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Health
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March 13, 2025
Merck Asks Justices To Block Fosamax Failure-To-Warn Suits
Merck has asked the U.S. Supreme Court to review a Third Circuit ruling that allowed more than 1,000 state-law failure-to-warn claims over its osteoporosis drug Fosamax, arguing that the U.S. Food and Drug Administration's formal rejection of a such a proposed warning label should block such lawsuits under federal law.
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March 13, 2025
Calif. AG Appealing State Limits On Pay-For-Delay Ban
California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.
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March 13, 2025
Judge Won't Toss $35M Ch. 11 Bank Fee Clawback Lawsuit
A Delaware bankruptcy judge has denied a summary judgment bid to dismiss a lawsuit alleging that an $1.8 billion loan set medical testing company Millennium Laboratories on course for its 2015 Chapter 11.
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March 13, 2025
PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial
The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.
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March 13, 2025
Pa. Justices Let Convicted Doctor Reapply For License
A former University of Pittsburgh Medical Center radiologist who lost his license for unlawfully prescribing Vicodin can seek reinstatement less than 10 years after his 2019 suspension thanks to a change in state law defining a drug trafficking offense, the Pennsylvania Supreme Court ruled Thursday.
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March 13, 2025
HHS Calls Back Terminated Attys Clearing Medicare Appeals
The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.
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March 13, 2025
9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal
A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge.
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March 13, 2025
SEIU Fund Escapes Surgery Centers' Underpayment Suit
A Service Employees International Union benefit fund no longer has to face a lawsuit four surgical centers launched accusing it of shortchanging them on patient treatments, with a New York federal judge saying Wednesday the centers have failed to show that any agreement existed between themselves and the fund.
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March 13, 2025
Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action
The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the Racketeer Influenced and Corrupt Organizations Act, a group of reimbursement recovery entities has said in asking the full court to rethink the ruling.
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March 13, 2025
Colo. Appeals Court Affirms $2.6M Award To Car Crash Victim
A Colorado Court of Appeals panel on Thursday declined to throw out a jury's $2.6 million economic damages award to a car accident victim following arguments that her experts didn't explicitly state her medical expenses were of "reasonable value," finding the jury had enough information to reach their decision.
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March 13, 2025
Days Into New Role, FDA's Top Lawyer Is Out
The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.
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March 13, 2025
Judge Orders Reinstatement Of Many Fired Federal Workers
A California federal judge on Thursday ordered the immediate reinstatement of certain probationary employees fired from six federal agencies, saying the Office of Personnel Management did not have the authority to direct those terminations, making the firings "unlawful."
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March 13, 2025
Lacking Votes, White House Pulls Weldon Nomination At CDC
The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.
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March 12, 2025
Fox News Cleared Of Sex Assault Claims, But Anchor Isn't
A New York federal judge on Wednesday agreed to free Fox News from a suit alleging that former host Ed Henry sexually harassed and raped a former producer but held that Henry must face the bulk of her claims before a jury trial set for May.
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March 12, 2025
GOP Senators Take Aim At CFPB Medical Debt Rule
Republican senators have introduced a measure to overturn the Consumer Financial Protection Bureau's recent rule banning medical debt from credit reports, one of the latest Biden-era regulations to be targeted for legislative repeal.
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March 12, 2025
Labcorp Warns Fed. Circ. Of 'Balkanization' In Prenatal IP Row
Labcorp, one of the world's largest chains of clinical lab providers, told the full Federal Circuit that a loss it incurred there over a patent tied to a $384 million judgment in Texas was the result of the "balkanization" of the court's patent obviousness jurisprudence.
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March 12, 2025
Women Attys, AGs Urge Justices To Protect Provider Choice
Women attorney groups and a group of state attorneys general urged the U.S. Supreme Court to reject South Carolina's attempt to stop Medicaid patients from seeing Planned Parenthood healthcare providers, saying in an amicus brief Wednesday that patients have a right to choose their healthcare providers and have a private right of action to enforce that right.
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March 12, 2025
SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval
The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.
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March 12, 2025
Trump Admin Seeks To End ACA Access For 'Dreamers'
The U.S. Department of Health and Human Services on Wednesday proposed a regulation that would do away with the Biden administration's rule allowing recipients of Deferred Action for Childhood Arrivals to qualify for Affordable Care Act coverage.
