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March 21, 2024
Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says
An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.
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March 21, 2024
Va. Court Affirms Doctor's Win, Refuses 'Empty Chair' Appeal
An emergency physician will keep his trial win in a malpractice case involving a patient's fatal aneurysm, a Virginia state appeals court has ruled, rejecting arguments that the trial judge flubbed by refusing to explicitly forbid the jury from considering the possibility that anyone else contributed to her death.
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March 21, 2024
CymaBay Investor Sues For Books On $4.3B Gilead Merger
A shareholder of liver disease-focused biopharmaceutical company CymaBay Therapeutics Inc. sued the company in Delaware Chancery Court to extract more information over a proposed $4.3 billion merger with Gilead Sciences Inc., saying CymaBay has refused to hand over previously requested documents regarding the valuation analyses without a legitimate excuse.
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March 21, 2024
Healthcare Co. Beats Suit Over TDF Funds' Performance
A California federal judge granted a win to a healthcare company and its investment adviser in a class action challenging what former workers claim are shoddy target-date-funds included in the company's 401(k) plan, saying the funds at issue performed better than comparable investments.
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March 21, 2024
VA May Have Acted In Bad Faith On $30M Debt Collection Deal
The U.S. Civilian Board of Contract Appeals refused to toss a $29.6 million appeal accusing the U.S. Department of Veterans Affairs of hampering a contractor's efforts to collect funds from outside insurers, saying the VA may have acted in bad faith.
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March 21, 2024
Gun Rights Org., Pa. DA Seek To Block Pot Patients' Gun Ban
A Pennsylvania prosecutor and a gun rights organization have asked a federal judge to block enforcement of policies that prohibit licensed medical marijuana patients from owning firearms, saying the ban violates the patients' Second Amendment rights.
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March 21, 2024
Business Coalition Rebuffs Biden Plan To Seize Drug Patents
The Biden administration's proposal to exercise so-called march-in rights to seize drug patents would harm innovation in the U.S., according to an assemblage of business-focused groups.
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March 21, 2024
Home Health Cos. Stiffed Workers On OT Pay, Suit Claims
The operators of several Ohio-based home care staffing agencies have been failing to pay their employees for all the overtime hours they worked, according to a recent proposed class and collective action.
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March 21, 2024
Woman Lost Independence Due To Strattice Mesh, Jurors Told
A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.
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March 21, 2024
Nursing Home Woes, Cyberattack Sparked Petersen's Ch. 11
Rising costs after the COVID-19 pandemic, cyberattacks and a general shift away from nursing homes led senior-living company Petersen Health Care to seek Chapter 11 bankruptcy protection this week with about $296 million in debt, according to a declaration filed Thursday by the company's top restructuring official.
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March 21, 2024
3rd Circ. Agrees Investors Have No Case Against Vax Maker
The Third Circuit on Thursday upheld a Pennsylvania federal judge's ruling that a putative class of investors alleging biopharmaceutical company Ocugen Inc. made misleading statements about its ability to quickly produce a COVID-19 vaccine failed to state a claim against the company.
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March 21, 2024
6th Circ. Doubtful Of Hospital Workers' Vax Exemption Claim
A Sixth Circuit panel appeared skeptical Thursday of an argument from a class of former employees of Ohio Children's Hospital that their First Amendment rights to freedom of religion were violated under the hospital's COVID-19 employee vaccination policy.
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March 21, 2024
Hospital Operator Alecto Healthcare Gets OK For Ch. 11 Plan
A Delaware bankruptcy judge agreed to give hospital operator Alecto Healthcare Services LLC the all-clear on the company's Chapter 11 reorganization plan, saying the scheme was fair, achievable and made appropriate provisions for disposable income.
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March 21, 2024
EBSA Gets Level Funding Of $191.1M In Spending Deal
Spending leaders in the House and Senate agreed Thursday to provide $191.1 million in fiscal year 2024 for the U.S. Department of Labor's sub-agency overseeing employee benefits, a level that's identical to what lawmakers agreed to last fiscal year.
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March 21, 2024
6th Circ. Revives 2 Workers' Claims In Religious Vax Bias Suit
The Sixth Circuit revived a case alleging an Ohio hospital discriminated against workers by requiring the COVID-19 vaccine despite their religious objections, but only for two of the 46 workers behind the suit, finding they were the only ones who showed they may have been harmed.
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March 21, 2024
Greenberg Traurig Adds Jackson Walker FDA Pro In Houston
Greenberg Traurig LLP's most recent Houston addition is a shareholder who came aboard from Jackson Walker LLP, where he established and led its U.S. Food and Drug Administration practice.
