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October 10, 2024
Suppliers' $7.6M Deal To End Daily Harvest Leek Claims OK'd
A New York federal judge has given the go-ahead to a $7.6 million settlement with suppliers for meal kit delivery service Daily Harvest Inc. to end claims from buyers that a lentil and leek meal caused gastrointestinal illness.
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October 10, 2024
Teva To Pay $450M To Settle Kickback Cases
Pharmaceutical giant Teva will pay $450 million to settle allegations it violated the False Claims Act by fixing the prices of several generic drugs and by raising the price of a multiple sclerosis treatment while covering Medicare recipients' copays, civil prosecutors said Thursday.
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October 10, 2024
Hyundai Plans IPO For Indian Biz, Plus More Rumors
Hyundai's Indian unit is eyeing a massive $3.3 billion initial public offering, rumors are swirling regarding ownership stakes of major European soccer clubs, and Saudi Arabia’s Public Investment Fund may buy a $1 billion minority stake in sports-streaming giant DAZN. Here, Law360 breaks down these and other notable rumors from the past week.
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October 10, 2024
Ex-NBA Pro Seeks Leniency In Health Fraud Sentencing
A former NBA player who pled guilty to his role in a scheme to defraud the league's healthcare plan and became a government witness has asked a Manhattan federal judge to be sentenced "as leniently as possible" and to only be assessed a $100 fine.
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October 09, 2024
$140M Chilean Hospital Award Fight Is Paused In Canada
A Canadian judge has paused a Chilean construction company's bid to enforce a $140 million arbitral award arising from a soured hospital construction project against Webuild while an Italian court determines whether the construction giant is obligated to pay.
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October 09, 2024
9th Circ. Upends Healthcare Workers' Montana Vax Law Win
The Ninth Circuit on Wednesday reversed a ruling from a Montana federal judge striking for all healthcare settings a state law that bars discrimination based on vaccine status, calling the claimed harms to healthcare workers and patients "too speculative" to find it conflicted with federal law.
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October 09, 2024
Montana High Court Upholds Temporary Abortion Ban Blocks
The Montana Supreme Court late Wednesday handed down two decisions upholding a state district court's temporary injunctions blocking numerous abortion restrictions stemming from four pieces of state legislation while the case plays out in lower courts.
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October 09, 2024
Patients' Families Say No Expert Needed In Transplant Case
The families of patients who died while on an organ donor waiting list are urging a Texas state court to deny a surgeon's bid to toss their suit aimed at blocking him from altering or destroying records, saying because their suit does not make any claims for damages, they do not need an expert report.
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October 09, 2024
Wash. Justices To Weigh $185M PCB Case Against Monsanto
The Washington State Supreme Court will consider school teachers' bid to reinstate a $185 million jury verdict against Monsanto in a chemical poisoning tort, marking the first in a series of cases tied to the same school to make it all the way to the state's high court.
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October 09, 2024
Judge OKs $9M Data Hack Deal, Asks How Public Views Fees
A Washington federal judge on Wednesday approved an $8.8 million settlement that ended a consolidated data breach class action against a Hearst Health unit, but not before pondering how the public might perceive the deal, in which one-third of the money is going toward legal costs.
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October 09, 2024
Ohio Worker Says Health Co. Doesn't Pay OT Or Promised Wages
An Ohio healthcare worker has accused provider CareStar Inc. of unlawfully denying her and a proposed class of current and former employees overtime pay and failing to fork over supplemental pay the company promised her.
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October 09, 2024
CVS, United Health Seek Removal Of FTC's Khan In PBM Case
Major pharmacy benefit manager owners are calling on a Federal Trade Commission administrative judge to disqualify three Democratic FTC commissioners from the agency's in-house lawsuit accusing them of artificially inflating insulin prices, arguing that the commissioners have repeatedly vilified PBMs and prejudged the proceeding.
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October 09, 2024
Senior Center Denied Total Win In Insurer's Coverage Suit
An insurer for an operator of a skilled nursing facility must still cover the portion of a $225,000 wrongful death damages award exceeding a $100,000 self-insured retention even if the operator can't pay that retention, an Illinois federal court ruled, citing state public policy.
