Policy & Compliance
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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.
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July 31, 2025
J&J Fired Sales Worker Who Reported Pay Issue, Suit Says
Johnson & Johnson wrongly credited a former executive sales representative's sales to another worker, leading to lost earned commissions, and then fired him once he complained, the former employee said in a suit in Texas federal court.
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July 30, 2025
Illumina To Pay $9.8M To Resolve Cybersecurity Qui Tam Case
Biotechnology company Illumina Inc. has agreed to pay $9.8 million in a settlement with the U.S. Department of Justice to put to rest a first-of-its-kind False Claims Act suit alleging the company violated cybersecurity regulations for medical devices, according to an announcement Wednesday.
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July 30, 2025
Anesthesia Giant Keeps Poaching Claims In Antitrust Row
A New York federal judge refused Tuesday to nix counterclaims from North America's largest anesthesia provider, facing a Syracuse hospital's antitrust allegations, accusing the hospital of illegally recruiting away dozens of its clinicians and thus interfering with its employment agreements.
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July 30, 2025
CVS Can't Arbitrate RICO Suit Over Alleged 'No Generic' Policy
CVS effectively forfeited its arbitration rights in proposed class action litigation accusing it of conspiring to block Medicare beneficiaries from accessing generic versions of prescription drugs, a Pennsylvania federal judge ruled in denying the company's bid to enforce an arbitration agreement.
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July 30, 2025
FDA's Vaccine Chief Is Out After Loyalty To Trump Questioned
Dr. Vinay Prasad's tenure as the top vaccine regulator at the U.S. Food and Drug Administration ended abruptly this week following intense criticism from conservative activists who questioned his loyalty to President Donald Trump.
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July 30, 2025
GTCR Denied Rival's Old Sales Prospects Data In FTC Case
An Illinois federal judge refused Tuesday to force a rival medical device coatings company to cough up old sales projections data so private equity firm GTCR BC Holdings can defend against a Federal Trade Commission challenge to its $627 million purchase of Surmodics.
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July 30, 2025
DHS Sinks Docs' Free Speech Suit Over COVID Policies
A Texas federal judge on Wednesday dismissed free speech claims brought against the U.S. Department of Homeland Security and three specialty medical boards by a doctor group claiming the government and boards punished them for disapproving of COVID-19 vaccines and mandates.
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July 30, 2025
$1.6M UHC Reimbursement Suit Kicked Back To State Court
A lawsuit alleging that United Healthcare of North Carolina Inc. underpaid a hospital system by at least $1.6 million in reimbursements does not belong in federal court, a North Carolina federal judge ruled Monday.
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July 30, 2025
Fla. AG Allowed To Drop Sandoz Generics Price-Fixing Claims
After several months of wrangling over the terms of a $10 million generic drug price-fixing settlement, a Connecticut federal judge on Wednesday granted Florida's request to permanently drop its claims against Sandoz, finding that it would be an abuse of discretion to hold up the resolution any longer.
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July 30, 2025
Database Administrator Was Employee, Court Told
A former database administrator was misclassified as an independent contractor, he alleged in a proposed class and collective action in New York federal court against companies including Express Scripts and Cigna, saying he was effectively an employee.
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July 29, 2025
Fed. Circ. Backs Rejection Of Man's HPV Vaccine Claims
A man who claimed vaccines he received as a teen, including one meant to guard against HPV, caused him to develop inflammatory bowel disease will receive no payments under the National Vaccine Injury Compensation Program, the Federal Circuit ruled on Tuesday, affirming a determination that his theory that vaccines caused his illness is unsupported.
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July 29, 2025
Ambulance Co. Can't Undo $2.3M Verdict In Wash. Crash Case
A Washington Court of Appeals panel has affirmed an ambulance operator's $2.3 million trial court loss in a patient's family's wrongful death case over a crash, rejecting the company's argument that its crew was shielded from liability by a state law that protects first responders providing emergency medical services.
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July 29, 2025
Trump Says High Court Rulings Undermine Wash. Halt On EOs
Recent decisions by the U.S. Supreme Court undermine a Washington federal judge's finding that portions of two executive orders concerning gender-affirming care and transgender identity likely violate the Constitution, the Trump administration argued in recent filings.
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July 29, 2025
9th Circ. Won't Renew Suit Over Wash. Ban On 'DIY' Rape Kits
A Ninth Circuit panel on Tuesday refused to revive a constitutional challenge to Washington state's ban on self-administered DNA evidence collection kits for sexual assault survivors, concluding that the plaintiff company failed to show the law illegally restricts commercial speech.
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July 29, 2025
DOD Expands Tricare's Clinical Trial Benefit
The U.S. Department of Defense has issued a final rule that makes health insurance coverage for clinical trials aimed at treating and preventing COVID-19 and other infectious diseases permanent for military personnel, retirees and their families.
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July 29, 2025
Detroit Casino Can't Beat Denied Vaccine Exemption Suit
A dozen former supervisors at a Detroit casino can proceed to trial on claims that their employer refused to accommodate their religiously motivated requests to skip the COVID-19 vaccine, a Michigan federal judge has ruled.
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July 29, 2025
9th Circ. Rescinds Ruling On Wash. Abortion Coverage Law
A Ninth Circuit panel has walked back a published March opinion rejecting a Christian church's challenge to a Washington state law mandating employer health coverage of abortion services, saying in a Tuesday order that the federal appeals court would issue a new ruling following additional oral arguments.
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July 29, 2025
RFK Jr. Slams Vaccine Injury Program: 3 Things To Know
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. is taking aim at the national program that compensates people for vaccine injuries, calling it a "heartless" system that he intends to fix.
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July 29, 2025
Travelers Gets Trim Of Ex-Worker's Tobacco Health Fee Suit
A Minnesota federal judge pared down claims Tuesday from a former Travelers worker's suit alleging the insurance and financial services company unlawfully imposed a surcharge on the health plans of employees who disclosed they were tobacco users and thereby violated nondiscrimination provisions in federal benefits law.
Expert Analysis
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10 Noteworthy CFPB Developments From 2024
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.
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The Future Of GLP-1 Policy After Drug Shortage Ends
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.
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Top 10 Whistleblowing And Retaliation Events Of 2024
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.
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How White Collar Defense Attys Can Use Summary Witnesses
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.
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Nutraceutical Patent Insights As Market Heats Up
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.
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How White Collar Attys Can Use Mythic Archetypes At Trial
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.
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What 2024 Election Means For Drugs, Medicare And Medicaid
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.
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Justices Mull Sex-Based Classification In Trans Law Case
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.
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Key Takeaways From FDA's Latest Social Media Warnings
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.
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Rank-And-File DOJ Attorneys Will Keep Calm And Carry On
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.
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Unpacking Arguments From High Court's Rural Hospital Case
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.
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Health Policy Predictions For Trump's Second Administration
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.
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What Trump's Next Term May Mean For Biz Immigration
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.