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August 14, 2024
J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival
Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.
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August 14, 2024
HHS Eyes 2025 For New Medicare Appeal Rule
In response to a Connecticut federal judge's stern demand for quicker progress, the U.S. Department of Health and Human Services has said in a court filing that it should be able to implement a new rule creating an avenue for Medicare beneficiaries to appeal their hospitalization status by Jan. 1.
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August 14, 2024
GSA Hit With Protest Over $985M Migrant Kid Transport Deal
Trailboss Enterprises Inc. is protesting the General Services Administration's decision to award a $985.4 million transportation and logistics contract for unaccompanied children in federal custody to a competitor, saying it lost the contract because of a flawed selection process.
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August 14, 2024
NC Judge OKs $15.2M Deal For Medical Device Investors
A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.
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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 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.
Expert Analysis
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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What Cos. Should Note In DOJ's New Whistleblower Pilot
After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.
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Motion To Transfer Venue Considerations For FCA Cases
Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
After Chevron: New Lines Of Attack For FCA Defense Bar
Loper Bright has given defense counsel new avenues to overcome the False Claims Act elements of falsity and scienter, as any FCA claim based upon ambiguous statutory terms can no longer stand solely on agency regulations to establish the statute's meaning, which is itself necessary to satisfy the FCA's basic requirements, says Elisha Kobre at Bradley Arant.
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CFPB's Medical Debt Proposal May Have Side Effects
The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.