PLANNED PARENTHOOD OF THE HEARTLAND, INC. and JILL MEADOWS, Appellants, vs. IOWA BOARD OF MEDICINE, Appellee.
No. 14–1415
Filed June 19, 2015
Appeal from the Iowa District Court for Polk County, Jeffrey D. Farrell, Judge.
Providers appeal a district court judgment upholding a rule by the Iowa Board of Medicine establishing standards of practice for physicians who prescribe or administer abortion-inducing drugs. AFFIRMED IN PART AND REVERSED IN PART.
Thomas J. Miller, Attorney General, Jeffrey S. Thompson, Solicitor General, and Julie J. Bussanmas and Meghan L. Gavin, Assistant Attorneys General, for appellee.
Paige Fiedler of Fiedler & Timmer, P.L.L.C., Urbandale, and Holly A. Harrison, Lynn D. Fleisher, Ph.D., Patrick E. Croke, Daniel C. Craig, and Andrew Chinsky of Sidley Austin LLP, Chicago, Illinois, for amicus curiae American College of Obstetricians and Gynecologists.
Roxanne Barton Conlin of Roxanne Conlin & Associates, P.C., Des Moines, for amici curiae Iowa Coalition Against Sexual Assault, Iowa Coalition Against Domestic Violence, and National Women’s Law Center.
Joe Austen of Austen Law Office, PLLC, West Des Moines, and Rita Bettis of ACLU of Iowa, Des Moines, for amicus curiae American Civil Liberties Union of Iowa.
Mailee R. Smith of Americans United for Life, Washington, D.C., and Arthur F. Gilloon of Gilloon, Wright & Hamel PC, Dubuque, for amici curiae Physicians for Life, National Association of Pro Life Nurses, Christian Medical Association, National Association of Catholic Nurses, and The National Catholic Bioethics Center.
Timm Reid of Galligan & Reid, P.C., Des Moines, and Michael J. Norton and Natalie L. Decker of Alliance Defending Freedom, Greenwood Village, Colorado, for amici curiae American Association of Pro-Life Obstetricians & Gynecologists, Donna Harrison, M.D., Iowa Right to Life, and Susan Thayer.
Matthew F. Heffron and Christine F. Delgado of Brown & Brown, P.C., L.L.O., Omaha, Nebraska, Patrick D. Smith of Bradshaw, Fowler, Proctor & Fairgrave, P.C., Des Moines, and Thomas Brejcha of Thomas More Society, Chicago, Illinois, for amici curiae Catholic Medical Association, Catholic Medical Association—Des Moines Guild, Catholic Medical Association—St. Thomas Aquinas Guild of the Quad Cities, Iowans for Life, and Women’s Choice Center of the Quad Cities.
WIGGINS, Justice.
In 2013, the Iowa Board of Medicine passed a rule establishing standards of practice for physicians who prescribe or administer abortion-inducing drugs. These standards require the physician to personally perform a physical examination and to be physically present when the abortion-inducing drug is provided. It is not disputed the rule would have the effect of prohibiting telemedicine abortions in Iowa.
Planned Parenthood of the Heartland, Inc. and Dr. Jill Meadows, M.D. (collectively Planned Parenthood) challenge the rule as both improperly enacted and violative of the Iowa Constitution. For purposes of this appeal, we will assume the Board properly enacted the rule and did not violate any of the procedural or rulemaking provisions of
The Board has conceded the Iowa Constitution provides a right to an abortion that is coextensive with the right available under the United States Constitution. Planned Parenthood argues the Iowa Constitution affords a broader right, and we should therefore apply a strict scrutiny analysis under the Iowa Constitution to the rule. We need not resolve this question because we conclude, for the reasons stated herein, that the Board’s rule violates the controlling “undue burden” test announced by the United States Supreme Court as the federal constitutional test. See Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 878–79, 112 S. Ct. 2791, 2821, 120 L. Ed. 2d 674, 715–16 (1992) (plurality opinion)
and Gonzales v. Carhart, 550 U.S. 124, 146, 158, 127 S. Ct. 1610, 1626–27, 1633, 167 L. Ed. 2d 480, 502, 509–10 (2007). Thus, the contested rule violates the Iowa Constitution under the less stringent Iowa constitutional standard advanced by the Board. We therefore reverse the decision of the district court as to the contested portions of the rule.
