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Health
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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.
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August 19, 2024
9th Circ. Agrees Nursing Home Must Pay Fees In COVID Case
The Ninth Circuit has ruled that a nursing home must pay plaintiffs' legal fees in an appeal over the remand of a suit accusing it of causing two dozen patients' COVID-19 deaths, saying the home knew the court had already issued a precedential ruling on the issue.
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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 2022 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
Chancery Resets Del. Hearing In Masimo-Politan Proxy Battle
Pointing to "very significant stockholder franchise issues at play" and a dwindling Masimo Corp. stockholder vote countdown, a Delaware vice chancellor on Monday scheduled a Sept. 13 hearing on Politan Capital Management LP challenges to Masimo's actions in the run-up to the contested Sept. 19 vote.
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August 19, 2024
Canadian Court Won't Yet Enforce $140M Hospital Award
Webuild SpA has told a Delaware federal court of a Canadian court's decision to wait on enforcing a $140 million arbitral award related to a Chilean hospital project, saying it is relevant to Webuild's bid in Delaware to dismiss a petition seeking to confirm the same award.
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August 19, 2024
4th Circ. Cuts Liberty Loose In Medicare Reimbursement Row
A North Carolina widow can't revive a proposed class action accusing Liberty Mutual of failing to reimburse Medicare for her deceased husband's medical costs, the Fourth Circuit said Monday, finding she wasn't injured and therefore lacked standing to sue.
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August 19, 2024
UnitedHealthcare Says Humana Can't Access Its Records
UnitedHealthcare has asked the Texas high court to review a decision requiring it to turn over Medicare plan documents for the state's teachers to a competing insurer, arguing that recent updates to the Public Information Act were too broadly interpreted by a lower appellate court.
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August 19, 2024
Philly To Pay $25M For Breaking Prison Conditions Settlement
A federal judge has ordered Philadelphia to set aside $25 million to ramp up recruitment and retention efforts for the city's Department of Prisons, just over a month after the court found the city in contempt of a settlement in a lawsuit over prison conditions.
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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 19, 2024
NIH Program To Use Tribal Research To Combat Opioid Crisis
The National Institutes of Health is investing $268 million over the next seven years in a program that will employ Indigenous research methods to help combat opioid use and the overdose crisis plaguing Indian Country with an additional focus on pain management and mental health and wellness.
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August 19, 2024
Ex-NJ County Exec Loses Bid To DQ Firm In Retaliation Suit
A former Cumberland County, New Jersey, health official claiming his firing was political retaliation cannot disqualify the county's counsel in his lawsuit, Testa Heck Testa & White PA, over interactions he had with two firm attorneys around the time of his firing, a state court judge ruled Friday.
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August 19, 2024
Doctor Accused Of Taking Connecticut Practice's Patient Data
An obstetrician-gynecologist took trade secrets including confidential patient information when she left a Connecticut practice, and solicited its employees and "hundreds" of patients to come to her new competing business, according to a lawsuit in state court.
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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.
Expert Analysis
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Bid Protest Spotlight: Standing, Prejudice, Conflicts
In this month's bid protest roundup, Caitlin Crujido at MoFo examines three recent decisions from the U.S. Government Accountability Office concerning whether a would-be protestor was an interested party with standing, whether an agency adequately investigated potential procurement violations and whether a proposed firewall sufficiently addressed an impaired objectivity organizational conflict of interest.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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The Good, The Bad And The Ugly Of Healthcare's PE Boom
While an influx of capital may provide access to new resources and innovative technologies, the private equity model's method of funding may be fundamentally at odds with patient-first healthcare, and in recent years that inherent tension has gotten ugly, say Eva Gunasekera and Jaclyn Tayabji at Tycko & Zavareei.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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How Tech Trackers May Implicate HIPAA After Hospital Ruling
A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accountability Act, so organizations should ensure all technology used is known and accounted for, say John Howard and Myriah Jaworski at Clark Hill.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.