Lead Opinion
MOORE, J., dеlivered 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. 513-18), with which, ROGERS, J., concurs.
OPINION
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 short
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 appеal.
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.
I. BACKGROUND
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,
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,
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,
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,
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
States, however, may limit off-label use. Taft II,
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 inducing abortions.
Ohio Rev.Code § 2919.123(A) (emphasis added). The Act also bans physicians from “knowingly failfing] to comply with the applicable requirements of any federal law that pertain to follow-up examinations or care for persons to whom or for whom RU-486 (mifepristone) is provided for the purpose of inducing an abortion,” and requires physicians prescribing mifepristone to submit reports under certain conditions. Id. § 2919.123(B), (C). Physicians who fail to comply with these terms will be “guilty of unlawful distribution of an abortion-inducing drug, a felony of the fourth degree,” and also subject to administrative penalties, including revocation of professional licenses. Id. § 2919.123(E). The Act defines “federal law” as “any law, rule, or regulation of the United States or any drug approval letter of the food and drug administration of the United States that governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing abortions.” Id. § 2919.123(F)(1).
Planned Parenthood submitted affidavits from clinic employees averring that from the introduction of mifepristone in the United States until 2010, regardless of which variation was in place, all of its patients chose one of the alternative dosage regimens over the FDA protocol.
Planned Parenthood offers evidence that the newer protocols have several advantages over the FDA-approved protocol, both in terms of women’s health and access to abortions. The FDA plan does not permit the use of mifepristone after 49 days LMP, but many women do not detect their pregnancy until after 49 days LMP. R. 144-1 (Paul Decl. at ¶ 57) (Page ID # 2393). The FDA plan requires a higher dosage of mifepristone, which Planned Parenthood asserts is not medically necessary (although it concedes the amount is safe). Id. at ¶ 58. Requiring the higher dosage of mifepristone (three pills instead of one) also raises the overall cost to the patient by about $150 for the two extra mifepristone pills alone, which depending on the clinic in question can amount to an increase in cost of twenty-eight to forty-two percent. R. 134-3 (Brenner Decl. at ¶ 9) (Page ID # 2114) (medical abortions cost $545); R. 134-4 (Clawson Decl. at ¶ 12) (Page ID # 2151) (medical abortions cost $410);
Planned Parenthood also points out several reasons why a woman may prefer a medical abortion over a surgical abortion, aside from women with particular health conditions that make one option medically preferable over another. See R. 144-1 (Paul Decl. ¶¶ 49-55) (Page ID # 2390-92) but see R. 139-1 (Defs.’ Mot. to Strike at 11) (Page ID # 2337) (objecting to testimony on this subject because Paul is not a psychologist). We consider Paul’s testimony on this subject only to the extent that it reflects Paul’s personal experiences in providing abоrtions and the common sense observation that “women know their own needs and desires and choose the abortion method that is best for them.” R. 144-1 (Paul Decl. ¶ 50) (Page ID #2390). The State does not argue that such statements are factually false. Indeed, one need not be a psychologist to observe that medical abortions involve ingesting medication rather than the insertion of instruments into the woman’s body and that medical abortions terminate the pregnancy in the privacy of a woman’s home through a process of bleeding as opposed to in a clinical setting. We need not conclude why women might prefer one procedure over the
The State offers its own competing statistics regarding the frequency of medical abortions in Ohio. Ohio requires mandatory reporting of induced abortions, and the Ohio Department of Health reported that in 2008, 17.7% of abortions in Ohio were medical/non-surgical and 80% were surgical. R. 128-16 (Paulson Decl. ¶¶ 6-7) (Page ID # 1930). The most common method of medical/non-surgical abortion was a combination of mifepristone and misoprostol.
