Policy & Compliance
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August 20, 2024
Fed Circ. Finds No Fault In Denial Of Flu Vaccine Claim
The Federal Circuit on Tuesday affirmed the denial of a family's petition for compensation alleging their child developed narcolepsy as a result of the FluMist vaccine, saying the special master's determination that the family hasn't properly established the link was not arbitrary.
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August 20, 2024
Did Biden Admin 'Play Nice' In Medicare Drug Price Talks?
In announcing the first agreements under Medicare's new drug price negotiating authority, the Biden administration took great pains to undermine one of the industry's central legal and rhetorical challenges to the program: that it isn't a negotiation at all.
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August 20, 2024
FTC Endorses Push For Broader Access To Biosimilar Drugs
The Federal Trade Commission is backing a proposal that would make it easier for drugmakers to show biosimilar medicines are safe substitutes for their more expensive counterparts, a move the agency says would boost competition and reduce confusion.
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August 20, 2024
Pathology Trade Group 2nd To Sue FDA Over Lab-Test Rule
A molecular pathology trade group has filed a lawsuit against the U.S. Food and Drug Administration, challenging a recent final rule to regulate laboratory-developed tests as medical devices and arguing the agency has abused its power — the second such case filed in recent months.
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August 20, 2024
'Full Steam Ahead' For Pandemic IG Despite Sunset Fear
A pandemic watchdog office is poised to shutter in seven months — its pleas for an extension have gone unheeded. But in the meantime, its remaining employees, some working away in their nondescript Alexandria, Virginia, office, others from their homes, are hustling to recover millions of dollars from COVID-19 fraudsters.
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August 20, 2024
Deadly Heat: Fighting 'Hidden' Health Crisis With AI, Free ACs
As extreme heat kills more Americans, the healthcare industry is turning to artificial intelligence and free air conditioners to help protect patients and the bottom line.
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August 20, 2024
With Billions At Stake, Texas Suits Target Nursing Home Rule
Legal clashes moving forward in Texas could reshape the nursing home industry, send ripples through the broader healthcare system and provide an early look at how the fall of Chevron deference will shape federal rulemaking, experts say.
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August 20, 2024
A Deep Dive Into Law360 Pulse's 2024 Women In Law Report
The legal industry continues to see incremental gains for female lawyers in private practice in the U.S., according to a Law360 Pulse analysis, with women now representing 40.6% of all attorneys and 51% of all associates.
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August 20, 2024
These Firms Have The Most Women In Equity Partnerships
The legal industry still has a long way to go before it can achieve gender parity at its upper levels. But these law firms are performing better than others in breaking the proverbial glass ceiling that prevents women from attaining leadership roles.
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August 20, 2024
Philadelphia, Insurer Settle Trans Firefighter's Surgery Suit
The city of Philadelphia, Independence Blue Cross and a firefighters union agreed to settle a transgender firefighter's suit claiming she was unlawfully denied coverage for facial feminization surgery, just weeks after a Pennsylvania federal judge refused to let the insurer out of the case.
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August 19, 2024
9th Circ. Told Psilocybin Petition Is Backed By Precedent
A Ninth Circuit panel on Monday dissected opposing arguments from the U.S. Drug Enforcement Administration and a Seattle doctor over whether there is precedent to allow the dispensing of psilocybin — a psychedelic compound — to treat terminally ill patients.
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August 19, 2024
MOVEit MDL Judge's Call For Order Met With Atty Squabbles
A federal judge's effort to streamline multidistrict litigation over a 2023 data breach involving Progress Software's MOVEit file transfer tool instead led to a lengthy and contentious joint filing in which the parties accused one another of gamesmanship.
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August 19, 2024
Second Pharmacist To Avoid Meningitis Murder Trial
A pharmacist charged with murder in a deadly fungal meningitis outbreak that killed dozens of people is expected to plead no contest to involuntary manslaughter charges this week, averting a Michigan trial that had been set for November.
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August 16, 2024
Humana To Pay $90M To End 8-Year Medicare Drug FCA Battle
Humana Inc. has agreed to pay the federal government $90 million to settle long-running False Claims Act allegations it submitted fraudulent bids for Medicare prescription drug deals, Phillips & Cohen LLP said Friday in announcing the "first case of its kind" to resolve allegations of fraud in the Medicare Part D contracting process.
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August 16, 2024
Baltimore Inks $152.5M Opioid Deal With Cardinal Health
Baltimore announced Friday that it settled claims for $152.5 million with Cardinal Health over its alleged role in helping fuel the city's opioid crisis, reaching the deal with the pharmaceutical distributor ahead of a September trial against five remaining defendants and following separate $45 million settlements with Allergan and CVS.
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August 16, 2024
24-Hour Abortion Delay Violates Ohio Constitution, Court Told
In the wake of an Ohio constitutional amendment enshrining the right to abortion, a state court heard arguments Friday as it considers whether to block laws requiring pregnant individuals to wait at least 24 hours before they can access abortions in the state.
