Justia Health Law Opinion Summaries

In this vaccination dispute, the First Circuit denied the motion brought by Appellants seeking an injunction pending appeal, holding that Appellants were not entitled to the injunction.Appellants, eight employees of Mass General Brigham, Inc. (MGB), challenged MGB's application of its mandatory vaccination policy to them individually. The policy was issued in June 2021 requiring all MGB employees to be vaccinated against COVID-19 unless they qualified for a medical or religious exemption. After Appellants' requests for exemptions were denied and they still refused to get vaccinated, MGB placed them on unpaid leave. Appellants sued under Title VII of the Civil Rights Act and the Americans with Disabilities Act, arguing that MGB unlawfully denied their individual exemption requests. The district court denied Appellants' motion for a preliminary injunction, which would have required Appellants' reinstatement from unpaid leave status. The First Circuit denied Appellants' motion for injunction pending appeal, holding that adequate legal remedies foreclosed injunctive relief. View "Together Employees v. Mass General Brigham Inc." on Justia Law

The Court of Appeals accepted a question certified by the United States Court of Appeals for the Second Circuit and answered that no provide cause of action exists for violations of New York Public Health Law 18(2)(e).Plaintiff filed a complaint alleging that Defendant, a hospital, violated section 18(2)(3) by charging her $1.50 per page for paper copies of her medical records. The district court concluded that no private right of action existed under section 18(2)(e) and therefore granted Defendant's motion to dismiss. On appeal, the Second District concluded that there was insufficient precedent to resolve the issue of whether a private right of action existed. After applying the factors set forth in Sheehy v. Big Flats Community Day, 73 NY2d 629 (1989), the Court of Appeals concluded that no private cause of action exists for violations of section 18(2)(e). View "Ortiz v. Ciox Health LLC" on Justia Law

Liver-transplant candidates and transplant hospitals challenged HHS's adoption of a new policy for allocating donated livers. In 2019, the Eleventh Circuit held that the plaintiffs had not shown a substantial likelihood of success on the merits of their claim that the Secretary failed to follow procedures under 42 C.F.R. 121.4(b) during the new liver-allocation policy's development. Section 121.4(b) does not require the Secretary to refer the new liver allocation policy to an Advisory Committee on Organ Transplantation or to publish the new policy in the Federal Register for public comment. The court remanded for the district court to consider the remaining Administrative Procedure Act and Fifth Amendment claims.The district court ordered limited discovery on remand. The defendants ultimately produced requested communications between its top-level personnel and outside policymakers that, according to the plaintiffs, exposed “bad faith and improper behavior.” The district court ultimately excluded the documents from the administrative record for the APA claim, while noting that the documents included “colorable evidence of animosity and even some measure of regional bias.” The hospitals moved to unseal the documents. In 2021, the Eleventh Circuit affirmed an order unsealing the documents. The documents here are “plainly judicial records” and the appellants have not shown good cause to keep them sealed. View "Callahan v. United Network for Organ Sharing" on Justia Law

This appeal presented an issue of first impression for the Court of Appeals: does a commercial property insurance policy provide coverage for a business’s lost income due to the COVID-19 pandemic? After review of the specific insurance policy that California Mutual Insurance Company (California Mutual) issued to The Inns by the Sea (Inns) for its five lodging facilities, the Court determined Inns could not recover from California Mutual for its lost business income resulting from the COVID-19 pandemic. Further, Inns did not identify any manner in which it could amend its complaint to state a claim for coverage. Accordingly, the Court affirmed the trial court’s order sustaining California Mutual’s demurrer without leave to amend. View "The Inns by the Sea v. Cal. Mutual Ins. Co." on Justia Law

This case concerns OSHA's November 5, 2021 Emergency Temporary Standard requiring employees of covered employers to undergo COVID-19 vaccination or take weekly COVID-19 tests and wear a mask.The Fifth Circuit granted petitioners' motion for a stay pending review, holding that the Nken factors favored a stay. The court concluded that petitioners' challenges to the Mandate are likely to succeed on the merits. The court stated that, on the dubious assumption that the Mandate does pass constitutional muster, it is nonetheless fatally flawed on its own terms. The court wrote that the Mandate's strained prescriptions combine to make it the rare government pronouncement that is both overinclusive (applying to employers and employees in virtually all industries and workplaces in America, with little attempt to account for the obvious differences between the risks facing, say, a security guard on a lonely night shift, and a meatpacker working shoulder to shoulder in a cramped warehouse) and underinclusive (purporting to save employees with 99 or more coworkers from a "grave danger" in the workplace, while making no attempt to shield employees with 98 or fewer coworkers from the very same. The court found that promulgation of the Mandate grossly exceeds OSHA's statutory authority and found arguments to the contrary unavailing.The court also concluded that it is clear that denial of petitioners' proposed stay would do them irreparable harm where the Mandate threatens to substantially burden the liberty interests of reluctant individuals, companies, and the States. In contrast, the court stated that a stay will do OSHA no harm whatsoever. Finally, the court concluded that a stay is firmly in the public interest. View "BST Holdings, LLC v. Occupational Safety and Health Administration" on Justia Law

