Case Title: Cline v. Oklahoma Coalition for Reproductive Justice

Citation: 

Docket Number: 111939

State: oklahoma

Court: Oklahoma Supreme Court

Date: 2013-10-29T00:00:00Z

Document:
CLINE v. OKLAHOMA COALITION FOR REPRODUCTIVE JUSTICE2013 OK 93Case Number: 111939Decided: 10/29/2013THE SUPREME COURT OF THE STATE OF OKLAHOMA
NOTICE: THIS OPINION HAS NOT BEEN RELEASED FOR PUBLICATION IN 
THE PERMANENT LAW REPORTS. UNTIL RELEASED, IT IS SUBJECT TO REVISION OR 
WITHDRAWAL. 

Terry Cline, in his official capacity as Oklahoma Commissioner 
of Health, Lyle Kelsey, in his official capacity as Executive Director of the 
Oklahoma State Board of Medical Licensure and Supervision, Catherine V. Taylor, 
in her official capacity as the President of the Oklahoma State Board of 
Osteopathic Examiners, Petitioners,v.Oklahoma Coalition for Reproductive 
Justice, on behalf of itself and its Members and Nova Health Systems, d/b/a 
Reproductive Services, on behalf of itself, its staff, and its patients, 
Respondents.
CERTIFIED QUESTIONS OF LAW FROM THESUPREME COURT OF THE 
UNITED STATES
¶0 On December 4, 2012, this Court issued a memorandum opinion, finding House 
Bill 1970, 2011 Okla. Sess. Laws 1276, facially unconstitutional pursuant to the 
U.S. Supreme Court's decision in Planned Parenthood v. Casey, 
505 U.S. 833 (1992). See Okla. Coal. for Reprod. Justice v. Cline, 
2012 OK 102, 292 P.3d 27. The Attorney General filed a Petition for 
Certiorari with the U.S. Supreme Court on March 4, 2013. On June 27, 2013, the 
U.S. Supreme Court granted certiorari in the case and certified two questions of 
law to the Supreme Court of Oklahoma. 
CERTIFIED QUESTIONS ANSWERED 
E. Scott Pruitt, Oklahoma Attorney General, Oklahoma City, Oklahoma, 
Attorney for PetitionersPatrick R. Wyrick, Solicitor General, Office 
of the Attorney General, Oklahoma City, Oklahoma, Attorney for 
PetitionersAnne E. Zachritz, Oklahoma City, Oklahoma, Attorney for 
RespondentsMartha M. Hardwick, Hardwick Law Office, Pauls Valley, 
Oklahoma, Attorney for RespondentsMichelle Movahed, Center for 
Reproductive Rights, New York, New York, Attorney for RespondentsE. 
Joshua Rosenkranz & Eric A. Shumsky, Orrick, Herrington & Sutcliffe 
LLP, New York, New York, Attorneys for RespondentsRandy Grau, Cheek 
& Falcone, PLLC, Oklahoma City, Oklahoma, Attorney for Amicus Curiae 83 
Oklahoma Legislators and Americans United for Life ActionAaron Parks, 
Norman, Oklahoma, Attorney for Amicus Curiae Dr. Mary Martin, M.D., FACOG; 
Dr. Rita Sanders, D.O., FACOG; Dr. Pablo Pinzon, M.D., FACOG; and Dr. Michael 
Glass, M.D., FACOGSamuel B. Casey & Amy T. Pedagno, Jubilee 
Campaign--Law of Life Project, Fairfax, Virginia, Attorneys for Amicus Curiae 
Dr. Mary Martin, M.D., FACOG; Dr. Rita Sanders, D.O., FACOG; Dr. Pablo Pinzon, 
M.D., FACOG; and Dr. Michael Glass, M.D., FACOGSteven H. Aden, 
Alliance Defending Freedom, Washington, D.C., Of Counsel for Amicus Curiae 
Dr. Mary Martin, M.D., FACOG; Dr. Rita Sanders, D.O., FACOG; Dr. Pablo Pinzon, 
M.D., FACOG; and Dr. Michael Glass, M.D., FACOG
PER CURIAM
¶1 The Supreme Court of the United States certified two questions of Oklahoma 
law under the Revised Uniform Certification of Questions of Law Act, 20 O.S. 
2011 §§ 1601-1611:
Whether H.B. No. 1970, Section 1, Chapter 216, O.S.L. 2011 prohibits: (1) the 
use of misoprostol to induce abortions, including the use of misoprostol in 
conjunction with mifepristone according to a protocol approved by the Food and 
Drug Administration; and (2) the use of methotrexate to treat ectopic 
pregnancies. 
We answer both certified questions in the affirmative. 
