Abstract
Nowhere is the role of state law in protecting the public’s health more evident than in state laws that regulate health care practice. At the end of its 2015-2016 term and despite the vigorous dissent of Justices Alito and Thomas and Chief Justice Roberts, the US Supreme Court let stand a decision by the US Court of Appeals for the Ninth Circuit in Stormans, Inc v Weisman. 1 In Stormans, a unanimous 3-judge panel ruled that Washington State’s pharmacy practice laws did not violate the First Amendment religious freedom guarantee by failing to permit religious pharmacists and pharmacies to engage in “facilitated referrals” (ie, referring the patient to another pharmacy rather than filling the prescription) in the case of customers who sought to fill prescriptions for morning-after contraceptives. Although the Court could, in the future, decide to take up such a case, the fact that Stormans may well not be the last word on this issue does not mean the case is not important. Whether other appellate courts will diverge from its holding remains to be seen, and under a more conservative Court, a pharmacy refusal case may reemerge. For this reason, a closer look at Stormans and its implications for public health policy and practice is worthwhile.
Background
In cases in which plaintiffs challenge public laws as violating their individual freedoms, the outcome can turn on the level of judicial scrutiny that the courts apply when reviewing their legality. In a democratic society, the courts generally defer to the actions of the legislative and executive branches of government. But when fundamental liberties are at stake, judicial theory holds that judges should weigh in more strongly by closely examining the basis for such laws, determining whether such laws are discriminatory, and further determining whether a law that is challenged has been crafted in a way that, as much as possible, limits its impact on individual freedoms. This heightened standard of review is often referred to as strict judicial scrutiny or strict scrutiny. 2
During the past several years, the question of when individual freedom of religion must give way to broader public health concerns has been hotly debated. This heightened level of public attention is the result of a series of cases arising under the Patient Protection and Affordable Care Act’s contraceptive coverage guarantee. 3 In these cases, the US Supreme Court was asked to decide 2 questions. The first is whether the guarantee of religious freedom embodied in the federal Religious Freedom Restoration Act (RFRA) 4 applies to privately held for-profit corporations that object to the inclusion of some or all contraceptives under their health plans. Second, are government’s efforts to “accommodate” (ie, adjust its policy) reasonable in the case of organizations eligible for accommodation that claim that their religious beliefs are burdened. The Court answered the first question in the affirmative in Burwell v Hobby Lobby Stores, 5 decided in 2013. The second question came before the Court in Zubik v Burwell, 6 and the justices ultimately sent the case back to the lower courts with instructions to attempt to reach a settlement. 7
The RFRA, under which the contraceptive cases arose, was enacted by Congress in 1993 in response to the US Supreme Court’s decision in Employment Division Department of Human Resources of Oregon v Smith. 8 In Smith, the Court set aside the strict scrutiny test that is applied to laws that target religion. It held that the free exercise clause of the First Amendment does not require a strict scrutiny standard when the law under review is determined to operate neutrally and is of general applicability. RFRA’s purpose was to reverse Smith and restore the strict scrutiny standard that applied before Smith. However, the Court later ruled that RFRA could not be applied to state laws, because Congress lacks the power to do so under the US Constitution. (Paradoxically, RFRA’s enactment itself was a response to a state law. 9 )
Thus, where the challenge is to a federal law, the RFRA standard applies, meaning that federal laws to promote broad public interests must withstand a strict scrutiny standard of judicial review that determines whether a law furthers a compelling governmental interest and is fashioned to operate in the least restrictive means. But because RFRA applies only to federal laws, in a First Amendment religious freedom challenge to a state law, the standard of judicial review is at the lower level if the law is found to operate neutrally and is generally applicable.
Washington State’s Law and the Procedural History of Stormans
State Law
Pursuant to its power to regulate health care, Washington State, like all states, extensively regulates pharmacies and pharmacy practice. In 1967, the state adopted a “stocking rule” 10 requiring, as a condition of licensure, that licensed pharmacies maintain at all times “a representative assortment” of US Food and Drug Administration–approved drugs to meet patient needs. In 2007, the Washington State Department of Health’s Pharmacy Quality Assurance Commission (hereafter, Pharmacy Commission) adopted a “pharmacist responsibility rule” 11 that, among other matters, regulates pharmacists’ dispensing conduct. The responsibility rule does not require individual pharmacists to dispense drugs that violate their religious beliefs; rather, it allows pharmacies employing such pharmacists to accommodate them by having another pharmacist available in the store or by telephone when such a prescription must be filled. In other words, the 2007 rule contains a religious accommodation designed to ensure that drugs are available at all pharmacies while recognizing the right of individual pharmacists to refuse to fill a prescription.
