(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for
the convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please
note that, in the interests of brevity, portions of any opinion may not have been summarized).
POLLOCK, J., writing for a unanimous Court.
In this medical malpractice case, the Court addresses the admissibility of pharmaceutical package
inserts in the Physicians' Desk Reference (PDR) as evidence of a physician's standard of care and the
propriety of 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, Angela Morlino visited the emergency room at
the Point Pleasant facility of the Medical Center of Ocean County (Medical Center) complaining of a sore
throat. She had visited the Medical Center two weeks earlier for similar complaints and was given a
prescription for amoxicillin, an antibiotic in the penicillin family. When she returned on this occasion, the
emergency room physician, Dr. Dugenio took her history, examined her, and ordered a variety of tests. He
diagnosed her condition as acute pharyngitis. Two days later, the results of Morlino's throat culture
confirmed the presence of a bacteria that was resistant to numerous antibiotics, including penicillin. Before
receiving those results, Dr. Dugenio considered prescribing Ciprofloxacin (Cipro), as the amoxicillin had not
cured the infection.
Prior to prescribing the Cipro, Dr. Dugenio consulted the PDR, a compilation of information about
prescription drugs distributed to the medical community annually. Generally, the information in a package
insert, which accompanies prescription drugs, is the same as that in the PDR. The PDR contained a warning
against use of Cipro in children and pregnant women because it caused lameness in immature dogs and
further indicated that risk to the fetus could not be ruled out. The PDR noted, however, that potential
benefits may justify the potential risk. From these 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.
Because he was concerned that the bacteria, left untreated, could lead to more serious illnesses to
both Morlino and her fetus, he concluded that the potential risk to the fetus posed by prescribing Cipro
outweighed the risks of more serious illnesses to Morlino and her fetus. He, therefore, gave Morlino a 500
milligram Cipro pill and a prescription for 250 milligrams of Cipro. He did not warn Morlino that Cipro
might pose a risk to her fetus.
Thereafter, 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. Although the
autopsy of the fetus did not reveal any joint cartilage damage (the subject of the PDR warning), Morlino
sued Dr. Dugenio, the Medical Center, and Dr. Thompson, claiming that the ingestion of Cipro had caused
her to suffer an allergic reaction, causing the fetus's death.
At trial, to establish the standard of care concerning the prescription of Cipro, Morlino's counsel
submitted requests to the trial court concerning the use of warnings in the PDR. Morlino also requested an
instruction modifying Model Jury Charge 5.36(A), which pertains to the role of the physician's judgment in
the practice of medicine, claiming that the model charge misled jurors to focus on the physician's subjective
intentions, rather than on the conformance of the physician's conduct to an objective standard of care. The
trial court denied each request. Following a three-week trial, and after less than an hour of deliberation, the
jury returned a unanimous verdict in favor of the defendants.
On appeal, the Appellate Division held that the trial court did not err by refusing to read verbatim
the part of the PDR warnings stating that Cipro should not be used by pregnant women and that risk to the
fetus could not be ruled out. In addition, although the Appellate Division expressed dissatisfaction with
the trial court's use of Model Jury Charge 5.36(A)'s exercise of judgment instruction, it nevertheless
declined to reverse the judgment for defendants because the instruction did not prejudice Morlino, given the
compelling evidence that Dr. Dugenio conformed to prevailing medical standards by weighing the risk of
administering Cipro against its benefits.
The Supreme Court granted Morlino's petition for certification.
HELD: The trial court did not commit reversible error in refusing to read to the jury the two warnings in the
PDR; PDR entries do not, as a matter of law, establish the standard of care or negligence; the trial court did
not commit reversible error in charging the jury in accordance with Model Jury Charge 5.36(A), as the
charge, when read in its entirety, does not have the capacity to mislead the jury.
1. Traditionally, courts measure a doctor's duty in a medical malpractice action by an objective standard of
care. With rare exception, expert testimony is needed to establish the standard of care. (pp. 20-21)
2. Although PDR entries and package inserts, when supported by expert testimony, may provide useful
information of the standard of care, drug manufacturers did not design package inserts and PDR entries to
establish a standard of medical care. (pp. 21-22)
3. A physician's failure to adhere to PDR warnings does not, by itself, constitute negligence. (pp. 22-23)
4. A party may not generally introduce a treatise into evidence as a substitute for expert testimony, and
allowing the admission of PDR warnings without accompanying expert testimony could transform drug
manufacturers into judges of acceptable medical care. (pp. 23-24)
5. In selecting among alternative treatments, the physician must exercise his or her judgment and select from
alternatives that are objectively reasonable. Whether the doctor has committed an act of malpractice
depends not on the outcome, but on whether the doctor adhered to the applicable standard of care. (pp. 27-29)
6. Model Jury Charge 5.36(A), as a whole, correctly describes the relationship between judgment and the
standard of care and does not suggest that a physician is immune from liability as long as he or she does his
or her best. (pp. 30-34)
7. Although the language in the Model Jury Charge (that indicates that a physician cannot be held liable if
he makes a mistake in the exercise of his judgment) creates a danger that it will be misconstrued to mean
that an honest, but mistaken, exercise of judgment insulates the physician from liability for a mistake that
violates a relevant standard of care, the charge, when read in its entirety, does not have the capacity to
mislead the jury. (pp. 35-36)
8. Model Jury Charge 5.36(A) is remanded to the Supreme Court Committee on Model Jury Charges to
determine whether fewer than eleven references to judgment adequately will communicate to the jury that
medicine is not an exact science and that physicians and surgeons must exercise judgment. Because of its
potential to confuse the jury, the revised charge should eliminate the sentence suggesting that a doctor is not
liable for a mistake that results from the exercise of judgment. Finally, the Committee should try to make
the charge shorter and clearer. (pp. 36-38)
The judgment of the Appellate Division is AFFIRMED as modified.