Procedural Background
¶2 In May of 2011, the Governor signed House Bill 1970, 2011 Okla. Sess. Laws 
1276, into law.1 The Respondents challenged the bill in Oklahoma County 
District Court. The District Court found H.B. 1970 was unconstitutional and 
issued a permanent injunction, prohibiting enforcement of H.B. 1970. The 
Attorney General appealed the order and filed a Motion to Retain in this Court. 
We retained the case and issued a memorandum opinion on December 4, 2012, in 
Case No. 110,765, affirming the district court's decision. We found H.B. 1970 
was facially unconstitutional pursuant to the U.S. Supreme Court's decision in 
Planned Parenthood v. Casey, 505 U.S. 833 (1992). See 
Okla. Coal. for Reprod. Justice v. Cline, 2012 OK 102, 292 P.3d 27. On January 15, 2013, the Chief Justice 
issued the mandate in Case No. 110,765.2 
¶3 The Attorney General filed a Petition for Certiorari with the U.S. Supreme 
Court on March 4, 2013. The U.S. Supreme Court Clerk filed a letter in Case No. 
110,765 on March 14, 2013, advising this Court that a petition for certiorari 
review of the order in Case No. 110,765 had been filed on March 4, 2013. The 
Attorney General has not asked this Court to suspend the effectiveness of 
mandate in Case No. 110,765. 
¶4 On June 27, 2013, the U.S. Supreme Court granted certiorari in the case 
and certified two questions of law to this Court. See Terry Cline et 
al. v. Okla. Coal. for Reprod. Justice et al., No. 12-1094 (June 27, 2013). 
Further proceedings in the U.S. Supreme Court were reserved "pending receipt of 
a response from the Supreme Court of Oklahoma." Id. The certified 
questions were filed in this Court on July 1, 2013, in Case No. 111,939. The 
briefs filed in the U.S. Supreme Court were included with the certification 
order. After the certified questions were filed, the Attorney General filed a 
request for briefing schedule. This Court entered a briefing schedule on July 
16, 2013. Applications for amicus briefs were filed by several organizations, 
and this Court granted those applications on August 16, 2013. Briefing was 
completed on October 2, 2013. 
This Court Has Jurisdiction to Answer the Certified 
Questions
¶5 Petitioners sought certiorari to the U.S. Supreme Court from Oklahoma 
Supreme Court Case No. 110,765, which has been mandated and is not before this 
Court at this time. Oklahoma Supreme Court Rule 1.16 permits a party to file a 
motion to suspend the effectiveness of mandate if the party contemplates the 
filing of a petition for certiorari in the U.S. Supreme Court and authorizes 
suspension of the effectiveness of the mandate until 1) expiration of time to 
file the petition; or 2) notice of final disposition by the U.S. Supreme 
Court.3 Until a party makes a request to suspend the mandate 
pursuant to Rule 1.16 in Case No. 110,765, or upon final disposition by the U.S. 
Supreme Court, this Court will not suspend or recall the mandate in Case No. 
110,765.4 
¶6 The jurisdictional basis for a majority of this Court's decisions is 
derived from the jurisdiction conferred upon the Court by Oklahoma Constitution 
Article VII, § 4.5 This section vests five types of jurisdiction in the 
Supreme Court: (1) appellate jurisdiction over all civil matters; (2) 
jurisdiction to determine whether the Court of Criminal Appeals or the Supreme 
Court has jurisdiction over a controversy; (3) superintending control 
jurisdiction; (4) jurisdiction to issue writs of habeas corpus, mandamus, quo 
warranto, certiorari, prohibition, and such other remedial writs as may be 
provided by law; and (5) further jurisdiction conferred by statute.6 
¶7 This Court may also exercise jurisdiction that arises independent of 
Article VII, § 4, and one example of this occurs when the Court answers a 
certified question from a federal court. In Bonner v. Oklahoma Rock 
Corp., we said:
This court needs no explicit grant of jurisdiction to answer certified 
questions from a federal court; such power comes from the United States 
Constitution's grant of state sovereignty. By answering a state-law question 
certified by a federal court, we may affect the outcome of federal litigation, 
but it is the federal court who hears and decides the cause. "Except in 
matters governed by the Federal Constitution or by Acts of Congress, the law to 
be applied in any case is the law of the state." Certification assures that 
federal courts are apprised of the substantive norms of the Oklahoma legal 
system.
