Comprehensive Health of Planned Parenthood Great Plains v. Williams
Comprehensive Health of Planned Parenthood Great Plains v. Williams
Opinion of the Court
Plaintiffs Comprehensive Health of Planned Parenthood Great Plains, ("Comprehensive Health"), and Reproductive Health Services of Planned Parenthood of the St. Louis Region, ("RHS"), filed suit challenging regulations governing facilities that administer medication abortions. Pending is their Motion for Preliminary Injunction. Following a hearing and extensive briefing by the parties, the Court concludes that the Motion for Preliminary Injunction, (Doc. 92), should be DENIED .
I. BACKGROUND
There are two common types of abortions: surgical abortions and medication abortions. The term "surgical abortion" is a slight misnomer in that the procedure is performed via vacuum aspiration and does not involve general anesthesia or require making an incision. Medication abortions are typically utilized in the early stages of pregnancy, and involve the administration of two medications. The first, mifepristone, must be administered in a health facility or clinic. The second, misoprostol, is taken 24-48 hours later and can be taken by the woman anywhere, and is often taken by the woman in her home.
In the summer of 2017, the Missouri Legislature amended section 188.021 of the Revised Missouri Statutes. Subsection 2 regulates medication abortions by prohibiting doctors from prescribing or administering the medications without first obtaining approval of a "complication plan" from the Department of Health and Senior Services, ("DHSS"). The complication plan must "include any information deemed *925necessary by the department to ensure the safety of any patient suffering complications as a result of the drug or chemical in question." Subsection 3 allows DHSS to "adopt rules, regulations, and standards governing complication plans to ensure" patient safety. A physician who violates this statute may be charged with a Class A misdemeanor, and the facility may face a penalty as well. E.g. ,
The amendments were due to go in effect on October 24, 2017. On October 2, 2017, DHSS issued a memorandum previewing the regulations that DHSS anticipated adopting. (Doc. 1-4.) The memorandum requires that a complication plan provide for a board-certified or board-eligible OB/GYN to be "available twenty-four hours a day, seven days a week to treat complications related to abortion drugs prescribed or administered." Further, either the facility or the physician who prescribes or administers the drug must have a written contract with the OB/GYN or group of OB/GYNs guaranteeing that an OB/GYN will "[p]ersonally treat all complications, including those requiring surgical intervention" and "[a]ssess each patient individually, and shall not, as a matter of course, refer all patients to the emergency room or other facilities or physicians unless the patient is experiencing an immediately life-threatening complication." If the physician who prescribes or administers the drugs is an OB/GYN, the physician or facility must have a "written agreement with an OB/GYN or group of OB/GYNs to ensure the required 24/7 coverage [by other OB/GYNs] when the physician is unavailable to treat complications." The memorandum does not specifically require that the OB/GYN have admitting privileges, but at the TRO hearing Defendants' attorney conceded that the regulation "likely" required that the OB/GYN have admitting privileges in order to satisfy the requirement that the OB/GYN "[p]ersonally treat all complications, including those requiring surgical intervention." And, Defendants have not suggested any circumstances in which admitting privileges would not be required as a condition for approval of a complication plan, and the testimony offered at the preliminary injunction hearing strongly suggests that no such circumstances actually exist.
DHSS promulgated an emergency regulation effectuating the statutory changes on October 24. (Doc. 1-2, pp. 6-9.)
Comprehensive Health eventually obtained approval for a complication plan specific to its Kansas City facility, and RHS eventually obtained approval for a complication plan specific to its facility in St. Louis. Previously, in 2015, Comprehensive Health attempted to comply with separate regulations on surgical abortions requiring a similar contractual association with an OB/GYN possessing admitting privileges, but was unable to find a qualifying OB/GYN who would contract with the Columbia clinic. So, believing that it would still not be able to find an OB/GYN to satisfy the requirements for a complication plan, Comprehensive Health submitted several "combined plans" for both the Kansas City and Columbia clinics. These proposals were rejected by DHSS insofar as the Columbia Clinic was concerned because the OB/GYN who would be available to "personally treat" patients was in Kansas City, and thus logistically unavailable *926to personally address an emergency in Columbia. Comprehensive Health then submitted a "Patient Transfer Agreement" with a local hospital that "provides for patients to be admitted to the hospital if necessary." (Doc. 4-1, ¶ 9.) The agreement also establishes a protocol to ensure continuity of care, including the procedure for communication between the entities, the transfer of patient records, etc. (Doc. 4-1, pp. 27-29.) The Patient Transfer Agreement makes no mention about the availability of an OB/GYN, and DHSS deemed this insufficient to constitute a complication plan.