I. Background Facts and Proceedings.
On our de novo review, we find the following facts.
A. Medication Abortions. In 2000, the United States Food and Drug Administration (FDA) approved the distribution and use of mifepristone in the United States. Mifepristone, also known as RU–486, is a prescription drug that terminates a pregnancy by detaching the gestational sac from the uterine wall. In the clinical trials, the woman returned two to four days later and took a second medication, misoprostol, which induced contractions to complete the medication abortion.
Consistent with the clinical trial documents submitted in support of the application for approval of the drug, the FDA label indicated the appropriate treatment regimen was to administer 600 mg of mifepristone orally, followed two days later by 0.4 mg of misoprostol administered orally. Additionally, the label indicated the patient should take the mifepristone within the first seven weeks of pregnancy.
Once the FDA approves a drug, the FDA does not prohibit physicians from using the drug in a different manner than the label provides—otherwise known as “off-label” use. See U.S. Food & Drug Admin., “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices–Information Sheet, available at www.fda.gov/regulatoryinformation/guidances/ucm126486. Off-label
use means the safety and effectiveness of the dosing regimen has not been established by the FDA.
Following FDA approval, additional studies led to the development of new protocols for administering these drugs. The new off-label method changed the dosage amounts of the drugs, lowering the amount of mifepristone from 600 mg to 200 mg and increasing the amount of misoprostol from 0.4 mg to 0.8 mg. The new method also changed the administration of misoprostol from oral ingestion to buccally—placing the pill between the cheeks and gums. The studies also showed this method was safe and effective for use within the first nine weeks of pregnancy. The American College of Obstetricians and Gynecologists (ACOG) accepts and approves of this off–label protocol as the standard of care to administer these drugs.
Telemedicine is a method of practicing medicine in which the physician is at one geographical location, the patient is at a different geographical location, and the two communicate through a secure electrical audio-visual connection that complies with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). In Iowa, physicians and hospitals deliver a variety of health care and education services to Iowans living in rural communities
through telemedicine. The Board has adopted a rule effective June 3, 2015, regarding the use of telemedicine by Iowa physicians. The regulations make the following findings:
1. The board recognizes that technological advances have made it possible for licensees in one location to provide medical care to patients in another location with or without an intervening health care provider.
2. Telemedicine is a useful tool that, if applied appropriately, can provide important benefits to patients, including increased access to health care, expanded utilization of specialty expertise, rapid availability of patient records, and potential cost savings.
3. The board advises that licensees using telemedicine will be held to the same standards of care and professional ethics as licensees using traditional in-person medical care.
The regulations also state that “[a] licensee who uses telemedicine shall utilize evidence-based telemedicine practice guidelines and standards of practice, to the degree they are available, to ensure patient safety, quality of care, and positive outcomes.”
Planned Parenthood has been utilizing telemedicine to perform medication abortions in Iowa since 2008.1 At all Planned Parenthood
locations in Iowa, a trained staff member takes a medical history from the patient, checks the patient’s vital signs, and gathers the patient’s blood for tests to check for any medical reasons the woman should not undergo a medication abortion.
A trained staff member then performs an ultrasound on the woman to check for an ectopic pregnancy and obtain the gestational age of the pregnancy. An ectopic pregnancy occurs when the fertilized egg is implanted somewhere other than the uterus. An ectopic pregnancy is a contraindication for a medication abortion because
Prior to administering the mifepristone, the physician reviews the lab results, the ultrasound images, and medical history provided by the patient. After the physician determines there is no medical reason the woman cannot proceed with the procedure, the patient and physician speak to each other. Whether the physician is present in person or communicating remotely through telemedicine, the physician does not personally perform a physical exam on the patient. The standard of care developed by ACOG is that a physical examination by the physician before proceeding with a medical termination of a pregnancy is medically unnecessary.