1993 OK 131, n.3, 863 P.2d 1176, 1178, n.3 (citations omitted). 
H.B. 1970 prohibits the use of misoprostol to induce abortions, 
including the use of misoprostol in conjunction with mifepristone according to a 
protocol approved by the Food and Drug Administration and prohibits the use of 
methotrexate to treat ectopic pregnancies
¶8 The U.S. Supreme Court certified two questions of law under the Revised 
Uniform Certification of Questions of Law Act, 20 O.S. 2011 §§ 1601-1611: 
Whether H.B. No. 1970, Section 1, Chapter 216, O.S.L. 2011 prohibits: (1) the 
use of misoprostol to induce abortions, including the use of misoprostol in 
conjunction with mifepristone according to a protocol approved by the Food and 
Drug Administration; and (2) the use of methotrexate to treat ectopic 
pregnancies. 
The certified questions are questions of statutory interpretation.7 The meaning of statutory 
language presents a pure question of law. W.R. Allison Enters., Inc. v. 
Compsource Okla., 2013 OK 24, ¶ 10, 301 P.3d 407, 410. Unresolved questions of state law 
may be answered by this Court if certified questions are presented in accordance 
with the Revised Uniform Certification of Questions of Law Act, 20 O.S. 2011 §§ 
1601-1611. Section 1602 outlines the discretionary power afforded this Court 
under the Act:
The Supreme Court . . . may answer a question of law certified to it by a 
court of the United States . . . if the answer may be determinative of an issue 
in pending litigation in the certifying court and there is no controlling 
decision of the Supreme Court or Court of Criminal Appeals, constitutional 
provision, or statute of this state. 
20 O.S. 2011 § 1602.
¶9 In 1996, a U.S. manufacturer filed a new drug application for 
mifepristone.8 The FDA approved the application for mifepristone in 
2000. According to mifepristone's FDA-approved final printed label, an 
informational document providing guidance about a drug's indications, 
precautions, and dosage, the protocol for administration of mifepristone for the 
termination of pregnancy requires three office visits by the patient.9 During the first office 
visit, the patient is given 600 mg of mifepristone orally. Two days later, the 
patient returns to the office and is given 400 g (0.4 mg) of misoprostol orally. 
Two weeks later, the patient returns to the office for a third visit to verify 
the procedure was successful. Mifepristone's FDA-approved label states 
mifepristone can be administered through forty-nine days of pregnancy. 
¶10 After FDA approval of mifepristone, additional clinical trials led to the 
development of new protocols for administering mifepristone. The practice of 
providing approved medications using regimens different from that described in 
the medication's final printed label is known as an "off-label use," or an 
"evidence-based regimen." The FDA has stated that evidence-based regimens are 
common, permissible, and can be required by good medical practice.10 
¶11 Evidence-based regimens for administering mifepristone vary from the 
protocol in mifepristone's FDA-approved label in three ways. First, the 
evidence-based regimens allow women to take one-third the dosage of mifepristone 
at the first office visit. Second, the evidence-based regimens allow a woman to 
self-administer the second drug, misoprostol, in the privacy of her own home 
rather than at a medical facility. Third, evidence-based regimens extend the 
effective use of mifepristone from forty-nine days to sixty-three days into the 
pregnancy. 
¶12 Both the protocol in mifepristone's FDA-approved label and the 
evidence-based regimens require mifepristone be used in conjunction with 
misoprostol to induce an abortion. Misoprostol has not been approved by the FDA 
for use in abortions but has been approved by the FDA to treat ulcers. The 
FDA-approved label for misoprostol is silent on abortion-related uses. 
¶13 Although the most common evidence-based regimens involve some combination 
of mifepristone and misoprostol, other evidence-based regimens involve the use 
of methotrexate. Methotrexate is also a drug frequently used by physicians to 
terminate early ectopic pregnancies without surgery. Ectopic pregnancies pose 
grave health risks, and surgical intervention can result in serious 
complications, including future infertility, organ damage, and death. 
Methotrexate was approved by the FDA to treat neoplastic diseases, psoriasis, 
and rheumatoid arthritis. The FDA-approved label for methotrexate is silent on 
abortion-related uses. 
¶14 In 2011, the Legislature passed H.B. 1970. Section 1, Subsection C, of 
H.B. 1970 provides: 
C. No physician who provides RU-486 (mifepristone) or any abortion-inducing 
drug shall knowingly or recklessly fail to provide or prescribe the RU-486 
(mifepristone) or any abortion-inducing drug according to the protocol tested 
and authorized by the U.S. Food and Drug Administration and as authorized in the 
drug label for the RU-486 (mifepristone) or any abortion-inducing drug.11 
To determine the meaning of H.B. 1970, we first look to the plain language of 
the statute. W.R. Allison, 2013 OK 24, ¶ 14, 301 P.3d  at 411. "The Legislature 
is presumed to have expressed its intent in the text of the statute." Id. 
The rules of statutory construction are employed "[o]nly where the legislative 
intent cannot be ascertained from the statutory language, i.e., in cases 
of ambiguity or conflict." McClure, 2006 OK 42, ¶ 12, 142 P.3d  at 395. 
