696 F.3d 490 (6th Cir. 2012), 11-4062, Planned Parenthood Southwest Ohio Region v. DeWine
|Citation:||696 F.3d 490, 83 Fed.R.Serv.3d 1086|
|Opinion Judge:||KAREN NELSON MOORE, Circuit Judge.|
|Party Name:||PLANNED PARENTHOOD SOUTHWEST OHIO REGION; Planned Parenthood of Central Ohio; Planned Parenthood of Northeast Ohio; Timothy Kress; Laszlo Sogor; Preterm, Plaintiffs-Appellants, v. Mike DeWINE, Attorney General of Ohio; Joseph Deters, Defendants-Appellees.|
|Attorney:||B. Jessie Hill, Case Western Reserve University School of Law, Cleveland, OH, for Appellants. Jeannine R. Lesperance, Office of the Ohio Attorney General, Columbus, OH, for Appellees. B. Jessie Hill, Case Western Reserve University School of Law, Cleveland, OH, Helene T. Krasnoff, Planned Parenth...|
|Judge Panel:||Before: MOORE, ROGERS, and McKEAGUE, Circuit Judges. MOORE, J., delivered the opinion of the court in which, ROGERS and McKEAGUE, JJ., joined in Parts I-V. MOORE, J. (pp. 507-13), delivered a separate Part VI, which dissents in part from the separate majority opinion delivered by McKEAGUE, J. (pp...|
|Case Date:||October 02, 2012|
|Court:||United States Courts of Appeals, Court of Appeals for the Sixth Circuit|
Argued: June 7, 2012.
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In 2004, Ohio passed a law criminalizing the distribution of mifepristone, also known as RU-486, unless the distribution mirrored certain protocols and gestational time limits identified by the FDA when mifepristone was first approved in 2000. Ohio Rev.Code § 2919.123 (the " Act" ). Mifepristone, in combination with misoprostol, was the only form of medical abortion offered by Planned Parenthood in Ohio. Planned Parenthood's Ohio regional clinics and two of its doctors (collectively, " Planned Parenthood" ) brought suit shortly
after the Act's passage challenging its constitutionality on several grounds. Although a preliminary injunction is in place to cover the Act's failure to make an exception for circumstances involving the health and life of the mother, the Act has otherwise been in force since February 2011.
The issue on this appeal is whether the district court erred in granting summary judgment in favor of the defendants on three of the four constitutional claims brought by Planned Parenthood facially challenging the Act. Following the resolution of certain certified questions by the Ohio Supreme Court, the district court held that (1) the Act was no longer unconstitutionally vague, (2) the Act did not violate a woman's right to bodily integrity under the Fourteenth Amendment, and (3) the Act did not impose an undue burden on a woman's Fourteenth Amendment right to choose abortion. The fourth claim, whether the Act unduly burdens a woman's right to health and life under the Fourteenth Amendment, is being held for trial and is not at issue on this appeal.
Upon review, we unanimously AFFIRM the district court's grant of summary judgment on Planned Parenthood's vagueness and bodily-integrity claims. Judge McKeague joined by Judge Rogers AFFIRM the district court's judgment in full. Judge Moore would reverse and remand on the undue-burden claim regarding the right to choose. Thus, this opinion is the opinion of the court with respect to all parts except Part VI, which is the opinion of Judge Moore dissenting in part, and Judge McKeague's opinion constitutes the opinion of the majority for Part VI. The judgment of the district court is therefore AFFIRMED.
A. Factual Background
Before 2000, most first-trimester abortions were surgical, performed by a procedure commonly known as vacuum aspiration or suction curettage. Planned Parenthood Cincinnati Region v. Taft, 444 F.3d 502, 505 (6th Cir.2006) (" Taft II " ). The parties agree that surgical abortions in the first trimester are extremely safe and, for most healthy women, can take less than five to ten minutes at an outpatient clinic, usually with only local anesthesia and often sedation. Briefly, a surgical abortion is performed by inserting a speculum into the woman's vagina, dilating the cervix, and then inserting a tube into her uterus that empties the contents by suction. Side effects include bleeding and cramping. Surgical abortions have been performed for decades, and the mortality rate is extremely low at roughly .1 per 100,000. R. 144-1 (Paul Decl. ¶ ¶ 14-20), as cited by R. 139-1 (Defs.' Mot. to Strike at 3 n. 1) and Appellee Br. at 5.1
In 2000, the Food and Drug Administration (" FDA" ) first approved the distribution and use of mifepristone in the United States. Mifepristone, also called RU-486, is a medication that " terminates the pregnancy by detaching the gestational sac from the uterine wall." Taft II, 444 F.3d at 505 n. 1. Approximately 24 to 48 hours later, the woman takes a second medication, misoprostol, which is " a prostaglandin which induces the contractions necessary to expel the fetus and other products of conception from the uterus." Id. 2 Side
effects of the procedure include bleeding for an average of nine to sixteen days and cramping and may also include fever, diarrhea, nausea, or vomiting. Joint Appendix (" J.A." ) at 255 (FDA Patient Information Sheet at 1).3 The parties agree that the mortality rate of mifepristone abortions is less than 1 per 100,000, but they debate the significance of this number. R. 144-1 (Paul Decl. ¶ 23), as cited by Appellee Br. at 5.
