To hear lawyers tell it, the legal and regulatory landscape surrounding CT screening is a vast, mostly untamed wilderness. Experts say it will take years to develop a body of case law sufficient to guide radiologists through its thorny complexities.
But in an environment of consumer-driven healthcare and money-driven providers, CT screening waits for no one. The business of imaging asymptomatic patients is bulldozing ahead, and quickly. Everything from whole-body scans to coronary calcium scoring to colorectal and lung cancer screening is already on the scene.
As a result, radiologists should be aware of the legal issues they might be dealing with, according to Dr. John Smith. He is an associate professor of radiology at Harvard Medical School in Boston, and an attorney specializing in the regulation of medical devices. Smith spoke in Boston at the 2002 Medically Principled CT Screening course hosted by the Society of Computed Body Tomography and Magnetic Resonance.
To begin, evidence supporting the use of CT screening is largely anecdotal, Smith said. Certainly there are a few large, controlled studies underway, but the real benefits of screening an asymptomatic population remain unproven. Smith based his comments on general legal theories, adding that specific guidance will have to wait for real-world court rulings on screening-related issues. He acknowledged Dr. Leonard Berlin, Professor of Radiology at Rush Medical College in Skokie, IL, for his assistance in preparing the talk.
Screening and the FDA
Under the Federal Food, Drug and Cosmetic Act as amended, the FDA administers medical device regulation governing the manufacture, distribution, and marketing of medical devices. The agency's approval or clearance means that products are generally safe and effective for their approved indications.
But the FDA's Center for Devices and Radiological Health (CDRH) won't be approving any CT scanners for screening anytime soon -- because the FDA regulates devices, not the practice of medicine, Smith said. And regardless of what the agency might prefer, the Corporate Practice of Medicine Doctrine has the effect of ensuring that radiologists may use an otherwise approved product, such as a CT scanner, for any purpose in the treatment of their patients, Smith said.
"Does this mean the FDA likes CT screening? No," he said. "I deal a lot with the agency, and let me say that their official position really reflects what their feelings are. They are very suspicious of screening."
To wit, the agency's Web site warns of unknown benefits and risks, high costs, and even premature death that could result from screening and follow-up procedures. So even though the agency can't regulate the use of CT scanners by licensed physicians, its position on screening could potentially be damaging in a legal setting, Smith said. "Suffice it to say that in the past, people have used these types of position statements from the FDA to paint a very negative picture of the technology."
Legal exposure from screening
"CT screening is relatively new, and right now I don't know of any major reported cases out there having to do with it," Smith said. At the same time, several legal concepts may apply.
First, the physician has a duty to the patient, and a doctor-patient relationship that establishes a physician's duty to treat the patient according to the standard of care. Malpractice, the liability physicians face every day for negligent medical practice, involves a breach of that duty, or practice outside the standard of care, that results in injury to the patient, Smith said.
Potential malpractice scenarios can involve misdiagnosis, the inappropriate use of iodinated contrast, and even complications resulting from overdiagnosis, he said. The misdiagnosis scenario best known to radiologists is the missed finding that leads to patient injury.
"Of the four most legal-exposure-prone procedures in radiology, three have to do with cancer screening," he said. "Mammography is far and away number one, missed lesions on chest radiography number two, and missed colon cancer on barium enema number three. So when you are dealing with cancer and you have a misdiagnosis, it is a heightened area of (legal) concern."
Iodinated contrast provides additional uncertainty. In CT screening there is little use of contrast, which can increase the conspicuity of lesions, especially in solid organs, and potentially reveal cancers that otherwise might have been missed.
"But the fact that you have people engaged in screening both with and without contrast means that if you ever come into a legal situation, you can get legitimate experts on either side saying you should...use contrast or you shouldn't use contrast."
And while screening without contrast may lead to a solid-organ pathology being missed, the use of contrast isn't risk-free either, due to adverse reactions in a defined percentage of patients.
"If you give contrast and the patient unfortunately has an untoward event, a reaction to the contrast, you can see the plaintiff's attorney coming back and saying, 'well, you really shouldn't have used contrast in an asymptomatic patient,'" Smith said.
