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Health
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August 12, 2024
Big Tobacco To Pay $600M In 'Historic' Mass. Deal
Philip Morris Inc. and RJ Reynolds Tobacco Co. will pay nine-figure sums as part of a $600 million settlement between Massachusetts and major tobacco companies that resolves yearslong disputes about how much the cigarette makers owe, the state attorney general announced Monday.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Split 9th Circ. Affirms Ax Of Meta Anti-Vax Censorship Suit
A split Ninth Circuit panel Friday affirmed the dismissal of Children's Health Defense's lawsuit challenging Meta's policy of censoring its anti-vaccine Facebook posts, with the majority concluding that the Robert F. Kennedy Jr.-founded nonprofit failed to show Meta was acting on the government's behalf to state viable constitutional claims.
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August 09, 2024
Delaware Jury Says Fecal Treatment Patents Are Worth $25M
A Delaware federal jury decided Friday that a Swiss drugmaker owes a smaller drug rival at least $25 million in a patent case involving an experimental enema used to treat a particularly deadly form of diarrhea.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
DC Circ. Pans Suit Claiming HHS Caused Health Aid Shortage
The D.C. Circuit said Friday that a judge properly dismissed a proposed class action blaming the U.S. Department of Health and Human Services for a lack of home health aides willing to assist Medicare beneficiaries with chronic illnesses, saying the private providers aren't required to accept those patients.
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August 09, 2024
Conn. Hospital Must Give Data To Competitor, Judge Says
Connecticut's Bristol Hospital must turn over a brand survey for use in Saint Francis Hospital and Medical Center Inc.'s antitrust lawsuit against Hartford HealthCare Corp., but the data can be redacted and restricted to attorneys only, a federal magistrate judge ruled Friday.
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August 09, 2024
Biotech Firms Mull Acquisition Offers Amid Shaky IPO Climate
Amid a shaky outlook for initial public offerings, more private biotechnology firms are exploring acquisition offers from larger pharmaceutical companies as a more certain exit strategy, according to experts who advise emerging drug developers.
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August 09, 2024
Wash. Hospital Patients Can't Certify 'Fail Safe' Classes
A Washington federal judge on Friday rejected a certification attempt in a proposed class action accusing a hospital system of incentivizing two of its doctors to perform medically unnecessary surgeries, but said the plaintiffs would have the chance to address the litany of defects by amending their suit.
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
DC Circ. Says Mining Cos. Can't Appeal Retiree Health Win
Four former subsidiaries of the now-defunct coal company Consol Energy Inc. can't challenge an arbitration award that banned unilateral changes to union-represented retirees' health benefits plan, the D.C. Circuit held Friday, saying the ex-subsidiaries weren't parties to the award and aren't injured by it.
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August 09, 2024
Novartis Wants DC Judge To Quickly Block Entresto Generic
Novartis Pharmaceuticals urged a D.C. federal judge Friday to temporarily restrain the U.S. Food and Drug Administration from officially approving a generic version of the company's blockbuster heart failure medication Entresto.
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August 09, 2024
The Long Road To Legalizing Pot In Florida And South Dakota
Voters in Florida and South Dakota will have the opportunity this Election Day to legalize recreational marijuana for adults 21 and over, and while the two efforts vary in their particulars, they both follow years of work by legalizers to craft a proposal that could gain court approval.
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August 09, 2024
Pharmacy Escapes Recklessness Claim In Septic Shock Suit
A Pennsylvania federal judge has dismissed a claim seeking punitive damages from a northern Pennsylvania pharmacist brought by a patient who alleges that her endocrinologist and the pharmacy overprescribed corticosteroids that opened holes in her intestines and subsequently made her go into septic shock and become suicidal.
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August 09, 2024
Aetna Illegally Axed Exec's Disability Benefits, Judge Says
A California federal judge said Aetna was wrong to end an executive's disability benefits after it found he suffered from a mental illness instead of a physical disability, stating the insurer used flawed doctor opinions and may have been motivated by cutting costs.
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August 09, 2024
Wash. AG Says Kroger Refusing To Delay Merger For Ruling
The Washington Attorney General's Office told a state court that Kroger will not agree to put off closing its planned merger with Albertsons until after a final ruling in the state's merger challenge, but the companies say they've already agreed not to finalize the deal until litigation plays out in another state.
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August 09, 2024
Jury's $1M Paralysis Verdict Against Insurer Overturned
A Texas federal judge overturned a jury's verdict and decided an insurer didn't have to cover a $1 million settlement between a former high school gymnast who became quadriplegic after taking LSD and the owners of the home where he ingested the drugs.
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August 09, 2024
Merck To Buy Autoimmune Treatment Drug For Up To $1.3B
Pharmaceutical giant Merck, advised by Hogan Lovells, said Friday it has agreed to buy a novel, investigational, clinical-stage, bispecific antibody used to treat B cell-associated diseases from Goodwin Procter LLP-led Curon Biopharmaceutical for up to $1.3 billion.
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August 09, 2024
Fannie Mae Seeks Memory Care Receiver After $28.3M Default
Fannie Mae asked a federal judge to appoint a receiver for three North Carolina senior living facilities after arguing that borrower Affinity Living Communities defaulted on $28.3 million worth of loans from the government-backed lender by missing three months of payments.
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August 09, 2024
Off The Bench: NCAA Antitrust Woes, Ohio Trans Sports Ban
In this week's Off The Bench, the NCAA still faces pushback from athletes after an NIL settlement, transgender youth athletes in Ohio lost their legislative battle, and the Seventh Circuit set an insurance broker straight on its actions in an NFL team's settlement with a former player.
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August 09, 2024
Trulieve Settles Fired Retail Worker's Race Bias Suit
Florida-based cannabis company Trulieve has agreed to settle a mixed-race former employee's suit alleging he was fired after complaining that a manager repeatedly made racist comments, including calling him a slur, the worker told a Florida federal court.
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August 08, 2024
15 Red-State AGs Sue To Block ACA Coverage For Dreamers
Fifteen states led by Kansas Attorney General Kris Kobach sued the Biden administration Thursday over a new regulation that is expected to allow about 100,000 immigrants brought to the U.S. as children without authorization to enroll in federal health insurance programs through Affordable Care Act exchanges.
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August 08, 2024
4th Circ. Upholds Asylum Denial Over Forced Hospitalizations
The Fourth Circuit on Thursday refused to revive an Indian foreign exchange student's bid for asylum, saying in a published opinion that his multiple involuntary hospitalizations in India and the administration of electroshock therapy to treat diagnosed mental illnesses did not amount to persecution.
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August 08, 2024
In Reddit Hot Seat, Chopra Touts CFPB Medical Debt Proposal
Consumer Financial Protection Bureau Director Rohit Chopra took to social media on Thursday to pitch the agency's proposed ban on medical debt reporting, defending it against concerns that the plan could interfere with credit scores and encourage people to skip out on medical bills.
Expert Analysis
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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.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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The Good, The Bad And The Ugly Of Healthcare's PE Boom
While an influx of capital may provide access to new resources and innovative technologies, the private equity model's method of funding may be fundamentally at odds with patient-first healthcare, and in recent years that inherent tension has gotten ugly, say Eva Gunasekera and Jaclyn Tayabji at Tycko & Zavareei.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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How Tech Trackers May Implicate HIPAA After Hospital Ruling
A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accountability Act, so organizations should ensure all technology used is known and accounted for, say John Howard and Myriah Jaworski at Clark Hill.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.
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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.