Plaintiffs filed a three-count Complaint, alleging that the regulation violates (1) substantive Due Process rights, (2) the Equal Protection Clause, and (3) procedural Due Process rights. Comprehensive Health then sought a temporary restraining order ("TRO") barring enforcement of the regulation at its facility in Columbia, and its arguments were limited to the Due Process claim. The Court denied the motion on November 3, 2017, because Plaintiffs could not demonstrate a likelihood of success on the merits for two reasons, both of which related to Plaintiffs' evidence that the regulation imposed an undue burden on women's right to an abortion. Specifically, the Court held that the evidence was insufficient to establish that (1) Comprehensive Health could not comply with the regulation or (2) that the regulation imposed a burden on a significant number of women. (Doc. 26.)
After the Court issued its ruling, Plaintiffs contacted all OB/GYNs in or near Springfield and Columbia. For various reasons that need not be detailed in this Order, none agreed to associate with Plaintiffs. In January 2018 RHS submitted a complication plan that included a transfer agreement with a local hospital similar to the one Comprehensive Health had submitted. (Plaintiffs' Ex. 10.) The plan was rejected by DHSS, apparently because the backup OB/GYNs were located in St. Louis and Overland Park, Kansas, and as with Comprehensive Health's application, RHS's transfer agreement was deemed insufficient to satisfy the regulation's requirements.
Plaintiffs then filed a Motion for Preliminary Injunction, seeking a preliminary injunction for both Plaintiffs based on Counts I and II. Evidence was received during hearings held on April 3 and April 6, 2018, and the parties have also submitted evidence via affidavits and depositions.
II. DISCUSSION
A. Jurisdiction
Defendants contend that the case must be dismissed due to lack of standing because neither Plaintiff submitted a complication plan or tried to associate with an OB/GYN before filing suit.
"[T]he 'irreducible constitutional minimum' of standing consists of three elements. The plaintiff must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision. The plaintiff, as the party invoking federal jurisdiction, bears the burden of establishing these elements." Spokeo, Inc. v. Robins , --- U.S. ----,
The existence of the regulation establishes Plaintiffs' standing to challenge its constitutionality. The regulation precludes Plaintiffs from providing medication abortions unless they meet certain requirements, and Plaintiffs face prosecution if they do not meet those requirements. Plaintiffs need not violate the allegedly constitutional law in order to challenge its constitutionality. E.g., MedImmune, Inc. v. Genentech, Inc. ,
This case is no different: Plaintiffs wish to provide medication abortions, and to do so they must either (1) comply with regulations that are expensive, difficult, and allegedly unconstitutional, or (2) face criminal prosecution. This establishes the injury necessary to satisfy the standing requirement.
*928B. Preliminary Injunctive Relief
The Eighth Circuit has "enumerated four factors to be weighed by the district court in deciding whether to grant or deny preliminary injunctive relief: (1) whether there is a substantial probability movant will succeed at trial; (2) whether the moving party will suffer irreparable injury absent the injunction; (3) the harm to other interested parties if the relief is granted; and (4) the effect on the public interest." Dataphase Sys., Inc. v. C L Sys., Inc. ,
1. Count I-Due Process
Plaintiffs contend that they will prevail on their claim that the regulation violates the Due Process Clause because it places an undue burden on women's access to abortion under the Supreme Court's recent decision in Whole Woman's Health v. Hellerstedt , --- U.S. ----,
*929(a) Likelihood of Success on the Merits
(i) The Regulation's Benefits
The Court begins by considering the regulation's benefits, and to do so the Court must also discuss the risks associated with medication abortions. The evidence establishes that complications are rare and the vast majority occur after the patient has taken the first medication and has returned home. Major complications-those requiring hospitalization, a blood transfusion, or surgery-occur in only 0.3% of all cases. Minor complications occur in no more than 5% of the cases.
The most common minor complication, occurring two to five percent of the time, is an incomplete abortion. This occurs when the treatment stops the pregnancy's progress but does not cause the woman to fully expel the tissue, blood, and other matter from her body. There are three appropriate treatments for an incomplete abortion: (1) wait to give the medication more time to work, (2) administer a second dose of misoprostol, or (3) undergo a vacuum aspiration (which is a standard treatment following a miscarriage). There is no evidence that any of these options-including vacuum aspiration -needs to be performed by an OB/GYN or in a hospital.
