Argued November 3, 1997 -- Decided February 26, 1998 On certification to the Superior Court, Appellate Division, whose opinion is reported at 295 N.J. Super. 113 (1996).
The opinion of the court was delivered by: Pollock, J.
This medical malpractice case presents two issues. The first is whether pharmaceutical package inserts in the Physicians Desk Reference (PDR) are admissible as evidence of a physician's standard of care. The second issue is whether the trial court committed reversible error by instructing the jury in accordance with Model Jury Charge 5.36(A) that a physician is not liable for diagnosis or treatment resulting from the exercise of the physician's judgment.
When she was eight and one-half months pregnant, plaintiff, Angela Morlino, visited the emergency room at the Point Pleasant facility of defendant Medical Center of Ocean County (Medical Center) complaining of a sore throat. Dr. J. Dugenio, the emergency room doctor, prescribed Ciprofloxacin (Cipro). A sonogram on the following day revealed that Morlino's fetus was dead.
Morlino sued Dr. Dugenio, the Medical Center, and her obstetrician, Dr. Flavius Thompson. Claiming that the ingestion of Cipro had caused the fetus's death, Morlino sought damages for severe emotional distress.
The trial extended over three weeks. After deliberating for less than an hour, the jury returned a unanimous verdict in favor of defendants.
The Appellate Division held that a PDR warning is admissible in conjunction with expert testimony to establish the appropriate standard of care. The court also held that proof of a violation of a warning in the PDR is not prima facie evidence of negligence. 295 N.J. Super. 113, 122-23 (App. Div. 1996). It concluded, however, that the trial court's failure to admit the PDR warning was harmless error. Id. at 126.
Finally, the Appellate Division upheld the trial court's reliance on Model Jury Charge 5.36(A)'s "exercise of judgment" instruction. Id. at 129.
We granted certification, 149 N.J. 34 (1997), and now affirm the judgment of the Appellate Division.
On March 5, 1990, four weeks before she was due to deliver her baby, Morlino visited the emergency room of the Medical Center. She was diagnosed with "acute pharyngitis," commonly known as a sore throat, and was given a prescription for 500 milligrams of amoxicillin, an antibiotic in the penicillin family.
Morlino returned to the emergency room of the Medical Center on March 20. She again sought treatment for a sore throat. Dr. Dugenio took her history, examined her, and diagnosed her condition as acute pharyngitis. He also ordered a variety of tests. Blood and sedimentation tests indicated an infection or inflammation. Dr. Dugenio believed that a bacteria known as Hemophilus influenza was causing Morlino's acute pharyngitis.
Two days later, the results of Morlino's throat culture confirmed the presence of Hemophilus influenza bacteria. The culture also revealed that Morlino's infection was resistant to numerous antibiotics such as ampicillin, cephalosporin, erythromycin, clindamycin, nafcillin, and penicillin.
Even before receiving the throat culture results, Dr. Dugenio considered prescribing Cipro. He consulted the PDR, a compilation of information about prescription drugs that is published annually and distributed to the medical professional free of charge. A typical entry includes the trade and chemical names of the drug, a description of the drug, indications and contraindications for its use, warnings, adverse reactions, administrations and dosage, and information on managing and adjusting the dosage of the drug. Ramon v. Farr, 770 P.2d 131, 133 n. 2 (Utah 1989). Generally, the information in a package insert, which accompanies prescription drugs, is the same as that in the PDR.
The PDR contains the following warning for Cipro:
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.
Additionally, the PDR characterizes drugs for pregnant women based on the degree to which the drug manufacturer has ruled out a risk to the fetus. Cipro was 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.
From the PDR warnings, Dr. Dugenio understood that he should prescribe Cipro for a pregnant patient only if the potential benefit to the patient outweighed the risk to her and the fetus. In weighing the risks and benefits, Dr. Dugenio was concerned that the Hemophilus influenzae bacteria, if untreated, could lead to more serious illnesses, such as infectious mononucleosis, pneumonia, and meningitis. These illnesses could pose serious risks to Morlino and her fetus. The PDR, he noted, did not state that the use of Cipro in pregnant women is contraindicated.
