Court: Court of Appeals for the Sixth Circuit; April 13, 2006; Federal Appellate Court
Plaintiffs in the case Planned Parenthood Cincinnati Region v. Bob Taft challenge an Ohio statute that restricts the off-label use of the abortion drug mifepristone (RU-486). The district court issued a preliminary injunction against the statute's enforcement on two grounds, prompting the State to file an interlocutory appeal. The appellate court found the district court's primary reasoning to be erroneous but upheld its alternative reasoning. The court vacated part of the district court's order and remanded the case for reevaluation of the injunctive relief scope, referencing the U.S. Supreme Court's ruling in Ayotte v. Planned Parenthood of Northern New England. Prior to 2000, most first-trimester abortions were surgical; however, the FDA approved mifepristone in September 2000, permitting its use as a non-surgical method based on clinical trials indicating its safety and efficacy up to forty-nine days' gestation. The FDA's approval specified a regimen of 600 mg of mifepristone followed by 0.4 mg of misoprostol two days later. While mifepristone's use is regulated by the FDA, physicians may prescribe it off-label without violating federal law, as the practice of medicine falls under state jurisdiction.
Following FDA-approved clinical trials, subsequent research led to the development of an off-label regimen for administering mifepristone and misoprostol, known as the Schaff protocol. This protocol involves administering 200 mg of mifepristone orally, followed by 0.8 mg of misoprostol vaginally one to three days later, and is used for medical abortions up to sixty-three days' gestation. It is endorsed by the National Abortion Federation and Planned Parenthood and is widely used in the U.S.
In 2004, Ohio enacted H.B. 126, which regulates mifepristone use, stipulating that only physicians who meet federal criteria may prescribe it for abortion purposes and must adhere to FDA-approved methods. The Act defines "federal law" as encompassing all relevant regulations governing mifepristone's use, which implies a prohibition on off-label applications. The State justified the Act by citing concerns over abortion providers using the Schaff protocol and reported incidents of severe complications from mifepristone use. The Act was intended to protect women from unsafe practices and was set to take effect on September 23, 2004.
In response, Dr. Roslyn Kade, Dr. Laszlo Sogor, and various Planned Parenthood chapters filed a lawsuit challenging the constitutionality of the Act. They argue that it is vague, infringes on a patient's bodily integrity by forcing surgical procedures when medical abortion is preferable, lacks necessary health exceptions, and imposes an undue burden on the right to choose abortion by banning a widely used method. The defendants include Ohio's Governor Bob Taft, Attorney General Jim Petro, and Hamilton County Prosecuting Attorney Michael K. Allen, representing a class of all Ohio prosecuting attorneys.
Plaintiffs sought a preliminary injunction before the Act's implementation, resulting in a two-day evidentiary hearing where both sides presented expert testimonies. The district court granted the injunction, primarily based on the Plaintiffs' assertion that the statute required a health or life exception. The court did not consider the other three arguments presented by the Plaintiffs. The State appealed the decision, and the Sixth Circuit's review is constrained to determining whether there was an abuse of discretion by the district court, which involves assessing factual findings for clear error and legal conclusions de novo. The district court cited Supreme Court precedent asserting that abortion regulations must include a health or life exception, viewing this as a per se requirement. The State contends that such a requirement applies only to statutes that directly threaten women's health or lives. However, the district court provided minimal justification for this per se stance, and a review of relevant case law does not support a blanket requirement. Notably, in Planned Parenthood v. Casey, the Supreme Court reiterated that while a woman has the right to an abortion pre-viability without undue state interference, post-viability restrictions are permissible except when a woman's health or life is at risk. Additionally, Stenberg v. Carhart clarified that health exceptions are necessary for all abortion regulations at any pregnancy stage, suggesting that the requirement for a health exception should apply to both pre- and post-viability regulations. The State's challenge reflects a misunderstanding of these distinct but related arguments.
