In re FDA Blood Donation Guidance and Related Regulations
Assorted Homosexuals of Sierra v. United States Food and Drug Administration
Case № 20–02 101 M.S.Ct. 115
Bsddc, J., delivered the unanimous opinion of the Court.
I. Introduction
In our Declaration of Independence we resolved that “all men” are created equal, but meant only some men. A civil war and a century later, we amended our Constitution to promise that “all persons” shall be treated equally before the law. But, again, we meant only some people. Here’s the truth: this country permitted racial segregation to persist well into the 1900’s. And it was not until 1976 that this Supreme Court discovered the term “persons,” surprising to some, included women too.
Regardless of those many missteps and delays, we’ve aspired towards greater equality under the law. Today we are asked to give renewed meaning to that promise of equal protection. We must determine whether the FDA has impermissibly violated the Constitution by requiring men who have sex with men to wait 12 months before donating blood.
21 C.F.R Part 630 establishes federal requirements for determining the eligibility of blood donors. To give effect to this regulation, the FDA issues guidance documents to provide standards to blood manufacturers as defined under the regulation. See, e.g., FDA, Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Productions — Questions and Answers (content current as of February 2, 2018).
Petitioners challenge these non-binding guidance documents as a violation of the Equal Protection Clause. Under the most recent guidance, the FDA recommends deferral of any man who has had sex with another man in the previous year. Id. According to Petitioners, this discrimination is given effect by the FDA eligibility requirements. That discrimination should be subject to strict scrutiny as classifications based on sexual orientation should be suspect under the Equal Protection Clause, Petitioners argue. Pets’ Br.
Petitioners then challenge the tailoring of the guidance. They insist that 12 months is far too long for a reasonable, non-biased deferral period. Id. Further, other actions or groups with higher rates of HIV infection go unregulated. The guidance cannot withstand this overinclusivity and underinclusivity according to Petitioners.
In response, the United States contends that suspect classification should not apply in this case. Resp’s Final Reply Br. The goal of the guidance, according to the government, is to address the higher instances of HIV infection that occur because of male-to-male sexual conduct. Id.; see FDA, Revised Recommendations, supra. The United States, in effect, contends that the FDA’s guidance is not motivated by animus towards gay people, but instead targets the specific action of having male-to-male sexual contact. Resp’s Final Reply Br.
The government therefore avers that rational basis review should apply, not heightened scrutiny. And the guidance survives under rational basis review because it is reasonably calculated to achieve a valid government interest. Id.
We must address two issues to resolve this dispute. First, we must determine what level of scrutiny applies to the guidance. Second, we must evaluate the guidance in light of that standard.[1]
II. The Equal Protection Clause
The first issue before the Court is whether a classification based on sexual orientation justifies heightened scrutiny under the Equal Protection Clause, and if so, what standard of review applies to those classifications?
A. History of the Equal Protection Clause
In 1861, the Civil War tore the United States apart as a great battle was fought over the nation’s soul. At stake was whether the moral stain of slavery could endure in a country founded on the premise that all are created equally. Liberty won the battle; slavery was abolished.
Seven years later, the Fourteenth Amendment to the United States Constitution was adopted. This amendment fundamentally altered the structure of the United States Constitution. Lee Epstein and Thomas G. Walker, Constitutional Law for a Changing America 625–27 (4th ed. 2009). It secured the privileges of national citizenship and enshrined a right relevant to the dispute before the Court today: equal protection.[2]
The Equal Protection Clause is rather clear: no government may “deny to any person within its jurisdiction the equal protection of the laws.” U.S. Const. Amend XIV. It contains no qualifiers limiting its application to any specific classification. Therefore, we have held it prevents discrimination based on sex as well as race. Brown v. Board of Education, 347 U.S. 483 (1954); United States v. Virginia, 518 U.S. 515 (1996).
Around this clause we have built an intricate structure of doctrines to determine which classification are worthy of protection and what scrutiny we apply when such classifications are implemented. For example, we have determined some classification of people to be “suspect” and apply strict scrutiny to resolve those cases. Fisher v. University of Texas, 570 U.S. 297 (2013). Others are “quasi-suspect” such as gender, and receive intermediate scrutiny. See Craig v. Boren, 429 U.S. 190, 197 (1976). Other classifications do not raise the specter of impermissible discrimination. Those classifications are reviewed for a rational basis, a very deferential standard.
As explained by Petitioners, the court has traditionally applied four factors to determine whether the Equal Protection Clause should extend heightened scrutiny to a new classification. See, e.g., Daniel J. Galvin Jr., There’s Nothing Rational About It: Heightened Scrutiny for Sexual Orientation Is Long Overdue, 25 W&M J. Race, Gender, and Social Justice 405 (2019). Those factors include whether the classification targets a discrete and insular minority, whether there is a history of discrimination, whether that class is politically powerless, and whether the classification is based on an immutable trait. Id.
