Planned Parenthood of the Heartland, Inc. and Jill Meadows v. Iowa Board of Medicine

865 N.W.2d 252, 2015 Iowa Sup. LEXIS 71, 2015 WL 3814831
CourtSupreme Court of Iowa
DecidedJune 19, 2015
Docket14–1415
StatusPublished
Cited by15 cases

This text of 865 N.W.2d 252 (Planned Parenthood of the Heartland, Inc. and Jill Meadows v. Iowa Board of Medicine) is published on Counsel Stack Legal Research, covering Supreme Court of Iowa primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Planned Parenthood of the Heartland, Inc. and Jill Meadows v. Iowa Board of Medicine, 865 N.W.2d 252, 2015 Iowa Sup. LEXIS 71, 2015 WL 3814831 (iowa 2015).

Opinion

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 viola-tive 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 rule-making provisions of Iowa Code chapter 17A (2013), other than Planned Parenthood’s claim the rule violates section 17A.19(10)(a), which provides an agency’s *254 action is invalid when “substantial rights of the person seeking relief have been prejudiced” and the action is “[u]nconstitutional on its face or as applied.” Iowa Code § 17A.19(10)(a). We will therefore focus on the constitutional question.

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 mi-fepristone 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, Biologies, and Medical Devices-Information Sheet, available at www.fda.gov/regulatoryin formation/guidances/ucml26486. 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.

*255 Since 2008, the medication abortions performed by Planned Parenthood in Iowa have involved 200 mg of mifepristone administered orally, followed one to four days later by 0.8 mg of misoprostol taken buccally. The clinic then instructs the patient to return to the clinic within two weeks after taking the misoprostol for a follow-up appointment. Planned Parenthood utilizes the same procedures for medication abortions if the patient is physically present in the doctor’s clinic or if the procedure is being performed utilizing tel-emedicine.

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 telemedi-cine. 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.

Iowa Admin. Code r. 653 — 13.11.

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.” Id. r. 653 — 13.11(2). The regulations further require the licensee to perform “a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient.” Id. r. 653 — 13.11(8).

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865 N.W.2d 252, 2015 Iowa Sup. LEXIS 71, 2015 WL 3814831, Counsel Stack Legal Research, https://law.counselstack.com/opinion/planned-parenthood-of-the-heartland-inc-and-jill-meadows-v-iowa-board-of-iowa-2015.