On appeal from the Superior Court of New Jersey, Law Division, Atlantic County.
Approved for Publication December 6, 1996.
Before Judges Shebell, Baime and P.g. Levy. The opinion of the court was delivered by Shebell, P.j.a.d.
The opinion of the court was delivered by: Shebell
The opinion of the court was delivered by
Plaintiffs appeal the dismissal by summary judgment of their medical malpractice action. On December 21, 1992, plaintiffs filed suit against defendant, Dr. James Wilson, alleging medical malpractice. On March 4, 1994, plaintiffs filed an amended complaint that added Dr. Ronald Loewe *fn1 as a defendant. On September 1, 1995, defendant, Dr. Wilson, moved for summary judgment. Defendant, Dr. Loewe, subsequently joined in the motion. The Judge granted defendants' motions on November 15, 1995. Plaintiffs moved for reconsideration, and on December 15, 1995, their motion was denied. Plaintiffs appeal.
On July 1, 1991, plaintiff, Mrs. Melissa Canesi, then 11 days overdue for her menstrual period, visited defendant, Dr. Wilson, a specialist in obstetrics and gynecology to have a pregnancy test. A few days earlier, she had taken a home pregnancy test which was negative. Dr. Wilson gave her a urinalysis pregnancy test, which also indicated she was not pregnant. The doctor then prescribed Provera which he told her would bring on her period. He gave her a packet of 10 pills and told her to take one a day for ten days, but to stop taking it if she felt like she was getting her period. She said he told her not to read the pamphlet that comes with the packet because it would scare her. Dr. Wilson conceded that he may have said that. Mrs. Canesi began taking the Provera on July 2, 1991 and continued for eight days. She started feeling "crampy," but did not begin her period, so she finished the packet. Because she was spotting but had not gotten her period, Mrs. Canesi was sent by Dr. Wilson for a blood serum pregnancy test. On July 18, 1991, he told her the test was positive. After she learned she was pregnant, Mrs. Canesi expressed concern to Dr. Wilson that she had taken pills while she was pregnant. He allegedly told her there was nothing to worry about.
Dr. Wilson admitted he never apprised Mrs. Canesi of any risk to the fetus related to Provera either when it was prescribed or after he learned that she was pregnant. He did have a copy of the Physicians Desk Reference (PDR) at the time and was aware of the "bordered box" *fn2 warning therein. The 1991 PDR "bordered box" warning for Provera contains the following:
THE USE OF PROGESTATIONAL AGENTS DURING THE FIRST FOUR MONTHS OF PREGNANCY IS NOT RECOMMENDED. Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion or treat threatened abortion. There is no adequate evidence that such use is effective and there is evidence of potential harm to the fetus when such drugs are given during the first four months of pregnancy. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum, which progestational agents could not be expected to influence. In addition, the use of progestational agents with their uterine-relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion. Therefore, the use of such drugs during the first four months of pregnancy is not recommended. Several reports suggest an association between intra-uterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. One study estimated a 4.7-fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 in 1,000.
If the patient is exposed to PROVERA Tablets (medroxyprogesterone acetate) during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus.
In 1993 the PDR "bordered box" warning was revised as follows:
THE USE OF PROVERA (MEDROXYPROGESTERONE ACETATE) DURING THE FIRST FOUR MONTHS OF PREGNANCY IS NOT RECOMMENDED.
Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion. There is no adequate evidence that such use is effective when such drugs are given during the first four months of pregnancy. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum, which progestational agents could not be expected to influence. In addition, the use of progestational agents with their uterine-relaxant properties, in patients with fertilized defective ova ...