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Health
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 22, 2025
Justices Urged To Undo Denial Of Fast Track For Gastro Drug
Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."
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May 22, 2025
Rehab Greenhouse Violated Zoning Rules, Conn. Justices Say
A drug rehab center's attempt to operate a 2,100-square-foot plastic greenhouse as a therapy facility on a northwestern Connecticut farm was an impermissible expansion of a previous nonconforming land use, the state's highest court ruled Thursday, overturning the center's earlier appellate court victory in a zoning dispute.
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May 22, 2025
EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal
Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.
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May 22, 2025
Medical Pot Patient's Bias Suit Against Penske Can Proceed
A Pennsylvania federal judge has refused to dismiss a discrimination case brought by a medical marijuana patient alleging a unit of Penske Corp. unlawfully rescinded his job offer.
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May 22, 2025
US, Swiss Medtech Groups Push For Tariff-Free Trade
Eliminating tariffs for imported medical technologies between the U.S. and Switzerland and new regulatory fast-track processes would safeguard the two countries from potentially catastrophic supply chain disruptions, according to a recent statement issued by top medical technology company trade associations in the U.S. and Switzerland.
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May 22, 2025
Colo. Health System Can't Dodge Nurses' Wage Suit
A suit by a group of nurses accusing a Colorado health system of miscalculating their overtime will stay fully in place, a federal judge ruled, agreeing with a magistrate judge's recommendation not to dismiss the Colorado Minimum Wage Act claim.
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May 22, 2025
Sutter Health's $228.5M Antitrust Deal Gets Initial OK
A California federal judge on Thursday preliminarily approved Sutter Health's $228.5 million deal settling a 13-year case over claims the hospital chain boosted costs by pushing all-or-nothing networks on insurers, saying that after a trial and a Ninth Circuit reversal, "it's nice that we didn't have to try this case twice."
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May 22, 2025
Mich. Judge Says Red Cross Can Depose Ex-Nurse's Husband
A Michigan federal judge on Thursday clarified that he intended to allow the American Red Cross to depose the husband of a nurse who alleges she was wrongfully denied a religious exemption from the organization's COVID-19 vaccine mandate, putting to rest a bout between the parties about the order's interpretation.
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May 22, 2025
Manufacturer Seeks Over $19M In Beryllium Release Coverage
A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the United Kingdom.
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May 22, 2025
Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'
A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."
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May 22, 2025
Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers
Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.
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May 22, 2025
Boies Schiller Stays In Row Of Mass Tort Firms, Ex-Counsel
Boies Schiller Flexner LLP was unable to convince a federal court that it does not belong in a suit between pharmaceutical mass tort firms and their former counsel, with a Miami federal judge on Thursday remanding the suit back to state court after finding allegations against Boies Schiller are viable.
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May 22, 2025
Texas Lawmakers Clarify Exceptions To Abortion Ban
The Texas House of Representatives passed a bill on Thursday specifying that women experiencing life-threatening pregnancies don't have to suffer "any effects" before they can obtain an abortion.
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May 21, 2025
'DIY' Rape Kit Ban Challenge Seems To Leave 9th Circ. Split
A Ninth Circuit panel appeared divided Wednesday over a company's appeal in its case challenging Washington state's ban on self-administered DNA collection kits for sexual assault survivors, with one judge remarking the product "doesn't do a whole heck of a lot" if the evidence isn't admissible in court.
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May 21, 2025
Latham Leads Pair Of Venture-Backed IPOs Raising $624M
Artificial-intelligence powered physical therapy startup Hinge Health Inc. raised an estimated $437 million initial public offering at the top of its range Wednesday, leading two venture-backed IPOs that netted more than $624 million combined, both represented by Latham & Watkins LLP.
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May 21, 2025
Florida Ex-Hospital Exec Charged In $3.6M Fraud Scheme
The former chief operating officer of the fundraising arm for a Miami-based health system was charged with wire fraud and conspiracy in connection with a scheme to falsify $3.6 million in vendor invoices that funneled more than $1 million in kickbacks paid directly to her, Florida federal prosecutors said Wednesday.
