                              RECOMMENDED FOR FULL-TEXT PUBLICATION
                                   Pursuant to Sixth Circuit Rule 206
                                         File Name: 06a0068p.06

                       UNITED STATES COURT OF APPEALS
                                     FOR THE SIXTH CIRCUIT
                                       _________________


                                                        X
                                 Plaintiffs-Appellees, -
 PLANNED PARENTHOOD CINCINNATI REGION, et al.
                                                         -
                                                         -
                                                         -
                                                             No. 04-4371
           v.
                                                         ,
                                                          >
 BOB TAFT, et al.,                                       -
                              Defendants-Appellants. -
                                                        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: December 7, 2005
                                Decided and Filed: February 24, 2006
                    Before: MOORE, ROGERS, and McKEAGUE, Circuit Judges.
                                         _________________
                                              COUNSEL
ARGUED: Anne Berry Strait, OFFICE OF THE ATTORNEY GENERAL, CHARITABLE LAW
SECTION, Columbus, Ohio, 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.
        McKEAGUE, J., delivered the opinion of the court, in which ROGERS, J., joined. MOORE, J. (p.
13), delivered a separate opinion concurring in part.
                                         _________________
                                             OPINION
                                         _________________
       McKEAGUE, Circuit Judge. 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

                                                   1
No. 04-4371                 Planned Parenthood, et al. v. Taft, et al.                                                 Page 2


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 (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.


    1
     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.
    2
      After this appeal was briefed, the American College of Obstetricians and Gynecologists (ACOG) issued a practice bulletin
stating that compared with the FDA protocol the Schaff protocol is “associated with a decreased rate of continuing pregnancies,
decreased time to expulsion, fewer side effects, improved complete abortion rates, and lower cost for women with pregnancies
up to 63 days’ gestation.” The previous relevant ACOG practice bulletin from 2001 had only recommended using the FDA
protocol and specifically stated that medical abortion should not be performed after forty-nine days’ gestation.
No. 04-4371                  Planned Parenthood, et al. v. Taft, et al.                                                     Page 3


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 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 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. Therefore, 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. 3Re.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).



    3
      The record in this case does not contain any indication that any woman died or was severely injured as a result of an off-label
mifepristone protocol. The only source cited did indicate that one death had been reported, but that was due to the fact that
mifepristone was administered to a woman with an ectopic pregnancy. All parties unequivocally agree that mifepristone is
contraindicated for ectopic pregnancies at any gestational age. Two cases of severe bacterial infection and one heart attack were
also reported in women who had taken mifepristone, but no causal link was established.
No. 04-4371                Planned Parenthood, et al. v. Taft, et al.                                               Page 4


                                                            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 abortion in a manner which might actually endanger
women’s health or lives. The district court offered little analysis to support its adoption of a per se
requirement, and close scrutiny of the case law reveals that no such blanket requirement has been imposed.
        In Planned Parenthood v. Casey the Supreme Court reaffirmed three basic principles which were
originally set forth in Roe v. Wade: (1) previability a woman has a right to obtain an abortion without the
state imposing an undue burden on her decision, (2) postviability the state may restrict abortion except when
a woman’s health or life is in danger, and (3) throughout a pregnancy the state has legitimate interests in
protecting both “the health of the woman and the life of the fetus that may become a child.” Planned
Parenthood v. Casey, 505 U.S. 833, 846 (1992). The Court later clarified that a state may not restrict
abortion procedures which are necessary to preserve the health or life of the mother at any time during a
pregnancy. Stenberg v. Carhart, 530 U.S. 914, 930 (2000) (“Since the law requires a health exception in
order to validate even a postviability abortion regulation, it at a minimum requires the same in respect to
previability regulation.”).
         The State’s challenge to the district court’s use of a per se requirement is a conflation of two similar,
but separate, arguments. The first argument is that a previability regulation must only have a health or life
exception if the lack of such an exception imposes an undue burden. The second is that there is no blanket
requirement anywhere in the case law that every single regulation which affects abortion must have a health
or life exception. The State’s briefing varies between treating these two propositions as separate arguments,
treating them as the same argument simply restated in different terms, and treating the second proposition
as the logical result of the first proposition. This creates confusion because although the arguments are
closely related, it is not correct to say that a previability regulation must only have a health or life exception
if the lack of such an exception imposes an undue burden, for reasons explained below, while it is correct
to say that there is no per se requirement for a health or life exception in all abortion statutes. The best way
to avoid this confusion is to address each proposition separately.
        According to the State, Casey mandates that all statutes affecting previability abortions are evaluated
using the undue burden standard, including to determine whether such a statute must contain a health or life
exception. Therefore, the State argues such an exception is only necessary if the absence of an exception
would impose an undue burden. While the State’s construction of Casey might be plausible in the absence
of any subsequent relevant case law, the Supreme Court has since made it abundantly clear that the necessity
and adequacy of a health or life exception is a question entirely separate from the undue burden analysis.
See Carhart, 530 U.S. at 930. In Carhart the Court struck down the statute at issue as it related to
previability abortions on the basis that it imposed an undue burden. Id. However, it unequivocally stated
that the statute needed a health exception and the lack of that exception was a separate and independent
basis for striking down the statute. Id.; see also Ayotte v. Planned Parenthood of Northern New England,
— U.S. —, 126 S. Ct. 961, 969 (2006). This analysis dooms the State’s argument that a health or life
exception is only necessary if its absence would impose an undue burden.
        The next component of the State’s argument is a direct challenge to the district court’s imposition
of a per se requirement. The Supreme Court cases the district court cited contain only one statement which

