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Malpractice Issues in Radiology |
1 Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076; and Rush Medical College, Chicago, IL 60612.
Received June 14, 2000;
accepted after revision June 20, 2000.
Case summaries are based on actual events and lawsuits, although certain
facts have been omitted or modified by the author. All opinions expressed
herein are those of the author and do not necessarily reflect those of the
American Journal of Roentgenology or the American Roentgen Ray
Society.
Introduction
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More fortunate were the victims of the sword than the victims of famine, for [the latter] pine away stricken, lacking the fruits of the field.The Prophet Jeremiah,
Lamentations 4:9 [1]
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After unenhanced MR images were obtained, 10 mL of IV gadoteridol (ProHance; Bracco, Princeton, NJ) was administered to the patient. Approximately 3 min after resuming MR imaging, the technologist noticed that the patient had suddenly become apneic. The technologist immediately stopped the examination and called the radiologist who was in a nearby office. The technologist and radiologist immediately entered the examination room and pulled the patient out of the magnet. The patient was diffusely erythematous, and her pulse was barely perceptible. Determining that the patient was undergoing an anaphylactic reaction, the radiologist and technologist placed the patient on a cart, moved her to an adjacent holding area, and immediately invoked a "code 99," which was the hospital's procedure for requesting immediate help to assist in cardiopulmonary resuscitation (CPR). Within 2 min, a team of physicians and nurses experienced in resuscitation appeared and took charge of the resuscitation effort. Shortly thereafter, the patient's vital signs were restored and she was transferred to the medical intensive care unit in stable condition. Twenty-four hours later, the patient was discharged and returned to the nursing home. Although incomplete, the MR study was later interpreted by the radiologist as disclosing no abnormalities.
Two days later, the radiologist received a telephone call from the supervisor of the nursing home. The supervisor informed the radiologist that the patient's daughter, who was an attorney, was "extremely upset" because resuscitation measures had been instituted. The supervisor explained that the patient's chart had contained a prominently displayed do-not-resuscitate (DNR) order with which the radiologist obviously had not complied. The radiologist responded that he had been unaware of the DNR order because he had not looked at the patient's chart, but even had he seen the order, he would have ignored it because "it wouldn't apply to treatment of a contrast media reaction." The radiologist added, "I don't understand the complaint; the daughter ought to be happy that we successfully treated the reaction. We did the right thing."
Six months later, a malpractice lawsuit was filed against the radiologist and the hospital.
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The defense attorney studied the hospital policy on DNR orders that had been adopted 5 years earlier. The policy stated that DNR orders were to be suspended during any operating room or other surgical procedure performed in the hospital, unless the DNR order specifically stated that resuscitation was to be withheld during such procedures. The defense attorney next reviewed the patient's nursing home records, noting that 2 weeks after the gadoteridol reaction, the patient suffered a stroke that left her severely disabled. The patient remained in this condition until she died 3 months later.
The lawsuit alleged that the defendants' violation of the DNR order had "directly and unnecessarily prolonged the life" of the patient "to such time that [the patient] sustained a cerebral vascular accident resulting in severe disability, the generating of enormous medical bills, and extreme mental anguish in the patient and her family." Had the DNR order been obeyed, charged the lawsuit, the patient would have died at the time of MR testing and the patient's "wrongful prolongation of life" would have been avoided. Attached to the legal complaint was an affidavit signed by a "physician and ethicist" that charged that the radiologist and hospital had been negligent and had committed battery by not complying with the DNR order.
The defense attorneys for the radiologist and hospital petitioned the court to dismiss the lawsuit, arguing that in their state a legal cause of action arising from "unlawful prolongation of life" was not recognized. The judge refused to dismiss the lawsuit and ordered both parties to begin discovery proceedings.
Over the next 4 months it became apparent that none of the participants in the lawsuit seemed enthusiastic about undertaking the costs of discovery and of appeals to the appellate and supreme courts that would almost certainly be brought by the losing party following any verdict reached by the trial court. The attorneys for both the plaintiff and defendants saw weaknesses and strengths in their respective cases and encouraged their clients to settle the matter. Eventually, all parties agreed to an out-of-court settlement of a "nominal" $25,000.
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Although the process of informed consent was conceived long before CPR was considered effective and acceptable to the medical community, the principle of informed consent over recent years has evolved to become the basis of the concept of advanced directives, defined as a method that allows a person to give directions about future medical care or to designate another person to make medical decisions, if the individual loses decision-making capacity [5]. Let us briefly review this evolution, particularly as it applies to DNR orders.