CHIEF JUSTICE PORITZ and JUSTICES HANDLER, O'HERN, GARIBALDI, STEIN and
COLEMAN join in JUSTICE POLLOCK's opinion.
SUPREME C
OURT OF NEW JERSEY
A-
36 September Term 1997
ANGELA MORLINO, Individually and
ANGELA MORLINO, Administratrix ad
prosequendum for the Estate of Baby
Girl Morlino, Deceased,
Plaintiff-Appellant,
v.
MEDICAL CENTER OF OCEAN COUNTY, J.
DUGENIO, M.D. and FLAVIUS THOMPSON,
M.D.,
Defendants-Respondents,
and
JOHN DOE, M.D., the Emergency Room
Physician(s), JANE DOE, R.N., the
Emergency Room Nurse(s) and JOHN
DOE II, M.D.,
Defendants.
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).
Robert B. Kurzweil argued the cause for
appellant (Katz, Ettin, Levine, Kurzweil &
Weber, attorneys).
Joseph A. DiCroce argued the cause for
respondent Medical Center of Ocean County
(DiCroce & Maggs, attorneys; Timothy J.
Wintrode, on the brief).
Martin J. McGreevy, argued the cause for
respondent J. Dugenio, M.D. (Carton, Witt,
Arvanitis & Bariscillo, attorneys; Russell J.
Malta, on the briefs).
John R. Orlovsky argued the cause for respondent Flavius Thompson, M.D. (Orlovsky,
Moody, Schaaff & Gabrysiak, attorneys; Mr.
Orlovsky and Paul F. Schaaff, Jr., on the
briefs).
Michael S. Berger argued the cause for amicus
curiae Association for Trial Lawyers of
America-New Jersey (Mr. Berger, attorney;
Kevin Haverty, on the brief).
Hugh Francis argued the cause for amicus
curiae American Insurance Association
(Francis & Berry, attorneys; Peter A. Olsen,
on the brief).
Herbert J. Stern submitted a brief on behalf of
amicus curiae The Medical Society of New Jersey
(Stern & Greenberg, attorneys; Joel M. Silverstein,
on the brief).
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
[sic] 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 woman if the potential benefits outweigh the risks.
In his opinion, however, the risk/benefit analysis for Mrs.
Morlino was absolutely on the side of: don't give Cipro. .
. .
According to Dr. Clark, the dose of Cipro given at the
hospital had caused Morlino, while driving home at night, to
suffer a severe allergic reaction, known as anaphylaxis.
Dr. Clark believed that the anaphylactic reaction caused the
fetus's death. He admitted, however, that anaphylactic
reactions among persons taking Cipro are very rare and
that it was equally likely that Morlino could have sustained
an anaphylactic reaction to any other antibiotic. Dr. Clark
also acknowledged the absence of any known cases of
anaphylaxis from the administration of Cipro to pregnant
women.
According to Dr. Clark, an anaphylactic reaction to an
antibiotic is almost instantaneous. Critical to Dr. Clark's
testimony was Morlino's version of the facts that she had
taken the Cipro at 12:30 a.m. on March 21. He conceded
that, if Morlino had ingested the drug at 12:30 p.m. on
March 20, not at 12:30 a.m. on March 21 as she claimed, the
reaction she experienced was not connected to Cipro.
Morlino also presented the expert testimony of Dr.
Chester Smialowicz, an infectious disease specialist. Dr.
Smialowicz testified that the PDR instructs that Cipro
should not be given to a pregnant woman unless the mother's
life is at risk and no safer antibiotic will help. Like Dr.
Clark, he testified that Dr. Dugenio had deviated from the
accepted standard of care by giving a pregnant woman Cipro
for a sore throat.
According to Dr. Smialowicz, Hemophilus influenzae,
which is found normally in a person's throat, does not cause
acute pharyngitis. In his opinion, Morlino did not require
an antibiotic. Dr. Smialowicz testified that Cipro yields
only a negligible effect on upper respiratory infections and
was of no benefit in the treatment of Morlino's acute
pharyngitis. Acute pharyngitis, according to Dr.
Smialowicz, is a superficial irritation. Consequently, Dr.
Dugenio should not have been concerned that Morlino was at
risk for acute epiglottis, meningitis, bronchitis, or
pneumonia. Finally, Dr. Smialowicz believed that even if
the cause of Morlino's pharyngitis was bacterial, the
preferred treatment would have been a form of penicillin.
