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Health
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July 17, 2025
FDA Signs Off On Juul E-Cig Products After 5-Year Review
The U.S. Food and Drug Administration on Thursday gave Juul the green light to market five e-cigarette products, although the FDA noted that the long-awaited authorization "does not mean these tobacco products are safe, nor are they FDA-approved."
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July 17, 2025
SEC Fraud Suit Against Ex-Online Pharmacy Execs Advances
A New York federal judge has declined to dismiss a majority of the U.S. Securities and Exchange Commission's claims against former executives of a now-defunct online pharmacy called Medly, finding the agency adequately pleaded that the executives made false statements or acted recklessly, among other misconduct.
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July 17, 2025
Accolade Faces $4.8M Suit Over Pre-Merger Profit Claims
Personalized healthcare solutions company Accolade Inc. was hit with an investor suit Thursday accusing it and its CEO of making false statements about its profitability to prop up share prices before announcing its plan to go private via a merger with healthcare company Transcarent Inc.
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July 17, 2025
11th Circ. Says Ex-Quest Diagnostics Worker's FCA Suit Fails
The Eleventh Circuit declined to revive a former Quest Diagnostics Inc. compliance officer's False Claims Act suit against the lab testing company, ruling she had failed to allege a specific claim of medical billing fraud after some 15 years of litigation.
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July 17, 2025
Stanford Trims Roche IP Suit, But Others Face Most Claims
Stanford University was let out of all but one claim brought by subsidiaries of F. Hoffmann-La Roche AG over alleged trade secret theft, but a California federal judge allowed most claims to move forward against several Stanford professors and a startup they founded.
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July 17, 2025
UMich Dental School Defeats Professor's PPE Retaliation Suit
A federal judge on Thursday tossed a former dentistry professor's lawsuit claiming he was fired for complaining about overheating from gowns faculty and staff were required to wear in University of Michigan's dental clinic as a COVID-19 precaution.
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July 17, 2025
Class Claims Target Anthem's 'Ghost' Provider Networks
Anthem Health Plans Inc. and its parent Elevance Health Inc. should be held liable for maintaining inaccurate directories of mental health providers that send patients on a "wild-goose chase" to find care, according to a putative class action in Connecticut state court that targets "ghost" networks.
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July 17, 2025
Senators Float 'Patent Thicket' Bill To Limit Generic Litigation
A bill floated in the U.S. Senate would limit the use of so-called patent thickets that are asserted by major pharmaceutical companies in litigation to restrict generic competition.
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July 17, 2025
Steward Health Says Ex-Execs Oversaw Fraudulent Transfers
Insolvent hospital operator Steward Health has sued former leaders of the business — including a surgeon who stepped down as CEO last year — in connection to its Chapter 11, alleging they executed a series of transactions that plundered the company's coffers when it was financially troubled.
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July 17, 2025
Insurer, Urology Practices Beat Puerto Rico Antitrust Suit
A Puerto Rico federal judge threw out an antitrust lawsuit accusing insurer Triple-S Salud and two urology firms of colluding to exclude rival practices from the commonwealth's government-run healthcare program, finding that the selection of a defendant practice through a competitive process means there was no anticompetitive harm.
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July 17, 2025
Nursing Home Suit Is Med Mal, Tossed For Lack Of Expert
A Texas appellate court on Thursday dismissed a man's suit against a nursing home claiming its negligence led to his mother's death after she fell and hit her head, finding his suit is a medical malpractice claim, so he needed an expert report to support his allegations.
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July 17, 2025
Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal
Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements.
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July 17, 2025
4th Circ. Orders New Trial After Doc Acquitted In Fraud Case
A Fourth Circuit panel ordered a new trial for a doctor who received a judge's acquittal after a jury found him guilty of alleged healthcare fraud, finding that the jury had sufficient evidence to convict, but the case was "close," and the district court was correct in hedging and allowing another shot at the case.