With the advent of sophisticated resuscitation technology in the late 1960s, physicians began applying CPR to patients of any age who experienced sudden or unexpected cardiopulmonary arrest [6]. During the next decade, increasing numbers of individuals from both the medical and lay communities began expressing concern about whether CPR was warranted in all patients experiencing cardiopulmonary arrest, particularly in those who were afflicted with terminal illnesses or other irreversible infirmities. As early as 1973, the American Hospital Association issued a statement that CPR is not indicated in certain clinical conditions such as terminal irreversible illness when death is not unexpected or in chronically ill individuals with no hope of recovery [6].
Notwithstanding occasional articles and commentaries voicing concern about excessive use of CPR during the 1970s, resuscitation techniques and life-support measures were applied to an ever-increasing number of sicker, older, and more disabled persons. In the hospital setting, CPR became a commonplace activity whenever a patient arrest occurred, frequently with no consideration given to patient selection or therapeutic aim. Some patients were left in worse clinical condition after resuscitation than what they were in before [6].
It was just a matter of time before the issue of the patient's right to forego life-sustaining measures commanded the attention of the legislative and judicial branches of government. In 1984 this issue was the subject of a California Appellate Court decision [7] that held that physicians must comply with a patient's demands to forego life-supporting treatment. A 70-year-old man who was terminally ill and severely disabled requested that his physicians disconnect him from a ventilator because his life was "unbearable, degrading and dehumanizing." Despite these strong and unequivocal pleas from both the man and his family, physicians refused to remove the ventilator and in fact even refused to remove restraints that would have allowed the patient to disconnect the ventilator himself. The appellate court ruled in the patient's favor, explaining [7]:
The right of a competent adult patient to refuse medical treatment has its origins in the constitutional right of privacy...and is in the `penumbra' of rights guaranteed by the Fifth and Ninth Amendments to the United States Constitution.... The constitutional right of privacy guarantees to the individual the freedom to choose or reject, or refuse to consent to, intrusions to his bodily integrity... Balanced against these rights are the interests...of maintaining the ethical integrity of the medical profession.... Doctors would view disconnecting a life-support system in a case such as this one as inconsistent with the healing orientation of physicians. We do not doubt the sincerity of [these] moral and ethical beliefs....[but] the right of the patient to self-determination as to his own medical treatment...must be paramount to the interests of the hospital and doctors.
Other well-publicized legal cases centering on patient self-determination relative to life-preserving treatment and resuscitation included the New Jersey Supreme Court decision regarding Karen Ann Quinlan in 1976 and the United States Supreme Court decision regarding Nancy Cruzan in 1990 [8]. National concerns regarding the use of CPR in patients who have not been informed they have the right to refuse such measures culminated with Congress' passing of the Patient Self-Determination Act of 1990 [9] that mandated that institutions receiving Medicare or Medicaid funds must advise all patients of their right to execute an advanced directive. The Joint Commission on Accreditation of Healthcare Organizations also included as one of its standards a similar requirement [5].
In 1991, the American Medical Association published its guidelines for the appropriate use of DNR orders that later were incorporated into the American Medical Association's Code of Medical Ethics [10]. The code states:
Efforts should be made to resuscitate patients who suffer cardiac or respiratory arrest except when circumstances indicate that CPR would be inappropriate or not in accord with the desire or best interests of the patient.... Patients at risk of cardiac or respiratory failure should be encouraged to express in advance their preference regarding the use of CPR.... The physician has an ethical obligation to honor the resuscitation preferences expressed by the patient....If, in the judgment of the attending physician, it would be inappropriate to pursue CPR, the attending physician may enter a DNR order into the patient's record.... When there is adequate time to do so, the physician must first inform the patient, or the incompetent patient's surrogate, of the content of the DNR order.... DNR orders only preclude resuscitative efforts in the event of cardiopulmonary arrest and should not influence other therapeutic interventions that may be appropriate for the patient.
Notwithstanding the issuing of formal directives by legislative and regulatory bodies and ethical guidelines by the American Medical Association that patients should be given the option of rejecting resuscitation measures, many physicians remain reluctant to comply with patients' DNR wishes. A survey taken of 193 anesthesiologists who had been requested to provide regional or general anesthesia for patients with active DNR orders disclosed a considerable amount of noncompliance. Almost two thirds of the respondents unilaterally "assumed" that the DNR orders were suspended in the perioperative period, and only half discussed this assumption with the patient or guardian [11]. Even after "agreeing" with a patient's decision to retain DNR status, 79% of anesthesiologists stated that they would still undertake some form of resuscitative measure in the event of cardiopulmonary arrest. The researchers who conducted the survey suggested that the primary reason for the high rate of non-compliance with DNR orders was that anesthesiologists believe such orders are contradictory to their performance as anesthesiologists, and they are ill at ease and lack experience discussing this sensitive issue with patients or guardians.