¶15 Three times in Subsection C the phrase "RU-486 (mifepristone) or any 
abortion-inducing drug" is used. The Legislature's use of the word "or" to 
separate the term "RU-486 (mifepristone)" from "any abortion-inducing drug" 
shows its intent to treat the terms as separate and distinct. In re 
J.L.M., 2005 OK 
15, ¶ 7, 109 P.3d 336, 339 ("The Legislature's use of the disjunctive word 'or' indicates its 
intent that either the custodial parent alone (with whom the child was living), 
or both parents, may be ordered to pay restitution."); Corp. Comm'n v. Union 
Oil Co., 1979 OK 
30, ¶ 8, 591 P.2d 711, 715 ("The use of the word 'or' to connect these phrases in [the 
statute] indicates that the grounds for relief connected thereby are 
disjunctive, and each is sufficient in itself to authorize the relief 
requested.").12 
¶16 Therefore, under H.B. 1970 if a physician wishes to provide or prescribe 
RU-486 (mifepristone), the physician must provide or prescribe RU-486 
(mifepristone) according to the FDA-approved label for RU-486 
(mifepristone). If a physician wishes to provide or prescribe any 
abortion-inducing drug, the physician must provide or prescribe the 
abortion-inducing drug according to the FDA-approved label for that 
abortion-inducing drug. 
¶17 Abortion-inducing drug is defined in Section 1, Subsection A, of H.B. 
1970 as: 
a medicine, drug, or any other substance prescribed or dispensed with the 
intent of terminating the clinically diagnosable pregnancy of a woman, with 
knowledge that the termination shall with reasonable likelihood cause the death 
of the unborn child. This includes off-label use of drugs known to have 
abortion-inducing properties, which are prescribed specifically with the intent 
of causing an abortion, such as misoprostol (Cytotec), and methotrexate. This 
definition does not apply to drugs that may be known to cause an abortion, but 
which are prescribed for other medical indications, such as chemotherapeutic 
agents or diagnostic drugs;
Misoprostol, when used in either the protocol described in the FDA-approved 
label for mifepristone or an evidence-based regimen, is an abortion-inducing 
drug as defined by subsection A because it is prescribed or dispensed with the 
intent of terminating the clinically diagnosable pregnancy of a woman, with 
knowledge that the termination shall with reasonable likelihood cause the death 
of the unborn child. Similarly, methotrexate, when used either in an 
evidence-based regimen or to treat ectopic pregnancies, is an abortion-inducing 
drug as defined by subsection A because it too is prescribed or dispensed with 
the intent of terminating the clinically diagnosable pregnancy of a woman, with 
knowledge that the termination shall with reasonable likelihood cause the death 
of the unborn child. 
¶18 The Attorney General argues that 63 O.S. 2011 § 1-730(A)(1) of the Public 
Health Code defines the term "abortion" to exclude the termination of ectopic 
pregnancies, so methotrexate can still be used off-label to treat ectopic 
pregnancies.13 But the operative term in H.B. 1970 is not the term 
"abortion," but rather the new, separately defined term "abortion-inducing 
drug." The Legislature could have defined abortion-inducing drug to mean a 
medicine prescribed with the intent of causing an abortion. It did not. Instead, 
it defined it as a drug prescribed or dispensed with the intent of terminating 
the clinically diagnosable pregnancy of a woman, with knowledge that the 
termination shall with reasonable likelihood cause the death of the unborn 
child. The fact that the Legislature excludes ectopic pregnancies from the 
definition of abortion in § 1-730(A)(1), yet defines "abortion-inducing drug" 
without incorporating § 1-730(A)(1) or including similarly exclusionary language 
indicates the Legislature intended to ban the off-label use of methotrexate, 
including its use in the treatment of ectopic pregnancies. 
¶19 The Attorney General states that "[w]hile the most common off-label 
protocols involve some combination of [mifepristone] and misoprostol, other 
off-label protocols involve the use of methotrexate followed by misoprostol, and 
others yet involve the use of just misoprostol or just methotrexate." 
Petitioners' Brief in Chief at 9, n.18 (emphasis added). The Legislature 
specifically referenced both misoprostol and methotrexate in the definition of 
an abortion-inducing drug: "This includes off-label use of drugs known to have 
abortion-inducing properties, which are prescribed specifically with the intent 
of causing an abortion, such as misoprostol (Cytotec), and methotrexate." We 
find that both misoprostol and methotrexate are abortion-inducing drugs as the 
term is used in Subsection A; therefore, under the plain language of Subsection 
C of the statute, the off-label use of both misoprostol and methotrexate is 
prohibited.14 
¶20 FDA-approved labeling is "not intended to limit or interfere with the 
practice of medicine nor to preclude physicians from using their best judgment 
in the interest of the patient."15 In an often-cited bulletin specifically addressing the 
use of approved drugs for unlabeled indications, the FDA stated:
The FD&C Act does not, however, limit the manner in which a physician may 
use an approved drug. Once a product has been approved for marketing, a 
physician may prescribe it for uses or in treatment regimens or patient 
populations that are not included in approved labeling. Such "unapproved" or, 
more precisely, "unlabeled" uses may be appropriate and rational in certain 
circumstances, and may, in fact, reflect approaches to drug therapy that have 
been extensively reported in medical literature.