Next, the physician informs the patient about the medication regime, potential complications, what to expect after ingesting the misoprostol, and answers questions the patient may have. After receiving informed consent from the patient that she wishes to go
forward with the termination, the doctor provides the medications to the patient.
In telemedicine administration, the patient–physician communication occurs over a real-time two-way HIPAA secured teleconference audio-visual connection with a staff person in the room with the patient and the physician at a different clinical location. After receiving informed consent, the physician remotely releases a secure drawer containing the medications located in the patient’s room.
Regardless of whether the physician dispenses the medications in person or by telemedicine, both the physician and the staff member watch the patient take the mifepristone (in the telemedicine situation, the physician watches over the two-way video). The clinic schedules a follow-up visit within two weeks. The woman then goes home, or to a location of her choosing, and takes the misoprostol twenty-four to forty-eight hours later.
The woman also receives a toll-free number that she may call to speak with medical staff or the physician regarding any complications or questions, as the actual uterine evacuation occurs while the woman is at home regardless of the location of the initial appointment. In the relatively uncommon case in which the physician feels the patient needs emergency care, the doctor refers the woman to the nearest hospital emergency room.
B. Administrative Proceedings. On June 25, 2013, the Board received a petition for rulemaking regarding the standards of practice for telemedicine medication abortions. The petition proposed the following rule:
653-13.10 – Standards of practice – chemical abortion.
This rule establishes the standards of practice for a physician or osteopathic physician who induces an abortion by an abortion-inducing drug.
13.10(1). Definition. As used in this rule, “abortion-inducing drug” means a drug, medicine, mixture, or preparation, when it is prescribed or administered with the intent to terminate the pregnancy of a woman known to be pregnant.
13.10(2). Physical Examination Required. A physician shall not induce an abortion by providing an abortion-inducing drug unless the physician has first performed a physical examination of the woman to determine, and document in the woman’s medical record, the gestational
13.10(3). Physical Presence Required. When inducing an abortion by providing an abortion-inducing drug, a physician must be physically present with the woman at the time the abortion-inducing drug is provided.
13.10(4). Follow-Up Appointment Required. If an abortion is induced by an abortion-inducing drug, the physician inducing the abortion must schedule a follow-up visit with the woman at the same facility where the abortion-inducing drug was provided, 12 to 18 days after the use of an abortion-inducing drug to confirm the termination of the pregnancy and evaluate the woman’s medical condition. The physician shall use all reasonable efforts to ensure that the woman is aware of the follow-up appointment and that she returns for the appointment.
13.10(5). Parental Notification regarding Pregnant Minors. A physician shall not induce an abortion by providing an abortion-inducing drug to a pregnant minor prior to compliance with the requirements of
On June 28, the Board held a public meeting and discussed the proposed rule. Three members of the public spoke at the meeting, Daniel McConchie, Vice President of Government Affairs for Americans United for Life, spoke in favor of the rule; Tom Ross, M.D., a doctor at Planned
Parenthood, spoke against the rule; and Kelly Larson, a registered nurse at InnerVisions HealthCare, spoke in favor of the rule. After hearing the public comments, board member Allison Schoenfelder, M.D., moved to accept the petition and begin the rulemaking process. The Board voted eight to two to accept the petition.
The Board held a public hearing on the proposed rule on August 28, and the public had thirty-five days to submit written comments on the proposed rule. The Board heard testimony from twenty-eight individuals at the public hearing and received 244 written comments from both individuals and organizations. The Board heard from many doctors both for and against the rule.
Dr. Sean Kenney, a practicing obstetrician and gynecologist from Lincoln, Nebraska, spoke in favor of the rule. Dr. Daniel Grossman, an obstetrician and gynecologist from Oakland, California, spoke against the rule. The Board also received public comment from the Iowa Medical Society and the Iowa Osteopathic Medical Association, both of which expressed concern regarding the procedures used to implement the rule and opposed the rule itself. Other physicians also testified the Planned Parenthood clinics follow the standard of care used for medication abortions, whether the physician performs the procedure at an in-clinic visit or by telemedicine.
