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Unraveling Plan B’s Legal Status

Jesse C. Vivian, RPh, JD
Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University

Detroit, Michigan



9/21/2009

US Pharm. 2009;34(9):69-72. 

The newspaper headline on July 9, 2009, proclaimed, “Pharmacists can’t refuse Plan B pill, appeals court says.”1 This was followed by the ominous sounding subtitle: “Pharmacists are obliged to dispense the Plan B pill, even if they are personally opposed to the ‘morning after’ contraceptive on religious grounds.”2 While there is some truth to these statements, the applicability and impact on the nation’s pharmacists is exceptionally misleading. To complicate matters, about the same time the decision in this case was rendered, the FDA took additional regulatory actions which will also affect the availability of the drug.3 To bring some clarity to what happened and the current status of dispensing Plan B, the case must be examined and the FDA activity explained. 

Facts of the Case

In Stormans v. Selecky, the Federal Ninth Circuit Court of Appeals was asked to decide: “[W]hether the [lower] district court abused its discretion by preliminarily enjoining the enforcement of new rules promulgated by the Washington State Board of Pharmacy that require pharmacies to deliver lawfully prescribed Federal Drug Administration-approved medications and prohibit discrimination against patients, on the ground that the rules violate pharmacies’ or their licensed pharmacists’ free exercise rights under the First Amendment to the U.S. Constitution.4 As will be discussed, this is a very narrow question with limited applications to pharmacists in the United States. 

The dispute arose after the Washington State Board of Pharmacy adopted two rules by unanimous vote on April 12, 2007. The rules were originally scheduled to take effect on July 26, 2007. Under the first rule, a pharmacist may be subject to professional discipline for destroying or refusing to return an unfilled lawful prescription, violating a patient’s privacy, or unlawfully discriminating against, or intimidating or harassing a patient.5 The rule, however, does not require an individual pharmacist to dispense medication in the face of a personal objection. 

The second rule requires pharmacies “to deliver lawfully prescribed drugs or devices to patients and to distribute drugs and devices approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies…in a timely manner consistent with reasonable expectations for filling the prescription.”6 Under this second rule, a pharmacy may substitute a “therapeutically equivalent drug” or provide a “timely alternative for appropriate therapy,” but apart from certain traditional exceptions (e.g., illegal or fraudulent prescriptions), a pharmacy is prohibited from refusing to deliver a lawfully prescribed or approved medicine.7 A pharmacy is also prohibited from destroying or refusing to return an unfilled lawful prescription, violating a patient’s privacy, or unlawfully discriminating against, or intimidating or harassing a patient.8 In an explanatory statement, the Board noted that it created a right of refusal for individual pharmacists by allowing a pharmacy to “accommodate” a pharmacist who has a religious or moral objection. However, a pharmacy may not refer a patient to another pharmacy to avoid filling a prescription because the pharmacy has a duty to deliver lawfully prescribed medications in a timely manner. A pharmacy may accommodate a pharmacist’s personal objections in any way the pharmacy deems suitable, including having another pharmacist available in person or by telephone. 

The Board began considering these regulations in January 2006 when it became concerned with the lack of clear authority regarding destruction or confiscation of lawful prescriptions and refusals by pharmacists to dispense lawfully prescribed medications. Recognizing the importance of providing patients in Washington State timely access to all medications, the Board initiated a rulemaking process to address these issues. For 16 months, the Board considered its various rulemaking options, receiving 21,000 written comments and testimony from the public and various interest groups.9 

On July 25, 2007, the day before the two rules were to take effect, a independent pharmacy and two pharmacists filed a lawsuit against the state in the U.S. District Court for the Western District of Washington claiming the rules violate, among other things, the Equal Protection and Due Process Clauses of the Fourteenth Amendment to the U.S. Constitution.10 The plaintiffs assert that their personal religious views do not permit them to dispense Plan B, and, consequently, they refuse to provide Plan B to patients who request it. They claim that the Board’s rules impinge on their constitutional right of free exercise of religion, arguing that the rules force them to choose between their religious beliefs as Christians and their livelihood, because a pharmacy might not be able to reasonably accommodate their religious objections. The two individual pharmacists claim that by compelling their employers to hire another pharmacist to work with them during their shift—an accommodation about which their employers have expressed varying degrees of concern—the regulations will cause them to voluntarily leave their jobs or be terminated. The district court also allowed five individual women to intervene as plaintiffs who were refused Plan B or may need Plan B in the future.11 