An unstructured, four-factor inquiry that sweeps across history, demographics, political power, and immutability is hardly a rigorous analysis, let alone a test. See In re: Public Law 98 (High Frequency Trading Regulation Act), 100 M.S. Ct. 119 (2016). The current standard invites too much judicial discretion turning what should be a rule into an unprincipled and unguided junket. Remember, courts can abuse their discretion as well as any others. See Plessy v. Ferguson, 163 U.S. 537 (1896).
Clear standards are necessary when the rights at issue are so dramatically important. Determining what level of scrutiny applies to a classification is critical and necessary in any equal protection case for it greatly impacts the results. Given the stakes of the result, this Court is bound to enunciate a clear standard for determining which classes are “suspect.” Doing otherwise is an abdication of this Court’s duty.
We therefore announce a revised framework to determine what level of scrutiny applies to classifications made by the government under the Equal Protection Clause. We are not creating or eliminating any factors, simply creating a structure for how courts should apply them.
B. The Revised Equal Protection Framework
Today the Court re-frames the analysis of the Equal Protection Clause in determining classification status. The first and primary inquiry is whether the classification is irrationally based on an immutable trait. As this Court has recognized, our classifications for race, gender, national origin, legitimacy, and alienage were motivated because those traits are immutable but unrelated to a person’s ability to contribute to society. Parham v. Hughes, 441 U.S. 347 (1979).
To establish a classification based on an immutable trait a court must be satisfied three elements are met: (1) there is competent evidence establishing the essentially unchangeable trait; (2) that trait must be ascertainable, meaning it is capable of definition so courts can tell who belongs and who doesn’t; and (3) the immutable trait is unrelated to the ability to perform or contribute to (or harm) society. This three-part test distills our approach and furthers our goals under the Equal Protection Clause, which is to eliminate irrational discrimination. See Cleburne v. Cleburne Living Ctr., 473 U.S. 432 (1985); Plyler v. Doe, 457 U.S. 202 (1982); Massachusetts Bd. of Retirement v. Murgia, 427 U.S. 307 (1976); Frontiero v. Richardson, 411 U.S. 677 (1973) (plurality); Reed v. Reed, 404 U.S. 71 (1971).
If the court is satisfied an immutable trait is proven, it raises the rebuttable presumption that classifications based on that trait are suspect. We caution, however, that the immutability analysis is not the end of the case.
After examining immutability the remaining factors can come into play. If clear and convincing evidence shows that the trait has not been used to subject a class to historic discrimination, the relevant class has political power, and the class is not an insular and discrete minority, then a court may determine the classification based on the trait is quasi-suspect, because there is no evidence the government has used the trait to engage in discrimination.[3] This analysis would, for example, obtain the same end as our race, national origin, and gender discrimination cases, which are fully affirmed today.
And finally, we remind everyone that it very well may be that a classification based on an immutable trait is constitutional — so long as it withstands strict scrutiny review.
The take-away is this: under the revised immutability analysis, classifications based on immutable traits are subject to heightened scrutiny.
Two terms used throughout this opinion must be defined and explained: “class” and “trait.” While related, the two terms are conceptually different. The trait is the characteristic on which the government’s regulation is based. The class is the group of people defined by that trait that is claiming disparate treatment or impact. For example, the trait in this case is sexual orientation. The class claiming disparate treatment because of that trait is gay men.
For our purposes, a class is only useful to examine history, demographics, and political power. But it is the trait that determines the level of scrutiny. Here, the Court defines the class narrowly as “gay men” and does not understand the class to be all men because the regulation is based on gender discrimination as argued in the alternative by the Petitioners. For one, the two classes (all men and gay men) are vastly different in terms of size, political power, and history of discrimination. If those are the relevant considerations — and they are — it makes little sense to treat two vastly different classes the same under the Equal Protection Clause.
Second, to treat this case as a gender discrimination case is reductive of the class definition. Of course all gay men are men. But the simple fact is not all men are gay. It is the narrower class that is disparately impacted by this regulation. It is their class and their claim that must be evaluated. Thus, the relevant class in this case is gay men.
Regardless, the trait at issue is sexual orientation. We analyze the history and demographics of classes only to determine whether the immutable trait that the government is regulating on should be demoted from suspect status to quasi-suspect. Put another way, we review the claim in this case from the perspective of the class of gay men. Under that analysis, we determine whether classifications based on the trait of sexual orientation are suspect.
