PLANNED PARENTHOOD ARIZONA, INC.; WILLIAM RICHARDSON, M.D., DBA Tucson Women's Center; WILLIAM H. RICHARDSON, M.D., P.C., DBA Tucson Women's Center, Plaintiffs-Appellants,
WILLIAM HUMBLE, Director of the Arizona Department of Health Services, in his official capacity, Defendant-Appellee
Argued and Submitted, San Francisco, California: May
Appeal from the United States District Court for the District of Arizona. D.C. No. 4:14-cv-01910-DCB. David C. Bury, District Judge, Presiding.
Alice J. Clapman (argued), Helene T. Krasnoff, Planned Parenthood Federation of America, Washington, D.C.; Lawrence J. Rosenfeld, Squire Sanders LLP, Phoenix, Arizona, for Plaintiffs-Appellants Planned Parenthood Arizona, Inc.
Robert Lawrence Ellman (argued), Solicitor General, G. Michael Tryon, Senior Litigation Counsel, and Thomas C. Horne, Attorney General, Arizona Attorney General's Office, Phoenix, Arizona, for Defendant-Appellee.
Kimberly A. Parker, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, D.C., for Amici Curiae American College of Obstetricians and Gynecologists and the American Medical Association.
Denise Mary Burke, Americans United for Life, Washington, D.C., for Amici Curiae Arizona Legislators.
David Brown, Julie Rikelman, Tiseme Zegeye, New York, NY, for Plaintiffs-Appellants William Richardson, M.D. and William H. Richardson M.D., P.C., doing business as Tucson Women's Center.
Before: Susan P. Graber, William A. Fletcher, and Richard A. Paez, Circuit Judges. Opinion by Judge W. Fletcher.
W. FLETCHER, Circuit Judge:
Plaintiffs Planned Parenthood Arizona, Inc., Dr. William Richardson, and Tucson
Women's Center appeal the district court's denial of their motion for a preliminary injunction. Plaintiffs seek to enjoin enforcement of an Arizona statute, Ariz. Rev. Stat. § 36-449.03(E)(6), and its implementing regulation, Ariz. Admin. Code § R9-10-1508(G), which restrict the manner in which certain medications may be used to perform abortions. The district court denied the preliminary injunction because it found that plaintiffs had not shown a likelihood of success on the merits. We reverse.
" Before 2000, most first-trimester abortions were surgical, performed by a procedure commonly known as vacuum aspiration or suction curettage." Planned Parenthood Sw. Ohio Region v. DeWine, 696 F.3d 490, 494 (6th Cir. 2012). In 2000, the Food and Drug Administration (" FDA" ) first approved the use of medications to perform abortions. Id.
A. Medication Abortion Regimens
The far-and-away most common method of medication abortion employs a combination of two prescription drugs, mifepristone (sometimes known as RU-486) and misoprostol. Mifepristone ends pregnancy by blocking the hormone progesterone, thereby causing the fertilized egg to detach from the uterine wall. Misoprostol causes the uterus to contract and expel its contents. In 2000, the FDA approved mifepristone for use in medication abortions under the brand name Mifeprex. The approved drug label for Mifeprex described an " on-label" regimen requiring a woman to take 600 milligrams of mifepristone orally at a clinic, return to the clinic two days later to take 400 micrograms of misoprostol orally, and return again for a follow-up visit. These three clinic visits are in addition to the visit Arizona law requires for a woman to receive an in-person consultation with her doctor at least twenty-four hours before an abortion. See Ariz. Rev. Stat. § 36-2153. Clinical evidence submitted by Mifeprex's manufacturer established this on-label regimen to be safe and effective through seven weeks of pregnancy, or 49 days from the woman's last menstrual period (" LMP" ). The FDA has approved misoprostol only for the treatment of stomach ulcers.
When the FDA approved mifepristone for use in abortions, it imposed restrictions on mifepristone's marketing and distribution--but not on its use--under the FDA's " Subpart H" regulations. See 21 C.F.R. § 314.520. These restrictions require the manufacturer to distribute mifepristone only to doctors who sign an agreement " stating that he or she possesses the necessary qualifications and will adhere to the other requirements." One Subpart H restriction requires doctors to agree to provide each patient " a copy of the Medication Guide and Patient Agreement" and obtain the patient's signature on the Patient Agreement. In the Patient Agreement, the patient attests that she " understand[s]" the steps involved in the on-label regimen. The patient agrees to " follow my provider's advice about when to take each drug." The Subpart H restrictions, Medication Guide, and Patient Agreement do not require doctors to administer mifepristone according to the on-label regimen. Cline v. Okla. Coal. for Reprod. Justice, 2013 OK 93, 313 P.3d 253, 261 n.17 (Okla. 2013) (per curiam).
