Opinion ID: 3181538
Heading Depth: 1
Heading Rank: 3

Heading: the undisputed facts which are supported by competent evidentiary materials

Text: ¶10 Medication abortion is a procedure for terminating a pregnancy using medications alone. In the United States, medication abortion generally follows a protocol using both Mifeprex and misoprostol, which are taken one after the other respectively. Methotrexate is used to abort ectopic pregnancies. In 2000, based on previously conducted clinical trials, the FDA approved Mifeprex's final printed label (FPL) pursuant to Subpart H of Part 314, Subchapter D, Chapter I, Title 21 of the Code of Federal Regulations, entitled Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses. The Mifeprex FPL only applies to marketing and distribution by the manufacturer, and it requires: (1) Mifeprex distribution only to doctors who have read and understand the prescribing information, 5 (2) three office visits for patients, (3) administration of Mifeprex only in a clinic, medical office, or hospital, by or under the supervision of a physician able to assess the gestational age of an embryo and to diagnose ectopic pregnancies, (4) patients to read the medication guide and read and sign the patient agreement before treatment, 6 (5) administration of one dose of 600 milligrams(mg) of Mifeprex, (6) oral administration of 400 micrograms (g) of misoprostol given two days later unless an abortion has been confirmed, (7) a follow-up visit about fourteen days after the administration of the Mifeprex to confirm complete termination of the pregnancy, (8) warning to patients that some women may experience vaginal bleeding or spotting up to sixteen days, 7 and (9) warning to patients that heavy or moderate bleeding is an indication of an incomplete abortion. This protocol was approved for use up to the first 49 days after a woman's last menstrual period. The FPL states that before administrating Mifeprex, physicians should provide patients with an explanation of the procedure along with a copy of the medication guide and patient agreement. The FPL also states that afterward, the physician should provide notice to the manufacture of any ongoing pregnancy or serious adverse events. It is uncontested that the FDA's requirements apply to the manufacturer and are marketing restrictions and other special distribution conditions, but the requirements do not restrict or control a doctor's practice of medicine or the use of medication once it is distributed. ¶11 Within a year of the FDA's approval of Mifeprex in 2000, ninety-six percent of medication abortions did not follow the FPL or the protocol used in the clinical trials on which the FPL's approval was based. Since the FPL's approval, eight fatal bacterial infections have been reported in the United States where the women were administered Mifeprex and misoprostol for a medication abortion and did not follow the FPL, but followed an off-label protocol. The FDA has not established a casual connection between the off-label protocol and the deaths. However, the FDA now warns on the FPL about the risk of a bacterial infection following Mifeprex's use. 8 These same fatal bacteria also occur following other obstetric and gynecologic processes. The ACOG materials state that the off-label protocol is more effective with fewer adverse effects. Mifeprex is on the list of medications that require a Risk Evaluation and Management Strategy (REMS). 9 ¶12 Plaintiff Reproductive Services follows an off-label protocol which is endorsed by the American College of Obstetricians and Gynecologists (ACOG). The ACOG recommended off-label, or evidence-based, protocol is based on good and consistent scientific evidence and includes vaginal, buccal, and sublingual administration of misoprostol by the patient away from a clinic. The ACOG off-label protocol provides for administration of one 200 milligram dose of Mifeprex, compared to the 600 milligrams of FDA on-label protocol, followed by 800 micrograms of misoprostol to be patient administered, compared to FDA's protocol of 400 milligrams to be doctor administered. The ACOG materials provide that medication abortions can be provided safely through nonphysician clinicians and that the protocol can be used for up to 63 days of gestation (calculated from the last menstrual period).