The Food and Drug Administration denied Breeze’s Premarket Tobacco Product Applications for its electronic nicotine delivery systems (ENDS). Breeze sought a stay of the FDA’s order. Under the Family Smoking Prevention and Tobacco Control Act “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. 387l(a)(1)(B). Breeze argued that seeking a stay from the FDA would have been impracticable because the order takes effect immediately and the FDA can take months to consider an agency-level request for a stay.The Sixth Circuit denied the requested stay, finding that Breeze had not made a strong showing that it is likely to succeed on the merits.” Breeze has not made a strong showing that it would likely succeed on its claim that the FDA’s review of its application was arbitrary or capricious nor that the FDA’s denial of its application contradicted the FDA’s nonbinding 2019 guidance. That guidance contemplated more rigorous scientific data than contained in Breeze's application that its ENDS product adequately protected public health. The FDA cited well-developed evidence showing that flavored ENDS products’ special appeal to youths harms public health to a degree not outweighed by the (far-less-supported) effects of adult cigarette smokers switching to e-cigarettes. View "Breeze Smoke, LLC v. United States Food and Drug Administration" on Justia Law

An opioid manufacturer appealed a $465 million verdict following a bench trial in a public nuisance lawsuit. The district court held the opioid manufacturer liable under Oklahoma's public nuisance statute for its prescription opioid marketing campaign. The State of Oklahoma counter-appealed. The Oklahoma Supreme Court retained the appeal and held that the opioid manufacturer's actions did not create a public nuisance. The district court erred in extending the public nuisance statute to the manufacturing, marketing, and selling of prescription opioids. View "Oklahoma ex rel. Attorney General of Oklahoma v. Johnson & Johnson" on Justia Law

The Hospitals filed suit to enjoin the OPTN's new policy, which significantly changes the method for allocating donated kidneys to kidney transplant patients, as unlawful under the Transplant Act and the Administrative Procedure Act (APA).The Eighth Circuit affirmed the district court's denial of the Hospitals' motion for a temporary restraining order and preliminary injunction. Examining the district court's balancing of the Dataphase factors, the court concluded that the district court did not err in concluding that the Hospitals failed to show that their procedural APA claim is likely to succeed on the merits. The court also agreed with the district court that the Hospitals failed to demonstrate that they are likely to succeed on the merits of their claim that adoption of the Fixed Circle Policy was arbitrary and capricious agency action. Furthermore, the district court did not abuse its discretion in concluding that the Hospitals' one-year delay refuted their allegations of irreparable harm, and the balance of the equities and public interest weigh in favor of denying the requested preliminary injunction. View "Adventist Health System v. U.S. Department of Health and Human Services" on Justia Law

New York’s “Prevention of COVID-19 transmission” Rule, issued in August 2021, directs hospitals, nursing homes, hospices, adult care facilities, and other healthcare entities to “continuously require” certain employees to be fully vaccinated against COVID-19. It establishes a medical exemption to the requirement, but—consistent with New York’s prior vaccination requirements for healthcare workers—does not include an exemption based on religious belief. The Rule permits, but does not require, employers to make other accommodations for individuals who choose not to be vaccinated based on their sincere religious beliefs.The plaintiffs, primarily healthcare workers, challenged the Rule, claiming that being vaccinated would violate their religious beliefs because the vaccines were developed or produced using cell lines derived from cells obtained from voluntarily aborted fetuses. One district court enjoined the Rule insofar as it prevented healthcare workers from being eligible for a religious exemption; the other denied relief.The Second Circuit rejected the Plaintiffs’ claims. With respect to the Free Exercise claim, they have not established that they are likely to prove that the Rule is not a neutral law of general applicability or that it does not satisfy rational basis review. Nor have they demonstrated a likelihood of success on their Supremacy Clause claim; they have not shown that it would likely be impossible for employers to comply with both the Rule and Title VII. The Plaintiffs are not likely to succeed on their claim that the Rule contravenes the Fourteenth Amendment. View "We The Patriots USA, Inc. v. Hochul" on Justia Law

Vargas received extensive medical care from the Veterans Administration. In his suit under the Federal Tort Claims Act, 28 U.S.C. 2671–80, he argued that a VA nurse was negligent in failing to order additional tests after receiving the results of urinalysis in October 2015. More testing, Vargas contended, would have revealed that he suffered from a urinary tract infection; failure to diagnose that infection led to a heart attack, which led to extended hospitalization, which led to pain and inflammation.The Seventh Circuit affirmed the rejection of his claims, upholding the district judge’s decision to allow testimony from a board-certified urologist. Federal Rule of Evidence 702 governs the admissibility of expert evidence in suits under the FTCA. The district judge was entitled to consider the urologist’s view that the applicable standard of care did not require follow-up testing to look for a urinary tract infection. If even a board-certified urologist would not have seen anything in the test result calling for further lab work, then a nurse practitioner’s identical decision cannot be negligent. Illinois does not hold nurses to the higher standard of specialists. View "Love v. United States" on Justia Law