A separate “delivery rule,” 12 also adopted in 2007, requires pharmacies to deliver drugs to patients. Unlike the pharmacist responsibility rule, the delivery rule contains no accommodation for a pharmacy that desires to refuse to deliver a drug that it stocks. The delivery rule does have exceptions tied to business justifications, such as erroneous prescriptions, national or state emergencies that direct the supply of drugs elsewhere, potential fraud, unavailability, or drugs for which there is no “payment at their usual and customary or contracted price.” 13 Both rules are enforced through an individual complaint process.
Procedural History
Following their adoption, the 2007 regulations were challenged by pharmacies and pharmacists on the ground that the rules violated their free exercise of religious rights under the First Amendment. The plaintiffs asserted that the rules violated the US Constitution because they contained no accommodation of the delivery rule and an insufficient accommodation under the responsibility rule. The plaintiffs sought an accommodation that would permit a pharmacy and individual pharmacist to make a facilitated referral to another pharmacy in cases involving drugs that are considered to violate religious beliefs. Although the case focused on morning-after contraceptives, nothing about the challenges limited the accommodation to a particular type of drug.
The plaintiffs ultimately lost their challenge in the Ninth Circuit after winning at trial. The appeals court’s Stormans I 13 decision applied the lower standard of review required in Smith and held that the rules were neutrally applied and generally applicable.
In 2010, after the decision in Stormans I, the state Pharmacy Commission began a new rulemaking process to consider whether to add a facilitated referral exception to the pharmacist and pharmacy rules. The Pharmacy Commission rejected the idea of an additional accommodation after considerable deliberation, having heard extensive testimony, including that from various public interest groups, such as people living with human immunodeficiency virus (HIV)/AIDS, about the potential for abuse of what could be thought of as a conscientious objector exception by professionals and entities that turned their conscientious objections into stigmatizing treatment.
The plaintiffs again filed suit, this time alleging that the Pharmacy Commission’s refusal to add a facilitated referral accommodation amounted to discrimination based on religion, thereby rendering the rule no longer operationally neutral or reasonable and triggering the higher standard of review. After a lengthy trial with extensive evidence, the court ruled in the plaintiffs’ favor. In so doing, the trial court applied a strict scrutiny standard and compiled a large trial record that, in the court’s view, showed evidence of discrimination by failing to adopt a facilitated referral exemption even though the rule contained numerous secular exemptions.
Appeals Court’s Decision
The appeals court began by recognizing that Smith presented the proper standard for judicial review and also noted that the Smith standard was affirmed by the US Supreme Court in Church of the Lukumi Babalu Aye, Inc v City of Hialeah. 14 In Lukumi, the Court struck down a local ordinance banning ritualistic animal slaughter, finding that the law did not operate in a neutral fashion but was designed to single out religious animal slaughter rituals for special bans. As such, the Court set aside the lower judicial review standard used in cases such as Smith in favor of the strict scrutiny standard that applies when reviewing laws that target religion or religious practices for tighter regulation.
To find that the case before it resembled Smith and not Lukumi and therefore merited the lower level of scrutiny required by Smith, the appeals court determined that Washington State’s rules were precisely the type of neutral laws of general applicability to which the Smith standard applies. Writing for the panel, Judge Graber noted that the word “sacrifice” in the Lukumi ordinance was defined to exclude virtually all forms of killings other than religious killings, including an exemption for kosher slaughter practices. The intent to discriminate against a certain type of religious practice was built into the way that the law was designed to operate.