B. Procedural History
After the Act was signed but before it took effect, Planned Parenthood sued the Ohio Governor, the Ohio Attorney General, and a class of local prosecutors in 2004 seeking to enjoin the enforcement of the Act. From the beginning, Planned Parenthood has maintained that the Act is unconstitutional for four independent reasons: (1) the Act is unconstitutionally vague; (2) the Act violates a woman’s right to bodily integrity; (3) the Act imposes an undue burden on a woman’s right to choose an abortion; and (4) the Act fails adequately to protect a woman’s health and life. Appellant Br. at 3. To our knowledge, this is the first federal challenge to state laws restricting the use of mifepristone to reach the Court of Appeals. On September 22, 2004, the district court issued a preliminary injunction enjoining enforcement of the entire Act on the likelihood of the plaintiffs’ success with
On appеal of the preliminary injunction, we held that the district court erred in treating a health and life exception as a per se requirement for an abortion regulation to be constitutional, but nonetheless affirmed the issuance of a preliminary injunction on the necessity of a health exception in this case. Taft II,
On remand, the district court granted the plaintiffs’ motion for summary judgment on the first issue of vagueness and permanently enjoined the Act in its entirety on this separate ground. Planned Parenthood Cincinnati Region v. Taft,
The Ohio Supreme Court accepted the certified questions and answered both in the affirmative. Cordray v. Planned Parenthood Cincinnati Region,
On remand, the parties cross-moved for summary judgment, the plaintiffs again on their first claim of vagueness and the defendants on all four claims.
II. JURISDICTION
The district court had federal subject matter jurisdiction over Planned Parenthood’s constitutional claims under 28 U.S.C. § 1331. Our jurisdiction, however, is less straightforward. We have jurisdiction under 28 U.S.C. § 1291 to review final orders of the district court. Typically, when a district court grants summary judgment on some but not all claims, the decision is not a final order for appellate purposes. However, under Federal Rule of Civil Procedure 54(b), the district court may certify a partial grant of summary judgment for immediate appeal “if the court expressly determines that there is no just reason for delay.” Fed.R.Civ.P. 54(b). If Rule 54(b) certification is improper, we lack jurisdiction because there would be no final order from which the parties could take an appeal. Lowery v. Fed. Express Corp.,
Proper cеrtification under Rule 54(b) is a two-step process. “First, the district court must expressly direct the entry of final judgment as to one or more but fewer than all the claims or parties in a case. Second, the district court must expressly determine that there is no just reason to delay appellate review.” Gen. Acquisition, Inc. v. GenCorp, Inc.,
The first inquiry — whether the district court entered judgment as to one or more but fewer than all of Planned Parenthood’s claims — is a difficult question. The parties were asked to submit additional letter briefs on this issue, and on de novo review, we agree with them that the remaining claims are in fact separate from the one claim remaining below.
Courts apply many different tests to determine whether multiple claims exist for the purposes of Rule 54(b), and we have previously recognized that there is no “ ‘generally accepted test’ ” for determining what constitutes a separate claim. Gen. Acquisition,
We are mindful not to apply the “operative facts” test too broadly, however. In Sears, Roebuck & Co. v. Mackey,
We'have not addressed the application of Rule 54(b) to multiple constitutional claims against the same statute before. Other circuits have, although sometimes applying different tests. See, e.g., Jordan v. Pugh,
We view these cases as informative and largely consistent with our approach today, but we decline to adopt a new test for analyzing multiple facial challenges to the same statute. Statutory challenges will certainly all contain at least one common operative' fact — the passage of the challenged law. ’ But the aggregate of operative facts will not necessarily include just the challenged law’s existence; rather, we must also consider the facts relating' to the law’s impact on similar or distinct constitutional rights. A single law that causes distinct injuries to distinct constitutional rights is not so easily analogized to a single retaliatory employment action causing one injury that can be vindicated through multiple channels of relief.
With that in mind, we turn to the claims in this case. Here, there are four potential claims that all seek to disqualify the Act as unconstitutional and admittedly seek the same declaratory and injunctive relief. However, the aggregate of operativе facts that give rise to each of the rights to be vindicated are sufficiently separate to confer jurisdiction despite the presence of some overlap. Count 1 alleges that the Act is unconstitutionally vague. The right at issue is the right of physicians to have notice of what behavior is criminal before they can be prosecuted. Because this is a legal question, the relevant inquiry is whether a reasonable physician would know that certain acts when performing an abortion are criminal or not. Count 2 alleges that the Act violates the right to bodily integrity of the women obtaining abortions. The facts necessary to establish this violation include proving that the Act will result in forcible physical intrusions by the state into a woman’s body against their will and whether the state has a compelling need for such an invasion. Count 2 bears no relation to whether the Act gives physicians constitutional notice of criminal conduct.