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July 17, 2025
PE Firm Is Denied FDA Docs For Defense In Deal Challenge
An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.
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July 17, 2025
Healthcare Co.'s Revised $120K Wage Deal Gets Green Light
A Connecticut-based healthcare company and its workers can move forward with their second attempt at a wage and hour settlement agreement, a Connecticut federal judge has ruled, finding that the new terms fix concerns he raised over the release of claims when rejecting the initial deal.
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July 17, 2025
6th Circ. Says Axed Expert Reports Doom Hip Implant Suit
The Sixth Circuit has sided with a medical device maker in a lawsuit brought by a man who alleged a component of his hip implant was faulty due to a manufacturing defect, saying the lower court correctly excluded his experts for their lack of knowledge about the surgery or the company's manufacturing processes.
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July 17, 2025
5th Circ. Affirms Nix Of Doctor's Captive Insurance Deductions
The owner of a Texas urgent care network is not entitled to $1 million in tax deductions for insurance premiums he paid to inside companies, the Fifth Circuit ruled, affirming the U.S. Tax Court's decision that the payments were not actually for insurance.
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July 16, 2025
4th Circ. Upends Gated Community's Win In Fair Housing Row
The owner of several assisted-living group homes for seniors won a second chance Tuesday to press claims that his Maryland gated community is illegally refusing to let him open a new home there, with the Fourth Circuit ruling that a reasonable jury could find violations of the federal Fair Housing Act.
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July 16, 2025
8th Circ. Sends Part Of OptumRx Pricing Fight To Arbitration
The Eighth Circuit partially reversed a ruling Wednesday that denied pharmacy benefits manager OptumRx's bid to send a drugstore's proposed class action over generics prescription reimbursements to arbitration, finding that OptumRx waived arbitration as to three claims, but an arbitrator must decide the fate of two recently pleaded claims.
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July 16, 2025
Telehealth Co. Says SEC Has Wrapped Securities Investigation
Fruit Street Health PBC announced that the U.S. Securities and Exchange Commission has closed an investigation into the telehealth company for which the agency previously sued it to comply with a subpoena.
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July 16, 2025
Pharmacy Benefit Managers Say Ohio Can't Recast Suit
The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.
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July 16, 2025
Maine Clinics Sue Over Medicaid Ban On Abortion Providers
A Maine family planning organization sued the U.S. Department of Health and Human Services on Wednesday over abortion-related Medicaid restrictions outlined in President Donald Trump's budget act, saying they violate constitutional equal protection rights.
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July 16, 2025
Hims & Hers Brass Face Suit Over 'Knockoff' Wegovy Sales
Executives and directors of telehealth company Hims & Hers Health Inc. have been hit with a shareholder derivative suit in California federal court accusing them of allowing the company to exploit its now-terminated partnership with Novo Nordisk to sell "knockoff" versions of Novo's weight loss drug Wegovy,.
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July 16, 2025
Senior Placement Co. Wants Out Of False Ad Suit
A company that places senior citizens in retirement homes has asked a Georgia federal judge to toss a proposed class action alleging it falsely advertised free services and steered business away from communities that declined to participate in its "pay-to-play" business model, arguing the claims were just "speculation and conjecture."
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July 16, 2025
Morris Manning Atty Trio Joins Husch Blackwell In Latest Exits
Husch Blackwell LLP announced Wednesday that a pair of Atlanta-based healthcare partners along with an associate in the same city have joined the firm from Morris Manning & Martin LLP, marking the latest departures from Morris Manning after the firm said it is in talks to join a larger firm.
Expert Analysis
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Opinion
IRS Should Work With Industry On Microcaptive Regs
The IRS should engage with microcaptive insurance owners to develop better regulations on these arrangements or risk the emergence of common law guidance as taxpayers with legitimate programs seek relief in the federal courts, says Dustin Carlson at SRA 831(b) Admin.
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How Providers Can Brace For Drug Pricing Policy Changes
Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.
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Discretionary Denial Rulings May Spur Calls For PTAB Reform
The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.
