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Malpractice Issues in Radiology |
1
Department of Radiology, Massachusetts General Hospital and Harvard University
School of Medicine, 32 Fruit St., Boston, MA 02114.
2
Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point
Rd., Skokie, IL 60076, and Department of Radiology, Rush Medical College,
Chicago, IL 60612.
Received July 11, 2001;
accepted after revision July 17, 2001.
Case summaries are based on actual events and lawsuits, although certain
facts have been omitted or modified by the authors. All opinions expressed
herein are those of the authors and do not necessarily reflect those of the
American Journal of Roentgenology or the American Roentgen Ray
Society.
The Case
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Before commencing the PICC line insertion, an interventional radiologist informed the patient of the risks and benefits of the procedure, as well as alternative measures. After granting consent, the patient was transferred to the interventional suite to undergo the procedure.
Placement of the PICC line was uneventful, with the interventional radiologist taking only a few minutes to gain peripheral venous access and advance the device to the junction of the superior vena cava and right atrium. While the radiologist was securing the catheter with sutures, he made a sudden movement and an un-intelligible comment that the patient later stated seemed to be an expression of concern. However, the radiologist mentioned nothing to the patient at the time. A few minutes later the procedure was completed without incident, and the patient was discharged.
One week after the PICC insertion procedure, the patient received a letter from the chairman of the radiology department informing her that the interventional radiologist involved in her care may have exposed her to a blood-borne disease and suggesting that she undergo testing at the radiology department's expense. The letter concluded by inviting the patient to contact her family physician for further information.
After receipt of the letter, the patient immediately contacted her personal physician, who told the patient that he had been informed by the chairman of radiology that the interventional radiologist involved in the patient's PICC line placement had been hepatitis C—positive and that there was the possibility that the radiologist may have exposed the patient to infected bodily fluids during the course of the procedure.
On the advice of her personal physician, the patient underwent immediate hepatitis C testing. The initial test was negative, as was a second test obtained approximately 6 weeks later. However, a third testing 12 weeks after the PICC line placement was positive for hepatitis C virus. The patient was promptly referred to an infectious disease specialist, who began antiviral therapy. Although the patient subsequently remained asymptomatic, periodic testing continued to show a persistent hepatitis C viremia.
Ten months after the PICC line procedure, the patient filed a malpractice lawsuit naming as defendants the interventional radiologist, his radiology group, and the hospital. The lawsuit alleged that the radiologist had been negligent by transmitting a communicable disease and that the two other parties had been negligent by allowing a healthcare provider with a potentially communicable disease to perform a procedure that posed a risk of transmission. The lawsuit further alleged that the patient suffered from severe anxiety and depression over her diagnosis, had been forced to make extensive lifestyle changes in matters involving reproductive health, and faced the possibility of active disease, cirrhosis, and cancer of the liver in the future.
The defendants notified their professional liability insurance carriers of the lawsuit, and defense attorneys were retained. The attorneys immediately undertook an investigation of the circumstances surrounding the patient's possible exposure to hepatitis C. This investigation revealed that the interventional radiologist had been in practice for 10 years, had never before been the subject of a malpractice lawsuit, and was uniformly praised by colleagues and peers for his technical skills and compassion for patients.
Further investigation revealed that on the day after the PICC line procedure, the radiologist had sought a meeting with the chairman of the radiology department. During this meeting, the radiologist had informed the chairman that he was positive for hepatitis C, a fact that had been unknown to the chair or any of the radiologist's colleagues. The interventional radiologist had explained that he had always considered this information to be private and confidential and would have continued to do so but that while suturing the patient's PICC line, a suture needle had inadvertently penetrated his glove. Although he briefly had considered changing gloves during the procedure, the radiologist explained that he had believed that no problem existed. It was only after he completed the procedure and discharged the patient that he noticed that his glove was ripped and what he thought had been exclusively the patient's blood was at least partially his own as well. Although the radiologist believed that there was a need to notify the patient of the possible exposure, he was quite anxious to keep the information on his own hepatitis C status reasonably confidential.