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March 12, 2025
Judge Says Hospital Orgs.' Input Not Needed In Multiplan MDL
The Illinois federal judge handling multidistrict litigation targeting Multiplan's out-of-network reimbursement rates has rejected two hospital organizations' bid to weigh in as he considers whether he should dismiss the case.
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March 12, 2025
4th Circ. Won't Undo Health Data Access Order
A Fourth Circuit panel issued a ruling Wednesday that affirmed a lower court's order requiring PointClickCare to allow Real Time Medical Systems to access patient data that it uses to provide nursing facilities with alerts for potential medical complications.
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March 12, 2025
Mich. Appellate Judge Pans Medical Pot Co.'s Sales Tax Claim
A Michigan Court of Appeals judge sounded skeptical Wednesday of a medical cannabis provisioning center's claim that nonbinding guidance from the state tax agency shielded it from collecting sales tax for the first year after a law regulating its type of business was enacted.
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March 12, 2025
Trump Admin Drops Biden Bid To Unfreeze ACA Trans Rule
The Trump administration asked the Fifth Circuit on Wednesday to dismiss its appeal, filed in July by the Biden administration, of a Texas federal judge's decision to halt a rule protecting access to gender-affirming healthcare.
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March 12, 2025
NC Organ Procurer Sues CMS Over Hospital Waiver
A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region.
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March 12, 2025
HHS To Eliminate 6 Regional Offices For Legal Staff
The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.
Expert Analysis
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How 2025 NDAA May Affect DOD Procurement Protests
A bid protest pilot program included in the 2025 National Defense Authorization Act shifts litigation costs onto unsuccessful bid protesters and raises claim-filing thresholds, which could increase risks to U.S. Department of Defense contractors who file protests, and reduce oversight of DOD procurement awards, say attorneys at Venable.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.
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Top 10 Noncompete Developments Of 2024
Following an eventful year in noncompete law at both state and federal levels, employers can no longer rely on a court's willingness to blue-pencil overbroad agreements and are proceeding at their own peril if they do not thoughtfully review and carefully enforce such agreements, say attorneys at Faegre Drinker.
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5 E-Discovery Predictions For 2025 And Beyond
In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.
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What 2024 Tells Us About Calif. Health Transaction Reviews
Looking back at the California Office of Health Care Affordability's first year accepting notices for material healthcare transactions reveals critical lessons on what the OHCA's review process may mean for the future of covered transactions in the state, say attorneys at Ropes & Gray.
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Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas
Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.
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Updated HIPAA Rule Is A Necessary Step For Data Protection
The U.S. Department of Health and Human Services' updated rules addressing cybersecurity threats in healthcare will necessitate significant investment in technology, training and compliance infrastructure, but are an essential evolution in safeguarding data in an increasingly digital world, say attorneys at Clark Hill.
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6 Predictions For Cyber Risk And Insurance In 2025
This year is likely to bring with it some thorny and expensive cyber challenges, including increased ransomware activity, more data breach class actions and continued efforts to define business interruption loss calculations, say attorneys at Wiley.
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7 Ways 2nd Trump Administration May Affect Partner Hiring
President-elect Donald Trump's return to the White House will likely have a number of downstream effects on partner hiring in the legal industry, from accelerated hiring timelines to increased vetting of prospective employees, say recruiters at Macrae.
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How Trump 2.0 May Change Business In Latin America
Companies in Latin America should expect to face more trade restrictions, tighter economic sanctions and enhanced corruption risks, as the incoming administration shifts focus to certain non-U.S. actors, most notably China, says Matteson Ellis at Miller & Chevalier.
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Opinion
Courts Must Curb The Drug Price Negotiation Program
The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.
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E-Discovery Quarterly: Rulings On Custodian Selection
Several recent rulings make clear that the proportionality of additional proposed custodians will depend on whether the custodians have unique relevant documents, and producing parties should consider whether information already in the record will show that they have relevant documents that otherwise might not be produced, say attorneys at Sidley.
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The OIG Report: Preparing For Oversight In 2025
Across sectors, Office of Inspector General work plans and challenge reports for 2025 provide a trove of information on the issues and industries that will likely be the focus of government oversight in the year to come, says Diana Shaw at Wiley.