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Health
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October 22, 2024
Pharma Co. Verrica Faces Derivative Suit Over FDA Inspection
Current and former officers and directors of dermatological medication maker Verrica Pharmaceuticals Inc. face a shareholder derivative action alleging the company concealed a "litany of issues" with a manufacturer's facility that ultimately delayed U.S. Food and Drug Administration approval for a skin treatment.
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October 22, 2024
Ark. Supreme Court Voids Nov. Effort To Expand Medical Pot
The Arkansas Supreme Court has determined that voters will not get to decide November 5 whether to expand the state's medical marijuana program via a ballot initiative after finding that the title and summary of the proposed constitutional amendment were misleading.
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October 22, 2024
Patent Office Finds Public Engagement Leader
The U.S. Patent and Trademark Office has tapped a former U.S. Small Business Administration program specialist to head the patent office's recently created section meant to bolster its outreach and communication efforts.
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October 22, 2024
Judge Skeptical Amgen Can't Sue Over Colo. Drug Price Caps
A Colorado federal judge on Tuesday seemed to doubt the state could short-circuit drugmaker Amgen's challenge to the state's drug price cap system, pressing the state to explain why limiting what consumers ultimately pay does not affect what companies like Amgen can charge.
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October 22, 2024
LA-Based Wound Group Hits Ch. 11 After Medicare Pay Pause
A Los Angeles-based multistate wound care practice has filed for Chapter 11 protection in a Texas bankruptcy court, saying it can't pay nearly $156 million in charges from its management company after its Medicare payments were suspended last month.
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October 22, 2024
Talkiatry CEO On How Digital Healthcare Has 'Matured'
Digital health has come a long way in recent years, but it's still got plenty of growing up to do. That's according to Robert Krayn, co-founder and CEO of virtual psychiatry platform Talkiatry.
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October 22, 2024
Baker Donelson Picks Up Carlton Fields Health Ace In Florida
Baker Donelson Bearman Caldwell & Berkowitz PC announced Tuesday that it had brought a former Carlton Fields PA healthcare attorney to its practice in Fort Lauderdale, Florida, enabling the firm to deepen its health law bench with a lawyer who has private practice and in-house experience.
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October 22, 2024
NJ Justices Create Mass Tort Track For Bard Catheter Suits
The New Jersey Supreme Court has established a multicounty litigation track for cases seeking to hold C.R. Bard Inc., Bard Access Systems Inc. and Becton Dickinson and Co. liable for injuries allegedly caused by Bard implanted port catheter products, according to a notice to the bar.
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October 22, 2024
The 2024 Prestige Leaders
Check out our Prestige Leaders ranking, analysis and interactive graphics to see which firms stand out for their financial performance, attractiveness to attorneys and law students, ability to secure accolades and positive legal news media representation.
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October 22, 2024
How Law Firms Get And Keep Elite Status
For decades, a handful of New York-based law firms thoroughly dominated the national consciousness when it came to power, profitability and prestige. But in today's legal market, increased movement of partners and clients from one firm to the next has begun to shake things up and create opportunities for go-getters to ascend the ranks.
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October 22, 2024
Ex-Ga. Insurance Commissioner Gives Up Law License
Georgia's justices accepted John Oxendine's voluntary surrender of his law license on Tuesday, months after the former state insurance commissioner was sentenced to prison for his role in a multimillion-dollar medical testing kickback scheme.
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October 21, 2024
Apple Tells Del. Jury It Wants Smartwatch Infringing To Stop
An Apple attorney told a federal jury in Delaware on Monday that the company is willing to accept only a token damage award from Masimo Corp. for the health tech company's infringement of Apple's smartwatch, but wants the alleged copying barred.
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October 21, 2024
9th Circ. Judge Slams 'Reprehensible' Policy In Jail Death
A Ninth Circuit judge on Monday blasted a healthcare contractor's policy that denied hospital treatment for a woman in a Washington jail who died from a ruptured intestine, but nevertheless questioned if a $24 million punitive damage jury award was excessive.
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October 21, 2024
NC Justices Revive Challenge To Hospital Competition Law
The North Carolina Supreme Court has ordered a trial court to reassess an optical surgeon's suit challenging the state's healthcare competition law over claims that the certificate of need statute violates the constitution by blocking him from using his own operating room.
