Health

  • December 19, 2024

    FDA Declaration May Restart Compounders' Shortage Suit

    Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.

  • December 19, 2024

    GAO Says Army Can Stop Solicitation After Multiple Protests

    The U.S. Government Accountability Office has rejected a protest over the U.S. Army's decision to cancel a medical instructor support deal, saying the Army reasonably found it had to address changed circumstances after a string of related protests.

  • December 19, 2024

    Michigan's Biggest Decisions Of 2024

    This year, the Michigan Supreme Court instituted sweeping changes to the state's wage and paid leave laws, took some damages off the table for wrongful death plaintiffs, and recognized third-party retaliation claims.

  • December 19, 2024

    Philips CPAP Suits Against SoClean Tossed From MDLs

    A Pennsylvania federal judge has tossed two complaints from Philips RS North America against SoClean Inc. from multidistrict litigation stemming from a CPAP machine recall, saying one would disrupt the wrap-up of the MDL surrounding Philips' products, while the other should not have been filed directly into the SoClean MDL.

  • December 19, 2024

    5th Circ. Urged To Deny Tax Break For Doc's Captive Insurance

    A physician who owns a network of urgent care clinics was correctly denied tax deductions along with his wife for over $1 million in premiums they paid to insurance companies they owned, the government told the Fifth Circuit, saying the captive arrangements didn't qualify as insurance for tax purposes.

  • December 19, 2024

    Addiction Group Pays $2M In Mass. AG False Billing Probe

    An addiction treatment physician group with offices across western Massachusetts will pay $2 million to settle allegations that it overcharged for visits and billed for tests that were not medically necessary, the state's attorney general said Thursday.

  • December 18, 2024

    Pharma Trial Consultant To Pay SEC $3M Over Insider Trading

    An oncologist and clinical professor at the University of California, Irvine agreed to pay the U.S. Securities and Exchange Commission $3 million to resolve allegations he purchased shares in a Massachusetts biotech company based on insider information regarding a clinical trial he was overseeing, the SEC announced Wednesday.

  • December 18, 2024

    Ex-US Rep. Urges 2nd Circ. To Nix Insider Trading Conviction

    Former Indiana Rep. Stephen Buyer on Wednesday urged the Second Circuit to reverse his insider trading conviction or grant him a new trial, saying federal prosecutors violated his Sixth Amendment rights and failed to prove Manhattan was the right place to be tried, which led a pair of circuit judges to voice doubt about the court's standard for establishing venue.

  • December 18, 2024

    Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try

    A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.

  • December 18, 2024

    Patent Limits For Biosimilar Litigation Lands In Spending Bill

    Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.

  • December 18, 2024

    Monsanto Protests DNA Damage Argument In PCB Closings

    An attorney in a toxic tort against Monsanto drew a sustained objection from the company's defense during closings Wednesday as he attempted to argue that some of the young girls allegedly exposed to PCBs "will give birth to children with altered DNA," as counsel sparred over whether the plaintiffs suffered "generational harm."

  • December 18, 2024

    FDA's Gastro Drug Fast-Track Denial Survives DC Circ.

    A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.

  • December 18, 2024

    Pa. Nursing Home Must Face Resident's Slip-And-Fall Suit

    A Pennsylvania appeals court on Wednesday reinstated a suit seeking to hold a nursing home liable for a resident's slip-and-fall injuries due to water that allegedly leaked from her room's ceiling, saying there was insufficient evidence that the home performed monthly checks for roof leaks.

  • December 18, 2024

    State AGs, Generic Cos. Fight Over Price-Fixing Trial Order

    A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.

  • December 18, 2024

    Morrison Foerster Cites Tariffs As Key M&A Variable For 2025

    International law firm Morrison Foerster LLP is among those citing President-elect Donald Trump's tariff plans as a key wild card that could affect mergers and acquisitions deal flow in 2025, a Wednesday report from the firm shows. 

  • December 18, 2024

    Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says

    A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.

  • December 18, 2024

    Philip Morris Sues FDA Over New Cigarette Warning Labels

    Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.

  • December 18, 2024

    Judge Eyes Limits To Medical Device Co.'s Poaching Verdict

    A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.

  • December 18, 2024

    CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say

    The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety. 

  • December 18, 2024

    Amgen Hit With $50M Infringement Verdict Over Leukemia Drug

    Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.

  • December 18, 2024

    Homeless Woman's Residency Unclear In Inter-Insurer Dispute

    A Michigan state appeals court has vacated a trial court order finding the insurer for a homeless woman's parents must cover injuries she suffered after being run over by a semitruck, ruling that questions remain over whether the woman had another established residence.

  • December 18, 2024

    FTC Wants Express Scripts' Defamation Suit Tossed

    The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.

