Policy & Compliance
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April 23, 2025
11th Circ. Considers Timeliness Of J&J Pelvic Mesh Claims
An Alabama couple urged the Eleventh Circuit on Wednesday to revive their lawsuit over injuries allegedly caused by pelvic mesh manufactured by Ethicon Inc. and its parent Johnson & Johnson, arguing that a district court wrongly found their claims were time-barred.
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April 23, 2025
Feds Oppose Ex-Conn. Official's 'Troubling' Greece Trip Plan
Federal prosecutors on Wednesday opposed a twice-indicted ex-Connecticut budget official's request to spend six weeks in Greece visiting family as he awaits twin corruption trials, citing a skipped deadline to relinquish guns and the risk that he might use Greek citizenship to evade justice.
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April 23, 2025
Genetic Testing Co., Marketer Settle FCA Case For $6M
A genetic testing company, marketing firm, and their top executives have agreed to pay $6 million to resolve the government's allegations that they billed Medicare for unnecessary medical tests, in violation of the False Claims Act.
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April 23, 2025
Eli Lilly Sues 4 Telehealth Cos. For Weight Loss Drug Copies
Eli Lilly filed a new round of lawsuits Wednesday over the compounding of its popular weight loss drugs Mounjaro and Zepbound, accusing four telehealth companies of making copies of the medications while alleging that two companies violated laws requiring doctors to make medical decisions, not corporations.
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April 22, 2025
Free Speech Experts Question DOJ Letter To Medical Journal
A federal prosecutor's letter to a medical journal skeptically asking about its commitment to nonpartisan debate is an unusual intrusion into editorial decision-making and may interfere with the publication's First Amendment rights, free speech experts say.
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April 22, 2025
'Fetal Personhood' Animates Neb. Aborted-Remains Debate
Nebraska lawmakers are sparring over a bill that would require healthcare facilities to bury or cremate fetal remains following an elective abortion. Supporters envision a "dignified" disposition. Opponents decry a requirement targeting providers while advancing the “fetal personhood” doctrine.
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April 22, 2025
Hogan Lovells Adds Ex-HHS Atty To Health Practice
Hogan Lovells on Tuesday announced the arrival of a former U.S. Department of Health and Human Services attorney to the firm's global regulatory and intellectual property practice group.
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April 22, 2025
Trump's Healthcare Order A Mixed Bag For Big Pharma
While Trump's executive order last week is more of a general road map than a clear plan for cutting prices, experts say it signals key policy priorities for the administration — including on a point of serious contention between drug companies and federal regulators.
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April 22, 2025
Pharma Co. Owner Cops To Selling $60M Of Sham HIV Drugs
An owner of a pharmaceutical company has pled guilty in Florida to participating in a $60 million nationwide scheme to illegally distribute misbranded and adulterated HIV drugs to patients.
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April 22, 2025
MoFo Adds Perkins Coie FDA Regulatory Leader In DC
Morrison Foerster LLP has hired a former Perkins Coie LLP leader who focuses his practice on a range of regulatory matters involving the U.S. Food and Drug Administration as its new head of food and regulatory, the firm announced Tuesday.
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April 22, 2025
Trump Deregulation Order Puts Target On Nurse Survey Rule
The Trump administration's push for mass deregulation is raising the hopes of nursing facilities that have spent years pushing back on a controversial rule limiting when a registered nurse must be present during facility safety inspections.
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April 22, 2025
State Legislatures Pull Back On Certificate-Of-Need Laws
Lawmakers in a handful of states are considering a fresh round of repeals and rollbacks to certificate-of-need laws, an often divisive tool designed to control healthcare costs by limiting duplication of services. That means more changes to a legal landscape that has evolved significantly since the advent of the statutes in the 1970s.
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April 22, 2025
Save Mart Reaches $20.5M Deal On Nonunion Retiree Benefits
California-based Save Mart Supermarkets will pay about $20.5 million to escape a suit from workers who alleged the company unlawfully revoked a monthly health reimbursement that it promised to nonunion retirees and their spouses for life, according to a proposed deal filed in federal court.
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April 22, 2025
Nossaman Health Atty Talks Staffing, Evolving Calif. Law
A former Procopio Health attorney has made the jump to Nossaman LLP at a time when California law around peer and judicial review processes for medical staff is evolving.
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April 21, 2025
Premera's Teen Trans Policy 'Textbook' Sex Bias, Judge Says
Premera Blue Cross discriminated based on sex against transgender teens at the center of a lawsuit alleging the insurer and health plan administrator illegally denied coverage for gender-affirming chest surgery, according to a Washington federal judge who also denied class certification because the teens' claims are not typical of class members.
