On appeal from Superior Court of New Jersey, Law Division, Ocean County.
Approved for Publication November 15, 1996. As Amended November 26, 1996.
Before Judges Havey, Brochin and Eichen. The opinion of the court was delivered by Havey, P.j.a.d.
The opinion of the court was delivered by: Havey
The opinion of the court was delivered by
In this medical malpractice case, defendant Jose Dugenio, M.D., prescribed Ciprofloxacin, an antibiotic, to plaintiff who was eight months pregnant. Plaintiff's fetus died one day after plaintiff ingested the drug. She sued defendant Dugenio, Flavius Thompson, M.D., her obstetrician, and the Medical Center of Ocean County, seeking damages for severe emotional distress as a result of the death of the fetus. A jury returned a unanimous verdict in favor of defendants.
On appeal, plaintiff argues that the trial Judge erred by: (1) refusing to instruct the jury that it could consider a violation by Dr. Dugenio of warnings included in the Physicians' Desk Reference (PDR) *fn1 as evidence of Dr. Dugenio's negligence; (2) giving the "exercise of judgment" instruction to the jury; and (3) refusing to instruct the jury that the testimony of a single witness may be sufficient to convince the jury of an essential element of plaintiff's claim. We affirm.
Plaintiff's due date was April 6, 1990. Her pregnancy was free of complications other than a minor urinary tract infection, upper respiratory infection and vaginitis. On March 20, 1990, plaintiff went to the emergency room of Ocean County Medical Center in Point Pleasant, seeking treatment for a sore throat. Dr. Dugenio, an emergency room physician, took a history from plaintiff. He noted that she was eight months pregnant and had visited the emergency room approximately two weeks earlier on March 5, 1990, complaining of a sore throat, congestion and swollen glands. According to hospital records, on plaintiff's March 5, 1990 visit, she was diagnosed as suffering from acute pharyngitis (sore throat), and was given a prescription for amoxicillin, an antibiotic.
Dr. Dugenio examined plaintiff and ordered blood tests and a throat culture. After examining the blood work and noting the resurgence of plaintiff's previous symptoms, Dr. Dugenio suspected a bacteria known as hemophilus influenzae as the primary cause of plaintiff's condition. He was concerned with the possibility of serious complications. Consequently, Dr. Dugenio administered a 500 milligram pill of Ciprofloxacin to plaintiff. Dr. Dugenio selected Ciprofloxacin because he feared that the hemophilus influenzae bacteria could lead to other illnesses which may pose a serious threat to both plaintiff and the fetus.
The next day, on March 21, 1990, plaintiff was examined by her obstetrician, Dr. Thompson. During the examination, a sonogram revealed fetal demise.
Dr. Steven Clark, plaintiff's expert in obstetrics and maternal/fetal medicine, testified that plaintiff had a severe reaction, known as anaphylaxis, to the Ciprofloxacin, causing low blood pressure and low oxygen intake. As a result, the fetus was deprived of oxygen and blood flow, ultimately causing its demise. It was his view that Dr. Dugenio deviated from the accepted standard of care when he administered Ciprofloxacin for a sore throat to a pregnant patient.
During his testimony, Dr. Clark referred to the following warnings about the use of Ciprofloxacin contained in the PDR:
CIPROFLOXACIN SHOULD NOT BE USED IN CHILDREN OR PREGNANT WOMEN. The oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage.
The PDR also placed Ciprofloxacin in "Use-In-Pregnancy Category C," which means:
Risk cannot be ruled out. Human studies are lacking, and animal studies are either positive for fetal risk, or lacking as well. However, potential benefits may justify the potential risk.
Dr. Clark stated that a reasonable and prudent practicing physician does not use Ciprofloxacin for pregnant patients unless they are critically ill and they fail to respond to all other antibiotics. He testified that there were a number of effective alternatives which were safer than Ciprofloxacin, and that the risks of administering Ciprofloxacin "absolutely" outweighed the benefits. Dr. Clark did acknowledge that the arthropathy (joint cartilage damage) warned of in the PDR is not what occurred to plaintiff's fetus; rather, the fetus expired because of an anaphylactic reaction suffered by the plaintiff. He also admitted that it was rare for a patient to have a reaction to Ciprofloxacin, and that it was just as likely that plaintiff could have had the same type of reaction to any other antibiotic.
Plaintiff also presented testimony by Dr. Chester Smialowicz, an infectious disease specialist. Dr. Smialowicz, like Dr. Clark, noted that the PDR instructs that Ciprofloxacin should not be given during pregnancy unless the mother's life is threatened and no safer antibiotic will help. He also stated that it was a deviation from the accepted standard of care to have given a pregnant patient Ciprofloxacin for acute pharyngitis. He added that acute pharyngitis is not caused by hemophilus influenzae, and therefore plaintiff did not even require an antibiotic. He knew of no reason why Dr. Dugenio, even if he believed the cause of plaintiff's pharyngitis to be bacterial, could not have attempted to treat plaintiff with a penicillin, a cephalosporin, or an erythromycin. Dr. Smialowicz declared that no competent physician would expect that the organisms causing plaintiff's pharyngitis would enter her blood stream or cross over into her fetus and threaten the fetus' life.
The defense presented Dr. Sidney Wilchins, who testified that the administration of Ciprofloxacin was proper because of the ineffectiveness of the amoxicillin. He added that the risks of not treating a pregnant patient in the presence of hemophilus influenzae were "infinitely catastrophic" to a developing fetus as compared with the risks of treating the mother with Ciprofloxacin. It was also his opinion that Ciprofloxacin played no role in the death of plaintiff's fetus; the death was more likely caused by the length of plaintiff's umbilical cord.
Also testifying for the defense was Dr. Julius Kaplan. Dr. Kaplan agreed with Dr. Wilchins that under the specific circumstances of this case, it was appropriate for a physician to use his medical judgment and prescribe a stronger antibiotic after the first, (amoxicillin), was unsuccessful, because the other drugs available to the plaintiff were not effective against the bacteria causing plaintiff's infection.
Plaintiff requested the trial Judge to read verbatim, as part of the jury instruction, the two recitals in the PDR containing the warnings that Ciprofloxacin should not be used by children or pregnant women, and that the risk to the human fetus from Ciprofloxacin could not be ruled out. She further requested that the jury be instructed that, if Dr. Dugenio knew of the warnings contained in the PDR and nevertheless ignored them, such "violation" was evidence ...