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Spinoff Transaction Considerations For Biotech M&A
Amid current market challenges, boards and management teams of biotech companies can consider several strategies for maximizing value should a spinoff opportunity arise, but not without significant advance planning and careful implementation, particularly in cases that might qualify as tax-free, say attorneys at Paul Hastings.
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Debunking 4 Misconceptions Around Texas' IV Therapy Law
Despite industry confusion, an IV therapy law enacted in Texas last week may actually be the most business-friendly regulatory development the medical spa industry has seen in recent years, says Keith Lefkowitz at Hendershot Cowart.
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Opinion
Senate's 41% Litigation Finance Tax Would Hurt Legal System
The Senate’s latest version of the Big Beautiful Bill Act would impose a 41% tax on the litigation finance industry, but the tax is totally disconnected from the concerns it purports to address, and it would set the country back to a time when small plaintiffs had little recourse against big defendants, says Anthony Sebok at Cardozo School of Law.
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Psychedelic Treatment Regs May Be At A Tipping Point
Recent scientific and public attention suggest that development of psychedelics as treatment for some conditions may be at a tipping point, which could bring on more rapid change and opportunities for stakeholders who may in the future benefit from greater access to safe and effective psychedelic medicines, say attorneys at King & Spalding.
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Series
Performing As A Clown Makes Me A Better Lawyer
To say that being a clown in the Macy’s Thanksgiving Day Parade has changed my legal career would truly be an understatement — by creating an opening to converse on a unique topic, it has allowed me to connect with clients, counsel and even judges on a deeper level, says Charles Tatelbaum at Tripp Scott.
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Focusing On Fluoride: From FDA To Class Action
A class action filed two days after the U.S. Food and Drug Administration announced plans to remove ingestible fluoride prescription drug products for children from the market may be the tip of the iceberg in terms of the connection between government pronouncements on safety and their immediate use as evidence in lawsuits, says Rachel Turow at Skadden.
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Series
Law School's Missed Lessons: Rejecting Biz Dev Myths
Law schools don’t spend sufficient time dispelling certain myths that prevent young lawyers from exploring new business opportunities, but by dismissing these misguided beliefs, even an introverted first-year associate with a small network of contacts can find long-term success, says Ronald Levine at Herrick Feinstein.
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Move Beyond Surface-Level Edits To Master Legal Writing
Recent instances in which attorneys filed briefs containing artificial intelligence hallucinations offer a stark reminder that effective revision isn’t just about superficial details like grammar — it requires attorneys to critically engage with their writing and analyze their rhetorical choices, says Ivy Grey at WordRake.
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How Ore. Law Puts New Confines On Corp. Health Ownership
A newly enacted law in Oregon strengthens the state’s restrictions on corporate ownership of healthcare practices, with new limitations on overlapping control, permissible services, restrictive covenants and more making it necessary for practices to review decades-old physician practice arrangements, say attorneys at Ropes & Gray.
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Handling Revenue Cycle Management Disputes In The AI Age
As healthcare providers and revenue cycle management vendors face an increasing use of artificial intelligence in claims adjudication, it's important for providers and their general counsel to plan in advance for potential disagreements with vendors and investigate the root causes behind any underperformance that arises, say consultants at AlixPartners.
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9th Circ. Has Muddied Waters Of Article III Pleading Standard
District courts in the Ninth Circuit continue to apply a defunct and especially forgiving pleading standard to questions of Article III standing, and the circuit court itself has only perpetuated this confusion — making it an attractive forum for disputes that have no rightful place in federal court, say attorneys at Gibson Dunn.
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Trump Antitrust Shift Eases Pressure On Private Equity Deals
Enforcement actions and statements by Trump administration antitrust officials forecast a shift away from specifically targeting private equity activity, which should be welcome news to dealmakers, but firms shouldn't expect to escape traditional antitrust scrutiny, says Nathaniel Bronstein at Fried Frank.