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Saurabh Jha, MBBS

Medicolegal issues in diagnostic iMaging

“There but for the grace of God, go I.”

—John Bradford, heretic, 1550

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1. Define medical negligence.

Negligence is the failure to possess and apply the knowledge that is possessed or applied by reasonable physicians

practicing in similar circumstances.

2. What must be proven for a physician to be found liable for malpractice?

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Establishment of a duty of care (i.e., physician-patient relationship)

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Breach of the duty of care, or negligence

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Adverse outcome with injury or harm

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Direct causality between negligence and outcome

3. Outline the history behind current malpractice law. What is unique about the legal

determination of medical negligence in the United States?

The relevant legal framework in the United States originates from the work of Blackstone, a renowned English legal

scholar whose Commentaries on the Laws of England, published in 1768, described the term mala praxis for injuries

resulting from professional neglect or want of skill, specifically by physicians. Malpractice is derived from this term.

Malpractice law is part of the tort, or personal injury, law. The plaintiff (injured party) files a suit against the defendant

(physician) in a civil court in front of a jury composed of ordinary (not belonging to the medical profession) citizens. This

adversarial system is different from the practice in countries such as the United Kingdom and Germany, where medical

negligence is adjudicated by a panel of judges or medical experts.

4. List factors that have been responsible for the expansion of medical litigation in the

United States.

•

The ethos of marketplace professionalism (no special status to medical societies) and antiegalitarian sentiments of the

early 19th century forced physicians to raise the level of their professionalism and medical organizations to stipulate

standards of practice that, ironically, would be used against them.

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Medical innovations made physicians victims of their own advancement.

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Liability insurance ensured an available financial pool for compensation.

•

Plaintiffs had nothing to lose by filing a lawsuit because of the contingent “no win–no fees” basis of legal

representation and because of the fact that both adversarial parties had to bear their own legal costs regardless of the

outcome.

5. There can be no malpractice without established practice. Who sets the established

practice, and who determines whether the established practice has been breached?

The expected standard may be defined in textbooks, presented in other medical literature, or stated by professional

organizations such as the American Medical Association and the American College of Radiology. The jury decides whether

a physician’s conduct is below that expected of a reasonable physician. The expert witness (an individual of the same

or similar clinical discipline as the defendant) outlines the standard to which the physician should be held, however. The

attorneys for the plaintiff and the defendant can retain an expert witness.

Key Points: Legal Requirements for a Finding

of Malpractice

1. Establishment of a duty of care (i.e., physician-patient

relationship)

2. Breach of the duty of care, or negligence

3. Adverse outcome with injury or harm

4. Direct causality between negligence and outcome

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diagnostic radiology as a profession

6. Would a general radiologist who misses a lesion on a brain magnetic resonance

imaging (MRI) study be held to the standard of a neuroradiologist?

No. The legal requirement is that the radiologist must possess the knowledge and skill that is ordinarily possessed by a

reasonable peer. He or she is not required to possess the highest skill level to which some aspire. A general radiologist

would be held to the standard of a reasonable generalist, but not a specialist.

7. The average plaintiff award in the United States is $3.5 million. What is the aim of

the award, and what are the types of damage awarded by the jury?

The ethos behind the jury award is restitution, not punishment. The award aims to compensate the patient and to deter

further such episodes of negligence from occurring.

Three types of damages are considered:

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Economic losses, such as the injured plaintiff’s health care costs and loss of wages

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Noneconomic losses, such as pain and suffering

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Punitive damages for cases in which the defendant exhibited wanton disregard for the plaintiff’s well-being (this type

of damage is awarded very rarely).

8. Can an exculpatory waiver signed by a patient shield the physician of a certain

degree of liability?

It is common for instructional facilities for scuba diving, skydiving, and similar risky activities to ask participants to

sign exculpatory waivers shielding them from lawsuits if injury or death results. Such a waiver implies a “contract”

because the parties have theoretically agreed in advance on acceptable and unacceptable outcomes. The patient-

physician relationship is not a contract, however, but rather a professional bond in which the physician assumes a

position of responsibility as the possessor of knowledge and skill beyond the ordinary toward patients who may not

know their own best interests. The signing of a waiver by a patient does not alter the legal course when medical

negligence is alleged.

