Policy & Compliance
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June 20, 2025
PE Firm Demands FDA Docs For Defense In Deal Challenge
Private equity firm GTCR BC Holdings LLC is seeking a court order for the U.S. Food and Drug Administration to produce over a decade's worth of medical device approval applications, arguing the documents are necessary in its defense against a merger challenge by the federal government.
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June 20, 2025
Nose Spray Co. Sues FTC Over Substantiation Requirement
Nasal spray maker Xlear Inc. is suing the Federal Trade Commission in Utah federal court, seeking a declaration that the agency is going beyond its statutory mandate by requiring scientific substantiation in marketing claims, even if the claims are not false and misleading.
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June 20, 2025
4 ERISA Cases To Watch In The 2nd Half Of 2025
The U.S. Department of Labor's challenge to a pair of injunctions blocking Biden-era regulations that broaden who qualifies as an investment advice fiduciary under federal benefits law tops the list of cases benefits attorneys will be watching in the latter half of the year.
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June 18, 2025
Texas Judge Vacates Biden-Era HHS Abortion Privacy Rule
A Texas federal judge on Thursday agreed to vacate a U.S. Department of Health and Human Services rule finalized during the Biden administration that aimed to protect the privacy of patients seeking abortions and gender-affirming care, ruling that the HHS didn't have the authority to "fashion special protections" in areas of "great political significance."
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June 18, 2025
NC Panel Rejects HCA Unit's Appeal Over Rival Project Award
A North Carolina appeals court on Wednesday rejected an HCA Healthcare subsidiary's challenge to an award of a certificate of need allowing a rival to build a new acute care facility, backing a decision in favor of the state health department behind the award.
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June 18, 2025
Nurse Staffing Exec Can't Nix Conviction, Sanctions Floated
A Nevada federal court has refused a nurse staffing executive's bid to undo his conviction on wage-fixing and wire fraud charges, and threatened his attorneys with sanctions for allegedly making repeated misrepresentations to the court.
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June 18, 2025
High Court Concurrences Signal Hard Battle For Trans Rights
U.S. Supreme Court Justice Amy Coney Barrett joined the court's two most conservative members Wednesday to suggest laws that differentiate based on transgender status should be subject to the lowest level of judicial review, providing guidance to lower courts that will likely make it harder for litigants to vindicate trans rights.
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June 18, 2025
NY High Court Lifts Block On NYC Shifting Retiree Healthcare
New York's highest court lifted an injunction Wednesday that had blocked New York City from switching retired city employees' health insurance provider, ruling that the city never promised its retirees that it would keep them on a Medicare supplemental plan.
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June 18, 2025
Ex-Drug Exec Must Testify, But Keeps 5th Amendment Rights
Sandoz, Teva, Actavis and Taro can again subpoena the deposition testimony of a former Actavis and Teva executive, but a Pennsylvania federal judge is still allowing the witness to invoke his Fifth Amendment rights against self-incrimination, even though the Justice Department dropped the criminal charges against him.
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June 18, 2025
Age Bias Taints Kansas Health Dept. Promotions, EEOC Says
The Kansas Department of Health and Environment overlooked an older worker for promotions to more senior lab tech roles solely because of her age, the U.S. Equal Employment Opportunity Commission told a federal court.
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June 18, 2025
DC Judge Throws Out Suits Over J&J Drug Discount Audits
A D.C. federal judge nixed five lawsuits brought by hospitals that accused federal healthcare regulators of illegally authorizing Johnson & Johnson to audit their business records for compliance with the 340B drug discount program.
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June 18, 2025
5th Circ. Affirms Nix Of Ex-Hospital Workers' COVID Vax Suit
The Fifth Circuit backed a Houston hospital's defeat of a lawsuit alleging that hundreds of employees were unlawfully fired when they refused to get the COVID-19 vaccine, saying the workers couldn't demonstrate that their right to reject the shot had been violated.
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June 18, 2025
Supreme Court Upholds Tennessee Transgender Care Ban
The U.S. Supreme Court on Wednesday upheld a Tennessee ban on gender-affirming medical care for minors, finding that the state law does not violate the equal protection clause.
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June 17, 2025
Chinese Co. Draws Fla. AG Probe Over Health Device Security
Florida's attorney general is taking a closer look at a Chinese manufacturer of health monitoring devices that he claims has been concealing "serious security problems" that have enabled unauthorized parties to manipulate and gain access to patient data.
