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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.
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September 04, 2025
10th Circ. Ends Huffing Death Product Liability Suit
The Tenth Circuit refused to revive a Kansas man's proposed class action seeking damages against the makers of canned compressed air after his adult son fatally inhaled their product, saying the manufacturers can't be held liable because intentionally huffing the toxic gases in the product is against state law.
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September 04, 2025
Feds Stand By $10M Medicare Fraud Conviction At 4th Circ.
The Fourth Circuit should uphold the six-year sentence of a physician assistant who was found guilty of Medicare fraud after prosecutors said he rubber-stamped bogus prescriptions for genetic testing worth about $10 million, the government told the court.
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September 04, 2025
Yale Hospital's Info Request Upheld In $435M Property Suit
Three third-party hospital real estate holding companies and their corporate parent cannot challenge a decision requiring them to give records to Yale New Haven Health Services Corp. for its $435 million asset sale dispute with bankrupt Prospect Medical Holdings Inc., a Connecticut appeals court has ruled.
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September 04, 2025
4th Circ. Affirms Gardasil's Vaccine Table Inclusion
A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.
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September 04, 2025
Admonished For 'Entitlement,' Pillsbury Atty Ducks Sanction
A Nevada federal judge opted against sanctions for Pillsbury Winthrop Shaw Pittman LLP partner Mark Krotoski, and instead issued a formal admonishment on the "entitlement" behind "misleading arguments and representations" about the reason an expert witness was unavailable during a wage-fixing and wire fraud trial.
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September 04, 2025
Why The Harvard Funding Case Is 'Clear As Mud' On Appeal
A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.
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September 04, 2025
Aetna, Optum's $8.3M ERISA Health Fee Deal Gets Final OK
A North Carolina federal judge granted final approval to an $8.3 million class action settlement to end an employee health plan participant's allegations that Aetna conspired with OptumHealth Care Solutions to pass on administrative fees disguised as medical expenses, according to an order docketed Thursday.
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September 04, 2025
DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive
The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.
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September 04, 2025
Monthly Merger Review Snapshot
The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.
Expert Analysis
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Series
Law School's Missed Lessons: Practicing Self-Care
Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.
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New Laws Show How States Are Checking AI Developers
Recent state consumer protection legislation shows Utah, Colorado and Texas are primed to impose controls on artificial intelligence, and exemplifies the states' unwillingness to accord strong deference to developers and deployers of AI tools, say attorneys at Polsinelli.
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ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'
The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.
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IRhythm IPR Denial Raises Key PTAB Discretion Questions
By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.
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Plan For Increased HSR Info Sharing With Wash. Antitrust Law
Washington's merger notification requirements, effective later this month, combined with the Federal Trade Commission's new Hart-Scott-Rodino Act rules, will result in greater information sharing among state and federal agencies, making it important for merging parties to consider their transaction's potential state antitrust implications early on, say attorneys at McDermott.
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Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.
A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.
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Opinion
IPR Denial In IRhythm Should Not Set A Blanket Rule
Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.
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What High Court's Tenn. Trans Care Ruling Means Nationally
The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.
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Series
My Opera And Baseball Careers Make Me A Better Lawyer
Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.
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High Court ACA Ruling May Harm Preventative Care
The U.S. Supreme Court's decision in Kennedy v. Braidwood last week, ruling that the U.S. Department of Health and Human Services secretary has authority over an Affordable Care Act preventive care task force, risks harming the credibility of the task force and could open the door to politicians dictating clinical recommendations, says Michael Kolber at Manatt.
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8 Ways Lawyers Can Protect The Rule Of Law In Their Work
Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.
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Is SEC Moving Away From Parallel Insider Trading Cases?
The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.
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Rising Enforcement Stakes For Pharma Telehealth Platforms
Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.
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Series
Law School's Missed Lessons: Communicating With Clients
Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.
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3 Judicial Approaches To Applying Loper Bright, 1 Year Later
In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.