By the time the FDA approved Mifeprex's label, studies already showed that a different regimen for medication abortion was safe and effective through nine weeks of pregnancy, or 63 days LMP (instead of 49 days LMP). This regimen requires taking 200 milligrams (instead of 600 milligrams) of mifepristone orally at the clinic,
taking 800 micrograms of misoprostol two days later at home (instead of at the clinic) by dissolving the drug between the cheek and gum, and then returning to the clinic for a follow-up visit. Consistent with common terminology, we call this off-label regimen the " evidence-based" regimen. Dr. Richardson states in a sworn declaration that " virtually all abortion providers" now use the evidence-based regimen. He further states, " Few if any [providers] use the [on-label] method." The American College of Obstetricians and Gynecologists strongly favors the evidence-based regimen over the on-label regimen. Brief for American College of Obstetricians & Gynecologists and the American Medical Ass'n as Amici Curiae at 7-8. Notably, the district court found that the evidence-based regimen is
considered the best practices . . . by practicing doctors. . . . [T]here is a clear advantage to the current protocol because it may be used through the 9th week of pregnancy, not just through the 7th week, which is significant because many women do not discover their pregnancies until approximately 49 days, which is the end of [the] 7th week. . . . Also, risk factors from medical abortions . . . have been reduced or eliminated by the current [evidence-based] regimen; medication abortion now has a lower rate of ongoing pregnancies and fewer surgical interventions are necessary to complete the abortion procedure.
Medication abortions now account for 41 percent of all first-trimester abortions performed at Planned Parenthood clinics nationwide. In 2012 in Arizona, 43 percent of all abortions performed during the first nine weeks of pregnancy were medication abortions. Plaintiffs presented uncontroverted evidence in the district court that many women who choose medication abortion strongly prefer it over surgical abortion. Medication abortion is less invasive than surgical abortion, which is a particularly important consideration for survivors of rape or sexual abuse. Further, some women have medical conditions that make medication abortion significantly safer than surgical abortion. The district court found that " medication abortion is extremely safe and safer than the alternative surgical procedure, which is also a very safe procedure."
Since the FDA approved mifepristone in 2000, there have been eight known deaths from infection in women using earlier off-label regimens (a fatality rate of less than 0.0005 percent). The FDA investigated these eight cases and found no causal connection between the infections and the use of mifepristone or misoprostol. A study conducted in 2013 surveyed the most recent six years of data and found no infection-related deaths out of 711,556 medication abortions performed under the current evidence-based regimen. James Trussell et al., Reduction in Infection-Related Mortality Since Modifications in the Regimen of Medical Abortion, 89 Contraception 193, 195 (2014).
The on-label regimen fails to terminate the pregnancy in about 1 percent of cases, and as many as 8 percent of women following the on-label regimen require surgical-abortion procedures to stop heavy bleeding caused by the medications. The evidence-based regimen fails in about 0.5 percent of cases, and fewer than 2 percent of women require subsequent surgical-abortion procedures. Because of the larger dose of mifepristone required by the on-label regimen, the drugs for the on-label regimen cost $160 more than for the evidence-based regimen. The on-label regimen also increases costs by requiring an additional clinic visit. Finally, the evidence-based regimen allows women to take misoprostol in their homes, eliminating the risk that they will pass their pregnancies, a process involving
heavy bleeding and cramping, during their trip home from the second clinic visit.
B. FDA Approval
When the FDA approves a drug, it does so on the basis of evidence of clinical trials submitted by the drug's manufacturer. The FDA generally does not conduct its own trials. According to plaintiffs' expert Dr. Lisa Rarick, who participated as an FDA official in the approval process for mifepristone, the FDA " does not authorize protocols for drugs . . . . Rather, approval of [a drug] allows the drug sponsor to advertise and promote the drug for a particular use." The drug's manufacturer also submits a proposed label for approval. The label " provides physicians with guidance about how to use a drug in accordance with how the drug sponsor requested and received FDA approval for its use." The label " does not impose binding obligations on physicians." The " FDA does not ...