Counts 3 and 4 are the most similar in that they both allege violations of the right not to have an undue burden imposed on the abortion decision. But although we apply the same legal framework to analyze both claims, the injuries (and the constitutional rights to be vindicated) are distinct from each other and from Counts 1 and 2. Count 3, the health and life argument, considers whether the Act imposes an undue burden on certain women with medical conditions that make a medical abortion safer than a surgical abortion, or an alternative protocol safer than the FDA protocol. Count 4, asserting a challenge based on the burden on the right to choose, considers whether thе added costs and inconveniences of the FDA-protocol, or the lack of a medical option entirely in certain contexts, will prevent a large fraction of women from exercising their constitutional right to choose abortion. The alleged injuries affect entirely separate classes of women: those whose lives may be placed at risk by the Act (Count 3) and those whose decision to choose abortion will be unduly burdened by the extra hurdles imposed by the Act (Count 4). Whether the women with health issues are burdened by the Act bears no .relation to whether the women with access issues will be burdened; proof of a constitutional violation against the rights of the former will, depend on entirely separate facts from those necessary to prove a violation against the latter.
After reviewing the operative facts necessary to give rise to relief in each claim, we hold that their differences sufficiently outweigh what they have in common. Because each count involves distinct facts relating to separate injuries, each count is a separate claim for purposes of Rule 54(b).
The second inquiry is also satisfied here. The district court independently reviewed the request for Rule 54(b) certification and issued an order expressly determining that there was no just reason for delay and expressly directing the entry of final judgment as to one or more but fewer than all claims in this case. DeWine,
(1) the relationship between the adjudicated and the unadjudicated claims; (2) the possibility that the need for review might or might not be mooted by future developments in the district court; (3) the possibility that the reviewing court might be obliged to consider the same issue a second time; (4) the presence or absence of a claim or counterclaim which could result in set-off against the judgment sought to be made final; (5) miscellaneous factors such as delay, economic and solvency considerations, shortening the time of trial, frivolity of competing claims, expense, and the like.
Corrosioneering, Inc. v. Thyssen Envtl. Sys., Inc.,
The district court considered the separateness of the claims, the unlikelihood that the need for appellate review would be mooted by future developments, the unlikelihood of duplicate review of related issues, the lack of off-setting claims, and the possibility that immediate appeal would shorten the time and expense of trial. The district court’s balancing of these issues was not an abuse of discretion. Therefore, we agree that certification under Rule 54(b) was proper in this case, and we have jurisdiction to entertain the appeal.
III. STANDARD OF REVIEW
We review de novo a district court’s grant of summary judgment. Int’l Union v. Cummins, Inc.,
IV. VAGUENESS CLAIM
Planned Parenthood’s first challenge is well-suited for summary judgment because it involves only a question of statutory interpretation. An Act criminalizing certain abortion procedures will not be unconstitutionally vague if it “provides doctors of ordinary intelligence a reasonable opportunity to know what is prohibited[,] ... sets forth relatively clear guidelines as to prohibited conduet[,] and provides objective criteria to evaluate whether a doctor has performed a prohibited procedure.” Gonzales v. Carhart,
The simple fact that the Ohio Supreme Court adopted the State’s interpretation of the Act does not mean that the Act is not unconstitutionally vague. However, we agree with the State that the Ohio Supreme Court’s explicit interpretation of the Act in Cordray resolved any facial vagueness concerns we might have had. Planned Parenthood points to four primary areas that it argues the Cordray opinion leaves unresolved. The district court rejected all of these issues as either unsupported by Cordray or cured by scienter, and we agree. See R. 161 (D. Ct. 5/23/11 Order at 13-21).
First, Planned Parenthood argues that because Cordray reached its holding by incorporating parts of the final printed labeling (“FPL”) into the approval letter, all ninety plus documents submitted in support of the approval letter must similarly be incorporated, including documents with unclear meaning. This same dilemma was presented to the Ohio Supreme Court in Cordray, however, and rejected. The Ohio Supreme Court explicitly discussed what requirеments the FDA-approval letter incorporated from the FPL and why; “the FDA based its approval of mifepristone on its use as recommended in the labeling text, thereby incorporating that text into its letter of approval.” Cordray,
Second, Planned Parenthood argues that even if only the FPL is incorporated, the Act is still vague because the FPL itself consisted of four documents, which contain internal contradictions that might confuse physicians. For example, Planned Parenthood notes that the Medication Guide recognizes that physicians prescribe drugs “off-label.” But no reasonable physician would view this reference as permitting off-label prescription of mifepristone when Cordray makes clear that physicians must stick to the FDA protocol. When a state’s highest court interprets a statute, its construction is considered part of the statute itself. Wainwright,
Third, Planned Parenthood argues that the FPL is subject to frequent revision, with no clear instruction to physicians on what would happen in the event of a revision. Appellant Br. at 32. However, the risk of possible revision is not enough to make the Act unconstitutionally vague on its face when the Act is otherwise clear. This argument was also presented and addressed by the Ohio Supreme Court. Cordray noted that despite two subsequent revisions, none had altered the gestational limits, dosage indications, or treatment protocols “originally approved by the FDA.”