Two experts testified on behalf of Dr. Dugenio. Dr.
Sidney Wilchins, an obstetrician and gynecologist,
contradicted Morlino's experts. Dr. Wilchins testified that
Dr. Dugenio had complied completely with the accepted
medical standard of care. According to Dr. Wilchins, it was
totally appropriate for Dr. Dugenio to prescribe Cipro for
three reasons. First, amoxicillin had not cured Morlino's
March 5 sore throat. Therefore, it would had been useless
to continue with the penicillin family of antibiotics.
Second, Dr. Dugenio could not use a tetracycline because of
the risk of fetal tooth discoloration.
Third, Dr. Wilchins emphasized the importance of
weighing the comparative consequences of treating and not
treating the patient. Unlike Dr. Smialowicz, Dr. Wilchins
stated that Hemophilus influenzae can cause acute
pharyngitis. Indeed, the throat culture confirmed bacteria
as the cause of Morlino's sore throat. Because Hemophilus
influenzae can cause meningitis and pneumonia, the risk of
not treating Morlino's infection was infinitely
catastrophic to the fetus as opposed to treating the
infection. Hence, the floxacin family, which includes
Cipro, was a logical choice.
Dr. Wilchins reasoned that Cipro was unrelated to the
fetus's death. First, the fetus's death was most likely
caused by the length of Morlino's umbilical cord. The
average length of umbilical cords is fifty-five to sixty-five centimeters. Morlino's umbilical cord, however, was
approximately thirty-six to thirty-eight centimeters. Thus,
Dr. Wilchins reasoned that the cause of the fetus's death
was short cord syndrome. Second, Dr. Wilchins noted the
absence of any recorded history indicating that a single
dose of Cipro is causally connected to a stillbirth.
Third, he rejected Dr. Clark's theory that Cipro caused
Morlino to suffer anaphylactic shock. In brief, Dr.
Wilchins emphasized the significance of the time lapse
between Morlino's ingestion of Cipro and her claimed
anaphylactic shock. According to Dr. Wilchins, anaphylactic
reactions occur automatically, virtually, immediately, upon
exposure of the medication. If Morlino had suffered a
reaction during the evening of March 20 and ingested only
one dose of Cipro at 12:30 p.m. on that date, then her
reaction was unrelated to Cipro. For Cipro to have had a
causal connection with anaphylaxis, Morlino's reaction would
have occurred between 12:30 and 12:40 p.m., not eight hours
later.
Finally, Dr. Wilchins referred to the PDR, which
specifically refers to Ciprofloxin causing
lameness in immature dogs: This [case] has nothing
to do with cartilage. There's nothing in this
case, going back to all reports of the fetus, that
in any way refers to any abnormality involving
cartilage. So automatically there was no
association.
Dr. Julius Kaplan, an emergency-medicine physician,
also testified for the defense. Dr. Kaplan stated that Dr.
Dugenio's care, including the administration of Cipro,
comported with the accepted standard of care for emergency
room physicians. Dr. Kaplan noted that Dr. Dugenio followed
each step required of an emergency room physician: he
obtained an appropriate patient history, conducted a
physical examination, ordered ancillary tests, made a
diagnosis, and made the appropriate disposition by
prescribing medication.
Dr. Kaplan decided that Cipro was an appropriate
antibiotic. He supported his decision by reasoning that two
weeks earlier Morlino had taken a first-line drug,
amoxicillin, and still had a sore throat. Under those
circumstances, Dr. Kaplan testified, it's perfectly
appropriate for a physician to use medical judgment, to then
give the patient a more potent antibiotic, a stronger
antibiotic. Prescription of an antibiotic from the
penicillin family, therefore, would have been inappropriate.
In Dr. Kaplan's opinion, Morlino suffered from both
viral and bacterial infections. Accordingly, Dr. Dugenio
properly prescribed an antibiotic to treat the bacterial
infection. Furthermore, Dr. Kaplan explained that
hemophilus influenzae can cause not only acute pharyngitis,
but also ear infections, pneumonia, sepsis, and is one of
the most serious causes of meningitis. Such diseases pose
potential risks to a fetus. For example, a sepsis infection
could either cross the placental barrier and affect the
fetus directly or, more likely, debilitate the mother to the
point where the fetus was stressed.
Finally, Dr. Kaplan did not believe that Morlino had
suffered an anaphylactic reaction. Although antibiotics can
cause anaphylactic shock, such shock is rare. Pointing to
the time lapse between the administration of the drug at
12:30 p.m. on March 20 and the onset of symptoms in the
evening, Dr. Kaplan stated, It is inconceivable, in my
opinion, that any reaction which happened in the evening
hours could have been related to taking a pill at 12 o'clock
noon or somewhere around there.
Although this appeal focuses on legal issues, Dr.
Dugenio argues that [Morlino's] theory that the fetal death
was caused by an anaphylactic shock was seriously
challenged. The credibility of this thesis relied to a
great extent upon the credibility of testimony given by
[Morlino]. During the course of the trial [Morlino's]
credibility was seriously eroded, if not completely
destroyed. When assessing Morlino's credibility, the jury,
for example, may have considered the inconsistency between
her testimony and the controverted facts about the date on
which she ingested Cipro, as well as other contradictions in
her testimony.