Dr. Dugenio described his decision-making process:
After analyzing the situation with the patient and the potential risk that she may have, based upon my previous experience with this kind of problem, Cipro was the medication that I know of that can possibly do the job as far as the possible infection that I thought this patient had, which turned out to be correct after the culture, anyway.
I considered giving her the ampicillin that was given on the 5th of March, but I found out that this, in all likelihood, will not kill the bacteria, because the patient came to the emergency room again. It stands to reason.
Next I was considering the other medications in similar category, like keflex, but these are similar to ampicillin, and in my experience, even to myself now, when I take this medication, it does not work, and it does not work for so many of my patients in the emergency room of a similar condition.
So I elected to give the Cipro, because I know in my heart it will work, and it does work for me and it does work for the other patients, knowing the risk, the possible risk. But see, the patient's risk far outweigh the risk, the potential risk, that it would harm as far as the warning's concerned.
That warning, it doesn't mean that because it's there, it's going to happen. It may happen, but it does not necessarily have to happen.
But I can tell you one thing, if my -- my potential, especially of this patient, of possibility of an infection of Hemophilus influenzae variety, which can cause sudden closing of the throat, which is a major cause of meningitis in children five years or under, I'm not going to give anything less that Cipro, because I know it's going to work.
Dr. Dugenio did not warn Morlino that Cipro might pose a risk to her fetus. He gave her a 500 milligram Cipro pill and a prescription for 250 milligrams of Cipro to be taken twice a day.
Missing from the abbreviated record before us is Morlino's testimony. The record nonetheless reflects conflicts that could have affected the jury's assessment of Morlino's credibility.
According to both Dr. Dugenio and Morlino, Morlino arrived at the emergency room on March 20, 1990 at 10:59, took the Cipro at 12:30, and was discharged ten minutes later. The parties' testimony differed on whether Dr. Dugenio saw Morlino at the emergency room in the morning or the evening of March 20, 1990. In her deposition, Morlino testified that she had sought treatment during the evening of March 20-21. According to the hospital records, however, Morlino was treated in the emergency room from 10:59 a.m. to 12:30 p.m. on March 20, 1990. In his testimony, Dr. Dugenio confirmed the accuracy of the hospital records. Moreover, the hospital's planning calendar and the physician's sign-in sheet both indicate that Dr. Dugenio worked from 8 a.m. to 8 p.m. on March 20. Finally, Morlino filled her prescription for Cipro at a local pharmacy on March 20, not March 21. If, as Morlino testified in her deposition, she did not leave the emergency room until March 21, she could not have filled the prescription on March 20.
At her deposition, Morlino further testified that she drove home from the hospital at night. She stated that while driving, she felt dizzy, weak, and short of breath and that her eyesight was blurred. Morlino testified that she lost consciousness for several hours when she returned to her home.
On March 21, 1990, Morlino's obstetrician, Dr. Thompson, was unable to detect a fetal heartbeat during a routine examination. A sonogram revealed that Morlino's fetus had died. During the course of his examination, Dr. Thompson called the Ocean County emergency room and ascertained that she had taken Cipro. After reviewing the PDR entry for Cipro, Dr. Thompson concluded that it could not have caused the death of the fetus. The autopsy of the fetus did not reveal any arthropathy (joint cartilage damage), the subject of the PDR warning.
The expert testimony was in sharp conflict. Dr. Steven Clark, an expert in obstetrics and maternal/fetal medicine, testified on behalf of Morlino. Referring to the warnings in the PDR, he asserted that Dr. Dugenio had violated the applicable standard of care by administering Cipro to Morlino. According to Dr. Clark, Cipro should not be prescribed for a pregnant woman unless she is critically ill and all other antibiotics had failed. He explained that Cipro can cause arthropathy in the joints of a fetus. Dr. Clark nonetheless admitted that the fetus's joints did not reveal any arthropathy. He acknowledged, moreover, that a Class C drug, such as Cipro, can be prescribed for a pregnant ...