9. A radiologist in an outpatient facility reads radiographs without ever meeting the

patients. Does he or she still form a physician-patient relationship?

Although a physician-patient relationship typically is a consensual one, a radiologist forms that relationship when he

or she renders an interpretation on an imaging study for the patient. This is true even if the radiologist never meets or

speaks with the patient or referring physician. This fact is important to appreciate because the basis of any malpractice

claim is the establishment of a duty of care by formation of a physician-patient relationship.

10. It is estimated that in any given year a lawsuit may be brought against 1 in 10

radiologists. What are the most common reasons radiologists get sued?

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Failure of diagnosis (includes perceptual errors, insufficient knowledge, incorrect judgment, and failure to correct

poor patient positioning and exposure)

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Failure to communicate findings in an appropriate and timely manner

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Failure to suggest the next appropriate procedure

Of these, failure to diagnose is the largest cause (70%), and two thirds of these cases are due to perceptual errors.

11. What are the groundbreaking findings of the Institute of Medicine’s report To Err is

Human: Building a Safer Health System?

The report, published in 2000, received much media interest and put medical errors in the spotlight. On reviewing the

1984 patient files of New York hospitals and the 1992 files of Colorado and Utah hospitals retrospectively for adverse

events, the report concluded that medical error alone could account for 44,000 to 98,000 deaths annually in U.S.

hospitals. This figure exceeds the number of deaths attributable annually to AIDS, motor vehicle accidents, or breast

cancer.

Key Points: Most Common Reasons

Radiologists Are Sued

1. Failure to diagnose

2. Failure to communicate findings in an appropriate and

timely manner

3. Failure to suggest the next appropriate procedure

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Medicolegal issues in diagnostic iMaging

12. Radiology has its unique set of errors. What is the most common radiologic error,

and how often is this error estimated to occur?

Failure-to-diagnose errors, which are the most common, are of two major types: cognitive, in which an abnormality

is seen, but its nature is misinterpreted (e.g., an infiltrate on a chest x-ray that represents cancer is interpreted as

pneumonia), and perceptual, or the “miss,” in which a radiologic abnormality is simply not seen by the radiologist

on initial interpretation. Since Garland’s seminal study in 1944, in which he found significant interobserver and

intraobserver variation in the interpretation of chest x-rays by radiologists, several studies have confirmed that

perceptual errors occur at an alarmingly high frequency. A University of Missouri study in 1976 reported an average

error rate of 30% among experienced radiologists interpreting chest, bone, and gastrointestinal radiographs.

13. What is hindsight bias, and why is it important medicolegally?

Medicolegally, radiology is unique in that the evidence for examination (the image) remains for subsequent scrutiny,

in contrast to physical examination findings or findings at endoscopy. It also lends itself to a phenomenon known

as the hindsight bias—the tendency for people with knowledge of the actual event to believe falsely that they

would have predicted the correct outcome. On 90% of chest films of patients with lung cancer that were reported

as normal, the cancer was seen in hindsight. When a radiologist makes a perceptual error, and the finding is

subsequently seen, it is difficult to determine whether the finding was seen only in retrospect and in lieu of all the

clinical information. In other words, it is difficult to determine when a “miss” is negligent, and when it is simply an

error of perception.

14. List ways to minimize the occurrence of perceptual errors.

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Adequate radiographic technique

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Appropriate clinical history: the knowledge of the site of pain reduces the “miss” of subtle fractures by 50%

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Comparison with old studies whenever possible

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Avoidance of “satisfaction of search,” where the presence of an overt finding diminishes the chances of making

a second, more subtle finding

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Double reading and spending more time examining the radiograph (controversial)

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Computer-aided detection (still experimental)

15. In 1997, the Wisconsin Court of Appeals issued a decision that has had a positive

effect for radiologists sued for perceptual errors. Outline the decision.

