Planned Parenthood Cincinnati v. Taft

• Decision Date: 13 April 2006
• Docket Number: No. 04-4371.,04-4371.
• Citation: 444 F.3d 502
• Parties: PLANNED PARENTHOOD CINCINNATI REGION, et al. Plaintiffs-Appellees, v. Bob TAFT, et al., Defendants-Appellants.
• Court: U.S. Court of Appeals — Sixth Circuit

444 F.3d 502

PLANNED PARENTHOOD CINCINNATI REGION, et al. Plaintiffs-Appellees, v. Bob TAFT, et al., Defendants-Appellants.

No. 04-4371.

United States Court of Appeals, Sixth Circuit.

Argued: December 7, 2005.

Decided and Filed: April 13, 2006.

COPYRIGHT MATERIAL OMITTED

ARGUED:

Anne Berry Strait, Office of the Attorney General, Charitable Law Section, for Appellants. Nicole G. Berner, Planned Parenthood Federation of America, Washington, D.C., for Appellees.

ON BRIEF:

Anne Berry Strait, Office of the Attorney General, Charitable Law Section, Columbus, Ohio, Sharon A. Jennings, Holly J. Hunt, Office of the Attorney General of Ohio, Constitutional Offices Section, Columbus, Ohio, for Appellants. Nicole G. Berner, Planned Parenthood Federation of America, Washington, D.C., Alphonse A. Gerhardstein, Gerhardstein, Branch & Laufman, Cincinnati, Ohio, Roger K. Evans, Mimi Y.C. Liu, Planned Parenthood Federation of America, New York, New York, Jeffrey M. Gamso, American Civil Liberties Union of Ohio Foundation, Cleveland, Ohio, Jessie Hill, Case Western Reserve University School of Law, Cleveland, Ohio, for Appellees. Peter O. Safir, Kelly A. Falconer, Covington & Burling, Washington, D.C., for Amicus Curiae.

Before: MOORE, ROGERS, and McKEAGUE Circuit Judges.

McKEAGUE, J., delivered the opinion of the court, in which ROGERS, J., joined.

MOORE, J. (p. 518-519), delivered a separate opinion concurring in part.

AMENDED OPINION

McKEAGUE, Circuit Judge.

This matter is before the court on Plaintiffs' petition for panel rehearing. Upon consideration of the relevant briefs and the record, we vacate our prior opinion, Planned Parenthood v. Taft, 439 F.3d 304 (6th Cir.2006), and replace it with this amended opinion.

Plaintiffs challenge an Ohio statute which prohibits the off-label use of the abortion drug mifepristone (more commonly known as RU-486). The district court granted a preliminary injunction enjoining enforcement of the statute on two alternative grounds. The State timely filed an interlocutory appeal. For the following reasons, we hold that the district court's primary holding was error, but affirm the reasoning of the district court's alternative holding. Nevertheless, we vacate the district court's order in part and remand for consideration of the appropriate scope of injunctive relief in light of the United States Supreme Court's recent decision in Ayotte v. Planned Parenthood of Northern New England, ___ U.S. ___, 126 S.Ct. 961, 163 L.Ed.2d 812 (2006).

I.

Until 2000 most first trimester abortions in this country were surgical abortions performed by vacuum aspiration or curettage. In September of 2000, the Food and Drug Administration ("FDA") approved mifepristone, a pill used to induce an abortion without surgical intervention, for manufacture and use in the United States. This approval was based on clinical trials which involved the oral ingestion of 600 mg of mifepristone followed two days later by the oral ingestion of 0.4 mg of misoprostol.¹ Upon examining the results of these trials, the FDA concluded that this regimen was a safe and effective method of medical abortion when employed up through forty-nine days' gestation. Consequently, the FDA approved the use of mifepristone. 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.