All of the plaintiffs moved for a preliminary injunction, asking that the court enjoin enforcement of the new rules against them pending litigation. On November 8, 2007, the district court issued an order granting a preliminary injunction based solely on plaintiffs’ free exercise of religion claims.12 On May 1, 2008, another panel of the appeals court denied the defendants’ motion to stay the district court’s injunction pending appeal.13 The plaintiffs appealed again on other grounds. 

Following that second appeal, the Ninth Circuit Court of Appeals issued a 58-page opinion on July 8, 2009, focusing almost exclusively on procedural issues, only to conclude that the district court judged abused his discretion in applying an erroneous legal standard of review, failing to properly consider the balance of hardships and the public interest, and entering an overbroad injunction. Thus, the precise holding of the Court of Appeals is that the “order granting the preliminary injunction is REVERSED; the preliminary injunction is VACATED; and the case is REMANDED to the district court for further proceedings consistent with this opinion.”14 (Emphasis in original.) This is a very narrow holding, having far less impact on the national practice of pharmacy than the media might have us think. 

This conclusion is based on the appellate court’s opinion that the district court used an erroneous standard to determine the propriety of granting the preliminary injunction. From a legal perspective, this is an interesting interpretation of the applicable law because in between the time that the district court issued the preliminary injunction and the time the appeals court reversed that decision, the U.S. Supreme Court issued an opinion that basically heightened the threshold standard for granting a preliminary injunction.15 Following that Supreme Court decision, the proper standard for granting a preliminary injunction requires a party to demonstrate “that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.”16 The appeals court determined that the preliminary injunction issued by the district court did not measure up to this new standard. Mandatory retroactive applications of subsequent precedents are unusual at best. 

Further Analysis

Under a traditional method of analysis, the story would end here, at least for the time being. This is because the preliminary injunction that was reversed and vacated no longer has any effect, meaning that the Washington Board of pharmacy may now enforce the two rules at the center of the controversy. However, because the case was also remanded to the district court for further proceedings consistent with this opinion, the district court will again have to consider the motion for preliminary injunction and determine whether or not it should be issued using the newly formulated guidelines.17 

Perhaps the most telling part of this procedural posture is that the district court must consider its further action on the case consistent with this opinion (i.e., the Opinion of the Ninth Circuit Court of Appeals). The thing to look for when this language is used in an appeals court decision is something lawyers call obiter dicta, which are statements in an opinion that do not necessarily constitute a part of the decision but are offered as guidance or helpful suggestions to the lower court in its further deliberations. Thus, while not binding precedent, an obiter dictum statement is usually considered highly persuasive. (Think about a sergeant asking a recruit to “volunteer” for an assignment.) Here is just part of what the appeals court told the district court to reconsider and why: “Underlying the Supreme Court’s jurisprudence is the principle that the Free Exercise Clause [of the First Amendment] embraces two concepts: freedom to believe and freedom to act. The first is absolute but, in the nature of things, the second cannot be. Conduct remains subject to regulation for the protection of society. This principle traces its roots to the idea that allowing individual exceptions based on religious beliefs from laws governing general practices would make the professed doctrines of religious belief superior to the law of the land, and in effect permit every citizen to become a law unto himself.”18 

Put into simpler terms, you can believe whatever you want in the name of free speech and religious freedom, but those beliefs do not necessarily translate into acceptable conduct on the part of individuals in our society when that individual conduct may be harmful to others. For example, the Supreme Court has held that congressional legislation prohibiting the practice of polygamy was constitutional, and that those who made polygamy part of their religious practice, such as members of the Mormon Church at the time, were not exempt from the statute’s operation. In another case, the Court concluded that requiring public school children to salute the flag as part of a daily school exercise did not violate the Free Exercise Clause because conscientious scruples have not, in the course of the long struggle for religious toleration, relieved the individual from obedience to a general law not aimed at the promotion or restriction of religious beliefs. In still another case, the Court found that a mother could be prosecuted pursuant to child labor laws when she used her children to disseminate Jehovah’s Witness religious literature in the streets. Furthermore, the Court upheld a law that prohibited retail sales on Sunday. Orthodox Jews challenged the law because they already closed their businesses on Saturdays for religious reasons, and claimed that to close their business on Sunday as well would result in economic hardship and thus interfere with the free exercise of their religion. The Court found that the law simply regulated a secular activity and declined to find the law invalid.19 