Wisconsin’s Medical Examining Board sought to revoke the medical license of a radiologist who had been sued for

perceptual errors twice in a 10-year career. The case eventually reached the appeals court, which affirmed a decision

in favor of the radiologist. The principles of the decision are as follows:

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Medicine is not an exact science.

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Error in and of itself is not negligence.

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A “miss” may not constitute negligence, even if the finding could be determined by a majority of radiologists as long

as the radiologist “conformed to the accepted standards of practice.”

16. What is the “Aunt Minnie” approach to film interpretation, and how may this

approach lead to errors in judgment?

The attachment of an interpretation to a radiographic finding with a strong preconceived notion is akin to spotting

a familiar face: “I know that’s my Aunt Minnie because it looks like my Aunt Minnie!” Researchers believe that such

an approach results in errors in interpretation because the self-imposed-limited mindset leads to a failure to include

a differential diagnosis. If a diagnosis is not considered, it is not investigated, and if it is not investigated, it is not

found.

17. How may errors in judgment be minimized?

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Analyze—not simply recognize—radiographic findings.

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Keep an open mind; always try to incorporate a differential diagnosis.

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Expand and maintain a comprehensive knowledge base.

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Avoid alliterative errors (i.e., the influence of another radiologist’s opinion). Look at a prior radiograph with a fresh set

of eyes.

18. Explain the following terms in the medicolegal context: proximate cause, law of

intervening cause, and joint and several liabilities.

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Proximate cause is the connection between an alleged act of negligence and the injury sustained by a patient.

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Law of intervening cause is when an intervening act of negligence breaks the causal link between the initial act

of negligence and injury.

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Joint and several liabilities is the fact that more than one person can be blamed for an injury (i.e., there can be

multiple proximate causes).

Medicolegal issues in diagnostic iMaging

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diagnostic radiology as a profession

The effect imaging has in clinical decision making makes radiologists vulnerable to erroneous medical decisions of their

referring physicians if it can be shown that a radiographic report resulted in an error in subsequent clinical judgment.

Radiologists may feel aggrieved at being named a co-defendant and ascribed a proximate cause for a plaintiff’s injury,

given that their report was followed by another’s act of negligence, particularly because the referring physician has

the bulk of clinical information. Courts are generally reluctant, however, to allow the law of intervening cause to apply.

Their stance is well summarized in an appeals court decision: “Where an original act is negligent and in a natural

and continuous sequence produces an injury that would not have taken place without the act, proximate cause is

established, and the fact that some other intervening act contributes to the original act to cause injury does not relieve

the initial offender from liability….”

19. Explain the following terms in the medicolegal context: vicarious liability and

respondeat superior.

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Vicarious liability is the placing of the negligence of one person on another.

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Respondeat superior is a Latin term meaning “let the superior respond” and is a form of vicarious liability incurred

by the employer (hospital or radiologist) because of the negligent acts of employees (nurses, physician assistants,

or technologists), with the rationale that because an employer gains financial benefit through the actions of an

employee, so should the employer be responsible for any harm as a result of an employee’s actions.

20. Who is responsible for the negligent action of a technologist?

Negligence of the technologist is vicariously incurred by the employer (i.e., the medical facility [hospital or private

medical imaging group]) through the respondeat superior principle. If the negligence occurs during a procedure when a

radiologist is normally present (e.g., fluoroscopy or interventional radiology), the supervising radiologist is liable through

a legal doctrine known as “borrowed servant” (the radiologist temporarily assumes authority over the actions of the

technologist).

21. What is meant by the term res ipsa loquitur? Give some examples.

Res ipsa loquitur means that the “situation speaks for itself” and is a legal concept that asserts that certain acts

cannot, by definition, occur without negligence. In such situations, the burden of proof does not rest with the

plaintiff. Medicolegal examples include retention of surgical instruments in the body; transfusion complications

resulting from administration of the wrong person’s blood; and, in radiologic practice, rectal perforation during

a barium enema.

22. A radiologist renders a report on an intensive care unit portable chest x-ray that

reads, “Endotracheal tube in the right main bronchus should be withdrawn by 2

inches to lie within distal trachea; left lower lobe atelectasis; otherwise normal.”

What additional step should the radiologist take?

