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Health
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April 09, 2024
Endo Sues FDA Over Generic Adrenalin Approvals
Endo has filed a lawsuit against federal health regulatory authorities, alleging that they are wrongfully giving the go-ahead for a generic version of the Adrenalin epinephrine injection, asking for a stay of the decision.
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April 09, 2024
Feds Cancel Disputed Sole-Source Health Deal, Call Suit Moot
The federal government is pressing the U.S. Court of Federal Claims to dismiss a contractor's complaint to a sole-source medical support contract, arguing the suit was moot after the U.S. Army voluntarily canceled the deal.
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April 09, 2024
4th Circ. Unravels MetLife's Win In Benefits Denial Suit
The Fourth Circuit on Tuesday reinstated a policyholder's lawsuit accusing Metropolitan Life Insurance Co. of wrongly cutting off his long-term disability benefits payments, saying a new precedent requires a bench trial in the dispute.
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April 09, 2024
Tech M&A Reigns Supreme In Q1 After Rare Hiccup In Q4
The technology sector logged the greatest total value of global mergers and acquisitions in the first quarter of 2024, following a rare quarter that saw the industry fall out of the top spot and into third place, data from Dealogic shows.
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April 09, 2024
White House, Senate Dems Want $1.3B To Fight COVID Fraud
The White House has been working with Senate Democrats on a $1.3 billion plan to expand the federal government's toolkit for going after pandemic fraudsters who took advantage of the influx of aid made available to different facets of the public during the COVID-19 pandemic.
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April 09, 2024
Life Sciences GCs On Tighter Regs, Outside Counsel Advice
General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.
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April 09, 2024
GAO Says Late Bid Blocks Protest Over VA Wellness Deal
The U.S. Government Accountability Office has tossed a dispute over a U.S. Department of Veterans Affairs contract for health and wellness classes, saying a late bid barred the protest even though the VA agreed to consider the protester's proposal.
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April 09, 2024
Ariz. High Court Restores Civil War-Era Abortion Ban
The Arizona Supreme Court on Tuesday revived the state's nearly 160-year-old abortion ban, concluding that a far more recent law that had allowed abortion through 15 weeks of pregnancy did not replace the older prohibition.
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April 09, 2024
Crowell & Moring Hires Senior Health Atty From Capitol Hill
Crowell & Moring LLP has hired a health care attorney from the U.S. House of Representatives who most recently served as a senior counsel in that body's Committee on Energy & Commerce, the firm announced Tuesday.
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April 08, 2024
Walmart Beats Investor Suit Over Opioid Probe Disclosures
Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.
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April 08, 2024
9th Circ. Urged To Revive J&J, Bausch Talc False Ad Suit
An attorney for a proposed class alleging they were misled by Johnson & Johnson and Bausch Health about their talc products' safety urged a Ninth Circuit panel on Monday to revive the suit, saying a lower court erred in finding his clients needed to point to specific advertisements that misled them.
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April 08, 2024
Feds Say Philly Clinics Billed For 'Impossible' No. Of Visits
The head psychiatrist at a group of Philadelphia mental health clinics allegedly billed Medicaid for enough "med check" patient visits that he would have exceeded the hours in a day if he had taken the state-mandated minimum of 15 minutes per patient, according to a federal False Claims Act suit filed Monday.
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April 08, 2024
High Court Creating DEI Headwinds, Colo. AG Says
Colorado Attorney General Phil Weiser said Monday that the state's major losses last year in cases involving gay rights and prosecuting threatening speech were part of what he views as a trend at the U.S. Supreme Court of hampering efforts to increase diversity, equity and inclusion.
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April 08, 2024
La. Drug Caps Conflict With Federal Law, AbbVie Says
Drugmaker AbbVie is asking a Louisiana federal judge to grant its summary judgment motion and block new state-level pharmaceutical caps for the federal 340B drug discount program, calling the state's competing summary judgment motion arguments "legally and factually wrong."
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April 08, 2024
Judge Urged To Reject UnitedHealth's Antitrust Deal Qualms
Patients who cut a $55 million antitrust settlement with NorthShore University HealthSystem are urging an Illinois federal court to reject objections by United Healthcare Services, arguing that the insurer has no standing to derail the deal and that its challenge to the agreement could dilute their recovery.
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April 08, 2024
PE Firm Calls FTC's Antitrust Claims 'Many Yesterdays' Old
A Texas anesthesiology company and the private equity firm that created it told a Houston federal judge Monday that the Federal Trade Commission has gone back "many yesterdays ago" in making its antitrust case, arguing that there's no imminent threat of a monopoly in an attempt to get the case dismissed.
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April 08, 2024
Feds Say Cannabis Cos. Can't Challenge CSA Pot Ban
The U.S. government is urging a Massachusetts federal court to throw out a suit by several cannabis companies alleging the ban on cannabis under the Controlled Substances Act is unconstitutional, saying they don't have standing to sue because their activities aren't being prosecuted.
