                                RECOMMENDED FOR FULL-TEXT PUBLICATION
                                     Pursuant to Sixth Circuit Rule 206
                                              File Name: 08a0216p.06

                        UNITED STATES COURT OF APPEALS
                                         FOR THE SIXTH CIRCUIT
                                           _________________


                                                          X
                                                           -
 PLANNED PARENTHOOD CINCINNATI REGION;
                                                           -
 PLANNED PARENTHOOD OF GREATER CLEVELAND;
                                                           -
 PLANNED PARENTHOOD OF CENTRAL OHIO;
                                                           -
                                                               Nos. 06-4422/4423
 PRETERM; DR. ROSLYN KADE; and DR. LASZLO
                                                           ,
 SOGOR,                                                     >
                                    Plaintiffs-Appellees, -
                                                           -
                                                           -
                                                           -
            v.

                                                           -
                                              Defendant, -
 TED STRICKLAND, Governor of the State of Ohio,
                                                           -
                                                           -
                                                           -
 NANCY H. ROGERS, Interim Attorney General of the -
                                                           -
                                                           -
 State of Ohio*; and JOSEPH T. DETERS, Hamilton
                                                           -
 County, Ohio, Prosecuting Attorney as
 representative of a class of all Prosecuting Attorneys -
                                                           -
                                 Defendants-Appellants. -
 in Ohio,

                                                           -
                                                          N
                           Appeal from the United States District Court
                          for the Southern District of Ohio at Cincinnati.
                           No. 04-00493—Susan J. Dlott, District Judge.
                                            Argued: April 23, 2008
                                     Decided and Filed: June 23, 2008
                                                                                                  *
                  Before: MOORE, ROGERS, and McKEAGUE, Circuit Judges.
                                              _________________
                                                   COUNSEL
ARGUED: Anne Berry Strait, OFFICE OF THE ATTORNEY GENERAL, Columbus, Ohio, for
Appellants. Mimi Y.C. Liu, PLANNED PARENTHOOD FEDERATION OF AMERICA,
Washington, D.C., for Appellees. ON BRIEF: Anne Berry Strait, OFFICE OF THE ATTORNEY
GENERAL, Columbus, Ohio, for Appellants. Alphonse A. Gerhardstein, GERHARDSTEIN &


         *
         Nancy H. Rogers, Interim Attorney General of the State of Ohio, has been automatically substituted for former
Attorney General, Marc Dann, pursuant to Fed. R. App. P. 43(c)(2).


                                                          1
Nos. 06-4422/4423                   Planned Parenthood Cincinnati Region                                     Page 2
                                    et al. v. Strickland et al.


BRANCH CO. LPA, Cincinnati, Ohio, Helene T. Krasnoff, PLANNED PARENTHOOD
FEDERATION OF AMERICA, Washington, D.C., Roger K. Evans, PLANNED PARENTHOOD
FEDERATION OF AMERICA, New York, New York, B. Jessie Hill, CASE WESTERN
RESERVE UNIVERSITY, Cleveland, Ohio, Jeffrey M. Gamso, AMERICAN CIVIL LIBERTIES
UNION OF OHIO FOUNDATION, Cleveland, Ohio, for Appellees. Mailee R. Smith, Denise M.
Burke, Clarke D. Forsythe, AMERICANS UNITED FOR LIFE, Chicago, Illinois, for Amici Curiae.
                              ______________________________________
                               ORDER OF CERTIFICATION TO THE
                                    SUPREME COURT OF OHIO
                              ______________________________________
         McKEAGUE, Circuit Judge. On remand from this court’s decision in Planned Parenthood
v. Taft, 444 F.3d 502 (6th Cir. 2006), the district court permanently enjoined the enforcement of
Ohio Revised Code (“O.R.C.”) § 2919.123 on the basis that it is unconstitutionally vague. The
defendants-appellants, Interim Ohio Attorney General, Nancy H. Rogers, and Hamilton County,
Ohio, Prosecuting Attorney, Joseph T. Deters, as representative for a class     of all Ohio county
prosecutors (collectively referred to in this order as the “State”), appealed.1 On appeal, both the
State and Planned Parenthood have presented this court with contrary, yet plausible, interpretations
of O.R.C. § 2919.123 that they respectively believe would save the statute from unconstitutionality.
        Because neither side addressed the issue of certification in their briefs, we instructed them
to discuss at oral argument the propriety of certifying the question of O.R.C. § 2919.123’s scope and
meaning to the Supreme Court of Ohio. When asked about certification at oral argument, both
Planned Parenthood and the State encouraged this court to speculate on how the Supreme Court of
Ohio would interpret the statute as opposed to seeking an authoritative interpretation from the Ohio
high court via certification. In our opinion, however, the interests of judicial federalism and comity
strongly counsel in favor of providing the Supreme Court of Ohio with the opportunity to interpret
O.R.C. § 2919.123. Accordingly, we sua sponte CERTIFY the questions set forth in § II, B of this
order to the Supreme Court of Ohio pursuant to Rule XVIII of the Rules of Practice of the Supreme
Court of Ohio. See generally Elkins v. Moreno, 435 U.S. 647, 662 (1978) (certifying, sua sponte,
a question of state law to the Maryland Court of Appeals).
                                              I. BACKGROUND
A. Factual History
         This court’s previous opinion set forth the relevant facts as follows:
                          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 [commonly referred to as RU-486], 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