In a New England Journal of Medicine article discussing the reluctance of surgeons to comply with DNR orders, Cohen and Cohen [12] pointed out that surgeons feel a special responsibility to treat every cardiopulmonary arrest that might occur as a result of their treatment. These researchers stated that, of all physicians, the surgeons' interventions are most visible and their therapeutic expectations are most specific. Indeed, write these researchers, many surgeons view the withholding of CPR in such circumstances as tantamount to killing. This view is echoed by author Barry Werth [13] in his book Damages. In the context of placing a physician on trial for alleged malpractice for failing to take action in a life-threatening situation, Werth observed, "Intervention was the capstone of modern medicine; it was simply self-defeating to argue that it was better to do nothing than something."
Other reasons physicians may not want to honor DNR orders include the fact that deaths occurring in the midst of a medical procedure are generally viewed as bad outcomes. Patient deaths are debated in morbidity and mortality conferences where they invite professional scrutiny, criticism, and censure. Patient deaths may also trigger internal quality assurance audits that might impair the physician's status with accrediting bodies and managed care organizations [14].
In their article on DNR orders in radiology departments, Jacobson et al. [15] discussed noncompliance by radiologists. These researchers point out that DNR orders are usually written for and applied to patients in contexts very different from the activities that ordinarily occur in radiology departments; therefore, radiologists have found that DNR orders are usually ambiguous if not irrelevant. Furthermore, write the researchers, many radiologists believe that it is unreasonable or irresponsible to perform invasive procedures such as tube placements if a DNR order bars the radiologist from resuscitating the patient in event of cardiopulmonary arrest. Radiologists who harbor these opinions often seek to override patients' DNR orders.
Jacobson et al. [15] observed that there are more deep-seated reasons why radiologists may decide to ignore DNR orders. If cardiac arrest occurs as a direct or indirect consequence of a radiologic procedure, radiologists believe they are responsible for the situation. These radiologists may believe that if the arrest is caused by what the radiologist has done, rather than by some other natural or catastrophic event that the patient may have envisioned, the patient would want resuscitation attempted. In other words, guilt and a sense of obligation may lead radiologists to ignore DNR orders. Lastly, suggest these researchers, there is an underlying fear among radiologists that if cardiopulmonary arrest occurs during a radiologic procedure and remains untreated, they will be sued for malpractice by the patient's family, will be accused of misconduct by their physician colleagues, or both.
Radiologists and other physicians may be justifiably concerned about possible adverse consequences of adhering to DNR orders, but they may not realize that adverse consequences may occur if DNR orders are ignored. In the case described in this article, the radiologist was accused of negligence and battery by resuscitating the patient against the documented wishes of the patient and her family. Battery is defined legally as a "touching of another without that person's express or implied consent"—that is, an assault [16]. In the medical setting, battery is most often seen in the context of unwanted medical treatment. To successfully prove a claim for medical assault or battery, the patient must show that he or she was subjected to an examination or treatment without consent. There must also be proof that the "touching" by the physician was intentional. If the patient sustains from the unlawful touching an adverse effect that can be measured, monetary damages may be awarded by the court.
The question of whether physicians who fail to comply with DNR orders can be held legally liable has been addressed in the court system. In May 1988, an 82-year-old man suffering from cardiac insufficiency was admitted to an Ohio hospital. In a prior discussion, the patient had informed his family physician that he did not want any resuscitative measures taken or other life-saving measures implemented if and when the patient's clinical condition deteriorated. As a result, the family physician entered into the patient's chart a "no code blue" order. Three days later, while still hospitalized, the patient developed a cardiac arrhythmia. A nurse, apparently unaware of the "no code blue" order, resuscitated the patient by defibrillation. Although recovering temporarily, 2 days later the patient suffered a cerebral vascular accident that resulted in hemiparalysis and other neurologic deficits. The patient was later transferred to a nursing home where he remained in debilitated condition until he died 2 years later. The administrator of the patient's estate sued the hospital, seeking damages for the patient's pain, suffering, disability, and medical expenses incurred during the period extending from the successful resuscitation to the patient's death. The trial court judge dismissed the case, ruling that damages resulting from "wrongful living" are not recognized in the state of Ohio.
