United States District Court, D. North Dakota
American Medical Association, on behalf of itself and its members; Access Independent Health Services, Inc., d/b/a Red River Women's Clinic, on behalf of itself, its physicians, and its staff; and Kathryn L. Eggleston, M.D.; Plaintiffs,
v.
Wayne Stenehjem, in his official capacity as Attorney General for the State of North Dakota; and Birch Burdick, in his official capacity as State Attorney for Cass County, as well as their employees, agents, and successors; Defendants.
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 ...