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Malpractice Issues in Radiology

Informed Consent
Leonard Berlin1

T he Case the patient was a known and unavoidable corn- Discussion

A 73-year-old woman was hos- plication of artenography and was not the result In 1976, Pennsylvania radiologist Robert

pitalized because of recurrent of negligence on the part of the defendant mdi- Allen wrote about a malpractice lawsuit filed
transient ischemic attacks. As part of the med- ologist in this particular case. against him by the family of a woman who,
ical workup, the patients physician requested The experts perusal of the medical record, while undergoing excretory urography, died of
that the radiologist obtain a four-vessel arteri- however, did disclose one glaring deficiency: an anaphylactic reaction after IV injection of
ogram. The radiologist began the procedure, although a standard hospital consent form had contrast medium. Although Allen and his
but encountered considerable difficulty in been signed by the patient authorizing the attorneys thought that they had a strong
catheterizing the aortic arch and its major family physician to perform the arteriography, defense based strictly on the medical facts, a
branches. The patient was short and obese, there was no documentation that the radiolo- jury found against the radiologist and awarded
and in addition, she became combative and gist had obtained informed consent from the damages to the plaintiff. At trial, the radiolo-
began to thrash. Although medication less- patient. Upon being questioned about this, the gist had been asked whether he thought the

ened the combativeness, the patient moved so radiologist stated that he had not discussed patient had the right to know that death could
much that the radiographs were deemed non- the performance of the arteriography with the result from the injection. Allen replied that he
diagnostic. Just as the radiologist was about to patient because she knew only Italian and did didnt warn the patient because he knew the
repeat the injections of contrast medium and not understand or speak English. The radiolo- indications for the radiologic study so out-

filming, the patient lost consciousness. The gist added that he had been assured by the weighed the remote likelihood of a fatal reac-
radiologist then terminated the study. Shortly family physician that the patient had appro- tion that it wouldnt have done her any good to
thereafter, the patient developed a cerebral priately signed a consent form after having alarm her, as he was sure she would have pro-
vascular accident and became hemiplegic. the procedure explained to her, and that ceeded with the urography anyway. Lament-
The patients condition deteriorated steadily, everything was in order. ing the intrusion of the legal system into what
and she died 3 days later. During pretrial discovery, the deceased Allen [11 considered to be his own excellent
patients son testified that he would never have standards of radiologic practice, he asked, the-
consented to his mothers undergoing the arte- torically, shouldnt informed consent be a
Malpractice Issues riogram had he been told beforehand that she medical rather than a legal decision?
The family of the deceased patient filed a might suffer a stroke. The patients daughter The answer to Allens question is that
malpractice suit against the radiologist, alleging stated that she would never have given permis- informed consent is both a medical and legal
negligence in the performance of arteriography. sion for the procedure had she been told before- issue. In Allens case, as in the case described
As part of its investigation, the radiologists hand that the radiologist would be introducing here 20 years later, the radiologist was judged
insurance company retained a radiology expert a catheter into her mothers groin. liable for malpractice not necessarily because
to review the medical records. The expert was Concluding that it would be extremely diffi- he had done anything substandard medically.
not critical of the poor-quality radiographs, cult to successfully defend the malpractice law- but, rather, because he had not obtained appro-
pointing out that occasionally radiologists sini- suit because of the radiologists failure to obtain priate informed consent. Obtaining infIrmed
ply cannot control an agitated patients move- informed consent from the patient, the insur- consent from the patient is indeed an integral
ment on the radiographic table. It was also the ance carrier settled the litigation by paying the part of the practice of medicine, and failing to
experts opinion that the stroke experienced by plaintiffs $320,000 on behalf of the radiologist. do so may just as much constitute negligence as

Received September 16, 1996: accepted without revision September 16, 1997.

Case summaries are based on actual events and lawsuits, although certain facts have been omitted or modified by the author. All opinions expressed herein are those of the author and
do not necessarily reflect those of the American Journal of Roentgenologyor the American Roentgen Ray Society.

tDepartment of Radio)ogy, Rush North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076, and Rush Medical College, Chicago, IL Address correspondence to L Berlin.