         1
          Ohio Governor Ted Strickland initially succeeded his predecessor, Bob Taft, as a defendant-appellant in this
action. Subsequent to the filing of this appeal, however, Governor Strickland was granted permission to withdraw as
an appellant.
Nos. 06-4422/4423                   Planned Parenthood Cincinnati Region                                      Page 3
                                    et al. v. Strickland et al.


                  followed two  days later by the oral ingestion of 0.4 mg of
                  misoprostol.2
                          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. 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.
                         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


         2
          The mifepristone is an abortifacient which terminates the pregnancy by detaching the gestational sac from the
uterine wall. The misoprostol is a prostaglandin which induces the contractions necessary to expel the fetus and other
products of conception from the uterus.
Nos. 06-4422/4423              Planned Parenthood Cincinnati Region                             Page 4
                               et al. v. Strickland et al.


               “because legislators became aware that several women had died or
               been severely injured recently as a result of their use of
               mifepristone.” 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 [it] banned all
               other uses of mifepristone to protect Ohio women from unsafe and
               ineffective mifepristone protocols.
Taft, 444 F.3d at 505-06.
       While Planned Parenthood previously instructed its doctors that mifepristone could be
administered up to sixty-three days’ gestation, its instructions now provide that mifepristone only
be administered up to fifty-six days’ gestation. Thus, there can be no debate that physicians in Ohio
continue to administer mifepristone beyond the FDA-approved use of forty-nine days’ gestation.
These doctors also continue to perform medical abortions using doses of mifepristone that are lower
than those approved by the FDA.
B. Procedural History
        Section 2919.123 was scheduled to go into effect on September 23, 2004. But, prior to the
effective date, Planned Parenthood filed a complaint in United States District Court for the Southern
District of Ohio alleging that the statute: (1) is void for vagueness; (2) violates a woman’s
constitutional right to bodily integrity by forcing her to undergo a surgical abortion where a medical
abortion using mifepristone would be more desirable; (3) lacks the constitutionally-mandated
exception for the life and health of the woman; and (4) imposes an undue burden on a woman’s right
to an abortion in violation of Supreme Court precedent. On September 22, 2004, the district court
issued a preliminary injunction against the State’s enforcement of O.R.C. § 2919.123. See Planned
Parenthood v. Taft, 337 F. Supp. 2d 1040, 1041 (S.D. Ohio 2004). The district court issued the
injunction based on its belief that Planned Parenthood would likely succeed on the merits of its
claim that O.R.C. § 2919.123 lacked the constitutionally required exception for the life or health of
the woman and that irreparable harm would result from enforcement of the law. Id. at 1047-48. The
State appealed.
        On appeal, we held that the district court erroneously determined that every abortion statute
must contain an exception for the life or health of the woman. Taft, 444 F.3d at 511. We explained
that neither the United States Supreme Court nor this court have announced a per se rule requiring
all abortion statutes to contain a life or health exception; rather, each case must be considered on its
facts. Id. In our prior decision, we went on to examine whether, under the facts of this specific case,
the statute was constitutionally infirm because it lacked a health or safety exception. Id. at 511-12.
With regard to that issue, we agreed with the district court that the record contained “substantial
medical authority” in support of Planned Parenthood’s contention that the strictures imposed by
O.R.C. § 2919.123 could endanger the life or health of the woman. Id. at 513. Relying on the
Supreme Court’s recent decision in Ayotte v. Planned Parenthood of Northern New England, 546
U.S. 320 (2006), we determined that the absence of a life or health exception did not necessarily
justify an injunction against the entire statute. Id. at 516-17. Therefore, we remanded the matter
to the district court for a determination of the proper scope of the preliminary injunction in light of
Ayotte, which explained that “we prefer . . . to enjoin only the unconstitutional applications of a
statute while leaving other applications in force.” Ayotte, 546 U.S. at 327-28.
        On remand, Planned Parenthood moved for summary judgment and sought a permanent
injunction on the basis that O.R.C. § 2919.123 is unconstitutionally vague. Agreeing with Planned
Nos. 06-4422/4423               Planned Parenthood Cincinnati Region                             Page 5
                                et al. v. Strickland et al.


