Policy & Compliance
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March 12, 2025
Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether
A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.
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March 12, 2025
Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto
Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.
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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
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.
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March 12, 2025
Harvard Docs Say Gov't Censored Articles With Gender Terms
A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."
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March 11, 2025
FTC Merger Suit, Hospital DEI Probe And Qui Tam At 11th Circ.
The Federal Trade Commission initiated its first merger challenge since the start of President Donald Trump's current term, arguing that a private equity firm's plans to buy a medical device company would lead to an unlawful level of market concentration.
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March 11, 2025
'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL
A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.
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March 11, 2025
Conversion Therapy Ban At High Court: 5 Cases To Know
The U.S. Supreme Court is set to hear a First Amendment challenge to a Colorado ban on mental health professionals using "conversion" therapy intended to help change minors' gender identity or sexual orientation.
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March 11, 2025
Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit
Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.
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March 11, 2025
Hospital Orgs. Say MultiPlan Must Not Duck Price-Fix Claims
Hundreds of American hospitals are "on the brink of collapse" and letting MultiPlan and a host of insurers who have been accused of conspiring to underpay out-of-network providers off the hook will not improve matters, two groups that represent thousands of hospitals have told the court.
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March 11, 2025
Alaska's RICO Claims Advance Against PBM In Opioid Suit
An Alaska federal judge has allowed most of the state's Racketeer Influenced and Corrupt Organization Act claims to move forward against pharmacy benefits manager Express Scripts for its alleged role in the opioid epidemic.
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March 11, 2025
Feds Turn To FCA As Enforcement Weapon In Opioid Crisis
Federal prosecutors are expanding their use of the False Claims Act to target pharmacies accused of contributing to the opioid crisis, a legal strategy that exposes the defendants to hefty penalties.
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March 11, 2025
Trump Admin Drops Suit Over COVID Nasal Spray Ads Claims
The U.S. Department of Justice quietly moved Monday to drop a Utah federal court lawsuit filed on behalf of the Federal Trade Commission accusing a sinus nasal spray company of falsely claiming its products could help prevent and treat COVID-19.
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March 11, 2025
HHS Comment Reversal Sets Stage For Quick Policy Changes
The sudden reversal at the U.S. Department of Health and Human Services of a longstanding commitment to robust public engagement clears the way for fast-paced changes to Medicaid and other massive programs, putting more pressure on compliance officers and sending more lobbying work behind closed doors.
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March 11, 2025
CEO, Staff Charged After Fatal Oxygen Chamber Explosion
Three people, including the CEO of a treatment center, have been charged with murder in connection with a hyperbaric oxygen chamber explosion that killed a 5-year-old boy, Michigan's attorney general announced Tuesday.
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March 11, 2025
Advocates Fear Abortion Drug U-Turn Under FDA Nominee
Ahead of a key Senate confirmation vote on Thursday, abortion rights advocates are sounding alarms about Marty Makary and indications that he may roll back expanded access to abortion medications as commissioner of the U.S. Food and Drug Administration.
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March 10, 2025
Justices Seen Resolving Circuit Split Over Med Mal Law
The U.S. Supreme Court said Monday it will decide whether a Delaware medical malpractice statute requiring an expert affidavit can apply in federal court, which experts said will give the justices the opportunity to reassess the so-called Erie doctrine and the relationship between state and federal courts.
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March 10, 2025
11th Circ. Urged To Find Qui Tam Cases Unconstitutional
A group of defendants accused of Medicare Advantage fraud urged the Eleventh Circuit on Monday to uphold a decision finding the False Claims Act's whistleblower provision unconstitutional, saying the statutory clause violates the Constitution in multiple ways.
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March 10, 2025
Medtronic Compliance Officer's Journey To State Senate Seat
A Medtronic compliance officer is taking on a role making different kinds of policies at the Minnesota State Capitol, following his successful bid for a state senate seat in late January. He told Law360 his compliance background is a natural fit for his new role in the public sector.
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March 10, 2025
Ga. Health System Says 'Vague,' 'Disorganized' Bias Suit Fails
A Georgia urologists' practice group on Monday hit back at a civil rights lawsuit from three doctors who said they were the victims of anti-Indian discrimination, arguing that their "shoot first and aim later" complaint fails to tie the company at all to their allegations.
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March 10, 2025
CVS PBM Caused Up To $330M In Part D Damages, Judge Told
A CVS-owned pharmacy benefits manager caused anywhere from $240 million to $330 million in damages by overbilling the government for Medicare Part D sponsored drugs, counsel for a whistleblower told a Pennsylvania federal judge at the beginning of a False Claims Act bench trial on Monday.
Expert Analysis
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AI In Health Law: The Top Guest Articles Of 2023
As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.
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The Most-Read Legal Industry Law360 Guest Articles Of 2023
A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.
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Inside Higher Education's New FCA Liability Challenges
As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.
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AI Executive Order's Life Science, Healthcare Industry Effects
The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.
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HHS Advisory Highlights Free Product Inducement Risks
A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.
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Attorneys' Busiest Times Can Be Business Opportunities
Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.
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In The World Of Legal Ethics, 10 Trends To Note From 2023
Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.
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How Attorneys Can Be More Efficient This Holiday Season
Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.
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Top 10 Whistleblowing And Retaliation Events Of 2023
The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.
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Children's Book Writing Makes Me A Better Lawyer
Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.
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The State Of CFPB Focus On Credit Reporting Of Medical Debt
An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.
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FDA's Recent Litigation Records Are Strong, But Imperfect
The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.