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April 21, 2025
Harvard Sues Trump Admin Over $2B Funding Freeze
Harvard University on Monday hit the Trump administration with a suit in Massachusetts federal court, escalating a high-profile battle after the government slashed more than $2 billion in funding amid allegations the elite school has failed to properly address antisemitism on its campus.
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April 21, 2025
NJ Panel Revives Ex-Group Home Worker's Whistleblower Suit
A New Jersey appeals court reinstated a group home worker's lawsuit alleging she was fired for raising concerns about staffing levels and training, reasoning Monday that she met the pleading standards for the state's whistleblower law.
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April 21, 2025
Unions Demand Halt To DOGE's Info Access At DOL, HHS
A D.C. federal judge must block Elon Musk's Department of Government Efficiency from accessing sensitive systems in the U.S. Department of Labor and Department of Health and Human Services, unions argued in a preliminary injunction bid, saying the government's search for "waste, fraud and abuse" doesn't warrant access.
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April 21, 2025
HCA, Workers Eye Mediation in Wage Suit
HCA Healthcare Inc. asked a North Carolina federal court to press pause on a respiratory therapist's class and collective action accusing the company of manipulating workers' time sheets to pay them less overtime wages, saying the parties are planning to attend mediation in July.
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April 21, 2025
Justices Mull 5th Circ. Redo In ACA Preventive Care Fight
The U.S. Supreme Court on Monday appeared skeptical of a Fifth Circuit ruling that found members of a task force setting preventive services coverage requirements under the Affordable Care Act were unconstitutionally appointed, with multiple justices suggesting kicking the case back down to the circuit court for additional arguments.
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April 21, 2025
Justices Kick Flavored-Vape Dispute Back To 5th Circ.
After the U.S. Supreme Court affirmed the U.S. Food and Drug Administration's authority to reject an e-cigarette company's application to market flavored vapes, the high court on Monday granted summary disposition on one other pending case on the same subject, while denying certiorari to three others.
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April 19, 2025
Up Next At High Court: Preventive Healthcare, LGBTQ Books
The U.S. Supreme Court will hear arguments in five cases this week, including disputes over the constitutionality of a task force that sets preventive healthcare coverage requirements, a school district's introduction of LGBTQ-themed storybooks and whether parties can establish standing based on harms affecting third parties.
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April 18, 2025
Walgreens To Pay DOJ $300M Over Invalid Prescriptions
Walgreens revealed in a U.S. Securities and Exchange Commission filing Friday that it will pay upward of $300 million to resolve U.S. Department of Justice allegations that it knowingly filed millions of prescriptions for opioids and other drugs that didn't have a legitimate medical purpose or weren't valid.
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April 18, 2025
Lilly Blasts Compounders' 'Scattershot' Bid To Reverse FDA
Eli Lilly urged a Texas federal judge to deny a request from pharmacies that produce copycat doses of its popular weight loss drug to have the court reverse an FDA decision taking the drug off a national shortage list, saying the bid was filled with unreliable "scattershot" arguments.
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April 18, 2025
Mass General Inks $8.25M Deal To End Retirement Fee Suit
Boston-based healthcare system Mass General Brigham Inc. agreed to pay $8.25 million to settle a proposed class action alleging it unlawfully allowed its employee retirement plan to pay excessive administrative fees, according to a filing in Massachusetts federal court.
Expert Analysis
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Breaking Down DOJ's Individual Self-Disclosure Pilot Program
The U.S. Department of Justice’s recently announced pilot program aims to incentivize individuals to voluntarily self-disclose corporate misconduct they were personally involved in, complementing a new whistleblower pilot program for individuals not involved in misconduct as well as the government's broader corporate enforcement approach, say attorneys at Paul Weiss.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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First 10b5-1 Insider Trading Case Raises Compliance Issues
The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.
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Policy Misrepresentations Carry Insurance Rescission Risks
The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.
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The Pros And Cons Of NIST's Proposed March-In Framework
Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Lessons For Nursing Facilities From DOJ Fraud Settlement
The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.
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HHS' Updated Tracking Tech Guidance Offers Little Clarity
The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.
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Takeaways From The 2023 DOJ Fraud Section Report
Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.
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NIST March-In Framework Is As Problematic As 2021 Proposal
While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.
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Spartan Arbitration Tactics Against Well-Funded Opponents
Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.
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The Road Ahead For Florida's Drug Importation Program
Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.