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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Expect More State-Level Scrutiny Of Noncompetes Ahead
Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.
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Cos. Should Inventory Issues To Prep For New Congress
As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Navigating DOJ's Patchwork Whistleblower Regime
In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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5 Areas Congress May Investigate After GOP Election Wins
With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.
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Takeaways From State Votes On Abortion In The 2024 Election
Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.
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Loper Bright Offers New Materiality Defense To FCA Liability
The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.
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How Expanded Birth Control Coverage May Affect Employers
Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.
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Legislation Most Likely To Pass In Lame Duck Session
As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.
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Preserving The FCA Is Crucial In Trump's 2nd Term
While the Trump administration may pursue weaker False Claims Act enforcement, it remains an essential tool in safeguarding public funds and maintaining corporate accountability, so now is not the time to undermine ethical behavior, or reduce protections and incentives for whistleblowers, says Adam Pollock at Pollock Cohen.
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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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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.