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Health
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August 20, 2024
Mesh Was Implanted After Serious FDA Alert, Jury Hears
A surgery patient went to trial Tuesday against an Oregon hospital and surgeon over an implant of prolapse mesh almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 20, 2024
Ala. AG Can't Prosecute Aiding Abortion Travel, DOJ Says
The Alabama attorney general's threats of criminal prosecution against individuals and corporations who assist others in traveling to obtain lawful abortions out of state violates the constitutional right to travel, the U.S. Department of Justice told an Alabama federal judge in a court filing Monday.
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August 20, 2024
Houston Medical Group Sued Over Unpaid $20M Bank Loan
A doctor, a Texas-based healthcare system and its subsidiaries were sued this week by Gulf Capital Bank over a $19 million loan they have allegedly failed to repay that has since grown to more than $20 million.
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August 20, 2024
NLRB Official Says Facts Are Solid In Hospital Injunction Fight
A National Labor Relations Board official is fighting the claim that her request for an injunction compelling a Michigan hospital to resume recognizing a union is light on evidentiary support, saying the hospital's attempt to contest the facts of the case falls flat.
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August 20, 2024
Amgen's Drug Price Suit An Issue For Legislature, Judge Told
A Colorado nonprofit that advocates for the poor told a federal judge Tuesday that Amgen's lawsuit over the state's drug price cap system is little more than a disagreement with lawmakers' policy choices disguised as a constitutional issue.
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August 20, 2024
Ga. Justices Weigh 'Malice' In Atty's Defamation Case
An orthopedic surgeon urged the Georgia Supreme Court on Tuesday to revive his case against a defense attorney who allegedly tarnished the surgeon's reputation during settlement talks with his attorneys for his former patients, arguing his appellate defeat last year flew in the face of 160 years of Georgia defamation law.
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August 20, 2024
Yale Health Liable For 840,000-Patient Data Breach, Suit Says
Yale New Haven Health, one of Connecticut's largest medical groups, is liable to 840,000 patients whose private records were hacked by the notorious online crime group Clop, a proposed class action lawsuit filed in Connecticut state court has alleged.
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August 20, 2024
9th Circ. Trans Health Appeal Hints At Supreme Court Fight
The Ninth Circuit will hear arguments Wednesday in an appeal from the state of Idaho seeking to preserve its ban on gender dysphoria treatment for minors, in a case that involves questions about trans health access that the U.S. Supreme Court is set to consider this fall, attorneys say.
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August 20, 2024
Steward Health, Landlord Spar Over Ch. 11 Hospital Sales
Bankrupt hospital operator Steward Health Care has filed an adversary suit against the landlord for 30 of its hospitals, Medical Properties Trust, saying the landlord is throwing a wrench in the sale process for the facilities and trying to hoover up all the proceeds.
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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
Colorado County Says Aetna Owes $1.1M In Rebates
Aetna Life Insurance Co. is withholding more than $1 million in pharmacy rebates from a Colorado county under an inapplicable early termination clause after local leaders switched to United Healthcare for health insurance services in 2023, according to a federal lawsuit.
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August 20, 2024
Vax Patent Battles Heat Up As Attention On Pandemic Wanes
It's been over four years since clinical trials began for COVID-19 vaccines, and while the shots have helped the pandemic recede, the lucrative technology has spurred numerous patent suits, many of which are still in the early stages. Here's a look at some of the key cases in the U.S.
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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
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
Catching Up With Delaware's Chancery Court
A nearly record-breaking attorney fee got the nod in Delaware last week, along with Chancery Court settlements involving an international private jet service and a chain of trampoline parks. New disputes involved a famous burger restaurant chain, a computer-chip maker, a now-defunct genomic science company, and a historic manor house in west London.
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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 20, 2024
J&J Boosting Cardio Portfolio With Up To $1.7B V-Wave Buy
Johnson & Johnson said Tuesday it has agreed to acquire V-Wave Ltd., the maker of an implant device that aims to treat heart failure, for up to $1.7 billion as it looks to bolster its cardiovascular disease portfolio.
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August 19, 2024
TPG Dumped Opioid Co. On 'Unsuspecting' Endo, Suit Says
After pushing Par Pharmaceutical to grow its market share in generic opioids and disregard federal requirements to report suspicious orders, TPG Capital saw other opioid manufacturers being inundated with litigation and sold Par to "an unsuspecting" Endo International PLC, according to a lawsuit filed in New York bankruptcy court.
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August 19, 2024
Biogen Paid To Help Curb Generic Tecfidera Sales, Says Suit
Biogen illegally impaired competition for its multiple sclerosis drug Tecfidera by paying major pharmacy benefit managers to prioritize the brand over generics while it worked to shift the market to a different version of the medication, a multi-employer welfare plan alleged Friday.
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August 19, 2024
Hospital Says NLRB Injunction Bid Relies On Disputed Facts
A National Labor Relations Board official's request for an injunction compelling a Michigan hospital to resume recognizing a Service Employees International Union affiliate is short on uncontested facts and heavy on pressure to adopt the official's findings, the hospital argued Monday, urging a federal judge to deny the request.
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August 19, 2024
Ore. Jury Awards $25M For Surgery Death, Clears Gastro Doc
A state court jury in Portland, Oregon, has awarded more than $24.6 million to the family of a colonoscopy patient who died, holding a healthcare provider group 40% responsible and an anesthesiologist 60% responsible, while saying the gastroenterologist who performed the procedure bore no fault.
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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.
Expert Analysis
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OSHA Workplace Violence Citation Highlights Mitigation Steps
The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.
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When Banks Unknowingly Become HIPAA Biz Associates
There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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Why DOJ's Whistleblower Program May Have Limited Impact
The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Opinion
DOL's Impending Mental Health Act Regs Should Be Simplified
The U.S. Department of Labor should consider revising these six issues in its forthcoming Mental Health Parity and Addiction Equity Act regulations to ease the significant compliance hurdles for group health plan sponsors, says Alden Bianchi at McDermott.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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9th Circ. Ruling Flags Work Harassment Risks Of Social Media
The recent Ninth Circuit ruling in Okonowsky v. Garland, holding an employer could be liable for a co-worker's harassing social media posts, highlights new challenges in technology-centered and remote workplaces, and underscores an employer's obligation to prevent hostile environments wherever their employees clock in, say Jennifer Lada and Phillip Schreiber at Holland & Knight.
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Vendor Rights Lessons From 2 Chapter 11 Cases
A Texas federal court’s recent critical vendor order in the Zachry Holdings Chapter 11 filing, as well as a settlement between Rite Aid and McKesson in New Jersey federal court last year, shows why suppliers must object to critical vendor motions that do not recognize creditors' legal rights, says David Conaway at Shumaker.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.