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March 20, 2024
Trans Kids' Attys May Face Sanctions Over Ala. Judges' Probe
Eleven attorneys, including lawyers from Cooley LLP, Lightfoot Franklin & White LLC and prominent LGBTQ rights organizations, have been ordered to show why they should not be sanctioned after a judicial report concluded they engaged in judge-shopping when challenging an Alabama law banning certain medical procedures for transgender youth, according to a newly unsealed order.
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March 20, 2024
Petersen Health Care Files Ch. 11 Amid Suits Over HUD Loans
Assisted living facility operator Petersen Health Care Inc. and more than 100 affiliates filed for Chapter 11 protection Wednesday in Delaware as the company faces claims it has failed to pay millions of dollars in federal housing loans.
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March 20, 2024
4th Circ. Backs Rockefeller Group in Guatemalans' Syphilis Suit
A group of Guatemalans who sued The Rockefeller Foundation over venereal disease experiments conducted on prisoners and psychiatric patients in the 1940s did not show an American doctor involved in the gruesome activities acted on behalf of the organization, a Fourth Circuit panel ruled Wednesday.
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March 20, 2024
Endo Plan To Trim $5B In Debt Confirmed By NY Judge
Drugmaker Endo International got a New York bankruptcy judge's approval for its Chapter 11 plan that aims to cut more than $5 billion in debt and hand over ownership to its lenders, roughly a month after it finalized a $465 million deal to resolve criminal and civil opioid claims.
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March 20, 2024
PTAB To Analyze Moderna COVID Vaccine Patents
The Patent Trial and Appeal Board has agreed to review two Moderna COVID-19 vaccine patents challenged by rivals Pfizer and BioNTech as having "unimaginably broad claims directed to a basic idea that was known long before."
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March 20, 2024
Health And Safety Top Risk For Directors, Global Survey Says
Health and safety is the top risk for directors and officers worldwide, according to a survey published Wednesday, in a "surprise" result partly attributed to the lingering impact of the COVID-19 pandemic on businesses and increasing mental health considerations.
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March 20, 2024
Defunct Philly Hospital Inks $32M End To Birth Injury Suit
A defunct Philadelphia hospital has agreed to pay $32 million to resolve allegations that a delayed cesarean section caused a baby to suffer severe brain damage, Kline & Specter announced Wednesday.
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March 20, 2024
Int'l Olympic Committee Rips Russia For Politicizing Sports
The International Olympic Committee has slammed Russia's newly created "Friendship Games" as a cynical ploy to politicize sports, saying that the Russian government's plan to host its own summer and winter games runs contrary to resolutions by the United Nations General Assembly.
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March 20, 2024
Calif. Firm Takes On AI, Dating Apps And 'Dopamine Culture'
A Valentine’s Day class action against dating platform MatchGroup was just the latest in a series of ambitious fights the Malibu-based boutique Clarkson Law Firm PC has picked with Big Tech and beyond, hoping to more broadly protect consumers from addictive and harmful business practices.
Expert Analysis
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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A Look At DOJ's New Nationwide Investment Fraud Approach
Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.
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AI Use May Trigger False Claims Act's Public Disclosure Bar
The likely use of publicly available artificial intelligence tools to detect government fraud by combing through large data sets will raise complex questions about a False Claims Act provision that prohibits the filing of claims based on previously disclosed information, say Nick Peterson and Spencer Brooks at Wiley Rein.
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Beware Privacy Risks In Training AI Models With Health Data
Because data used to train artificial intelligence models may be protected by the Health Insurance Portability and Accountability Act or other regulations, users of these models should conduct proper diligence to avoid costly compliance failures, say Neha Matta and Barbara Bennett at Frost Brown.
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Unpacking GAO's FY 2023 Bid Protest Report
The U.S. Government Accountability Office's recent bid protest report reflects an increase in sustained protests, illustrating that disappointed offerors may see little reason to refrain from seeking corrective action — but there is more to the story, say Aron Beezley and Patrick Quigley at Bradley Arant.
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How Fla. Bankruptcy Ruling May Affect Equity Owners
A Florida bankruptcy court’s recent ruling in Vital Pharmaceuticals — which rejected the Third Circuit’s Majestic Star decision that determined a bankrupt corporation’s flow-through status was not protected by the automatic stay — may significantly affect how equity owners can mitigate the impact of flow-through structures in bankruptcy, say Eric Behl-Remijan and Natasha Hwangpo at Ropes & Gray.
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.
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White House AI Order Balances Innovation And Regulation
President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.
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How Biden's AI Order Stacks Up Against Calif. And G7 Activity
Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.
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ITC Ban On Apple Watch Could Still Be Reversed
The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.