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WASHINGTON, D.C. — (Mealey's) The U.S. Supreme Court on Nov. 4 decided not to review an Oklahoma Supreme Court ruling that found that the state’s ban on off-label use of abortion drugs is unconstitutional (Terry Cline, et al. v. Oklahoma Coalition for Reproductive Justice, et al., No. 12-1094, U.S. Sup. [lexis.com subscribers may access Supreme Court briefs for this case]).
In June, the U.S. Supreme Court granted certiorari in the case. On Nov. 4, it dismissed the writ, saying it was improvidently granted.
The U.S. Supreme Court’s action comes just seven days after the Oklahoma Supreme Court answered two questions the U.S. high court certified to the state high court. The questions were: “Whether H.B. [House Bill] 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.”
Effectively Banned Medical Abortion
In its Oct. 29 decision, the Oklahoma Supreme Court ruled that Oklahoma House Bill No. 1970 (H.B. 1970) prohibited the use of the drugs, effectively banning medical abortions (Terry Cline, et al. v. Oklahoma Coalition for Reproductive Justice, et al., No. 2013 OK 93, Okla. Sup.; 2013 OK 93; 2013 Okla. LEXIS 124 [enhanced opinion available to lexis.com subscribers]). Previously, the Oklahoma Supreme Court had affirmed a lower court ruling that H.B. 1970’s restrictions on the drugs is unconstitutional.
H.B. 1970 prohibits physicians from using mifepristone (also known as RU-486) “or any abortion-inducing drug” in an off-label manner not authorized by the Food and Drug Administration.
The Oklahoma Coalition for Reproductive Justice and Nova Health Systems, doing business as Reproductive Services, challenged the law in the Oklahoma County District Court. The District Court found the law unconstitutional and issued a permanent injunction preventing enforcement of the law.
The Oklahoma attorney general appealed, and in December, the Oklahoma Supreme Court affirmed the District Court ruling, finding that the law was facially unconstitutional under the U.S. Supreme Court’s decision in Planned Parenthood v. Casey (505 U.S. 833  [enhanced opinion]).
Drug’s Protocols Changed
At issue is the approved protocol for mifepristone versus the current standard-of-care use. The protocol approved by the FDA in 2000 was that a woman be given 600 milligrams of mifepristone orally during her first doctor’s office visit, be given 0.4 milligrams two days later during an office visit and be seen two weeks later in the office to verify that the procedure was successful.
The approved label also says mifepristone can be used through 49 days of pregnancy.
Post-approval clinical trials led to new protocols for using mifepristone, which are off-label or an “evidence-based regimen.” They allow women to take one-third the recommended dosage of mifepristone during the first visit and to take another drug, misoprostol, also known as Cytotec, at home.
The new protocols also extend the use of mifepristone from 49 days to 63 days.
Misoprostol has not been approved by the FDA for use in abortions, but the approved mifepristone label and evidence-based regimens require that the two drugs be used together.
Other evidence-based protocol call for the use of methotrexate, a drug frequently used to terminate early ectopic pregnancy without surgery to avoid grave risks to the mother.
In a per curiam opinion, the Supreme Court said the exclusionary language of H.B. 1970 “indicates the Legislature intended to ban the off-label use of methotrexate, including its use in the treatment of ectopic pregnancies.”
Ectopic Pregnancies Affected
“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,” the court held.
The court noted that medical research and advances don’t stop when a drug is approved by the FDA and that through clinical trials and experience, doctors learn about alternative dosing and new uses for drugs. It said 96 percent of medical abortions (as opposed to surgical abortions) are performed through regimens not on an FDA-approved label.
The FDA-approved regimen, the court said, is no longer the standard of care, and it said the American College of Obstetricians and Gynecologists and the World Health Organization have endorsed the alternate regimens as safer and more effective than the outdated FDA-approved label.
The court also noted that in other areas of the law, the Oklahoma Legislature has recognized the importance of allowing doctors to prescribe drugs based on science and their medical judgment “rather than dogmatic adherence to FDA labeling.” In addition, the court said state law prohibits health insurers from denying coverage for drugs prescribed for off-label uses.
Effectively Bans Medical Abortions
“The use of misoprostol and 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,” the court said. “H.B. 1970 effectively bars all medical abortions.”
Concurring were Vice-Chief Justice John F. Reif and Justices Yvonne Kauger, James R. Winchester, James E. Edmundson, Steven W. Taylor, Douglas L. Combs and Norma Gurich. Chief Justice Tom Colbert and Justice Joseph M. Watt did not vote.
The state is represented by Oklahoma Attorney General E. Scott Pruitt and Solicitor General Patrick R. Wyrick of the Attorney General’s Office in Oklahoma City.
The respondents are represented by Anne E. Zachritz of Oklahoma City; Martha M. Hardwick of the Hardwick Law Office in Pauls Valley, Okla., Michelle Movahed of the Center for Reproductive Rights in New York and E. Joshua Rosenkranz and Eric A. Shumsky of Orrick, Herrington & Sutcliffe in New York.
Randy Grau of Cheek & Falcone in Oklahoma City represents amici curiae 83 Oklahoma legislators and Americans United for Life Action.
Aaron Parks of Norman, Okla., Samuel B. Casey and Amy T. Pedagno of the Jubilee Campaign — Law of Life Project in Fairfax, Va., and Steven H. Aden of the Alliance Defending Freedom in Washington represent amici Mary Martin, M.D., Rita Sanders, D.O., Pablo Pinzon, M.D., and Michael Glass, M.D.
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