AJR 1997:169:15-18 0361-803X/97/1691-15 American Roentgen Ray Society

AJR:169, July 1997

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U f jwear /)y jj)fl() Phsi ian, !) .lJ(IeplUS, b !Italt/i, liv Pa,,a,,a, an,1 by all the gis at:1 god-
ilej.cej, nakii iheni ,ny witPisse.c, that I will arr out, atordmg to mr ability and judgment, this
oath aPi/ this indeniure. Jo ho/1 ??1) teahcr in this art equtti tf tny on parents; t make him partner in
fli% Ike1ihoo1 when he is in p:cd of p,:opicy to .c/;arc tnine with /ii,,z, to onsider his family as my own
brothers, and to teah the,n this art, if they want to learn it, w,tho:t fce or indenture. 1 will use treatment
10 lie/p i/it siik th( (,r,Iiflg to my ability a,,1 judg merit, hut never wit/i a viecx to injury and wrongdoing.
I wi/I keep pure and ho/v both pn life and mv art. In whatsoever houses I enter, 1 will en/er to help the
sik, and I will a/)cttiin from all intentio,,al wro;,gdoiig and harm. 1 ,:l c-/zatsoever I shall see or hear in
the course of my profession iii my intercourse with uzen, if it be what should not be published abroad, I will
tiever ilivul,ge, holding .u Ii thin,s to be Ito/v sec re/s. ?ow if 1 tarry out this rath, and break it not, may I
gain forever reputatlo?: among all men for ny life anti for ,,zv art; but it I transgress it and forswear my-
self, may //ic opposite befall tne. may I examine you?

Drawing by Richard Decker: 1962 The New Yorker Magazine, Inc.

a failing to correctly interpret a radiograph or That patients should determine for them- tice Benjamin Cardozo, who wrote, Any
appropriately obtain an angiogram. A brief his- selves what kind of medical procedures, if human being of adult years and sound mind
torical review of informed consent may help any, they will undergo was ingrained into has a right to determine what shall be done
radiologists to better understand its importance. American common law 83 years ago by Jus- with his own body; and a surgeon who per-

