"Everything that can be invented has already been invented," said Charles Duell, director of the U.S. Patent Office in 1899.
Sure, we laugh at him now. In radiology, a new invention emerges every day. But keeping up with the latest technologies is a very unfunny burden that befalls every doctor. Why? Physicians have a legal responsibility to inform their patients of all their diagnostic and treatment options. When they do not, they can be sued for violating the "reasonable patient rule" of their duty to obtain informed consent.
Patient rule rules
What is the patient rule? In short, it requires a physician to disclose all relevant facts, risks, and alternatives that a reasonable patient needs to know in order to make a decision to undergo the recommended treatment. It’s the law in most states.
The modern standard of informed consent was defined decades ago by case law. Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees (154 Cal. App. 2d 560, 317 P.2d 170 [1957]), a case involving translumbar aortography that resulted in spinal cord injury, established a doctor's duty to disclose the nature, purpose, risks, and alternatives of a procedure.
Canterbury v. Spence (464 F.2d 772 [DC Cir. 1972]) rejected the old doctor-knows-best standard of physician rule in favor of the reasonable patient rule, or the " materiality of riskv standard, when a patient was rendered paraplegic by a surgeon who considered it counterproductive to disclose the risk of paralysis.
Venerable case law notwithstanding, radiologists have been slow to get with the program. According to the American Journal of Roentgenology, 12% of medical malpractice lawsuits involve radiologic procedures or radiologists (October 1995, Vol. 165:4, pp. 781-788). In addition, 41% of U.S. radiologists are sued at least once (AJR, November 1993, Vol. 161:5, p. 931).
Many malpractice cases have a basis in patient rule violations, which become more complicated with every new medical advance. Are your bases covered? Here’s what you should know.
Discuss benefits, but don’t downplay risks
Negatives associated with a physician’s recommendations -- the dangers of radiation, contrast media, or MRI magnets, for example -- are among the subjects that should be discussed with patients.
Radiation. Experts differ on how much to discuss radiation with patients. They do agree that patients are rarely informed of annual dose tolerances, or how much radiation is emitted from any given modality.
"Most centers don’t adequately warn patients about the risks of radiation," said Dr. James Ehrlich, president of the Society for Responsible Preventive Imaging. One example is noninvasive coronary angiograms. "Multislice CT spirals have an effective radiation dose to the female breast equivalent to 19 mammograms. It’s about three times the dose they would get in a cath lab," noted Ehrlich, who is also the medical director of Colorado Heart and Body Imaging in Denver.
"If your 12-year-old is getting a bunch of CT scans, you as the parent might worry about the kid’s radiation, and it is important to have some knowledge of it," said Dr. Peter Mueller, division head of abdominal imaging and interventional radiology at Massachusetts General Hospital in Boston. However, he added, " if we have to talk to every patient or parent about how many rads they’re going to get, we’re going to drive people nuts."
Some experts say cumulative volume is the real issue, now that the government has officially declared radiation a carcinogen. The U.S. Department of Health and Human Services says 66% of physicians perform extra radiological tests just to protect themselves from lawsuits. The Congressional Office of Technology Assessment estimated that for minor injuries in patients aged 5-24, 53,049 extraneous skull x-rays are performed annually; 59,415 cervical spine x-rays; and 115,646 head CT scans.
According to research cited in the British Medical Journal, as many as a third of radiological exams are inappropriate. Baseless exams have vast potential for litigation on grounds of informed consent. If a patient believes he got cancer as a byproduct of you covering your assets, he’ll see you in court.
Contrast agents. This is another area frequently subjected to trivialization. Catheter angiography has been around for so long that the use of contrast isn’t considered particularly dangerous. However, when the rare reaction does occur, it can be extremely serious.
Pauscher v. Iowa Methodist Medical Center (408 N.W.2d 355, 358 [Iowa 1987]) was a case brought against a hospital for wrongful death. The hospital insisted that it was unnecessary to inform a patient that intravenous pyelogram (IVP) tests result in death for only one in 100,000 people. When the patient died from the test, her family sued and won.
And in Smith v. Shannon (100 Wn.2d 26, 666 P.2d 351 [Washington 1983]), the plaintiff suffered phlebitis and other complications following an exam using Renografin-60, an ionic x-ray contrast agent, and sued the radiologist for not revealing 10 risks associated with it that were listed in the Physicians’ Desk Reference.
Today all modalities are being used with contrast for at least some applications. New products are introduced constantly, including non-ionic agents, non-blood-product agents, and improved radioactive agents. It’s more important than ever to keep up, and to be able to explain the pros and cons to patients. Is contrast-enhanced ultrasound staggeringly more detailed than unenhanced ultrasound? Is PET/CT the greatest cancer sniffer ever? Is noninvasive MR angiography really as vivid as catheter angiography? Well, yes. But if the smallest chance exists that any contrast agent being proposed may cause a grave adverse reaction, the patient has a legal right to know that, too.
Explain alternative exams and procedure details
Like many clinics, yours may have a considerable investment in the latest imaging equipment. Naturally you’d like to recoup, and when advising your patients about options it is understandably tempting to omit services you don’t sell.