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May 21, 2025
Judge Mulls National Scope Of Bid To Restore COVID Grants
A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.
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May 21, 2025
AbbVie Gets Victory In Allergan Shareholder Suit Upheld
An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.
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May 21, 2025
6th Circ. Revives Yacht Co.'s ERISA Health Fee Claims
The Sixth Circuit on Wednesday revived a Michigan yacht company's federal benefits lawsuit against Blue Cross Blue Shield of Michigan, holding that a lower court wrongly tossed allegations that excessive healthcare fees breached fiduciary duties and caused prohibited transactions.
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May 21, 2025
GOP FTC Renews Calls For Orange Book Patent Delistings
The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.
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May 21, 2025
Texas Bills To Watch Before The End Of The 2025 Session
With less than two weeks remaining in the Texas legislative session, lawmakers will hit several deadlines in the coming days that will seal the fate of bills surrounding legal procedure, abortion, artificial intelligence and other topics.
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May 21, 2025
Court Won't Revive Mental Health Class Suit Against Fla. Blue
A Florida appeals court Wednesday declined to revive a proposed class suit by state employees enrolled in a Blue Cross and Blue Shield of Florida healthcare plan alleging the insurer designed a claims process to obstruct approval and payment of claims for mental health care.
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May 21, 2025
Rite Aid Cleared To Sell Pharmacy Assets To CVS, Others
A New Jersey bankruptcy judge Wednesday gave drugstore chain Rite Aid the go-ahead to transfer millions of prescriptions and dozens of stores to CVS, Walgreens and other pharmacy businesses in Chapter 11 transactions.
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May 21, 2025
Device Maker Who Evaded Tax Gets 2 Years In Prison
A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.
Expert Analysis
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UPS Penalty Demonstrates Goodwill Impairment Red Flags
The U.S. Securities and Exchange Commission's recent $45 million penalty against UPS for withholding reports of goodwill impairment should warn investors to watch for the telltale signs of companies inflating their worth by delaying tests that would reveal similar declines in the value of intangible assets, say attorneys at Labaton Keller.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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Courts Must Stick To The Science On Digital Addiction Claims
A number of pending personal injury and product liability lawsuits allege that plaintiffs have developed behavioral addictions to the use of social media and video games — but this is not yet recognized by relevant authorities as an addiction, so courts must carefully scrutinize such claims, say attorneys at DLA Piper.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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FTC Privacy Enforcement Takeaways From 2024
In 2024, the Federal Trade Commission distinguished three prominent trends in its privacy-related enforcement actions: geolocation data protections, data minimization practices, and artificial intelligence use and marketing, say Cobun Zweifel-Keegan at IAPP and James Smith at Dechert.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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Issues To Watch In 2025's ERISA Litigation Landscape
Whether 2024’s uptick in new Employee Retirement Income Security Act cases will continue this year will likely depend on federal courts’ resolution of several issues, including those related to excessive fees, defined contribution plan forfeitures, and pleading standards for ERISA-prohibited transaction claims, say attorneys at Groom Law.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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2024 Was A Significant Year For HIPAA Compliance
The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and press releases about its specific focus on certain cybersecurity issues make it abundantly clear that the OCR is not going to tolerate widespread compliance complacency, says Nathan Kottkamp at Williams Mullen.
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5 Notable Information Security Events In 2024
B. Stephanie Siegmann at Hinckley Allen discusses 2024's largest and most destructive data breaches seen yet, ranging from ransomware disrupting U.S. healthcare systems on a massive scale, to tensions increasing between the U.S. and China over cyberespionage and the control of U.S. data.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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How 2025 NDAA May Affect DOD Procurement Protests
A bid protest pilot program included in the 2025 National Defense Authorization Act shifts litigation costs onto unsuccessful bid protesters and raises claim-filing thresholds, which could increase risks to U.S. Department of Defense contractors who file protests, and reduce oversight of DOD procurement awards, say attorneys at Venable.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.