Policy & Compliance
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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.
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July 29, 2025
UnitedHealth Urges 6th Circ. To Affirm ERISA Preemption
UnitedHealth Group Inc. urged the Sixth Circuit to affirm the dismissal of a man's claims that UnitedHealth defrauded him into reimbursing the health insurance giant for $25,000, arguing that the Employee Retirement Income Security Act of 1974 completely preempts such claims brought under state law.
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July 29, 2025
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.
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July 29, 2025
FDA Recommends Federal Restrictions On Kratom Extract
The U.S. Food and Drug Administration announced Tuesday that it recommends placing federal restrictions on 7-Hydroxymitragynine, or 7-OH, an opioid-like alkaloid compound derived from the kratom leaf that the agency said had a strong potential for abuse.
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July 29, 2025
Attys Blast 'Chilling Message' Of Judge Shopping Sanctions
Three attorneys sanctioned for judge shopping while challenging an Alabama statute that criminalizes gender-affirming care have asked the Eleventh Circuit to clear their names, castigating the process that led to their censure as "so extraordinary as to approach unprecedented."
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July 29, 2025
22 States Sue To Block Defunding Of Planned Parenthood
California and more than 20 other states on Tuesday launched their own legal challenge to budget legislation that halts federal Medicaid funding for Planned Parenthood, alleging the measure illegally targets the organization and violates its First Amendment rights.
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July 29, 2025
Ark. Law Banning PBM-Owned Pharmacies Put On Ice
Arkansas can't enforce a law banning pharmacy benefit managers from owning pharmacies in the state, a federal judge ruled, saying that CVS, Express Scripts, Optum and a trade group are likely to succeed on their claims that the statute unlawfully restricts interstate commerce.
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July 29, 2025
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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Navigating Scrutiny Of Friendly Professional Corps. In Calif.
In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.
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Takeaways From New HHS Substance Use Disorder Info Rules
A new U.S. Department of Health and Human Services rule continues the agency's efforts to harmonize complex rules surrounding confidentiality provisions for substance use disorder patient records, though healthcare providers will need to remain mindful of different potentially applicable requirements and changes that their compliance structures may require, say attorneys at Ropes & Gray.
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Calif. Banking Brief: All The Notable Legal Updates In Q2
The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.
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How Cannabis Rescheduling May Affect Current Operators
The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.
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Air Ambulance Ruling Severely Undermines No Surprises Act
A Texas federal court's recent decision in Guardian Flight v. Health Care Service — that the No Surprises Act lacks a judicial remedy when a health insurer refuses to pay the amount established through an independent review — likely throws a huge monkey wrench into the elaborate protections the NSA was enacted to provide, says Mark DeBofsky at DeBofsky Law.
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Class Actions At The Circuit Courts: June Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.
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How Congress Is Tackling The US Healthcare Shortage
With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.
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The Current State Of Healthcare Transaction Reviews In Calif.
As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.
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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Inside Antitrust Agencies' Rollup And Serial Acquisition Moves
The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.