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Health
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September 08, 2025
FibroGen To Pay SEC $1.25M Over Drug Mistatements
Biopharmaceutical company FibroGen Inc. has agreed to pay a $1.25 million penalty to the U.S. Securities and Exchange Commission to resolve claims that its former chief medical officer fudged results for its primary drug, Roxadustat, which treats anemia in kidney disease patients.
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September 08, 2025
23andMe's Ch. 11 Sale Flouted State Privacy Law, Calif. Says
The state of California has asked a Missouri federal judge to undo the $305 million bankruptcy sale of consumer DNA testing group 23andMe, arguing it sidestepped state consumer data protections.
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September 05, 2025
DC Circ. Won't Halt Order Releasing Billions In Foreign Aid
Both a divided D.C. Circuit panel and a district court judge Friday refused to hit pause on the judge's recent order requiring the Trump administration to release billions of dollars in frozen foreign aid.
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September 05, 2025
Stewart Tackles Markets, Injunctions In Newest PTAB Reviews
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart released 14 institution decisions in the last week, providing more insight on the scope of settled expectations and the impact of a district court preliminary injunction.
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September 05, 2025
Judge Doubts DOE Stance On Ending Mental Health Grants
A Seattle federal judge hinted on Friday that 16 states have valid claims against the U.S. Department of Education for arbitrarily discontinuing mental health funding for public schools, expressing frustration with the federal government's argument that it could terminate grant funding the same way it could fire a landscaper under contract. Â
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September 05, 2025
DOJ Pushes To DQ Attorney Over Conflict In Fraud Case
Federal prosecutors in Georgia are seeking to disqualify an attorney from representing a defendant accused of making false statements in relation to a criminal fraud investigation of Hi-Tech Pharmaceuticals Inc., arguing the lawyer was previously disqualified from representing the company's CEO for a conflict and that "the same is true now."
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September 05, 2025
Merck Shakes Off Some Claims From Cholesterol Drugs Suit
A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.
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September 05, 2025
HCA Healthcare Can't Halt Discovery In 401(k) Forfeiture Suit
A Tennessee federal judge denied HCA Healthcare's bid Friday to stop discovery while the court considers its motion to toss a worker's suit claiming it illegally used forfeited 401(k) funds to cover its own contribution costs, finding the alleged novelty of her claims can't block case information collection.
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September 05, 2025
Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed
Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.
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September 05, 2025
FDA Explains Rejection Of MDMA Therapy For Treating PTSD
The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.
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September 05, 2025
Casper Can't Escape Innovator-Liability Drug Label Suit
A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.
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September 05, 2025
Ga. Ban On Trans Prisoner Healthcare Paused, Class Certified
A Georgia federal judge has reached what he described as a "straightforward" decision to temporarily pause the state's law banning the use of state resources for hormone replacement therapies for transgender state prisoners, and is considering granting the plaintiffs' request for permanent injunctive relief.
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September 05, 2025
Integra Wound Dressing Disfigured Woman's Foot, Suit Says
Integra Lifesciences Corp. is facing a lawsuit in North Carolina federal court alleging the medical device and technology company's recalled wound dressing was defective and ultimately caused a kidney infection in a woman that required multiple surgeries.
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September 05, 2025
6th Circ. Finds Boss' Pregnancy Remark Supports Bias Claim
A split Sixth Circuit panel revived part of a lawsuit from a woman who alleges a Michigan hospital system laid her off because she was pregnant, finding that evidence that the worker's supervisor was concerned about the pregnancy's effects on department productivity supports pregnancy discrimination claims.
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September 05, 2025
Brown Univ. Prof Says Top Court Ruling Bolsters Habeas Bid
A Lebanese nephrologist who teaches at Brown University under an H-1B visa argued last week that the U.S. Supreme Court's ruling this summer in Kennedy v. Braidwood Management, a case focusing on whether members of a U.S. government task force were constitutionally appointed, bolsters her argument that the U.S. Customs and Border Protection officers who deported her lacked the authority to do so.