To be clear, a statute that disparately impacts white people is still based on the suspect trait of race, and would be subject to strict scrutiny because the trait (race) has historically been used to engage in discrimination against a class (African Americans). In this regard, the protection provided by the immutability analysis applies the same to all classes defined by a trait, and is static once set.
C. Application of the Immutability Analysis
The text of the Equal Protection Clause clearly applies to the case at hand. The class in this case challenges the disparate treatment of gay men, a subset of “all persons.” The law treats them differently based on the relevant trait of sexual orientation. The question then becomes what standard of scrutiny should this Court apply? To answer that question, we must start by examining competent evidence to determine whether sexual orientation is immutable. After that, examine the remaining factors as related to the class in this case (gay men) to see if the presumption that arises under the immutability analysis stands.
Immutability. The causes that lead to the development of sexual orientation are complex. There is simply no answer as to what causes a person to develop their orientation. American Psychological Association, Answers to Your Questions: For a Better Understanding of Sexual Orientation and Homosexuality (2008).
The scientific consensus is clear on one thing, however: sexual orientation cannot be changed nor is it a product of choice. Id.; see American Psychiatric Association, Position Statement on Issues Related to Homosexuality (2013) (“No credible evidence exists that any mental health intervention can reliably and safely change sexual orientation; nor, from a mental health perspective does sexual orientation need to be changed.”). Both the American Psychological Association and the American Psychiatric Association agree on this critical point.
So too do the states. Dixie and Sierra, for example, have banned conversion therapy within their borders. Other states like the Atlantic Commonwealth have prohibited the “gay panic” defense in their courts. This trend shows the growing recognition that same-sex sexual orientation is immutable and worthy of protection.
That evidence supports the finding that sexual orientation is a fundamental expression of a person’s humanity that cannot be changed. It further confirms the self-evident point that sexual orientation in no way impacts a person’s contributions to society. Therefore, competent evidence supports the finding that sexual orientation is essentially unchangeable and not a product of choice. The legal steps taken by the states confirm this finding.
The trait is also ascertainable. It is defined by sexual attraction. Finally, sexual orientation is entirely unrelated to a person’s ability to contribute to (or harm) society. Thus, we concluded that classifications based on sexual orientation are presumptively subject to strict scrutiny under the equal protection clause.
The government contends, however, it is not concerned about the class defined by that trait. Resp’s Final Reply Br. Instead, it is worried about a particular expression of that trait: male-to-male sexual conduct.
The Court disagrees. If discrimination were permissible upon those grounds, then the holding of Lawrence v. Texas makes no sense. 539 U.S. 558 (2003). Further, such a standard could allow women to be treated differently because they can get pregnant, for example. We recognize that an action is distinguishable from a trait. Not every woman will or can get pregnant, to continue our example. But the unavoidable conclusion is that at some level expressive action can be part of an immutable trait.
We forcefully reject the additional argument that because blood donation is not a “fundamental right” that the Government may discriminate in this area. See Resp’s Br. An equal protection claim is not contingent on the existence of another right. The right at issue is equal protection. It is violated any time state action discriminates on the basis of a protected trait. The harm is dignitary and occurs when the government’s distinctions tell someone they are worth less than others. The Equal Protection Clause rejects such ignorance, affirming the inherent right of all persons to be free of discrimination.
The Remaining Factors Do Not Overcome the Presumption. On the whole, we see no reason to rebut the presumption that strict scrutiny applies. The trait of sexual orientation has been used to engage in discrimination against gay men and women, who are part of a small and insular community. See Gallup, In U.S., Estimate of LGBT Population Rises to 4.5% (May 22, 2018). Further, the historic discrimination suffered by gay people supports application of strict scrutiny. In 2017, 15.8% of hate crimes were committed on the basis of sexual orientation. Federal Bureau of Investigation, Uniform Crime Report: Hate Crime Statistics (2017).
This is a far cry from the clear and convincing evidence necessary to depart from the presumption raised by the immutability analysis. Because a class has been subject to historic mistreatment based on the immutable trait of sexual orientation at issue, we hold that the presumption of strict scrutiny has not been overcome. Classifications based on sexual orientation are suspect.
D. Strict Scrutiny Applies
Sexual orientation is not a choice. Yet in the United States, gay men and women have historically been denied equal protection. They have been mistreated by unjust laws and subjected to vitriolic rhetoric, all motivated by unfounded bias.
They have been beaten and they have been killed because of who they are and who they love.
It is exactly this irrational animus that the Equal Protection Clause was designed to minimize and eliminate. We hold that strict scrutiny applies to classifications based on sexual orientation under the Equal Protection Clause. Such classifications are suspect. The government bears a heavy burden to justify their application.