With this backdrop in place, the Court turns to the regulation's benefits as identified by Defendants. First, they address a provision requiring Plaintiffs to make a triage nurse or other practitioner available by phone at all times of the day or night to address concerns and potential complications when the patient returns home. (Doc. 122, p. 27.) However, Plaintiffs do not challenge this requirement; their challenge is limited to the requirement that they have a contract with a backup OB/GYN or group who is available 24/7 to personally treat complications and has admitting privileges at a nearby hospital.
Defendants next assert that the regulation increases the accuracy of diagnosis because in-person evaluation is superior to evaluation over the phone. (Doc. 122, pp. 24-27.) However, the regulation does not require in-person evaluations. To the contrary, as stated in the preceding paragraph, the regulation requires that Plaintiffs provide patients with the ability to consult over the phone, and permits a consultation to take place with a nurse practitioner. Moreover, the regulation does not require that in-person evaluations be performed by OB/GYNs. Therefore, requiring an arrangement with an OB/GYN does not augment the diagnostic process.
Defendants also claim that the regulation promotes the State's interest in accurately tracking and documenting complications from medication abortions. However, the evidence does not establish how the regulation furthers this interest. In their written arguments Defendants point to the fact that for at least six years one abortion provider in Missouri did not file reports of complications as required by state law. (Doc. 122, p. 38.) Accepting this as true, Defendants do not explain how requiring that doctor-or any doctor-to enter a contractual agreement with an OB/GYN
*930possessing admitting privileges will addresses the problem, either with respect to that one abortion provider's failings or as a general matter. The closest explanation is Defendants' suggestion that follow-up care by an OB/GYN will provide "greater opportunity to obtain treatment with a physician ... who will know that the complications are abortion related." (Doc. 122, p. 38.) However, there was no evidence that underreporting occurs because doctors and nurse practitioners do not recognize that complications are abortion-related. And, as discussed in the preceding paragraph, even with the regulation a significant amount of assessment and treatment may be performed by health care professionals other than the OB/GYN mandated by the regulation-so the regulation is ill-suited to this purpose.
In a series of related arguments,
Defendants also justify the regulation as a method of minimizing referrals to emergency rooms.
They will take the first medication at the clinic, then travel back home to take the second medication. Should complications arise, the woman will (presumably) call the OB/GYN in Kansas City-but then, because of the distance involved, that *931OB/GYN will not personally treat the woman, regardless of the severity of the complication. Thus, the "continuity of care" the state extolls will be meaningless. And, if surgical intervention is required, the OB/GYN in Kansas City will have no choice but to refer the woman to her own doctor or the emergency room.
(Doc. 26, p. 10.) Defendants respond to this point by suggesting that this observation is "essentially arguing that the Regulation has no benefit if Plaintiffs do not comply with it." (Doc. 122, p. 35.) However, nothing in this sequence of events violates the regulation. Comprehensive Health's clinic in Kansas City has an approved complication plan, and it is permitted to provide medication abortions to women. Nothing in the regulation precludes the clinic from providing medication abortions to women in and around Columbia or Springfield. And, nothing in the regulation requires a woman who returns home and develops complications to return to Kansas City for treatment-or precludes such a woman from going to the emergency room near her home. The regulation prohibits referring patients to the emergency "as a matter of course," but this sequence of events does not seem to be prohibited.
Thus, the Court concludes that the regulation has virtually no benefit. The regulation may provide an alternative to emergency room care for an uncertain portion of the 0.3% of women who need hospital care, but it simultaneously increases the possibility that other women who traveled to Kansas City will to go the emergency room closer to home for routine care that would otherwise have been performed at the clinic in Springfield or Columbia. The regulation may also insure that there is a doctor capable of performing a vacuum aspiration as recommended by OCAG, but its effort to do so is stricter than necessary; achieving this objective does not require a regulation mandating that Plaintiffs have an agreement with (1) an OB/GYN who (2) has hospital admitting privileges.
(ii) The Regulation's Burdens
The Court must weigh these benefits against the regulation's burdens, but first it is necessary to discuss the law that guides this inquiry. A state regulation that increases the distance a woman must travel or the expense of the procedure will not, alone, constitute an undue burden. E.g., Hellerstedt , 136 S.Ct. at 2313 ; Casey ,
*932Casey ,
In determining the fraction for whom the regulation is a substantial obstacle, the fraction's denominator is the women for whom the regulation is "an actual rather than an irrelevant restriction." Hellerstedt , 136 S.Ct. at 2320 (quoting Casey ,
Finally, calculating the fraction requires Plaintiffs to present evidence regarding the number of women for whom the regulation serves as an obstacle. In Jegley , the Eighth Circuit applied Hellerstedt and held that "the district court was required to make a finding that the Act's contract-physician requirement is an undue burden for a large fraction of women seeking medication abortions in Arkansas." Jegley ,
Jegley applies and interprets Hellerstedt , and Plaintiffs rely on Hellerstedt. Labels aside, Hellerstedt involves a comparison of the regulation's benefits and burdens, and Jegley holds that Hellerstedt requires evidence of both. In addition, the Court notes that Jegley focused on the statute's effects on women in Fayetteville (who would have had to travel to Little Rock). This makes it hard to conclude that Jegley does not apply to a claim brought by or on behalf of women in Columbia (who would have to travel to Kansas City).
