Policy & Compliance
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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.
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August 14, 2024
HHS Eyes 2025 For New Medicare Appeal Rule
In response to a Connecticut federal judge's stern demand for quicker progress, the U.S. Department of Health and Human Services has said in a court filing that it should be able to implement a new rule creating an avenue for Medicare beneficiaries to appeal their hospitalization status by Jan. 1.
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August 14, 2024
Hospital Groups Tell High Court HHS 'Stingy' In SSI Pay Row
Six of the nation's leading hospital associations told the Supreme Court on Wednesday that the U.S. Department of Health and Human Services is being "stingy" when miscalculating a formula that could cost hospitals treating low-income patients more than a billion dollars in special payments each year.
Expert Analysis
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The Most-Read Legal Industry Law360 Guest Articles Of 2023
A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.
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Inside Higher Education's New FCA Liability Challenges
As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.
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AI Executive Order's Life Science, Healthcare Industry Effects
The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.
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HHS Advisory Highlights Free Product Inducement Risks
A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.
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Attorneys' Busiest Times Can Be Business Opportunities
Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.
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In The World Of Legal Ethics, 10 Trends To Note From 2023
Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.
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How Attorneys Can Be More Efficient This Holiday Season
Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.
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Top 10 Whistleblowing And Retaliation Events Of 2023
The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.
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Children's Book Writing Makes Me A Better Lawyer
Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.
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The State Of CFPB Focus On Credit Reporting Of Medical Debt
An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.
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FDA's Recent Litigation Records Are Strong, But Imperfect
The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.
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Giving The Gov't Drug Patent March-In Authority Is Bad Policy
The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.