16 AJR:169, July 1997

 Malpractice Issues in Radiology

forms an operation without his patients con- to medical care, rather than by what the medi- risks a proposed treatment entails, what
sent commits an assault 12]. This now cal profession thinks the patient should be told the alternatives thereto are and the rela-
universally accepted right of self-determina- 181. The trend toward the prudent patient stan- tive probabilities of success. The phy- .
tion is evidenced legally in the form of con- dard of informed consent begun by the Can- sicians duty to disclose in an informed
sent, or permission, that must be sought from, terbury decision grew substantially over the consent case, therefore, is not what the
and granted by, a patient before any medical next quarter century as more and more state physician believes his or her patient
.
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diagnostic or therapeutic measure is instituted. courts adopted similar positions. needs to hear. the focus should be on
A physicians failure to obtain consent from It behooves radiologists to be aware of the what a reasonable person obctively
the patient before instituting medical care attitudes of many appeals court justices who needs to hear from his or her physician
could expose the physician to a charge of bat- deliberated over the role of the physician in to allow the patient to make an informed
tery, defined legally as unconsented or harm- obtaining informed consent. In 1988, the and intelligent decision regarding pro-
ful touching [3]. The type of consent required Supreme Court of New Jersey changed its posed medical treatment.
depends on the medical procedure that is position from the prudent physician standard
being contemplated. As elucidated by Reuter to the prudent patient standard, stating, The Currently, the number of state judiciaries
in his classic monograph, implied consent, [prudent physician] standard is totally subject that have adopted the prudent patient stan-
that which is given by a patients actions to the whim of the physicians in the particular dard is about equal to those that have adhered
rather than by spoken words, satisfies legal community. Under this view a physician is to the prudent physician standard [10]. Radi-
requirements for simple procedures in the vested with virtually unlimited discretion in ologists should learn which of the two stan-
practice of radiology, such as ordinary radio- establishing the proper scope of disclosure; dards of informed consent their state follows
graphic examinations and most noninvasive this is inconsistent with the patients right of so that they can modify their practice policies
studies [4]. Examples of legally acceptable self-determination [7]. A similar legal stance accordingly. It must be remembered that in a
acts of implied consent include a patients was taken by a Pennsylvania appellate court medical malpractice lawsuit involving informed
voluntary climbing onto a radiographic table, in 1995, when it emphasized, In determining consent that is tried in a prudent physician
voluntary drinking of a liquid barium mixture, whether a physician breached his duty to his state. the conduct of a defendant radiologist
or voluntary extending of an arm to receive an patient, the standard of care is not what a rea- must be compared with the conduct of the
Iv injection. The other kind of consent is sonable medical practitioner would have done ordinary radiologist practicing with a reason-
express consent, that which is explicitly in the situation but whether the physician dis- able degree of knowledge and skill, and thus
stated. It is required for all patients who are closed those risks which a reasonable man the determination by a judge or jury of
about to undergo radiologic procedures other would have considered material to his deci- whether a radiologist was negligent must be
than procedures that are considered simple. sion whether or not to undergo treatment [9]. based on testimony presented by radiology
For the express consent of a patient to be An even more recent Hawaii Supreme expert witnesses. In courtrooms of states that
meaningful and legally valid, the consent has Court decision I I0J further expounded on this subscribe to the prudent patient standard,
to be given only after the patient has been movement toward the prudent patient rather radiology expert testimony need not be pm-
fully informed about the procedure [5]. A than the prudent physician standard: sented, and jurors can decide the defendant
disclosure must be made to the patient that radiologists negligence by considering their
includes the benefits and risks of the proce- Under the patient standard, expert tes- own knowledge and experience as to whether
dure, alternative measures that might give timony is not critical to demonstrate the the patient was given sufficient information
similar results, and the risks of not performing amount of information the patient needs by the radiologist to intelligently grant
the procedure [6J. During the nearly six in order to intelligently decide between informed consent.
decades that followed the Cardozo decision, two treatment options. The decision as From a technically legal point of view, the
most state courts adopted the prudent physi- to what procedure to undergo is ulti- plaintiffs burden of proving a radiologist ha-
cian doctrine, also known as the majority mately the patients; to impose a stan- ble for malpractice for failing to obtain
rule of informed consent, meaning that phy- dard of disclosure dictated by experts informed consent is more difficult in a pru-
sicians were required to make such disclosure would be to undermine the decision- dent physician state. From a practical point of
that comported with the prevailing medical making power of patients. . Courts view, however, the actual consent standard
standard of the community-that is, the dis- which apply [the patient-oriented] stan- followed by the state in which they practice
closure of those risks that a reasonable physi- daiyl emphasize what the patient needs may not make much difference to radiolo-
cian in the community would customarily to know to make an informed decision. gists. I believe the interests of radiologists and
make in similar circumstances 171. rather than what the medical community their patients are best served by developing
In 1972, a new standard of disclosure for thinks the patient should be told. . [The informed consent policies that are based on
informed consent was introduced into corn- patient-oriented] standard provides the what radiologists believe the patient wants or
mon law. Ruling in the case of Canterbury vs. patient with effective protection against needs to be told rather than on what other
Spence, a District of Columbia federal a possible conspiracy of silence wher- radiologists in their community choose to tell
appeals court fashioned the prudent patient ever it may exist among physicians. their patients. Even in the prudent physician
doctrine, also known as the minority rule, Moreover, since the patients must suffer state, where expert testimony is required to
when it held that the scope of the physicians the consequences. and since he or she establish that a radiologist breached the stan-
duty to disclose information must be mea- bears all of the expenses of medical dard of care in failing to obtain adequate
sured by the patients need to be given infor- treatment, fundamental fairness requires informed consent, it would probably not be
mation material to making a decision relative that the patient be allowed to know what difficult for the plaintiffs attorney to find an