A pre-viability regulation requiring a health or life exception must be assessed through the undue burden standard, as established in Casey. The State asserts that such an exception is only necessary if its absence imposes an undue burden. However, the Supreme Court has clarified that the necessity of a health or life exception is distinct from the undue burden analysis. In Carhart, the Court invalidated a statute for imposing an undue burden while explicitly stating that it required a health exception, indicating that the two issues are independently relevant. The State's argument challenges a district court's imposition of a per se requirement for health exceptions, based on a single statement from Casey. This statement must be interpreted alongside other Supreme Court rulings, which emphasize that states cannot restrict access to abortions necessary for the mother's life or health. The Court’s previous decisions, including Carhart, which invalidated a law lacking a health exception despite having a life exception, further demonstrate the need for such exceptions when appropriate medical judgment dictates. The arguments presented by the State do not sufficiently justify the absence of a health exception in Nebraska’s law.
A health exception is deemed necessary under the law for abortion statutes, but it is not a per se requirement. The Court's analysis indicates that simply noting an abortion statute lacks a health exception does not alone constitute a constitutional violation. Various circuit courts have addressed the necessity of health exceptions differently. The First Circuit acknowledges a health or life exception but indicates that the Supreme Court's prior cases suggest exceptions are required only when a woman's health is endangered. The Ninth Circuit's reference to a "per se constitutional requirement" for health exceptions is contextual and does not align with the district court's interpretation. Similarly, the Fourth and Eighth Circuits have discussed health exception requirements but did not support the district court’s broad application of a per se rule. The Tenth Circuit's considerations imply that health exceptions are necessary only when statutes pose a risk to health or life, contrasting with a blanket requirement. Therefore, the district court's conclusion of a per se necessity for health exceptions is incorrect, necessitating a review of its alternative findings.
The district court determined that Plaintiffs demonstrated a substantial likelihood of success on the merits regarding the constitutionality of a statute affecting abortion, asserting that the State must prove the absence of significant health risks to uphold the statute without a health or life exception. The State contested this burden of proof and the conclusion that evidence presented during the preliminary injunction hearing indicated the necessity of such an exception. However, the court concluded that the evidence was sufficient to support the need for a health or life exception, independent of which party bore the burden of proof.
The legal standard established by the Supreme Court in the Carhart case dictates that while states are not required to grant physicians unrestricted discretion in abortion methods, they must include a health exception when substantial medical authority indicates that banning a procedure could jeopardize women's health. A health exception is constitutionally required when it is shown that a banned procedure would be safer than available alternatives, particularly in circumstances where the statute poses significant health risks.
During the preliminary injunction hearing, expert testimony from two doctors highlighted that enforcing the statute would create significant health risks for women in specific scenarios where alternatives pose greater risks, such as in cases of a bicornuate uterus and other medical conditions. Although the Plaintiffs acknowledged that surgical abortions generally present no greater risks than medical abortions for most women, they argued that for those with certain health conditions, medical abortions using mifepristone would be significantly less risky. The State's expert, Dr. Crockett, acknowledged that in rare cases where surgical abortion is necessary, mifepristone may also be contraindicated, but did not refute the testimony that for some women, surgical abortion can be riskier than a medical abortion. Additionally, the record indicated a high success rate of at least ninety percent for mifepristone medical abortions.
Dr. Crockett's sworn statement lacks merit as it contends that patients should not be allowed to opt for a less risky medical abortion over a more risky surgical abortion based on a minimal chance (ten percent or less) that the surgical option may ultimately be necessary. This statement is the only evidence presented by the State at the preliminary injunction stage regarding the risks associated with medical versus surgical abortions. The State cited the cross-examination of Dr. Schaff, a plaintiff's expert, who acknowledged that methotrexate, an unregulated drug, can be safely used for medical abortions. However, Dr. Schaff clarified that methotrexate is less safe than mifepristone, explaining that while methotrexate is effective in terminating early pregnancies due to its action on rapidly dividing cells, it is also toxic to all rapidly dividing cells, posing greater health risks.