    4
      Other circuits have made reference to a “per se” requirement but with inconsistent meanings. See Richmond Med. Center
for Women v. Hicks, 409 F. 3d 619, 625 (4th Cir. 2005); Reproductive Health Services of Planned Parenthood v. Nixon, 429 F.3d
803, 805-06 (8th Cir. 2005); Planned Parenthood v. Wasden, 376 F.3d 908, 922 (9th Cir. 2004).
No. 04-4371             Planned Parenthood, et al. v. Taft, et al.                                      Page 5


offers textual support for a per se requirement. In Casey the Court stated that the second essential holding
of Roe v. Wade was “a confirmation of the State’s power to restrict abortions after fetal viability, if the law
contains exceptions for pregnancies which endanger the woman’s life or health.” Casey, 505 U.S. at 846.
However, this lone statement must be read in the context of the many other statements in Casey, Carhart,
and Ayotte which frame the same general principle in slightly, but significantly, different terms. For
example, the Casey Court stated that “the essential holding of Roe forbids a State to interfere with a
woman’s choice to undergo an abortion procedure if continuing her pregnancy would constitute a threat to
her health.” Id. at 880; see also Carhart, 530 U.S. at 931 (“[T]he governing standard requires an exception
where it is necessary, in appropriate medical judgment for the preservation of the life or health of the
mother.”); Ayotte, 126 S. Ct. at 967 (“[O]ur precedents hold, that a State may not restrict access to abortions
that are necessary, in appropriate medical judgment, for preservation of the life or health of the mother.”).
The latter, more predominant, way the health or life exception requirement is expressed indicates that a
statute which regulated abortion, but did not pose any significant risk to a woman’s health or life, would not
violate the health or life exception requirement.
        Furthermore, the Supreme Court’s application of the health or life exception requirement further
undermines the slender textual support for a per se requirement. In Carhart, the Court invalidated
Nebraska’s ban on partial-birth abortion because although it contained a life exception, it did not contain
a health exception. Carhart, 530 U.S. at 930-38. The language throughout the opinion shows that before
coming to this conclusion the Court carefully considered whether a health exception was necessary. Id. at
934-37 (“We find these eight arguments insufficient to demonstrate that Nebraska’s law needs no health
exception.” “Given these medically related evidentiary circumstances, we believe the law requires a health
exception.”). If an abortion statute is per se unconstitutional without a health or life exception, the Court
would only have had to note that the statute at issue regulated abortion and that it did not have a health
exception. Those two facts alone (neither of which was disputed) would have been sufficient to find a
constitutional violation. Both the Court’s predominant discussion of the health or life exception requirement
and its application demonstrate that there is no such per se requirement.
        Neither can support for a per se requirement be found in any of the cases from other circuits cited
in the briefs. Although the First Circuit has stated that a health or life exception is a per se requirement, in
the same case it went on to observe that all three times an abortion statute has been challenged in the
Supreme Court, “the Court has indicated that an exception must be provided when the restriction would
place a woman’s health at risk.” Planned Parenthood of Northern New England v. Heed, 390 F.3d 53, 59-
60 (1st Cir. 2004) (emphasis added), vacated and remanded on other grounds sub nom. Ayotte v. Planned
Parenthood of Northern New England, — U.S. —, 126 S. Ct. 961 (2006). Since the court expressed the
requirement both ways and did not examine the issue in detail, its commentary is not helpful one way or the
other.
         At first glance, it appears that the Ninth Circuit has followed a per se approach because it has stated
that “[a]n adequate health exception . . . is a per se constitutional requirement.” Planned Parenthood v.
Wasden, 376 F.3d 908, 922 (9th Cir. 2004). However, the context shows that the Ninth Circuit was not
imposing a per se requirement as the district court did here, but rather holding that determining whether a
health or life exception is constitutionally necessary “requires an analysis separate from any undue burden
inquiry.” Id. The Ninth Circuit’s use of the phrase “per se requirement” describes the fact that the health
or life exception requirement is separate and distinct from the undue burden standard. See id. The Wasden
court does not use the phrase “per se requirement” the same way that the parties and the district court in this
litigation have used it, which is to refer to the proposition that every law which affects abortion must contain
a health or life exception. Consequently, Wasden does not support a per se requirement that all abortion
statutes must have a health or life exception.
       The Fourth and Eighth Circuits have also stated that the health or life exception requirement is a “per
se constitutional rule.” Richmond Med. Center for Women v. Hicks, 409 F.3d 619, 625 (4th Cir. 2005);
Reproductive Health Services of Planned Parenthood v. Nixon, 429 F.3d 803, 805-06 (8th Cir. 2005);
No. 04-4371             Planned Parenthood, et al. v. Taft, et al.                                       Page 6