Parenthood, the district court declared the statute void for vagueness and permanently enjoined the
entire statute’s enforcement. Planned Parenthood v. Taft, 459 F. Supp. 2d 626, 640 (S.D. Ohio
2006). The State has once again appealed.
                                          II. DISCUSSION
A. The Propriety of Certification
        Rule XVIII of the Rules of Practice of the Supreme Court of Ohio provides the Supreme
Court of Ohio with discretion to answer questions of Ohio law certified to it by the federal courts.
As a prerequisite to certifying a question, we must determine that “there is a question of Ohio law
that may be determinative of the proceeding and for which there is no controlling precedent.” R.
of Prac. Sup. Ct. Ohio XVIII, § 1. In an opinion exhorting the values of federal court certification
where resolution of a question of Ohio law is unclear, the Supreme Court of Ohio has explained that
“state[] sovereignty is unquestionably implicated when federal courts construe state law.” Scott v.
Bank One Trust Co., N.A., 577 N.E.2d 1077, 1080 (Ohio 1991) (per curiam). The Scott court further
explained that “[c]ertification ensures that federal courts will properly apply state law.” Id. Echoing
similar sentiments regarding the virtues of certification, the United States Supreme Court has
recognized that certification of “novel or unsettled questions of state law for authoritative answers
by a State’s highest court . . . may save time, energy, and resources and help build a cooperative
judicial federalism.” Arizonans for Official English v. Arizona, 520 U.S. 43, 77 (1997) (internal
quotations and alterations omitted). Submitting uncertain questions of state law to the state’s highest
court by way of certification acknowledges that court’s status as the final arbiter on matters of state
law and avoids the potential for “friction-generating error” which exists whenever a federal court
construes a state law in the absence of any direction from the state courts. See id. at 79.
         Where statutory interpretation is at issue, the United States Supreme Court has instructed the
federal courts to employ certification or abstention if the “unconstrued state statute is susceptible
of a construction by the state judiciary which might avoid in whole or in part the necessity for
federal constitutional adjudication, or at least materially change the nature of the problem.” Bellotti
v. Baird, 428 U.S. 132, 146-47 (1976) (internal quotations omitted). In Bellotti, the Court held that
the district court erred in failing to order certification and choosing instead to enjoin a Massachusetts
statute governing the ability of minors to consent to an abortion. Id. at 151. The Court stressed that
certification should have been ordered by the lower court because the state law was unclear, and
there was no doubt that “adoption of appellant’s interpretation would at least materially change the
nature of the problem.” Id. at 147 (internal quotations omitted). Furthermore, the Bellotti Court
explained that absent an authoritative interpretation by the state court “it is impossible to define
precisely the constitutional question presented.” Id. at 148.
         Like the Massachusetts abortion statute involved in Bellotti, at the heart of this appeal is the
interpretation of a novel and previously uninterpreted state statute. To resolve the issues presented
in this case, we must ascertain what O.R.C. § 2919.123 means when it states that physicians who
perform abortions using mifepristone must comply with “federal law,” as that term is defined in the
statute. See generally Kansas Judicial Review v. Stout, 519 F.3d 1107, 1120 (10th Cir. 2008)
(concluding that certification to the Kansas Supreme Court was appropriate because it was necessary
to determine the scope and meaning of a previously uninterpreted state law before addressing
whether it was unconstitutionally vague or overbroad). According to the State, by including the
approval letter in the statute’s definition of “federal law,” O.R.C. §2919.123 effectively prohibits
physicians from administering mifepristone to women who are beyond forty-nine days’ gestation
and from using a treatment protocol different from that found in the drug’s final printed labeling
(i.e., the statute prohibits the off-label use of mifepristone).
Nos. 06-4422/4423               Planned Parenthood Cincinnati Region                            Page 6
                                et al. v. Strickland et al.