On August 30, the Board held a meeting to determine whether it should adopt the rule. The Board passed the rule, again with an eight to two vote. The Board announced it would publish the adopted rule on October 2, and it would become effective November 6.
On September 27, the Board issued a statement regarding the adoption and filing of the rule. The Board listed its principal reasons in support of the rule as follows:
1. To protect the health and safety of patients, standards of practice are needed for physicians who prescribe and administer abortion-inducing drugs to terminate a pregnancy.
3.
4. A physical examination of the patient in telemedicine settings is not being performed by the physician who prescribes and administers the abortion-inducing drugs, but is delegated to non-physician persons who do not have appropriate training to confirm or discover contraindications or to perform an ultrasound to determine the age and location of the embryo.
5. Physicians who prescribe and administer abortion-inducing drugs using telemedicine may never meet with the patient in person and may never see the patient again for a follow-up appointment.
The Board also provided its reasons for overruling the objections to the rule.
1. The rule would limit rural Iowa women’s access to medical abortions. The new rule does not restrict where medical abortion services may be provided. The emphasis of the rule is on the patient’s health and safety and the responsibility of physicians who perform medical abortions. The Board believes that all Iowans are entitled to the same high level of health care, regardless of whether they live in rural or urban areas. The Board believes that the physician’s decision that the patient should have a medical or surgical abortion should depend on multiple factors including patient preference, medical and psychological status of the patient, and the patient’s access to emergency medical services.
2. The rule is politically motivated and is not sound public policy. While issues such as abortion have been politicized, the Board does not have authority to react politically to any issue. The Board is only authorized to adopt all necessary and proper rules for the licensure and
standards of practice for health care providers licensed pursuant to
3. The rule is an attempt to ban access to a procedure that is legal. It deprives Iowa women of their constitutionally protected right to obtain a pre-viability abortion. Abortion is legal in Iowa and the goal of the new rule is to protect the health and safety of patients who seek medical abortions. Federal court decisions have set the guidelines for the availability of abortion. Nothing in the rule bans medical abortion. Rather, the rule sets forth the standards of practice that must be followed by physicians who perform medical abortions.
4. The Board previously addressed this matter in 2010 when it reviewed Planned Parenthood of the Heartland’s medical abortion services using telemedicine and concluded they were safe. The membership of the Board has changed completely over the past three years. The Board has not previously promulgated any rules addressing medical abortion services using telemedicine. This is the first rulemaking proceeding which has given licensed physicians and the public an opportunity to comment on the use of telemedicine in this context. Because there was no rule in place addressing this particular
5. The Board promulgated rulemaking without a thorough study or analysis of the matter under regulatory consideration and the Board did not take into consideration the impact the rule may potentially have on expectations and requirements for telemedicine delivery of other medical services. After accepting a petition on June 28, 2013, to promulgate rulemaking on the standards of practice for physicians who perform medical abortions, Board members studied the matter and reviewed medical research papers and a significant amount of public comments received on a broad spectrum of issues regarding medical abortions. The Board determined that the new rule is narrowly focused on the standards of practice for physicians who perform medical abortions. The Board may determine in the future to more broadly address the standards of practice for other medical services using telemedicine.
