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Health
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September 25, 2024
Cancer Detection Biz To Go Public Via $694M SPAC Merger
Special purpose acquisition company Breeze Holdings Acquisition Corp. on Wednesday announced that it has agreed to merge with and take public clinical-stage biopharmaceutical company YD Biopharma Ltd. in a deal that gives the combined company an estimated enterprise value of $694 million and was built by three firms.
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September 24, 2024
Google Can't Ditch Privacy Suit Over Period App Data Sharing
A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures.
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September 24, 2024
Full 9th Circ. Vaporizes First-To-File Precedent For FCA Suits
The full Ninth Circuit on Tuesday overruled circuit precedent and held that the so-called first-to-file rule governing False Claims Act cases is not jurisdictional, meaning that courts can't toss a whistleblower action on jurisdictional grounds rooted in the first-to-file provision.
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September 24, 2024
Neb. Advocates Bash Effort To Upend Medical Cannabis Vote
Marijuana advocates are urging a Nebraska state judge to toss a lawsuit aiming to block state residents from voting on measures that could legalize medical cannabis and establish a state regulatory system, calling the suit a baseless attack on the "integrity, credibility, and accuracy of Nebraska's election officials."
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September 24, 2024
ATI To Pay $31M In SPAC Merger Litigation Settlement
An Illinois federal judge on Tuesday approved ATI Physical Therapy Inc.'s $31 million deal to resolve stockholder and derivative accusations that the company's top brass hid attrition issues to get shareholder approval of ATI's merger with Wilco Holding Inc.
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September 24, 2024
Conn. Officials Want Nursing School Students' Claims Nixed
Pointing to the state's interests in regulating professions and the principle of sovereign immunity, Connecticut officials accused of "overreach" for withholding licenses from students at a shuttered nursing school say a federal judge must dismiss proposed class claims by affected students.
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September 24, 2024
Novo Nordisk Tells Sens. Ozempic Costs Are Linked To PBMs
Novo Nordisk's CEO argued Tuesday that the high prices of the company's diabetes and weight loss drugs Ozempic and Wegovy primarily stem from the actions of pharmacy benefit managers, earning support from many members of a Senate committee and frustrating others who wanted more direct answers on the Danish drugmaker's own responsibilities.
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September 24, 2024
Insurer Wants Quick Appeal At 8th Circ. In DOL Tax Fight
A health insurer will seek the Eighth Circuit's review after a federal judge refused to toss a suit from the U.S. Department of Labor claiming the company unlawfully took at least $66.8 million in Minnesota state tax liability from plans it administered to pay in-network providers.
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September 24, 2024
Commercial REIT Unveils $251M IPO As Pipeline Builds
Real estate investment trust FrontView Inc. on Tuesday launched plans for an estimated $251 million initial public offering, represented by Fried Frank Harris Shriver & Jacobson LLP and underwriters' counsel DLA Piper LLP, joining a growing IPO pipeline.
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September 24, 2024
Senators Spar Over Abortion Bans Where 'Docs Play Lawyer'
Republican and Democratic senators on Tuesday grappled with whether some states' abortion bans conflict with a federal emergency care law and whether exceptions under those bans put doctors in situations where they must decide between a prison sentence or providing emergency stabilizing care.
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September 24, 2024
2nd Circ. Partly Revives Suit Over $18.5B Telehealth Deal
The Second Circuit on Tuesday partially revived a suit against telehealth company Teladoc Health Inc. brought by investors who claim they were misled about the status of its integration with Livongo following their $18.5 billion merger.
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September 23, 2024
Calif. Schools To Limit Or Ban Cellphones Under New Law
California Gov. Gavin Newsom on Monday signed into law a bill requiring Golden State school districts to limit or ban students from using smartphones during school hours in a bid to address mental health issues among the state's youth.
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September 23, 2024
J&J Talc Claims Paused In Latest Spinoff Ch. 11
A Texas bankruptcy judge Monday froze certain talc personal injury litigation against Johnson & Johnson, saying a three-week administrative stay will give the court time to decide key jurisdictional issues in the Chapter 11 case of Red River Talc LLC, a newly created J&J spinoff and the pharmaceutical and cosmetics giant's latest attempt to settle claims in bankruptcy that its baby powder caused cancer.
