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May 31, 2024
Judge Doubts Okla. Can Stop Title X Cut Over Abortion Stance
A Tenth Circuit judge appeared skeptical Friday that Oklahoma could prevent federal officials from stripping $4.5 million in funding over the state's refusal to provide abortion referrals, suggesting the state's claim of anti-abortion discrimination is better suited to an attack on Title X writ large.
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May 31, 2024
Judge Wonders If Wash. Social Media Ban Blocks Free Speech
A Washington appellate judge on Friday questioned the constitutionality of a state law barring injured workers from posting video of their state workers' compensation medical exams on social media, saying it could be cutting off someone's only way of communicating with the outside world.
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May 31, 2024
3rd Circ. Preview: Labor Battles Heat Up In June
Several cases are heating up the Third Circuit argument calendar in June, including a home care company's attempt to duck a $7 million payout to thousands of workers who claimed the company violated the Fair Labor Standards Act by not compensating them for travel time.
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May 31, 2024
15 States Sue To Block Biden's ACA Trans Discrimination Rule
The Biden administration was hit with a lawsuit on Friday over its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, with a group of 15 states claiming the guidance is an effort "to enshrine sweeping gender-identity mandates without congressional consent."
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May 31, 2024
COVID Test Contract Suit 'Cries Out' For Jury, NC Judge Says
A fight between two companies over a doomed distribution deal for COVID-19 tests has gone from "ships passing in the night" to not even "sailing in the same ocean," a North Carolina Business Court judge said, paring the case for trial.
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May 31, 2024
Polsinelli's Medical Device Team Gains Ex-Lerner David IP Trio
Polsinelli PC is continuing to grow its intellectual property bench, saying Thursday that it has brought on three attorneys from the boutique Lerner David LLP who focus on intellectual property strategy and protection.
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May 31, 2024
Weight Loss Drug Caused Stomach Paralysis, Suit Says
A Kentucky woman on Friday sued Novo Nordisk A/S and its affiliates in federal court, alleging that the company failed to warn patients that its weight loss treatment Saxenda carried the risk of incurable stomach paralysis.
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May 31, 2024
Gov't Contracts Of The Month: Health, Spacecraft And Bombs
The U.S. Defense Health Agency unveiled contracts worth tens of billions of dollars in May, including a scrutinized $43 billion medical staffing vehicle, and the National Aeronautics and Space Administration added $6 billion to a spacecraft deal. Here, Law360 looks at some of the most noteworthy government contracts over the last month.
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May 31, 2024
Ex-Penn State Football Team Doc Wins $5.25M Retaliation Suit
A Pennsylvania jury awarded $5.25 million to a former doctor for the Pennsylvania State University football team who claimed he was fired for reporting that head coach James Franklin pressured him to push student-athletes back onto the field before they were ready, according to a verdict sheet made public Friday.
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May 31, 2024
Texas Supreme Court Rejects Challenge To Abortion Ban
The Texas Supreme Court unanimously rejected a petition Friday that challenged the state's near-total ban on abortion, ruling the law's narrow exceptions for pregnant women in life-threatening emergencies are broad enough to withstand a constitutional challenge.
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May 31, 2024
In Rarity, 1 Party's Judges Gain 100% Control Of Circuit Bench
At the First Circuit, the judges' robes are all black, but the judges are all blue. It's a new and unusual instance of one political party's judicial picks controlling each active seat on a federal appeals court, and the Democratic dominance could prove magnetic for ideologically charged litigation.
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May 30, 2024
FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security
The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit.
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May 30, 2024
Healthcare Data Co. Says Blocked Access Could Kill Patients
A healthcare data company asked a Maryland federal court on Thursday to stop a rival from blocking access to nursing home patient records it said are needed to identify potential complications that could lead to hospitalization or death.
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May 30, 2024
Veradigm Execs Sued Over Company's Nasdaq Delisting
Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.
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May 30, 2024
Physician, Health Cos. Spar Over Docs In Fla. Qui Tam Suit
A doctor and several healthcare businesses accused each other of withholding evidence in a Florida federal False Claims Act lawsuit, with the doctor saying several key Zoom meeting records were destroyed, although the businesses have alleged the doctor refused to provide a financial agreement she made with a cohort.