AJR:169, July 1997

 Berlin

expert witness to testify that the defendant patients best interest will be considered by patient, radiologists should take special care in
radiologist failed to obtain appropriate con- most courts as displaying omniscient arro- documenting in detail the reasons for omission.
sent. Even if expert testimony is given on gance and insufferable paternalism. To this, #{149}
Radiologists should not exceed the con-
behalf of the defense, the jurors, when consid- I would add that if radiologists would then sent given to them by the patient. For example,
ering the relative weight of the competing testify further that they felt justified in with- if consent is obtained for the performance of
experts testimony, might well decide the case holding this information because other radiol- peripheral angiography, the radiologist should
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according to what they would want to have ogists in the community would have done the not proceed with angioplasty without procur-
been told if they were the patient. same, I would propose that only ill will and ing additional consent [9].
As to the question of which specific radio- possibly anger would be engendered in the #{149}
It is the patients right to both grant and
logic procedures require consent that is minds of a judge or jury. withdraw consent at will. If, during a proce-
informed, rather than that which is implied, no Finally, who should be the person obtain- dure for which consent was granted, the patient
simple answer exists. The American College ing informed consent from the patient? Most demands that the radiologist stop the proce-
of Radiology recommends that informed con- authorities agree that radiologists themselves dure, the radiologist must comply with the
sent be obtained from patients on whom radio- should obtain the consent; they should not patients wishes and terminate the procedure
logic procedures with a significant incidence rely on referring physicians or other personnel as soon as it is safe to do so.
of serious complications are to be performed to do so [6].
[1 1]. vanSonnenberg et al. [12] state that it is
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Radio!ogy 1976:119:233-234
5%. There seems to be unanimous agreement Informed consent is a complex issue that 2. Sch!oendo,ffs The Society ofNew York Hosp, 105
in the radiologic community that informed can insidiously entangle radiologists mcdi- NE 92 (NY 1914)
consent must be obtained for all interventional cohegaihy. Risk management can minimize 3. JamesAEJr, Hall DJ. Infoimedconsent and diagnos-
procedures. With regard to less invasive stud- radiologic errors and the likelihood of incur- tic medical tmaging. In: JamesAEJr, ed Lega!med-
ies such as those requiring IV injection of ring medical malpractice lawsuits involving icine with special reference to diagnostic imaging.
Baltimore: Urban & Schwarzenberg, 1980:295-305
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4. Reuter SR. An overview of informed consent for
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radiologists. AIR 1987:148:219-227
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ers are referred to previous articles written in agement pointers will help radiologists meet 6. Obergfell AM. Lass & ethics in diagnostic imaging
this series [13] and elsewhere [14]. these objectives. and therapeutic radiology. Philadelphia: Saunders,
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9. Hoffman sMogi!etal. 665 A2d 478 (Pa Super 1995)
or specifically requests that no information be This policy should be in compliance with state 10. Carr 5. Strode, et a!., 904 P2d 489 (HI 1995)
given and waives the right to disclosure [15, and local legal and legislative requirements. .
1 1 Digest of council actions. Reston, VA: American
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sent, but they should be certain to document and the law, with an emphasis
ogy on interven-
sure of risks, benefits, alternatives to the pro-
tional radiology. Radiology 1993:187:297-303
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13. Berlin L. Ionic versus nonionic contrast media.
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taken. Radiologists who wish to invoke this should be standardized within a specific radiol-
ology. In: James Jr AE. Medical/legal issues for
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radiologists. Chicago: Precept Press and American
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such physician conduct with suspicion and chart detailing that a discussion regarding effect of informed consent on the level of anxiety
skepticism [4, 17]. Johnson [18] bluntly informed consent took place. It is preferable to in patients given IV contrast material. AIR 1994:

pointed out that radiologists who testify that 162:531-535

use a customized form that contains information
18. Johnson BA. An overview of infoimed consent:
they withheld information from a patient unique to the procedure being recommended
majority and minority rules. In: James AE Jr. Legal
because they feared the patient would be rather than a generic, hospital-wide form. medicine with special reference to diagnostic imag-
unduly alarmed and thus unwisely refuse a #{149}
In those rare circumstances in which ing. Baltimore: Uthan & Schwarzenberg, 1980:
procedure that the radiologist thinks is in the informed consent cannot be obtained from the 281-293

18 AJR:169, July 1997

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6. James A. Brink, Marilyn J. Goske, John A. Patti. 2012. Informed Decision Making Trumps Informed Consent for Medical
Imaging with Ionizing Radiation. Radiology 262:1, 11-14. [CrossRef]
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9. Paul H. Ellenbogen, Thomas R. Hoffman, Bradley W. Short, Ariel Gonzalez. 2007. The Radiologist Assistant: What Radiologists
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16. Leonard Berlin. 2000. Do Not Resuscitate. American Journal of Roentgenology 175:6, 1513-1517. [Citation] [Full Text] [PDF]
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