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June 17, 2025
Novo Nordisk Settles TM Suit Against Clinic Over Compounds
Novo Nordisk, the company behind drugs Ozempic, Rybelsus and Wegovy, struck a deal with an Ohio clinic to end its federal trademark infringement case, one of a slew of suits the pharmaceutical giant has filed against health facilities offering custom-made compounded drugs purporting to yield similar results to its blockbuster products used for weight loss.
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June 17, 2025
5 Court Battles Hinging On High Court's Trans Care Ruling
An imminent U.S. Supreme Court decision regarding Tennessee's ban on gender transition care for minors is poised to have a sweeping impact as courts across the country weigh similar state and federal restrictions.
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June 17, 2025
NJ Court Says Unqualified Expert Dooms Med Mal Suit
A New Jersey appellate panel on Tuesday tossed a medical malpractice suit alleging a physician failed to properly treat a man's internal bleeding that proved to be fatal, ruling that the plaintiff's expert affidavit was insufficient because the expert did not specialize in the same area as the defendant doctor.
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June 17, 2025
Ga. Panel Considers New Statute In $46M Med Mal Case
Atlanta Women's Specialists LLC and one of its physicians urged the Georgia Court of Appeals to reconsider a $13.7 million attorney fee award in a $45.8 million case in which they were found liable for medical malpractice resulting in a woman suffering severe brain damage days after childbirth.
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June 17, 2025
Health Insurance Co. Owes Workers OT Wages, Suit Claims
Humana Inc. and Humana Government Business Inc. were hit with a proposed class action in Georgia federal court on Tuesday over allegations they failed to pay registered nurse case managers proper overtime wages.
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June 17, 2025
HHS Says Trump Orders Merit Ending Trans Health Rule Case
The federal government urged a Mississippi federal court to end a lawsuit challenging a Biden-era rule that protected gender-affirming care under the Affordable Care Act, arguing the Republican attorneys general leading the case can't show imminent harm given the Trump administration's position on the definition of "sex."
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June 17, 2025
FDA Unveils Voucher Program For Fast-Paced Drug Reviews
Pharmaceutical companies that boost domestic drug manufacturing or address other national priorities will have a chance to secure speedier review and approval of new drugs under a pilot program the U.S. Food and Drug Administration unveiled Tuesday.
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June 17, 2025
9th Circ. Backs Class Cert. In Suit Over Diabetes Drug Risk
The Ninth Circuit refused to disband a class of third-party payors who claim Takeda Pharmaceutical and Eli Lilly & Co. hid their anti-diabetes drug's bladder cancer risks, finding no issue with a lower court's analysis of expert evidence showing prescriptions fell after the risks were disclosed.
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June 17, 2025
Healthcare Worker's Wage Collective 'Amorphous,' HCA Says
A respiratory therapist's proposed collective is far too expansive and "amorphous" and is based on scant evidence that HCA Healthcare Inc. illegally manipulated workers' time sheets, the company told a North Carolina federal court, urging it to deny certification.
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June 17, 2025
Trump's Abortion Guidance U-Turn Sparks Legal Risks
Now that the Trump administration has pulled guidance telling doctors they must perform abortions in emergency situations, healthcare attorneys are warning their clients to diligently document their decisions, especially when they find themselves caught in the middle of conflicting federal and state law.
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June 17, 2025
'A Warning Shot?' Experts Eye Surge In Drug Ad Enforcement
Despite its recent staff cuts and leadership changes, the U.S. Food and Drug Administration has launched a burst of enforcement activity targeting prescription drug promotion, singling out a "sex pill" post on Instagram and an exhibit panel touting a diuretic.
Expert Analysis
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A Look At Healthcare Transaction Oversight In Oregon
Understanding Oregon's enforcement authority and its impact on proposed transactions last year provides a road map to the state's plans to strengthen its processes this year, though enforcement could be challenged by ongoing litigation, say attorneys at Ropes & Gray.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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High Court Must Acknowledge US History Of Anti-Trans Laws
Despite Justice Amy Coney Barrett's claim to the contrary during oral arguments in U.S. v. Skrmetti, U.S. governments at every level have systematically discriminated against transgender people, and the U.S. Supreme Court must consider this historical context in upcoming cases about transgender issues, says Paisley Currah at the City University of New York.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Dispelling 10 Myths About Health Provider-Based Compliance
Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.
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Preparing For A Possible End To The Subminimum Wage
The U.S. Department of Labor's proposed rule to end the subminimum wage for employees with disabilities may significantly affect the community-based rehabilitation and training programs that employ these workers, so certified programs should be especially vigilant about compliance during this period of evaluation and scrutiny, say attorneys at Jackson Lewis.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.