After this private meeting, the chairman had convened a meeting with representatives of the hospital administration. It was decided that the patient should be contacted as soon as possible and that she should be directed to consult her family physician for more specific information concerning the exposure. With the hepatitis C—positive radiologist's concurrence, the letter containing this information was sent to the patient.
A review of the patient's medical records disclosed that she had never been tested for hepatitis C before receiving the radiology department chairman's letter. Although it was thought to be quite possible that the patient had been exposed to hepatitis C virus during the PICC line placement, the patient's medical records also indicated that the patient had received multiple blood transfusions as part of her acute care after the mountain biking accident. All of these blood products had been tested for the presence of hepatitis C and found to be negative.
Acknowledging that although it was still conceivable that the patient had contracted hepatitis C as a result of the blood transfusions, defense attorneys nevertheless conceded that it was as, if not more, likely that the defendant interventional radiologist was the source of the infection. Believing that a defense verdict in a jury trial would be quite unlikely, the attorneys recommended to the insurance companies and defendants that the lawsuit be settled. After considerable negotiation with the attorney for the plaintiff, the parties agreed to settle the lawsuit for $500,000, all of which was borne by the company insuring the interventional radiologist and his radiology group. The hospital did not participate in the settlement.
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The Physician's Duty to Avoid Patient Injury
Physicians have long had an ethical duty to avoid injuring patients they
treat. This duty is reflected in the Hippocratic oath and related physician
standards of conduct that have developed over the centuries. Although most of
these standards were developed long before the risk of blood-borne disease
transmission was recognized, there is little doubt that this moral authority
applies equally to such transmission
[1].
The American Medical Association has been instrumental in sensitizing physicians to ethical considerations regarding impairment and transmission of contagious disease. Three sections of the Association's Code of Medical Ethics deal directly with these subjects [2]:
8.15, Substance Abuse [issued in 1986]: It is unethical for a physician to practice medicine while under the influence of a controlled substance, alcohol, or other chemical agents which impair the ability to practice medicine.9.15, Physicians and Infectious Disease [issued in 1989]: A physician who knows that he or she has an infectious disease, which if contracted by the patient would pose a significant risk to the patient, should not engage in any activity that creates a significant risk of transmission of that disease to the patient.
9.131, HIV-Infected Patients and Physicians [issued in 1992]: A physician who knows that he or she is seropositive should not engage in any activity that creates a significant risk of transmission of the disease to others. A physician who has HIV disease or who is seropositive should consult colleagues as to which activities the physician can pursue without creating a risk to patients.
Beyond the moral weight carried by ethical duty, the doctrine of medical malpractice is very much applicable. Courts have long held that physicians have a broad duty to protect the welfare of the community [1]. More specifically, radiologists are negligent when they fail to follow the accepted standard of care as established by other radiologists testifying as experts. In the healthcare setting, case law strongly suggests that actual transmission of an infectious agent from physician to patient may indeed violate the standard of care. For example, in a case in which a hepatitis-positive dentist during a dental procedure inadvertently lacerated both his own finger and a patient's lip and their blood intermingled, the Supreme Court of Tennessee allowed a malpractice lawsuit against the dentist to go forward [3]. In a similar case, a hepatitis B-positive oral surgeon paid a substantial settlement for disease transmission to a patient and through her to her husband and unborn child [4].
Hepatitis C virus infects an estimated 170 million persons worldwide, five times more than infection with the HIV virus, according to a recently published review article [5]. Needle-stick injuries in the healthcare setting can indeed result in nosocomial transmission of the virus. The rate of transmission after a needle-stick injury is estimated to be 3% for hepatitis C virus, compared with 30% for hepatitis B virus and 0.3% for HIV virus. Acute C virus infection leads to chronic infection in most people, and most chronic infections will lead to hepatitis and some degree of fibrosis. Severe complications and death usually occur in persons with cirrhosis, which is estimated to develop in 15-20% of those infected.
Although there is little case law dealing with hepatitis C—infected physicians, legal scholars have examined the standard of care issue in the setting of HIV-infected health care providers. One legal expert has observed that there is little doubt that a malpractice case alleging negligence in the actual transmission of disease would succeed if adequate infection control guidelines were not followed [6]. The expert further noted that violation of the standard of care would be less certain where adequate infection control practices and precautions were followed. However, it is difficult as a practical matter to envision instances when patient transmission would occur if there were full compliance with such precautions.