To establish the standard of care concerning the
prescription of Cipro, Morlino's counsel submitted requests
to the trial court concerning the use of warnings in the
PDR. Morlino also requested an instruction modifying Model
Jury Charge 5.36(A), which pertains to the role of judgment
in the practice of medicine. The trial court denied each
request.
In affirming, the Appellate Division held that the
trial court did not err by refusing to read verbatim that
part of the two PDR warnings stating that Cipro should not
be used by pregnant women and that the [r]isk cannot be
ruled out. The Appellate Division identified three
approaches concerning the use of the manufacturer's insert
and the parallel PDR warning to establish a medical standard
of care. 295 N.J. Super. at 120-21. The first approach,
adopted by this Court in Sanzari v. Rosenfeld,
34 N.J. 128,
140 (1961), is that product packaging inserts do not
establish a standard of care but are admissible to show what
the physician knew or should have known about the drug.
295 N.J. Super. at 120. According to the Appellate
Division, out-of-state cases support two other approaches.
The second approach is to allow product inserts (and the
PDR) into evidence to show the standard of care, provided
expert testimony is also presented to explain the standard
of care to the jury. Ibid. The third approach is that
the product insert, standing alone without expert testimony,
is evidence of negligence by the physician who fails to
adhere to its rules. Id. at 121. Rejecting the first and
third approaches, the Appellate Division adopted the rule
that package inserts and their parallel PDR references may
be considered by the jury along with expert testimony to
determine the appropriate standard of care. Id. at 123.
Nevertheless, the Appellate Division found no error in the
trial court's refusal to instruct the jury that it could
consider the PDR references, along with expert testimony, to
define the standard of care. Id. at 125.
Next, the Appellate Division expressed its
dissatisfaction with the trial court's use of Model Jury
Charge 5.36(A)'s exercise of judgement instruction for
three reasons. Id. at 127. First, it criticized the
sentence [t]he physician cannot be held liable if, in the
exercise of his judgment, he nevertheless made a mistake.
The sentence suggested that an honest, good-faith exercise
of judgment alone insulates a physician from liability.
Ibid. Second, the Appellate Division reasoned that the
charge's repetitive use of judgment has the clear
capacity to muddle the jury's understanding of whether the
physician met the standard of care. Ibid. Finally, the
Appellate Division noted that courts in other jurisdictions
have rejected exercise of judgment charges. Id. at 128.
The Appellate Division, however, declined to reverse
the judgment for defendants because the Model Charge
followed the statement in Schueler v. Strelinger,
43 N.J. 330, 344-45 (1963). Id. at 129. It noted that any
shortcomings in the charge did not prejudice Morlino, given
the compelling evidence that Dr. Dugenio conformed to
prevailing medical standards by carefully weighing the risk
of administering Cipro against its benefits. Ibid.
The trial court refused, ruling that the PDR was
relevant only to Dr. Dugenio's knowledge of the warnings,
and not to the standard of care pertaining to his treatment
of Morlino.
The Appellate Division held, however, that the trial
court should have instructed the jury to consider the PDR
references as explained by the expert testimony as evidence
of Dr. Dugenio's satisfaction of the appropriate standard of
care. Nevertheless, the Appellate Division affirmed the
judgment for defendants, holding further that the trial
court's failure to so instruct the jury was harmless error.
295 N.J. Super. at 125.
The Appellate Division reasoned that the jury
undoubtably considered the PDR warnings concerning the
issues not only of Dr. Dugenio's knowledge, but also of the
standard of care. Ibid. The court noted that the jury
viewed blow-ups of the PDR's relevant sections and heard
extensive expert testimony concerning the PDR. Morlino's
experts testified about the PDR warnings and their opinion
concerning the prescription of Cipro. The experts relied,
in part, on the PDR to establish the standard of care and to
describe the risk/benefit analysis required for Category C
drugs. Also, Dr. Dugenio admitted that he had learned from
the PDR not only of the risks of giving Cipro to a pregnant
woman, but also of the necessity for a risk/benefit
analysis. As the Appellate Division stated, the PDR "merely
embodied the warnings and risk/benefit analysis which were
addressed extensively by the experts." 295 N.J. Super. at
125.
Additionally, the trial court did not give a limiting
instruction on the use of the PDR. It merely instructed the
jury that it could consider the testimony of all witnesses,
records, exhibits, documents, and depositions in reaching
the verdict. The court did not instruct the jury to
consider the PDR only in relation to Dr. Dugenio's
knowledge. Accordingly, the jury was free to consider the
warnings in the PDR with respect to any matter at issue in
the trial.
Moreover, the trial court instructed the jury on how to
weigh the expert testimony. It reminded them that the
value or weight of the opinion of the expert is dependent
upon and is no stronger than the facts upon which [the
expert] bases that opinion.