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September 05, 2025
Mass. Justices Mull Privacy Issues In Era Of Online Records
Massachusetts' highest court heard arguments Friday in a pair of cases asking the justices to balance the public's right to access court documents against the privacy interests of potential medical malpractice victims and people charged with but later cleared of crimes.
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September 05, 2025
Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit
Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.
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September 05, 2025
Court Denies Vape Interests' Bid To Halt Wisconsin E-Cig Law
A Wisconsin federal judge on Friday rejected vaping interests' motion to halt enforcement of a new state law banning the sale of e-cigarettes not approved by the U.S. Food and Drug Administration, saying they were unlikely to succeed on claims the law was preempted.
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September 05, 2025
Workers Say Tenet Misspent Forfeitures In Mega 401(k) Plan
A Tenet Healthcare ex-employee alleged in a proposed class action Friday in Texas federal court that the healthcare company misspent nearly $28.6 million in forfeitures from an employee 401(k) plan by using the assets to reduce employer-side contribution obligations to other workers' accounts.
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September 05, 2025
CEO's Alleged Threat After Records Demand Prompts Del. Suit
A major stockholder and officer of a health risk software venture who reported receiving a threatening reply from the company's CEO when he requested records has sued for the documents in Delaware's Court of Chancery, saying the earlier request was otherwise ignored.
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September 05, 2025
GRSM Launches Practice For Correctional Healthcare
Gordon Rees Scully Mansukhani has announced that it is launching a new practice to advise correctional healthcare providers.
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September 05, 2025
Taxation With Representation: Milbank, Wachtell, Latham
In this week's Taxation With Representation, aircraft lessor Air Lease Corp. agrees to a take-private deal, Evernorth Health Services invests billions in Shields Health Solutions, Cadence Design Systems Inc. acquires the design and engineering business of Hexagon AB, and Kraft Heinz Co. plans to split into two independent, publicly traded companies.
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September 04, 2025
Feds Seek Stay On Court Order Releasing Foreign Aid Billions
The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."
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September 04, 2025
Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal
A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.
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September 04, 2025
Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence
A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.
Expert Analysis
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How Attorneys Can Become Change Agents For Racial Equity
As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.
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CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits
Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.
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Series
Running Marathons Makes Me A Better Lawyer
After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.
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3 Takeaways From Recent Cyberattacks On Healthcare Cos.
For the healthcare industry, the upward trend in styles of cyberattacks, costs, and entities targeted highlights the critical importance of proactive planning to help withstand the operational, legal and reputational turmoil that can follow a data breach, say attorneys at Troutman Pepper.
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Series
Law School's Missed Lessons: Supporting A Trial Team
While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.
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FAR Rewrite May Cloud Key Gov't Contract Doctrine
The Trump administration's government procurement overhaul, under which sections of the Federal Acquisition Regulation are eliminated by default, is bound to collide with a doctrine that allows courts to read omitted clauses into government contracts if they represent long-standing pillars of federal procurement law, say attorneys at Rogers Joseph.
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Series
Adapting To Private Practice: From US Attorney To BigLaw
When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.
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Most-Favored Nation Drug Pricing Could Shake Up US Pharma
Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.
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The Ins And Outs Of Consensual Judicial References
As parties consider the possibility of judicial reference to resolve complex disputes, it is critical to understand how the process works, why it's gaining traction, and why carefully crafted agreements make all the difference, say attorneys at Pillsbury.
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How Focus On Menopause Care Is Fueling Innovation, Access
Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.
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Opinion
The BigLaw Settlements Are About Risk, Not Profit
The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.
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Neb.'s Cannabis Regulatory Void Poses Operational Risks
With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.
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Del. Dispatch: A Look At Indemnification Notice Provisions
The Delaware Supreme Court's recent decision in Thompson Street Capital Partners v. Sonova U.S. Hearing Instruments serves as a reminder that noncompliance with contractual requirements for an indemnification claim notice may result in forfeiture of the indemnification right, depending on both the agreement language and the circumstances, say attorneys at Fried Frank.
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Series
Brazilian Jiujitsu Makes Me A Better Lawyer
Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.
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FDA Commissioner Speech Suggests New Vision For Agency
In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.