Policy & Compliance
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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.
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July 29, 2025
Meet Josh Craddock, Fetal Personhood Advocate Joining DOJ
President Donald Trump has named a former BigLaw attorney and outspoken proponent of the fetal personhood legal doctrine to serve as deputy assistant attorney general at the legal arm of the U.S. Department of Justice.
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July 28, 2025
PBMs Can't Escape NY State Law Claims In Opioid MDL
Two UnitedHealth subsidiaries cannot escape claims that they exacerbated the opioid crisis by providing data analytics and consulting services to drugmakers, a federal judge overseeing the multidistrict litigation ruled on Monday, saying the New York state municipalities have adequately alleged RICO by claiming they were part of the same criminal conspiracy.
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July 28, 2025
Express Scripts, Prime Urge Court To Toss Mich. Price-Fix Suit
Two pharmacy benefit managers sought to shake allegations of price-fixing brought by Michigan Attorney General Dana Nessel, arguing Friday that her antitrust suit suffers from several fatal legal flaws, including that the state does not have standing to sue on pharmacies' behalf.
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July 28, 2025
DOJ Probes NewYork-Presbyterian Over Antitrust Allegations
The U.S. Department of Justice has opened an investigation into NewYork-Presbyterian Healthcare System for allegedly violating antitrust laws by cutting deals with insurance companies that have led to rising healthcare costs, according to a subpoena viewed by Law360.
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July 28, 2025
Judge Again Cites Bias In NIH Fund Freeze As Gov't Appeals
A Massachusetts federal judge on Monday reiterated his conclusion that the Trump administration's freeze of $783 million worth of National Institutes of Health grants was based on "palpable" gender and racial discrimination, as he acknowledged a pending request by the government to the U.S. Supreme Court to stay his order that the money be released.
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July 28, 2025
Judge Says Trump Admin Can't Defund Planned Parenthood
A Massachusetts federal judge on Monday blocked President Donald Trump's administration from denying Medicaid reimbursements to Planned Parenthood clinics, expanding an earlier ruling that had applied only to those that do not provide abortions or that receive minimal federal support.
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July 25, 2025
Utah Docs Say Billing Expert's Report Rife With AI Falsehoods
Utah anesthesiologists facing a False Claims Act suit are moving to bar the testimony of a medical billing expert they say used artificial intelligence to draft a report riddled with errors and fake citations, calling it an extraordinary example of AI gone wrong.
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July 25, 2025
Hospital Giant To Pay $3.5M Over Nurse Training Repayments
HCA Healthcare Inc., a major U.S. hospital operator, has agreed to pay roughly $3.5 million to settle claims that it unlawfully trapped new nurses in agreements requiring them to repay training costs if they left their jobs within two years, according to a trio of state attorneys general.
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July 25, 2025
Health Data Co. Investor Fraud Suit Headed To Mediation
The parties in a putative class action claiming a healthcare technology company misled investors about a data platform it claimed to operate, but which didn't actually exist, told a Connecticut federal court that they "agree this case is well suited for mediation."
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July 24, 2025
Trump Admin Asks Justices To Stay Block On NIH Grant Cuts
The Trump administration on Thursday urged the U.S. Supreme Court to stay a district court's preliminary injunction so that the National Institutes of Health can resume terminating $783 million in grants, saying the lower court, under a recent high court ruling, lacked jurisdiction to make the government pay the grants.
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July 24, 2025
Hospital Must Face Claims Of Mismanaging Retirement Funds
A Colorado federal judge on Thursday said a proposed class action will continue against a hospital over allegations of mismanaging employees' retirement funds after an amended complaint added new allegations about the fund's mismanagement.
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July 24, 2025
UnitedHealth Discloses DOJ Medicare Civil, Criminal Probes
UnitedHealth Group Inc. has disclosed that it is complying with formal criminal and civil requests from the U.S. Department of Justice, following media reports about investigations into aspects of the insurance giant's participation in Medicare.
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July 24, 2025
3rd Circ. Rules Philly Injection Site Equals Religious 'Person'
A nonprofit battling government resistance to its planned safe drug injection site in Philadelphia can qualify for religious freedom protections, the Third Circuit said in a precedential opinion on Thursday, reasoning the organization meets the definition of a "person" practicing religion.
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July 23, 2025
FTC Wants PE Firm's Medical Device Coating Deal Put On Ice
Private equity firm GTCR BC Holdings' $627 million merger with Surmodics will bring the previously fierce competition for medical device coatings to a grinding halt, the FTC says, which is all the more reason a federal court should block the deal while an agency challenge plays out.
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July 23, 2025
Symbria Workers' $5.9M ESOP Deal Gets Ill. Judge's Final OK
An Illinois federal judge gave his final blessing Tuesday to a $5.9 million settlement between Argent Trust Co. and a group of Symbria Inc. employees who accused the company of mismanaging their employee stock ownership plan.
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July 23, 2025
Bird Marella And Bioscience Client Accused Of $87M Fraud
An investment group that includes a "Toy Story" screenwriter is suing a Culver City, California-headquartered bioscience company and its Bird Marella attorneys in California state court, accusing them of manipulating the valuation of a company whose acquisition they funded, in order to defraud investors of $87 million.
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July 23, 2025
Co., Lenders Hit With Suit Over Medical Spa Financing Scam
A medical device manufacturer and several financing companies worked together to manipulate boutique clinics and medical spas into purchasing expensive cosmetic devices based on inflated revenue projections and false promises of marketing support, according to a proposed class action filed Monday in California federal court.
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July 22, 2025
FCA Draws Heavy Constitutional Fire After $1.6B J&J Verdict
Reeling from a record fraud verdict tied to drug promotion practices, Johnson & Johnson is pursuing a sweeping constitutional challenge to the False Claims Act, and in filings this week at the Third Circuit, major industry allies rallied behind its views of whistleblower litigants usurping executive branch power.
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.