Violation of the standard of care is virtually certain when a radiologist is impaired by abuse of substances such as alcohol or drugs. This is illustrated by a recent federal appeals court decision that examined the question of dismissal from employment of an internist whose impairment was due to alcoholism. The court noted [7]:
Alcohol use by physicians can have many adverse effects.... The risks of harm when a patient is seen by a physician under the influence of alcohol are many and serious. A physician under the influence of alcohol could prescribe the wrong medication or an incorrect dosage of medication...could misdiagnose the patient's condition or could miss an important symptom indicative of a more serious condition, possibly one needing immediate attention or posing a threat to life. Moreover, a physician under the influence of alcohol might be clumsy with his/her instruments and cause serious harm to the patient because of a slip of the hand or a second of inattention. Furthermore, the confidence of a patient in the capabilities of the physician understandably would be undermined if the patient became aware that the physician was under the influence of alcohol.
There is little doubt that similar rationale would apply where a radiologist is impaired by abuse of substances other than alcohol.
When an infected or impaired radiologist has violated the standard of care, a court would then examine whether patient injury was present. Such injury would be obvious when actual transmission of an infectious disease occurred between radiologist and patient, or when an impaired radiologist's direct actions or inaccurate diagnosis caused harm to the patient. In fact, in the setting of infected physicians, patient injury has been established even in the absence of actual disease transmission. In one reported case, injury was found in which the patient had merely been exposed to an infected provider's bodily fluids. In another case, a patient who had submitted to an invasive procedure exhibited reasonable fear that she had been infected because she subsequently discovered that the physician performing the procedure was infected with potentially transmissible HIV. In the first case involving an HIV-infected surgeon, a New Jersey appeals court stated [8]:
It is axiomatic that physicians performing invasive procedures should not knowingly place a patient at risk because of the physician's physical condition.... The risk of a surgical accident, i.e., a needle stick or scalpel cut, during surgery performed by an HIV-positive surgeon, may subject a previously uninfected patient to months or even years of continual HIV testing....Physicians performing seriously invasive procedures, such as surgeons, have a potential to cut or puncture their skin with sharp surgical instruments, needles, or bone fragments. Studies indicate that a surgeon will cut a glove in approximately one out of every four cases, and probably sustain a significant skin cut in one out of every forty cases.... The risk of infection from surgeon to patient...is unlikely...but there does come a point where the risk of a detrimental outcome becomes sufficiently real....
In the second case, a Maryland appeals court ruled that even though a patient did not test positive for HIV virus after a surgical procedure performed by an HIV-infected surgeon, the patient could be awarded compensation for such injuries as [9]:
...fear and mental and emotional distress...accompanied by headache, sleep-lessness, and the physical and financial sting of blood tests for the AIDS virus.
Courts do not generally recognize patient injury when the fear of transmission is unreasonable or when no specific exposure has been established. In upholding the dismissal of a lawsuit filed against a department store by a customer seeking to recover emotional distress damages based on her fear of contracting AIDS or other serious disease because she had pricked her finger on a hypodermic needle left in the pocket of a jacket that had been returned to the store by another customer, a California appeals court stated [10]:
A plaintiff must do more than simply establish knowledge of a toxic ingestion or exposure and a significant risk of cancer. The plaintiff must further show that based upon reliable medical or scientific opinion, the plaintiff harbors a serious fear that the toxic ingestion or exposure was of such magnitude and proportion as to likely result in the fear of cancer.... Is a mere needle stick enough, as claimed by [the customer or], is some level of bodily harm such as symptoms of disease or a positive test for HIV required?... The question before us is whether a routine needle stick constitutes harm for purposes of damages. We conclude it does not. In a routine needle stick, harm, if it occurs, takes place when a hazardous foreign substance, introduced to the body through the needle, causes detrimental change to the body. Only if the plaintiff proves detrimental change to the body may he or she recover emotional distress damages.