Overdiagnosis is another area of potential exposure. CT findings are often equivocal, of course, and may overstate the presence of disease, Smith said. Follow-up exams or procedures are routinely needed to clarify the diagnosis. There is usually little consequence if the follow-up is a high-resolution CT scan of a suspected lung nodule, but what about a biopsy or resection that puts the patient at risk?
In one well-known case, a radiologist became gravely ill following the removal of lung nodules that turned out to be benign, Smith said (Radiology, September 2002, Vol. 224:3, p. 927).
The radiologist did not pursue legal action, but if a similar case were to end up in court, it's easy to imagine the plaintiff's attorney accusing the radiologist of overcalling the lesions, and alleging that their resection was the proximal cause of the patient's injury, he said.
In another case that did lead to a lawsuit, a patient whose lung lesion had been missed died some time later during an attempted pneumonectomy.
"The radiologists who had missed the lesion 18 months earlier were named in the suit," Smith said. "In other words, (the plaintiffs) were claiming that if the lesion had been found earlier, the surgery would have been easier and death would not have resulted. So people do get creative with a lot of these situations."
Other sources of legal exposure
Today's heightened public fear of radiation can itself be damaging in a legal setting, Smith said. What if an asymptomatic woman were to undergo CT screening, and later turn out to be pregnant? And what if the infant were born with birth defects, which may or may not have resulted from the screening exam?
Certainly there are guidelines in place for pregnancy termination, Smith said, but "it's not unreasonable that in this situation someone might reach back and say, 'my child would have been fine if it hadn't been for this radiation exposure.' It's a little bit out there to try and (prove) causation, which is necessary -- again the radiation would have to be the proximal cause of injury -- but it is possible with the legal environment we have today that somebody could try that particular theory."
A more plausible scenario might involve allegations of patient abandonment. After all, radiologists have traditionally been more concerned with writing reports than caring for patients, Smith said. And with the exception of mammography, most patients have been referred to radiologists by primary care providers.
But a radiologist who performs CT screening on an asymptomatic patient may become the patient's primary healthcare provider for the purposes of that study, a definition that has important legal implications.
"First of all, if there are findings of consequence with the self-referred patient, you have to effectively communicate the results to the patient," he said. "And that's not just reading a standard radiology report. In most cases it means a report the patient can understand, in his or her language, at his or her level of sophistication."
In environments where many patients are functionally illiterate, the radiologist might have to sit down with the patient to discuss the results, Smith said. And if the results raise concerns, the radiologist will need to exercise due diligence in efforts to ensure that the patient receives the necessary biopsy or follow-up exam.
This doesn't mean the patient belongs to the radiologist forever, Smith said. But terminating the relationship requires sufficient notice to the patient, and efforts on the part of the radiologist to find another physician.
Informed consent
Also unresolved is what patients need to be told about CT screening itself, Smith said. Do they need to know how sensitive and specific the exam is, and be warned of the risks and complications of the procedures? Do they need to know that the FDA does not specifically approve of the screening exam being performed?
"Informed consent very rarely shows up as a cause of action where there is no untoward event," Smith said. "But if you do get involved in, say, a complication like the overdiagnosis issue -- the patient has a biopsy, complications, and they decide to sue somebody -- there's a good chance that informed consent is going to show up when something else went wrong."
In summary, the FDA can't prevent a licensed physician from using a CT scanner in any way he or she sees fit, Smith said. But the radiologist faces liability on any number of fronts.
"And for awhile," he said, "probably the next five or 10 years, we're going to be living in an environment where the real legal exposure is unclear, and the definitive word from the courts will probably take years, if not decades."
By Eric BarnesAuntMinnie.com staff writer
February 27, 2003
Related Reading
Lung CAD applications starting to outread radiologists, February 13, 2003
U.S. cancer screening rates have increased in all categories over two decades, December 20, 2002
CT screening centers: Is there a right way to start one?, November 12, 2002
Following up incidental findings may do more harm than good, September 5, 2002
Medical practice uninsurable, says Australian Medical Association, July 19, 2002
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