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Health
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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.
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August 08, 2024
Mass. Atty, 2 Others Settle SEC Insider Trading Claims
A Massachusetts business lawyer, his friend and his friend's father have agreed to collectively pay more than $230,000 to settle the U.S. Securities and Exchange Commission's allegations they used intel to trade ahead of an announcement made by the biotechnology company Frequency Therapeutics Inc., the SEC said Thursday.
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August 08, 2024
Pot Cos. Get Creative To Boost Brands Despite Feds' TM Ban
The marijuana industry still lives in the shadows of trademark law while the drug remains federally illegal, leaving businesses and their lawyers to seek workarounds to protect their brands.
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August 08, 2024
Cooley Hit With Fla. Malpractice Suit Over Financial Docs
Genetic Networks LLC has sued California-based Cooley LLP in Florida state court, alleging the law firm failed to file documentation needed to secure a lien when preparing loan papers for $1.2 million lent to ECI Pharmaceuticals.
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.