Fourth, Planned Parenthood points to other supposedly vague terms still present in the Act, such as “criteria” or “provisions,” claiming that these terms make it impossible to ascertain what is prohibited. Appellant Br. at 36. But Cordray made clear what a physician must to do comply with the Act. Any risk of uncertainty regarding hidden, extra requirements is cured by the scienter provisions, which forbid penalty under the Act unless a doctor knowingly violates one of the requirements. A physician with a good-faith belief that a certain action would comply with the Act .or a рhysician who accidentally takes an action not in compliance with the Act would not be penalized. Gonzales,
V. BODILY-INTEGRITY CLAIM
Under the substantive due process clause of the Fourteenth Amendment, individuals possess a constitutional right to be free from forcible physical intrusions of their bodies against their will, absent a compelling state interest. See Winston v. Lee,
The Fourteenth Amendment undoubtedly protects as a liberty interest the right against forcible physical intrusions of the body by the government. Rochin v. California,
Although we understand why Planned Parenthood took this approach — requiring the government to show a compelling state interest for the Act would relieve Planned Parenthood of its obligation to show an undue burden on the right to choose an abortion — this argument is unconvincing. “Strict scrutiny, of course, no longer applies to abortion legislation.” Women’s Med. Prof'l Corp. v. Taft,
We emphasize, however, that policies restricting a method of abortion do impact a woman’s right to bodily integrity. “As far back as 1891, the Supreme Court recognized that no right is held more sacred, or is more carefully guarded[,] than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority of law.” Kallstrom v. City of Columbus,
By making a bodily-integrity claim part and parcel with a right-to-privacy claim, Casey and its progeny serve as the proper cases for examining bodily-integrity claims in the abortion context. In light of these abortion-specific cases applying the undue-burden framework, there is little constitutional support for Planned Parenthood’s attempt to return to the stricter balancing standard used in traditional bodily-integrity claims. Thus, the argument that the Ohio restrictions unduly impact a woman’s right to bodily integrity is a viable claim, but, from a purely legаl perspective, the analysis will map the undue-burden framework set out in Planned Parenthood’s third claim of constitutional infirmity.
VI. UNDUE-BURDEN CLAIM
(Judge Moore’s Partial Dissent)
“ ‘[A] law designed to further the State’s interest in fetal life which imposes an undue burden on the woman’s decision before fetal viability’ is unconstitutional.” Stenberg v. Carhart,
A number of adverse effects
A. Outright Ban on Medical Abortions During 50 to 63 Days LMP
The Supreme Court has not explicitly defined when a total method ban constitutes a “substantial obstacle” to a woman’s exercise of her rights. Planned Parenthood argues that any regulation that prohibits a “commonly used method” of abortion is a substantial obstacle and therefore imposes an undue burden. The State argues that regulations banning a particular method are a substantial obstacle only if they serve to inhibit the “vast majority” of abortions such as by banning the “most common” procedure for obtaining those abortions.
