Stormans, Inc. v. Selecky

Decision Date22 February 2012
Docket NumberCase No. C07–5374RBL.
PartiesSTORMANS, INCORPORATED, et al., Plaintiff, v. Mary SELECKY, Defendant.
CourtU.S. District Court — Western District of Washington

854 F.Supp.2d 925

STORMANS, INCORPORATED, et al., Plaintiff,
v.
Mary SELECKY, Defendant.

Case No. C07–5374RBL.

United States District Court,
W.D. Washington,
at Tacoma.

Feb. 22, 2012.






Unconstitutional as Applied


WAC 246–863–095, 246–869–010, 246–869–150(1)

[854 F.Supp.2d 931]

Kristen K. Waggoner, Steven Thomas O'Ban, Ellis Li & McKinstry, Seattle, WA, Luke W. Goodrich, Eric N. Kniffin, The Becket Fund for Religious Liberty, Steven H. Aden, Alliance Defense Fund, Washington, DC, Benjamin W. Bull, Alliance Defense Fund, Scottsdale, AZ, for Plaintiff.


Alan D. Copsey, Joyce A. Roper, Rene David Tomisser, Agriculture & Health, Olympia, WA, for Defendant.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

RONALD B. LEIGHTON, District Judge.

After considering the evidence and the argument and authorities presented by the parties' counsel, the Court makes the following findings of fact and conclusions of law.

FINDINGS OF FACT
I. The Parties

1. Plaintiff Stormans, Inc. is a closed corporation, owned by Ken Stormans who serves as President, and his three children, Kevin Stormans, Greg Stormans, and Charelle Foege, who serve as Vice Presidents of the corporation.

2. Stormans, Inc. owns Bayview Thriftway and Ralph's Thriftway in Olympia, Washington. Ralph's is a fourth-generation, family-operated grocery store that includes a general retail pharmacy. Ralph's has had a pharmacy located in the building since it began its operations in 1944.

3. Plaintiff Margo Thelen is a pharmacist licensed by the State of Washington. Ms. Thelen currently works as a staff pharmacist at a hospital pharmacy within Washington. Prior to the Regulations becoming effective, she worked as a staff

[854 F.Supp.2d 932]

pharmacist at Safeway. She has spent nearly all of her 40–year career in retail pharmacy, both independent community and chain pharmacies. She has never been employed by Ralph's.

4. Plaintiff Rhonda Mesler is a pharmacist licensed by the State of Washington. Ms. Mesler works as a pharmacy manager at a pharmacy within Washington. She has been employed by her chain pharmacy for nearly eight years. She has spent over 20 years working mainly at chain pharmacies in Washington. She has never been employed by Ralph's.

5. Defendant Mary Selecky is the Secretary of the Washington State Department of Health (“DOH”). Defendant Laurie Jinkins was an Assistant Secretary responsible for the Washington Health Systems Quality Assurance, which includes the Board of Pharmacy. The remaining defendants, George Roe, Susan Teil Boyer, Dan Connolly, Gary Harris, Vandana Slatter, Rebecca Hille, and Rosemarie Duffy, or their successors are members of the Washington Board of Pharmacy (“Board”).

6. All Board members, like the Secretary and Assistant Secretary of the Department of Health, are appointed by the Governor. Five of the seven Board members are licensed pharmacists and the two remaining members are public members, not affiliated with any aspect of pharmacy. The term of appointment is four years. A member can be appointed to a second term, but can serve no more than two consecutive terms.

7. The Department of Health provides all staff to the Board of Pharmacy. Staff assigned to the Board are employees of the Department of Health.

8. The Board of Pharmacy is responsible for the practice of pharmacy in the state of Washington and to enforce all laws placed under its jurisdiction. The Board also determines the qualifications for licensure and administers discipline against the licenses held by licensees under procedures required in Wash. Rev.Code §§ 18.64, 18.130, 34.05. Discipline for pharmacies and pharmacists may include suspension and revocation of one's license.

9. The Mission Statement of the Board, which appears on its website and is central to its decision making process, is “to promote public health and safety by establishing the highest standards in the practice of pharmacy and to advocate for patient safety through effective communication with the public, profession, Department of Health, Governor, and the Legislature.” See http:// www. doh. wa. gov/ hsqa/ professions/ Pharmacy/ default. htm.

10. Defendant–Intervenors Judith Billings, Rhiannon Andreini, Jeffrey Schouten, Molly Harmon, Catherine Rosman, Emily Schmidt, and Tami Garrard (together “Defendant–Intervenors”) each claim to have an interest in this lawsuit. Two of the intervenors are HIV-positive and the remaining intervenors are women of child-bearing age who seek to ensure access to emergency contraception.