The term "unapproved uses" is, to some extent, misleading. It includes a 
variety of situations ranging from unstudied to thoroughly investigated drug 
uses. Valid new uses for drugs already on the market are often first discovered 
through serendipitous observations and therapeutic innovations, subsequently 
confirmed by well-planned and executed clinical investigation.
FDA Drug Bulletin 12:4-5, 1982.16 
¶21 As Respondents correctly point out, and as the FDA recognizes, human 
progress is not static: medical research and advances do not stop upon a 
particular drug's approval by the FDA. Researchers continue to perform clinical 
trials, doctors continue to gain experience, and widespread use of a particular 
treatment allows the medical community to collect data about side effects, 
alternative doses, and potential new uses for treatments. Ninety-six percent of 
medication abortions in the United States are now provided according to a 
regimen different from the one described in mifepristone's FDA-approved label.17 At the clinic operated by Respondent Reproductive 
Services, an evidence-based regimen for administering mifepristone is the most 
prevalent method for terminating early pregnancies, accounting for two-thirds of 
all abortions performed by the clinic, and the physicians at Reproductive 
Services have concluded that the protocol in the mifepristone FDA-approved label 
likely no longer meets the standard of care.18 Both the American College of Obstetricians and 
Gynecologists and the World Health Organization have endorsed these alternate 
regimens as safer and more effective than the now-outdated regimen provided for 
in mifepristone's FDA-approved label.19 "Good medical practice and the best interests of the 
patient require that physicians use legally available drugs, biologics and 
devices according to their best knowledge and judgment."20 
¶22 In other areas of the law, the Oklahoma Legislature has recognized the 
importance of allowing physicians to prescribe medications based on science and 
their medical judgment rather than dogmatic adherence to FDA labeling. Title 
59 O.S. 2011 § 509(16) provides that 
unprofessional conduct for physicians includes, among other criteria:
Prescribing, dispensing or administering of controlled substances or narcotic 
drugs in excess of the amount considered good medical practice, or 
prescribing, dispensing or administering controlled substances or narcotic drugs 
without medical need in accordance with published standards. 

59 O.S. 2011 § 509(16) (emphasis added).
While § 509(16) requires physicians only dispense certain drugs in amounts 
considered good medical practice, nowhere does it globally require physicians to 
dispense those drugs in accordance with their FDA-approved labels. 
¶23 Title 63 O.S. 2011 § 
1-2604 prevents health insurers from denying coverage for prescription drugs 
for cancer treatment merely because their use in the treatment of cancer or 
study of oncology is off-label. It provides: 
No individual policy of accident and health insurance issued which provides 
coverage for prescription drugs, nor any group blanket policy of accident 
and health insurance issued which provides coverage for prescription drugs 
shall exclude coverage of prescription drugs for cancer treatment or the 
study of oncology because the off-label use of such prescription drug has not 
been approved by the Federal Food and Drug Administration for that 
indication in one of the standard reference compendia, as defined in 
paragraph (d) of Section 1-1401 of Title 63 of the Oklahoma Statutes.
Any coverage of a prescription drug required by this section shall also 
include provisions for coverage of medically necessary services 
associated with the administration of the prescription drug. . . . 

63 O.S. 2011 § 
1-2604 (emphasis added).
¶ 24 Title 63 O.S. 2011 §§ 
5030.1-5030.5 provide authorization and guidelines for the Medicaid Drug 
Utilization Review Board. The board is charged to:
develop and recommend to the Oklahoma Health Care Authority Board a 
retrospective and prospective drug utilization review program for medical 
outpatient drugs to ensure that prescriptions are appropriate, medically 
necessary, and not likely to result in adverse medical outcomes. 

63 O.S. 2011 § 
5030.4(1) (emphasis added). 
Nowhere in §§ 5030.1-5030.5, however, is the board constrained by uses 
authorized in the FDA-approved labels for prescription drugs in making its 
determinations. Instead, the statute uses the term "medically necessary" in 
deference to the knowledge and experience of physicians exercised in the 
practice of medicine.