The Supreme Court first addressed complete bans on a particular method in Planned Parenthood of Central Missouri v. Danforth,
The only other previability method bans reviewed by the Supreme Court involve partial-birth abortion techniques in the second trimester. In Stenberg, similarly to Danforth, the Supreme Court held that
In Gonzales, the Supreme Court upheld a federal abortion ban because the statute prohibited only D & X abortions (called “intact D & E” abortions in the opinion), and the plaintiffs had failed to show “that the Act would be unconstitutional in a large fraction of relevant cases.” Gonzales,
This court has also addressed method bans similar to the ones in Danforth, Stenberg, and Gonzales. In Wolfe v. Schroering,
What these cases tell us is that, at the least, statutes banning the most common method of an abortion impose an unconstitutional burden on a woman’s rights. The cases do not engage in a strict mathematical inquiry of percentages to identify the frequence of a procedure, nor, as facial challenges, do they demand affidavits from women indicating that they would not obtain an abortion via some other lawful method if D & E abortions were made unavailable. We can safely presume that a statute banning the most common method of abortions for a certain group of women imposes a substantial obstacle on the ability of a woman to obtain an abortion. But that does not tell us whether a ban on any common method could not also constitute a
The State relies heavily on the use of the phrase “vast majority” in Supreme Court jurisprudence when describing the most common method to suggest that any common method can be banned so long as the most common method remains. In Gonzales, the Supreme Court stated that the ban on D & X abortions “cannot be held invalid on its face” because the requirement would not “prohibit the vast majority of D & E abortions.” Gonzales,
In Gonzales, the Supreme Court highlighted the similarities between D & E abortions and D & X abortions, which the opinion even calls “intact D & E” abortions because they are a “D & E variation.” Gonzales,
The frequency of the D & X method, although statistically unclear with any certainty, was also very infrequent relative to standard D & E abortions. The Supreme Court referenced the district court opinion for many of its facts, which noted that most doctors reported D & X abortions occurring in five to fifteen percent of all D & E procedures; D & E abortions as a whole, depending on the gestational age, constituted between eighty-five to ninety-five percent of second-trimester abortions. See Planned Parenthood Fed’n of Am. v. Ashcroft,
With that in mind, I turn to the facts of this case. When viewed in the light most favorable to Planned Parenthood, the evidence suggests that medical abortions were elected over surgical abortions on average by about thirty-one percent of Planned Parenthood’s patients in 2009. The State reminds us that Planned Parenthood is not the only abortion provider in Ohio, but even the State’s number, that 17.7% of cases in 2008 were medical/nonsurgical, is a non-trivial percentage. And, in the very study cited by the State for its statistic, the Ohio Department of Health observed that FDA approval of mifepristone “was expected to shift many of the early abortions from surgical to non-surgical methods.” Ohio Department of Health, Induced Abortions in Ohio (2008), available online at http://www.odh.ohio. gov/healthstats/vitalstats/abortion mainpage.aspx. Indeed, by 2010, that same category had increased to 20 percent.
We should not expect Planned Parenthood to present specific numbers of women who would not have obtained a surgical abortion at all had the medical abortion been unavailable. As an initial matter, the Act was not enforced in Ohio until February 2011 when the district court clarified the scope of the preliminary injunction. Planned Parenthood suspended the provision of medical abortions at its Ohio clinics in January 2011. See, e.g., R. 153-1 (2d Brenner Decl. at ¶ 3) (Page ID # 2535). Since then, Planned Parenthood had to deny medical abortions to between 50 and 100 women. R. 153 (Pis.’ Mem. Prelim. Inj. at 4) (Page ID #2516). The majority fixates on the 'affidavits of nine of those women who testified that they thereafter obtained a surgical abortion, despite the extra anxiety and pain it caused them, as conclusively establishing as a matter of law that the method ban in this case does not impose a substantial obstacle in a large fraction of women. But women deterred by the ban who decided not to obtain any abortion at all would be unlikely to return to Planned Parenthood’s clinics or volunteer to give their names or testimony.
More importantly, the majority points to no case either from our court or the Supreme Court requiring affirmative testimony from individual women that they would not have obtained an abortion but for the ban to establish that a total method ban imposes a substantial obstacle. See Stenberg,
Nor has the Supreme Court defined “substantial obstacle” as requiring a showing of a total obstacle. Just by examining the physical differences between the methods, our common sense tells us that the differences between the procedures from the perspective of the woman are substantial. Surgical abortions, as the name suggests, require surgery, a physically invasive procedure, including
At the very least, the frequency of medical abortions among women prevents us from concluding as a matter of law that medical abortions do not constitute a “large fraction” among women within the specific gestational time frame banned by the Act — 50 to 68 days LMP. The sheer fact that roughly a third of Planned Parenthood’s patients have eleсted a medical abortion over a surgical abortion suggests that eliminating medical abortions may cause a large fraction of women to forego having an abortion altogether. The State’s own statistics suggest a rise in popularity of this procedure, and the Supreme Court itself has acknowledged that the most common procedure can change over time. Stenberg,
B. Restrictions on Dosage and Treatment Protocols
That brings us to the restrictions that the Act imposes on medical abortions during the first 49 days LMP. “[N]ot every law which makes a right more difficult to exercise is, ipso facto, an infringement of that right.” Casey,
In light of these cases, I agree -with the district court that requiring a third doctor’s visit adds an insubstantial cost to procuring a medical abortion. The extra visit appears no different from the extra visit caused by a 24-hour waiting period, which the Supreme Court has explicitly
The majority again feels comfortable resolving these fact questions on summary judgment against Planned Parenthood due to the price difference between surgical abortions and medical abortions. But the majority ignores the fact that the very reason surgical abortions are now less expensive is because the Act requires the medical abortions to use more medicine. Again, a “substantial obstacle” has never been defined as a total obstacle. And in evaluating the impact of restrictions, rarely do courts rely exclusively on percentages. See id. at 374 (“[T]he term ‘large fraction,’ which, in a way, is more conceptual than mathematical, envisions something more than the 12 out of 100 women identified here.”); Planned Parenthood, Sioux Falls Clinic v. Miller,
The extent of the Act’s burden on a woman’s constitutional rights, as it relates to the gestational limits and the dosage requirements, is a genuinely disputed issue of material fact not ripe for summary judgment in this case. Therefore, I dissent from the contrary view expressed in Judge McKeague’s majority opinion.