A U.S. manufacturer first filed a New Drug Application for mifepristone in 1996. J.A. at 187 (FDA Approval Letter at 1). Consistent with the three clinical trials submitted in support of the application, see J.A. at 192 (FDA Approved Labeling at 3), the " FDA labeling and approval letter indicated that the appropriate treatment regimen was to administer 600 mg of mifepristone orally followed by 0.4 mg of misoprostol administered orally two days later and that mifepristone was not to be administered after forty-nine days' gestation." Taft II, 444 F.3d at 505. The FDA approved mifepristone's application under 21 C.F.R. § 314 Subpart H, and imposed eight heightened restrictions on the post-approval distribution of the drug to " assure safe use." See J.A. at 188 (FDA Approval Letter at 2); 21 C.F.R. § 314.520.
Following FDA approval, additional clinical trials led to the development of new protocols for administering the drugs, one of which called for " 200 mg of mifepristone administered orally followed one to three days later by 0.8 mg of misoprostol administered vaginally" and could be " employed up to sixty-three days' gestation." Taft II, 444 F.3d at 505-06. This new protocol, called the Schaff protocol, changed (1) the dosage amounts of the drugs, lowering the amount of mifepristone from 600 mg to 200 mg and increasing the amount of misoprostol from .4 mg to .8 mg; (2) the number of days between the drugs, from two days to between one and three; (3) the method of administering the misoprostol, from orally at the clinic to vaginally at home; and (4) the number of days' gestation up to which the protocol could be successfully performed, from 49 to 63 days after the woman's last menstrual period (" LMP" ). The Schaff protocol was the primary protocol implemented at Planned Parenthood's Ohio clinics following the approval of mifepristone in 2000.
In 2006, Planned Parenthood's Ohio clinics shifted to a variation of the Schaff protocol that called for self-administration of the misoprostol buccally, i.e., via gum absorption. Because the first clinical trials for buccal administration initially only went up to 56 days LMP, Planned Parenthood limited this new protocol to that time period. By 2010, additional trials had demonstrated the safety and efficacy of buccal absorption up to 63 days LMP, and prior to the enforcement of the Act in 2011, Planned Parenthood began again offering patients the option of a medical abortion up to 63 days LMP. See, e.g., R. 134-3, Ex. 1 (S.E. Ohio Medical Abortion Protocol at 385-86) (Page ID # 2131-32).
Once a drug has been approved, the FDA does not ban the sort of " off-label
use" that Planned Parenthood uses in its clinics, i.e., prescribing the drug for uses or in doses not identified in the approved labels.4 Taft II, 444 F.3d at 505. The State does not dispute that " [i]t is standard medical practice in the United States for physicians to prescribe FDA-approved drugs in dosages and for medical indications that were not specifically approved— or even contemplated— by the FDA, particularly where the alternative use is supported by adequate study." R. 133-1 (State's Resp. to Pls.' Facts at ¶ 12) (Page ID # 1994).
States, however, may limit off-label use. Taft II, 444 F.3d at 505. And on March 13, 2003, several members of the Ohio House of Representatives did just that, introducing House Bill 126 to regulate the distribution of RU-486 and to criminalize a physician's failure to follow the regulations. The Act was approved by both chambers and signed into law by the Governor on June 24, 2004, stating in relevant part:
No person shall knowingly ... prescribe RU-486 (mifepristone) to another for the purpose of inducing an abortion ... unless the person ... is a physician, the physician satisfies all the criteria established by federal law that a physician must satisfy in order to provide RU-486 (mifepristone) for inducing abortions, and the physician provides the RU-486 (mifepristone) to the other person for the purpose of inducing an abortion in accordance with all provisions of federal law that govern the use of RU-486 (mifepristone) for...
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