Policy & Compliance

  • July 16, 2024

    Health System Strikes Deal To End EEOC Race Bias Suit

    A Michigan healthcare system has agreed to pay a Black home health aid $30,000 to resolve a U.S. Equal Employment Opportunity Commission suit alleging she was immediately fired in contradiction with system policy after a white worker accused her of starting a verbal conflict.

  • July 16, 2024

    North Carolina High Court Has Eyes On Certificate Of Need

    A recent North Carolina Supreme Court decision in a property-owner discrimination suit may have opened the door to new legal challenges to the state's decades-old medical control spending law.

  • July 15, 2024

    Ex-Pfizer Worker Seeks No Time For Paxlovid Insider Trading

    A former Pfizer employee argued that he shouldn't go to prison after a Manhattan federal jury convicted him of insider trading over clinical trial results for the drug Paxlovid, pointing out that a friend of his and co-defendant had dodged a custodial sentence in the case after helping prosecutors.

  • July 15, 2024

    Cigna, Chuck Close Estate Settle Reneged Benefits Suit

    The estate of renowned artist Chuck Close told a New York federal judge that Cigna has agreed to settle a suit claiming the company wouldn't pay for more than $686,000 in at-home skilled nursing care that it claimed was owed to him under his Pace Gallery employee benefit plan.

  • July 15, 2024

    Split 2nd Circ. Nixes Surgeon's Default In Sex Assault Case

    A split panel of the Second Circuit said a Connecticut surgeon should have been fully freed from the default judgment against him in a sex assault suit after a jury concluded his accuser failed to prove the assault happened, with one judge dissenting Monday that parts of the default ruling should remain.

  • July 15, 2024

    Theranos Ex-Exec's Lead Atty Joins Boutique Firm In LA

    A former BigLaw attorney who was lead defense counsel for Theranos' former president Ramesh Balwani has joined Los Angeles boutique Foundation Law Group LLP to lead its white collar practice, the firm announced Monday.

  • July 15, 2024

    Machinery Co. Defends 'Right' To Ax Trans Care In Health Plan

    A turbomachinery company asked to intervene on a transgender worker's New Hampshire federal court claim that its health plan administrators violated Affordable Care Act anti-bias provisions by enforcing a gender dysphoria treatment ban in the company's health plan, arguing that the issue is intertwined with its mission.

  • July 15, 2024

    Wage Cases To Follow As Justices Rein In Agencies

    A trio of U.S. Supreme Court rulings this term that dulled administrative agencies' power are likely to make an impact on how the U.S. Department of Labor enforces wage and hour law. Here, Law360 reviews six cases where their application is already becoming a point of contention.

  • July 15, 2024

    11th Circ. Upholds UMiami's Win In Retaliation Suit

    The Eleventh Circuit affirmed a Miami federal jury's verdict rejecting claims that the University of Miami fired a compliance officer for his refusal to close an investigation into the college's alleged Medicare overcharging, ruling that the officer had "invited" the jury instruction on which he based his appeal.

  • July 12, 2024

    Law360 Names 2024's Top Attorneys Under 40

    Law360 is pleased to announce the Rising Stars of 2024, our list of 158 attorneys under 40 whose legal accomplishments belie their age.

  • July 12, 2024

    Whistleblower's Attys Get $5.9M After Losing $11.5M Fee Ask

    A Massachusetts federal judge awarded a whistleblower's counsel $5.9 million in fees plus $651,845 in costs and expenses after slashing their prior "exorbitant" $11.5 million fee request in May in a decade-old False Claims Act lawsuit alleging Fresenius Medical Care billed Medicare for unnecessary hepatitis tests.

  • July 12, 2024

    Military's IVF Policy Defense Fails Post-Chevron, Group Says

    A nonprofit that's challenging the U.S. military's in vitro fertilization coverage policy for service members told a New York federal judge that federal agencies cannot claim they're entitled to Chevron deference in the wake of the U.S. Supreme Court's recent decision overturning the decades-old precedent.

  • July 12, 2024

    3 Fla. Labs Settle Medicare Overbilling Case For $2.45M

    Three medical labs in Clermont, Florida, have agreed to pay $2.45 million to resolve allegations they were manipulating diagnosis codes, or "code jamming," to submit more lucrative claims to Medicare and Medicaid for reimbursement by having a computer macro tack on extra diagnosis codes before filing the claims with the government.

  • July 12, 2024

    Boston To Pay $1M To End Health Dept. Harassment Case

    A high-profile sexual harassment case against the city of Boston and its former health director settled for $1 million earlier this month, according to a copy of the agreement released Friday.

  • July 12, 2024

    Widower Drops Suit Over Surgical Robot-Related Death

    A widower agreed Thursday to drop his suit against Intuitive Surgical Inc. over an alleged defect in its da Vinci surgical robots that allowed electricity to arc during his wife's surgery, burning her small intestine and leading to her death.

