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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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Recent Developments In Insurance Coverage For FCA Claims
As the U.S. Department of Justice continues its vigorous False Claims Act enforcement, companies looking to their insurers to help defray the costs of an investigation or settlement should note recent decisions on which types of policies cover FCA claims, which policy periods apply and which portions of FCA-related losses are covered, say attorneys at Covington.
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Opinion
PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.
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Striking A Balance Between AI Use And Attorney Well-Being
As the legal industry increasingly adopts generative artificial intelligence tools to boost efficiency, leaders must note the hidden costs of increased productivity, and work to protect attorneys’ well-being while unlocking AI’s full potential, says Ed Sohn at Factor.
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Empathy In Mediation Offers A Soft Landing For Disputes
Experiencing a crash-landing on a recent flight underscored to me how much difference empathy makes in times of crisis or stress, including during mediation, says Eydith Kaufman at Alternative Resolution Centers.
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Series
Being An Artist Makes Me A Better Lawyer
My work as an artist has highlighted how using creativity and precision together — qualities that are equally essential in both art and law — not only improves outcomes, but also leads to more innovative and thoughtful work, says Sarah La Pearl at Segal McCambridge.
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How Judiciary Can Minimize AI Risks In Secondary Sources
Because courts’ standing orders on generative artificial intelligence and other safeguards do not address the risk of hallucinations in secondary source materials, the judiciary should consider enlisting legal publishers and database hosts to protect against AI-generated inaccuracies, say attorneys at Lankler Siffert & Wohl.
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Newly Acquired Information Can Be Key In Drug Label Cases
The question of whether federal law preempts state law claims is often central in pharmaceutical labeling cases, like the Fosamax litigation now before the Third Circuit — but parties must also consider whether there is newly acquired information to justify submitting a proposed labeling change in the first place, say attorneys at Arnold & Porter.
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Justices Face Tough Question On HHS Hospital Pay Formula
In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.
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How Attorneys Can Break Free From Career Enmeshment
Ambitious attorneys can sometimes experience career enmeshment — when your sense of self-worth becomes unhealthily tangled up in your legal vocation — but taking the time to discover and realign with your core personal values can help you recover your identity, says Janna Koretz at Azimuth Psychological.
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Key Healthcare Issues That Hinge On The Election Outcome
The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.
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Patent Lessons From 4 Federal Circuit Reversals In September
Cases that were reversed or vacated by the Federal Circuit last month provide helpful clarity on collateral estoppel, patent eligibility, construction of claim terms that have different boundaries across different claims, and the role of courts as neutral arbiter, say attorneys at Bunsow De Mory.
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Lawyers With Disabilities Are Seeking Equity, Not Pity
Attorneys living with disabilities face extra challenges — including the need for special accommodations, the fear of stigmatization and the risk of being tokenized — but if given equitable opportunities, they can still rise to the top of their field, says Kate Reder Sheikh, a former attorney and legal recruiter at Major Lindsey & Africa.
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Fostering Healthcare Industry Success With Joint Ventures
As the healthcare industry continues to evolve, joint ventures remain a key strategy to unite health systems, private equity firms and physician practices in leveraging their collective strengths to foster innovation and improve patient care, say Carole Becker and Travis Jackson at McDermott.
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Opinion
Judicial Committee Best Venue For Litigation Funding Rules
The Advisory Committee on Civil Rules' recent decision to consider developing a rule for litigation funding disclosure is a welcome development, ensuring that the result will be the product of a thorough, inclusive and deliberative process that appropriately balances all interests, says Stewart Ackerly at Statera Capital.
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The Strategic Advantages Of Appointing A Law Firm CEO
The impact on law firms of the recent CrowdStrike outage underscores that the business of law is no longer merely about providing supplemental support for legal practice — and helps explain why some law firms are appointing dedicated, full-time CEOs to navigate the challenges of the modern legal landscape, says Jennifer Johnson at Calibrate Strategies.