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August 16, 2024
NC Litigation Highlights Of 2024: A Midyear Report
Several-high profile cases in North Carolina came to a close in the first half of the year, from a second bribery conviction against an insurance magnate beset by legal woes, to the anticlimactic withdrawal of a state Supreme Court justice's much-watched free speech suit. Here, Law360 looks at those and other notable rulings so far in North Carolina.
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August 16, 2024
New Jersey Litigation Highlights Of 2024: A Midyear Report
A court's upheaval of New Jersey's longstanding "county line" ballot layout for the Democratic primary fueled both sides of the lively political aisle this year, while the same federal judge also riled the state's pharmaceutical hotbed by ending two challenges to Medicare's ability to negotiate drug prices. Here, Law360 looks at some of the notable cases so far in New Jersey.
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August 15, 2024
2023 Rule Revising Hospital Payments Struck Down
A Texas federal judge on Thursday sided with about a dozen hospitals challenging a federal regulation that they say will curtail their payments for treating low-income patients, declaring the rule unlawful and setting it aside.
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August 15, 2024
Matthew Perry's Assistant And 2 Drs. Charged In Actor's Death
The former personal assistant for actor Matthew Perry and two doctors have been criminally charged in connection with the "Friends" star's death last year from an overdose of ketamine, according to a criminal complaint unsealed Thursday in California federal court.
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August 15, 2024
9th Circ. Judges Seem To Split On Wash. Abortion Coverage
A Ninth Circuit judge asked Thursday how a church could be harmed by a Washington law requiring employee health plans to cover abortions, since none of its workers had ever actually sought one, while another judge asked if tossing the case would slam the door on religious objections.
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August 15, 2024
CMS Posts Final Costs For 1st Set Of Drugs After Negotiations
The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.
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August 15, 2024
Ill. Health Center Challenges NLRB Constitutionality
An Illinois health center on Wednesday filed the latest constitutional challenge to the National Labor Relations Board, urging an Illinois federal judge to block an NLRB prosecution over its decision to fire employees who allegedly provided fake Social Security numbers when they were hired.
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August 15, 2024
Del. Chancery OKs $175M Judgment Against Insys Founder
The convicted founder of drugmaker Insys has told Delaware's Chancery Court he agreed to accept a $175 million judgment as part of a settlement with the company's liquidation trust over his role in an opioid kickback scheme that drove the firm into bankruptcy.
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August 15, 2024
Full 11th Circ. To Weigh Georgia Deputy's Trans Health Win
The Eleventh Circuit agreed Thursday to a full-court rehearing of an appeal from Georgia county officials looking to overturn a deputy's win in her suit alleging a health plan coverage exclusion for gender-affirming surgery violated federal anti-discrimination law.
Expert Analysis
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.
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Handling Religious Objections To Abortion-Related Job Duties
While health care and pharmacy employee religious exemption requests concerning abortion-related procedures or drugs are not new, recent cases demonstrate why employer accommodation considerations should factor in the Title VII standard set forth by the U.S. Supreme Court’s 2023 Groff v. DeJoy ruling, as well as applicable federal, state and local laws, say attorneys at Epstein Becker.
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Why Hemp-Synthesized Intoxicants Need Uniform Regs
State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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The Self-Funded Plan's Guide To Gender-Affirming Coverage
Self-funded group health plans face complicated legal risks when determining whether to cover gender-affirming health benefits for their transgender participants, so plan sponsors should carefully weigh how federal nondiscrimination laws and state penalties for providing care for trans minors could affect their decision to offer coverage, say Tim Kennedy and Anne Tyler Hall at Hall Benefits Law.
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ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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3 Tips For Defending Against Data Breach Litigation
As cyberattacks become more prevalent, companies responding to data breaches must consider several strategies to better position themselves in the event of litigation even during their preliminary investigations and breach notifications, say attorneys at Davis Wright.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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Air Ambulance Ch. 11s Show Dispute Program Must Resume
Air Methods’ recent bankruptcy filing highlights the urgent need to reopen the No Surprises Act’s independent dispute resolution program for air ambulances, whose shutdown benefits insurance companies and hurts providers, says Adam Schramek at Norton Rose.
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Pro Bono Work Is Powerful Self-Help For Attorneys
Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.
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Playing In A Rock Cover Band Makes Me A Better Lawyer
Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.
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The Pop Culture Docket: Judge Espinosa On 'Lincoln Lawyer'
The murder trials in Netflix’s “The Lincoln Lawyer” illustrate the stark contrast between the ethical high ground that fosters and maintains the criminal justice system's integrity, and the ethical abyss that can undermine it, with an important reminder for all legal practitioners, say Judge Adam Espinosa and Andrew Howard at the Colorado 2nd Judicial District Court.
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Calif. GHG Disclosure Law Will Affect Companies Worldwide
California's Climate Corporate Data Accountability Act, which will require comprehensive greenhouse gas emissions disclosures from large companies operating in the state, will mean compliance challenges for a wide range of industries, nationally and globally, as the law's requirements will ultimately trickle out and down, say attorneys at Brownstein Hyatt.