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Health
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March 12, 2025
SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval
The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.
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March 12, 2025
Trump Admin Seeks To End ACA Access For 'Dreamers'
The U.S. Department of Health and Human Services on Wednesday proposed a regulation that would do away with the Biden administration's rule allowing recipients of Deferred Action for Childhood Arrivals to qualify for Affordable Care Act coverage.
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March 12, 2025
Judge Says Hospital Orgs.' Input Not Needed In Multiplan MDL
The Illinois federal judge handling multidistrict litigation targeting Multiplan's out-of-network reimbursement rates has rejected two hospital organizations' bid to weigh in as he considers whether he should dismiss the case.
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March 12, 2025
4th Circ. Won't Undo Health Data Access Order
A Fourth Circuit panel issued a ruling Wednesday that affirmed a lower court's order requiring PointClickCare to allow Real Time Medical Systems to access patient data that it uses to provide nursing facilities with alerts for potential medical complications.
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March 12, 2025
Mich. Appellate Judge Pans Medical Pot Co.'s Sales Tax Claim
A Michigan Court of Appeals judge sounded skeptical Wednesday of a medical cannabis provisioning center's claim that nonbinding guidance from the state tax agency shielded it from collecting sales tax for the first year after a law regulating its type of business was enacted.
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March 12, 2025
Trump Admin Drops Biden Bid To Unfreeze ACA Trans Rule
The Trump administration asked the Fifth Circuit on Wednesday to dismiss its appeal, filed in July by the Biden administration, of a Texas federal judge's decision to halt a rule protecting access to gender-affirming healthcare.
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March 12, 2025
NC Organ Procurer Sues CMS Over Hospital Waiver
A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region.
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March 12, 2025
HHS To Eliminate 6 Regional Offices For Legal Staff
The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.
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March 12, 2025
Harvard Docs Say Gov't Censored Articles With Gender Terms
A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."
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March 11, 2025
Ga. Appeals Court Backs Stroke Patient's $75M Med Mal Win
A Georgia appellate panel has affirmed a $75 million verdict won by a stroke patient who alleged that his doctors at an Atlanta-area emergency room failed to diagnose his condition in time to save him from developing complete bodily paralysis.
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March 11, 2025
NJ Justices Say NY Doc Can't Be On Med Mal Verdict Form
The New Jersey Supreme Court ruled Tuesday that an anesthesiologist accused of causing a patient's death during surgery can't have the verdict sheet at the upcoming trial apportion blame to a New York doctor who was never named as a party in the suit.
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March 11, 2025
Conn. Judge Puzzled By Agency's 'Flip-Flop' On Rehab Permit
A Connecticut appellate judge said Tuesday that a state agency's recommendation to reject a residential substance use treatment facility in the town of Kent, followed by its "flip-flop" to approve the plan without any changes to the underlying facts, "truly puzzles me."
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March 11, 2025
Ill. Transpo Applicant's GIPA Claim Isn't Blocked, Judge Says
A transportation service applicant can proceed with allegations that he was illegally required to divulge his family medical history during a pre-employment physical since they don't conflict with federal driver safety regulations, an Illinois federal judge has ruled.
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March 11, 2025
Fla. Court Urged To Remove Cigna Claims Processor In MDL
Cigna Healthcare on Tuesday urged a Florida federal court to remove a settlement claims processor in a long-running multidistrict litigation case involving alleged underpaid insurance reimbursements to medical providers, telling a judge that the company has misspent more than $25 million in funds meant for members of a class action within the MDL.
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March 11, 2025
5th Circ. Hopes For 'Sanity' In Backing Legal Malpractice Arb.
Untangling a "ridiculous" arbitration proceeding that produced four contradictory awards in a legal malpractice dispute, the Fifth Circuit on Tuesday affirmed three awards and most of another, adding that the parties are "free to arbitrate another day" in the hope that their disagreements will be resolved "for the sake of sanity."