        Conversely, Planned Parenthood argues that the statute imposes no restrictions on the
prescribing practices of physicians; it reads O.R.C. § 2919.123 to require only that physicians who
prescribe mifepristone comply with the eight Subpart H requirements set forth in the approval letter
because those are the only “requirements” in the letter that refer to physicians. Planned Parenthood
further argues that, by its terms, O.R.C. § 2919.123 does not incorporate the treatment protocol set
forth in the drug’s final printed labeling.
         Planned Parenthood concedes that if its interpretation is adopted, then its claims that the
statute is unconstitutional will be rendered moot. However, Planned Parenthood asserts that if the
statute is interpreted to mean what the State says it means, then the statute is unconstitutional and
was correctly enjoined by the district court. Under the provisions of Rule XVIII and precedent from
the United States Supreme Court, certification is appropriate here because the manner in which
O.R.C. § 2919.123 is interpreted “may be determinative of the proceeding,” R. Prac. Sup. Ct. Ohio
XVIII, § 1, and “might avoid in whole or in part the necessity for federal constitutional
adjudication.” Bellotti, 428 U.S. at 146-47.
        While certainly we are capable of speculating on how the Supreme Court of Ohio would
interpret O.R.C. § 2919.123, such “[s]peculation by a federal court about the meaning of a state
statute in the absence of prior state court adjudication is particularly gratuitous when . . . the state
courts stand willing to address questions of state law on certification.” Arizonans for Official
English, 520 U.S. at 79 (internal quotations omitted); see also Scott, 577 N.E.2d at 1080 (stating that
“certification frees federal courts from having to guess how state courts will decide important
questions of state law”) (internal quotations omitted). This is especially true in circumstances like
the present case, where the potential for state-federal friction generated by federal court intervention
is heightened because O.R.C. § 2919.123 is a novel statute passed pursuant to Ohio’s longstanding
power to regulate the practice of medicine within its borders.
B. The Certified Questions of State Law
      For the reasons set forth above, we certify the following questions of state law to the
Supreme Court of Ohio pursuant to Rule XVIII of the Rules of Practice of the Supreme Court of
Ohio:
         1) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using
         mifepristone do so in compliance with the forty-nine-day gestational limit described in the
         FDA approval letter?
         2) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using
         mifepristone do so in compliance with the treatment protocols and dosage indications
         described in the drug’s final printed labeling?
C. The Information Required by Rule XVIII
       Because this court is certifying questions to the Supreme Court of Ohio, we provide the
following information in accord with Rule XVIII, § 2(A)-(E).
         1. Name of the case: Please refer to the caption on page 1 of this order.
         2. Statement of facts: Please refer to § I of this order for a full recitation of the pertinent
facts.
Nos. 06-4422/4423           Planned Parenthood Cincinnati Region                          Page 7
                            et al. v. Strickland et al.