The State did not provide any evidence contradicting Dr. Schaff’s assertion that methotrexate presents higher health risks compared to mifepristone. Both plaintiffs' experts affirmed that methotrexate and mifepristone are the only drugs for medical abortions. Dr. Crockett's claim that there are other medical methods to evacuate the uterus is irrelevant, as mifepristone's purpose is to terminate the pregnancy, with misoprostol (also unregulated) used for evacuation. No evidence was presented that alternatives to methotrexate would be available for medical abortions between seven and nine weeks' gestation if the Act were enacted.
The medical authority at the preliminary injunction phase found mifepristone to be the safest method, with significantly less risk to a specific group of women compared to surgical abortion. Although the State referenced a Supreme Court case supporting a statute limiting abortion providers to doctors to enhance safety, it failed to address that the necessity of a statute as a safety measure does not negate the need for health exceptions in scenarios where a banned procedure could be significantly safer. The Mazurek case does not clarify this issue, as no health or life risks were identified concerning the statute in question.
The State presents several arguments regarding the safety and availability of surgical versus medical abortions, primarily focusing on mifepristone. While acknowledging that surgical abortion is generally safe, the State fails to address expert testimony indicating that surgical options can be riskier for certain women in specific circumstances. The absence of studies demonstrating that mifepristone is the safest option under particular conditions does not negate the relevance of expert testimony, which the Supreme Court has indicated is sufficient to justify the use of a restricted procedure. The State claims that Plaintiffs' expert's testimony shows mifepristone is dangerous past seven weeks’ gestation, but the record does not support this assertion. Additionally, the State argues that Dr. Schaff's protocol is less safe than the FDA-approved one; however, this comparison is irrelevant to the necessity of a health or life exception. The court must evaluate the safety of mifepristone against available alternatives after seven weeks, and the State did not provide evidence that any alternative is as safe or safer in all foreseeable medical scenarios. The evidence at the preliminary injunction stage does not substantiate the State's claim that the Act can constitutionally exclude a health or life exception. The Supreme Court's Carhart decision established that such exceptions are necessary when specific health risks are mitigated by the banned procedure, supported by plausible expert testimony and conflicting expert opinions. The court found that Plaintiffs met these criteria, presenting uncontradicted expert evidence that mifepristone could be safer than other methods. Consequently, the district court's conclusion that Plaintiffs are likely to prevail on the merits is upheld. The State's argument regarding the exclusion of Dr. Crockett as an expert on medical and surgical abortion, due to her lack of experience performing elective procedures, is viewed as an abuse of discretion by the district court.
The State contends that expertise in elective abortion procedures can be established through means other than performing those procedures, arguing that requiring such experience would hinder the availability of expert witnesses. The district court judge indicated that a doctor's performance of elective abortions does not determine their expert recognition, focusing instead on their qualifications and experience. However, there is concern that the judge's decision not to recognize Dr. Crockett as an expert may have been influenced by her lack of experience in performing elective abortions. The court emphasizes that it need not address this issue now, as Dr. Crockett's testimony would not have altered the outcome of the Plaintiffs' motion for a preliminary injunction.
Dr. Crockett's testimony included criticism of studies by Plaintiffs' experts regarding the Schaff protocol's efficacy compared to an FDA-approved protocol, but the effectiveness debate does not influence whether the Act must include a health or life exception. Additionally, her hypothesis about dosage efficacy is similarly unrelated to the core issue. The State also argues that the district court erred in enjoining the entire Act, including non-controversial reporting and record-keeping provisions, without suggesting a more limited injunction that could align with Supreme Court precedent (Ayotte v. Planned Parenthood) regarding the need for health or life exceptions. The Plaintiffs assert that the State's argument on severability was not properly raised, as it was inadequately presented at the trial court level, leading to a waiver of this argument during the preliminary injunction phase.
