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Health
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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.
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August 13, 2024
FTC Makes 2nd Request In Review Of Medical Device Co. Deal
Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.
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August 13, 2024
3 Firms Drive $3.8B Carlyle-Baxter Kidney Care Deal
Kirkland & Ellis LLP-led private equity firm Carlyle on Tuesday agreed to acquire the kidney care unit of Baxter International Inc., represented by Sullivan & Cromwell LLP and Baker McKenzie, for $3.8 billion, Baxter said in a statement Tuesday.
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August 12, 2024
WWE Accuser Says Doc's Lawsuit Threat Meant To Silence Her
A celebrity doctor with alleged ties to World Wrestling Entertainment Inc. and ex-CEO Vince McMahon should be sanctioned for filing a "vexatious" presuit discovery request in an effort to intimidate the woman who claimed the company and former executives sexually abused and trafficked her, she argued in a Monday motion.
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August 12, 2024
Accused Accounting Prof Is No Tax Expert, NJ Jury Told
New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.
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August 12, 2024
Groups Call On IHS To End Amalgam Use On Tribal Lands
A consortium of groups, including Consumers for Dental Choice and the International Indian Treaty Council, are calling on the U.S. Indian Health Service and other governments to immediately stop using mercury-containing dental fillings on Native Americans.
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August 12, 2024
GAO Says VA Deal Awardee Wasn't Missing Key Staff Member
The U.S. Government Accountability Office has rejected Booz Allen Hamilton's protest over a U.S. Department of Veterans Affairs agreement for healthcare market assessments, saying there was no evidence that a key worker for the awardee wasn't available to work on the deal.
Expert Analysis
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Justices' Intent Witness Ruling May Be Useful For Defense Bar
At first glance, the U.S. Supreme Court’s recent Diaz v. U.S. decision, allowing experts to testify to the mental state of criminal defendants in federal court, gives prosecutors a new tool, but creative white collar defense counsel may be able to use the same tool to their own advantage, say Jack Sharman and Rachel Bragg at Lightfoot Franklin.
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Eye On Compliance: New Pregnancy And Nursing Protections
With New York rolling out paid lactation breaks and extra leave for prenatal care, and recent federal legislative developments enhancing protection for pregnant and nursing workers, employers required to offer these complex new accommodations should take several steps to mitigate their compliance risks, says Madjeen Garcon-Bonneau at Wilson Elser.
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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.