American Medical Association v. Stenehjem

          ORDER GRANTING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION

          Daniel L. Hovland, Chief Judge United States District Court.

         Before the Court is the Plaintiffs' “Motion for Preliminary Injunction” filed on June 25, 2019. See Doc. No. 6. The Plaintiffs seek a preliminary injunction, pursuant to Rule 65 of the Federal Rules of Civil Procedure, restraining the Defendants from enforcing North Dakota House Bill No. 1336. The Defendants separately filed responses to the motion for a preliminary injunction on July 19, 2019. See Doc. Nos. 35 and 36. The Plaintiffs filed a reply brief on July 31, 2019. See Doc. No. 44. For the reasons set forth below, the Court grants the Plaintiffs' motion for a preliminary injunction.

         I. BACKGROUND

         On June 25, 2019, the American Medical Association, Access Independent Health Services, Inc., d/b/a Red River Women's Clinic, and Kathryn L. Eggleston, M.D., filed a complaint against North Dakota Attorney General Wayne Stenehjem (the “State”) and Cass County State's Attorney Birch Burdick (the “County”), in their official capacities, challenging the constitutionality of House Bill No. 1336 (“H.B. 1336”) and N.D. Cent. Code § 14-02.1-02(11)(a)(2).^[1] See Doc. No. 1. North Dakota Governor Doug Burgum signed H.B. 1336 into law on March 22, 2019. See Doc. No. 36-1. Section 1 of H.B. 1336 amends and reenacts N.D. Cent. Code § 14-02.1-02(11)(b)(5) to require:

The woman is informed, by the physician or the physician's agent, at least twenty-four hours before the abortion:

. . .

(5) That it may be possible to reverse the effects of an abortion-inducing drug if she changes her mind, but time is of the essence, and information and assistance with reversing the effects of an abortion-inducing drug are available in the printed materials given to her as described in section 14-02.1-02.1.

Id. Section 2 of H.B. 1336 creates and enacts a new subdivision to subsection 1 of N.D. Cent. Code § 14-02.1-02.1, providing the state department of health shall publish:

Materials including information it may be possible to reverse the effects of an abortion-inducing drug but time is of the essence. The materials must include information directing the patient where to obtain further information and assistance in locating a medical professional who can aid in the reversal of abortion-inducing drugs, such as mifepristone and misoprostol.

Id.

         In the complaint, the Plaintiffs allege the Red River Women's Clinic (the “Clinic”) “provides a range of reproductive health care to women, including medication and surgical abortions.” See Doc. No. 1. The Clinic's director, Tammi Kromenaker, stated, “Of our patients who elect to terminate their pregnancies, approximately thirty percent (30%) of our patients receive medication abortions and the rest receive surgical abortions.” See Doc. No. 6-2. According to Dr. Kathryn Eggleston, the Clinic's medical director, in the case of a medication abortion, patients take a combination of two medications orally: mifepristone at the Clinic, followed 24 to 48 hours later by misoprostol taken at the patient's home. See Doc. No. 14. The FDA has approved Mifeprex (a.k.a. mifepristone) in conjunction with misoprostol as an effective alternative to an in-clinic abortion. Id. at ¶ 6. As Dr. Eggleston explained,

In simple terms, mifepristone stops the pregnancy from growing. My understanding from the scientific literature is that by itself, mifepristone fails to terminate a pregnancy up to 46% of the time. Misoprostol works in conjunction with mifepristone to cause uterine contractions to expel the pregnancy from the uterus. Together, the two medications are effective at terminating an early pregnancy in nearly all cases.

Id. at ¶ 7.

         The State describes the procedure “to reverse the effects of an abortion-inducing drug, ” as provided in H.B. 1336, as taking progesterone, instead of misoprostol. The State's expert, Dr. Richard Vetter, a family physician with obstetrics at Essentia Health in Fargo, North Dakota, and the Medical Director of First Choice Clinic, explained,

I have been involved in the use of progesterone to reverse the effects of Mifeprostone [sic] (RU486). A woman ingested Mifepristone (first step of a medication abortion) as a part of the protocol for a medication abortion which she sought. After ingesting the Mifepristone, the woman subsequently changed her mind later that day wishing to continue the pregnancy. Upon receiving a request from the woman through First Choice Clinic to assist, I prescribed progesterone to the patient to assist in reversing the effects of Mifepristone. The rationale for this treatment recommendation was that a higher level of progesterone could help by counteracting the antiprogesterone effects of Mifepristone.

See Doc. No. 36-6, ¶ 19.

         The Plaintiffs contend that a “so-called abortion ‘reversal' [is] based on controversial, unproven theories rejected by major medical organizations.” See Doc. No. 6-1. For support, the Plaintiffs submit the declarations of several medical experts. Dr. Brian Wildey, an obstetrician/gynecologist at Altru Health System in Grand Forks, North Dakota, states,

First, I practice evidence-based medicine, meaning that I endeavor to base recommendations and decisions about patient care on the most credible scientific information. I am not aware of any credible medical evidence supporting the notion that the effects of mifepristone or misoprostol can be reversed.

I have read the papers about so-called abortion “reversal” published by Dr. George Delgado and Dr. Mary Davenport in 2012 and 2018 in Annals of Pharmacotherapy and Issues of Law and Medicine. The data in Dr. Delgado's and Dr. Davenport's papers do not support their claims that administering progesterone to patients may reverse the effects of mifepristone. In fact, the papers do not show that progesterone has any effect on patients who have taken mifepristone.