The administrator of the patient's estate appealed, and in 1995 an Ohio Appellate Court reversed the trial court decision [17]. The appellate court acknowledged that in Ohio a patient cannot recover damages for "wrongful living," but the court went on to explain that the state does recognize "a right of privacy, defined as the right to be let alone." The court stated [17]:
A patient is entitled to compensation for the foreseeable injuries proximately caused by unwanted medical intervention.... [The patient's] right to refuse treatment was expressly violated.... The right of a competent adult to refuse treatment has been judicially recognized....[and]...in 1990 Congress passed what is known as the Federal Patient's Self Determination Act...[under which patients have a] right to refuse treatment and to formulate advanced directives about the use or non-use of life-support systems.... While [these] provide immunity from civil liability for following a patient's advanced directives, neither provides immunity for failure to follow these directives....The legislative enactment of the right to make advanced directives about health care when terminally ill is not limited to the right to refuse treatment. The same laws give a person the right to chose extraordinary and heroic measures to preserve his or her life at any cost. The point is that there is no right or wrong choice, only a very personal one. Patient's self-determination is especially important in decisions for or against resuscitation.... Different patients will have markedly different needs and concerns at the end of their lives; having a few more hours, days, or even weeks of life under constrained conditions can be much less important to some people than to others. In decisions concerning competent patients, therefore, first importance should be accorded to patient self-determination, and the patient's own decision should be accepted.
If the jury determines that adverse consequences to the patient's health occurred in a natural and continuous sequence following the unwanted resuscitative effort, then the patient's estate may recover all damages related thereto.
The hospital appealed to the Ohio Supreme Court. By a narrow 4-3 margin, the Ohio Supreme Court reversed the appellate court, thereby permanently dismissing the patient's lawsuit. The court stated [18]:
Because a person has a right to die, a medical professional who has been trained to preserve life, and who has taken an oath to do so, is relieved of that duty and is required by a legal duty to accede to a patient's expressed refusal of medical treatment. Whether intentional or negligent, interference with a person's legal right to die would constitute a breach of that duty to honor the wishes of the patient. Where a breach of duty has occurred, liability will not attach unless there is a causal connection between the conduct of the medical professional and the loss suffered by the patient.... Assuming that the plaintiff can show a duty, breach of the duty and proximate cause between the breach and the prolongation of life, the difficult issue is what damages flow from the harm caused the plaintiff. There is perhaps no issue that better demonstrates the outer bounds of liability in the American civil justice system than this issue.[The appellate court] held that a patient may recover damages based upon the torts of negligence or battery for all the foreseeable consequences of the [resuscitation], including the pain, suffering, and emotional distress beyond that which he normally would have suffered had [resuscitation] not been initiated.... Our holding here makes this theory untenable.... There are some mistakes, indeed even breaches of duty or technical assaults that people make in this life that affect the lives of others for which there simply should be no monetary compensation; not every wrong is deserving of a legal remedy....
The only damages that [the patient] may recover are those damages suffered by [the patient] due directly to the battery.... In the present case, [the patient] suffered no damages as a result of the defibrillation of his heart, i.e., no tissue burns or broken bones.
Three Supreme Court judges supported the family's right to sue the hospital and dissented:
[The patient] told his doctors that he did not wish to be subjected to certain medical treatment, as was his constitutional right.... Nevertheless, [the patient's] instructions were not followed, he was defibrillated and subsequently suffered a stroke. [The patient's] estate should have been afforded an opportunity to prove that the hospital was negligent, that [the patient's] constitutional rights were violated, and that [the patient] suffered harm as a consequence.... Plaintiff was not seeking to recover because [the patient's] life was prolonged. He was seeking to recover because the hospital failed to follow the instructions [the patient] gave them.
Even though the Ohio case was finally resolved in favor of the hospital, it should serve as a wake-up call to all radiologists and physicians who are confronted with DNR orders. Physicians should keep in mind that the Ohio Supreme Court decision was a split one, with only one vote tilting the supreme court to the finding of no liability. Other state courts, and even the Ohio court itself, may rule otherwise in similar cases in the future. Another reason why radiologists and other physicians should not be lulled into complacency regarding DNR orders is the following admonition that was also included in the Ohio Supreme Court decision [18]:
We also observe that unwanted life-saving treatment does not go undeterred. When a patient clearly delimits the medical measures he or she is willing to undergo, and a health care provider disregards such instructions, the consequences for that breach would include the damages arising from any battery inflicted on the patient as well as appropriate licensing sanctions against the medical professionals.
A final comment should be made regarding the frequency of adverse reactions to gadolinium-based agents. Although the patient in the case described in this article seemingly suffered a severe allergic reaction, a survey of 105 radiologic facilities covering 825,000 injections of gadolinium-based contrast material disclosed an extremely low incidence of reactions. Allergic reactions were reported in 241 patients, but of these only 16 were severe, an incidence of 0.002% [19].
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Risk management can minimize the likelihood of incurring medical malpractice lawsuits involving DNR orders, maximize the chances of a successful defense if such a suit is filed, and enhance patient care. The following risk management pointers will help radiologists meet these objectives.
...that first and foremost radiologists are physicians and, like other medical colleagues, should have as their standard of care the primary obligation to act in their patients' best interest. This best interest extends to the circumstances surrounding a DNR order in the radiology suite.
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