Carhart v. Gonzales, 413 F.3d 791, 796 (8th Cir. 2005). However, once again the context indicates that
neither circuit was embracing the test employed by the district court in this case. Nixon, 429 F.3d at 805-06;
see also Hicks, 409 F.3d at 625-26; Gonzales, 413 F.3d at 796-97. Neither were these courts using the
phrase “per se rule” in the same sense as the Ninth Circuit. The cases decided by the Fourth and Eighth
Circuits involved statutes banning partial birth abortion which were similar to the statute struck down by
the Carhart Court for lack of a health exception. The Fourth Circuit case was decided first and used the
phrase “per se constitutional rule” to describe the fact that the Supreme Court had already determined that
statutes banning partial birth abortions were required to contain a health exception as well as a life
exception. Hicks, 409 F.3d at 625-26. The Fourth Circuit concluded that the body of medical evidence
relevant to whether substantial medical authority indicated that a ban of partial birth abortion created a
significant health risk did not need to be “reproduced in every subsequent challenge to a partial birth
abortion statute lacking a health exception.” Id. The Eighth Circuit reached the same conclusion and
referred to the “per se rule” that a partial birth abortion ban must contain a health exception (at least until
a state is able to demonstrate that medical procedures have advanced to the point where the Carhart Court’s
conclusion is no longer valid). Nixon, 429 F.3d at 805-06; Gonzales, 413 F.3d at 796-97.
        The Tenth Circuit has also faced the issue of whether a particular abortion statute needed to contain
a health or life exception. Planned Parenthood v. Owens, 287 F.3d 910 (10th Cir. 2002). The statute at
issue required a forty-eight hour waiting period after parental notification. Id. at 920. The Tenth Circuit
concluded that an exception was necessary based on the observation that experts from both sides agreed that
there were medical emergencies which could arise which would endanger the health or life of a minor if she
could not obtain an abortion before the expiration of the waiting period. Id. The court’s discussion of
whether the statute at issue could affect the health or life of a minor is an implicit rejection of a per se
requirement that all abortion statutes contain a health or life exception regardless of whether the statute
endangers the health of life of the woman. See id. at 919-20.
         In light of the way the Supreme Court has both expressed and applied the health or life exception
requirement, the district court’s holding that the requirement is a per se rule was erroneous. Consequently,
it is necessary to consider the district court’s alternative holding.
                                                      IV.
        The district court held that Plaintiffs had established a significant likelihood of prevailing on the
merits even if there is no per se requirement. The district court held that at a minimum the Supreme Court
case law requires the State to demonstrate that there are no circumstances under which a statute would result
in significant health risks in order to preserve a statute from being held unconstitutional due to lack of a
health or life exception. The State challenges both the district court’s placement of the burden of proof on
the State and the district court’s conclusion that the evidence submitted at the preliminary injunction hearing
was sufficient to show a substantial likelihood that the Act must contain a health or life exception. We find
that there is no need to address the burden of proof issue because the evidence submitted was sufficient to
merit the district court’s conclusion as to the necessity of a health or life exception regardless of which party
had the burden of proof.
        The legal standard for determining when a statute which affects abortion must contain a health or
life exception was succinctly set forth by the Carhart Court.
        By no means must a State grant physicians unfettered discretion in their selection of abortion
        methods. But where substantial medical authority supports the proposition that banning a
        particular abortion procedure could endanger women’s health Casey requires the statute to
        include a health exception when the procedure is necessary, in appropriate medical
        judgment, for the preservation of the life or health of the mother.
No. 04-4371                 Planned Parenthood, et al. v. Taft, et al.                                                   Page 7


