Melbourne, Australia - 1st November 2021: A person wearing full PPE holds a vial of sotrovimab medicine covid-19 virus treatment. It is under an emergency use authorization to treat covid in Australia.

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

By James Lytle

Recent guidance from the U.S. Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2.

The guidance proved to be highly controversial, prompting two states, Utah and Minnesota, to withdraw their guidance, and leading a third state, New York, to become the subject of two federal lawsuits that challenge the guidance’s legality: one (Jacobson v. Bassett) brought by a white, non-Hispanic Cornell Law Professor, William Jacobson, in the Northern District of New York (“Jacobson”) and a second (Roberts v. Bassett) initiated by Jonathan Roberts and Charles Vavruska, two white, non-Hispanic residents of New York City in the Eastern District (“Roberts”).

Public health and policy experts have published commentaries on the challenging issues underlying New York’s COVID treatment guidelines and others have offered more detailed guidance, including on this blog, on what criteria should be used in allocating scarce COVID treatments. What follows is focused on the litigation pending in New York and its potential impact on the broader issues at the intersection of the pandemic response and racial equity.

New York’s Policy

In a December 27, 2021 memorandum titled “Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies and Oral Antivirals for the Treatment of COVID-19 During Times of Resource Limitations,” the New York State Department of Health advised health care providers and facilities to allocate oral antiviral medications and monoclonal antibodies to the patients at greatest risk of severe illness from COVID, referencing a long list of CDC-identified medical conditions as risk factors, including cancer, diabetes, and a host of other conditions. The policy noted, as well, that “non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.”

The New York policy, perhaps predictably, prompted a strong reaction, particularly within conservative media, and even inspired one commentator to conclude that “If you’re white and middle class, the push for health-care ‘equity’ could kill you.” Within a few weeks after the New York guidelines were issued, the federal lawsuits commenced.

The Lawsuits

In his class action complaint, on behalf of himself and other white, non-Hispanic individuals in New York State, Jacobson contends that the New York guidelines render “non-Hispanic white individuals who test positive for COVID-19 . . . ineligible for oral antiviral treatments unless they also demonstrate ‘a medical condition or other factors that increase their risk for severe illness,” while making “similarly situated ‘non-white’ or ‘Hispanic/Latino’ individuals . . . automatically eligible for these life-saving antiviral treatments—regardless of the individual’s medical situation.” (Emphasis in original.) The complaint asserts that non-Hispanic white people are being subjected to “an increased risk of serious illness or death when they acquire COVID-19” and that the policy inflicts “emotional and psychological harm on Plaintiff (and others) who are facing increased risk of harm from the pandemic on account of New York’s racially discriminatory policies.”

Similarly, the Roberts complaint challenges the guidelines’ use of race and ethnicity as an independent risk factor in prioritizing COVID treatments, asserting that “an unvaccinated 64-year-old African American with diabetes receives priority over an unvaccinated white 64-year-old with diabetes” and that “[a] vaccinated 66-year-old who is Hispanic receives priority over a vaccinated 66-year-old who is not.” The complaint claims that “New York’s designation of race as an independent risk factor deprives deserving individuals of much-needed medical treatments solely due to their race” and that “a white, non-Hispanic person with cancer is treated the same as a non-white or a Hispanic person who is disease-free.”

Both complaints allege that the guidelines violate the 14th Amendment guarantee of “equal protection of the laws.” In addition, Jacobson contends that the guidelines violate Title VI of the Civil Rights Act of 1964 (42 U.S.C. § 2000d), which prohibits discrimination on the grounds of race, color or national origin in any program that receives federal funds, and section 1557 of the Affordable Care Act (42 USC § 18116), which contains a similar nondiscrimination provision. Jacobson requests class action certification, declaratory relief, and “a preliminary and permanent injunction that restrains Acting Commissioner Bassett and her successors from implementing and enforcing any discriminatory racial preferences in the Department’s programs.” The Roberts complaint seeks a declaratory judgment that the guidelines are unconstitutional and a preliminary injunction prohibiting the use of race in determining priority for these treatments.

The State Responds

In State Health Commissioner Mary T. Bassett’s public statements on these issues, she took issue with the litigants’ characterization of the disputed policy. In response to questions from Assemblyman Colin Schmitt at a budget hearing, Dr. Bassett emphasized that that no rationing of the COVID treatment proved to be necessary since the State had “adequate stocks” of the monoclonal antibodies and that, in any case, she “wouldn’t ever support using race as a basis for treatment.” In the end, she emphasized, “nothing ever takes the place of a clinician’s judgment” in determining what treatment to recommend.

In an affidavit in response to the Jacobson complaint, the Department of Health’s First Deputy Commissioner, Dr. Eugene Heslin, stressed that the challenged memorandum was merely “guidance” and not a treatment policy, denied that there was any actual “scoring system” that would dictate whether a particular patient would get the medication, and emphasized that race and ethnicity were included among many other risk factors that would be considered in making these treatments available. In addition, Dr. Heslin asserted that the guidance was issued “at a time when oral antiviral treatments were anticipated to be in short supply,” but noted that “there is currently no shortage of the medications in New York.”

