Justia Health Law Opinion Summaries

The 1949 Federal Property and Administrative Services Act is intended to facilitate the “economical and efficient” 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, under the supposed auspices of the Act, issued a “Guidance” mandating that employees of federal contractors in “covered contract[s]” with the federal government become fully vaccinated against COVID-19. Ohio, Kentucky, and Tennessee and Ohio sheriffs’ offices sued, alleging that the Property Act does not authorize the mandate, that the mandate violates other federal statutes, and that its intrusion upon traditional state prerogatives raises federalism and Tenth Amendment concerns.The district court enjoined enforcement of the mandate throughout the three states and denied the federal government’s request to stay the injunction pending appeal. The Sixth Circuit denied relief. The government has established none of the showings required to obtain a stay. The government is unlikely to succeed on claims that the plaintiffs lack standing and the plaintiffs likely have a cause of action under the Administrative Procedure Act. The court noted the plaintiff’s concerns about disruptions to the supply chain if workers leave their jobs rather than receiving vaccinations and also stated: Given that expansive scope of the Guidance, the interpretive trouble is not figuring out who’s “covered”; the difficult issue is understanding who, based on the Guidance’s definition of “covered,” could possibly not be covered. View "Commonwealth of Kentucky v. Biden" on Justia Law

In November 2021, 5he Occupational Safety and Health Administration (OSHA), the federal agency tasked with assuring a safe and healthful workplace, issued an Emergency Rule on COVID-19 Vaccination and Testing, 86 Fed. Reg. 61402. The rule does not require anyone to be vaccinated but allows covered employers—employers with 100 or more employees—to determine for themselves how best to minimize the risk of contracting COVID-19 in their workplaces. Employers may require unvaccinated workers to wear a mask on the job and test for COVID-19 weekly; they can require workers to do their jobs exclusively from home. Workers who work exclusively outdoors are exempt. The next day, the Fifth Circuit stayed the rule pending judicial review; it renewed that decision in an opinion issued on November 12. Under 28 U.S.C. 2112(a)(3), petitions challenging the rule, filed in Circuits across the nation, were consolidated into the Sixth Circuit, which dissolved the stay issued by the Fifth Circuit. The language of its enabling act plainly authorizes OSHA to act on its charge “to assure safe and healthful working conditions for the nation’s workforce and to preserve the nation’s human resources.” OSHA’s issuance of the rule is not a transformative expansion of its regulatory power, The factors regarding irreparable injury weigh in favor of the government and the public interest. View "In re: MCP No. 165, Occupational Safety and Health Admin., Interim Final Rule: COVID19 Vaccination and Testing, 86 Fed. Reg. 61402" 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

Owsley. a nurse for Care Connection, a company providing home healthcare to Medicare patients, alleged that she observed, firsthand, documents showing that her employer had used fraudulent data from Fazzi to submit inflated claims for payment to the federal and Indiana state governments. She sued both companies under the False Claims Act, 31 U.S.C. 3729(a)(1)(A), (B), (C), (G), and an Indiana statute.The Sixth Circuit affirmed the dismissal of the suit. Owsley’s complaint provided few details that would allow the defendants to identify any specific claims—of the hundreds or likely thousands they presumably submitted—that she thinks were fraudulent, and did not meet the requirements of Civil Rule 9(b). While Owsley’s allegations describe, in detail, a fraudulent scheme: Fazzi fraudulently upcoded patient data, which Care then used to submit inflated requests for anticipated Medicare payments, that information does not amount to an allegation of “particular identified claims” submitted pursuant to the fraudulent scheme. View "Owsley v. Fazzi Associates., Inc." on Justia Law

Western Michigan University, a public university, requires student-athletes to be vaccinated against COVID-19 but considers individual requests for medical and religious exemptions on a discretionary basis. Sixteen student-athletes applied for religious exemptions. The University ignored or denied their requests and barred them from participating in any team activities. The student-athletes sued, alleging that University officials violated their free exercise rights.The district court preliminarily enjoined the officials from enforcing the vaccine mandate against the plaintiffs. The Sixth Circuit declined to stay the injunction and proceedings in the district court pending appeal. The court called the issue “a close call” but concluded the free exercise challenge will likely succeed on appeal. The University’s vaccine mandate does not coerce a non-athlete to get vaccinated against her faith because she, as a non-athlete, cannot play intercollegiate sports either way. The mandate does penalize a student otherwise qualified for intercollegiate sports by withholding the benefit of playing on the team should she refuse to violate her sincerely held religious beliefs. The court applied strict scrutiny and reasoned that the University did not establish a compelling interest in denying an exception to the plaintiffs or that its conduct was narrowly tailored to achieve that interest. View "Dahl v. Board of Trustees of Western Michigan University" on Justia Law

A drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the drug’s official label, 21 U.S.C. 355(a). The Act does not prohibit doctors from prescribing FDA-approved drugs for “off-label” use but leaves the regulation of doctors to the states. Hydroxychloroquine is approved to treat malaria, lupus, and arthritis but not to treat COVID-19. In 2020, the FDA relied on then-available data and issued an Emergency Use Authorization, permitting hydroxychloroquine in the federal government’s strategic stockpile to be distributed to treat COVID-19 patients in limited circumstances.The Association, a nonprofit organization with physician members, sued, challenging restrictions barring use of hydroxychloroquine to treat COVID-19 except for hospitalized patients. The Association alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment; violated the First Amendment right to associate by limiting access to medication useful for meeting in groups; and violated the Administrative Procedure Act. The Association alleged an injury to itself: it was considering canceling a conference purportedly due to the restrictions. It also invoked associational standing on behalf of its physician members who could not prescribe hydroxychloroquine for COVID-19.The district court held that none of these injuries plausibly pleaded the Association’s standing to challenge the Authorization. The court dismissed the complaint for lack of subject matter jurisdiction. The Sixth Circuit affirmed. The Associaiton failed to plausibly plead that any member has been injured by the FDA’s actions. View "Association of American Physicians & Surgeons v. United States Food & Drug Administration" on Justia Law