Carhart, 530 U.S. at 938 (internal quotations and citations omitted). An exception is constitutionally
necessary where substantial medical authority indicates that a banned procedure would be safer than the
other available procedures, not just when banning the procedure subjects a woman to risks from the
pregnancy itself. Id. at 931. As emphasized previously by this circuit, an exception is only necessary (and
must only cover) circumstances where a statute poses a significant health risk. Id.; Women’s Medical Pro.
Corp. v. Taft, 353 F.3d 436, 448-49 (6th Cir. 2003). Finally, an adequate showing of a significant health
risk in certain circumstances is sufficient to require an exception even if those circumstances rarely occur.
Carhart, 530 U.S. at 934 (“The State cannot prohibit a person from obtaining treatment simply by pointing
out that most people do not need it.”); see also Ayotte, 126 S. Ct. at 967.
        At the preliminary injunction evidentiary hearing Plaintiffs introduced expert testimony from two
doctors which established that, if enforced, the statute would result in significant risk to women’s health in
particular, albeit narrow, circumstances. They pointed to the fact that the statute prohibits the use of
mifepristone for a medical abortion after seven weeks’ gestation although many doctors would offer a
mifepristone medical abortion as an option up to nine weeks’ gestation pursuant to the Schaff protocol in
the following specific circumstances where other alternatives pose a significant risk to a woman’s health:
a bicornuate (i.e. divided) uterus, extreme flexion of the uterus, large uterine fibroids, cervical stenosis,
female genital mutilation, and other abnormalities of the female genital tract. While Plaintiffs’ experts did
not challenge the fact that for most women surgical abortion is an alternative which does not present any
more risk than medical abortion, they testified that for some women these health conditions make surgical
abortion significantly more risky. For such women, a medical abortion using mifepristone would pose
significantly less risk than undergoing a surgical abortion.
        The State’s expert, Dr. Crockett, stated in her affidavit that when surgical abortion is contraindicated
because of a woman’s medical condition, a mifepristone medical abortion is also contraindicated because
surgical abortion is necessary in the small percentage of cases in which the mifepristone medical abortion
fails. However, Dr. Crockett did not, either in her affidavit or hearing testimony, contradict Plaintiffs’
experts’ testimony that certain medical conditions render a surgical abortion more risky than a successful
mifepristone medical abortion. An unsuccessful medical abortion would place a woman in the same
position she would be in if a medical abortion was not available. Moreover, the record5 indicates that a
mifepristone medical abortion would be successful at least ninety percent of the time. In light of the
uncontested facts, Dr. Crockett’s sworn statement is unavailing. She is essentially asserting that no patient
should be permitted to choose a less risky medical abortion over what both parties agree may be a
significantly more risky surgical abortion for that patient simply because of a ten percent or less chance that
the surgical abortion might be necessary anyway if the medical abortion fails. This is the only evidence the
State proffered at the preliminary injunction stage which addresses Plaintiffs’ experts’ testimony        that in
some circumstances a surgical abortion poses significantly greater risk than a medical abortion.6
        The State also points to the cross-examination of Plaintiff’s expert, Dr. Schaff, who agreed that a
medical abortion can be safely performed using the drug methotrexate (which is not regulated by the Act)
instead of mifepristone. However, on re-direct Dr. Schaff explained that while methotrexate is an excellent
drug, using it for a medical abortion is far less safe than mifepristone. He explained the reason for this as
follows:
         Methotrexate again is a cancer agent [in addition to being used for medical abortions]
         because it stops cells dividing. It’s not selective. It stops all cells that are rapidly dividing.
         An embryo or early pregnancy is rapidly dividing, and that’s why it works to end an early

    5
     The precise efficacy rate of the Schaff protocol at various gestational ages has been vigorously disputed. However, the
highest failure rate claimed by the State is ten percent.
    6
     Since the State did not present any other evidence on this point, the list of circumstances enumerated by Plaintiffs’ experts
under which surgical abortion can be significantly more risky is uncontested.
No. 04-4371                 Planned Parenthood, et al. v. Taft, et al.                                                   Page 8