In sum, we agree with the Appellate Division that the
jury was free to consider the PDR warnings on questions of
both Dr. Dugenio's knowledge and the standard of care
applicable to his conduct. We further hold that the jury
may consider package inserts and parallel PDR references,
when they are supported by expert testimony, to determine
the appropriate standard of care in a medical malpractice
case.
This holding is consistent with our opinion in Sanzari
v. Rosenfeld, supra, 34 N.J. at 139, which sustained the
introduction of a manufacturer's brochure to prove that the
defendant physician knew of the contents of the insert.
When reaching that result, we stated it is unnecessary for
us to determine whether a manufacturer's brochure, alone or
in conjunction with other evidence, is admissible as proof
of the standard of care in the administration of a drug.
Ibid.
Traditionally, courts measure a doctor's duty in a
medical malpractice action by an objective standard of care.
With rare exception, expert testimony is needed to establish
the standard of care. See Rosenberg ex rel. Rosenberg v.
Cahill,
99 N.J. 318, 325 (1985) ([I]n the ordinary medical
malpractice case, 'the standard of practice to which [the
defendant-practitioner] failed to adhere must be established
by expert testimony . . . .') (citation omitted); Schueler
v. Strelinger,
43 N.J. 330, 345 (1964) (holding that with
rare exceptions, evidence of deviation from accepted medical
standards must be provided by expert testimony).
Expert testimony is necessary to establish the standard
of care in a medical malpractice action for several reasons.
Ordinarily a jury of laymen cannot be allowed to speculate
as to whether the procedure followed by a treating physician
conformed to the required professional standards.
Schueler, supra, 43 N.J. at 345. See also Walck v. John
Manville Products Corp.,
56 N.J. 533, 562 (1970)
(Ordinarily, a court cannot be permitted to speculate as to
whether the diagnosis and procedure followed by a treating
physician conformed to the required professional
standards.). In most cases, without expert testimony, it
would expect too much of jurors to ask them to set the
standard by which to measure a medical doctor's conduct. As
we have explained, jurors generally lack the 'requisite
knowledge, technical training, and background to be able to
determine the applicable standard without the assistance of
an expert.' Rosenberg, supra, 99 N.J. at 325 (quoting
Sanzari, supra, 34 N.J. at 134-35).
The first issue on this appeal is whether the PDR may
be introduced in evidence to prove the standard of care
applicable to a doctor's prescription of medicine. When
supported by expert testimony, PDR entries and package
inserts may provide useful information of the standard of
care. Physicians frequently rely on the PDR when making
decisions concerning the administration and dosage of drugs.
James R. Bird, Package Inserts for Prescription Drugs as
Evidence in Malpractice Suits,
44 U. Chi. L. Rev. 398, 416
(1977) (citing Survey of Drug Information Needs and Problems
Associated with Communications Directed to Practicing
Physicians (May 6, 1974), reprinted in Examination of the
Pharmaceutical Industry, 1973-74, Hearings before the
Subcomm. on Health of the Senate Comm. on Labor and Public
Welfare, 93rd Cong., 1st & 2nd Sess. (1973-74)). Often, the
drug manufacturer, which has developed and tested the drug,
may be in a better position than the physician to determine
the appropriate usage and dosage of drugs.
Nevertheless, drug manufacturers do not design package
inserts and PDR entries to establish a standard of medical
care. Ramon, supra, 770 P.
2d at 135; Salgo v. Leland
Stanford Jr. Univ. Bd. of Trustees,
317 P.2d 170, 180 (Cal.
1957). Manufacturers write drug package inserts and PDR
warnings for many reasons including compliance with FDA
requirements, advertisement, the provision of useful
information to physicians, and an attempt to limit the
manufacturer's liability. Thompson v. Carter,
518 So.2d 609, 612 (Miss. 1987); Ramon, supra, 770 P.
2d at 136. After
a drug has been on the market for a sufficient period of
time, moreover, physicians may rely more on their own
experience and the professional publications of others than
on a drug manufacturer's advertisements, inserts, or PDR
entries. Salgo, supra, 317 P.
2d at 180.
Those considerations highlight the reasons expert
testimony must accompany the introduction of PDR warnings to
establish the applicable standard of care in prescribing a
drug. Additionally, expert testimony often is needed to
explain the information contained in package inserts or the
PDR. Drug manufacturers write explanations and warnings for
doctors, not the general public. Comprehension of the terms
and their significance may depend on medical expertise.
Craft v. Peebles,
893 P.2d 138, 151 n.17 (Haw. 1995).
Accordingly, we hold that package inserts and PDR
references alone do not establish the standard of care. It
follows that a physician's failure to adhere to PDR warnings
does not by itself constitute negligence. Reliance on the
PDR alone to establish negligence would both obviate expert
testimony on an issue where it is needed and could mislead
the jury about the appropriate standard of care.
Similarly, a party may not generally introduce a
treatise into evidence as a substitute for expert testimony.
Adamski v. Moss,
271 N.J. Super. 513, 519-22 (App. Div.
1994); Biunno, Current New Jersey Rules of Evidence, Comment
on N.J.R.E. 803(c)(18). As we recently stated when
considering the admissibility of learned treatises under
N.J.R.E. 803(c)(18), a learned treatise's use as
'substantive evidence is limited to situations in which an
expert is on the stand and available to explain and assist
in the application of the treatise if desired.' Jacober v.