11. Plaintiffs' religious beliefs prevent them from taking part in the destruction of innocent human life, and Plaintiffs believe that human life begins at the moment of fertilization. Plaintiffs have reviewed the labeling, FDA directives and other literature regarding the mechanism of action of Plan B and ella (“emergency contraceptives”) and believe that emergency contraceptives can prevent implantation of a fertilized ovum. Accordingly, Plaintiffs' religious beliefs forbid them from dispensing these drugs.

12. When Plaintiffs receive requests for these drugs, they provide the customer with a “facilitated referral.” By stipulation, Plaintiffs and the State–Defendants

[854 F.Supp.2d 933]

have defined a facilitated referral as “referr[ing] the customer to a nearby provider and, upon the patient's request, call[ing] the provider to ensure the product is in stock.” 1 None of Plaintiffs' customers has ever been denied timely access to emergency contraception.

13. In 2007, the Board enacted a new regulation (WAC 246–869–010) and revised an existing regulation (WAC 246–863–095). Together with WAC 246–869–150(1) (collectively, the “Regulations”), these Regulations prohibit pharmacies from providing facilitated referrals if a pharmacy or pharmacist has a conscientious objection to delivering or dispensing that drug. Plaintiffs challenge the Regulations as a violation of the Free Exercise Clause, the Supremacy Clause, and the Due Process Clause of the U.S. Constitution.

II. Pharmacy Practice before the 2007 RegulationsA. Pharmacies' discretion over stocking and referral.

14. The business of pharmacy is complex. There are over 6,000 FDA-approved drugs, and no pharmacy stocks them all. Thus, every pharmacy must make decisions about which drugs to stock.

15. Pharmacies also face significant financial and competitive pressures. In recent years, pharmacies have faced higher operational costs, decreasing reimbursement rates, and more aggressive auditing from the insurance sector. 2 For many drugs, pharmacies receive minimal net profits and dispensing fees.3 Often, pharmacies must order more of a drug than what the patient requires. And they also receive “numerous high cost yet low volume prescriptions.” 4

16. As a result of these pressures, pharmacies work to balance inventory expense against patient demand. Many pharmacies emphasize inventory control, imposing inventory benchmarks and urging pharmacists to turn over their inventory on a monthly basis.

17. The impact of inventory costs on pharmacies varies depending on the size of the pharmacy, whether it is an independent or chain pharmacy, the clientele it has chosen to serve, and other factors. As the State's attorney explained in an email, pharmacies cannot carry “all medications needed by their community or patient population....” 5 Thus, more and more pharmacies have begun to limit their inventory to certain medications and patient populations. 6 And all pharmacies must make choices about how to control variable costs, including labor and inventory.

18. Pharmacies decide which drugs to stock based on a variety of factors. These factors include, among other things, the niche market the pharmacy chooses to serve, the expense of the drug, the shelf-life of the drug, the demand for the drug, insurance reimbursement amounts and requirements, monitoring or training required to dispense the drug, inventory carrying costs, contractual limitations of wholesalers and buying groups, and the administrative resources associated with the drug.

[854 F.Supp.2d 934]

19. Board Regulations have long given pharmacies broad discretion to decide which drugs to stock. The primary regulation applicable to stocking decisions is WAC 246–869–150(1). The Stocking Rule provides: “The pharmacy must maintain at all times a representative assortment of drugs in order to meet the pharmaceutical needs of its patients.” Id. Although the Stocking Rule has been part of the Board's regulations for over forty years, the Board has made no effort to police compliance, and no pharmacy has ever been cited for violating it.

20. Board regulations have also long given pharmacies broad discretion to decide which patients to serve and when to refer patients to a nearby pharmacy. Because pharmacies stock only a fraction of all FDA-approved drugs, they receive requests many times a day for a drug that is out of stock. 7 When a pharmacy receives a request for a drug that is out-of-stock, the standard practice is to do one of three things: (1) obtain the drug for the customer (for example, by ordering it, and asking the patient to return to pick it up later); (2) return the unfilled prescription to the customer; or (3) refer the customer to another pharmacy that will fill the patient's prescription.

21. Referring the customer to another pharmacy is a very common method for dealing with an out-of-stock drug. Pharmacies refer patients to other pharmacies at least several times a day because a drug is not in stock. 8 The State formally stipulated that referral is often the most effective means to meet the patient's request when a pharmacy or pharmacist is unable or unwilling to provide the requested medication or when the pharmacy is out of stock of medication.9

B. Referrals for reasons of conscience.

22. Before the 2007 Regulations, pharmacies in Washington were also permitted to refer patients for reasons of conscience.10

23. In 1995, when the Washington legislature enacted the Basic Health Care Law, it...

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