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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.
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August 16, 2024
The Biggest Texas Rulings Of 2024: A Midyear Report
Texas has seen a bevy of major decisions, including a $1.4 billion settlement with Facebook over alleged biometric data collection, a ruling banning gender-affirming care for minors, and the conclusion of a long-running securities case against Attorney General Ken Paxton. Here's some of the biggest decisions so far this year.
Expert Analysis
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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FTC Focus: Private Equity Investments In Healthcare
As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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How 5 States' Deal Notification Laws Are Guiding Healthcare
Healthcare transaction notification laws at various stages of implementation in California, Illinois, Indiana, Oregon and Washington are shaping sector mergers and acquisitions, with significant transparency, continuity of care and compliance implications as providers tackle complex regulatory requirements, says Melesa Freerks at DLA Piper.
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Contract Disputes Recap: Preserving Payment Rights
Stephanie Magnell and Zachary Jacobson at Seyfarth examine three recent decisions that together illustrate the importance of keeping accurate records and adhering to contractual procedures to avoid inadvertently waiving contractual rights to cost reimbursements or nonroutine payments.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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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.