VII. CONCLUSION
For the reasons expressed in Parts I through V and in Judge McKeague’s opinion, the judgment of the district court is AFFIRMED.
Notes
. The State objects to the admissibility of the declaration of Dr. Maureen Paul. The district court has not yet ruled on the admissibility of her testimony, and we take no position on this evidentiary matter. We cite only her statements that are undisputed by the State.
. The Act does not explicitly ban or regulate the prescription of misoprostol, which has not
. The main FDA documents were filed before the district court on plaintiffs’ motion for a permanent injunction, which were then submitted to this panel as a Joint Appendix in the prior appeal. The exhibits were resubmitted by the parties to the district court for consideration on the summary-judgment motions; for. ease of reference, we continue to cite the prior Joint Appendix to the extent that the parties relied on the same exhibits in support of summary judgment.
. The FDA regulates the marketing and distribution of drugs by manufacturers, not the practices of physicians in treating patients. However, manufacturers can apply to the FDA to update a drug's approval letter based on new studies. That has not been done in this case.
. Because the FDA protocol stops at 49 days LMP, all of the women between 49 and 63 days LMP would be using a non-FDA protocol regarding the gestational time limits and presumably the dosages would also mirror a non-FDA protocol as а result.
.The State responds that Planned Parenthood may very well have recommended that its patients choose an alternative regimen.
. Clawson estimated an increase in cost from $410 to $700 when the extra medication as well as the extra clinic visit are both considered. R. 134-4 (Clawson Decl. ¶ 12) (Page ID #2151).
.Medical abortions may also be performed using just a high dose of misoprostol, or by using the drug methotrexate in combination with misoprostol. The parties debate the safety, prevalence, and efficacy of these alternative medical abortions, but do not dispute that neither misoprostol nor methotrexate has been approved by the FDA for use in abortions. Planned Parenthood has a nationwide policy of not offering medical abortions with methotrexate because of the lack of medical evidence on its safety. At the preliminary injunction hearing, the plaintiffs' expert testified that methotrexate poses greater health risks than mifepristone when used for medical abortions, and we have previously determined this to be a fact that the State did not contest. Taft II,
. The 2010 version of that same report, also publicly available online at http://www.odh. ohio.gov/healthstats/vitalstats/abortion mainpage.aspx, indicates that the percentage of medical/non-surgical abortions increased to 20%.
. Planned Parenthood rejects the State’s argument that this shows the FDA plan is safer, noting that the statistic is also explained by the overall prevalence of the alternative regimen over the FDA protocols. Appellant Br. at 15 & n. 8.
. Bob Taft was the Governor of Ohio at the time, succeeded by Ted Strickland. The parties have since stipulated to the dismissal of the Governor. Appellant Br. at 3 n. 2. The lead defendant is now Ohio’s Attorney General, Mike DeWine.
