With the high legal exposure of radiologists who interpret breast imaging studies and those who perform image-guided interventional procedures, it is imperative that interventional breast radiologists are aware of the relevant legal issues.
Dr. Frankel is the Medical Director of the Tower Imaging
Women's Center in Beverly Hills, CA. Dr. Brenner is the Medical
Director of the EisenbergKeefer Breast Cancer Center (Tower
Imaging) at the John Wayne Cancer Institute, Santa Monica,
The leading cause of lawsuits against physicians is the delay in
diagnosis of breast cancer. In these types of actions, the most
frequently named defendant is the radiologist.
It has been reported that approximately 10% of lawsuits against
radiologists are related to image-guided procedures.
Additionally, a review of jury verdicts suggests that about
one-third of lawsuits against radiologists are related to
Because of the high legal exposure of radiologists who interpret
breast imaging studies and the concurrent exposure of those who
perform image-guided interventional procedures, it is imperative
that the interventional breast radiologist understand the relevant
These types of lawsuits may occur so frequently partially due to
public expectation of early detection and cure, perhaps amplified
by clinical studies reporting decreased mortality with regular
A common misperception may relate to the presumed (inflated)
accuracy of interpretation of breast imaging (specifically
mammographic) studies. As is well known to those interpreting
breast imaging studies, there is considerable overlap in the
appearance of benign and malignant processes by mammography.
Additionally, there is both interobserver and intraobserver
variability in visual perceptions, in diagnostic criteria, and in
biopsy rates. Due to the increased frequency of women undergoing
mammographic examinations, legal exposure of the radiologist is
At least for the short term, image-guided breast interventions
are likely to continue to increase. Given the relatively high cost
of surgical excision for nonspecific breast lesions, image-directed
tissue sampling (by stereotactic methods and ultrasound guidance)
has gained favor with patients, payers, and many clinicians, though
some resistance is still present within the surgical community.
Most medical malpractice cases are resolved as issues of civil
law, specifically tort law. Tort law arises when there is a
presumed departure from a reasonable standard of care perpetrated
by one party upon another. Civil law derives from statutory law and
common law, with most lawsuits for medical malpractice covered by
common law. Common law is based upon decisions of appellate courts.
These decisions can establish legal precedent to be used as
guidance in future lawsuits. Statutes are laws passed by
legislative bodies and are less relevant in cases of medical
malpractice. One exception, which is very relevant for breast
imaging, is the Mammography Quality Standards Act (MQSA) passed by
Congress in 1992.
The law of negligence covers most medical malpractice cases.
Negligence is concerned with a physician's conduct rather than with
the actual outcome related to that conduct. However, it is
generally an adverse outcome that prompts a lawsuit to be brought
and to come to the court's attention. In law, medical negligence is
based upon a departure from an acceptable standard of care of a
reasonable and prudent physician.
The standard of care to which radiologists, and physicians in
general, are held is one of reasonable care, not optimal care.
Proof of negligence often requires the testimony of experts to
establish the standard of care.
Intentional torts may be defined as prohibited acts that one
person intends to commit upon another and that actually occur.
Battery is the unlawful, nonconsensual touching of another person
and, as such, is an intentional tort. If there is the possibility
of adding another interventional component or step to an intended
and consented procedure, this contingency must be discussed first,
during the initial consent process, or a new consent must be
obtained. For example, battery may be found for performing a core
biopsy if a fine-needle aspiration biopsy (FNAB) was the only
procedure discussed during the informed consent process. This
situation exemplifies the notion that exceeding consent may
constitute battery. Because any invasive procedure is legal
battery, it is recommended that consent be obtained for all breast
interventional procedures. Properly obtained consent is a defense
for, and will defeat, the charge of battery.
Most medical malpractice lawsuits that involve informed consent
are pursued under the law of negligence. Certain questions must be
asked of the physician. Has the physician obtained the consent in a
manner in which a reasonable physician would have obtained consent
under similar circumstances? Has a substantial injury occurred?
Have the physician's actions breached the duty to obtain consent
and been the cause of the injury? Alternatively, some states use
the "reasonable patient" standard in which a "reasonable
patient"may be thought of as an average "typical" person. In this
situation, proper consent is complied with if relevant information
is disclosed in such a way that it is deemed what a reasonable
patient would expect to know.
Classic federal appellate courts define "informed consent" as
"disclosure of risks, complications, and alternatives to the
The physician's discussion with the patient of risks,
complications, and alternatives should include mention of the
possibility of the following: the physician's inability to make the
diagnosis in a finite number of cases, nondiagnostic yield,
findings of atypical ductal hyperplasia (ADH), and disconcordant
results as related to the preprocedural images,
which may prompt additional surgery. Patients should be informed
that post-procedural imaging/pathology correlation is necessary to
assure concordance; if the results are discordant, appropriate
further management steps are necessary.
Additionally, possible serious complications and milder ones that
occur with a relatively high frequency should be discussed.
The physician who will perform the procedure is responsible for
the patient being informed of the risks, possible complications,
and alternatives to the procedure. The discussion itself--not the
signed consent form that is obtained prior to the procedure--is the
critical aspect of the informed consent process. The patient's
signature on a consent form is only evidence that such a discussion
Performance of the procedure
All images obtained that lead up to a recommendation for tissue
diagnosis or other intervention should be analyzed. Performance of
any breast interventional procedure should be predicated on
determining that an imaged abnormality has been evaluated
appropriately by the interventionalist. It is the duty of the
mammographer to detect and analyze possible abnormalities and then
determine the best approach to attempt to diagnose the abnormality.
