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Health
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August 14, 2024
Grassley Asks HHS For Clarity On Cannabis Position
Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.
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August 14, 2024
Florida AG Can't Nix Hospitals', School Boards' Opioid Claims
A Florida state appeals court on Wednesday reversed a trial court's order allowing the state's attorney general to wipe out a group of suits by hospitals and school boards in opioid litigation, holding that she doesn't have the authority to release their claims without their consent.
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August 14, 2024
Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says
A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.
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August 14, 2024
6th Circ. Backs Ohio Dept. In Ex-Auditor's Disability Bias Suit
The Sixth Circuit upheld an Ohio state health department's win over a former auditor's lawsuit alleging she was fired for requesting a schedule adjustment because of her depression and anxiety, saying Wednesday that the worker refused to engage in conversations that could've identified a suitable accommodation.
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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.
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August 14, 2024
Texas Sues HHS Over 'Arbitrary' Nursing Home Staffing Rule
The state of Texas on Wednesday challenged a new federal rule that sets minimum staffing standards at nursing homes, contending the Biden administration overstepped its statutory authority and crafted a rule almost impossible to meet because of nursing shortages.
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August 14, 2024
HHS Calls For More Research, Planning To Combat Heat Risks
Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.
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August 14, 2024
Nursing Co. Exec Can't Split Up Fraud, Wage-Fixing Charges
A Nevada federal magistrate judge has struck two blows against a home healthcare staffing executive facing criminal charges of fixing nurses' wages and hiding that probe when selling the business for $12.5 million, as the judge refused to break up the allegations and recommended against dismissing the fraud counts.
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August 14, 2024
Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs
The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.
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August 14, 2024
1st Circ. Revives Vax Refusal Suit Against Beth Israel
The First Circuit on Tuesday revived a suit against health facility system Beth Israel Lahey Health Inc. from an office manager who was fired over her refusal to be vaccinated against COVID-19, disagreeing with a lower court that said she hadn't shown a genuine religious belief meriting a vaccine exemption.
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August 14, 2024
Surgeon Keeps Win In 'Hyperkinetic' Gallbladder Surgery Suit
A Virginia appeals panel won't revive a man's medical malpractice claims against his surgeon over complications from surgery to remove his "hyperkinetic" gallbladder, rejecting his argument that the surgeon was wrongly allowed to present evidence about the condition.
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August 14, 2024
K&L Gates Hires 340B Health Counsel In DC
K&L Gates LLP's newest healthcare counsel, Amanda Smith, has never worked at a private practice law firm until now.
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August 13, 2024
Anesthesia Co. Says FTC Lacks Authority To Bring 'Rollup' Suit
U.S. Anesthesia Partners has told the Fifth Circuit the Federal Trade Commission lacks authority to bring its case directly in federal court without also filing an administrative case accusing the group of monopolizing the Texas anesthesiology market.
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August 13, 2024
Judge Urged To Toss Novel Insider Trading Conviction
Former Ontrak CEO Terren Peizer has moved to rid himself of a first-of-its-kind insider trading conviction, arguing that the government's case "watered down" the standard it had to prove by failing to demonstrate that he believed Ontrak was about to lose its biggest customer at the time he shed $20 million in stock.
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August 13, 2024
Entresto Release Delayed As Novartis Goes To Fed. Circ.
A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.
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August 13, 2024
9th Circ. Reverses Order Sending Insulin Suit To State Court
The Ninth Circuit on Tuesday sided with CVS Caremark and Express Scripts, ruling that a lower court erred in 2023 when it agreed to send California's allegations of inflated insulin prices back to state court.
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August 13, 2024
Ga. Court Ropes Hospital Back Into Patient Death Suit
A Georgia appeals court reinstated Tuesday a suit accusing a hospital of failing to properly treat an unstable patient and instead taking her home to be left alone, which allegedly caused her death, saying an allegation of failure to screen a patient didn't require a medical expert's report.
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August 13, 2024
Former In-House Atty Says Healthcare Co. Can't Duck Suit
A onetime assistant general counsel for Panoramic Health told a Colorado federal judge on Tuesday that her former employer could not escape the wrongful-termination suit she filed in May, arguing that a bid to dismiss the case must fail because she had plausibly alleged that her firing was a result of having reported compliance issues.
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August 13, 2024
Gene Tech Co. Execs Pilfered Biz Amid Collapse, Suit Says
The senior lender to Sequencing Health Inc. has sued former officers and directors of the now-defunct genomic science company, alleging they squandered the company's assets, awarded themselves big bonuses and shut down the business, costing Oxford tens of millions of dollars in losses.
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August 13, 2024
Wash. Social Media Ban Violates Workers' Free Speech
The Washington State Court of Appeals has said a state law barring injured workers from posting videos of their state workers' compensation medical exams on social media is an unconstitutional violation of free speech rights.
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August 13, 2024
Mother Can't Revive Suit Against GE For Child's Brain Damage
A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.
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August 13, 2024
Spinal Implant Patents Verdict Must Stand, Pa. Judge Says
A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.
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August 13, 2024
NC Lawmakers Ask 4th Circ. To Restore Abortion Drug Limits
North Carolina Republican lawmakers want the Fourth Circuit to reinstate restrictions on the abortion drug mifepristone, telling the court the new rules concerning the medication are not preempted by U.S. Food and Drug Administration regulations.
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August 13, 2024
NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach
Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.
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August 13, 2024
Ga. Justices To Weigh Arbitrator's Closed-Door Discussions
The Georgia Supreme Court on Tuesday agreed to weigh if an arbitrator's ex parte communications with BioTek Services LLC in an allergy testing payment dispute warranted vacating BioTek's $1.7 million arbitration award over compensation for its testing of patients from Docs of CT LLC.
Expert Analysis
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Think Like A Lawyer: Always Be Closing
When a lawyer presents their case with the right propulsive structure throughout trial, there is little need for further argument after the close of evidence — and in fact, rehashing it all may test jurors’ patience — so attorneys should consider other strategies for closing arguments, says Luke Andrews at Poole Huffman.
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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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9th Circ. Clarifies ERISA Preemption For Healthcare Industry
The Ninth Circuit's recent ruling in Bristol SL Holdings v. Cigna notably clarifies the broad scope of the Employee Retirement Income Security Act's preemption of certain state law causes of action, standing to benefit payors and health plan administrators, say attorneys at Troutman Pepper.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Unpacking NY's Revised Hospital Cybersecurity Rule Proposal
The New York State Department of Health's recently revised hospital cybersecurity rule proposal highlights increased expectations and scrutiny around cybersecurity in the healthcare sector, while adapting to both recent industry developments and public comments, say Christine Moundas and Gideon Zvi Palte at Ropes & Gray.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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FDA's Data Monitoring Guidance Reveals Future Expectations
As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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New OSHA Memo Helps Clarify Recordkeeping Compliance
Based on recent Occupational Safety and Health Administration guidance on whether musculoskeletal disorders are recordable injuries under the agency's recordkeeping regulation, it appears that OSHA may target active release techniques and stretching programs during its inspections, say attorneys at Morgan Lewis.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.