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This month’s newsletter discusses lawsuits concerning vaccines (including updates on two cases previously discussed), gender-affirming care, and the federal organ transplant system. If you would like to read any of our past newsletters, please access the archive on our website here.
Vaccine Cases
Update to Miller et al v. McDonald et al
Notably, on December 8, 2025, the U.S. Supreme Court granted certiorari and vacated the judgment below in Miller et al v. McDonald et al, a case challenging whether New York’s removal of its religious exemption for vaccines violated the First Amendment’s free exercise clause. We have covered this case in previous updates, most recently in our March 14, 2025 newsletter. That month, the U.S. Court of Appeals for the Second Circuit upheld the removal of the religious exemption and affirmed the motion to dismiss. In granting certiorari, the U.S. Supreme Court remanded the case to the Court of Appeals for further consideration in light of its decision in Mahmoud v. Taylor. In Mahmoud, the U.S. Supreme Court held that parents that challenged a County Board’s decision to include LGBTQ+ storybooks and to withhold parental opt-outs from that instruction were entitled to a preliminary injunction because the policy was an unconstitutional burden on their religious exercise. Although the Miller case now returns to the Court of Appeals for further proceedings, the Supreme Court’s command that the lower court review the case in light of Mahmoud suggests that a majority of the justices believe that state vaccine mandates may need to have a religious exemption. This would mark a significant change in the law, and would mark another blow to state efforts to ensure high vaccination rates among schoolchildren. We will continue to follow this case in future newsletters.
Update to Guzman v. State Department of Education and Hess v. West Virginia Department of Health
We have covered two recent West Virginia cases related to that state’s vaccination requirements. One is Guzman et al v. West Virginia Board of Education et al in which a parent sued the West Virginia and Raleigh County Boards of Education for not offering religious exemptions to the state’s school vaccine mandate. The other is Hess et al v. West Virginia Department of Health et al, which asked the circuit court to stop enforcement of Governor Patrick Morrisey’s executive order allowing religious and philosophical exemptions to the school vaccination requirements – an attempt to unilaterally overturn vaccine protections the legislature chose to keep in place. These two cases were consolidated. We previously covered them in our September 5, 2025 and July 11, 2025 newsletters.
On November 26, 2025, a West Virginia Circuit Court judge ruled in the consolidated cases that the West Virginia and Raleigh County Boards of Education violated the West Virginia Equal Protection for Religious Act of 2023 by not accepting religious exemptions to the state’s school vaccine requirements. The judge permanently enjoined the defendants from enforcing the West Virginia Compulsory Vaccination Law. However, on December 2, 2025, the West Virginia Supreme Court temporarily stayed the circuit court judge’s ruling (meaning it cannot be enforced) until the appeal of the underlying case is resolved.
In Re: Thomas, MD et al
In In Re: Thomas, MD et al (Docket No. 1:25-CV-02685), Doctors Paul Thomas and Kenneth Stoller along with the nonprofit Stand for Health Freedom challenge the Centers for Disease Control and Prevention’s (CDC) recommended childhood immunization schedule, which is approved through the Advisory Committee on Immunization Practices (ACIP). Dr. Thomas stated his medical license was suspended in Oregon for developing individualized vaccine protocols, while Dr. Stoller stated his license was revoked in California for issuing medical exemptions based on genetic testing to identify children at risk for vaccine injury.
The complaint, filed on August 15, 2025, in the D.C. District Court, states that the CDC has never studied the cumulative effects of administering all of the vaccines in the childhood schedule despite several recommendations for this research from the Institute of Medicine (IOM). It also states that ACIP provides two categories for vaccines: Category A whose recommendations apply universally; and Category B which includes shared decision-making based on individual circumstances, with almost all childhood vaccines being in Category A. The complaint further notes that most states incorporate ACIP’s recommendations into their state law, effectively making ACIP’s recommendations a binding national mandate.
Plaintiffs argue the CDC vaccination framework should be declared arbitrary and capricious under the Administrative Procedure Act (APA) because the CDC failed to study the cumulative, long-term impact of the vaccine schedule on children. Plaintiffs further claim that the CDC violated the APA by creating binding rules without the required notice and comment. As noted, plaintiffs argue that the ACIP recommendations are mandates since every state enforces them, and under the APA, agency guidance that is binding requires rulemaking. As relief, plaintiffs want all vaccines put onto ACIP’s Schedule B until studies show the cumulative effects of childhood vaccines are safe.