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May 30, 2024
Rite Aid Ch. 11 Timeline Extended To Allow More Plan Review
A New Jersey judge on Thursday lengthened the timeline for Rite Aid to seek an exit from its Chapter 11 bankruptcy, pushing the confirmation hearing date out by seven days after insurers and others said the company's schedule would not provide enough time to review its restructuring plan.
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May 30, 2024
FTC, Novant Ask To Delay In-House Trial On Merger Challenge
The Federal Trade Commission and Novant Health have asked to postpone an upcoming administrative hearing over the nonprofit's proposed purchase of two North Carolina hospitals, a purchase that regulators are concerned will dampen competition in the region, according to a notice filed in federal court.
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May 30, 2024
Retired NBA Star Ends Coverage Suit Against BCBS
Former NBA player Rodney Rogers on Thursday dropped claims that Blue Cross Blue Shield abruptly ended at-home nursing care in violation of his policy but kept the door open to refile the claims.
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May 30, 2024
Pa. Court Blocks State's Recall Over Cannabis Vape Additives
The Pennsylvania Commonwealth Court has permanently blocked the state Department of Health from enforcing a 2022 recall of medical cannabis products containing certain additives, on the grounds that the department's reversal on the additives' approval was a "de facto regulation" that was enacted without the proper procedures.
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May 30, 2024
Ozempic Maker Says Texas Pharmacy Selling Knockoff Drug
The manufacturer behind the Ozempic weight loss drug has asked a federal court to prohibit a Houston-area pharmacy from selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient.
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May 30, 2024
Slapping Groping Patient Isn't Protected Action, 4th Circ. Says
A former certified nursing assistant at a nursing home operator didn't show that smacking the hand of a patient whom she alleged groped her constituted protected activity under West Virginia law, a Fourth Circuit panel ruled Thursday, affirming the company's win in a lower court.
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May 30, 2024
Sen. Warren Pushes CMS On 'Medical Loss Ratio' Data
Sen. Elizabeth Warren, D-Mass., is urging the Centers for Medicare & Medicaid Services to collect more data to determine whether private healthcare insurers in Medicare Advantage that employ vertical integration are evading a statutory requirement that they spend the bulk of their earnings on medical claims.
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May 29, 2024
Fla. Medicare Companies Get Class Cert. In Suit Against USAA
A Florida state court judge granted certification to a class of Medicare-contracted businesses suing USAA Casualty Insurance Co. over allegations the insurer withheld policy information and intentionally passed its obligation to pay automobile injury claims downstream to other companies, according to attorneys representing the group of businesses.
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May 29, 2024
Benefits Trade Group Urges Changes To New York PBM Regs
A trade group representing large employers who sponsor employee benefit plans warned New York's insurance regulator that a proposal affecting pharmacy benefit managers — which act as intermediaries between pharmacies, drugmakers and insurers — will trigger litigation without changes before they're finalized to eliminate conflicts with federal benefits law.
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May 29, 2024
FDA Sued Over Controversial Lab Test Rule
A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.
Expert Analysis
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Examining Illinois Genetic Privacy Law Amid Deluge Of Claims
After a federal court certified an Illinois Genetic Information Privacy Act class action in August, claims under the law have skyrocketed, so employers, insurers and others that collect health and genetic information should ensure compliance with the act to limit litigation risk, say attorneys at Squire Patton.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures
The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.
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Action Steps To Address New Restrictions On Outbound Data
Companies should immediately assess all their data-based operations so they can consider strategies to effectively mitigate new compliance risks brought on by recently implemented transaction restrictions, including a Justice Department proposal and landmark data legislation, say attorneys at Wiley.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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8 Questions To Ask Before Final CISA Breach Reporting Rule
The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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A Recipe For Growth Equity Investing In A Slow M&A Market
Carl Marcellino at Ropes & Gray discusses the factors bolstering appetite for growth equity fundraising in a depressed M&A market, and walks through the deal terms and other ingredients that set growth equity transactions apart from bread-and-butter venture capital investing.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Notable Q1 Updates In Insurance Class Actions
Mark Johnson and Mathew Drocton at BakerHostetler discuss notable insurance class action decisions from the first quarter of the year ranging from salvage vehicle titling to rate discrimination based on premium-setting software.