¶25 In contrast to the deference physicians receive regarding treatment 
decisions in almost all other areas of medicine, H.B. 1970 requires a physician 
to provide or prescribe mifepristone, misoprostol, and methotrexate according 
only to their respective FDA-approved drug labels.21 It is undisputed that the FDA-approved label for 
mifepristone requires a dosage level no longer considered medically necessary. 
It is also undisputed that misoprostol has not been FDA-approved for 
abortion-related uses, and methotrexate has not been approved for either 
abortion-related uses or for treating ectopic pregnancies. The use of 
misoprostol in the protocol described in the mifepristone FDA-approved label is 
an off-label use prohibited by the terms of H.B. 1970, and the use of 
methotrexate in treating ectopic pregnancies is an off-label use also prohibited 
by H.B. 1970. H.B. 1970 effectively bans all medication abortions. 
Conclusion
¶26 The role of the physician is to heal the sick and the injured, and 
physicians are required to undergo rigorous training to develop the required 
knowledge and experience to perform that role well. Physicians must inform their 
patient of the risks involved in any treatment, and together with the patient, 
must determine the best course of treatment. Part of the Hippocratic Oath 
requires Physicians to "follow that system of regimen which, according to my 
ability and judgment, I consider for the benefit of my patients, and abstain 
from whatever is deleterious and mischievous."22 
¶27 When the district court originally found H.B. 1970 unconstitutional, it 
correctly concluded that:
[t]he Act's restriction of the use of the drug RU-486 or "any other abortion 
inducing drug, medicine or other substance" in the manner and to the regimen set 
forth in the medication FPL when used for abortion is so completely at odds 
with the standard that governs the practice of medicine that it can serve no 
purpose other than to prevent women from obtaining abortions and to punish and 
discriminate against those who do. 
Okla. Coal. for Repro. Justice v. Cline, No. CV-2011-1722, slip op., ¶ 7 
(Dist. Ct. Okla. Cnty. May 11, 2012) (emphasis added). The plain language of the 
statute and the manner in which H.B. 1970 restricts the long-respected medical 
discretion of physicians in the specific context of abortion compels an 
affirmative answer to both of the questions asked, a position entirely 
consistent with our decision to affirm the ruling of the district court: H.B. 
1970 prohibits the use of misoprostol to induce abortions, including the use of 
misoprostol in conjunction with mifepristone according to a protocol approved by 
the Food and Drug Administration and prohibits the use of methotrexate to treat 
ectopic pregnancies.
CERTIFIED QUESTIONS ANSWERED 
¶28 REIF, V.C.J., KAUGER, WINCHESTER, EDMONDSON, TAYLOR, COMBS and GURICH, 
JJ., concur. 
¶29 COLBERT, C.J. and WATT, J., not voting. 
FOOTNOTES
1 Section 1, Subsection C, 
of H.B. 1970 provides: 
C. No physician who provides RU-486 (mifepristone) or any abortion-inducing 
drug shall knowingly or recklessly fail to provide or prescribe the RU-486 
(mifepristone) or any abortion-inducing drug according to the protocol tested 
and authorized by the U.S. Food and Drug Administration and as authorized in the 
drug label for the RU-486 (mifepristone) or any abortion-inducing drug. 
Section 1, Subsection A, defines "abortion-inducing drug" as:
[A] medicine, drug, or any other substance prescribed or dispensed with the 
intent of terminating the clinically diagnosable pregnancy of a woman, with 
knowledge that the termination shall with reasonable likelihood cause the death 
of the unborn child. This includes off-label use of drugs known to have 
abortion-inducing properties, which are prescribed specifically with the intent 
of causing an abortion, such as misoprostol (Cytotec), and methotrexate. This 
definition does not apply to drugs that may be known to cause an abortion, but 
which are prescribed for other medical indications, such as chemotherapeutic 
agents or diagnostic drugs; 
H.B. 1970 was codified at 63 O.S. 2011 § 1-729a. 
2 See Mandate, Okla. Coal. for Reprod. Justice 
v. Cline, No. 110,765 (Jan. 15, 2013). This Court "can take judicial notice 
of its own records in litigation interconnected with a case before it." 
Robinson v. Texhoma Limestone, Inc., 2004 OK 50, ¶ 13, 100 P.3d 673, 677. 
3 Okla. Sup. Ct. R. 1.16. 
4 Although the Attorney General's failure to move to 
suspend the effectiveness of mandate is not fatal to our exercise of 
jurisdiction in this case, litigants practicing before this Court must conform 
to the rules and procedures of this Court. The file also indicates that no one 
from the Attorney General's office has filed an entry of appearance in Case No. 
