Justia Health Law Opinion Summaries

Several individuals, representing a class, challenged a health insurance company’s refusal to cover gender-affirming care for transgender individuals diagnosed with gender dysphoria. The company, acting as a third-party administrator for employer-sponsored, self-funded health plans, denied coverage for such treatments based on explicit plan exclusions requested by the employer sponsors. Some plaintiffs also alleged that they were denied coverage for treatments that would have been covered for other diagnoses, such as precocious puberty, but were denied solely because of the concurrent diagnosis of gender dysphoria.The United States District Court for the Western District of Washington certified the class and granted summary judgment in favor of the plaintiffs. The district court rejected the company’s arguments that it was not subject to Section 1557 of the Affordable Care Act because its third-party administrator activities were not federally funded, that it was merely following employer instructions under ERISA, and that it was shielded by the Religious Freedom Restoration Act (RFRA). The district court also found that the exclusions constituted sex-based discrimination under Section 1557.On appeal, the United States Court of Appeals for the Ninth Circuit agreed with the district court that the company is subject to Section 1557, that ERISA does not require administrators to enforce unlawful plan terms, and that RFRA does not provide a defense in this context. However, the Ninth Circuit held that the district court’s analysis of sex-based discrimination was undermined by the Supreme Court’s intervening decision in United States v. Skrmetti, which clarified the application of sex discrimination standards to exclusions for gender dysphoria treatment. The Ninth Circuit vacated the summary judgment and remanded the case for further proceedings to consider whether, under Skrmetti, the exclusions at issue may still constitute unlawful discrimination, particularly in cases involving pretext or proxy discrimination or where plaintiffs had other qualifying diagnoses. View "PRITCHARD V. BLUE CROSS BLUE SHIELD OF ILLINOIS" on Justia Law

An Oregon nonprofit organization, whose board members are guided by sincerely held religious beliefs, challenged a state law requiring most employers to provide insurance coverage for abortion and contraceptive services. The organization’s governing documents and public statements reflect a commitment to traditional Judeo-Christian ethics, including opposition to abortion based on religious grounds. Although the law contains exemptions for certain religious employers, the organization does not qualify for any of these exceptions, a point not disputed by the state. The organization sought relief, arguing that being compelled to provide such coverage violates its rights under the First and Fourteenth Amendments.The United States District Court for the District of Oregon denied the organization’s request for a preliminary injunction and dismissed its complaint. The district court found there was doubt as to whether the organization’s opposition to abortion was genuinely religious in nature. It further concluded that the law was neutral and generally applicable, subject only to rational basis review, which it satisfied.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s dismissal and vacated the denial of a preliminary injunction. The Ninth Circuit held that the organization’s beliefs are religious and sincerely held, and that the district court erred by not accepting these allegations as true at the motion to dismiss stage. The appellate court remanded the case for the district court to reconsider, in light of the Supreme Court’s decision in Catholic Charities Bureau, Inc. v. Wisconsin Labor & Industry Review Commission, whether the selective denial of a religious exemption to the organization violates the First Amendment. The Ninth Circuit expressed no opinion on the ultimate constitutional question, leaving it for the district court to address in the first instance. View "OREGON RIGHT TO LIFE V. STOLFI" on Justia Law

A group of more than 80 former at-will employees of a nonprofit healthcare system in Washington were terminated after refusing to comply with a COVID-19 vaccination mandate issued by their employer, which was in response to an August 2021 proclamation by the state’s governor requiring healthcare workers to be vaccinated. The employees alleged that, at the time, only an “investigational” vaccine authorized for emergency use was available, and they claimed their rights were violated when they were penalized for refusing it. They also argued they were not adequately informed of their right to refuse the vaccine.The United States District Court for the Western District of Washington first dismissed all claims against the governor, then dismissed the federal claims against the healthcare system, and denied the employees’ motions for leave to amend and reconsideration. The district court also declined to exercise supplemental jurisdiction over the remaining state-law claims against the healthcare system.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed the district court’s dismissal. The Ninth Circuit held that none of the employees’ statutory or non-constitutional claims, which were based on various federal statutes, regulations, agreements, and international treaties, alleged specific and definite rights enforceable under 42 U.S.C. § 1983. The court also found that the employees’ constitutional claims failed: the Fourteenth Amendment substantive due process claim was foreclosed by Jacobson v. Massachusetts and Health Freedom Defense Fund, Inc. v. Carvalho; the procedural due process claim failed because at-will employment is not a constitutionally protected property interest; and the equal protection claim failed because the mandate survived rational-basis review. The court further held that amendment of the federal claims would be futile and upheld the district court’s dismissal of the state law claims against the governor and its decision to decline supplemental jurisdiction over the state law claims against the healthcare system. View "Curtis v. Inslee" on Justia Law