The appropriateness of the preliminary injunction's scope is closely linked to the Ayotte decision's implications. Although the State did not challenge this broader issue, it should not be penalized for not raising an argument that lacked legal support at the time. Waiving such an argument under these circumstances would be inequitable and counterproductive, as noted in Hormel v. Helvering, which stresses the importance of addressing waived issues when intervening case law could alter outcomes. In Ayotte, the Supreme Court ruled that if enforcing a statute regulating abortion is unconstitutional during medical emergencies, it is not always necessary to invalidate the statute entirely. Instead, lower courts may provide narrower relief by prohibiting only the unconstitutional applications of the statute. However, complete invalidation is warranted if the legislature prefers no statute over one that is partially enjoined. The Court remanded the case for lower courts to ascertain legislative intent but did not vacate the underlying injunction, which is significant as the Court typically vacates injunctions explicitly when desired. Absent a new automatic-vacatur rule from Ayotte, a conventional approach to overbroad injunctions is appropriate. Courts generally vacate only the overly broad portions of an injunction while maintaining the remaining parts, as demonstrated in various cases where injunctions were modified or vacated in part for being too broad.
The court affirmed one basis for the preliminary injunction but vacated another aspect related to broader applications. It referenced the Supreme Court's precedent in Guste v. Jackson, where an overbroad injunction was narrowed, allowing for the enforcement of certain statutory provisions. The district court's order was partially vacated, maintaining the injunction against unconstitutional applications of the statute while requiring a reassessment of whether a broader injunction is necessary. This reassessment should consider legislative intent and unresolved claims regarding vagueness, bodily integrity, and undue burden. The State's challenge focused on the district court's finding of a strong likelihood of success for the Plaintiffs, which the court found was based on an erroneous requirement for a health or life exception in abortion regulations. However, substantial medical evidence indicated that the Act could significantly risk women's health, supporting the district court's conclusion without abuse of discretion. The court affirmed the preliminary injunction against unconstitutional applications of the Act but vacated it concerning constitutional applications, remanding the case for further determination of the injunction's appropriate scope.
Misoprostol, a prostaglandin, facilitates uterine contractions to expel the fetus and other conception products. The American College of Obstetricians and Gynecologists (ACOG), after the appeal was briefed, released a bulletin indicating that the Schaff protocol offers benefits over the FDA protocol, such as lower rates of continuing pregnancies, quicker expulsions, fewer side effects, improved abortion rates, and reduced costs for pregnancies up to 63 days' gestation. ACOG's earlier bulletin from 2001 had only endorsed the FDA protocol and discouraged medical abortion after 49 days. There is no evidence in the case record indicating severe injuries or deaths from an off-label mifepristone protocol, aside from one reported death linked to its use in an ectopic pregnancy, which is contraindicated. Two cases of severe bacterial infections and one heart attack occurred post-mifepristone, but no causal links were established. The efficacy of the Schaff protocol is disputed, with the State asserting a maximum failure rate of 10%. The State did not contest the risks of surgical abortion as outlined by Plaintiffs' experts. The absence of evidence during the preliminary injunction does not rule out existing medical knowledge, as procedural constraints may have limited the State's case presentation. The State did not appeal the district court's refusal to qualify Dr. Crockett as an expert in medical literature review, despite her claims of relevant training and experience, which the court dismissed.
Qualifications presented by the plaintiffs are deemed adequate to establish their expertise in the case at hand. The court allows for the consideration of the American College of Obstetricians and Gynecologists' updated support for the mifepristone protocol during remand. Judge Moore concurs with the majority on the plaintiffs’ likelihood of success on the merits and agrees that the preliminary injunction should be partially vacated and remanded for reevaluation. She also concurs that the district court's limitation on the state's expert witness's testimony, Dr. Susan Crockett, is irrelevant to the appeal's outcome, and thus finds the majority's detailed examination of this evidentiary ruling unnecessary.
The plaintiffs provided substantial evidence supporting the safety of the abortion procedure in question, which the state attempted to counter through Dr. Crockett's testimony, some of which was excluded by the district court. However, the court cites precedent, noting that the presence of differing medical opinions does not inherently refute the plaintiffs' position, particularly when there is significant medical consensus in their favor. Even if the district court's exclusion of evidence was erroneous, it would not alter the appeal's result. The majority acknowledges that Dr. Crockett's testimony would not have been sufficient to undermine the plaintiffs' motion for a preliminary injunction, yet Judge Moore criticizes the majority for unnecessarily analyzing this evidentiary issue when it has no bearing on the case's outcome.
