Justia Health Law Opinion Summaries

During the COVID-19 pandemic, Twitter broadened its definition of censorable, harmful information to include “content that goes directly against guidance from authoritative sources of global and local public health information.” Twitter began permanently suspending any user who received five or more infractions for violating its COVID-19 policy. The plaintiffs,Twitter users who used their accounts to question responses to the COVID-19 pandemic, suffered multiple temporary suspensions. They claim the Biden administration became involved, announcing that “[t]he President’s view is that the major [social-media] platforms have a responsibility ... to stop amplifying untrustworthy content, disinformation, and misinformation, especially related to COVID-19 vaccinations.” Later, the Surgeon General released an advisory statement related to COVID-19 misinformation and (according to Plaintiffs) “command[ed] technology platforms” to take several steps. President Biden stated that social media platforms are “killing people” with COVID-19 misinformation. Days later, USA Today reported that the “[t]he White House is assessing whether social media platforms are legally liable for misinformation.”Plaintiffs sued the Department of Health and Human Services (HHS), asserting claims under the First Amendment, Fourth Amendment, and Administrative Procedure Act, citing HHS’s unlawful efforts to “instrumentalize[] Twitter” to “silenc[e] opinions that diverge from the White House’s messaging on COVID-19.” The Sixth Circuit affirmed the dismissal of the complaint. The plaintiffs have not adequately pleaded that HHS compelled Twitter’s chosen course of conduct, leaving a “highly attenuated chain of possibilities” that is too speculative to establish a traceable harm View "Changizi v. Department of Health and Human Services" on Justia Law

Waters was born with homocystinuria and diagnosed with that condition at the age of six. Homocystinuria is a genetic attribute that causes metabolic issues that prevent Waters’s liver from metabolizing methionine, an amino acid, that produces L-cysteine, another amino acid. Her physician prescribed HCU coolers–a medical food containing a methionine-free protein formula. Waters ingests HCU coolers orally; she has a fully functioning gastrointestinal tract. Waters sought reimbursement for HCU coolers purchased during 2018-2019, under the prosthetic-device benefit of Medicare Part B, 42 U.S.C. 1395k(a)(2)(I); 1395x(s)(8). The National Coverage Determinations Manual explains that, as part of the prosthetic-device benefit, enteral nutrition is considered reasonable and necessary when a patient “cannot maintain weight and strength commensurate with his” “general condition” because food does not reach the digestive tract and specifies that “[e]nteral therapy may be given by nasogastric [nose], jejunostomy [small intestine], or gastrostomy [stomach] tubes.” The NCD acknowledges “[s]ome patients require supplementation of their daily protein and caloric intake,” but “[n]utritional supplementation is not covered under Medicare Part B.”The Sixth Circuit affirmed several levels of denial of Waters’s claim, acknowledging the difficult circumstances of Waters and her family. An HCU cooler is not a stand-alone prosthetic device based on the plain meaning of prosthetic “device” and because an HCU cooler is a medical food according to the FDA. View "Waters v. Becerra" on Justia Law

The district court preliminarily enjoined Kentucky’s ban on sex-transition care for minors. The court later stayed its injunction in light of a recent Sixth Circuit decision in which the court balanced the likelihood of success on the merits, irreparable harm, the balance of harms, and the public interest and held that those factors favored allowing Tennessee to enforce its law. Kentucky bans the same conduct as in that case; the plaintiffs bring the same Equal Protection and Due Process claims that the Sixth Circuit held were unlikely to succeed. The Sixth Circuit declined to lift the stay. As a sovereign state, Kentucky has an interest in creating and enforcing its own laws. The people of Kentucky enacted the ban through their legislature. View "Doe v. Thornbury" on Justia Law

