Policy & Compliance
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December 03, 2025
Baxter Defeats Suit Over Stable Value Fund In $4B 401(k) Plan
An Illinois federal judge tossed a suit Wednesday from a worker who said medical products company Baxter International Inc. violated federal benefits law by retaining a lackluster stable value fund in its $4 billion retirement plan, ruling the data backing his case failed to capture long-term performance.
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December 03, 2025
AT&T Sues Generic Drug Manufacturers, Alleging Price-Fixing
AT&T has joined the bevy of litigants suing a swath of pharmaceutical companies over alleged generic drug price-fixing, claiming it shelled out billions of dollars for medication reimbursements to the drugmakers as part of its employee health plans when it could have spent far less if the drugs weren't subject to anticompetitive pricing.
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December 03, 2025
AGs Say Sun, Taro Settlement Mustn't Touch State Claims
State attorneys general have asked a Pennsylvania federal judge to again ensure their claims remain untouched by a settlement between private plaintiffs and generic-drug makers in sprawling price-fixing litigation, this time focusing on a $200 million deal between Sun Pharmaceutical, Taro Pharmaceuticals and employee benefit plans.
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December 02, 2025
States Hit Abbott With FCA Suit Over Infant Formula Recall
Seven states, including California, Michigan and New York, on Monday intervened in a False Claims Act suit brought by the federal government against Abbott Laboratories over the 2022 infant formula crisis seeking to recoup funds spent on the tainted baby food.
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December 02, 2025
CR Bard's Faulty Blood Filter Killed Wash. Woman, Suit Says
The family of a woman allegedly killed by a faulty blood filter implant accused device maker C.R. Bard Inc. in Washington federal court Monday of taking dangerous shortcuts as it rushed its line of products to market.
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December 02, 2025
Judge Blocks Planned Parenthood Funding Cut In 22 States
A Massachusetts federal judge Tuesday stopped the Trump administration from halting Medicaid reimbursements to Planned Parenthood clinics in 22 states, ruling the funding cutoff likely violated requirements to warn the states ahead of time about the change.
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December 02, 2025
6th Circ. Affirms UnitedHealth's Escape From Preempted Suit
The Sixth Circuit on Tuesday backed a decision to toss a worker's lawsuit accusing his employer and UnitedHealth and its subsidiaries of defrauding him into reimbursing his health insurance company for $25,000, agreeing with a lower court that federal benefits law completely preempted his state law claims.
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December 02, 2025
U Of Colo. To Pay $10M In Religious Bias Suit Over Vax Policy
The University of Colorado's medical school will pay $10.3 million to a group of employees and students who claimed in federal court that their religious exemption requests to the university's COVID-19 vaccine mandate were unlawfully denied, according to the group's attorneys.
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December 02, 2025
Lawyers Adapt To Crop Of New FDA Pilots
A slew of new FDA pilot programs is forcing life science attorneys to adjust to a new reality of programs that shed bureaucratic processes and eschew some of the typical push-and-pull with industry players.
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December 02, 2025
Health Hires: Goodwin Partner Joins Incyte, Gilead GC Exits
Law360 Healthcare Authority looks at the week's most notable personnel changes in the healthcare and life sciences industries.
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December 02, 2025
Post-Gazette Publisher Tries Again To Pause Benefits Order
If the Pittsburgh Post-Gazette must restore its union-represented editorial staff's pre-2020 healthcare benefits, it will shut down, the newspaper's publisher claimed in a brief filed with the Third Circuit, requesting another shot at pausing an injunction that compelled the paper to restore the benefits.
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December 02, 2025
Defamation Litigation Roundup: FDA, Lively, Alexander Bros.
In this month's review of defamation fights, Law360 highlights a pharmaceutical company's suit against a former U.S. Food and Drug Administration official, as well as the latest decision siding against President Donald Trump in his fights with media companies.
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December 02, 2025
5th Circ. Wary Of FDA Process Behind Rule For New Vapes
A Fifth Circuit panel appeared skeptical Tuesday that the U.S. Food and Drug Administration properly accounted for how a new rule for premarket authorization of new tobacco products would affect small businesses in the industry.
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December 02, 2025
Breast Pump Co. To Pay $1M For Alleged Tricare Overbilling
The U.S. Attorney's Office for the Eastern District of Pennsylvania reached a $1 million settlement with a breast pump company and its owner, resolving allegations that they submitted false claims for reimbursement for service members and their families.
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December 02, 2025
Plan Members Assert Standing In Cigna Data Breach Fight
A group of Cigna health plan participants who claimed that the company failed to protect their data when it tracked their website activities asked a Pennsylvania federal judge not to throw out the suit, arguing that the proposed class had standing to sue over the alleged violations of state and federal privacy laws.
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December 02, 2025
Under New Chair, Fed. Vax Panel To Redo Hep B Vote
The new chair of an influential federal vaccine advisory panel is set to lead a vote this week on whether to roll back federal recommendations that newborns get vaccinated against hepatitis B.