Jill Esche, who was seven months pregnant, was admitted to Renown Regional Medical Center in Nevada with severe hypertension and erratic behavior. Hospital staff, believing she was mentally ill and a danger to herself and her fetus, petitioned for her involuntary commitment under Nevada law. While the petition was pending, Esche was kept in the hospital, given psychiatric and medical treatment against her will, restricted from visitors and phone use, and not informed that a public defender had been appointed for her. After giving birth by C-section, the hospital decided to withdraw the commitment petition but allowed Esche to leave while she was still in fragile condition. She died outside near the hospital that night. Her estate and survivors sued the hospital and several staff members, alleging violations of her constitutional rights under 42 U.S.C. § 1983 and Nevada law.The United States District Court for the District of Nevada granted summary judgment to the defendants on some claims, including unreasonable seizure and procedural due process claims, but denied summary judgment on others, such as substantive due process, conspiracy, and failure-to-train-or-supervise claims. The court also denied the defendants’ assertion of a good-faith defense to § 1983 liability, finding that the defense did not apply because the hospital was not required by law or directed by a public official to hold Esche involuntarily. Both sides appealed: the defendants challenged the denial of the good-faith defense, and the plaintiffs cross-appealed the dismissal of other constitutional claims.The United States Court of Appeals for the Ninth Circuit reviewed the case and held that the district court’s denial of the good-faith defense was not immediately appealable under the collateral order doctrine, as the defense is a defense to liability, not an immunity from suit. The court dismissed both the defendants’ appeals and the plaintiffs’ cross-appeal for lack of jurisdiction. View "Estate of Esche v. Bunuel-Jordana" on Justia Law

After the Washington Medical Commission adopted a policy to discipline physicians for spreading COVID-19 “misinformation,” several plaintiffs—including physicians who had been charged with unprofessional conduct, physicians who had not been charged, and advocacy organizations—filed suit. The Commission’s actions included investigating and charging doctors for public statements and writings about COVID-19 treatments and vaccines. Some plaintiffs, such as Dr. Eggleston and Dr. Siler, were actively facing disciplinary proceedings, while others, like Dr. Moynihan, had not been charged but claimed their speech was chilled. Additional plaintiffs included a non-profit organization and a public figure who alleged their right to receive information was affected.The United States District Court for the Eastern District of Washington dismissed the plaintiffs’ First Amended Complaint. The court found that the claims were constitutionally and prudentially unripe, and that the doctrine of Younger abstention required federal courts to refrain from interfering with ongoing state disciplinary proceedings. The district court also addressed the merits, concluding that the plaintiffs failed to state a plausible First Amendment or due process claim, but the primary basis for dismissal was abstention and ripeness.On appeal, the United States Court of Appeals for the Ninth Circuit affirmed the district court’s dismissal. The Ninth Circuit held that Younger abstention barred claims challenging ongoing state disciplinary proceedings (including as-applied and facial constitutional challenges, and due process claims) for all plaintiffs subject to such proceedings. The court also held that Younger abstention did not apply to claims for prospective relief by plaintiffs not currently subject to proceedings, but those claims were constitutionally and prudentially unripe because no concrete injury had occurred and further factual development was needed. The Ninth Circuit thus affirmed the dismissal of all claims. View "STOCKTON V. BROWN" on Justia Law

