State May Regulate Dispensing of Emergency Contraception

US Pharm. 2015;40(10):57-60.

In a case that could have a major impact on the practice of pharmacy throughout the country, a court has determined that a state is allowed to require the stocking and dispensing of emergency contraception (EC) medications even if the owner of a pharmacy or the pharmacists on duty holds sincere beliefs that EC drugs cause the death of a fetus.¹ The holding, for now, applies only in Washington State, where the court holds jurisdictional authority. The case could well be appealed to the U.S. Supreme Court. If the case is upheld on appeal, the ruling would be applicable in any state that has regulations similar to those in existence in the state of Washington. It might also inspire some states to adopt similar regulations.

Case Overview

The plaintiffs in this case are the owner of a pharmacy and two individual pharmacists who have religious objections to delivering EC such as Plan B and ella. The plaintiffs include Stormans, Inc., a family business that operates Ralph’s Thriftway (Ralph’s), a grocery store and pharmacy located in Olympia, Washington. Stormans declined to stock Ralph’s with the EC drugs Plan B and ella because the pharmacy’s owners have religious objections to their use.¹ Since 2006, 24 complaints have been filed with the Washington Pharmacy Quality Assurance Commission (the Commission) against Ralph’s in connection with this policy. Twenty-one of the complaints have been dismissed for procedural reasons, but three remain pending.

The two other plaintiffs are Rhonda Mesler and Margo Thelen, Washington-based pharmacists who are unwilling to dispense Plan B or ella for religious reasons. Before 2007, Mesler and Thelen referred customers who were seeking Plan B to another pharmacy. After the regulations took effect, Thelen was transferred to a different pharmacy because her employer could not accommodate her religious objection. Mesler alleges that she will be forced to move out of state if the regulations are upheld. These pharmacists challenged the rules on Free Exercise and other constitutional grounds.

After a bench trial, the district court held that the rules violate the Free Exercise and Equal Protection clauses of the U.S. Constitution, and the court permanently enjoined enforcement of the rules. In the case at hand, the defendant, the state of Washington, appealed to the federal 9th Circuit Court of Appeals. Defendants included the Commission’s members and the secretary of the Washington State Department of Health. The district court also permitted several Washington residents to intervene to defend the rules. Intervenors Rhiannon Andreini and Molly Harmon had negative experiences after being denied or delayed access to Plan B. Intervenor Jeffrey Schouten, MD, is HIV-positive, and Intervenor Judith Billings has AIDS; both fear being denied timely access to their prescription medications.

This case has been rattling around the trial court and Court of Appeals since 2007. Several opinions and court rulings have been entered before this most recent proclamation. The name of the defendant has even changed a few times. If the case is researched, be sure to know which decision is being considered and its date in order to avoid confusion. A brief history of the case and some background facts may be useful.

Rules to Consider

The Commission regulates the practice of pharmacy and is the equivalent of the Board of Pharmacy as it is termed in most other states.² As part of its responsibilities, the Commission promulgates rules. In 1967, the Commission established the so-called Stocking Rule, which requires a pharmacy to “maintain at all times a representative assortment of drugs” approved by the FDA “in order to meet the pharmaceutical needs of its patients.”³ Violation of this rule “shall constitute grounds for refusal, suspension, or revocation of licenses or any other authority to practice issued by the Commission.”⁴

Pharmacist Responsibility Rule: In 2007, the Commission, by unanimous decision, established two new rules. The first, known as the Pharmacist Responsibility Rule, amends a section titled “Pharmacist’s Professional Responsibilities,” and it applies to the conduct of individual pharmacists.⁵ As amended, this rule states that it is considered “unprofessional conduct” for a pharmacist to: “a) destroy unfilled lawful prescription[s]; b) refuse to return unfilled lawful prescriptions; c) violate a patient’s privacy; d) discriminate against patients or their agent in a manner prohibited by state or federal laws; and e) intimidate or harass a patient.”⁶

Both of the plaintiffs and the defendants agree that the “foregoing rule does not require an individual pharmacist to dispense medication if the pharmacist has a religious, moral, philosophical, or personal objection to delivery.”⁷ A pharmacy may “accommodate” an objecting pharmacist in any way that the pharmacy deems suitable, including having another pharmacist available in person or by telephone.