Tennessee enacted the Prohibition on Medical Procedures Performed on Minors Related to Sexual Identity, citing concerns that gender dysphoria treatments “can lead to the minor becoming irreversibly sterile, having increased risk of disease and illness, or suffering adverse and sometimes fatal psychological consequences” while less risky, non-irreversible treatments remain available. Prohibited procedures include surgically removing, modifying, or entering into tissues, cavities, or organs and prescribing or dispensing any puberty blocker or hormone with exceptions for treating congenital defects, precocious puberty, disease, physical injury, and continuation of ongoing treatment. It provides for professional discipline of healthcare providers and creates a private right of action.The district court entered a preliminary injunction, finding that the challengers lacked standing to contest the surgery ban but that the ban on hormones and puberty blockers infringes the parents’ “fundamental right” to direct their children’s medical care, improperly discriminates on the basis of sex, that transgender persons constitute a quasi-suspect class, and that the state could not satisfy the necessary justifications.The Sixth Circuit stayed the injunction, finding that Tennessee is likely to succeed on appeal. The district court erred in its facial invalidation of the law, as opposed to an as-applied invalidation. “Life-tenured federal judges should be wary of removing a vexing and novel topic of medical debate from the ebbs and flows of democracy by construing a largely unamendable federal constitution to occupy the field.” A right to new medical treatments is not “deeply rooted" in history and traditions. Tennessee could rationally exercise caution before permitting irreversible medical treatments of children. View "L. W. v. Skrmetti" on Justia Law

The False Claims Act imposes civil liability for “knowingly present[ing], or caus[ing] to be presented, a false or fraudulent claim [to the government] for payment or approval,” 31 U.S.C. 3729(a)(1)(A). Individuals with knowledge of false claims may bring private qui tam lawsuits, on behalf of the government. The Act covers claims resulting from a violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(g), which prohibits medical providers from making referrals “in return for” “remuneration.”Oaklawn Hospital is in Marshall, Michigan, which had two ophthalmologists. Oaklawn extended one of those doctors (Martin) a tentative offer to work at the hospital after hearing that the other doctor (Hathaway) planned to move his surgeries elsewhere. Hathaway told the hospital’s CEO that he wanted to continue working with Oaklawn and that Oaklawn hiring Martin would be the “death knell” of his practice. Oaklawn’s Board ultimately did not hire Martin.Martin filed a qui tam action, alleging an illegal fraudulent scheme under the Anti-Kickback Statute and that claims for Medicare and Medicaid reimbursement resulting from the kickbacks violated the False Claims Act. The Sixth Circuit affirmed the dismissal of the suit, which essentially argued that Oaklawn’s rejection of Martin’s employment in return for Hathaway’s commitment to continue sending surgery referrals violated the Anti-Kickback Statute. The Martins have not plausibly alleged causation; the alleged scheme did not change anything. When Oaklawn decided not to establish an internal ophthalmology line, it simply left things where they were. View "Martin v. Hathaway" on Justia Law

Smucker’s is a federal contractor that supplies food items to the federal government. In 2021, by Executive Order, President Biden directed all federal contractors to “ensure that all [their] employees [were] fully vaccinated for COVID-19,” unless such employees were “legally entitled” to health or religious accommodations. The order made contractors “responsible for considering, and dispositioning, such requests for accommodations.” In September 2021, Smucker’s notified its U.S. employees that it would “ask and expect” them to “be fully vaccinated.” A month later, in the face of “deadlines in the federal order,” Smucker’s announced a formal vaccine mandate with exemptions based on “sincerely held religious beliefs.”The plaintiffs unsuccessfully sought religious exemptions, then sued Smucker's under the First Amendment's free-exercise guarantee. The Sixth Circuit affirmed the dismissal of the suit. When Smucker’s denied the exemption requests, it was not a state actor. Smucker’s does not perform a traditional, exclusive public function; it has not acted jointly with the government or entwined itself with it; and the government did not compel it to deny anyone an exemption. That Smucker’s acted in compliance with federal law and that Smucker’s served as a federal contractor, do not by themselves make the company a government actor. View "Ciraci v. J.M. Smucker Co." on Justia Law

In May 2020, Koballa died of COVID-19. Hudak, the executrix of Koballa’s estate, sued, asserting negligence and related state-law claims against Elmcroft, an assisted-living facility. Elmcroft removed the case to federal court under the general removal statute, 28 U.S.C. 1441(a), and the federal-officer removal statute, 28 U.S.C. 1442(a)(1), based on arguments it made under the Public Readiness and Emergency Preparedness Act (PREP), 42 U.S.C. 247d-6d.The district court found that the PREP Act did not provide grounds for removal under either removal statute and remanded the case to state court for lack of subject-matter jurisdiction. The Sixth Circuit affirmed. Hudak does not allege that Elmcroft engaged in willful misconduct in the administration or use of a covered COVID-19 countermeasure, so the PREP Act does not “provide[] the exclusive cause of action for the claims” and does not completely preempt Hudak’s state-law claims. Hudak’s state-law claims do not arise under federal law and could not be removed. Elmcroft is not a "federal officer"; it operated a facility that came under significant federal regulation as part of the federal government’s COVID-19 response but did not have an agreement with the federal government, did not produce a good or perform a service on behalf of the government, and has not shown that the federal government exercised control over its operations to such a degree that the government acted as Elmcroft’s superior. View "Hudak v. Elmcroft of Sagamore Hills" on Justia Law