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March 11, 2025
Wash. Pharmacy Strikes $600k Class Deal In Data Breach Suit
An Evergreen State pharmacy has agreed to a $600,000 class deal to end a lawsuit over a 2023 cyberattack that allegedly exposed the personal information of thousands of current and former customers and employees, according to recent filings in Washington federal court.
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March 11, 2025
Pharmacies To Appeal In Bid To Keep Making Weight Loss Drug
A group of compounding pharmacies said Monday they would appeal to the Fifth Circuit after a Texas federal judge denied an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug.
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March 11, 2025
Brazilian 'Drug King' Ran Black Market Pharmacy, Feds Say
Federal prosecutors said a Brazilian national living in the United States without permission falsely portrayed himself as a pharmacist to sell members of a large Portuguese-speaking community west of Boston an array of medications, including painkillers, steroids and other controlled drugs.
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March 11, 2025
Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit
Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.
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March 11, 2025
Captive Insurer Shareholders Can't Target Owner, Court Told
The majority owner of a now-defunct North Carolina captive insurer wasn't personally obligated to pay premiums for nursing homes reportedly under his control, his counsel told a state court judge in seeking to pare down a self-dealing suit lobbed by the minority shareholders.
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March 11, 2025
Eli Lilly Suit Over Compounded Drugs Survives Dismissal
A Washington federal judge has trimmed Eli Lilly's lawsuit against two Seattle-area clinics and the doctors who run them for allegedly duping consumers into buying copycat versions of its diabetes and weight loss medications Mounjaro and Zepbound, nixing the pharmaceutical giant's consumer protection claim while preserving its trademark infringement and false advertising allegations.
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March 11, 2025
9th Circ. Panel Won't Renew Wash. Nurse's Employment Suit
A Ninth Circuit Panel has declined to revive a nurse's employment suit against the University of Washington Medical Center, finding a poor performance review wasn't enough to form the basis of a discrimination claim against the Seattle hospital.
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March 11, 2025
Hospital Orgs. Say MultiPlan Must Not Duck Price-Fix Claims
Hundreds of American hospitals are "on the brink of collapse" and letting MultiPlan and a host of insurers who have been accused of conspiring to underpay out-of-network providers off the hook will not improve matters, two groups that represent thousands of hospitals have told the court.
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March 11, 2025
Software Co. Tells Fed. Circ. It's Owed Over $12.7M In IP Dispute
A software developer pushed back at the federal government's defense of a $12.7 million copyright infringement award on Monday, telling the Federal Circuit that the judgment should be based on the company's actual negotiations with the Defense Health Agency.
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March 11, 2025
VA Did Not Pre-Select Awardee For $257M Telehealth Contract
A Court of Federal Claims judge has rejected a protest over a $256.8 million U.S. Department of Veterans Affairs telehealth program support contract, saying the protester hadn't shown the VA "pre-selected" the awardee before making a formal award decision.
Expert Analysis
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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Notable Q4 Updates In Insurance Class Actions
In a continuation of trends in property and casualty insurance class actions, last quarter insurers struggled with defending the merits and class certification of sales tax and fee suits, and labor depreciation cases, but succeeded in dismissing privacy class actions at the pleading stages, says Mathew Drocton at BakerHostetler.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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A Look At Healthcare Transaction Oversight In Oregon
Understanding Oregon's enforcement authority and its impact on proposed transactions last year provides a road map to the state's plans to strengthen its processes this year, though enforcement could be challenged by ongoing litigation, say attorneys at Ropes & Gray.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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Opinion
High Court Must Acknowledge US History Of Anti-Trans Laws
Despite Justice Amy Coney Barrett's claim to the contrary during oral arguments in U.S. v. Skrmetti, U.S. governments at every level have systematically discriminated against transgender people, and the U.S. Supreme Court must consider this historical context in upcoming cases about transgender issues, says Paisley Currah at the City University of New York.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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Biden-Era M&A Data Shows Continuity, Not Revolution
While the federal antitrust agencies under former President Joe Biden made broad claims about increasing merger enforcement activity, the data tells a different story, with key claims under Biden coming in at the lowest levels in decades, say attorneys at Covington.