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December 02, 2025
Justices Skeptical Of NJ Subpoena For Anti-Abortion Donors
Several U.S. Supreme Court justices appeared sympathetic Tuesday to an anti-abortion pregnancy-center network's bid to challenge a subpoena from the New Jersey attorney general, pressing the state on whether its demand for donor identities and internal documents risked unconstitutionally chilling First Amendment associational rights.
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December 02, 2025
Safe-Injection Site Ignites New Religious Liberty Debate
Law360 Healthcare Authority talks to Benjamin A. Barsky of the University of California College of the Law, San Francisco about safe injection sites, religious liberty arguments in healthcare, and a Third Circuit ruling with possible ramifications for both.
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December 02, 2025
Conflict Looms Over State Medical Debt Credit-Report Bans
An about-face by the Consumer Financial Protection Bureau on medical debt and credit reports is animating a legal debate over preemption and state-level prohibitions meant to protect consumers.
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December 02, 2025
Hospital Says EEOC Neglected Presuit Conciliation Obligation
The U.S. Equal Employment Opportunity Commission failed to satisfy its conciliation obligations before filing an age discrimination lawsuit against a Colorado hospital, the facility told a federal court, arguing that the case should be paused for the parties to try to work out a deal.
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December 02, 2025
$4.6M Garnet Health Deal Over Retirement Plan Gets Initial OK
A New York federal judge granted initial approval Tuesday to a $4.6 million class action settlement between Garnet Health Medical Center and workers who challenged their employee retirement plan's fees and investments, which comes after parties reported a deal to end the case in September.
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December 01, 2025
Hospitals Slam HHS' Move From Drug Discounts To Rebates
The American Hospital Association is leading litigation challenging the Trump administration's abrupt changes to a decades-old program governing the distribution of discounted prescriptions to low-income patients, telling a Maine federal court Monday that the government is unlawfully ignoring the costly impacts a rebate system will have on hospitals.
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December 01, 2025
1st Circ. Tosses Omni's Medicare Fraud Suit Over UTI Tests
A First Circuit panel declined to revive Omni Healthcare's False Claims Act suit accusing MD Labs of billing Medicare for unnecessary urinary tract infection tests, explaining in a published opinion Monday that Omni Healthcare's own staff ordered each test — sometimes even replacing doctors' orders for cheaper tests with the pricier ones.
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December 01, 2025
2nd Circ. Backs Anti-Abortion Groups' Free Speech Rights
New York Attorney General Letitia James can't sue faith-based groups promoting a so-called treatment to reverse medication-induced abortions, finding the groups are likely to succeed on the merits of their First Amendment challenge, the Second Circuit said Monday.
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December 01, 2025
J&J Narrows Ex-Employees' Prescription Benefits Suit
Johnson & Johnson narrowed a proposed class action claiming it unlawfully overcharged employees through a prescription drug benefits program, with a New Jersey federal judge ruling workers leading the suit failed to show how allegedly excessive fees the company paid to a benefits manager caused participants' costs to rise.
Expert Analysis
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Takeaways From State Votes On Abortion In The 2024 Election
Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.
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Loper Bright Offers New Materiality Defense To FCA Liability
The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.
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How Expanded Birth Control Coverage May Affect Employers
Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.
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Legislation Most Likely To Pass In Lame Duck Session
As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.
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Preserving The FCA Is Crucial In Trump's 2nd Term
While the Trump administration may pursue weaker False Claims Act enforcement, it remains an essential tool in safeguarding public funds and maintaining corporate accountability, so now is not the time to undermine ethical behavior, or reduce protections and incentives for whistleblowers, says Adam Pollock at Pollock Cohen.
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PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.
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Justices Face Tough Question On HHS Hospital Pay Formula
In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.
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Key Healthcare Issues That Hinge On The Election Outcome
The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.
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The Key To Solving High Drug Costs Is Understanding Causes
One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.
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Next Steps For FCA Defendants After Fla. Qui Tam Ruling
Because a Florida federal court's recent decision in Zafirov v. Florida Medical Associates could eventually prove to be a watershed event for False Claims Act suits, defendants should consider potential next steps to ensure that their litigation benefits from the court's reasoning and further developments, says Scott Gallisdorfer at Bass Berry.
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A Look At Calif.'s New AI Law For Health Insurers
A newly enacted California law prohibits artificial intelligence tools from making medical necessity determinations for healthcare service plans or disability insurers, addressing core questions that have arisen around AI's role in coverage decisions, say attorneys at DLA Piper.
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New HHS Research Misconduct Rules Bring Seismic Changes
The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.
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Fla. Ruling May Undermine FCA Whistleblowers' Authority
A Florida federal court's decision in Zafirov v. Florida Medical Associates last month will deprive relators of their ability to bring suits under the False Claims Act, limiting their capability to expose and rectify wrongdoings and potentially affecting billions in FCA recoveries, say Matthew Nielsen and Lily Johnson at Bracewell.