Absent state regulation, once a drug has been approved by the FDA, doctors may prescribe it for indications and in dosages other than those expressly approved by the FDA. This is a widely employed practice known as "off-label" use. Off-label use does not violate federal law or FDA regulations because the FDA regulates the marketing and distribution of drugs in the United States, not the practice of medicine, which is the exclusive realm of individual states. Subsequent to the clinical trials relied upon by the FDA, other trials were conducted experimenting with different possible regimens for administering mifepristone and misoprostol. As a result of this research, an off-label protocol was developed consisting of 200 mg of mifepristone administered orally followed one to three days later by 0.8 mg of misoprostol administered vaginally. This regimen is employed up to sixty-three days' gestation and is known as the Schaff protocol after the doctor whose research primarily led to its development. The Schaff protocol is the method of medical (i.e., non-surgical) abortion recommended by the National Abortion Federation and Planned Parenthood Federation of America and has come to be widely employed across the United States.²

In 2004, the Ohio General Assembly enacted H.B. 126 ("the Act") to regulate the use of mifepristone in Ohio. Specifically, the Act provides:

No person shall knowingly give, sell, dispense, administer, otherwise provide, or 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 Ann. § 2919.123(A). 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." Ohio Rev.Code Ann. § 2919.123(F). This arguably requires doctors who prescribe mifepristone for the purpose of inducing an abortion to do so only in accordance with the indication, regimen and distribution restrictions approved by the FDA. In other words, the Act arguably prohibits the "off-label" use of mifepristone.

According to the State, the Act was passed because abortion providers in Ohio were openly using the Schaff protocol and "because legislators became aware that several women had died or been severely injured recently as a result of their use of mifepristone."³ The State further suggests that Ohio legislators concluded that the FDA had only approved one specific protocol for the administration of mifepristone because that was the only safe and effective protocol. Accordingly, the State argues that they banned all other uses of mifepristone to protect Ohio women from unsafe and ineffective mifepristone protocols.

The Act was scheduled to go into effect on September 23, 2004. Dr. Roslyn Kade, Dr. Laszlo Sogor, and various Planned Parenthood chapters in Ohio (collectively, "Plaintiffs") brought this action challenging the constitutionality of the Act on the grounds that it (1) is unconstitutionally vague, (2) violates a patient's right to bodily integrity by compelling surgery in circumstances where a medical abortion would otherwise be the desired or appropriate treatment, (3) lacks the constitutionally-mandated exception to allow otherwise restricted practices where they are necessary to preserve a woman's health or life, and (4) imposes an undue burden on a patient's right to choose abortion by prohibiting a safe and common method of pre-viability abortion. Plaintiffs named as defendants Bob Taft, the Governor of Ohio, and Jim Petro, the Attorney General of Ohio, in their official capacities, and Michael K. Allen, as Prosecuting Attorney for Hamilton County, Ohio, and as a representative of a class of all prosecuting attorneys in Ohio (collectively, "the State").

Before the Act went into effect, Plaintiffs moved for a preliminary injunction. A two-day evidentiary hearing was held in which each side was allotted a total of three hours to present testimony and cross-examine opposing witnesses. Plaintiffs presented the expert testimony of Dr. Eric Schaff and Dr. Laszlo Sogor. The State presented the testimony of Dr. Susan Crockett. The district court granted the motion for a preliminary injunction on the basis that Plaintiffs had established a strong likelihood of prevailing on their third argument, that the statute needs a health or life exception. The district court did not address the other three arguments. The State timely filed an interlocutory appeal.

II.

The Sixth Circuit's review of a district court's grant of a preliminary injunction is limited to an abuse of discretion standard. Lexmark Int'l, Inc. v. Static Control Components, Inc., 387 F.3d 522, 532 (6th Cir.2004); ACLU v. Taft, 385 F.3d 641, 645 (6th Cir.2004); United States v. Edward Rose & Sons, 384 F.3d 258, 261 (6th Cir.2004); Sec'y of Labor v. 3 Re.com, Inc., 317 F.3d 534, 537 (6th Cir.2003). The district court's determination will be disturbed only if it relied upon clearly erroneous findings of fact, improperly applied the governing law, or used an erroneous legal standard. Nightclubs, Inc. v. City of Paducah, 202 F.3d 884, 888 (6th Cir.2000). Under this standard, the court must review the district court's legal conclusions de novo and its factual findings for clear error. Taubman Co. v. Webfeats, 319 F.3d 770, 774 (6th Cir.2003).

III.

The district court held that "a long line of Supreme Court authority mandates and reaffirms that the Due Process Clause of the Constitution requires that every statute regulating abortion include an exception for those situations where necessary, in appropriate medical judgment, to preserve the life and health of the mother." These cases are said to impose a "per se" requirement on all abortion statutes.⁴ The State argues that the requirement of a health or life exception does not apply to every single statute which regulates abortion, but only to those statutes which regulate...