Liability of Other Parties
Liability for patient injury at the hands of an infected or impaired
radiologist may not be limited to the individual actually responsible for the
injury. When a radiology group or hospital is aware or should be aware that a
radiologist poses a potential threat to patients, there is a strong
possibility that legal liability will be extended to encompass them. In a
Massachusetts case, the Commonwealth's Supreme Court explored whether a
hospital could be held liable for a physician's rape of an off-duty employee,
when there was evidence that the hospital had been informed on multiple
occasions of the physician's abuse of women. The court allowed the victim to
sue the hospital, noting in its decision
[11]:
Where the hospital received actual notice...[and] took only limited measures...it was not unforeseeable that [the physician] would continue to act in [a manner that might cause harm to employees or patients].... We think that a jury reasonably could find that the hospital owed a duty of care to [a victim]...who, in deciding to enter into a doctor-patient relationship with [the accused physician], reasonably relied on [the physician's] good standing and reputation within the hospital community, and that the hospital violated this duty by failing to take sufficient action in response to previous allegations of [the physician's] wrongdoing.
What constitutes actual or presumptive third-party knowledge of the danger posed by an infected or impaired physician has not been fully explored by the courts. In the Massachusetts case, hospital administration had been notified of at least two incidents of alleged sexual abuse involving the physician in question. An analogous situation with an infected physician would be actual knowledge of a potentially transmissible infection, such as would be the case where a radiologist informed his or her department chairman or a hospital officer of the presence of infection. With an impaired physician, reports of any witnessed incidents of substance abuse or its effects would also likely constitute actual knowledge.
A much more difficult question emerges if the infected physician's illness is asymptomatic and unknown to the group or hospital, or if the impaired provider's substance abuse problem is either unwitnessed or not easily recognized. In the setting of infectious disease, courts have been extremely reluctant to allow mandatory testing of hospital staff, absent of an extremely strong showing of likely infection and legitimate concern of its transmission to patients [12, 13]. Thus, it is unlikely that a court would hold that a radiology group or hospital would be expected to become aware of asymptomatic infection when a radiologist neither revealed this information nor underwent testing in which the results would be made available to third-party individuals.
A difficult situation also arises when a substance abuse—impaired radiologist does not manifest overt, unambiguous evidence of his or her condition. Although there is no published case law known to the authors addressing this issue in radiology, courts examining legal issues surrounding other impaired physicians are generally quick to recognize the danger such individuals pose to patients and to support steps that may mitigate these risks, including mandatory drug testing. An example is a Nebraska case in which the court upheld the dismissal from employment of an anesthesiologist for repeated instances of alcohol abuse. Although not directly calling for mandatory testing, the court endorsed a voluntary agreement entered into between the anesthesiologist and the hospital, which allowed for random drug screening of the physician. The court concluded [14]:
It seems obvious that the skill and delicacy required of an anesthesiologist demand, at minimum, complete sobriety. The hospital should not have to wait until [the anesthesiologist] injures or kills someone before taking action.... Given that an anesthesiologist literally has the life of surgical patients in her hands, the potential threat to patients from [an impaired anesthesiologist] is obvious.... The hospital need not have waited for a patient's death or injury at her hands before acting, when faced with the evidence showing the hold alcohol had over her.
Applied to the hypothetical question of real or actual knowledge of a radiologist's impairment, the Nebraska case would seem to support the contention that radiology groups or hospitals are expected to take appropriate action when there is even the suggestion of substance abuse. This possibly could extend to making mandatory testing a condition of employment, even when relatively subtle or equivocal signs of drug or alcohol abuse are present.
Informed Consent, Battery, and the Duty to Warn
Even when a radiologist's infection with a potentially transmissible agent
is acknowledged by the radiologist and his or her own group and institution,
and all appropriate precautions are taken, there is case law suggesting that
more may be necessary. Specifically, courts have found that physicians have a
duty to warn the patient [1],
and that information about a physician's potentially transmissible disease may
be required for the patient to make an informed decision regarding his or her
care [8,
9,
15]. As such, information on a
radiologist's potentially transmissible disease may be required as part of the
informed consent process.