In the event that these examples did not suggest to the district court that the appeals court takes a dim view of the Washington State Board of Pharmacy rules, it went on to offer its own analysis of the rules using the Supreme Court precedents: “There is no evidence that the rules prohibit or mandate certain practices because of their religious motivation…. [The] record sufficiently reflects that the object of the rules was to ensure safe and timely patient access to lawful and lawfully prescribed medications. The rules, as written and in their effect, require delivery of all lawfully prescribed medications, save for when one of several narrow exemptions permits refusal.20 Aside from those exemptions, any refusal to dispense—regardless of whether it is motivated by religion, morals, conscience, ethics, discriminatory prejudices, or personal distaste for a patient—violates the rules. Therefore, the rules are neutral on their face and in their operation.” 

“That the rules may affect pharmacists who object to Plan B for religious reasons does not undermine the neutrality of the rules. The Free Exercise Clause is not violated even though a group motivated by religious reasons may be more likely to engage in the proscribed conduct.” The Fourth Circuit’s decision in American Life League v. Reno was considered to be on point.21 There, the Fourth Circuit upheld the Freedom of Access to Clinic Entrance Act, which established criminal penalties and civil remedies for certain conduct intended to injure, intimidate, or interfere with persons seeking to obtain or provide reproductive health services. 

Concluding its opinion, the appeals court stated, “Thus, the district court erred in finding that ‘the object of the regulations is to eliminate from the practice of pharmacy those pharmacists who, for religious reasons, object to the delivery of lawful medications, specifically Plan B.’22 The neutrality of the new rules is not destroyed by the possibility that, disproportionately, it is pharmacists with religious objections to Plan B who will require accommodation under the rules. The narrow class of exemptions—necessary reasons for failing to fill a prescription—does not impair the general applicability of the rules. These provisions exempt a pharmacy from its comprehensive duty to deliver medications in certain enumerated situations, such as when a state of emergency is declared, a prescription is potentially fraudulent or erroneous, or the patient cannot pay.”23 

While the court opinion expresses additional reasons for finding the Washington State rules constitutional under the First Amendment, the gist of the decision is that pharmacists cannot simply walk away from a patient with a prescription for Plan B without doing something more to assist the patient. They can still object, but the pharmacies they work in must make the medication available in some other manner. Religious objections to the conduct of providing medication pursuant to a lawful prescription are simply not defensible in the eyes of these judges. 

Case Limitations

There are some exceptionally important limitations on the holding of this case. First, it only applies to states and territories in the Ninth Circuit Court of Appeals.24 Unless or until another circuit in the Federal Court of Appeals decides on the constitutionality of a state law requiring the dispensing of lawful prescriptions despite religious objections or unless a state court rules on the issue, the Ninth Circuit decision is not binding elsewhere. The rule only applies to the dispensing medication on prescription. It says little about the practice of selling Plan B over the counter as an emergency contraceptive without a prescription. The drug is generally available to Washington State residents and in other jurisdictions who are over the age of 18 (now 17)25 without prescription through pharmacies, physicians’ offices, government health centers, hospital emergency rooms, Planned Parenthood, the Internet, and a toll-free hotline. As of the time of this publication, women under 17 still need a prescription for the drug; this could change at some point.26 

If nothing else, by now readers should be able to see the gaping holes in the headline that started this story. Pharmacists may object to dispensing the medication on moral grounds. At the moment, only pharmacies in Washington State are required to dispense Plan B pursuant to a prescription and cannot refuse to dispense it on religious grounds without doing something else to help the patient obtain the drug. Accommodations of pharmacists’ religious preferences are necessary. Refusals to supply the medication without prescription do not appear to be affected by the law (at least not yet). 

