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Health
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October 21, 2024
PBMs Keep Door Open To Constitutional Riposte Against FTC
Attorneys for Caremark Rx, Express Scripts and OptumRx kept the door open Monday to challenging the Federal Trade Commission's constitutionality as they face an in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes.
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October 21, 2024
Google, Meta Want Out Of GoodRx Health Data Sharing Suit
Google, Meta Platforms and Criteo have asked a California federal court to cut them loose from litigation alleging that GoodRx improperly shared patients' protected health information with the tech companies, saying the claims are "fundamentally flawed."
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October 21, 2024
GOP Pols Want Probe Into FDA Laboratory Safety
Three Republican lawmakers on Friday sought information from the U.S. Food and Drug Administration about its oversight of its laboratory safety practices, following a long investigation over an incident about vials of smallpox virus and other hazards found on a National Institutes of Health campus.
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October 21, 2024
Weight Loss Clinic Denied Quick Relief In TM Suit
A North Carolina hospital and healthcare provider don't have to stop using the trademarks targeted in a weight loss clinic's infringement suit, a federal judge ruled Monday, finding that the clinic will not suffer significant consequences absent the immediate relief.
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October 21, 2024
Blue Cross Escapes Mental Health Coverage Denial Suit
A Pennsylvania federal judge tossed a patient's suit that claimed Independence Blue Cross violated federal benefits law when it declined to cover his stay at a residential facility, ruling the insurance company adequately backed up its decision that the treatment wasn't imperative to his health.
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October 21, 2024
Novartis Loses Challenge To Medicare Drug Price Talks
A New Jersey federal judge on Friday tossed Novartis Pharmaceuticals' challenge to a Medicare drug price negotiation program, ruling the company is not required to participate, and that participating in the program does not violate its First Amendment rights.
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October 21, 2024
Ontrak Jury Lacked Key Compliance Instruction, Judge Told
Counsel for convicted Ontrak founder Terren Peizer urged a California federal judge Monday to grant a new trial in the healthcare executive's novel insider trading case, saying jurors weren't properly instructed that they should acquit if Peizer's $20 million share sale was blessed by a compliance officer.
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October 22, 2024
Post-Dobbs Ballot Questions May Spell Litigation With No End
A record-setting number of abortion-related constitutional ballot questions this year has unleashed a wave of litigation over reproductive rights in the wake of the U.S. Supreme Court's Dobbs decision. But they may just be the start of the legal battles over the ballot measures.
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October 21, 2024
Feds Say Doctor Used Pandemic Funds For Cars, Real Estate
A Washington state dermatologist used $1.5 million from a loan intended for small business COVID-19 relief on two luxury Porsches, a second home and a storage unit, prosecutors said Monday.
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October 21, 2024
McGuireWoods Adds Healthcare Atty From Cooley In NY
McGuireWoods LLP has added a digital health expert from Cooley LLP, aiming to boost its offerings for clients in the space combining healthcare services with information and communications technology, the firm announced Monday.
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October 21, 2024
Fla. Dept.'s Ex-GC Says Gov.'s Office Directed TV Ad Letters
The former general counsel for the Florida Department of Health said Monday that he was directed by Gov. Ron DeSantis' office to send out letters threatening television stations with criminal prosecution if they did not pull a campaign ad promoting an abortion rights ballot initiative.
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October 21, 2024
Catalent CEO Defends Novo Deal, Will Stay On After Buyout
Catalent CEO Alessandro Maselli told the medical company's customers Monday that Catalent will continue to support them following its planned $16.5 billion sale to Novo Holdings, seeking to assure clientele after Sen. Elizabeth Warren and advocacy groups pressured the Federal Trade Commission to scrutinize and potentially block the deal.
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October 21, 2024
Biden Admin Proposes Expanded OTC Birth Control Coverage
The U.S. Department of Labor and two other agencies unveiled proposed regulations on Monday that for the first time would require private health insurers to cover the full cost of over-the-counter contraception, including male condoms and the morning-after pill.
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October 18, 2024
Law360 MVP Awards Go To Top Attys From 74 Firms
The attorneys chosen as Law360's 2024 MVPs have distinguished themselves from their peers by securing hard-earned successes in high-stakes litigation, complex global matters and record-breaking deals.
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October 18, 2024
Oklahoma Brings Title X Funding Cut Fight To Justices
Oklahoma is asking the U.S. Supreme Court to review the Tenth Circuit's decision allowing the U.S. Department of Health and Human Services to cut Title X funding over the state's refusal to refer family planning patients for abortion care following the high court's Dobbs decision last year.
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October 18, 2024
Tenn. Court Clarifies Scope Of Abortion Ban's Exceptions
A Tennessee state court has partly sided with a group of women who said they were denied or delayed in receiving medically necessary abortions, ruling that certain pregnancy-related conditions constitute serious medical emergencies that meet the state's exception to its criminal abortion ban.