(Doc. 26, p. 9.)
*933Plaintiffs have established that the clinics in Columbia and Springfield cannot submit a compliant complication plan because they cannot associate with an OB/GYN who possesses admitting privileges.
Plaintiffs' expert testified that 14% of the women who desire a medication abortion will forgo or postpone their abortions because of the increased distance to Kansas City or St. Louis. The Court will accept this figure for purposes of discussion. However, this figure must be reduced because, as Defendants point out, women can and will elect to have a surgical abortion. As stated earlier, the Columbia clinic already provides surgical abortions, and according to Defendants there is no "legal impediment" to the Springfield clinic performing them.
*934
(iii) Conclusion with Respect to Likelihood of Success on the Merits
For these reasons, the Court preliminarily concludes that Plaintiffs have established that requiring Plaintiffs to have a contractual agreement with an OB/GYN (1) near the clinic in question who is (2) available around the clock to provide personal care and who (3) possesses hospital admitting privileges will produce-at best -very limited medical benefit. However, Plaintiffs have not established that the regulation is a substantial burden to a large fraction of women seeking a medication abortion because (1) few of those women will forego a medication abortion and (2) a large number of those who do forego a medication abortion will opt to have a surgical abortion. Therefore, despite the regulation's minimal benefits, the Court cannot conclude that Plaintiffs have demonstrated that the regulation is a substantial obstacle to a large fraction of women's right to obtain an abortion, so Plaintiffs have not demonstrated that they are likely to succeed on the merits.
(b) The Remaining Dataphase Factors
The remaining Dataphase factors are less important than the first. While the State's (i.e., the public's) interests in the regulation are minimal, they exist. Plaintiffs have intimated that the transfer agreements they have are sufficient to satisfy these interests, but beyond the existence of the transfer agreements Plaintiffs presented little basis for concluding that they would adequately serve the regulation's objectives (limited though those objectives may be). The remaining factors are too insubstantial to outweigh the Court's conclusion that Plaintiffs have not demonstrated a likelihood of success on the merits.
2. Count II-Equal Protection
Plaintiffs also contend that a preliminary injunction is justified based on its Equal Protection claim. Their argument is that the regulations subject medication abortion to different requirements than other medical procedures, and that the different scrutiny is subject to strict scrutiny because it discriminates based on a fundamental right (abortion.) (Doc. 124, pp. 65-66.) However, Plaintiffs have not established that their Equal Protection claim is analyzed differently than their Due Process Claim. In fact, the Court strongly suspects that the Supreme Court and the Eighth Circuit would hold that Casey and Hellerstedt apply to Count II just as they apply to Count I. Given the Court's prior analysis of Count I, Plaintiffs' request for a preliminary injunction on Count II must also be denied.
III. CONCLUSION
For these reasons, the Motion for Preliminary Injunction, (Doc. 92), is DENIED.
IT IS SO ORDERED.
The Defendants in this case consist of the Director of DHSS, the Attorney General, and various county prosecutors, all of whom have been named in their official capacities. The prosecutors have deferred to the state defendants' defense of the regulation, and all arguments from Defendants have been presented by DHSS and the Attorney General.
All page numbers are those generated by the Court's CM/ECF system.
Plaintiffs' motion to strike some of the deposition excerpts submitted by Defendants, (Doc. 118), is denied.
This argument ignores the fact that Comprehensive Health submitted complication plans for its facilities in Columbia and Kansas City, and the plans were rejected.
Several of these cases discuss a plaintiff's standing to bring a facial challenge to a regulation or statute. As will be addressed later in this Order, the parties do not agree whether Plaintiffs bring a facial or an as-applied challenge to the regulation, but the standing analysis does not depend on whether the constitutional challenge is facial or as-applied. Regardless of whether Plaintiffs bring a facial or as-applied challenge, they have standing to challenge the constitutionality of a regulation that they must obey upon penalty of criminal sanction.