The Delivery Rule: The second rule, known as the Delivery Rule, is titled “Pharmacies’ Responsibilities” and applies to pharmacies, not individual pharmacists.⁸ This rule requires pharmacies to “deliver lawfully prescribed drugs or devices to patients and to distribute drugs and devices approved by the [FDA] for restricted distribution by pharmacies, or provide a therapeutically equivalent drug or device in a timely manner consistent with reasonable expectations for filling the prescription.” The Delivery Rule also prohibits pharmacies from destroying or refusing to return an unfilled lawful prescription; violating a patient’s privacy; or unlawfully discriminating against, intimidating, or harassing a patient.

Under the Delivery Rule’s enumerated exemptions, a pharmacy need not deliver a drug or device in the following or substantially similar circumstances⁸:

a) Prescriptions containing an obvious or known error, inadequacies in the instructions, known contraindications, or incompatible prescriptions, or prescriptions requiring action in accordance with Wash Admin Code §246-875-040;

b) National or state emergencies or guidelines affecting availability, usage, or supplies of drugs or devices;

c) Lack of specialized equipment or expertise needed to safely produce, store, or dispense drugs or devices, such as certain drug compounding or storage for nuclear medicine;

d) Potentially fraudulent prescriptions; or

e) Unavailability of a drug or device despite good faith compliance with the Stocking Rule.

The Delivery Rule also provides that pharmacies are not required to deliver a drug or device “without payment of their usual and customary or contracted charge.”⁸

In contrast to the Pharmacist Responsibility Rule, the Delivery Rule contains no exemption for pharmacies whose owners object to delivery on religious, moral, philosophical, or personal grounds. An objecting pharmacy must deliver the drug or device and may not refer a patient to another pharmacy.

Procedural History

The Delivery Rule and the amended Pharmacist Responsibility Rule took effect on July 26, 2007. The plaintiffs filed their action on July 25, 2007, the day before the rules were to take effect. The plaintiffs sought declaratory and injunctive relief under the Free Exercise Clause, the Due Process Clause, the Equal Protection Clause, and the Supremacy Clause. The plaintiffs limited their claims to the Pharmacist Responsibility Rule and the Delivery Rule. They did not challenge the Stocking Rule.⁹

In 2007, the district court issued a preliminary injunction prohibiting enforcement of the rules. The district court held that the plaintiffs were likely to succeed on the merits of their free exercise claim because the rules were neither neutral nor generally applicable, and the rules could not survive strict scrutiny. The court preliminarily enjoined the defendants from enforcing the rules against any pharmacy or pharmacist who declined to dispense Plan B.⁹

Stormans I

In 2009, the 9th Circuit Court of Appeals vacated the preliminary injunction and remanded the case back to the district court judge for further findings.⁹ The Appeals Court held that the rules were both neutral and generally applicable. It also held that the district court had erred in its analysis of the remaining preliminary injunction factors and that it had abused its discretion in enjoining enforcement of the rules as to all pharmacies and pharmacists, rather than limiting the relief to the named plaintiffs. Also in 2009, the district court stayed enforcement of the two rules in dispute.

Remand: After a 12-day bench trial, the district court ruled in the plaintiffs’ favor, issuing an opinion accompanied by extensive findings of fact and conclusions of law.¹⁰ The court entered a final judgment 1) declaring the Delivery Rule, the Pharmacist Responsibility Rule, and the Stocking Rule unconstitutional under the Free Exercise Clause; 2) declaring those rules unconstitutional under the Equal Protection Clause; 3) enjoining Defendants from enforcing those rules against Plaintiffs; and 4) retaining jurisdiction to enforce the judgment.

Stormans II

It was in this posture that the defendants and intervenors appealed the instant case. Addressing the plaintiffs’ Free Exercise claim, a panel of the 9th Circuit Court of Appeals held that the rules, promulgated by the Commission, were facially neutral. The Court also held that the rules operated neutrally because they prescribed and proscribed the same conduct for all, regardless of motivation.