The radiologist should phone the physician or nurse treating the patient and include this in the final report. The

American College of Radiology’s Practice Guidelines advise that the radiologist should directly communicate a

report to the physician (or other responsible personnel) or the patient (or responsible legal guardian) in the following

situations:

•

Discrepancy between the preliminary and final reads, which could affect management

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Conditions for which immediate treatment is required (e.g., pneumothorax or a misplaced support line)

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Significant unexpected findings (e.g., cancer)

23. A radiologist renders a report on a posteroanterior chest x-ray of a 60-year-old man

with dyspnea that reads, “Infiltrate in the right lower lobe, likely pneumonia, clinical

correlation is advised.” Is this report adequate?

No. Although the infiltrate in the right lower lobe may represent pneumonia, malignancy should be considered either as

a differential diagnosis or as an etiologic factor of the pneumonia, and the recommendation for follow-up films to ensure

diagnostic resolution should be made clear. Failure to include a differential diagnosis may lead to an error in judgment.

Failure to suggest the next appropriate step is a recognized area for malpractice.

24. A radiologist renders a report on a barium enema that reads, “Filling defect in

the splenic flexure with abrupt shelflike margins, cannot rule out malignancy;

colonoscopy may be of help if clinically indicated.” What is wrong with this

report?

When a radiologist suspects a malignancy (or any other significant finding), there is no merit in being ambiguous when

reporting the findings. The report should use more assertive language (e.g., “Filling defect in the splenic flexure with

abrupt shelflike margins, findings are highly suggestive of colonic cancer and should be confirmed with colonoscopy

and biopsy. Findings were conveyed to…”). Ambiguous reporting can lead to a lawsuit.

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Medicolegal issues in diagnostic iMaging

25. A patient develops anaphylactic shock from iodinated contrast material for excretory

urography performed to rule out renal calculi. This older examination (rather than

the current standard—a noncontrast helical computed tomography [CT] scan)

was performed at the insistence of the referring urologist. Who is to blame, the

radiologist or urologist?

The blame lies with the radiologist. Certain risk management principles should be obvious. The radiologist must

follow the principle of primum non nocere—“first, do no harm.” A hazardous procedure should be avoided if a safer

alternative is available. Although anaphylaxis is a recognized complication of iodinated contrast material, the physician

is considered negligent for not using an examination that is safer than an excretory urogram and is at least as equally

diagnostic. It is important for radiologists to keep referring physicians up-to-date with progress in radiology. In this

example, the accepted method of diagnosing renal calculi is no longer with excretory urography, but with a noncontrast

CT scan. The ultimate responsibility for the performance of a radiographic procedure is the radiologist’s, not the referring

physician’s. It is radiologists who decide which patients should or should not receive iodinated contrast material.

26. A radiologist reports that a case of trauma to the lateral cervical spine is “normal

except for straightening, which could be positional.” Later the patient has weakness

in the legs, and a CT scan shows “fracture-dislocation” at C7/T1—an area not

covered by the lateral film. How was the original reading substandard?

The report did not mention specifically that the C7/T1 junction was not visualized. It is the radiologist’s duty to comment

on the adequacy (or inadequacy) of a radiographic examination and to suggest repeat or alternative radiographs. This

must be done as a matter of routine, and it must not be assumed that other clinicians would realize the inadequacy

of a study.

27. A radiologist reports an upper gastrointestinal study as follows: “Findings are highly

suggestive of a scirrhous carcinoma of the stomach, endoscopy with biopsy is

advised.” Biopsy results are negative. What should the radiologist do next?

The radiologist must advise the physician to repeat the biopsy or assume the diagnosis without further pathologic

findings. There are a few situations in imaging in which the findings of malignancy are so strong that negative biopsy

results do not exclude the diagnosis. Radiologists should be aware of these situations. Conversely, there are situations

in which the findings are so typically benign that it would be negligent to advise a biopsy.

28. Failure to diagnose breast cancer is the number one cause for litigation in radiology.

Summarize how may one practice safe mammography.

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Communicate with the patients about their examination and the need for follow-up. Communicate with referring

physicians.