  • July 12, 2024

    7 Gender-Affirming Care Cases To Watch In 2024's 2nd Half

    The U.S. Supreme Court has agreed to review a constitutional challenge by the federal government to Tennessee's ban on gender-affirming care for minors, while other appeals courts are weighing the constitutionality of states' and employers' restrictions on gender dysphoria treatment. Here are seven cases involving gender-affirming care access that attorneys will be tracking in the second half of the year.

  • July 12, 2024

    Biggest Washington Decisions Of 2024: A Midyear Report

    The first half of 2024 in Washington courts was punctuated by a fizzled startup's $72 million trial win against The Boeing Co., and Monsanto Co.'s appellate reversal of a $185 million verdict in one of a series of high-profile PCB poisoning cases. Here is a closer look at some of the biggest decisions in Washington state and federal courts in the first half of 2024.

  • July 11, 2024

    Panel Says Kansas BCBS Unit Can't Face Rehab Suit In Colo.

    A Kansas Blue Cross Blue Shield unit can't be sued in Colorado for terminating the coverage of a patient who was receiving treatment for an autoimmune syndrome, a state appellate panel ruled Thursday.

  • July 11, 2024

    9th Circ. Signals Dr.'s Vax-Refusal Case Deserves New Chance

    Ninth Circuit judges signaled Thursday that they were likely to revive a doctor's case claiming he was wrongfully fired from his Washington State University residency for refusing to get a COVID-19 vaccination, with two judges questioning if the school went far enough to accommodate his religious beliefs.

  • July 11, 2024

    Fed. Circ. Pauses Ouster Of Teva Patents From Orange Book

    Teva can keep challenged asthma inhaler device patents listed on, and protected by, an important government database after the Federal Circuit agreed Wednesday to pump the brakes on the patents' delisting while the Israeli drugmaker appeals an order won by Amneal in an infringement lawsuit.

  • July 11, 2024

    Opiate MDL Judge Flags Evidence Preservation Shortfall

    An Ohio federal judge has said "at least some" of the plaintiff local government entities in four chosen bellwether cases against pharmacy benefit managers for the multidistrict litigation over the opioid epidemic failed to preserve documents and evidence for trial, warning the parties he may replace those cases.

  • July 11, 2024

    Hospital Urges 4th Circ. To Back Win In Worker's Vax Bias Suit

    A Virginia health system told the Fourth Circuit to let its win stand in a former nurse's lawsuit claiming she was unlawfully fired for refusing the COVID-19 vaccine because of her Christian beliefs, saying the nurse raised only her personal misgivings, not religion, in her exemption request. 

  • July 11, 2024

    Sens. Say Medical Debt Acute 'Symptom' Of Chronic Issues

    A Senate health committee panel said that medical debt is a "symptom" of high costs in the healthcare system in a hearing on Thursday, with lawmakers and federal agencies proposing solutions to stabilize the issue that impacts consumers and providers. 

  • July 10, 2024

    Drug Test Co. Pays $1M To Settle Medicare Fraud Claims

    A Los Angeles drug testing lab will pay at least $1 million to settle claims it doubled-billed Medicare for toxicology tests for people undergoing treatment for opioid use disorder, Boston federal prosecutors said Wednesday.  

  • July 10, 2024

    Buyers Say Teva Had Multipart Scheme To Delay Inhaler Rivals

    Employee benefit funds accusing Teva of orchestrating a decadelong scheme to delay generic competition for its QVAR asthma inhalers told a Massachusetts federal court the drugmaker is trying to end the case by addressing merely one aspect of a multipart scheme.

Expert Analysis

  • Air Ambulance Ruling Severely Undermines No Surprises Act

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    A Texas federal court's recent decision in Guardian Flight v. Health Care Service — that the No Surprises Act lacks a judicial remedy when a health insurer refuses to pay the amount established through an independent review — likely throws a huge monkey wrench into the elaborate protections the NSA was enacted to provide, says Mark DeBofsky at DeBofsky Law.

  • Class Actions At The Circuit Courts: June Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.

  • How Congress Is Tackling The US Healthcare Shortage

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    With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.

  • The Current State Of Healthcare Transaction Reviews In Calif.

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    As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.

  • High Court's Abortion Pill Ruling Shuts Out Future Challenges

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    The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.

  • Orange Book Warnings Highlight FTC's Drug Price Focus

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    In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.

  • A Plaintiffs-Side Approach To Cochlear Implant Cases

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    As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.

  • Inside Antitrust Agencies' Rollup And Serial Acquisition Moves

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    The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.

  • Short-Term Takeaways From CMS' New Long-Term Care Rules

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    The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.

  • FDA's Data Monitoring Guidance Reveals Future Expectations

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    As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • 'Food As Health' Serves Up Fresh Legal Considerations

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    The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.