Perhaps the most thorough examination of this issue is found in the New Jersey case referred to earlier in which a surgeon with AIDS was required to explicitly inform patients of his HIV infection before performing an invasive procedure [8]:
Taking into account...the patient's informational needs, the physician must make reasonable disclosure of the information and those risks which a reasonably prudent patient would consider material or significant in making the decision about what course of treatment, if any, to accept.... The "duty to warn" imposed on a physician provides additional support to conclude that an HIV-positive surgeon is required to inform a patient of his HIV positivity before performing an invasive procedure.
The court upheld this policy, citing a strong commitment to patients' rights and the small but real risk of HIV transmission between physician and patient. Although this case involved a surgeon, there is little reason to doubt that courts would apply a similar analysis to a radiologist performing procedures that carried a risk of disease transmission.
Although legal actions alleging physician misconduct because of failure to disclose substance-abuse impairment or the harboring of a transmissible disease are generally based on negligence or breaching the standard of care, a New Jersey appellate court recently ruled that if the informed consent from the patient was obtained through fraud or misrepresentation, the physician may also be charged with battery. Defining battery as any nonconsensual touching of the body, the court pointed out that this charge would be appropriate if the patient could prove that the defendant physician made a material misrepresentation of an existing fact and had knowledge of its falsity, and if the patient had relied on the misrepresentation and sustained injury. The court ruled [16]:
Where an action is predicated upon battery, plaintiff is not required to show that the physician deviated from the appropriate standard of care in performing the surgery. Even if harmless, plaintiff is entitled to nominal damages for an unauthorized invasion of the patient's person. To warrant punitive damages, the defendant's conduct must be either an "evil minded act" or an act accompanied by willful and wanton disregard of a patient's rights.... The plaintiff may further recover for all injuries proximately caused by the mere performance of the operation, whether the result of negligence or not.... [Furthermore], a jury could award damages for mental anguish resulting from the belated knowledge that the operation was performed by a doctor to whom the patient had [without being informed of the physician's condition] given consent.
Whether physicians are unequivocally required by common law to disclose to patients adverse life factors such as substance abuse is not clear-cut. The Georgia Supreme Court recently ruled that a urologist who had allegedly performed unnecessary surgery on a patient was not required to have included as part of the informed consent process the fact that he was addicted to cocaine. The court stated [17]:
Where a physician knowingly misrepresents a patient's condition or the proper treatment, or fails to truthfully respond to a patient's queries about a diagnosis or treatment, or performs procedures outside the scope of consent, a patient's consent may be vitiated, leaving the physician liable for having committed a battery.... Notwithstanding the repugnance of [the urologist's] conduct at the time he rendered medical services to [the patient], [the urologist was not] under an affirmative obligation, either under statute or common law, to disclose his drug use to his patients prior to rendering services.... The record appears not to include evidence that [the urologist] was under either the direct or residual influence of cocaine at the time he treated [the patient].... To conclude, neither the common law nor the statutes impose a duty upon physicians or any other professionals to disclose personal life factors which might adversely affect their professional performance.
We should take note of the strong dissent issued by a minority of the court, a dissent that may portend the direction in which not only the Georgia court, but other state courts as well, could take in future decisions:
A physician and patient share a confidential relationship. Where such a relationship exists, silence when one should speak or the failure to disclose what one ought to reveal is equivalent to an actual affirmative false representation.... In order to avoid liability for the intentional tort of battery, the physician must obtain the patient's consent.... [The urologist] was addicted to and used cocaine and the use of that drug is always illegal, and the use of illegal drugs are factors which can result in the loss of a physician's license to practice in this state.... [The urologist] has violated the beliefs and standards of society in general and his profession in specific.... Consent which is obtained by a material misrepresentation is invalid, since fraud vitiates all contracts.... [The urologist's] non-disclosure of his addiction to and use of cocaine vitiated [the patient's] consent to undergo the medical procedure, [and therefore the finding of battery is valid].
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Risk management in radiology can lessen the likelihood of incurring a medical malpractice lawsuit and maximize the chance for a successful defense if a suit is filed, while at the same time enhancing good patient care. The following risk-management pointers will help meet all three of these objectives when faced with potential liability resulting from an impaired or infected radiologist:
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