Other Cases

Just about the same time the above case was decided, another U.S. district court judge sitting in New York determined on March 23, 2009, that the FDA’s restriction on the availability of Plan B to only women 18 or older was arbitrary and capricious.27 The judge ordered the FDA to immediately make the medication available to 17-year-old women as emergency contraception and remanded the case back to the FDA “for reconsideration of whether to approve the emergency contraceptive for over-the-counter status without age or point-of-sale restrictions.” Just a few months earlier, a federal district court judge dismissed a case against the city of Philadelphia brought by the parents of their 16-year-old daughter who sought and received the “morning after” pills from a city health center.28 That holding was affirmed by the Third Circuit Court of Appeals.29 

FDA Activity

Following the New York case, on April 22, 2009, the FDA notified the manufacturer of Plan B that it may, “upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”30 Note that this does not mean anyone between 17 and 18 can buy the drug without a prescription. It only means that the FDA will approve the drug for sale to those 17 and older if the manufacturer secures advance permission from the FDA. How long that will take is anyone’s guess. On June 24, 2009, the FDA approved a generic prescription-only version of Plan B for women ages 17 and under.31 The press release contained the statement, “No generic levonorgestrel [Plan B] product for emergency contraception can be approved for nonprescription use in women ages 18 and older until August 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.” (As of the date of this publication, no action had been announced.) This position leads to the obvious inequity: if a woman is under 17, she can be prescribed a generic version of the drug; however, if she is 17 or older, only the branded Plan B is available with or without a prescription, at least until the patent expires.32 At any rate, generic Plan B is now widely available without a prescription for women 17 and older. 

Final Words

None of the decisions or other activities discussed here are final as of yet. Expect the abortion-rights activists and antiabortionists to advocate for further developments, more appeals, and additional attention to these important concepts. Also, do not forget that there are “right of conscience” bills pending and court decisions that are diametrically opposed to the holding in the Ninth Circuit Court of Appeals.33 Someday, the U.S. Supreme Court may get a chance to reconcile opposing viewpoints and provide some degree of clarity to the opposing forces behind the rules and decisions. No one can predict if and when that will happen. So, for now, stay tuned. 