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October 18, 2024
Ill. Justices Find Broad COVID Immunity For Health Facilities
The Illinois Supreme Court on Friday read broad immunity into an emergency order that immunized healthcare facilities aiding the state's COVID-19 response, saying the order shields those facilities from ordinary negligence claims during that time, not just ones directly relating to their pandemic care.
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October 18, 2024
What Attorneys Expect From Harris And Trump On Patents
Patents have scarcely been mentioned during the presidential campaign, but attorneys say that positions taken by the candidates suggest Donald Trump would favor stronger patent rights, while Kamala Harris would focus on steps to make drugs and other patented inventions more widely available.
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October 18, 2024
HHS Slams Hackensack Meridian's Chevron-Inspired Suit
The U.S. Department of Health and Human Services has torn into a suit from New Jersey's largest healthcare network over Medicare reimbursements, arguing the network has "chosen to blaze a path … that is both prohibited by Congress and unsanctioned by precedent."
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October 18, 2024
Cigna Says Florida Labs Owe $16M After 'Cheating' For Benefits
Three Florida substance abuse laboratories wrongly filed $16 million in claims for medically unnecessary tests and doubled their scheme by failing to seek patient payments, Cigna attorneys told a federal jury on Friday. The labs, however, accused the insurer of breaching policy agreements by failing to pay for services rendered.
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October 18, 2024
Hospital, Medical Practice Ink $12M Deal In Brain Damage Suit
A New Jersey hospital and other entities sued by the family of a woman who suffered permanent brain damage during childbirth have settled the lawsuit for $11.9 million, with about a quarter of the deal earmarked for attorney fees, according to court documents.
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October 18, 2024
AGs Slam 4th Circ. Bid To Restore NC Abortion Drug Limits
In a joint amicus brief to the Fourth Circuit, a coalition of 17 states and the District of Columbia has said the abortion drug mifepristone is a part of women's reproductive healthcare, assailing the "needless" limits that states including North Carolina have sought to impose on the drug's access.
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October 18, 2024
Suit Wants Fla. Abortion Measure Struck Over Fraud Claims
A group of Florida voters represented by former Florida Supreme Court Justice Alan Lawson have filed suit to invalidate an abortion rights ballot measure over allegations of wide-scale fraud by the initiative's sponsor during the signature gathering process.
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October 18, 2024
NC Hospital Fights Competitor's Expansion Bid Approval
A North Carolina hospital operator urged a state appellate court to invalidate an administrative judge's approval of a competitor's expansion bid, arguing that members of the public were wrongfully denied input.
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October 18, 2024
Polsinelli Adds K&L Gates Litigation Team In SC
A group of three federal healthcare litigators, plus consultants and support staff, has departed K&L Gates LLP for Polsinelli PC in Charleston, South Carolina.
Expert Analysis
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PE Firms Should Prepare For Increased False Claims Scrutiny
The impact private equity firms may have over medical decisions and care is increasingly attracting potential liability under the False Claims Act and attention from states and the federal government, so investors should follow best practices including conducting due diligence both before and after acquisitions, say attorneys at K&L Gates.
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3 Healthcare FCA Deals Provide Self-Disclosure Takeaways
Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.
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Series
After Chevron: ERISA Challenges To Watch
The end of Chevron deference makes the outcome of Employee Retirement Income Security Act regulatory challenges more uncertain as courts become final arbiters of pending lawsuits about ESG investments, the definition of a fiduciary, unallocated pension forfeitures and discrimination in healthcare plans, says Evelyn Haralampu at Burns & Levinson.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Takeaways From High Court's Tribal Health Admin Cost Ruling
The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.
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Justices' Intent Witness Ruling May Be Useful For Defense Bar
At first glance, the U.S. Supreme Court’s recent Diaz v. U.S. decision, allowing experts to testify to the mental state of criminal defendants in federal court, gives prosecutors a new tool, but creative white collar defense counsel may be able to use the same tool to their own advantage, say Jack Sharman and Rachel Bragg at Lightfoot Franklin.
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Eye On Compliance: New Pregnancy And Nursing Protections
With New York rolling out paid lactation breaks and extra leave for prenatal care, and recent federal legislative developments enhancing protection for pregnant and nursing workers, employers required to offer these complex new accommodations should take several steps to mitigate their compliance risks, says Madjeen Garcon-Bonneau at Wilson Elser.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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FTC Focus: Private Equity Investments In Healthcare
As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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How 5 States' Deal Notification Laws Are Guiding Healthcare
Healthcare transaction notification laws at various stages of implementation in California, Illinois, Indiana, Oregon and Washington are shaping sector mergers and acquisitions, with significant transparency, continuity of care and compliance implications as providers tackle complex regulatory requirements, says Melesa Freerks at DLA Piper.
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Contract Disputes Recap: Preserving Payment Rights
Stephanie Magnell and Zachary Jacobson at Seyfarth examine three recent decisions that together illustrate the importance of keeping accurate records and adhering to contractual procedures to avoid inadvertently waiving contractual rights to cost reimbursements or nonroutine payments.