         pregnancy. But it also is toxic to all cells in the body; that’s why it also works as a cancer
         chemotherapeutic agent.
The State offered no testimony or other evidence at the preliminary injunction hearing refuting Dr. Schaff’s
opinion that using methotrexate for a medical abortion poses greater health risks than using mifepristone.
        Both of Plaintiffs’ experts testified that there are no other drugs besides methotrexate and
mifepristone which can be used to perform a medical abortion. While Dr. Crockett asserted that there are
a variety of other ways to evacuate a uterus medically besides using mifepristone, this assertion is irrelevant
because mifepristone is not used to evacuate the uterus; it is used to terminate the pregnancy. Misoprostol
(which is not regulated by the Act) is then administered to evacuate the uterus. The State did not provide
any evidence that any drug other than methotrexate would be available for performing medical abortions
between seven and nine weeks’ gestation if the Act took effect. Consequently, the medical authority
available at the preliminary injunction phase of this case permitted the finding that using mifepristone is the
safest available method of medical abortion and that in some circumstances a medical abortion using
mifepristone would pose significantly less risk to the health or life of a discrete class of women than a
surgical abortion.
        In its appellate brief, the State points to a case in which the Supreme Court upheld a statute which
allowed only doctors (and not physician assistants) to perform abortions in spite of evidence that this
regulation might not have been necessary to accomplish its stated purpose of increasing the safety of
abortion procedures. See Mazurek v. Armstrong, 520 U.S. 968, 973 (1997). The State argues that there is
even more reason to uphold the statute at issue here because there is evidence that the statute is necessary
to make abortion procedures safer. Regardless of the accuracy of the State’s characterization of the
evidence, the argument misses the mark. The issue of whether a statute is justified as a safety measure in
general is not dispositive. As long as there are certain circumstances in which a statutorily-banned
procedure is significantly safer, the statute must contain a health or life exception. The Mazurek case sheds
no light on this issue because there was no indication or argument that the statute considered there would
create a significant risk to any woman’s health or life. See Mazurek, 520 U.S. 968.
        The State goes on to make various arguments which can each be disposed of briefly. First, the State
emphasizes that surgical abortion is a safe and available alternative. While true in the vast majority of
situations, this is not dispositive because it does not address the expert testimony that there are some
circumstances in which the surgical option is considerably more risky for some women. Next, the State
points to the absence of any studies which show that a mifepristone medical abortion is the safest procedure
under particular circumstances. However, the Supreme Court has made it clear that such studies are not
necessary where there is expert testimony that a restricted procedure is safer than the alternatives. Carhart,
530 U.S. at 936-37. The State goes on to claim that Plaintiffs’ own expert’s testimony shows that using
mifepristone to induce medical abortions past seven weeks’ gestation is dangerous. This argument is
unsupported in the record. According to the State, Dr. Schaff’s testimony indicates that his protocol is not
as safe or effective as the FDA-approved protocol. Putting aside the accuracy of this statement (which is
contested), the relative efficacy and safety of the two mifepristone protocols has nothing to do with whether
a health or life exception is required. To answer this question the court must examine the difference
between the safety of the banned procedure (mifepristone medical abortion) and the safety of other available
procedures (surgical abortion or methotrexate medical abortion) after seven weeks’ gestation. The State
does not point to any evidence which demonstrates that there is an alternative abortion procedure which is
available after seven week’s gestation which is as safe  or safer than a mifepristone medical abortion for all
medically foreseeable circumstances or conditions.7

    7
      The lack of such evidence at the preliminary injunction stage does not necessarily indicate that there is no such authority
in the vast store of medical knowledge. Procedural factors inherent in the preliminary injunction determination–such as the
compressed time frame in which to present testimony related to four complex constitutional issues, a relatively short period of
time to prepare for the hearing, and the lack of available discovery–may well have had a role in the dearth of evidence introduced
No. 04-4371                 Planned Parenthood, et al. v. Taft, et al.                                                     Page 9


        The evidence presented at the preliminary injunction stage does not adequately support the State’s
claim that the Act may constitutionally omit a health or life exception. In Carhart the Supreme Court ruled
that a health or life exception was necessary where the record demonstrated:(1) that the banned abortion
procedure significantly obviated health risks in particular circumstances, (2) there was “a highly plausible
record-based explanation of why that might be so,” (3) there was conflicting expert testimony over whether
the banned procedure was safer, and (4) there was an absence of any clinical studies relevant to the issue.
Carhart, 530 U.S. at 936-37. For purposes of determining whether to grant a preliminary injunction in this
case, all of these requirements have been met. There was uncontroverted expert evidence that the restricted
abortion procedure obviated health risks in particular circumstances. The testimony of Plaintiffs’ experts
provided an explanation of why this might be the case. As this explanation was both uncontradicted and
facially reasonable, it can be fairly characterized as “highly plausible.” At the preliminary injunction
hearing the State did not effectively contest Plaintiffs’ evidence that the banned procedure could be safer
than other available procedures. Finally, as in Carhart, here there were no clinical studies relevant to this
particular issue. Accordingly, the evidence presented to the district court established at least as persuasive
a case as that presented in Carhart that the abortion regulation at issue could pose a significant health risk
to women with particular medical conditions. Consequently, the district court’s ruling that Plaintiffs
established a strong likelihood of prevailing on the merits has not been shown to be erroneous.
                                                                V.
        During the evidentiary hearing on the preliminary injunction, the district court recognized the State’s
witness, Dr. Crockett, as an expert in the areas of obstetrics, gynecology and the FDA approval process but
refused to allow Dr. Crockett8to testify as an expert regarding medical and surgical abortion or the critical
review of medical literature. The State argues that refusing to recognize Dr. Crockett as an expert on
medical and surgical abortion because she did not perform elective abortion procedures was an abuse of
discretion. The State argues that performing elective abortion procedures is not a prerequisite to being an
expert on such procedures and points out that such a rule would make it extremely difficult for governmental
entities to secure the services of expert witnesses in such cases. The practical point is well taken, and the
legal principle is sound. As with any other procedure or topic, an individual can acquire expertise regarding
elective abortion procedures through a variety of means other than actually performing the precise procedure
at issue. See, e.g., Berry v. City of Detroit, 25 F.3d 1342, 1350 (6th Cir. 1994) (observing that an
aeronautical engineer would be qualified to testify about the flight of a bumblebee based on general flight
principles even if he had never actually seen a bumblebee).
        Furthermore, the record is far from clear as to whether the district court judge even based her ruling
solely on the fact that Dr. Crockett did not perform elective abortions. The district judge explicitly stated
that whether a doctor performs elective abortions “has nothing to do with my recognizing someone as an
expert or not. The only thing, I’m not looking at their point of view; I’m just looking at the experience and
qualifications they need to be designated by the Court as an expert.” (JA 594.) Nevertheless, viewing the
record as a whole, there is some merit to the State’s argument that in spite of what the district court said,
the only conceivable reason for failing to recognize Dr. Crockett as an expert on elective medical and
surgical abortion was, in fact, because she does not perform elective abortions. While the district court will