This requires knowledge and experience in diagnostic breast
imaging. The mammographer has the duty to recommend appropriate
action based upon his or her interpretation of the findings.
The interventionalist must corroborate that the lesion truly
exists, and if so, must validate its location. Following these
determinations, the final question is to determine whether it lends
itself to either needle biopsy (including which type) or
preoperative localization. Under most circumstances, it is
necessary to define a mammographic abnormality in two orthogonal
projections prior to performing a needle localization procedure or
stereotactic procedure. This is especially important when initially
deciding if a lesion is real or is representative of
superimposition artifact. Abnormalities demonstrated in only one
projection require further diagnostic work-up before evaluation is
considered to be complete. Assuring that a lesion is real and that
it has been found in two orthogonal planes is also needed prior to
performing a diagnostic sonographic evaluation of a mammographic
finding. Once tissue diagnosis has been recommended, the
appropriate interventional procedure must be chosen.
Reasonable performance of any procedure requires educational
training and experience. Continuing Medical Education (CME) courses
may be advisable prior to actually performing any of these
procedures on patients. Alternatively, watching and working with an
experienced colleague prior to performing any procedure may be
enough, and there should be sufficient documentation of gained
experience. An important component of risk management is
establishing competency when a new procedure is introduced to the
practice, especially if a patient challenges this skill, which may
occur after a (perceived) complication occurs.
Stereotactic and ultrasound-guided breast
A key question is actually a somewhat technical one: whether or
not the lesion is accessible. On most commercially available
stereotactic equipment, very deep lesions or those in the axillary
tail may be inaccessible because the mammographic abnormality
cannot be placed within the field of view of the equipment. With
some digital equipment in which resolution capabilities are
limited, certain lesions may be difficult to identify confidently
due to diminished contrast resolution compared with mammographic
film. The stereotactic digital devices have a relatively small
field of view, and the entire breast cannot be visualized;
therefore, determining the correct target can be difficult. If the
lesion cannot be recognized with sufficient confidence by the
interventionalist performing the stereotactic biopsy, there may
arise a duty to not perform the biopsy and to instead refer the
patient for a more appropriate procedure (e.g., needle localization
Another key aspect to performance of any procedure is
familiarity with the equipment. For stereotactic procedures, two of
the most important pieces of equipment are the guidance unit and
needle being used to obtain the tissue samples. The stereotactic
unit operates on the principle of triangulation with the position
of the lesion localized in the horizontal (x) and the vertical (y)
axes; the depth (z axis) is calculated from the surface of the
breast using two angled (15š along the x axis) images.
Prone units or attachable upright units are available. A variety of
needle designs are available to perform large core procedures,
including vacuum-assisted devices using an 11-gauge needle.
Ultrasound-guided procedures (fine-needle aspiration biopsy or
large-core biopsy) are also effective methods of obtaining a
cytologic or histologic diagnosis. Sonography is also useful for
cyst aspirations and preoperative needle/wire placement for
excisional biopsy. Most devices used for sonographically guided
breast-core biopsy are spring-loaded with 14-gauge needles (16- and
18-gauge needles are less commonly used); however, 11-gauge
vacuum-assisted devices specifically designed for ultrasound are
now on the market. The ability to introduce a metallic clip during
an ultrasound procedure is now possible. A linear array transducer
is also the preferred sonographic device for breast interventional
procedures given the relative ease in verifying needle location.
Use of other transducers requires similar ability to document
needle tip location.
Because the interventionalist is the main participant in the
actual procedure, it is important that he or she obtain results for
all image-directed biopsies. The breast interventionalist should
discuss the results and management strategies with the referring
(ordering) clinician in cases in which additional procedures or
treatment is indicated (i.e., cases that are discordant or show
atypia, as well as positive cases diagnosing breast cancer). This
type of action and involvement by the breast interventionalist is
Another important issue to keep in mind is the self-referred
patient--the woman who requests a mammogram herself but is not
under the care of a primary care clinician. In such situations, the
radiologist places himself or herself in the role of the primary
care provider with respect to breast health care.
If the final recommendation is to obtain tissue diagnosis, the
radiologist becomes responsible for informing the patient,
discussing the different procedure options, and ensuring that the
obtaining of a tissue diagnosis (eventually) occurs. This more
active primary care role by the radiologist requires a mechanism to
help verify that the patient has complied with the radiologist's
recommendations or that there are documented efforts to achieve
Other torts or civil actions of which the interventionalist
should be aware are the torts of abandonment and negligent
may arise if a patient suffers a complication of a procedure
requiring further care or if the results of a procedure necessitate
additional care (such as surgery or other treatment options for
positive cases), and these issues have not been resolved by the
primary physician, who may possibly be the radiologist (in
self-referred cases, for example).
occurs if complication occurs related to the patient's care or
treatment after the patient is referred by the interventionalist to
another physician or facility for additional care, follow-up, or
treatment when that interventionalist knows or has reason to
believe that the physician or facility may not be competent to
manage the patient's medical situation. AR