By contrast, Washington State’s pharmacy responsibility rule protected religious conduct by permitting individual pharmacists to refuse to fill prescriptions on religious grounds as long as another pharmacist was available in person or by telephone. Furthermore, in the case of the pharmacy delivery rule, the exemptions applied across the board were neutral ones that were tied to pharmacy business practices, public health emergencies, and other situations applicable to all pharmacies, not only those with religious owners. In such a situation, the state had no obligation to affirmatively add a religious exemption, because nothing in its rule targeted religion; the rule was neutral. The court concluded that the Washington State rules under challenge lacked the type of underlying motivation to stop a particular religious practice that was present in Lukumi: “By prohibiting all refusals [to dispense] that are not specifically exempted, the rules establish a practical means to ensure the safe and timely delivery of all lawful and lawfully prescribed medications to the patients who need them.” 1 Judge Graber pointed out that the plaintiffs did not object to the stocking rule, only to the delivery rule; that is, the plaintiffs did not object to the fact that all Washington State pharmacies are expected to stock a full range of Food and Drug Administration–approved drugs—they objected only to the requirement that they deliver drugs to customers. The purpose of the rules, he concluded, was to ensure timely access to necessary drugs, not to bar religious practices.
The courts said that not only did the Washington State rules lack the type of discriminatory animus that sank the Lukumi ordinance but, moreover, there was no evidence that in practice the rules regulated only conduct “motivated by religious belief.” 1 Plaintiffs tried to argue that the commission took a hands-off approach to violations of the delivery rule’s secular standards while sanctioning pharmacies for violations resulting from their religious beliefs. To the contrary, the court said that there was no evidence that the rule looked the other way in the case of harmful secular conduct while punishing only religious refusals; the fact that the delivery rule contained certain secular exemptions but no religious exemptions did not make it discriminatory. The court concluded that the delivery exemptions reflect the pharmacy business and sound medical practice; they do not target religion simply by failing to contain a religious exception. To the charge that the Pharmacy Commission actively enforced its rules in only the case of religious violators, the court responded by observing that the regulatory enforcement scheme was limited to individual complaints filed against pharmacies. As a result, one could infer that the Pharmacy Commission had received complaints only about religious violators, not that the Pharmacy Commission was not enforcing the law in an even-handed fashion.
Finally, plaintiffs argued that because their refusal related to contraception, which they deemed to be abortion, the rule violated their fundamental right not to take human life by not granting an exemption and that because a fundamental right was involved, a strict scrutiny standard was in order. To this argument, the court countered that the plaintiffs had not established the fundamental nature of their liberty interest and that the right at stake was simply the right to own and operate a pharmacy. This is not the type of right—an economic liberty interest to be sure, not a fundamental one—to which the strict scrutiny standard applies.
Implications for Public Health Policy and Practice
Although the US Supreme Court ultimately may choose to weigh in, Stormans nonetheless stands as an important insight into the types of public health laws that do and do not trigger a strict scrutiny standard. Where federal laws are concerned, RFRA effectively imposes a strict scrutiny test even when laws are neutral, are of general applicability, and do not target religion for special regulation. At the state and local levels, however, RFRA does not apply. Instead, public health laws are subject to the lower standard of review set forth in Smith, which is deferential to regulators in the case of any law determined to be neutral in operation and generally applicable (ie, not selectively enforced). That a state or local law does not contain a religious exemption does not render it unlawful, so long as the design of the law and its enforcement reflect broader public health, economic, and other interests. Furthermore, the fact that enforcement is by means of individual complaints and that such complaints are limited to religious violators does not mean that a law is being selectively enforced in a discriminatory fashion. Only where a law is determined, as in Lukumi, to single out religious practice for special treatment—through either regulatory structure or enforcement (or both)—does a state or local law run the risk of falling under the higher standard reserved for public laws that target religion.
Stormans also provides insight into the importance of public records in creating laws at the state and local levels. The absence of a facilitated referral exemption under the Washington State rules rests on a hearing record that led regulators to conclude that the threat to public health from adding such an exemption—and thereby potentially delaying timely access to care—outweighed the importance of a broader facilitated referral exemption.
The question of whether and to what degree to grant religious exceptions to public health laws arises with regularity. California recently faced this question for immunization school entry laws, deciding to end personal and religious exemptions in the wake of a serious measles outbreak. 15 Stormans is the latest reminder that where the public’s health is concerned, state and local lawmakers have broad powers to regulate the public’s health and to do so without religious exemptions, as long as they act in a neutral fashion. Whether they have done so is, of course, a question for the courts to resolve. Here, the existence of a public record that carefully sets forth the reasons for a law, along with an enforcement approach that is general in its design and application, is key.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.