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September 23, 2024
Med Mal Case Is Settled After Scuttled $111M Verdict in Minn.
On the eve of a second trial, a Minnesota-based orthopedic center has settled a suit that previously ended in a $111 million verdict that was later vacated for being excessive, with federal court records indicating a deal has been reached in principle.
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September 23, 2024
Mallinckrodt Brass Can't Avoid Investor Suit Over 2nd Ch. 11
A New Jersey federal judge ruled Monday that senior leaders of drugmaker Mallinckrodt cannot escape a lawsuit brought by shareholders alleging the company tricked them into thinking it had recovered from bankruptcy and would make a $200 million payment to opioid claimants, finding the investors sufficiently pleaded securities law violations.
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September 23, 2024
'Dreamers' Want In On GOP States' Suit Over ACA Coverage
Deferred Action for Childhood Arrivals recipients and a Maryland nonprofit have moved to intervene in a Republican states-led lawsuit challenging a rule giving DACA beneficiaries access to Affordable Care Act health insurance programs, saying the Biden administration can't adequately represent their interests.
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September 23, 2024
Suit Says LAPD Stormed Medical Office Looking For Pot
The Los Angeles Police Department "maliciously" raided an X-ray and imaging clinic in North Hollywood, erroneously thinking it was an illicit marijuana grow site, destroying an MRI machine in the process, according to a lawsuit filed in California federal court.
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September 23, 2024
Medical Records Co. Accused Of Blocking Data Access
A company that helps insurance providers access patient data on Monday accused medical records company Epic Systems Corp. of violating antitrust law by using its monopoly over electronic health records to squash an emerging competitor.
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September 23, 2024
Bio Lab Settles Conn. False-Claims Allegations For $1.73M
Enzo Biochem Inc. and subsidiary Enzo Clinical Labs Inc. will pay nearly $1.73 million to settle accusations that the companies' former Farmingdale, New York, laboratory billed higher rates to the state of Connecticut's Medicaid coffers than it billed to other payers, the state attorney general announced Monday.
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September 23, 2024
SEC Scores $12M Judgment In Unregistered Dealer Case
A Minnesota federal judge has ordered financial firm Carebourn Capital LP, its founder and an affiliated company to pay more than $12 million in disgorgement and prejudgment interest over U.S. Securities and Exchange Commission claims they made millions selling securities as unregistered dealers.
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September 23, 2024
Blogging Co. Can't Nab Health Aides For Traveling CEO
A blogging company was denied the ability to hire foreign health aides for its Mexico-based CEO during his visits to the U.S., with an administrative law judge saying the U.S. Department of Labor couldn't assess how on-and-off employees would affect domestic workers.
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September 23, 2024
Fed. Circ. OKs Novartis Loss In Eye Syringe Patent Feud
The Federal Circuit has backed a Patent Trial and Appeal Board finding that more than two dozen claims in a Novartis pre-filled eye injection syringe patent weren't patentable.
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September 23, 2024
Adjuster Has No Duty To Insured In La. Hurricane Row
A Louisiana federal judge ruled Monday that an insurance adjuster can't be dragged into a third-party demand by a nursing facility property owner over Hurricane Ida damage to its New Orleans location, finding that only "in very rare circumstances" would the adjuster have any duty to an insured.
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September 23, 2024
Edelson, Susman, Berger To Lead MultiPlan Collusion MDL
An Illinois federal judge on Monday tapped a team of lawyers from Edelson PC, Susman Godfrey LLP and Berger Montague PC to take the lead for plaintiffs in multidistrict litigation accusing MultiPlan and a host of insurers of colluding through the use of the data firm's pricing tools to systematically underpay out-of-network providers.
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September 23, 2024
Amneal Latest Generic EpiPen Maker To Fight Colo. Law
Amneal Pharmaceuticals has sued Colorado in federal court alleging that a state drug affordability program resulted in unconstitutional takings of its generic epinephrine auto-injectors.
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.