REFERENCES

1. Williams CJ. Pharmacists can’t refuse Plan B pill, appeals court says. Los Angeles Times. July 9, 2009. www.latimes.com/news/ nationworld/nation/la-na-pill- ruling9-2009jul09,0,6469894. story. Accessed August 4, 2009.
2. See note 1, supra.
3. Stacey D. Contraception. Who can buy Plan B? June 29, 2009. http://contraception.about.
com/od/emergencycontraception/ i/buyplanb.htm. Accessed August 5, 2009.
4. Stormans v. Selecky, Slip Op No 07-36039 (July 8, 2009), p. 8435. www.ca9.uscourts.gov/media/
view_subpage.php?pk_id= 000000000293. Accessed August 4, 2009. Plan B was described as:a post-coital hormonal emergency contraceptive which contains the same hormones as ordinary birth control pills, estrogen and progestin, in much stronger dosages. It is used to prevent pregnancy after the intended method of birth control fails or after unprotected sexual activity. Plan B is most effective within the first 12 to 24 hours after sexual intercourse and becomes less effective with each passing hour. It should be taken within 72 hours of sexual intercourse. After 120 hours, it has no effect. Plan B is approved for over-the-counter dispensation nationwide to adults 18 and over. The drug must be held behind the pharmacist’s counter and can be sold to any adult, male or female, upon age verification. At the time of the district court’s decision, females younger than 18 were required to present a medical prescription to obtain the drug.” The Court went on to note that “As of April 22, 2009, pursuant to a court order, the FDA had notified the manufacturer of Plan B that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”
5. Wash Admin Code § 246-863-095.
6. Wash Admin Code § 246-869-010.
7. Wash Admin Code §§ 246-869-010(1)(a)-(e), (2). Exempting pharmacies from the general duty to deliver when the prescription cannot be filled due to lack of payment, because it may be fraudulent or erroneous, or because of declared emergencies, lack of specialized equipment or expertise, or unavailability of a drug despite good faith compliance with Washington Administrative Code § 246-869-150, which provides in part that “the pharmacy must maintain at all times a representative assortment of drugs in order to meet the pharmaceutical needs of its patients.”
8. See note 7, supra.
9. See note 4, supra.
10. 42 USC § 1983.
11. Federal Rules of Civil Procedure 24(a).
12. Stormans. v. Selecky, 524 F Supp 2d 1245, 1266 (WD Wash 2007). The court enjoined the State Defendants “from enforcing [Wash Admin Code] §§ 246-863-095(4)(d) and 246-869- 010(4)(d) (the anti-discrimination provisions) against any pharmacy which, or pharmacist who, refuses to dispense Plan B but instead immediately refers the patient either to the nearest source of Plan B or to a nearby source for Plan B.”
13. Stormans Inc. v. Selecky, 526 F 3d 406, 408 (9th Cir 2008).
14. See note 4, supra.
15. Winter v. Natural Resources Defense Council, Inc., 555 U.S. ___, 129 S Ct 365, 374 (2008). Case summary at: www.oyez.org/cases/2000-2009/
2008/2008_07_1239. Complete opinion at: www.supremecourtus.gov/ opinions/08pdf/07-1239.pdf. Accessed August 5, 2009.
16. Winter, 129 S Ct at 374.
17. One or more of the parties could seek immediate review from the Supreme Court. Although not unheard of, it would be unlikely that the Supreme Court would take up the question at this procedural stage.
18. See note 4, supra.
19. See note 4, supra.
20. See note 7, supra.
21. 47 F 3d 642 (4th Cir 1995).
22. Stormans, 524 F Supp 2d at 1258.
23. Wash Admin Code §§ 246-869-010(1)(a)-(e), (2). The first draft of the rule allowed a pharmacist to refuse to fill a lawful prescription if another onsite pharmacist would dispense the medication without delay. One of the second drafts required pharmacists to fill lawful prescriptions, but the alternative second draft allowed a pharmacist to refuse and refer a patient to another provider. The third draft did not require pharmacies to fill lawful prescriptions and allowed pharmacies and pharmacists to refuse to dispense a medication. In response to that draft, Washington State Governor Christine Gregoire offered the assistance of her office to help the Board work toward a solution to prevent the potentially deleterious effects of allowing pharmacists to refuse to dispense legally prescribed medication on the basis of unlimited and illegitimate reasons. A fourth draft was negotiated, but subsequent substantive changes to it precluded agreement. Finally, two more drafts were prepared for public comment, the text of which corresponded substantially with the final rules.
24. Alaska, Washington, Oregon, Idaho, Montana. Nevada, Arizona, California, Hawaii and Guam. U.S. Court of Appeals for the Ninth Circuit. www.ca9.uscourts.gov/content/
view.php?pk_id=0000000135. Accessed August 4, 2009.
25. See note 27, infra.
26. See note 27, infra.
27. Tummino v. Torti, 603 F Supp 2d 519, 2009 US Dist Lexis 23218, March 23, 2009.
28. Anspach v. City of Philadelphia, 503 F 3d 256, 2005 US Dist Lexis 12546, June 27, 2005 (Slip Op No 05-810).
29. Anspach v. City of Philadelphia, 503 F 3d 256, 2008 US Dist Lexis 87444, 3rd Cir (2008).
30. See note 4, supra.
31. FDA approves generic prescription-only version of Plan B emergency contraceptive for women ages 17 and under. FDA news release. June 24, 2009. http://contraception.about.
com/gi/dynamic/offsite.htm?zi= 1/XJ&sdn=contraception&cdn= health&tm=385&gps=641_603_ 1676_803&f=11&su=p284.9.336. ip_p619.12.336.ip_&tt=15&bt=0& bts=1&zu=http%3A//www.fda.gov/ NewsEvents/Newsroom/ PressAnnouncements/ucm168870. htm. Accessed August 5, 2009.
32. See note 3, supra.
33. Vivian JC. Right of conscience: federal developments. US Pharm. 2009;34(2):42-43. www.uspharmacist.com/content/
d/pharmacy_law/c/12276/. Accessed August 5, 2009.

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