In support of the merits of considering race and ethnicity, among other factors that may warrant access to these medications, Dr. Heslin cited CDC data that showed that, compared to non-Hispanic whites, Black people were 2.5 times more likely to be hospitalized and 1.7 times more likely to die from COVID-19 and that Hispanic people were 2.4 times more likely to be hospitalized and 1.9 times more likely to die. In addition, a January 21, 2022 MMWR report concluded that Black patients with COVID-19 were 22.4% less likely to receive monoclonal antibodies than white patients, while Hispanic COVID-19 patients were 57.7% less likely to receive the treatment than whites.

The underlying policy also won support from prominent medical, public health, and social science experts, who filed an amicus brief in the Jacobson case to urge its dismissal. The amici — including the American Medical Association, the American Public Health Association, the American College of Physicians, the Medical Society of the State of New York, and a host of other organizations — contend that “there is no serious medical or public health dispute that longstanding systemic health and social factors have led to a disproportionately higher burden of COVID-19,” including disproportionately higher rates of serious illness, complications and death. These outcomes were, the amici argued, compounded by “social drivers of health” such as racially segregated housing, lower access to health care services, adverse working conditions, homelessness, and racism. Given these social inequities, “considering a patient’s BIPOC race or ethnicity in evaluating their risk of severe progression is justified.”

Threshold Issues

While all parties and the amici seem prepared for a robust debate on the merits of the guidelines, the outcomes of these cases may have more to do with one or more threshold issues, including mootness and standing. The Department of Health’s briefs contend that the Plaintiff’s claims are moot because, unexpectedly, a shortage of these COVID treatments has not yet materialized and, therefore, the Department foresaw no need “to provide guidance in the extreme situation of an antiviral therapy shortage.”

Moreover, the Department’s briefs are even more pointed in their characterization of the lack of standing by these plaintiffs to challenge the guidelines. In the Northern District complaint, Jacobson characterized himself as being “especially at risk for contracting COVID-19 because he teaches at Cornell University, which recently had a severe outbreak despite its extensive COVID protocols.” Taking aim at whether this is sufficient to allow the opportunity to seek legal redress, the Department’s brief counters:

Plaintiff does not have COVID-19 and may never contract it. If he does contract it, his physician may or may not deem Plaintiff’s medical condition suitable for antiviral therapy. If his physician does deem Plaintiff’s condition to be warranted, based upon a full review of his medical history and a discussion of any possible contraindications, Plaintiff may or may not be eligible for the therapy for reasons unrelated to his race. If he is eligible, there is no shortage of antiviral therapies such that the Guidance would be invoked. If there was a shortage, a physician’s medical judgment may or may not result in plaintiff receiving the therapy. There is no automatic qualifier/disqualifier for the antiviral therapy and whether or not Plaintiff will ever be given the therapy will be in accordance with his health care provider’s medical judgment.

The State’s response to the Eastern District complaint was even more succinct: “Plaintiffs, who self-identify as white, non-Hispanic individuals under the age of 65, do not allege that they have COVID-19; that they have ever sought the Therapies to treat COVID-19; or that they have ever been denied treatment with the Therapies due to their race or ethnicity, or for any reason.”

Looking Ahead

At least as of now, it would appear that the standing arguments may prove to be dispositive. On March 15th, District Court Judge Nicholas Garaufis dismissed the Roberts complaint based on the plaintiffs’ failure to establish standing to challenge the guidelines. The Roberts plaintiffs filed a notice of appeal. While no decision has yet been reached in Jacobson, the plaintiffs’ attorneys were sufficiently worried about a similar ruling that they wrote a letter on March 17th to Northern District Judge Mae D’Agostino, urging her to conclude that the Roberts decision “is not persuasive” on the standing question.

Regardless of the ultimate outcome of these cases, if health care policymakers continue to wrestle with the longstanding and systemic racial and ethnic disparities in the American health care system, we can expect that there will be legal challenges to the steps taken to address disparities. In fact, the reactions to COVID-19 therapy allocation policies have drawn comparison to the long history of debate over affirmative action in higher education, a matter that will again be before the Supreme Court during its next term. To whatever extent race and ethnicity are explicitly considered in the allocation of resources, a fierce legal and political debate is almost certain to ensue.

James W. Lytle

Jim Lytle is Senior Counsel in the Albany and Boston offices of Manatt, Phelps & Phillips LLP, a national law and consulting firm. He is also currently a Senior Fellow with the Advanced Leadership Initiative at Harvard University and an adjunct professor at New York University Law School. He has provided health law and governmental relations representation to a broad array of clients in the fields of healthcare and human services, education and cultural affairs, insurance, biomedical research, and economic development. He has been recognized by Chambers USA as a Leading Lawyer since 2011 and was included in Best Lawyers in America since 2013, where he was named Best Lawyer of the Year in Albany for Health Law in 2017 and for Government Relations Law in 2017 and 2020. He served as Assistant Counsel for Health and Human Services for Governor Mario M. Cuomo, was the founding director of the Volunteer Legal Services Project in Rochester, NY and began his legal career as an Assistant District Attorney in Manhattan. He graduated from Princeton University in 1974 and received his JD from Harvard Law School in 1978, where he was the Director of the Harvard Legislative Research Bureau. He is a former Chair of the Health Law Section of the New York State Bar Association, the co-President of the Hermann Biggs Society and is a board member of the Schuyler Center for Analysis and Advocacy and of DonateLife New York.

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