by the State on the narrow issue which became the central focus.
    8
      The State has not appealed the district court’s order refusing to recognize Dr. Crockett as an expert in the critical review
of medical literature. Although that order has not been placed before us, the only reason the district court gave for her ruling was
that Dr. Crockett did not have any specific training in the critical review of medical literature beyond the training incorporated
in her general medical school and residency training. This ruling ignored Dr. Crockett’s testimony that her residency program
at Georgetown University put particular emphasis on training residents in the critical review of medical literature, that she had
taught classes on the subject, that she had done extensive reading and self-education on the subject, and that she had critically
reviewed medical literature for the FDA. If these qualifications are not sufficient to demonstrate expertise, this court is hard-
pressed to imagine what qualifications would suffice.
No. 04-4371             Planned Parenthood, et al. v. Taft, et al.                                      Page 10


have to resolve this issue at the trial on the merits, this court need not resolve this issue now because Dr.
Crockett’s proffered testimony, even if admitted into evidence, would not have been sufficient to defeat
Plaintiffs’ motion for a preliminary injunction.
        Dr. Crockett’s proffered testimony addressed two topics. First, she criticized the studies relied upon
by Plaintiffs’ experts to show the efficacy of the Schaff protocol as compared to the FDA-approved
protocol. Dr. Crockett opined that Dr. Schaff’s studies manipulated the numbers to make his protocol
appear more effective than the FDA protocol. However, whether the Schaff protocol is effective ninety-five
percent of the time (as asserted by Plaintiffs) or ninety percent of the time (as asserted by the State) does
not determine whether the Act must contain a health or life exception. Second, Dr. Crockett opined that the
lower dosage of mifepristone used in the Schaff protocol might only be effective because of the larger
dosage of misoprostol used. This point is also not related to the central issue. Since Dr. Crockett’s
proffered testimony does not affect the issue on appeal, there is no reason to scrutinize the district court’s
evidentiary ruling.
                                                      VI.
        The State’s final argument is that the district court erred by enjoining the entire Act, including the
reporting and record-keeping provision which Plaintiffs do not argue is unconstitutional. The State has not
argued that even if the Act was required to contain a health or life exception, the preliminary injunction
should have only enjoined those particular applications of the Act which would have posed a significant risk
to a woman’s health or life. At the time this case was briefed and argued, there was not any concrete
support for such an argument. However, after oral argument was heard in this case, the Supreme Court held
that when an abortion statute lacks a constitutionally necessary health or life exception, a narrow injunction
prohibiting only unconstitutional applications of the statute should be employed where such an approach
is not contrary to legislative intent. Ayotte v. Planned Parenthood of Northern New England, — U.S. —,
126 S. Ct. 961 (2006).
        Plaintiffs claim that the State’s severability argument with respect to the reporting and record-
keeping provision of the Act is not properly raised on appeal because it was not adequately presented to the
trial court. In spite of the State’s protestations to the contrary, Plaintiffs are correct that the State waived
its severability argument at the preliminary injunction stage. However, this issue is intertwined with the
broader issue of whether the scope of the preliminary injunction was appropriate in light of the Ayotte
decision. Although the State did not pose this broader challenge, it can hardly be faulted for failing to raise
an argument before there was legitimate legal support for such an argument. Regarding an argument as
waived under such circumstances would be both inequitable and counterproductive. Hormel v. Helvering,
312 U.S. 552, 557-59 (1941) (noting an efficiency rationale for addressing waived issues where intervening
case authority might change the result). Parties would be forced to either litter their pleadings with every
argument which might conceivably be adopted during the pendency of a proceeding or forgo the benefit of
any new relevant case law.
         In Ayotte, the Supreme Court held that “[i]f enforcing a statute that regulates access to abortion
would be unconstitutional in medical emergencies,” then “invalidating the statute entirely is not always
necessary or justified.” 126 S. Ct. at 964. Instead, “lower courts may be able to render narrower declaratory
and injunctive relief,” namely the prohibition of the statute’s unconstitutional applications. Id. at 964, 969.
Invalidating the statute in toto is still appropriate, however, if the legislature would “prefer[] no statute at
all to a statute enjoined in [this] way.” Id. at 969. The Court vacated the First Circuit’s opinion affirming
the district court’s order granting a permanent injunction and remanded the case for the lower courts in the
first instance to determine the legislative intent. Id. at 966, 969. Notably, the Court did not vacate the
underlying injunction itself. This silence as to the injunction is significant because the Court has not
hesitated to vacate all or part of an injunction explicitly when it so desires. E.g., Scheidler v. Nat’l Org. for
Women, Inc., 537 U.S. 393, 411 (2003); Morales v. Trans World Airlines, Inc., 504 U.S. 374, 382-83
(1992); see also Branch v. Smith, 538 U.S. 254, 265 (2003).
No. 04-4371              Planned Parenthood, et al. v. Taft, et al.                                         Page 11