111,939 as required by Oklahoma Supreme Court Rule 1.5, which provides that 
"[a]ll parties to any proceeding in the appellate courts shall immediately, but 
no later than filing the first document in the appellate court, file an Entry of 
Appearance on the forms set forth in Rule 1.301, by counsel or an unrepresented 
party representing himself or herself." Okla. Sup. Ct. R. 1.5. "When no counsel 
enters a formal appearance on behalf of an appellate party this Court possesses 
the discretion to list as counsel the lawyer who has signed and submitted a 
brief or motion for that party." State ex rel. Okla. Bd. of Medical Licensure 
and Supervision v. Pinaroc, 2002 OK 20, n.1, 46 P.3d 114, 116 n.1. 
5 The Oklahoma Constitution, Article VII, § 4 provides: 

The appellate jurisdiction of the Supreme Court shall be co-extensive with 
the State and shall extend to all cases at law and in equity; except that the 
Court of Criminal Appeals shall have exclusive appellate jurisdiction in 
criminal cases until otherwise provided by statute and in the event there is any 
conflict as to jurisdiction, the Supreme Court shall determine which court has 
jurisdiction and such determination shall be final. The original jurisdiction of 
the Supreme Court shall extend to a general superintendent control over all 
inferior courts and all Agencies, Commissions and Boards created by law. The 
Supreme Court, Court of Criminal Appeals, in criminal matters and all other 
appellate courts shall have power to issue, hear and determine writs of habeas 
corpus, mandamus, quo warranto, certiorari, prohibition and such other remedial 
writs as may be provided by law and may exercise such other and further 
jurisdiction as may be conferred by statute. Each of the Justices or Judges 
shall have power to issue writs of habeas corpus to any part of the State upon 
petition by or on behalf of any person held in actual custody and make such 
writs returnable before himself, or before the Supreme Court, other Appellate 
Courts, or before any District Court, or judge thereof in the State. The 
appellate and the original jurisdiction of the Supreme Court and all other 
appellate courts shall be invoked in the manner provided by law. 
Okla. Const. art. VII, § 4. 
6 See 20 O.S. 2011 § 1602.
7 Curiously, although the Attorney General has not issued 
an opinion interpreting H.B. 1970, the Attorney General states:
[I]t should not be overlooked that this interpretation comes from the 
Attorney General, whose opinion "is binding upon the state officials whom it 
affects." Thus, this interpretation of the law is not Petitioners' "best guess" 
as to how the law will be interpreted and enforced; it is in fact how it will 
be enforced. 
Petitioners' Brief in Chief at 23, n.41 (citations omitted). 
The Supreme Court of Oklahoma "alone has the power to authoritatively 
determine the validity or invalidity of a statute." State ex rel. York v. 
Turpen, 1984 OK 
26, ¶ 10, 681 P.2d 763, 767 (emphasis added). 
8 "In answering a certified question, the Court does not 
presume facts outside those offered by the certification order. Although we will 
neither add nor delete facts, we may consider uncontested facts supported by the 
record." McClure v. ConocoPhillips Co., 2006 OK 42, n.3, 142 P.3d 390, 392, n.3. Although the record on appeal 
to the U.S. Supreme Court is not before this Court, the facts recited are not 
disputed by the parties. Additionally, neither party disputes that these facts 
are included in the record, and neither party has provided a citation to the 
record indicating evidence to the contrary exists. 
9 The FDA does not design or test the proposed protocol 
and does not conduct its own clinical trials; rather, FDA experts scrutinize 
submissions by the drug's sponsor, and other interested parties, concerning the 
safety and efficacy of the drug. See Petitioners' Brief in Chief at app. 
2-3; See also Planned Parenthood v. Dewine, 696 F.3d 490, 
495 (6th Cir. 2012). 
10 Dewine, 696 F.3d  at 496 ("'[I]t is standard 
medical practice in the United States for physicians to prescribe FDA-approved 
drugs in dosages and for medical indications that were not specifically 
approved--or even contemplated--by the FDA, particularly where the alternative 
use is supported by adequate study.'"). 
11 Title 63 O.S. Supp. 2010 § 1-729a regulated the specific 
drug RU-486 (mifepristone) prior to the passage of H.B. 1970. Section 1-729a was 
originally enacted by Senate Bill 1902, 2010 Okla. Sess. Laws 1086, and provided 
specific restrictions regarding the distribution and use of RU-486 
(mifepristone). It required the prescribing physician to have certain 
qualifications and prescribe the medication under specific conditions, but it 
made no mention of drug labels and did not apply to other substances. 