  • December 18, 2024

    Medical Center Escapes COVID Outbreak Blame-Trading Suit

    A Michigan state appeals panel nixed a wedding venue's defamation suit alleging it was falsely blamed after several guests at a reception contracted COVID-19, handing a win to a healthcare provider the venue pointed to as the source of the outbreak. 

  • December 18, 2024

    Senate Sends $895B Defense Bill To Biden's Desk

    The U.S. Senate on Wednesday easily passed an $895.2 billion defense policy and budget bill for 2025, despite criticism over a contentious clause effectively barring gender-affirming healthcare coverage for service members' transgender children.

  • December 18, 2024

    Yale Eyes Quick Win In $435M Conn. Hospital Purchase Suit

    Yale New Haven Health Services Corp. has asked a Connecticut state court judge for permission to file a summary judgment motion in a feud with Prospect Medical Holdings Inc. over the sale of several hospitals in the state, saying Prospect's "stunning" failure to fund pensions and pay taxes resulted in property liens that breached the $435 million deal.

Expert Analysis

  • New HHS Research Misconduct Rules Bring Seismic Changes

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    The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.

  • Fla. Ruling May Undermine FCA Whistleblowers' Authority

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    A Florida federal court's decision in Zafirov v. Florida Medical Associates last month will deprive relators of their ability to bring suits under the False Claims Act, limiting their capability to expose and rectify wrongdoings and potentially affecting billions in FCA recoveries, say Matthew Nielsen and Lily Johnson at Bracewell.

  • State Of The States' AI Legal Ethics Landscape

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    Over the past year, several state bar associations, as well as the American Bar Association, have released guidance on the ethical use of artificial intelligence in legal practice, all of which share overarching themes and some nuanced differences, say Eric Pacifici and Kevin Henderson at SMB Law Group.

  • 11th Circ. Kickback Ruling May Widen Hearsay Exception

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    In a $400 million fraud case, U.S. v. Holland, the Eleventh Circuit recently held that a conspiracy need not have an unlawful object to introduce co-conspirator statements under federal evidence rules, potentially broadening the application of the so-called co-conspirator hearsay exception, say attorneys at ArentFox Schiff.

  • 8 Childhood Lessons That Can Help You Be A Better Attorney

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    A new school year is underway, marking a fitting time for attorneys to reflect on some fundamental life lessons from early childhood that offer a framework for problems that no legal textbook can solve, say Chris Gismondi and Chris Campbell at DLA Piper.

  • Navigating Complex Regulatory Terrain Amid State AG Races

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    This year's 10 attorney general elections could usher in a wave of new enforcement priorities and regulatory uncertainty, but companies can stay ahead of the shifts by building strong relationships with AG offices, participating in industry coalitions and more, say Ketan Bhirud and Dustin McDaniel at Cozen O’Connor.

  • Sublimit And Policy Interpretation Lessons From Amtrak Case

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    The recently settled dispute between Amtrak and its insurers over sublimit coverage illustrates that parties with unclear manuscript policies may wish to avoid litigation in favor of settlement — as the New York federal court declined to decide the case by applying prior term interpretations, says Laura Maletta at Chartwell Law.

  • Opinion

    This Election, We Need To Talk About Court Process

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    In recent decades, the U.S. Supreme Court has markedly transformed judicial processes — from summary judgment standards to notice pleadings — which has, in turn, affected individuals’ substantive rights, and we need to consider how the upcoming presidential election may continue this pattern, says Reuben Guttman at Guttman Buschner.

  • Navigating HHS' New Reproductive Healthcare Privacy Rule

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    The U.S. Department of Health and Human Services' new final rule regarding protections for the privacy of reproductive health information will require regulated entities to grapple with difficult questions about whether to comply with state law requirements or federal privacy prohibitions, says Christine Chasse at Spencer Fane.

  • Mental Health Parity Rules: Tips For Plans And Issuers

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    Following federal agencies' release of final mental health parity rules, plan sponsors and health insurance issuers should develop protocols for preparing compliant nonquantitative treatment limitation comparative analyses, say attorneys at Ropes & Gray.

  • Series

    Playing Diplomacy Makes Us Better Lawyers

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    Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.

  • Mental Health First Aid: A Brief Primer For Attorneys

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    Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.

  • Opinion

    FTC's Report Criticizing Drug Middlemen Is Flawed

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    The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.

  • Series

    Collecting Art Makes Me A Better Lawyer

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    The therapeutic aspects of appreciating and collecting art improve my legal practice by enhancing my observation skills, empathy, creativity and cultural awareness, says attorney Michael McCready.

  • Plan Sponsors Must Prep For New Mental Health, Drug Rules

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    To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.

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