A company alleged that a manufacturer of cardiac rhythm devices engaged in an unlawful compensation arrangement involving the sale of implanted cardiac devices paid for by Medicare and other public health insurance programs. The manufacturer hired a sales representative whose brother, a physician, implanted the devices at a hospital. The hospital billed federal health insurance programs for the devices, and the manufacturer paid the sales representative a commission for each sale. The relator claimed that this arrangement violated the Anti-Kickback Statute and the Stark Law, as the commissions were tied to the number of devices implanted by the physician brother.Previously, the United States District Court for the Central District of California dismissed the complaint. The district court found that the action was barred by the False Claims Act’s public disclosure bar, reasoning that a New York Times article had already disclosed that the manufacturer used financial incentives to encourage physicians to use its devices. The district court concluded that the relator’s allegations were not materially different from what had already been publicly disclosed and denied the relator’s motion to amend the judgment.The United States Court of Appeals for the Ninth Circuit reviewed the case. The Ninth Circuit held that the public disclosure bar did not apply because the relator’s complaint provided genuinely new and material information not previously disclosed by the New York Times article or other public documents. The court found that the specific three-way compensation arrangement involving commissions to a physician’s family member was not substantially the same as the general financial incentives described in the article. The Ninth Circuit reversed the district court’s dismissal, vacated the denial of the motion to amend as moot, and remanded the case for further proceedings. View "SAM JONES COMPANY, LLC V. BIOTRONIK, INC." on Justia Law

Oregon enacted a law requiring prescription drug manufacturers to report detailed information about certain drugs, including pricing, costs, and factors contributing to price increases, to the state’s Department of Consumer and Business Services. The law also directs the agency to post most of this information online, but prohibits public disclosure of information designated as a trade secret unless the agency determines that disclosure is in the public interest. Since the law’s enactment, manufacturers have claimed thousands of trade secrets, but the agency has not publicly disclosed any such information.A trade association representing pharmaceutical manufacturers sued the director of the Oregon agency in the United States District Court for the District of Oregon, raising several facial constitutional challenges. The district court granted summary judgment for the association on two claims: that the reporting requirement violated the First Amendment by compelling speech, and that any use of the public-interest exception to disclose trade secrets would constitute an uncompensated taking under the Fifth Amendment. The court declared the entire reporting requirement unconstitutional and held that any disclosure of trade secrets under the public-interest exception would violate the Takings Clause unless just compensation was provided.The United States Court of Appeals for the Ninth Circuit reviewed the case. It reversed the district court’s summary judgment for the association on both the First and Fifth Amendment claims. The Ninth Circuit held that the reporting requirement compels commercial speech and survives intermediate scrutiny under the First Amendment, as it directly advances substantial state interests in transparency and market efficiency and is not more extensive than necessary. On the takings claim, the court found the association’s challenge justiciable but concluded that, under the Penn Central regulatory takings framework, none of the factors supported a facial claim that every disclosure under the public-interest exception would constitute a taking. The court remanded with instructions to enter summary judgment for the state on these claims. View "Pharmaceutical Research and Manufacturers of America v. Stolfi" on Justia Law

A pharmaceutical company developed a sublingual opioid painkiller, DSUVIA, which could only be administered in medically supervised settings due to safety concerns and was subject to a strict FDA Risk Evaluation and Mitigation Strategy (REMS). The company marketed DSUVIA with the slogan “Tongue and Done” at investor conferences, accompanied by additional disclosures about the drug’s limitations and REMS requirements. After the FDA issued a warning letter objecting to the slogan as potentially misleading under the Federal Food, Drug, and Cosmetic Act, several shareholders filed suit, alleging that the slogan misled investors about the complexity of administering DSUVIA and the drug’s limited market potential.The United States District Court for the Northern District of California dismissed the shareholders’ complaint, finding that the plaintiffs failed to adequately plead facts supporting a strong inference of scienter, but did not rule on whether the statements were false or misleading. The plaintiffs were given two opportunities to amend their complaint, but the court ultimately dismissed the case with prejudice.On appeal, the United States Court of Appeals for the Ninth Circuit reviewed the dismissal de novo. The Ninth Circuit held that the plaintiffs failed to adequately plead falsity because a reasonable investor would not interpret the “Tongue and Done” slogan in isolation, but would consider the context provided by accompanying disclosures and other available information. The court also held that the FDA’s warning letter did not establish falsity under securities law, as the standards and intended audiences differ. Additionally, the court found that the plaintiffs did not plead a strong inference of scienter, as the facts suggested the company’s officers acted in good faith. The Ninth Circuit affirmed the district court’s dismissal. View "Sneed v. Talphera, Inc." on Justia Law

