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June 04, 2025
Vape Cos. Urge 5th Circ. To Toss FDA Vape Marketing Rule
A group of small e-cigarette companies is asking the Fifth Circuit to revive their suit challenging the U.S. Food and Drug Administration's rule for premarket authorization of new tobacco products, saying the FDA failed to account for how the rule would affect small businesses.
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June 04, 2025
Ohio Nonprofit, Nursing Homes To Pay $3.6M To End FCA Suit
An Ohio-based nursing home operator has agreed to pay $3.61 million to settle False Claims Act allegations brought against it by the government over purportedly substandard and in some cases nonexistent care, according to a new announcement from the U.S. Department of Justice.
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June 03, 2025
Trump Admin. Nixes Guidance Protecting ER Abortion Care
The Trump administration said Tuesday that it is rescinding post-Dobbs guidance from 2022 that emphasized medical providers' abortion care obligations under federal law and that assured federal law protected providers' clinical judgment, regardless of conflicting state laws or mandates.
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June 03, 2025
Pharma Group Can Pursue Challenge To Insulin Pricing Law
A Minnesota federal judge refused Tuesday to throw out a lawsuit over a state law requiring drugmakers to provide insulin to low-income diabetic patients, finding the drug industry's top lobbying group has plausibly alleged that a new registration fee imposed by the law could be unconstitutional.
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June 03, 2025
Patent Deals Accelerate Access To Generics, Drug Group Says
Deals between the makers of brand name drugs and the companies behind their generic versions have led to billions of dollars in healthcare cost savings and faster access to cheaper medicines, according to a new report.
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June 03, 2025
6th Circ. Denies PBMs' Privilege Claim In Opioid MDL
A Sixth Circuit panel on Tuesday denied a petition from Cigna's Express Scripts and UnitedHealth's Optum seeking to reverse discovery orders allowing certain personnel files and internal communications into the multidistrict opioid litigation, finding that the two pharmacy benefit managers failed to show extraordinary abuses justifying relief.
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June 03, 2025
MultiPlan Must Face Reimbursement Pricing Antitrust MDL
An Illinois federal judge on Tuesday largely rejected a bid by MultiPlan to ditch multidistrict litigation accusing the company of illegally fixing out-of-network reimbursement rates, trimming only unjust enrichment claims while allowing antitrust claims to move forward.
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June 03, 2025
Plan Providers Must Face DOJ Overpayment Suit, Judge Says
A Maine federal judge refused to let five military healthcare plan providers escape a False Claims Act suit alleging that they knowingly pocketed millions of dollars that were overpaid, holding that U.S. Department of Justice claims against them pass muster for now.
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June 03, 2025
Adidas, UChicago Failed To Protect Data In Hacks, Suits Say
Adidas' American arm and the University of Chicago Medical Center have been sued for allegedly failing to keep sensitive identifying information safe from hackers who stole it through certain third-party vendors.
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June 03, 2025
InnovAge To Pay $27M To Resolve IPO Investors' Suit
InnovAge Holding Corp. and a class of stockholders have agreed to a $27 million settlement to resolve claims that the senior-health care company made misleading statements in an initial public offering that later caused stock prices to tank after a government audit exposed the falsehoods.
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June 03, 2025
Canada Customers Agree To Halt 23andMe Data Breach Suits
23andMe and Canadian customers suing over a data breach agreed on Tuesday to pause lawsuits against non-bankrupt third parties for up to six months amid the DNA testing company's Chapter 11 proceedings in Missouri.
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June 03, 2025
Feds Extend Pause On Fight Over Short-Term Insurance Regs
The Trump administration can have more time to develop a replacement for regulations that made it harder to offer short-term health insurance plans, a Texas federal judge said, rejecting a trade group's argument that keeping their legal challenge on ice wasn't justified.
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June 03, 2025
Rosen, Pomerantz To Lead Seattle Biotech Class Action
The Rosen Law Firm PA and Pomerantz LLP will serve as co-lead counsel for shareholders accusing Seattle-based Sana Biotechnology Inc. of misleading investors about its ability to develop certain genetic therapy treatments.
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June 03, 2025
HHS, DOGE Accused Of Using Flawed Data In Mass Layoffs
Former federal workers laid off by the U.S. Department of Health and Human Services brought a putative class action Tuesday in D.C. federal court alleging their terminations were unlawful because they were based on "hopelessly error-ridden" personnel records, in violation of the Privacy Act.
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June 03, 2025
Latham Advises Atai In $390M Merger With Beckley Psytech
U.S.-German biopharmaceutical company atai Life Sciences, advised by Latham & Watkins LLP, said in an announcement Monday that it will acquire Beckley Psytech, led by Mayer Brown LLP and CMS Cameron McKenna Nabarro Olswang LLP, in an all-share transaction that values Beckley at approximately $390 million, creating a combined company focused on fast-acting mental health therapies.