Lawsuits brought by governmental bodies and health clinics alleged that Quest, a wholesale pharmaceutical distributor, engaged in misconduct that contributed to a nationwide epidemic of opioid abuse. The plaintiffs plead violations of the RICO Act and state statutes, common law public nuisance, and negligence, seeking damages for “significant expenses for police, emergency, health, prosecution, corrections, rehabilitation, and other services.” Some complaints clarify that the claims “are not based upon or derivative of the rights of others” and that the plaintiffs “do not seek damages for death, physical injury to person, emotional distress, or physical damages to property[.]”Quest's insurance policies covered "damages because of 'bodily injury' or 'property damage'" and explain that “[d]amages because of ‘bodily injury’ include damages claimed by any person or organization for care, loss of services or death resulting at any time from the ‘bodily injury.’” “Bodily injury” is defined as “bodily injury, sickness or disease sustained by a person, including death resulting from any of these at any time.”The insurers sought declaratory judgments that they had no duty to defend or indemnify Quest. The district court granted the insurers summary judgment. The Sixth Circuit affirmed. Based on the plain language of the policies and their overall context and purpose, the court concluded that the Kentucky Supreme Court would find that the insurers have no duty to defend because the lawsuits do not seek damages “because of bodily injury” and claim only economic damages. View "Westfield National Insurance Co. v. Quest Pharmaceuticals, Inc." on Justia Law

The 1949 Federal Property and Administrative Services Act concerns the purchase of goods and services on behalf of the federal government, 40 U.S.C. 101. In November 2021, the Safer Federal Workforce Task Force, citing the Act, issued a “Guidance” mandating that employees of federal contractors in covered contracts with the federal government become fully vaccinated against COVID-19. Ohio, Kentucky, and Tennessee and Ohio sheriffs’ offices challenged the mandate. The district court enjoined its enforcement in the three states and denied the government’s request to stay the injunction pending appeal.The Sixth Circuit denied relief in January 2022 and, a year later, affirmed. The Property Act does not authorize the President to issue directives that simply “improve the efficiency of contractors and subcontractors.” The plaintiffs are likely to succeed in showing that the President exceeded his authority in issuing the mandate. The plaintiffs are likely to lose valuable government contracts and incur unrecoverable compliance costs if the mandate is not enjoined. The public interest “lies in a correct application” of the law. Because an injunction limited to the parties can adequately protect the plaintiffs’ interests while the case is pending, the district court abused its discretion in extending the preliminary injunction’s protection to non-party contractors in the plaintiff states. View "Commonwealth of Kentucky v. Biden" on Justia Law

The Air Force ordered over 500,000 service members to get COVID-19 vaccinations. About 10,000 members requested religious exemptions; about 135 of these requests were granted, only to those planning to leave the service. It has granted thousands of exemptions for medical or administrative reasons. The Plaintiffs allege that the vaccine mandate substantially burdens their religious exercise in violation of the First Amendment and the Religious Freedom Restoration Act (RFRA). The district court granted a preliminary injunction that barred the Air Force from disciplining the Plaintiffs for failing to take a vaccine, then certified a class of thousands of similar service members and extended this injunction to the class.The Sixth Circuit affirmed. In opposing class-action certification, the Air Force argued that RFRA adopts an individual-by-individual approach: it must show that it has a compelling interest in requiring a “specific” individual to get vaccinated based on that person’s specific duties. In challenging the injunction, however, the Air Force failed to identify the specific duties or working conditions of any Plaintiff, citing the “general interests” underlying the mandate. The court reasoned that it could uphold the injunction based on RFRA alone but also noted common questions for the class: Does the Air Force have a uniform policy of relying on its generalized interests in the vaccine mandate to deny religious exemptions regardless of individual circumstances? Does it have a discriminatory policy of broadly denying religious exemptions but broadly granting secular ones? View "Doster v. Kendall" on Justia Law