. On remand, the district court also clarified the scope of the preliminary injunction to prohibit enforcement of the Act “only insofar as it prohibits off-label mifepristone abortions that are 'necessary, in appropriate medical judgment, for the preservation of the life or health of the mother.' ” Planned Parenthood Cincinnati Region v. Dewine, No. 1:04-CV-493,
. Indeed, in the context of res judicata where a similar inquiry regarding “operative facts” is frequently made, the Seventh Circuit has advised that “courts should examine the 'facts’ of a case at a sufficient level of specificity”-and not consider them too broadly or too narrowly when identifying individual transactions, defined as “a single core of operative facts which give rise to a remedy.” Andersen v. Chrysler Corp., 99 F.3d 846, 852-53 (7th
. The lead opinion in Cordray is only a plurality; however, a majority of justices joined the syllabus and the judgment, which clearly incorporated the final printed labeling's gestational limits, treatment protocols, and dosage indications into the FDA approval letter. Cordray,
. The opinion also references "three office visits,” defeating Planned Parenthood's argument that the Act is unclear regarding whether the misoprostol can be administered at home; it cannot. Cordray,
. Bodily integrity claims have occasionally been given strict-scrutiny review by the lower courts. Kallstrom v. City of Columbus,
. Although Casey discusses the "purpose or effect” of the challenged legislation, Planned Parenthood does not attempt to argue that Ohio had an illicit purpose in passing the Act
. Casey itself was not a method-ban case and analyzed whether certain restrictions such as informed-consent and spousal-notification laws constituted an undue burden. Casey,
. The State seizes on the fact that we later repeated the "most common[]” language when discussing a state ban on D & X procedures, see Women’s Med.,
. I therefore reject the State's position that Planned Parenthood must explicitly “quantify the number of women deterred’’ in order to make its case. Appellee Br. at 47 n. 7.
Concurrence Opinion
concurring in part and writing the majority as to Part VI.
I agree with Judge Moore’s opinion as to parts I-V. I write separately with regard to Planned Parenthood’s undue burden claim because, as Judge Dlott’s well-reasoned opinion stated: “Even viewing the evidence in the light most favorable to [Planned Parenthood], it is clear that the record does not create a triable issue of material fact as to whether the Act has the effect of creating a substantial
As Judge Moore’s opinion correctly notes, we must view the inferences to be drawn from the underlying facts in the light most favorable to Planned Parenthood. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp.,
A. Method Ban on Medical Abortions 50-63 days LMP
It is true that governing case law analyzing method bans in the context of “partial-birth” techniques does not provide controlling guidance for this case. At most, the Supreme Court in Gonzales v. Carhart,
But here, viewing the evidence in the light most favorable to Planned Parenthood, we examine a method preferred by approximately 31% of women to whom it is available. Because jurisprudence from the Supreme Court and this Circuit does not clearly address a method ban comparable to the instant one, we áre left to apply the more general undue-burden standard. Thus, for Planned Parenthood to survive summary judgment, there must be a genuine dispute of material fact as to whether “ ‘in a large fraction of the cases in which [the Act] is relevant, it will operate as a substantial obstacle to a woman’s choice to undergo an abortion.’ ” Women’s Med. Prof. Corp. v. Voinovich,
Importantly, the Supreme Court has not articulated any rule that would suggest that the right to choose abortion encompasses the right to choose a particular
Planned Parenthood submitted a list of disputed issues of material fact in opposition to summary judgment. Assuming the evidence therein is admissible, the organization alleges that “first trimester surgical abortion is an invasive procedure that many women seek to avoid” and that abortion is an emotional procedure and there are many factors that affect the particular procedure a woman may elect. (Plaintiffs Resp. to Ohio’s Prop. Undisputed Facts, Page ID #2072.) The organization also submits that “[o]nce women are counseled about both medication and surgical abortion, most women demonstrate a strong and clear preference for the type of procedure [that they] choose and are satisfied with that method.” (Id. at Page ID # 2073.) Some of the specific reasons that Planned Parenthood says “[w]omen choose medication” are a higher degree of personal control, the feeling that a medical abortion is more natural, and the ability to execute a medical abortion in the privacy of the woman’s home. (Id.) Finally, Planned Parenthood states “for victims of rape, or for women who have experienced sexual abuse or molestation, medication abortion is often less traumatic ... [and] many women simply fear invasive surgery....” (Id.)
Planned Parenthood also offered the affidavits of nine women, some of whom had their scheduled medication abortion can-celled because of the Act. For example, one woman stated she was upset and sad because she felt a medical abortion was more natural, but she had scheduled a surgical abortion anyway. (Dawn Doe Aff., Page ID # 2574-75.) Another woman said that her daughter “wanted her abortion experience to be the least invasive possible, and wanted to have the abortion in the privacy of our home.” (Leslie Doe Aff., Page ID # 2558.) When the medical abortion was cancelled, her daughter went forward with the surgical procedure on the scheduled day. (Id. at Page ID #2559.) She added that her daughter was “nervous and scared [about the surgical procedure], and at the same time relieved that she was going to terminate the pregnancy.” (Id.) Another woman said that' she was “shocked by the news and scared” about the surgical procedure, but decided to go ahead with it on the scheduled day. (Maria Doe Aff., Page ID #2653.) Another woman said she felt “very frustrated and exasperated with the situation” but “decided to go ahead with the surgical procedure that day.” (Doreen Doe Aff., Page ID # 2555.)