St. Peter's Medical Ctr.,
128 N.J. 475, 491 (1992) (citing
Fed. R. Evid. 803(18) advisory committee's note).
Allowing the admission of PDR warnings without
accompanying expert testimony could transform drug
manufacturers into judges of acceptable medical care. The
effect would be to force doctors to follow the PDR's
recommendations or run the risk of liability for
malpractice. Michael J. Farell, Medication Malpractice:
Claims, Culprits and Defenses, 16 Am. J. Trial Advoc. 65, 80
(1992).
Whether to prescribe a drug and, if so, what drug to
prescribe are issues that demand careful consideration. The
decision to prescribe a particular drug ultimately is a
matter of judgment for the physician. In addition to
considering the individual patient, the physician may
consider all available information concerning a drug. The
information may include the manufacturer's inserts and PDR
warnings, as well as medical journals, advice from
colleagues, and the physician's own experience.
To confine the treatment choices to those expressly
permitted in the PDR would be too restrictive. Ramon,
supra, 770 P.
2d at 133. Such an approach also would be
inconsistent with the FDA's position that physicians are not
bound by PDR recommendations. Ibid. Indeed, the forward to
the 1997 PDR advises the following:
The FDA has always recognized that the
[Food, Drug, and Cosmetics] Act does
not, however, limit the manner in which
a physician may use an approved drug.
Once a product has been approved for
marketing, a physician may choose to
prescribe it for uses or in treatment
regimens or patient populations that are
not included in approved labeling. The
FDA also observes that accepted medical
practice often included drug use that is
not reflected in approved drug labeling.
In sum, we hold that the trial court did not commit
reversible error in refusing to read to the jury the two
warnings in the PDR. We further hold that the trial court
did not err in refusing to instruct the jury that if Dr.
Dugenio knew of the PDR warnings and nonetheless violated
them, his conduct was evidence of negligence. Although
admissible along with expert testimony on the issue of the
standard of care, the PDR's recommendations are not
conclusive evidence of the standard of care or accepted
practice in using the drug. Thus, the PDR entries do not,
as a matter of law, establish the standard of care or
negligence.
If a physician has applied the required knowledge, skill and care in the diagnosis and treatment of a patient, he
or she is not negligent merely because
there was a bad result.
Likewise, where, according to accepted
medical standards or practice, the
manner in which the diagnosis or
treatment is conducted is a matter
subject to the judgment of the
physician, the physician must be allowed
to exercise his judgment.
The physician cannot be held liable if,
in the exercise of his judgment, he
nevertheless made a mistake. Where
judgment must be exercised, the law does
not require the doctor to have
infallible judgment. Thus, a physician
cannot be found negligent so long as he
or she employs such judgment as is
allowed by the accepted medical
practice.
If, in the exercise of his judgment, a
doctor selects one or two or more
courses of action, each of which in the
circumstances has substantial support as
proper practice by the medical
profession, the doctor cannot be found
negligent if the chosen path produces a
poor result.
On the other hand, a doctor who departs
from the standard medical practice where
no judgment is permitted, he cannot be
excused, and nor can he excuse himself
from the consequences by saying that it
was an exercise of his judgment. Or, to
state it in a different way, if the
exercise of a
doctor's judgment
causes him to do
that which the
standard medical
practice forbids,
the doctor would be
negligent.
Similarly, a doctor whose judgment
causes him or her to omit doing
something which is required by the
standard medical practice, he is also
negligent.
At issue in this case is the role of judgment in medical practice. Physicians and surgeons frequently grapple with uncertainty when diagnosing and treating patients. Each patient presents a unique set of facts and a
range of possible responses. Symptoms often point in
different directions or in no distinct direction.
Having made a diagnosis, the doctor must decide whether
and how to treat the patient. Doctors must select treatment
options from an evolving body of scientific and medical
information. Medicine remains an inexact science. Crego v.
Carp,
295 N.J. Super. 565, 574 (1996), certif. denied,
149 N.J. 34 (1997). The choice may not be clear and
alternatives may abound, but choose the doctor must. In
selecting among alternative treatments, however, the doctor
must exercise his or her judgment and select from
alternatives that are objectively reasonable. The selection
of an alternative that is objectively unreasonable would
violate the doctor's duty of care to the patient.
In making diagnoses and selecting among treatment
options, doctors must rely on their training and experience,
as well as such considerations as the patient's age, gender,
and physical or mental condition. When evaluating those
variables, physicians should not act mechanically, but with
due regard for the individual needs of each patient.
Newmark v. Gimbel's Inc.,
54 N.J. 585, 596-97 (1969). Not
recognizing the role of judgment in making a diagnosis or in
deciding on a course of treatment would be to deny an
essential element in the practice of medicine. Accordingly,
Model Charge 5.36(A) rightly recognizes that a physician may
exercise judgment when choosing among acceptable treatment
alternatives.
Doctors may exercise reasonable care and still produce
a bad result. A doctor is not an insurer of his patient's
recovery. He is not a guarantor. Clark, supra, 72 N.J.