6. An appropriate physical examination, including an ultrasound to determine age and location of the embryo, is performed by appropriately trained staff in the telemedicine setting and this information is provided to an off-site physician who remotely prescribes and administers the abortion-inducing drugs. The Board considers a thorough medical history and physical examination to be the cornerstone of good medical care. On this foundation an accurate diagnosis can be made and the most appropriate treatment plan offered to the patient. The Board is concerned about the quality and sufficiency of the physical examination being performed prior to a medical abortion. The first area of concern is the lack of opportunity for a physician to perform a basic physical examination of the patient to screen for conditions that would be contraindications to medical abortion. The drugs used in a medical abortion are mifepristone and misoprostol. As listed in the FDA literature the contraindications to these medications include “confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; an intrauterine device (IUD) in place; chronic adrenal failure; concurrent long-term corticosteroid therapy; history of allergy to mifepristone, misoprostol, or other prostaglandins; hemorrhagic disorders or concurrent anticoagulant therapy; and inherited porphyrias.” As stated in the FDA literature on abortion-inducing drugs, “There are no data on the safety and efficacy of mifepristone in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory, or renal disease; insulin-dependent diabetes mellitus; severe anemia or heavy smoking. Women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with caution because such patients were generally excluded from clinical trials of mifepristone.” The Board believes that a basic physical examination of a patient is necessary to exclude this narrower list of contraindications and essential to exclude the list of exclusionary conditions that were not part of the clinical studies. The second area of concern is the quality of the ultrasound that is being performed prior to a medical abortion. Without the option of a clinical pelvic examination of the patient to confirm dating of the embryo, these remote clinics are relying primarily on ultrasound to date the embryo and rule out ectopic pregnancy, which occurs when an embryo implants somewhere
embryo and may lead to delayed diagnosis and treatment of this dangerous condition. In the FDA reports of deaths from mifepristone and misoprostol two of the 14 deaths were related to ruptured ectopic pregnancies, and 58 other women suffered morbidity from failed diagnosis of ectopic pregnancy. The Board believes that a basic physical examination for every patient will help to exclude the conditions that are contraindications to the medications. The Board believes that a pelvic examination may be necessary in some cases to correlate with ultrasound findings and should be available to all women presenting for a medical abortion. The Board believes that adequate ultrasound services and interpretation are necessary if a clinical pelvic examination is not being used to date the embryo. For all these reasons the Board believes that a physician should be present to conduct this physical examination before proceeding with a medical abortion.
7. The treatment and consultation recommendations made by the physician in the telemedicine setting are the same standards of appropriate practice as those in face-to-face settings. The physician does not have to be present to perform a medical abortion.
8. Patients are already receiving appropriate follow-up care to their medical abortions in remote clinics where a physician is not physically present. The Board believes that follow-up care of the patient is critical after providing a medical abortion. The new rule requires the physician who prescribes and performs a medical abortion to make all reasonable efforts to ensure that the patient is aware of the importance of follow-up care and that she returns for an appointment with the prescribing physician. The Board believes that the physician’s in-person interview to collect the patient’s medical history and an in-person physical examination will strengthen the physician-patient relationship and result in improved and increased follow-up care of the patient.
The final rule adopted by the Board reads:
653—13.10 Standards of practice–physicians who prescribe or administer abortion-inducing drugs.
13.10(1) Definition. As used in this rule:
“Abortion-inducing drug” means a drug, medicine, mixture, or preparation, when it is prescribed or administered with the intent to terminate the pregnancy of a woman known to be pregnant.
13.10(3) Physician’s physical presence required. When inducing an abortion by providing an abortion-inducing drug, a physician must be physically present with the woman at the time the abortion-inducing drug is provided.
13.10(4) Follow-up appointment required. If an abortion is induced by an abortion-inducing drug, the physician inducing the abortion must schedule a follow-up appointment with the woman at the same facility where the abortion-inducing drug was provided, 12 to 18 days after the woman’s use of an abortion-inducing drug to confirm the termination of the pregnancy and evaluate the woman’s medical condition. The physician shall use all reasonable efforts to ensure that the woman is aware of the follow-up appointment and that she returns for the appointment.
13.10(5) Parental notification regarding pregnant minors. A physician shall not induce an abortion by providing an abortion-inducing drug to a pregnant minor prior to compliance with the requirements of
C. District Court Proceedings. On September 30, Planned Parenthood filed a petition for judicial review and a motion to stay the enforcement of the rule. The district court granted Planned Parenthood’s
motion to stay the enforcement of the rule pending its ruling. On August 18, 2014, the district court denied Planned Parenthood’s claims and upheld the rule addressing each of Planned Parenthood’s challenges.