      3. Name of each of the parties:
       a. Plaintiffs-Appellees: Planned Parenthood Cincinnati Region; Planned
       Parenthood of Greater Cleveland; Planned Parenthood of Central Ohio; Preterm;
       Dr. Roslyn Kade; and Dr. Laszlo Sogor.
       b. Defendants-Appellants: Nancy H. Rogers, Interim Ohio Attorney General,
       in her official capacity; Joseph T. Deters as Prosecuting Attorney for Hamilton
       County, Ohio, and as a representative of a class of all Prosecuting Attorneys in
       Ohio.
      4. Names, Addresses, and Telephone Numbers of Counsel for Each Party:
       a. Plaintiffs-Appellees’ Counsel:
       Ms. Mimi Y.C. Liu                                  Mr. Jeffrey M. Gamso
       Ms. Nicole G. Berner                               American Civil Liberties Union
       Planned Parenthood Federation of                   of Ohio Foundation
       America                                            4506 Chester Ave.
       1780 Massachusetts Ave., N.W.                      Max Wohl Civil Liberties Center
       Washington, D.C. 20036                             Cleveland, OH 44103-2136
       (202) 973-4862                                     (216) 472-2220
       Mr. Roger K. Evans                                 Ms. B. Jessie Hill
       Planned Parenthood Federation of                   Case Western Reserve
       America                                            University School of Law
       434 W. 33rd St.                                    11075 East Boulevard
       New York, NY 10001-0000                            Cleveland, OH 44106-0000
       (212) 541-7800                                     (216) 368-0553
       Ms. Jennifer L. Branch
       Mr. Alphonse A. Gerhardstein
       Gerhardstein & Branch
       617 Vine St.
       Suite 1409 Enquirer Building
       Cincinnati, OH 45202-0000
       (513) 621-9100
       b. Defendants-Appellants’ Counsel:
       Ms. Anne Berry Strait                              Mr. Roger Friedmann
       Office of the Attorney General                     Assistant Prosecuting Attorney
       Court of Claims Defense Section                    Hamilton County, Ohio
       150 E. Gay St.                                     230 E. Ninth St.
       23rd Floor                                         Suite 4000
       Columbus, OH 43215                                 Cincinnati, OH 45202
       (614) 466-7447                                     (513) 946-3025
       Ms. Sharon A. Jennings                             Mr. Michael G. Florez
       Office of the Attorney General                     Assistant Prosecuting Attorney
       30 E. Broad St.                                    Hamilton County, Ohio
       15th Floor State Office Tower                      230 E. Ninth St., Suite 4000
       Columbus, OH 43215                                 Cincinnati, OH 45202
       (614) 466-2872                                     (513) 946-3229
Nos. 06-4422/4423              Planned Parenthood Cincinnati Region                           Page 8
                               et al. v. Strickland et al.


        Ms. Holly J. Hunt
        Office of the Attorney General
        Constitutional Offices Section
        30 E. Broad St.
        17th Floor
        Columbus, OH 43215
        (614) 466-2872
       5. Designation of Moving Party: Although neither side has sought certification, we
designate Interim Ohio Attorney General, Nancy H. Rogers, and Hamilton County, Ohio,
Prosecuting Attorney, Joseph T. Deters, as representative for a class of all Ohio prosecuting
attorneys— who have been collectively referred to throughout this order as the “State”—as the
moving parties.
D. Instructions to the Clerk
          In accordance with Rule XVIII, § 3 of the Rules of Practice of the Supreme Court of Ohio,
Mr. Leonard Green, Clerk of the United States Court of Appeals for the Sixth Circuit, is hereby
instructed to serve copies of this certification order upon counsel for the parties and to file this
certification order under the seal of this court with the Supreme Court of Ohio, along with appropriate
proof of service.
                                       III. CONCLUSION
         For the foregoing reasons, we CERTIFY questions of state law to the Supreme Court of Ohio.
It is further ordered that the district court’s injunction against the enforcement of O.R.C. § 2919.123
remain in full force and effect pending further order of this court.


______________________________________________
David W. McKeague
United States Court of Appeals for the Sixth Circuit