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October 21, 2024
PBMs Keep Door Open To Constitutional Riposte Against FTC
Attorneys for Caremark Rx, Express Scripts and OptumRx kept the door open Monday to challenging the Federal Trade Commission's constitutionality as they face an in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes.
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October 21, 2024
Google, Meta Want Out Of GoodRx Health Data Sharing Suit
Google, Meta Platforms and Criteo have asked a California federal court to cut them loose from litigation alleging that GoodRx improperly shared patients' protected health information with the tech companies, saying the claims are "fundamentally flawed."
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October 21, 2024
GOP Pols Want Probe Into FDA Laboratory Safety
Three Republican lawmakers on Friday sought information from the U.S. Food and Drug Administration about its oversight of its laboratory safety practices, following a long investigation over an incident about vials of smallpox virus and other hazards found on a National Institutes of Health campus.
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October 21, 2024
Weight Loss Clinic Denied Quick Relief In TM Suit
A North Carolina hospital and healthcare provider don't have to stop using the trademarks targeted in a weight loss clinic's infringement suit, a federal judge ruled Monday, finding that the clinic will not suffer significant consequences absent the immediate relief.
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October 21, 2024
Blue Cross Escapes Mental Health Coverage Denial Suit
A Pennsylvania federal judge tossed a patient's suit that claimed Independence Blue Cross violated federal benefits law when it declined to cover his stay at a residential facility, ruling the insurance company adequately backed up its decision that the treatment wasn't imperative to his health.
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October 21, 2024
Novartis Loses Challenge To Medicare Drug Price Talks
A New Jersey federal judge on Friday tossed Novartis Pharmaceuticals' challenge to a Medicare drug price negotiation program, ruling the company is not required to participate, and that participating in the program does not violate its First Amendment rights.
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October 21, 2024
Ontrak Jury Lacked Key Compliance Instruction, Judge Told
Counsel for convicted Ontrak founder Terren Peizer urged a California federal judge Monday to grant a new trial in the healthcare executive's novel insider trading case, saying jurors weren't properly instructed that they should acquit if Peizer's $20 million share sale was blessed by a compliance officer.
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October 22, 2024
Post-Dobbs Ballot Questions May Spell Litigation With No End
A record-setting number of abortion-related constitutional ballot questions this year has unleashed a wave of litigation over reproductive rights in the wake of the U.S. Supreme Court's Dobbs decision. But they may just be the start of the legal battles over the ballot measures.
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October 21, 2024
Feds Say Doctor Used Pandemic Funds For Cars, Real Estate
A Washington state dermatologist used $1.5 million from a loan intended for small business COVID-19 relief on two luxury Porsches, a second home and a storage unit, prosecutors said Monday.
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October 21, 2024
McGuireWoods Adds Healthcare Atty From Cooley In NY
McGuireWoods LLP has added a digital health expert from Cooley LLP, aiming to boost its offerings for clients in the space combining healthcare services with information and communications technology, the firm announced Monday.
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October 21, 2024
Fla. Dept.'s Ex-GC Says Gov.'s Office Directed TV Ad Letters
The former general counsel for the Florida Department of Health said Monday that he was directed by Gov. Ron DeSantis' office to send out letters threatening television stations with criminal prosecution if they did not pull a campaign ad promoting an abortion rights ballot initiative.
Expert Analysis
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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How 5 States' Deal Notification Laws Are Guiding Healthcare
Healthcare transaction notification laws at various stages of implementation in California, Illinois, Indiana, Oregon and Washington are shaping sector mergers and acquisitions, with significant transparency, continuity of care and compliance implications as providers tackle complex regulatory requirements, says Melesa Freerks at DLA Piper.
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Contract Disputes Recap: Preserving Payment Rights
Stephanie Magnell and Zachary Jacobson at Seyfarth examine three recent decisions that together illustrate the importance of keeping accurate records and adhering to contractual procedures to avoid inadvertently waiving contractual rights to cost reimbursements or nonroutine payments.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Bid Protest Spotlight: Standing, Prejudice, Conflicts
In this month's bid protest roundup, Caitlin Crujido at MoFo examines three recent decisions from the U.S. Government Accountability Office concerning whether a would-be protestor was an interested party with standing, whether an agency adequately investigated potential procurement violations and whether a proposed firewall sufficiently addressed an impaired objectivity organizational conflict of interest.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.