Planned Parenthood appealed and asked us to stay the enforcement of the rule pending the resolution of its appeal. We entered a stay and retained the appeal.
II. Issues.
Planned Parenthood raised a number of issues before the district court challenging both the rulemaking process and the constitutionality of the rule. For purposes of this appeal, we will assume the Board properly enacted the rule and did not violate any of the procedural or rulemaking provisions of
Planned Parenthood did not challenge the ruling regarding provisions (1) and (5) of
III. Standard of Review.
We review Planned Parenthood’s constitutional claims de novo. Gartner v. Iowa Dep’t of Pub. Health, 830 N.W.2d 335, 344 (Iowa 2013).
IV. Analysis.
A. The Right of a Woman to an Abortion Under the Iowa Constitution. On appeal, Planned Parenthood asks us to declare the rule unconstitutional under the
her pregnancy. Over forty years ago, the United States Supreme Court recognized a woman has a constitutionally protected liberty interest in the decision to terminate a pregnancy. Roe v. Wade, 410 U.S. 113, 153–54, 93 S. Ct. 705, 727, 35 L. Ed. 2d 147, 177–78 (1973). The Supreme Court reaffirmed the “constitutional liberty of the woman to have some freedom to terminate her pregnancy” in 1992. Casey, 505 U.S. at 869, 112 S. Ct. at 2816, 120 L. Ed. 2d at 709.
Many states considering this issue under their state constitutions have found their state constitutions provide such a right. See, e.g., Valley Hosp. Ass’n, Inc. v. Mat-Su Coal. for Choice, 948 P.2d 963, 967–69 (Alaska 1997); Comm. to Defend Reprod. Rights v. Myers, 625 P.2d 779, 784 (Cal. 1981); In re T.W., 551 So. 2d 1186, 1192–93 (Fla. 1989); Hope Clinic for Women, Ltd. v. Flores, 991 N.E.2d 745, 760 (Ill. 2013); Moe v. Sec’y of Admin. & Fin., 417 N.E.2d 387, 398–99 (Mass. 1981); Women of the State of Minn. by Doe v. Gomez, 542 N.W.2d 17, 27 (Minn. 1995); Pro-Choice Miss. v. Fordice, 716 So. 2d 645, 653 (Miss. 1998); Reprod. Health Servs. of Planned Parenthood of St. Louis Region, Inc. v. Nixon, 185 S.W.3d 685, 692 (Mo. 2006) (en banc) (per curiam); Armstrong v. State, 989 P.2d 364, 374–75 (Mont. 1999); Hope v. Perales, 634 N.E.2d 183, 186 (N.Y. 1994); Planned Parenthood of Middle Tenn. v. Sundquist, 38 S.W.3d 1, 15 (Tenn. 2000). But cf. Taylor v. Kurapati, 600 N.W.2d 670, 687 (Mich. Ct. App. 1999) (“This Court has held that the Michigan Constitution does not provide a right to end a pregnancy.”); Mahaffey v. Att’y Gen., 564 N.W.2d 104, 111 (Mich. Ct. App. 1997) (“We merely hold that the Michigan Constitution does not guarantee a right to abortion that is separate and distinct from the federal right.”); MKB Mgmt. Corp. v. Burdick, 855 N.W.2d 31, 31–32, 52, 64, 89, 91, 98 (N.D. 2014) (per curiam) (upholding the constitutionality of amendments to the state
abortion control act that limited medication abortions where two justices determined the law violated the North Dakota Constitution, two justices concluded the law did not violate the state constitution, three justices determined the statute violated the Federal Constitution, one justice concluded the law did not violate the Federal Constitution, and one justice concluded the federal constitutional issue was not properly before the court because there was not a sufficient majority of the court that agreed the law was unconstitutional). However, in this case, we need not decide whether the Iowa Constitution provides such a right, and if so, whether regulations affecting that right must pass strict scrutiny.2 The