Dionne Marie Nadon applied for disability insurance benefits and supplemental security income in April 2015 and May 2016, respectively, citing conditions such as fibromyalgia, spinal abnormalities, depression, and anxiety. The administrative law judge (ALJ) initially denied her applications in January 2017, finding she could return to her past work as a cashier/checker. On appeal, the case was remanded because the ALJ had not adequately addressed Nadon’s post-traumatic stress disorder (PTSD). On remand, the ALJ again determined that Nadon was not disabled, following the five-step sequential analysis for determining disabilities.The ALJ found that Nadon had engaged in substantial gainful activity as a personal care attendant from July 2021 through 2022 but continued the analysis due to a continuous period of at least twelve months during which Nadon did not engage in substantial gainful activity. The ALJ found that Nadon had severe impairments but did not have an impairment or combination of impairments that met or equaled the severity of a listed impairment. The ALJ determined that Nadon’s residual functional capacity allowed her to perform light work with certain limitations and found that she could perform her past relevant work as a personal care attendant and other work as a housekeeper, marker, or small products assembler.The district court affirmed the ALJ’s decision. The United States Court of Appeals for the Ninth Circuit reviewed the case de novo and affirmed the district court’s decision. The court held that the ALJ did not err by considering Nadon’s work as a personal care attendant, as an ALJ is permitted to consider any work done by a claimant when evaluating a disability claim. The court also found that the ALJ provided several reasons for discounting Nadon’s testimony and the opinions of several healthcare professionals, beyond her work as a personal care attendant. The court rejected Nadon’s argument that the ALJ erred by relying on the vocational expert’s testimony, as it relied on the rejected premise that the ALJ erred in discounting the healthcare professionals’ opinions. View "Nadon v. Bisignano" on Justia Law

Mark Schena operated Arrayit, a medical testing laboratory in Northern California, which focused on blood tests for allergies. Schena marketed these tests as superior to skin tests, despite their limitations, and billed insurance providers up to $10,000 per test. To maintain a steady flow of patient samples, Schena paid marketers a percentage of the revenue they generated by pitching Arrayit’s services to medical professionals, often misleading them about the tests' efficacy. During the COVID-19 pandemic, Schena transitioned to COVID testing, using similar deceptive marketing practices to bundle allergy tests with COVID tests.The United States District Court for the Northern District of California denied Schena’s motion to dismiss the EKRA counts, arguing that his conduct did not violate the statute as a matter of law. The jury convicted Schena on all counts, including conspiracy to commit healthcare fraud, healthcare fraud, conspiracy to violate EKRA, EKRA violations, and securities fraud. The district court sentenced Schena to 96 months in prison and ordered him to pay over $24 million in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed Schena’s convictions. The court held that 18 U.S.C. § 220(a)(2)(A) of EKRA covers payments to marketing intermediaries who interface with those who do the referrals, and there is no requirement that the payments be made to a person who interfaces directly with patients. The court also concluded that a percentage-based compensation structure for marketing agents does not violate EKRA per se, but the evidence showed wrongful inducement when Schena paid marketers to unduly influence doctors’ referrals through false or fraudulent representations. The court affirmed Schena’s EKRA and other convictions, vacated in part the restitution order, and remanded in part. View "United States v. Schena" on Justia Law