H.B. 1970 made several significant changes to § 1-729a. For example: 1) it 
extended the existing restrictions on RU-486 (mifepristone) to "any 
abortion-inducing drug" and defined that term to include "a medicine, drug, or 
any other substance prescribed or dispensed with the intent of terminating the 
clinically diagnosable pregnancy of a woman, with knowledge that the termination 
shall with reasonable likelihood cause the death of the unborn child"; 2) it 
added a definition for "drug label" to essentially reference FDA-approved 
guidelines for use of medications; and 3) in addition to earlier restrictions, 
it altered § 1-729a to require that RU-486 (mifepristone) and any 
"abortion-inducing drug" be provided or prescribed only "according to the 
protocol tested and authorized by the U.S. Food and Drug Administration and as 
authorized in the drug label for the RU-486 (mifepristone) or any 
abortion-inducing drug." 
12 See also Hedrick v. Virginia, 513 S.E.2d 634, 640 (Va. 1999) ("[T]he use of the disjunctive word 'or' . . . 
signifies the availability of alternative choices."); Resolution Trust Corp. 
v. United Trust Fund, Inc., 57 F.3d 1025, 1033 (11th Cir. 1995) ("[T]he 
disjunctive 'or' gives independent meaning to the words it separates."); 
Knutzen v. Eben Ezer Lutheran Housing Ctr., 815 F.2d 1343, 1349 (10th 
Cir. 1987) ("[T]he use of a disjunctive in a statute and regulations indicates 
that alternatives were intended."); Azure v. Morton, 514 F.2d 897, 900 
(9th Cir. 1975) ("As a general rule, the use of a disjunctive in a statute 
indicates alternatives and requires that they be treated separately."). 
13 Section 1-730(A)(1) provides:
"Abortion" means the use or prescription of any instrument, medicine, drug, 
or any other substance or device intentionally to terminate the pregnancy of a 
female known to be pregnant with an intention other than to increase the 
probability of a live birth, to preserve the life or health of the child after 
live birth, to remove an ectopic pregnancy, or to remove a dead unborn child who 
died as the result of a spontaneous miscarriage, accidental trauma, or a 
criminal assault on the pregnant female or her unborn child. 
63 O.S. 2011 § 1-730(A)(1). 
14 We find no merit to the Attorney General's argument 
that an ectopic pregnancy is not a "true 'pregnancy,'" so methotrexate can still 
be used off-label to treat ectopic pregnancies. Petitioners' Brief in Chief at 
22. Title 63 O.S. 2011 § 
1-730(A)(4) defines an "unborn child" as the "unborn offspring of human beings 
from the moment of conception, through pregnancy, and until live birth including 
the human conceptus, zygote, morula, blastocyst, embryo and fetus." And 
63 O.S. 2011 § 1-730(A)(7) defines 
"conception" as "fertilization of the ovum of a female individual by the sperm 
of a male individual." Further discrediting this argument is the fact that the 
Legislature believed an ectopic pregnancy was a pregnancy having excluded the 
termination of ectopic pregnancies from the definition of "abortion" in 
63 O.S. 2011 § 1-730(A)(1). 
15 Weaver v. Reagan, 886 F.2d 194, 198 (8th Cir. 
1989).
16 See also 59 Fed.Reg. 59,820, 59,821 (Nov. 
18, 1994).
17 Respondents' Answer Brief at 7 (citing R. on Appeal, 
Tab 14, App. 4, ¶¶ 21-24). Neither side in this cause disputes that when the FDA 
originally approved mifepristone, it did so under a regulatory provision known 
as Subpart H, which allows the FDA to restrict distribution of an approved drug 
by its sponsor to ensure safe use. See 21 C.F.R. § 314.520. Although the 
FDA required mifepristone's sponsor to distribute the drug only under conditions 
where it would be provided by or under the supervision of a physician who was 
able to meet certain criteria, the FDA did not go so far as to require that 
administering physicians utilize mifepristone according only to the protocol 
described in the FDA-approved label. 
18 Respondents' Answer Brief at 8 (citing R. on Appeal, 
Tab 14, App. 7, ¶¶ 9, 14-15, 21). 
19 Respondents' Answer Brief at 7 (citing R. on Appeal, 
Tab 14, App. 4, Ex. B at 2).
20 United States Food and Drug Administration, 
Regulatory Information: "Off-Label" and Investigational Use Of Marketed 
Drugs, Biologics, and Medical Devices - Information Sheet, available at 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm.
21 Abortion is the only area of medicine where it appears 
the Oklahoma Legislature has seen fit to restrict a physician's use of certain 
practices. See also 63 O.S. 2011 § 1-745.3; 63 O.S. 2011 § 
1-745.5; 63 O.S. 2011 § 1-745.5(A). 
22 Grant H. Morris, Dissing Disclosure: Just What the 
Doctor Ordered, 44 Ariz. L. Rev. 313 (2002) (quoting 20 Encyclopedia 
Americana 217 (int'l ed., deluxe libr. ed. 
1993)).