Omission is unlawful in most places, though, and there are other reasons to resist the urge. Think your fancy new MRI is just what your patient needs? Maybe not, if he’s like the plaintiff with panic disorder in Curtis v. RI Imaging Services II (148 Or App 607, 941 P2d 602 [Oregon 1997]). Curtis sued for psychological injuries sustained when an imaging provider failed to explain the claustrophobic effects of MRI scanners and never obtained a history of Curtis’s asthma condition prior to his exam.
Doctors who don’t own imaging equipment may still shortchange patients by not keeping current on newer technologies. For instance, some exams traditionally performed using IVP, such as cardiac and urologic procedures, can now be done with noninvasive or minimally invasive CT techniques. Would the reasonable patient want to know about them? You bet.
Unfortunately, there’s usually a downside to address, too.
"What happens in radiology a lot is that referring physicians don’t necessarily understand all the nuances of the procedures patients will undergo," Mueller said. "Most patients’ concept of radiology is getting an x-ray. When they get anything different, it’s a little bit of a shock to them."
Mueller cited a common example, a shoulder problem best diagnosed by MRI with contrast. " The patient may not have been told he’s going to get an injection. Now the radiologist is faced with the referring doctor wanting MR arthrography, which is much better than a standard MR, and the patient is expecting just an MR. He’s upset, anxious, and nervous. Then it’s the obligation of the radiologist to explain it and assuage the patient’s fears."
If it ain’t broke, don’t fix it. But if it is, follow up.
The relatively new industry of screening services has its own set of informed consent issues -- caveat emptor, if you own or plan to establish a screening center.
"In preventive imaging, the risk/benefit ratio is not as well worked out as it is in diagnostic imaging," Ehrlich said, "and every imaging center has its own vested interest. A whole lot of radiology groups have purchased multislice CT scanners meant for diagnostic imaging, and, as an add-on profit center, they decide to use them for coronary scanning."
CT is not approved for any body screening applications by the FDA, which states: "The main risks are...benign or incidental finding(s) leading to unneeded, possibly invasive, follow-up tests that may present additional risks, and the increased possibility of cancer induction from x-ray exposure."
"Some people want a CT body scan for the wrong reason, like following malignancies, and are not informed that this is not the way to go, " Ehrlich said. And on the flip side, screening centers sometimes find abnormalities they weren’t looking for. They become huge liability targets if, for example, they find a lung abnormality during a cardiac exam, or a patient suffers a heart attack after an exam, and the screening center never told the patient at the exam how to follow up.
In the majority of malpractice actions against all radiologists, failure to diagnose or misdiagnosis are the most frequent claims. Typical is Smith v. Daneshjoo, (C.A. Case No. 18802 and 19088 [Ohio 2002]), in which a patient claimed a radiologist told her not to worry about a breast tumor that turned out to be malignant. The delayed diagnosis resulted in radical mastectomy and cardiomyopathy that was caused by aggressive chemotherapy, and the patient sued for negligence.
So if you find anything at all, say so right away and suggest further action.
Tag, you’re it
If you think a negligence lawsuit can’t happen to you, check your malpractice insurance premiums and think again. The first court award for x-ray burns occurred back in 1899, right after x-ray was introduced to medicine. Fast forward to 2003. X-ray is still the predominant modality in medical imaging, not to mention the most litigated, and the median award for medical malpractice is a sobering $1.2 million (U.S.).
For any imaging service, job one is patient-rule risk management: explaining to your patients all the technology options available, and informing them of risks versus benefits. Malpractice attorneys also recommend that you have systems in place to ensure that the exams you’ve ordered are performed (or noted if they’re not) and patients are told how to follow up. Document phone conversations with patients to avoid he-said/she-said scenarios.
Patients who refuse treatment should sign a " refusal of consent" form. You probably want to avoid situations like Broek v. Park Nicollet Health Services (Case No. C9-02-1611 [Minnesota 2003]), which involved a man with a heart muscle disease who ignored his doctor’s advice to have regular exams. Seven years after his last echocardiogram, he died of cardiac arrest while playing racquetball. His widow filed a wrongful death suit that was eventually thrown out, but not before everyone spent a small fortune in attorneys’ fees.
Long story short, you’ll need all the ammo you can get. Ehrlich advised asking yourself -- and acting on -- the following questions:
- Do your doctors actually understand the recommendations based on the findings?
- Do they get the latest information from specialty conferences?
- Do they know what to do with a polyp on a virtual colonoscopy or a lesion on a lung CT?
When they write their recommendations of how to follow up, are they correct?
If not, "a patient could easily put this in the closet until two years later, when they’re coughing up blood," Ehrlich said. "Legally, that’s a big can of worms."
By Sydney SchusterAuntMinnie.com contributing writer
April 2, 2004
Related Reading
Disclosure of medical errors does not increase likelihood of litigation, March 17, 2004
BMJ article calls for "radiological driving licenses," March 4, 2004
U.S.-European survey shows confusion about mammography, December 17, 2003
Radiocontrast-induced nephropathy poses serious risk in patients, study shows, March 3, 2003
Imaging and imaging-related drugs: A pharmacist’s perspective, October 8, 2002
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