Super. at 495. The practice of medicine according to
accepted medical standards will sometimes lead to a poor or
unanticipated result. Whether the doctor has committed an
act of malpractice depends not on the outcome, but on
whether the doctor adhered to the applicable standard of
care.
By comparison, whether a trial lawyer has committed an
act of legal malpractice depends not on the outcome of the
proceeding, but on whether the lawyer adhered to the
appropriate standard of care in representing the client.
Thus, the exercise of judgment is critical to both the legal
profession and the medical profession. Neither the trial
lawyer nor the doctor insures a good result. Both, however,
must act consistently with the relevant standard of care.
Plaintiff and amicus curiae, American Trial Lawyers'
Association (ATLA), invite us to delete entirely from the
Model Charge the phrase exercise of judgment. Similarly,
the Appellate Division states that a growing number of
courts from other jurisdictions have rejected exercise of
judgment instructions because they confuse jurors into
focusing on the health care provider's subjective intentions
and judgments rather than the real issue of whether the health care provider's conduct conformed to an objective standard of care. 296 N.J. Super. at 128 (quoting Parodi v. Wahoe Medical Ctr., Inc., 892 P.2d 588, 590 (Nev. 1995)). Our reading of the cases both in this state and elsewhere leads us to a different conclusion. Courts in other jurisdictions have rejected charges not because they recognize that physicians and surgeons exercise judgment, but because the charges contained language such as good faith judgment, bona fide judgment, honest mistake, honest error in judgment, and bona fide error in judgment. See Jefferson Clinic, P.C. v. Roberson, 626 So.2d 1243, 1247 (Ala. 1993) (rejecting reverse honest error in judgment charge, which instructed jury that it was no defense if acts or omissions of defendant physician or employees and agents of defendant clinic were made in good faith or through error in judgment, because injection of subjective standard rather than objective standard into the jury's deliberative process clearly causes confusion); Shumaker v. Johnson, 571 So.2d 991, 994 (Ala. 1990) (holding that honest error in judgment and good-faith error jury charge should not be given in medical malpractice cases because of its potential for confusing the jury); Logan v. Greenwich Hosp. Ass'n, 465 A.2d 294, 303 (Conn. 1983) (finding error in charge containing term bona fide error in judgment because term seems only to confuse a jury by
implying that only an error in judgment made with bad faith can be actionable); Krattenstein v. Thomas, 509 A.2d 1077, 1079 (Conn. App. Ct.) (finding error in charge containing term bona fide error in judgment, but holding that charge as whole did not mislead or confuse jury given repetition of applicable standard of care and lack of allegation that defendant acted in bad faith), certif. denied, 515 A.2d 378 (Conn. 1986); Veliz v. American Hosp., Inc., 414 So.2d 226, 227-28 (Fla. Dist. Ct.) (rejecting honest error in judgment charge because jury could have found the defendant [hospital] not liable because it believed the nurse on duty made an honest mistake of judgment while at the same time it could also have believed her conduct constituted a clear departure from the standard of care), review denied, 424 So.2d 760 (Fla. 1982); Day v. Morrison, 657 So.2d 808, 815 (Miss. 1995) (rejecting use of mere error of judgment, good faith error in judgment, or honest error in judgment instructions because of their potential for confusing the jury); Parodi, supra, 892 P. 2d at 591 (rejecting error in judgment, honest or best judgment language because they may confuse jurors into focusing on the health care provider's subjective intentions and judgments rather than on the real issue of whether the health care provider's conduct conformed to an objective standard of care); Wall v. Stout, 311 S.E.2d 571, 577 (N.C. 1984) (holding inappropriate honest error language because
it could easily be interpreted by jury to mean that physician could not be liable for negligence unless he was somehow dishonest); Kurzner v. Sanders, 627 N.E.2d 564, 567 (Ohio Ct. App. 1993), reh. denied, 626 N.E.2d 689 (1994) (finding prejudicial error in charge containing term honest error or mistake in judgment because it changed the standard of care from an objective one to a subjective one); DiFranco v. Klein, 657 A.2d 145, 148 (R.I. 1995) (holding that phrases such as good faith, good faith judgment, honest mistake, and honest error of judgment in jury charge tend to create confusion among jurors by erroneously implying that only dishonest or bad-faith deviation from applicable standard of care constitutes actionable negligence); Shamburger v. Behrens, 380 N.W.2d 659, 663 (S.D. 1986) (rejecting use of phrase good faith error in judgment in charging jury because it unduly confuses the issues in a negligence action); Rooney v. Medical Ctr. Hosp. of Vermont, Inc., 649 A.2d 756, 760-61 (Vt. 1994) (rejecting use of: (1) best judgment language because instruction would improperly permit a jury to conclude that a physician who lacked the requisite skill or knowledge is not liable as long as she used her best judgment and reasonable care in the exercise of whatever skill or knowledge she did possess, however limited; and (2) mere error in judgment language because it is ambiguous and subjective); Ten Len Chu v. Fairfax
Emergency Medical Assocs., Ltd.,
290 S.E.2d 820, 822 (Va.
1982) (stating that terms such as honest mistake and bona
fide error in judgment have no place in jury instructions
because they defy rational definition and tend to muddle
the jury's understanding of the plaintiff's burden in a
malpractice action).