The Sixth Circuit previously affirmed the Federal Trade Commission’s decision to block a merger of ProMedica and St. Luke’s Hospital in Lucas County, Ohio. As part of the unwinding of the merger, ProMedica and St. Luke’s signed an agreement in which ProMedica’s insurance subsidiary, Paramount, agreed to maintain St. Luke’s as a within-network provider; Paramount could drop St. Luke’s if ownership of the hospital changed. A large healthcare company based in Michigan, McLaren, subsequently merged with St. Luke’s. Paramount ended its relationship with St. Luke’s, removing the hospital from its provider network. St. Luke’s then alleged that ProMedica’s refusal to do business with it violated the antitrust laws. The district court preliminarily enjoined ProMedica from ending the agreement. The Sixth Circuit vacated. Because ProMedica had a legitimate business explanation for ending the relationship, St. Luke’s is unlikely to show that ProMedica unlawfully refused to continue doing business with it. St. Luke’s has little likelihood of establishing an irreparable injury given the option of money damages. View "St. Luke's Hospital v. ProMedica Health System, Inc." on Justia Law

Tennessee Code 39-15-202(a)–(h) requires that women be informed, orally and in-person by the attending physician or by the referring physician that she is pregnant; of the fetus’s probable gestational age; whether the fetus may be viable; of services “available to assist her”; and of “reasonably foreseeable medical benefits, risks, or both of undergoing an abortion or continuing the pregnancy.” There is a 48-hour waiting period, beginning when the woman receives the mandated information, which can be reduced to 24 hours by court order.The district court declared the waiting period unconstitutional and permanently enjoined its enforcement. The Sixth Circuit denied a stay pending appeal but subsequently, “en banc,” reversed. The facial attack fails as a matter of law. Given Tennessee’s strong “interest in protecting the life of the unborn,” there was a rational basis to enact a waiting period, which is not a substantial obstacle to abortion in a large fraction of cases. The plaintiffs claimed that the law—even if facially valid— is unconstitutional as applied to women who will miss the cutoff date for an abortion because of the waiting period; women whose medical conditions increase the risk of delaying the procedure; and women who are survivors of rape, incest, or violence. But, although the law has been in effect for five years, the plaintiffs failed to identify any “discrete and well-defined instances” where women in these groups faced (or were likely to face) a particular burden because of Tennessee’s waiting period. View "Bristol Regional Women's Center, P.C. v. Slatery" on Justia Law

Rite Aid’s “Rx Savings Program” provides generic prescription drugs at reduced prices. The program is free and widely available but excludes customers whose prescriptions are paid by publicly funded healthcare programs like Medicare or Medicaid. Federal regulations require pharmacies to dispense prescriptions for beneficiaries of those programs at their “usual and customary charge to the general public” (U&C rate). Rahimi alleged that Rite Aid overbilled the government programs because the amounts it charged did not take into account the lower Rx Savings Program prices. Rahimi claimed Rite Aid's submission of bills for those covered by publicly funded health insurance, representing the price to be the U&C rate, violated the False Claims Act, 31 U.S.C. 3729(a).The Sixth Circuit affirmed the dismissal of Rahimi’s claim. The Act’s public disclosure bar precludes qui tam actions that merely feed off prior public disclosures of fraud. From the beginning, communications about the Rx Savings Program have stated that publicly funded health care programs were ineligible for the discounted prices. Before Rahimi’s disclosures, Connecticut investigated membership discount prices; the Department of Health and Human Services announced that it would review Medicaid claims for generic drugs to determine the extent to which large chain pharmacies are billing Medicaid the usual and customary charges for drugs provided under their retail discount generic programs; and a qui tam action was unsealed in California, describing an identical scheme. View "Rahimi v. Rite Aid Corp." on Justia Law

The plaintiffs retired from the Louisville Metropolitan police department and received free health insurance, administered by Kentucky Retirement Systems. Kentucky initially paid all of their healthcare costs. After the officers turned 65, Medicare became the primary payer, leaving Kentucky to cover secondary expenses. Each officer came out of retirement, joining county agencies different from the ones they served before retiring. They became eligible for healthcare benefits in their new positions. Kentucky notified them that federal law “mandate[d]” that it “cannot offer coverage secondary to Medicare” for retirees “eligible to be on [their] employer’s group health plan” as “active employees.” Some of the officers then paid for insurance through their new employers; others kept their retirement insurance by quitting or going part-time. The officers sued.The district court granted summary judgment to the officers, ordered Kentucky to reinstate their retirement health insurance, and awarded the officers some of the monetary damages requested. The Sixth Circuit affirmed. The officers have a cognizable breach-of-contract claim. Under Kentucky law, the Kentucky Retirement Systems formed an “inviolable contract” with the officers to provide free retirement health insurance and to refrain from reducing their benefits, then breached that contract. The Medicare Secondary Payer Act of 1980 did not bar Kentucky from providing Medicare-eligible police officers with state retirement insurance after they reentered the workforce and became eligible again for employer-based insurance coverage, 42 U.S.C. 1395y. View "River City Fraternal Order of Police v. Kentucky Retirement Systems" on Justia Law