All of these statements give rise to the inference that some women prefer a medi
I agree with the common-sense inference that because “the differences between the procedures from the perspective of the woman are substantial,” some — maybe even most — women will prefer medical abortion over surgical abortion. See ante at ¶ 56. However, our consideration cannot end there. The abortion right as it has been described by the Supreme Court protects the “freedom to decide whether to terminate” a pregnancy. Casey,
Accordingly, the district court properly granted summary judgment with regard to the method ban for women 50-63 days LMP.
B. Increased Dosage
The district court also properly found that Planned Parenthood failed to allege sufficient evidence to survive summary judgment on its claim that the added cost associated with increased dosage under the Act creates an undue burden.
Planned Parenthood alleges a “significant” increase in the cost of a medical abortion due to the increased dosage of mifepristone required by the Act. (Plaintiffs Resp. to Ohio’s Prop. Undisputed Facts, Page ID # 2072.) More concretely, the organization submitted affidavits from clinic directors indicating an increase of $150. (See, e.g., Harrington Aff. ¶ 8, Page ID # 2180; Brenner Aff. ¶ 9, Page ID #2114.) Viewing the evidence submitted in the light most favorable to the organization, that would constitute an increase of more than 40% over what medical abortion currently costs. (See Harrington, Page ID # 2180.) Notably, before the Act, surgical abortion was offered at the same price as medical abortion in all of the clinics that submitted affidavits. (See id. (both procedures currently cost $360); Brenner, Page ID # 2114 (both procedures currently cost $545); Clawson Aff. ¶ 12, Page ID # 2151 (both procedures currently cost $410); Lonn Aff. ¶ 9, Page ID # 2186 (both procedures currently cost $450)). So, unless the cost of surgical abortion is independently raised, the alleged increased cost of medical abortion would make surgical abortion a less-expensive option. Planned Parenthood also submitted the affidavit of a woman who stated: “If a medication abortion were offered at a price that was $100-$200 higher than a surgical abortion, it would be really difficult for me. I am not certain I would be able to still choose medication, though I would try to raise more money, because it would be worth a lot to me.” (Emily Poe Aff., Page ID # 2565.)
The findings of fact ... indicate that because of the distances many women must travel to reach an abortion provider, the practical effect will often be a delay of much more than a day because the waiting period requires that a woman seeking an abortion make at least two visits to the doctor. [I]n many instances this will increase the exposure of women seeking abortions to “the harassment and hostility of anti-abortion protestors demonstrating outside a clinic.” As a result, ... for those women who have the fewest financial resources, those who must travel long distances, and those who have difficulty explaining their whereabouts to husbands, employers, or others, the 24-hour waiting period will be “particularly burdensome.”
Casey,
In Women’s Med. Prof. Corp. v. Baird,
Similarly here, Planned Parenthood has not placed on the record any evidence suggesting that the added cost of a medical abortion would unduly burden the right to choose abortion for a large fraction of affected women. Moreover, the evidence submitted by Planned Parenthood shows that surgical abortion remains available at a lower price. In fact, the only woman who mentioned the increased cost in her statement specifically said that this would make it difficult for her to choose medical abortion, but not that it would be a burden on her choice to abort her pregnancy. This evidence does not give rise to a reasonable inference that the dosage increase is a substantial obstacle to the choice to undergo abortion.
Even more than in the method-ban analysis, we cannot infer a substantial obstacle from the evidence submitted regarding the increased dosage requirement. The record arguably supports an inference that the increased cost would burden women’s ability to choose medical abortion, which may be their preferred method. However, that does not permit a reasonable inference that an undue burden on the constitutionally protected “freedom to decide whether to terminate” a pregnancy would result. Casey,
Thus, the district court properly granted summary judgment on this claim as well.
. Judge Moore refers to this conclusion as "resolving these fact questions,” and "conclusively establishing as a matter of law that the method ban in this case does not impose a substantial obstacle....” See ante at ¶¶ 57, 63. Not at all. Instead, on the record before us and under the summary judgment standard, Planned Parenthood did not sustain its burden of adducing enough evidence to create a genuine question of fact. For an issue of fact to be genuine, the nonmovant must do more than simply show that there is some metaphysical doubt as to the material facts. Matsushita Elec.. Indus. Co., Ltd. v. Zenith Radio Corp.,