         Given the absence of a new automatic-vacatur rule in Ayotte, it is appropriate simply to adhere to
the usual approach to overbroad injunctions. Cf. United States v. Booker, 543 U.S. 220, 125 S. Ct. 738, 769
(2005) (instructing the courts of appeals to use “ordinary prudential doctrines” when applying Booker to
cases pending on direct appeal). The courts’ practice has long been to vacate an injunction only insofar as
it is too broad, leaving the balance intact. E.g., Morales, 504 U.S. at 382-83 (vacating in part an injunction
prohibiting state officers from enforcing state law — under the doctrine of Ex Parte Young, 209 U.S. 123
(1908) — “insofar as it restrain[ed] the operation of state laws” that the officers had not threatened to
enforce); Tumblebus Inc. v. Cranmer, 399 F.3d 754, 768 (6th Cir.) (vacating and remanding for further
factfinding one part of a preliminary injunction while affirming the other part), cert. denied, — U.S. —, 126
S. Ct. 361 (2005); PACCAR Inc. v. TeleScan Techs., L.L.C., 319 F.3d 243, 258 (6th Cir. 2003) (affirming
in part and vacating in part a preliminary injunction where “the scope of the injunction [was] too broad”);
Michigan State AFL-CIO v. Miller, 103 F.3d 1240, 1244, 1253 (6th Cir. 1997) (vacating a preliminary
injunction prohibiting enforcement of three statutory sections only “insofar as it applie[d] to” one section);
Sheeran v. American Commercial Lines, Inc., 683 F.2d 970, 981 (6th Cir. 1982) (generally affirming a
preliminary injunction but modifying it as to one defendant and vacating it as to another); Blaylock v.
Cheker Oil Co., 547 F.2d 962, 966 (6th Cir. 1976) (vacating one provision of a preliminary injunction while
affirming three others); see also Branch, 538 U.S. at 265 (affirming one basis of an injunction but vacating
an alternative ground). Although it went unmentioned in Ayotte, the Supreme Court has even employed this
approach in the context of an injunction prohibiting the enforcement of an abortion regulation. Guste v.
Jackson, 429 U.S. 399, 400 (1977) (per curiam) (noting that the injunction “appear[ed] to extend to the
entire statute” and vacating the injunction “insofar as it bars enforcement of the ‘informed consent’
requirements”).
         In light of this well-established method of dealing with overbroad injunctions, the proper course is
to vacate in part the district court’s order, leaving the preliminary injunction undisturbed insofar as it
prohibits unconstitutional applications of the statute. On remand, the district court must determine whether
a broader injunction is still required by considering the legislative         intent and the Plaintiffs’ as-yet-
unaddressed vagueness, bodily integrity, and undue burden claims.9 Ayotte, 126 S. Ct. at 969 (explaining
that if the legislature “preferred no statute at all to a statute enjoined” in its unconstitutional applications,
then “consistency with legislative intent requires invalidating the statute in toto”); Planned Parenthood
Fed’n of America, Inc. v. Gonzales, — F.3d —, 2006 WL 229900, at *17-20 (9th Cir. 2006) (noting that
the court might have been able to draft a narrowly drawn injunction consistent with the legislative intent
if the statute’s only constitutional infirmity was the lack of a health exception but ultimately invalidating
the entire statute because it was also unconstitutionally vague and imposed an undue burden).
                                                        VII.
         The only aspect of the district court’s preliminary injunction analysis which the State challenges is
its conclusion that Plaintiffs established a strong likelihood of prevailing on the merits. The State has not
questioned the district court’s conclusion that the remaining preliminary injunction factors of irreparable
injury, the interests of third parties, and the public interest also weighed in favor of granting the preliminary
injunction. The district court’s primary basis for concluding that Plaintiffs had established a strong
likelihood of success on the merits was the conclusion that every statute which regulates abortion must
contain a health or life exception. This holding was error. However, the district court alternatively held that
Plaintiffs were likely to succeed on the merits even if the health or life exception requirement was not a per
se requirement because substantial medical evidence had been presented that the Act could pose a
significant risk to women’s health or lives. Based on the evidence presented at the preliminary injunction
stage, this conclusion was not an abuse of discretion. Consequently, there is no basis for overturning the
district court’s determination that Plaintiffs had established a strong likelihood of succeeding on the merits


