Last week the United States Court of Appeals for the Ninth Circuit Court decided Storman's, Inc. v. Selecky, the case challenging a Washington State law requiring pharmacists to dispense "Plan B," is here. An analysis follows.
Plan B is an over-the-counter emergency contraceptive that works best if taken 12 to 24 hours after having sex. It is supposed to be taken within 72 hours after intercourse, and has no effect if taken more than five days afterwards. Plan B is not the same as RU-486, which is a true abortion drug. According to the manufacturer's website, the active ingredient in Plan B is levonorgestrel, a hormone which is similar to progesterone and which is contained in regular birth control pills. The manufacterer asserts that "Plan B is not an abortion pill. It won't work if you're already pregnant. If you take Plan B and are already pregnant, it will not affect your existing pregnancy." Plan B usually works by preventing ovulation, but if the woman ovulates the same day as intercourse, the drug may also prevent implantation, and for that reason some pro-life groups consider Plan B to be a form of abortion.
For several years the Bush administration blocked over-the-counter sale of the drug. Finally, in 2006 the FDA approved over-the-counter sale of Plan B to women 18 and older, but the agency refused to allow over-the-counter sale to women younger than 18. On March 23, 2009, Judge Korman of the Federal District Court for the Eastern District of New York issued a ruling severely criticizing the performance of the FDA under the Bush Administration. Judge Korman stated:
The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays. … These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making.
Judge Korman stated that the agency could, if it wished, immediately allow sale of the drug over the counter to 17-year-olds. On April 22, 2009, the FDA announced that it would not appeal the federal court's ruling, and it stated that the manufacturer could begin marketing the drug to women aged 17 and older on a non-prescription basis.
But there has arisen another barrier to women's access to Plan B. Even though the FDA approved the use of Plan B and later approved its sale over-the-counter, some hospitals and pharmacies have refused to dispense the drug, even in cases of rape, because of they consider it to be a form of abortion. Here is a link to a program on that subject by Daniel Shorr of the CBS program 60 Minutes, dated June 11, 2006.
The case in Storman's, Inc. v. Selecky arose out of those considerations. In the State of Washington a survey revealed that 2 % of Washington pharmacies refused to sell Plan B on account of personal, religious, or moral objections to the use of the drug. In response to this situation, on April 12, 2007, the Washington State Board of Pharmacy adopted a regulation which requires all pharmacies within the State
"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."
This regulation does not apply to individual pharmacists. Individual employees may still refuse, for religious or moral reasons, to refuse to dispense Plan B or any other drug. Furthermore, the law does not require pharmacies to dispense drugs to customers who have not paid for them, or to dispense drugs that the pharmacy in good faith was not able to obtain.
This regulation was challenged in court by a pharmacy and two pharmacists for being in violation of their rights to the free exercise of religion under the First Amendment. (The pharmacists claimed that the regulation affected them because their employers would have to have two persons on duty at all times in order to comply with the regulation.) The federal district court issued a preliminary injunction prohibiting enforcement of the regulation anywhere in the state while the lawsuit was pending. The Ninth Circuit Court of Appeals reversed this ruling. In other words, the Court of Appeals did not find that the regulation was constitutional – it simply found that the District Court should not have entered a preliminary injunction prohibiting enforcement of the regulation. However, the effect of the Court's ruling means that the regulation will probably be upheld.
The Court of Appeals gave two reasons for reversing the trial court's issuance of the preliminary injunction. First, the trial court had stated that one reason that the injunction should be issued was because of the possibility that the plaintiffs would be irreparably injured if they were forced to dispense Plan B contrary to their moral and religious beliefs. The Court of Appeals found that the district court had applied the wrong standard, and that the trial court should not have issued the injunction unless there irreparable harm was likely.
The principal and substantive point of difference between the district court and the court of appeals, however, concerned whether the State Board of Pharmacy's regulation was a "generally applicable" law which was "neutral" towards religion, or whether this was a law that was specifically directed against religion or religious practice. For example, laws prohibiting polygamy, child endangering, or the ingestion of peyote have all been found to be laws of general application which are neutral towards religion. Employment Division v. Smith (1988). A law that prohibited "ritual sacrifice" of animals, however, was found to be specifically directed at religious practice. Church of Lukumi Babalu Aye v. Hialeah (1993).
The District Court had found that the regulation in quesiton was not in fact neutral because the administrative history of the law revealed that it was adopted in response to some pharmacies' refusal to dispense the drug for religious reasons. The Court of Appeals ruled that the trial court should not have attempted to determine the agency's specific motivation for adopting the regulation, and that in any event the law on its face appeared to be neutral towards religion. Specifically, the Court of Appeals noted that the regulation was not limited to situations where pharmacists failed or refused to dispense lawful drugs for religious reasons. Instead, the law applied to all situations where pharmacists failed or refused to provide customers with access to lawful drugs or medical devices. The Court drew an analogy to laws that guarantee access to medical clinics. These laws are mainly applied against abortion protestors who attempt to block clinic access, but they have been upheld on the ground that they are not directed at the protestors' message of opposition to abortion, but rather are intended simply to allow women to enter these clinics without being subject to intimidation. The Court of Appeals also found that the regulation requiring pharmacies to dispense lawful drugs was a law of general application, even though the regulation contained exceptions for situations where the customer had not paid for the items or where the drug was not available.
The distinction is important under the First Amendment. Laws that are directed at religion are subject to strict scrutiny and are presumed to be unconstitutional. In such cases the government bears a heavy burden of proving that the law is constitutional. In contrast, neutral laws of general application are unconstitutional under the Free Exercise Clause only if the law lacks a rational basis – that is, only if there the law has no tendency to achieve any legitimate state purpose. The Court of Appeals ruled that the District Court applied the wrong standard in awarding the preliminary injunction to the persons challenging the law. The Court of Appeals remanded the case to the lower court so that it could determine whether the law in fact serves a rational basis – or, as the Court of Appeals stated, whether the plaintiffs challenging the law had "negated every conceivable basis supporting the new rules."
In light of the standard established by the Court of Appeals' ruling, it is likely that on remand the District Court will uphold the constitutionality of the regulation.
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The religion card looks like a deuce to me here, and so does the state reg complained of. It looks like the type of decision that if left to the individual opharmacies would take care of itself the same as to sell ot not to sell 6-packs of beer. Those who decide as a matter of personal conscience not to sell what must be a very popular product do so knowing well what revenue they are losing and what advantage they are ceding to competitors. Another example of legislating ok regulating – for the sake of legis/regulating.