Risk Management
Sarah D. Cohn
The practice of radiology has been no less affected by the developments in the professional liability field than any other specialty. Studies reported in 1990 (delay in diagnosis of breast cancer) (1) and in 1992 (delay in diagnosis of lung cancer) (2) indicated that failure to diagnose cancer continued to be a significant claim area for radiologists. In 2002, the Physicians Insurers Association of America (PIAA) studied 450 paid malpractice claims involving failure to diagnose breast cancer; in these cases, the most commonly named defendant was the interpreting radiologist. The average malpractice payment in these cases was $438,047 (3). These older data continue to be updated. In 2013, a study of causes of medical malpractice suits against radiologists in the United States was published (4); it analyzed credentialing data from 8,401 radiologists. Results showed that error in diagnosis of breast cancer remained the most frequent malpractice case allegation, followed by failure to diagnose nonvertebral fractures and spinal fractures. After error in diagnosis, procedural complications (only of procedures actually performed by the defendant radiologist) were the most frequent, although much less common. Liability concerns also seem to continue to influence the practice choices made by radiology house staff (5,6).
A recent study found that the likelihood of a radiologist being a named defendant in:
At least one lawsuit is 50% by age 60, but both the frequency and average number of lawsuits varies widely by state of residence and sex. Among resolved suits, the percentage of cases in which payment was made to the plaintiff differs markedly by state, as do median and mean award amount. (7)
Litigation risks attributed to radiology in general and interventional radiology in particular are not limited to the United States. A study published in 2012 examined malpractice insurance claims against interventional radiologists in Italy between 1993 and 2006. The data were derived from the files of the Italian Society of Medical Radiology. Although the absolute number of claims was not large (n = 98), the numbers increased over the years, and in 21 cases, the event was said to have caused the patient’s death. The most frequent cause of claim was complications “after interventional procedures on the vascular district” (8).
Although it is not possible to prevent injury and claims, it is possible to create an environment in which patients understand their risks and in which any claim brought is less likely to be successful.
Credentialing of Interventional Radiologists
1. Interventional radiology procedures are most often done in hospitals, but regardless of where they take place, appropriate credentialing of the physician must occur.
2. Many private practices hiring interventional radiologists delegate this assessment to the hospital where privileges are requested. In fact, the hospital has a legal corporate responsibility to avoid negligence in credentialing.
a. In addition to checking other required matters, such as training, licensure, malpractice insurance, and claims data, hospitals and practices should check references. Specifically, the person providing the reference should be given explicit information about what procedures or categories of procedures are to be done and asked about the applicant’s training and competence in these procedures.
b. Hospitals will be found liable if they credential an interventional radiologist or other physician without any practice restrictions that would have been required had the medical staff office made the appropriate inquiries.
3. Many physicians are reluctant to be completely honest in the provision of references. They worry about professional repercussions or that the applicant will sue for defamation of character.
a. In order to prevent suit and to protect reference writers, hospitals require their applicants to sign a broad waiver of liability to protect those who provide information about a practitioner. A copy of this waiver should be provided or may be requested before a reference is written.
b. In addition to the waiver, states also provide a “qualified immunity” to reference writers: that is, if the reference is provided in good faith, there will be no liability.
c. Regardless of the legal risks, it remains important to be honest, balanced, and complete in reference writing—it may cause patients harm to release problem physicians to other practices without appropriate supervision.
4. Interventional radiology practices should track complications, morbidity, and mortality for recredentialing. Care provided by individuals that exceeds expected complication rates should be reviewed to determine if retraining, extra assistance, or other mechanisms are needed.
Informed Consent
1. Once the radiologist is appropriately credentialed, the law requires that consent for the procedure be obtained from the patient or family, except in an emergency. In fact, early interventional radiology procedures were involved in some of the cases in which the consent doctrine developed.
2. One of the earliest of these more modern cases was decided in 1957 (Salgo v Leland Stanford Jr. University Board of Trustees). The plaintiff was a 55-year-old man who was experiencing symptoms of vascular insufficiency in his legs. He was referred to a surgeon who felt that the patient might have a blockage in the aorta and advised an aortogram. The patient agreed to the procedure. The court’s opinion states that the aortogram was done under general anesthesia. The surgeon inserted a needle and penetrated the wall of the aorta; the stylet was removed, contrast was injected directly into the aorta and films were taken. The films showed a blockage in the descending aorta below the renal arteries; further contrast was injected to define the extent of the blockage. The procedure was without apparent complication. However, when the patient awoke, his lower extremities were paralyzed and remained so. Subsequently, he sued. Experts who testified in the case differed: The plaintiff’s expert testified that the needle was in the wrong place when the contrast was injected, whereas the defense expert stated that the contrast could have affected the spinal cord even if it were in the aorta. A jury awarded the plaintiff $250,000, which the judge reduced to $215,355. The defendants appealed. Among other things, the plaintiff testified that he was not informed about the procedure; the physicians acknowledged that they had not warned him of the possible dangers. The court held that the physician need not discuss every risk no matter how remote but must
disclose facts that are “necessary to form the basis of an intelligent consent by the patient to the proposed treatment.” The verdict was reversed (on other grounds), and a new trial was ordered (9).
disclose facts that are “necessary to form the basis of an intelligent consent by the patient to the proposed treatment.” The verdict was reversed (on other grounds), and a new trial was ordered (9).
3. The process of obtaining consent should not be viewed as a clerical task. Although the actual discussion can be delegated to a nurse or resident (if the hospital policies permit such delegation), the radiologist who performs the procedure remains responsible for the adequacy of the consent. Some patients may request to audiotape or videotape the consent discussion. The physician may refuse this request and should do so if the taping may alter the interactive nature of the consent discussion. To the greatest extent possible, language used in the consent discussion and on the consent form should be language that is understandable to the patient.
4. The law requires that the following categories of information be disclosed and discussed:
a. Name of procedure
b. Potential benefits