In its decision, the Court noted that “as they pertain to pharmacists, the rules specifically protect religiously motivated conduct. The Commission created a right of refusal for pharmacists by allowing pharmacies to ‘accommodate’ individual pharmacists who have religious, moral, philosophical, or personal objections to the delivery of particular prescription drugs. The rules do not require pharmacists to dispense a prescription medication to which they object.”¹¹

The Court further elaborated that “as they pertain to pharmacies, the rules’ delivery requirement applies to all objections to delivery that do not fall within an exemption, regardless of the motivation behind those objections. By prohibiting all refusals 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; see also Wash Rev Code §18.64.005 (assigning to the Commission the responsibility of regulating the practice of pharmacy so as to protect and promote the public health, safety, and welfare). The delivery requirement also applies to all prescription products—not just Plan B, ella, or other emergency contraceptives. In both trial testimony and official documents accompanying the final regulations, Commission members expressed their expectation that the Delivery Rule’s effect would extend beyond Plan B, for example, by guaranteeing access to medications for HIV patients. Evidence before the Commission and at trial demonstrated that pharmacists and pharmacies had refused to fill prescriptions for several kinds of medications other than emergency contraceptives. Specific examples included refusals, for a variety of reasons, to deliver diabetic syringes, insulin, HIV-related medications, and Valium.”¹¹

The Court further held that the rules were generally applicable and that according to the evidence produced at trial, the rules: 1) were not substantially underinclusive in their prohibition of religious objections but allowance of certain secular exemptions; 2) did not create a regime of unfettered discretion through the individualized exemptions that would permit discriminatory treatment of religion or religiously motivated conduct; and 3) were not selectively enforced.

Because the rules were neutral and generally applicable, rational basis review applied. The Court held that the rules were rationally related to Washington’s legitimate interest in ensuring that its citizens have safe and timely access to their lawful and lawfully prescribed medications. The Court rejected the plaintiffs’ Equal Protection claim on the same basis as the Free Exercise claim.

Addressing the plaintiffs’ Due Process claim, the Court declined to recognize a new fundamental right. The judges on this panel of the Court were not convinced that the right to own, operate, or work at a licensed professional business free from regulations requiring the business to engage in activities that one sincerely believes lead to the taking of human life was so rooted in conscience and the nation’s tradition as to be ranked as fundamental.¹¹

Analysis

With the rights and obligations at stake in this case, it is of little doubt that the case will be appealed further, whether to the en blanc (full bench) 9th Circuit or to the U.S. Supreme Court. It is highly unlikely that the religious freedom alliances in this country will allow the decision to go unchallenged. Though dressed in the cloth of a pharmacist’s right to refuse to dispense a perceived abortifacient, the broader picture is whether any retail establishment of any healthcare professional has the right to refuse to participate in any potential abortive procedure.

Politics and the law aside, this case also raises important ethical issues for pharmacists. Of course there is the question of the individual pharmacist’s right to refuse to engage in conduct that might lead to an abortion in the eyes of that pharmacist. But there is also a duty question: What are the obligations of individual pharmacists to patients? In this case, the pharmacy owners and individual pharmacists claim they refer patients to other pharmacists who do not hold a conscientious objection to dispensing EC and other similar drugs. Is this enough to satisfy the needs of the vast majority of patients? Or are there some patients who cannot tolerate this “accommodation”? Is there some kind of “super” duty owed to these patients?

It is doubtful that any of these legal, political, or ethical questions can ever be answered to the satisfaction of everyone. Nevertheless, it behooves pharmacists to pay attention to these types of decisions to determine where the courts stand on the legal aspects of these issues.

REFERENCES

1. Storman’s Inc. v. Wiesman, Nos. 12-35221, 12-35223, 9th Cir, 2015 U.S. App LEXIS 12692, July 23, 2015.
2. Wash Rev Code §18.64.001.
3. Wash Admin Code §246–869–150(1).
4. Wash Rev Code §18.64.005(7).
5. Wash Admin Code §246-863-095.
6. Id §246–863–095(4).
7. Stormans, Inc. v. Selecky (Stormans I), 586 F3d 1109, 1116 (9th Cir 2009).
8. Wash Admin Code §246-869-010.
9. Stormans I, 586 F3d at 1118.
10. Stormans, Inc. v. Selecky, 854 F Supp 2d 925 (WD Wash 2012).
11. Justia Opinion Summary. Stormans, Inc. v. Wiesman, No. 12-35221 (9th Cir 2015). http://law.justia.com/cases/federal/appellate-courts/ca9/12-35221/12-35221-2015-07-23.html. Accessed September 8, 2015.

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