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April 08, 2024
Ex-NBA Player Sues BCBS Over 'Outrageous' Care Denial
Former NBA player Rodney Rogers, who was paralyzed in 2008 after retiring, has accused Blue Cross and Blue Shield of North Carolina of exhibiting "outrageous" disregard for his medical needs by denying him life-saving in-home nursing assistance.
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April 08, 2024
Catching Up With Delaware's Chancery Court
Last week, a much-watched Chancery Court Match.com decision got reversed, a Philip Morris motion got stubbed out, and a long-frozen Blue Bell Creameries suit started churning again. Delaware's Court of Chancery also saw new suits filed for legal fees, arguments over multibillion-dollar pay packages, and a judge flummoxed over Truth Social.
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April 08, 2024
Healthcare Research Co. Clario Hires Chief Legal Officer
Clario, a healthcare research and technology company that works with endpoint technology used for clinical trials, has hired a new chief legal and administrative officer who joins from Thermo Fisher Scientific, the company announced Monday.
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April 08, 2024
Doctors Say MSU Vax Mandate Suit Needs High Court Review
Three doctors urged the U.S. Supreme Court to take up a case challenging Michigan State University's vaccine mandate after the Sixth Circuit backed the suit's dismissal, arguing that the circuit court should have applied a stricter standard when considering whether the government could interfere with patients' medical decisions.
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April 08, 2024
Cannabis Co. Says DEA Administrative Procedure Is Illegal
A Rhode Island cannabis company sued the U.S. Department of Justice and the Drug Enforcement Administration claiming the agency is subjecting it to an illegal proceeding before an administrative judge.
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April 05, 2024
Apple Asks Fed. Circ. To Upend ITC Watch Feature Ban
The U.S. International Trade Commission overstepped its authority in banning the import of the Apple Watch after finding it infringes Masimo Corp. patents on technology measuring oxygen in blood, Apple told the Federal Circuit on Friday, saying Masimo rushed its claims before the commission without having a product practicing the asserted patents.
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April 05, 2024
Ind. Can't Undo Abortion Law Injunction In Jewish Org's Case
An Indiana law banning most abortions in the state remains blocked for certain people with sincerely held religious beliefs, after a state appeals court largely upheld — in a sometimes sharply worded opinion — a preliminary injunction issued in a lawsuit brought by a Jewish reproductive rights group and other individual plaintiffs.
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April 05, 2024
Target, Major Employers Raise New Drug Price-Fixing Claims
Target Corp., Lowe's Cos. Inc. and American Airlines Inc. are among major employers that lodged new price-fixing claims in Pennsylvania federal court against dozens of pharmaceutical companies, accusing them of orchestrating illegal agreements to allocate customers and markets and fix the prices of hundreds of generic drugs for more than a decade.
Expert Analysis
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Navigating New Regulations In Healthcare And Other M&A
While notice requirements recently enacted in several states are focused on the healthcare industry for now, this trend could extend to other industries as these requirements are designed to allow regulators to be a step ahead and learn more about a transaction long before it occurs, say Kathleen Premo and Ashley Creech at Epstein Becker.
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New CMS Rule Will Change Nursing Facility Disclosures
A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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What To Know About WDTX Standing Order For Patent Cases
Patent litigators should review and ensure compliance with the standing order recently issued by U.S. District Judge Alan Albright of the Western District of Texas — a popular patent litigation venue — which encompasses new deadlines, seeks to streamline discovery disputes, and further reflects the court's existing practices, says Archibald Cruz at Patterson + Sheridan.
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What New Calif. Strike Force Means For White Collar Crimes
The recently announced Central District of California strike force targeting complex corporate and securities fraud — following the Northern District of California's model — combines experienced prosecutorial leadership and partnerships with federal agencies like the IRS and FBI, and could result in an uptick in the number of cases and speed of proceedings, say attorneys at MoFo.
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Healthcare Collabs Can Alleviate Labor, Antitrust Challenges
Two major challenges facing hospitals and health systems include labor shortages and increased antitrust scrutiny at both federal and state levels, but collaborative efforts may help with addressing these difficulties, says Sumaya Noush at McDermott.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Vagueness In Calif. Climate Law Makes Compliance Tricky
California's recently enacted Voluntary Carbon Market Disclosures Act requires companies making claims of carbon neutrality, or significant greenhouse gas emissions reductions, to disclose information supporting those claims — but vague and conflicting language in the statute poses multiple problems for businesses, say John Rousakis and Chris Bowman at O'Melveny.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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Potential Defendant Strategies Amid Calif. Privacy Questions
Although the current case law surrounding the California Consumer Privacy Act is in its infancy, courts have begun addressing important issues related to the notice-and-cure provisions of the statute, and these decisions show defendant-businesses would be wise to assert their notice rights early and repeatedly, say Viola Trebicka and Dan Humphrey at Quinn Emanuel.
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How Facilities Can Address Legal Risk Of Wandering Patients
Wandering behavior in acute care facilities is a challenging healthcare issue rife with legal ramifications, so it's crucial for facilities to perform the correct risk assessments and appropriate interventions, says legal nurse consultant Marilyn McCullum.