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October 09, 2024
Insurer Wins Ex-PwC Exec's Long-Term Disability Suit
An Illinois federal judge handed Hartford Life and Accident Insurance Co. a win in a federal benefits lawsuit from a former PricewaterhouseCoopers LLP executive who alleged she was wrongly denied long-term disability benefits after fibromyalgia left her unable to continue working.
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October 09, 2024
Ex-NC Govs. Back Cooper In Power Struggle With Lawmakers
Five former governors of North Carolina have thrown their support behind the current Democratic governor as he wrestles with Republican lawmakers over appointment powers, telling the state appeals court that the legislature has trampled on "a bedrock constitutional principle" by seeking to divest the governor of his ability to select members of executive branch agencies.
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October 09, 2024
GSK Settles Nearly All State Zantac Cases For Up To $2.2B
GSK said Wednesday that it will pay up to $2.2 billion to settle roughly 80,000 state court cases claiming Zantac heartburn medication or the generic ranitidine caused them to develop cancer.
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October 09, 2024
Lead Test Maker Vows Compliance As $42M Deal Approved
The general counsel of Magellan Diagnostics promised Wednesday that the medical device maker "will be better," as a Boston federal judge officially sentenced the company for hiding flaws in its lead-testing kits, signing off on a $42 million plea agreement.
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October 09, 2024
Novant Ex-Exec's Counsel Wins $154K In Fees For Race Case
Counsel for a former Novant Health Inc. executive who won $4.3 million after accusing the company of firing him during a diversity push because he was white got $154,000 in attorney fees for successfully defending the award on appeal, slightly less than what was requested.
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October 09, 2024
Medical Device Service Co. Hits Ch. 11 After Fight With Rival
The parent company of medical device sale and service business Avante Health Solutions filed for Chapter 11 protection in Delaware court, saying prepetition litigation with competitors drained significant resources that led to a default on its secured debt obligations.
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October 08, 2024
Cedars-Sinai OB-GYN Accused Of Abusing, Harassing Patients
A Beverly Hills, California-based obstetrician-gynecologist who practiced at Cedars-Sinai Medical Center has been accused of sexually assaulting, battering and harassing hundreds of patients under his care, according to a suit filed Monday in Los Angeles County Superior Court.
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October 08, 2024
$424M Medicare Fraud Suspect Asks NJ Court To Modify Bail
The lead suspect charged in a $424 million international telehealth fraud scheme has asked a New Jersey federal judge for more freedom while out on house arrest in Florida, requesting to attend religious services, go to a gym, have unmonitored communications with his counsel, and to work.
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October 08, 2024
RFK Jr. Tells 5th Circ. Biden Admin Is Working To Censor Him
A Fifth Circuit panel seemed reluctant to buy Robert F. Kennedy Jr.'s argument that it was bound by a case overturned by the U.S. Supreme Court, with one judge saying it shouldn't follow an opinion the nation's highest court had decried as "yuck, yuck, yuck" during oral arguments Tuesday.
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October 08, 2024
Military Health Plans Deny They Were Overpaid On DOD Deal
Five military healthcare plan providers have asked the Maine federal court to dismiss the U.S. Department of Justice's claims that they were overpaid for healthcare services, arguing they were paid exactly what they were owed under their fixed-price contracts.
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October 08, 2024
Fla. Court Revives Nursing Home Death Suit
A Florida state appeals court on Tuesday revived a wrongful death suit seeking to hold an assisted living facility liable for a resident's death after she got into an altercation with another resident.
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October 08, 2024
Ropes & Gray Attys Chided For Wielding Excessive Footnotes
A D.C. federal judge on Tuesday struck a summary judgment motion penned by Ropes & Gray LLP lawyers representing Vertex Pharmaceuticals in a challenge to the government's interpretation of the Anti-Kickback Statute, finding that the filing improperly employed "excessive" footnotes to circumvent page limitations.
Expert Analysis
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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.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.