III. Discussion
We caution, however, that strict scrutiny is not “strict in theory, but fatal in fact.” Fisher, supra (quoting Adarand Constructors, Inc. v. Peña, 515 U. S. 200, 227 (1995)). The test is clear and means exactly what it says. If strict scrutiny applies, the government bears the burden to prove its regulation at issue is narrowly tailored to serve a compelling government interest. Id. If this standard is met, the regulation survives scrutiny. See Williams-Yulee v. The Florida Bar, 575 US __ (2015). We stress that strict scrutiny does not automatically invalidate the challenged law.
This test is familiar, spans various doctrinal areas, and we fully reaffirm the test as articulated today regardless of any concern our decision in the Dixie Inn matter altered that analysis. See In Re: San Francisco Resolution №190841, Case №20–01 (Sierra 2020) (citing Robert Carey v. Dixie Inn, Case №19–21, 101 M.S. Ct. 112 (2020)). The Sierra Supreme Court’s discussion on the matter was entirely correct.
We assume, without deciding, that the guidance at issue serves a compelling interest of achieving an HIV transmission rate through blood transfusion as low as reasonably achievable.[4] Even if this is the purported interest the government means to achieve, the guidance is not narrowly tailored to day in light of the evidence before the Court.
Petitioners point to overinclusivity and underinclusivity that is fatal to the guidance. Pets’ br. The guidance requires deferral of men who have had sexual conduct with other men in the past twelve months. But an HIV test will certainly detect an HIV infection within three months of the most recent sexual encounter. See Mayo Clinic, HIV Testing (last accessed May 1, 2020).
Thus the twelve month deferral is nearly four times longer than necessary taking the government’s argument at face value. If a man had sexual contact with another man four months earlier, but had a negative test a month before giving blood, the chances that they are donating HIV positive blood is effectively impossible. Moreover, donated blood is tested as well. The chances of two blood tests both failing to detect an HIV infection is, for all intents and purposes, impossible. This is not to say that a three-month deferral would automatically survive scrutiny, only that the guidance as it stands is clearly overinclusive.
It is also underinclusive. People who have recently paid for sex with money or drugs are likewise a concern for transmitting HIV. Yet the deferral period for such people is only three months. Exactly the time-frame recommended by the Mayo Clinic.
In light of both the overinclusivity and the underinclusivity of the guidance, we are compelled to conclude it is not motivated by the purported interest in this case. It is instead clear that the year-long deferral period is motivated by an unfounded bias against gay men. We hold the guidance void. It is that guidance that has been the critical regulation at issue. We do not pass judgment on the promulgated blood donation regulations. See 21 CFR 630.
IV. Conclusion
At the opening of this opinion, we described the many times our country and this Court have failed to secure the equal protection of the law for all people. But as any first-year law student can tell you, law is reason free of passion. Animus — a fancy word for hate — has no place in our law.
No matter your race, your gender, your sexual orientation, or your creed, the law of the United States will treat you equally. Such a promise is fitting for our nation. After all, our diversity makes us strong. Put another way, e pluribus unum: out of many, one.
We hold that classifications based on sexual orientation are suspect. The guidance at issue has a disparate impact on gay men. The government contends the goal of the guidance is to minimize the transmission of HIV. But if that’s true, the guidance is dramatically overbroad and fatally underinclusive. We hold the 12 month deferral period under the FDA’s guidance void.
Accordingly, the Court enters judgment for the Petitioner.
It is so ordered.
Footnotes
[1] We do not reach the question of whether the guidance intrudes upon the zone of privacy protected by the Due Process Clause as we resolve this case along the firmer grounds of the Equal Protection Clause.[2] The Equal Protection Clause applies against the federal government through the Fifth Amendment’s due process clause, for it would be unthinkable that the due process clause would require less of the federal government than the states. Bolling v. Sharpe, 347 U.S. 497 (1954).[3]The Court recognizes that political power and demographics vary across the nation. But the Equal Protection Clause applies nationwide. The standard does not vary jurisdiction to jurisdiction. Discrimination in one state can justify strict scrutiny in another. As to history, determining whether a class historically held political power is also difficult. For that reason, the Court has emphasized the importance of immutability in this analysis. If a court is in equipose, an unclear history of political power should not overcome the presumption established by the immutability analysis. Moreover, the historic mistreatment of another class based on a trait is relevant evidence under this analysis as well. All-told, the guiding inquiry is immutability.[4] The Government failed to identify or defend a compelling interest in this case. We assume the “as low as reasonably achievable” standard is likely the strongest articulation of a compelling interest in this case. We do not hold that, however, as the Government entirely failed to satisfy that burden. We articulate this interest as we need a basis for determining tailoring, which is fatal to the guidance regardless. All parties before this Court would do well to remember the applicable burdens they must satisfy and to articulate their arguments on those bases.