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June 03, 2025
Fla. Jury Finds CEO Guilty In $1.4B Medicare Fraud
A Florida federal jury on Tuesday found a software company CEO guilty of participating in a scheme to coordinate illegal medical kickbacks through an internet platform, resulting in about $1.4 billion worth of false billings to Medicare and other insurers for unnecessary medical products, including orthotic braces.
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June 03, 2025
2nd Circ. Says Social Worker Can't Challenge NY Abortion Law
The Second Circuit on Tuesday rejected a social worker's constitutional challenge to a New York law decriminalizing abortion, finding that she lacked standing to sue because she couldn't identify any specific fetus facing harm.
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June 03, 2025
Simpson Thacher Adds Ex-Weil M&A Pro In NYC
Simpson Thacher & Bartlett LLP announced Monday the hiring of a former counsel at Weil Gotshal & Manges LLP as a partner in its mergers and acquisitions practice in New York.
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June 03, 2025
The Law360 400: A Look At The Top 100 Firms
A rebound in client work sent the nation’s largest law firms into growth mode last year, driving a wave of hiring, mergers and strategic moves that reshaped the top tier of the Law360 400. Here's a preview of the 100 firms with the largest U.S. attorney headcounts.
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June 03, 2025
Calif. Panel Won't Restore Subclasses In Nurses' Wage Suit
Two nurses failed to back up their assertions that a hospital system similarly refused to provide their colleagues with meal and rest breaks, a California state appeals court ruled, upholding an order that decertified two subclasses in their wage suit.
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June 03, 2025
Katten Adds 4 Ex-Kirkland Attys To Healthcare Practice
Katten Muchin Rosenman LLP announced Tuesday that it has hired two partners and two associates from Kirkland & Ellis LLP to boost Katten's regulatory and transactional expertise in the firm's healthcare practice.
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June 02, 2025
Pa. Panel Grants New Trial In Death Suit Against ER Doctor
A Pennsylvania appeals court on Monday ordered a new trial in a suit accusing an emergency room physician of negligently treating a man's cardiac issues which proved fatal, saying a medical journal article written by the defense's medical expert should have been admitted as evidence.
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June 02, 2025
9th Circ. Sends Express Scripts Opioid Case To State Court
The Ninth Circuit sent California's public nuisance lawsuit against Express Scripts and OptumRx over opioid dispensing back to state court Monday and denied the pharmacy benefit managers' bid to stay the remand pending appeal, saying the U.S. Supreme Court's 2009 Nken decision controls, not its later Coinbase ruling.
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June 02, 2025
23andMe Founder Pushes Alternative Ch. 11 Sale
The founder of 23andMe has urged a Missouri bankruptcy court to revisit the $256 million sale of the company's assets to Regeneron, saying she has a better bid backed by an unnamed corporation.
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June 02, 2025
Ore. Psilocybin Access Suit Can Continue, Judge Says
An Oregon federal judge has ruled that the state's health regulator must face a suit brought under a federal antidiscrimination law that seeks to broaden access for homebound patients to the state's regulated psilocybin program.
Expert Analysis
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Class Actions At The Circuit Courts: February Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses five federal appellate court class certification decisions and identifies practice tips from cases involving breach of life insurance contracts, constitutional violations of inmates and more.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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Axed ALJ Removal Protections Mark Big Shift For NLRB
A D.C. federal court's recent decision in VHS Acquisition Subsidiary No. 7 v. National Labor Relations Board removed long-standing tenure protections for administrative law judges by finding they must be removable at will by the NLRB, marking a significant shift in the agency's ability to prosecute and adjudicate cases, say attorneys at Proskauer.
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11th Circ. TCPA Ruling Signals Erosion Of Judicial Deference
The U.S. Court of Appeals for the Eleventh Circuit recently came to the rescue of the lead generation industry, striking down new regulations that were set to go into effect on Jan. 27, a decision consistent with federal courts' recent willingness to review administrative decisions, say attorneys at Troutman.
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The Case For Compliance During The Trump Administration
Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.
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Opinion
Undoing An American Ideal Of Fairness
President Donald Trump’s orders attacking birthright citizenship, civil rights education, and diversity, equity and inclusion programs threaten hard-won constitutional civil rights protections and decades of efforts to undo bias in the law — undermining what Chief Justice Earl Warren called "our American ideal of fairness," says Reuben Guttman at Guttman Buschner.
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Dispelling 10 Myths About Health Provider-Based Compliance
Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.
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How Ill. Ruling Could Influence Future Data Breach Cases
The Illinois Supreme Court's recent decision in Petta v. Christie Business Holding, which was based solely on standing, establishes an important benchmark for the viability of Illinois-based lawsuits arising out of data security incidents that defendants can cite in future cases, say attorneys at Wilson Elser.
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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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Virginia AI Bills Could Serve As Nationwide Model
If signed into law, two Virginia bills focused on regulating the use of high-risk AI systems in the private and public sectors have the potential to influence similar legislation in other states, as well as the compliance strategies of companies operating in the commonwealth and across the U.S., say attorneys at Woods Rogers.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.