Defendants attach significance to the fact that "in Plaintiff's motion for a TRO, this Court held that Plaintiffs had not established that they could not comply with the Regulation at the time they sued." (Doc. 130, p. 8; see also Doc. 91, p.4.) However, as will be discussed in Part II.B, the substantive law governing Plaintiffs' claim required the Court to consider the burden imposed by the regulation, and the Court made its observation in the context of discussing whether Plaintiffs had demonstrated a likelihood of success on the merits. (Doc. 26, pp. 7-8 ("Plaintiffs have not demonstrated that they cannot comply with the regulation. [Therefore] the Court cannot find that Plaintiffs are likely to succeed in demonstrating that the regulation imposes an undue burden.").) Plaintiffs believed that they could demonstrate the burden necessary to prevail by relying on their experiences in 2015 and their inability to propose a complication plan that complied with the regulation. But the Court's conclusion that Plaintiffs failed to demonstrate a likelihood of success on the merits when they sought a temporary restraining order does not mean that they lacked standing to present their claim; it is well-accepted that a plaintiff's inability to prove its claim does not mean that it lacks standing. E.g., Braden v. Wal-Mart Stores, Inc. ,
In many states, nurse practitioners are permitted to perform vacuum aspirations, but not in Missouri. Doctors other than OB/GYNs can perform vacuum aspirations, although most emergency room doctors are not trained to do so. (E.g. , Doc. 115, pp. 30, 112-13, 286; Doc. 116, pp. 62, 90.)
This discussion relates to several of Defendants' proffered justifications, which seem to be different ways of saying the same thing. For instance, it addresses the justifications of insuring patient access to a physician, (Doc. 122, pp. 29-30), insuring availability of treatment of a physician, (Doc. 122, pp. 30-31), insuring that the administering doctor has a pre-existing relationship with another doctor, (Doc. 122, p. 32), assuring continuity of care, (Doc. 122, pp. 32-33), and assuring that a doctor is responsible for the patient's care, (Doc. 122, pp. 34-35).
In addition, the Court notes that DHSS relaxes similar requirements for birthing centers, even though carrying a pregnancy to term poses greater risks than a first trimester abortion. In fact, at least one birthing center has a transfer agreement with a local hospital, which sounds similar to the transfer agreements Plaintiffs have with area hospitals. These observations undermine Defendants' insistence that the regulation provides significant benefits.
This discussion addresses several of Defendants' proffered justifications related to emergency rooms. (Doc. 122, pp. 30-32.)
The Court takes particular note of the requirement for admitting privileges, in light of Hellerstedt 's reliance on the trial court's findings that this requirement provided no medical benefit. Hellerstedt , 136 S.Ct. at 2311-12. In this case, Defendants did not specify any particular reason for the requirement, and there is evidence that Defendants either do not impose or agree to waive the requirement in a variety of contexts. The Court strongly suspects that this requirement has been imposed specifically because DHSS is aware that it is difficult for abortion providers to comply with it, and simply constitutes a backdoor effort to require admitting privileges in an attempt to avoid (or ignore) Hellerstedt. The Court's suspicions do not justify an injunction, however, because (1) Plaintiffs challenge the regulation as a whole, and not just this component and (2) for reasons that will be discussed, the primary reason for denying an injunction is the current lack of proof that the regulation imposes an undue burden on women's right to obtain an abortion.
In Jegley , the court and the parties treated the availability of surgical abortions in Little Rock as a "viable alternative" to medication abortions. Thus, women in Little Rock were regarded as not burdened by the regulation, which is why the focus was on women outside of the Little Rock area. Jegley ,
The Court specifically rejects Defendants' arguments that Plaintiffs have not sufficiently proven this point.
The Court finds Defendants' reliance on the availability of surgical abortions to defend the constitutionality of the regulation on medication abortions interesting for a variety of reasons. In particular, DHSS has enacted similar regulations on surgical abortions, requiring the doctor performing the vacuum aspiration have a contractual relationship with an OB/GYN who possesses hospital admitting privileges. Surgical abortions are available in Columbia (and potentially in Springfield) only because the regulations related to surgical abortions were preliminarily enjoined in another case pending in this court, Comprehensive Health of Planned Parenthood Great Plains v. Williams , No. 16-4313. The Court further notes that Defendants are seeking to overturn that injunction; if they succeed, and if the Columbia and Springfield clinics are precluded from performing surgical abortions, the Court's analysis in this case may need to be revisited.
Reference
- Full Case Name
- COMPREHENSIVE HEALTH OF PLANNED PARENTHOOD GREAT PLAINS v. Randall W. WILLIAMS, M.D., in his official capacity as Director of the Missouri Department of Health and Senior Services
- Status
- Published