccine because she was allergic to it, the U.S. Equal Employment Opportunity Commission alleged in Illinois federal court Thursday.
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July 31, 2025
HHS Plans To Test Rebates In 340B Drug Pricing Program
The Trump administration on Thursday announced plans for a pilot project that would allow certain drugmakers to abandon upfront discounts in the 340B program and instead require hospitals to apply for rebates, testing an idea that would fundamentally reshape the long-running program.

'Shocked' By Eye-Watering Fines, Fed. Judges Redo FCA Math
District courts handling big-dollar False Claims Act cases are increasingly wrestling with the Eighth Amendment ban on excessive fines as more defendants go to trial and face whopping jury verdicts. An order last month in a New York case reducing an FCA penalty was the third of its kind in 18 months.

Organ Procurement's Dilemma: How Do You Diagnose Death?
A Kentucky man nearly had his organs removed for donation despite showing signs of life. Now a federal investigation is putting a spotlight on how doctors diagnose death prior to organ transplants.

9th Circ. Clarifies Kickback Boundaries For Referral Bonuses
A Ninth Circuit opinion affirming a California man's fraud conviction provides some clarity — and a warning — to the owners of medical testing laboratories wondering what sales tactics are allowed under a 2018 kickbacks law.
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.