Plaintiffs also claim the vaccine schedule violates substantive due process rights under the Fifth Amendment as parents have a fundamental liberty interest in their children’s medical care and as children have a fundamental right to bodily integrity. Plaintiffs claim that by CDC having an untested schedule it knows states will enforce, it is eliminating informed consent and physician discretion. Interestingly, the complaint notes that it is not challenging state mandates or Jacobson v. Massachusetts (the 1905 seminal Supreme Court decision upholding a mandatory vaccine law as constitutional). Further, the plaintiffs argue the CDC framework denies the existence of medically vulnerable children, which violates the Equal Protection Clause of the Fifth Amendment. Finally, plaintiffs argue that the CDC is violating the First Amendment by suppressing medical and scientific dissent, which constitutes viewpoint discrimination.
Crites-Bachert v. Providence Health & Services – Oregon
On November 10, 2025, the U.S. Court of Appeals for the Ninth Circuit upheld a U.S. District of Oregon court opinion dismissing a lawsuit in Crites-Bachert v. Providence Health & Services – Oregon (Docket No. 24-06664, D.C. No. 3:23-cv-1510) in which Dr. Melanie Crites-Bachert alleged that Providence Health & Services – Oregon (Providence) had violated her constitutional, statutory, contractual, and tort rights by denying her request for a religious exemption and suspending her for refusing to get a COVID-19 vaccine.
In the district court’s findings, which were adopted and ordered, the court dismissed all of her allegations for a failure to state a claim. The Ninth Circuit upheld all these findings. It confirmed that Crites-Bachert’s constitutional claims failed because Providence is a private company and not a government actor. Her informed consent claim under the Food, Drug, and Cosmetic Act (FDCA) failed because the FDCA does not confer a private right of action. The contractual claims failed as Crites-Bachert did not identify any terms that Providence had breached and because she did not have enforcement rights. Finally, her tortious interference claim failed because she did not allege any facts to suggest that Providence’s compliance with state and federal vaccine policies were improper.
Health Information and Gender-Affirming Care
In Terdal et al v. Hathi et al (Docket No. 3:25-CV-01358), Paul Terdal and his company Terdal Consulting, LLC filed a lawsuit on August 5, 2025 in a U.S. District Court of Oregon against several staff at the Oregon Health Authority (OHA) alleging that OHA violated his First Amendment right to freedom of speech by failing to provide him with data regarding gender-related medical treatments. According to the complaint, Oregon law requires OHA to maintain and make available to the public the Oregon All Payer All Claims Reporting Program, which collects data to better inform policymakers and the public about health care in the state.
Terdal argues that OHA flagged his request as politically sensitive and subjected it to greater scrutiny, which was inconsistent with OHA’s rules and practices. Terdal further argues this denial was based on his previous use of state data to advocate for the reversal of OHA’s endorsement of gender-identity treatments, which included advocacy with the Oregon Health Evidence Review Commission and a public report detailing how OHA had silenced concerns about the safety and efficacy of treatments for children with gender-identity disorders. In addition, he claims that OHA’s denial of his data request based on the Health Insurance Portability and Accountability Act was pretextual given other OHA releases over the years and that the denial discriminates against him for his viewpoint and retaliates against him for protected speech in violation of the First Amendment. The defendants filed an answer on October 28, 2025, and the case is moving toward discovery.
Health Information and Organ Transplantation
In America First Legal Foundation v. Health and Human Services et al (Docket No. 1:25-CV-02101), America First Legal Foundation’s (AFL’s) complaint (filed on July 1, 2025) seeks to require the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services (CMS), and the Health Resources and Services Administration (HRSA) to comply with AFL’s Freedom of Information Act (FOIA) request for information regarding federal organ transplant programs and racial equity.
In its FOIA request, AFL notes that President Joe Biden issued Executive Order 13985 on January 20, 2021 titled “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.” AFL notes that part of the Executive Order required the heads of agencies to assess “whether underserved communities and their members face systemic barriers in accessing benefits and opportunities available pursuant to those policies and programs” and to provide an action plan to address any barriers. The FOIA request claims that in response to the Executive Order, CMS took action to collect information about racial inequities and the federal organ transplant program and that HRSA announced a “Modernization Initiative” to strengthen equity in the organ donation and transplant system and to break up the United Network for Organ Sharing to help address racial inequities. AFL argues that the actions of HHS, CMS, and HRSA, taken based on the Biden’s executive order, present a danger of allocating organs based on race and not medical criteria, which AFL says is required under the National Organ Transplant Act of 1984. The defendants filed an answer on September 19, 2025, and the court ordered the parties to provide a schedule for the case moving forward.
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