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Correlate and follow up on pathologic findings.

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Compare findings with findings of old radiographs, not just the most recent ones, but even the more remote films.

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Participate in continuing medical education—breast imaging (and most of radiology) is expanding at an alarming

pace.

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Comply with the Practice Guidelines of the American College of Radiology.

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Use computer-aided detection (still experimental).

29. Only 2% of medical negligence injuries result in claims, and only 17% of claims

apparently involve negligent injuries. About 60 cents of every malpractice dollar is

taken by administrative and legal costs. The current tort system is inefficient. What

are some reforms that have been suggested?

•

Creating a “no-fault” system, such as worker’s compensation; in this case, patients would be compensated for all

adverse events that are avoidable, even if the event may not be negligent.

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Capping of noneconomic damages (e.g., for pain and suffering).

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Eliminating the collateral rule, which prohibits jurors from knowing about payments the plaintiffs have already

received from other sources.

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Eliminating joint and several liability.

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Eliminating the doctrine of res ipsa loquitur.

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Relocating responsibility from a personal to an institutional level (enterprise liability).

30. A 45-year-old man with uncontrollable hypertension is referred for “magnetic

resonance angiography with contrast” to exclude renal artery stenosis by his

cardiologist. His glomerular filtration rate is 25 mL/min/1.73 m

2

. He is not on

dialysis. What should be your course of action?

The administration of gadolinium-based MRI contrast agents has been linked to a rare and debilitating multisystem

condition, nephrogenic systemic fibrosis. This progressive, nonremitting, and generally untreatable condition is

characterized by skin thickening and contractures. Although nephrogenic systemic fibrosis is almost invariably

Medicolegal issues in diagnostic iMaging

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diagnostic radiology as a profession

associated with gadodiamide and related compounds in patients with advanced renal failure and on dialysis, the

exact pathophysiology is unknown. Nonetheless, the U.S. Food and Drug Administration (FDA) cautions against using

gadolinium-based agents in renal impairment, and this means that the radiologist needs to counsel the referring

physician and patient regarding the risks involved and the alternatives. The risk of nephrogenic systemic fibrosis may

be difficult to extrapolate to this group because of the absence of long-term studies, but a figure of 3% to 6% would be

prudent to quote.

The radiologist should ascertain the history and pretest probability of renal artery stenosis. Alternative strategies include

magnetic resonance angiography (MRA) without gadolinium (e.g., time of flight, phase contrast, and balanced steady-

state free precession) or duplex ultrasound (US). These modalities may be less accurate than contrast-enhanced MRI,

but safety supersedes accuracy initially. CT with contrast agent is a possibility. The patient is not on dialysis, however,

and the nephrotoxicity of iodinated contrast material should be borne in mind. If the suggested alternatives have not

affected clinical decision making, the examination is still deemed necessary, and the referring clinician and the patient

are aware of the risks and wish to go ahead, after careful documentation the examination may be performed with

reduction of the contrast agent dose (which may be aided by increasing the field strength) and use of an agent other

than gadodiamide. Emphasis that the added safety of the maneuvers remains unproven is recommended.

31. A report states “History—suspected pulmonary embolus…. Technique—CT scan of

the chest was performed….” If all reports in this radiology practice were of similar

disposition, why would this practice expect to hemorrhage money?

The report is inadequate for billing purposes. First, the history does not state the history, but the suspected diagnosis.

Patients do not complain of “suspected pulmonary embolus,” but of symptoms pertaining to the diagnosis, such as

dyspnea, chest pain, or syncope. Payers are very particular that the right study be done for the right reason, and the

onus is on the imagers to ensure that the content of the report reflects appropriateness of the imaging examination

in the clinical context. Second, if the patient received iodinated contrast agent (which is likely for the exclusion of

pulmonary embolus) that has not been mentioned in the technique section of the report, the practice cannot bill for the

use of contrast agent. The report must contain a sufficient description in the technique section that reflects the reason

for imaging and type and complexity of the examination, so that the reimbursement is appropriate and unambiguous.

Insufficient description risks nonpayment for the procedure and accusation of fraud.

B

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