    9
     Nothing in our decision today prohibits consideration on remand of the changed stance of the American College of
Obstetricians and Gynecologists, which now supports the mifepristone protocol at issue in this case.
No. 04-4371             Planned Parenthood, et al. v. Taft, et al.                                    Page 12


of their claim that the Act is unconstitutional because it lacks a health or life exception. However, in light
of Ayotte, the validity of the broad preliminary injunction entered by the district court must be reconsidered.
For the reasons discussed above, this court need not address the merits of the State’s remaining claims of
error. The district court’s order is AFFIRMED in part and VACATED in part. We AFFIRM the
preliminary injunction insofar as it prohibits unconstitutional applications of the Act, but VACATE the
preliminary injunction insofar as it prohibits constitutional applications of the Act. The case is
REMANDED for the district court to determine the appropriate scope of preliminary injunctive relief
consistent with this opinion.
No. 04-4371             Planned Parenthood, et al. v. Taft, et al.                                       Page 13


                                             _________________
                                              CONCURRENCE
                                             _________________
        KAREN NELSON MOORE, Circuit Judge, concurring in part. Because I agree that Plaintiffs have
satisfied the preliminary-injunction standard of demonstrating a strong likelihood of prevailing on the
merits, I join Parts I though IV of the majority opinion. I also agree that in light of Ayotte v. Planned
Parenthood of Northern New England, — U.S. —, 126 S. Ct. 961 (2006), the preliminary injunction should
be vacated in part and the case remanded to the district court to reconsider the scope of the injunction. Thus,
I join Parts VI and VII. Finally, I join Part V only insofar as it recognizes that the district court’s limitation
of the state’s expert-witness testimony is irrelevant to the outcome of this appeal. This irrelevance is
precisely why I cannot, however, endorse the majority’s needless dicta on the merits of the evidentiary
question.
         Plaintiffs presented significant evidence on the safety benefits of the banned abortion procedure.
The state attempted to counter this evidence with the testimony of its expert witness, Dr. Susan Crockett,
but the district court excluded some of her testimony. The state now appeals this evidentiary ruling. The
Supreme Court has instructed us that in these circumstances, Dr. Crockett’s testimony is irrelevant: “Where
a significant body of medical opinion believes a procedure may bring with it greater safety for some patients
and explains the medical reasons supporting that view, we cannot say that the presence of a different view
by itself proves the contrary.” Stenberg v. Carhart, 530 U.S. 914, 937 (2000). Because Plaintiffs presented
“a significant body of medical opinion” supporting their position, Dr. Crockett’s “different view” could not
have affected the merits. Id.; Richmond Med. Ctr. for Women v. Hicks, 409 F.3d 619, 625 n.1 (4th Cir.
2005) (“Even if we assumed without deciding that the district court abused its discretion in excluding the
Commonwealth’s opinion evidence, the consideration of that evidence would not change our result.”),
petition for cert. filed, 74 U.S.L.W. 3352 (U.S. Dec. 1, 2005) (No. 05-730). Thus, it matters not a whit that
the testimony was excluded. See FED. R. EVID. 103(a) (“Error may not be predicated upon a ruling which
admits or excludes evidence unless a substantial right of the party is affected . . . .”).
        Presumably in recognition of Stenberg, the majority states that “this court need not resolve this issue
now because Dr. Crockett’s proffered testimony, even if admitted into evidence, would not have been
sufficient to defeat Plaintiffs’ motion for a preliminary injunction.” Majority Op. at 10. It reiterates that
“there is no reason to scrutinize the district court’s evidentiary ruling.” Id. Unfortunately, the majority
ignores its own advice, as it proceeds to “scrutinize” the evidentiary ruling even though “there is no reason”
to do so. Because the evidentiary issue has no impact on the outcome of this appeal, I do not join the
majority’s dicta regarding this evidence.
