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Health
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October 29, 2024
NY Judge Tosses $14B Decongestant MDL
A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.
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October 29, 2024
NY Health Provider To Boost Data Security To End AG's Probe
An Albany-based healthcare provider has agreed to pay $2.75 million in penalties and data security enhancements to resolve the New York attorney general's claims it failed to protect private medical data that was exposed in a pair of 2023 cyberattacks, the regulator said Tuesday.
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October 29, 2024
DOJ Will Restrict Data Swapping With 'Countries Of Concern'
The U.S. Department of Justice has proposed new rules that will make it the regulator of any type of transaction that would put certain kinds of sensitive privacy data in the hands of any "covered persons" or "country of concern."
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October 29, 2024
Judge Extends Block On Florida's Threats Over Abortion Ad
A Florida federal judge on Tuesday extended a temporary order blocking the state from threatening television stations with criminal prosecution if they did not pull a campaign ad promoting an abortion rights ballot initiative.
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October 29, 2024
Fla. Health Agency's All-Out Battle Against Abortion Measure
Florida's health agencies are testing the limits of their power — and generating plenty of controversy in and outside of court — for their role in an aggressive effort to defeat a ballot measure that would enshrine abortion rights in the state constitution.
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October 29, 2024
Pa. Seeks State Takeover Of Embattled Hospital System
Pennsylvania urged a state court to appoint a receiver for a hospital system after its operator, Prospect Medical Holdings Inc., allegedly violated an asset purchase agreement by spending millions of dollars on its investors instead of healthcare system management.
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
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October 29, 2024
Beyond Abortion, 7 Ballot Questions Set To Shape Care
While reproductive rights have led the healthcare debate this election season, voters across the country will shape state policies on a number of other hot issues, including a Medicaid work requirement and coverage for IVF. Law360 Healthcare Authority looks at seven ballot measures that go beyond abortion.
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October 29, 2024
Pa. DA Says ATF's Pot Patients Ban Doesn't Fit With Bruen
A Pennsylvania district attorney is urging a federal judge not to throw out his suit challenging a Bureau of Alcohol, Tobacco, Firearms and Explosives policy blocking medical cannabis patients from buying or owning firearms, saying the U.S. Supreme Court's recent precedent preempts the restriction.
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October 29, 2024
Warren Pushes FTC Chair To Probe Oncology Acquisitions
Massachusetts Sen. Elizabeth Warren on Tuesday urged the Federal Trade Commission to scrutinize McKesson Corp.'s proposed $2.49 billion acquisition of a controlling stake in Core Ventures, and Cardinal Health's proposed $1.12 billion purchase of a controlling stake in Integrated Oncology, saying the deals would further consolidate the "already highly consolidated" oncology market.
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October 29, 2024
PBM Group Federal Affairs VP Joins Akin In Lobbying Role
A former Capitol Hill health policy advocate who worked in the U.S. Department of Health and Human Services and guided federal and state stakeholders through the implementation of the Affordable Care Act has joined Akin Gump Strauss Hauer & Feld LLP's lobbying team.
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October 29, 2024
Senate Panel Targets 'Clever' Pharma Pricing
The Senate Judiciary Committee on Tuesday railed against drugmakers and pharmacy benefit managers for allegedly causing the high cost of prescription drugs, arguing that "Big Pharma" has used anticompetitive tactics through patenting to fleece American patients.
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October 28, 2024
Masimo Sues Founder Over Alleged 'Empty Voting' Scheme
Masimo Corp. has sued its founder for allegedly conspiring with an investment firm and company stockholder to manipulate a shareholder vote in order to maintain his seat on the medical technology company's board of directors.
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October 28, 2024
Wash. AG Candidates Clash On Consumer Protection, Guns
The candidates vying to replace Washington Attorney General Bob Ferguson, who carved out a national reputation as an antitrust champion, present starkly different visions on whether to build upon his tenure or reverse course, clashing not just on consumer protection, but also gun safety and access to reproductive care.
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October 28, 2024
SEC Sues To Enforce Subpoena On Telehealth Co.
The U.S. Securities and Exchange Commission has asked a New York federal judge to order a weight loss-focused telehealth company to comply with a subpoena issued in connection with the SEC's investigation into whether the company violated federal securities laws.
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October 28, 2024
Ontrak Founder Can't Wipe Novel Insider Trading Verdict
A California federal judge has upheld Ontrak founder Terren Peizer's first-of-its-kind insider trading conviction, holding that jurors had "more than enough evidence" to determine he based a $20 million share sale on nonpublic information that the health tech company was about to lose its biggest client.
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October 28, 2024
Consciousness Not A Factor In $15M Pain And Suffering Verdict
A urological surgeon can't trim a $15 million jury verdict awarded to the wife of an octogenarian patient who died due to the doctor's alleged negligence, a Georgia state appeals court has ruled, rejecting arguments that a patient can't get pain and suffering damages because he was mostly unconscious.
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October 28, 2024
Gov't Says No Duty To Pay $69M In COVID Testing Claims
The Health Resources and Services Administration has urged the Court of Federal Claims to toss a lawsuit alleging the agency owes a laboratory $69 million in unpaid claims under a COVID-19 program for the uninsured, saying there was no contractual duty to pay.
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October 28, 2024
Moderna Brass Hit With Investor Suit Over RSV Shot Claims
Officers and directors of Moderna face shareholder derivative allegations that they overstated how effective the company's RSV vaccine candidate was as the pharmaceutical giant sought regulatory permission to expedite its development.
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October 28, 2024
Surge In Nicotine Fee Suits Shows Wellness Program Risks
A recent crop of suits accusing large employers of violating nondiscrimination provisions in federal benefits law by making workers who use nicotine pay more for health insurance underscore the risk of using fees to offset healthcare costs, attorneys say. Here are five nicotine surcharge suits to keep an eye on.
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October 28, 2024
HHS Says In-Home Evals Raised Insurers' Medicare Payments
Private Medicare insurers collected an estimated $4.2 billion in extra federal payments last year from in-home health assessments they conducted, even though the evaluations led to no treatment, according to a report by the U.S. Department of Health and Human Services' internal watchdog.
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October 28, 2024
Conn. Healthcare Co.'s $1.5M Data Breach Deal Gets Final OK
A Connecticut federal judge has given his final approval to a class action settlement that requires Merritt Healthcare Advisors to pay thousands of people whose personal information was exposed in a data breach.
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October 28, 2024
Mass. Court's Wiretap Ruling May Be Bad Omen For Plaintiffs
A ruling by the Massachusetts high court rejecting wiretap claims over website operators' use of tracking software like Meta Pixel and Google Analytics shows the steep climb plaintiffs may continue to face as they try to apply older laws to modern technologies, experts told Law360.
Expert Analysis
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Series
In The CFPB Playbook: Making Good On Bold Promises
The U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's funding structure in the second quarter cleared the way for the bureau to resume a number of high-priority initiatives, and it appears poised to charge ahead in working toward its aggressive preelection agenda, say Andrew Arculin and Paula Vigo Marqués at Blank Rome.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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1st Gender Care Ban Provides Context For High Court Case
The history of Arkansas' ban on gender-affirming medical care — the first such legislation in the U.S. — provides important insight into the far-reaching ramifications that the U.S. Supreme Court's decision in U.S. v. Skrmetti next term will have on transgender healthcare, says Tyler Saenz at Baker Donelson.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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Series
After Chevron: FDA Regulations In The Crosshairs
The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.