Only one case cited by the Appellate Division, Yeager
v. Riverside Methodist Hosp.,
493 N.E.2d 559, 561 (Ohio Ct.
App. 1985), criticized the use of the word judgment alone
in a jury charge. In that case, the court first noted that
the defendant doctor's conduct should be measured by an
objective standard of care. Id. at 561. The court then
criticized part of the charge stating that the jury should
consider a physician's judgment in determining whether he
was medically negligent as suggesting a subjective standard
of care. Id. at 562. Nevertheless, the court found the
judgment instruction to be harmless error because the
charge as a whole recognized that the defendant's conduct
was to be measured by an objective standard of care. Ibid.
We disagree that a charge that recognizes the doctor's
exercise of judgment necessarily will mislead jurors to
focus on a physician's subjective intentions, rather than on
the conformance of the physician's conduct to an objective
standard of care. Indeed, a charge that does not recognize
the critical role of judgment would be deficient.
By comparison, terms such as good faith, honest,
and bona fide, could lead the jury to believe that, to
find the defendant negligent, the plaintiff must prove bad
faith, dishonesty, or fraud. Motivation, however, plays no
part in determining negligence with regard to an objective
standard of care. The physician's exercise of judgment is
to be evaluated not on the basis of the physician's good
faith or honesty, but solely on whether it falls below an
objective standard of care.
Model Jury Charge 5.36(A) does not contain the language
that the out-of-state cases found offensive, and, as a
whole, correctly describes the relationship between judgment
and the standard of care. The charge does not suggest that
a physician is immune from liability as long as he or she
does his or her best. Indeed, two other parts of the
Appellate Division recently have concluded that the Model
Charge when read in its entirety does not have the capacity
to confuse jurors. Crego, supra, 295 N.J. Super. at 574;
Hofstrom v. Share,
295 N.J. Super. 186, 195 (App. Div.
1996), certif. denied,
148 N.J. 462 (1997). See also Pepe
v. Jayne,
761 F. Supp. 338 (D.N.J.) (holding that New Jersey
Model Charge containing sentence physician cannot be held
liable if in the exercise of judgement he has, nevertheless,
made a mistake, was not confusing or likely to mislead jury
when read in context), aff'd sub nom Pepe v. Shore Memorial
Hosp.,
947 F.2d 936 (3rd Cir. 1991).
One sentence in the Model Charge is problematic. The
sentence reads, The physician cannot be held liable if, in
the exercise of his judgment, he nevertheless made a
mistake. See Riggins v. Mauriello,
603 A.2d 827, 831 (Del.
1992) (rejecting charge stating that a physician cannot be
held liable for a mere error of judgment in deciding what to
do or what not to do for the patient provided he has done
what he thinks best in the exercise of reasonable care
because a jury could too readily conclude, incorrectly,
that a physician is not liable for malpractice even if he or
she is negligent in administering the treatment selected);
Rogers v. Meridian Park Hosp.,
772 P.2d 929, 933 (Or. 1989)
(holding that error in judgment instruction obscures the
fact that, to avoid liability, the defendant must exercise
the degree of care, skill, and diligence required by law,
and suggest[s] that substandard conduct is permissible if
it is garbed as an 'exercise of judgment').
The purpose of the sentence is to advise the jury that,
as between two or more courses of action, each of which
accords with accepted medical practice, a doctor will not be
found negligent if the course of action he or she chooses
turns out to be unsuccessful. Taken out of context, the
sentence could be understood to mean that a doctor who
deviates from the relevant standard of care is not liable if
the mistake was the result of the exercise of medical
judgment. The danger is that the sentence could be
construed to mean that an honest, but mistaken, exercise of
judgment insulates the physician from liability for a
mistake that violates a relevant standard of care. A
mistake, however, connotes an instance in which the
physician violates such a standard of care. Consequently, a
physician who fails to abide by an objective standard of
care is subject to liability even if the failure results
from the exercise of judgment.
As the Appellate Division recognized, however, the
balance of the subject charge refers to the pertinent
medical standard of care by which to measure the physician's
judgment. 296 N.J. Super. at 127. The charge as a whole
thus clarifies that a deviation from the standard of care is
negligence:
[A] doctor who departs from standard
medical practice where no judgment is
permitted cannot excuse himself from the
consequences by saying that it was an
exercise of his judgment. Or, to state
it in a different way, if the exercise
of a doctor's judgment causes him to do
that which standard medical practice
forbids, the doctor would be negligent.
Similarly, a doctor whose judgment
causes him to omit doing something which
is required by standard medical practice
is also negligent.
Accordingly, we hold that Model Jury Charge 5.36(A), when
read in its entirety, does not have the capacity to mislead
the jury.
Another criticism of the Model Charge is the repetitive
use of the term exercise of judgment. Id. at 127-28. In
fact, the charge mentions exercise of judgment eleven times. Similarly, the ch