Court Opinion

ID: 2973629
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Date Created: 2015-09-22 17:04:57.7867+00
Date Added: 2024-06-11T11:43:46.898470
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                                    File Name: 06a0129a.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: April 13, 2006
                Before: MOORE, ROGERS, and McKEAGUE Circuit Judges.
                                    _________________
                                         COUNSEL
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.
         McKEAGUE, J., delivered the opinion of the court, in which ROGERS, J., joined. MOORE,
J. (p. 14), delivered a separate opinion concurring in part.

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

                                          ______________________
                                           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 (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 Planned2Parenthood Federation of
America and has come to be widely employed across the United States.

         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
No. 04-4371               Planned Parenthood, et al. v. Taft, et al.                                             Page 3

       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 that3several 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 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.

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.
         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

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).
                                                       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.

        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

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 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.
No. 04-4371            Planned Parenthood, et al. v. Taft, et al.                                 Page 6

        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); 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.
No. 04-4371           Planned Parenthood, et al. v. Taft, et al.                               Page 7

       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.
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.
No. 04-4371              Planned Parenthood, et al. v. Taft, et al.                                        Page 8

         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 record indicates    that a mifepristone medical abortion would be successful
at least ninety percent of the time.5 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 in6 some
circumstances a surgical abortion poses significantly greater risk than a medical abortion.
        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 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

        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 9

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 safer7 than a
mifepristone medical abortion for all medically foreseeable circumstances or conditions.
         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

         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 by the State on the narrow issue which became the central focus.
No. 04-4371                Planned Parenthood, et al. v. Taft, et al.                                            Page 10

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. Crockett to testify 8as 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 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.

         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 11

                                                   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).
        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
No. 04-4371             Planned Parenthood, et al. v. Taft, et al.                                   Page 12

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 9intent and the
Plaintiffs’ as-yet-unaddressed vagueness, bodily integrity, and undue burden claims. 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 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.

        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 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.