The 2012 published paper had a sample size of seven patients, and results were available for only six of the seven. This sample size is far too small to rely on as evidence for making any changes in clinical practice.

Most concerning, neither paper appears to have employed a control group. Randomized, double-blind, placebo control studies are the gold standard for clinical studies, and I consider results from those studies to be of the highest value to my medical practice. I generally would not make medical decisions or recommendations based on studies that did not have a control group because it is usually difficult or impossible to draw any inferences about causation from them. Studies without a control group are among the weakest forms of medical evidence. A control group would be especially important to a study about medication-abortion “reversal” because it is known that taking mifepristone without misoprostol does not have a high success rate for terminating a pregnancy. So before believing that progesterone can reverse the effects of mifepristone, I would need to see a randomized trial with a control group comparing statistically viable groups of patients receiving mifepristone alone against patients receiving mifepristone and progesterone.

. . .

Second, because there is no credible medical evidence behind it, I consider administering progesterone to try to “reverse” an abortion to be unethical experimentation on patients. There is no dose and method of administering progesterone that has been shown to be both safe and effective to “reverse” a medication abortion. So giving a patient progesterone for that purpose is pure experimentation. It would be unethical for me, as a physician, to experiment on my patients outside the context of controlled research monitored and approved by an institutional review board.

. . .

I have read H.B. 1336. In my opinion, H.B. 1336 is an unwarranted and inappropriate intrusion on the practice of evidence-based medicine. By forcing physicians to speak a message with which they disagree, it improperly interferes with the ability of physicians to practice medicine ethically. It is also dangerous for patients because it misleads them into believing an unproven, unsupported theory, introduces needless health risks, and has the potential to stigmatize physicians.

As an OB/GYN, I am not aware of any other medical procedure where I would be required to discuss with my patients purported results of controversial or experimental papers. I would object to any such imposition on my ability to speak freely and honestly with my patients.

Having to tell patients that an irreversible procedure may nevertheless be reversed interferes with and is completely contrary to the physician's ethical and legal obligation to obtain informed consent for a medical procedure. Before beginning a medical procedure, I make sure the patient has provided her informed consent; my staff or I discuss the procedure with the patient, explain its risks and benefits and the risks and benefits of alternative procedures, and explain what she should expect during and after the procedure. I am ethically bound to provide my patients with only information that is true, relevant, not misleading, and based on my professional medical judgment.

Even if it were true that progesterone can theoretically “reverse” mifepristone, of which there is no credible evidence, that does not mean that medication abortion is “reversible” and telling patients otherwise will not aid in their ability to consent to abortion. For example, I would only perform a sterilization procedure such as a tubal ligation for a patient who wants a permanent sterilization. I would not, as part of the consenting process, tell the patient that some clinics have had limited success in bypassing or reversing a tubal ligation in some, but not all, cases, as that does not mean the procedure is “reversible, ” is not relevant to the patient's ability to provide informed consent, and would serve only to confuse patients. In fact, if the patient expressed an interest in being able to later have a tubal ligation reversal, I would direct the patient away from having a tubal ligation and toward using a long-lasting, reversible contraceptive instead. For similar reasons, before performing a hysterectomy, I would not inform a patient that a handful of physicians have had isolated success with uterine transplant after a hysterectomy. Where a drug or procedure is not reliably reversible, understanding the permanent nature of the procedure is critical to ensuring that the patient's consent to the procedure is truly informed and voluntary, and telling patients otherwise would only serve to confuse patients and impede their ability to consent.

H.B. 1336 disrupts medical practice by encouraging patients to participate in unmonitored and experimental research. Even Dr. Delgado and Dr. Davenport acknowledge that further research is needed to determine “which mode of delivery, dose and duration of progesterone therapy is most efficacious and carries the least burden for the patient.”

I am also concerned that H.B. 1336 will lead to stigmatization of physicians who refuse to administer progesterone to try to “reverse” an abortion. In North Dakota, abortion providers and women who exercise their constitutional right to have an abortion are often stigmatized by those who are opposed to abortion. I am concerned that physicians like myself who practice evidence-based medicine and thus would refuse to try to “reverse” a medication abortion would be accused of facilitating abortion and consequently be exposed to anti-abortion stigma.

See Doc. No. 19, ¶¶ 8-11, 13, 18-23. Dr. Eggleston also commented on the flaws of these papers and stated:

There is no medically acceptable or reliable evidence proving that progesterone can reverse the effects of any abortion-inducing drugs, including mifepristone and misoprostol. I am familiar with the literature on so-called mifepristone “reversal, ” including two papers authored by Dr. George Delgado together with co-authors. The Delgado papers claim that progesterone can counteract the effects of mifepristone to “reverse” an abortion. These papers are flawed and do not represent ethical, evidence-based medicine. The flaws in these papers include: lack of a control group, meaning it is very possible that the studied pregnancies would have continued regardless of the administration of progesterone; flawed statistical analysis because the authors excluded from their calculations patients whose ultrasounds confirmed embryonic death; failure to separate patients based on gestational age, which effects the success of mifepristone; and lack of proof that the ...