Judge: “Has the jury reached a verdict?”
Jury head: “Yes, your honor.”
Judge: “What is the verdict?”
Jury head: “Guilty.”
Judge: “The court finds the defendant guilty of medical malpractice.”
The court awards the defendant and his family $5 million, the limit of the malpractice insurance policy.
PRESENTATION OF CASE
The patient is a healthy man who at the age of 32 years moved to a new home in southern California. The family bought a pet cat, and shortly thereafter, the patient began to experience symptoms of allergic rhinitis that were initially treated with over-the-counter antihistamines. The symptoms persisted. The patient consulted his physician, who continued the antihistamine therapy, added nasal steroid medications, and recommended environmental control. Skin testing revealed strong allergy to cat, dust mites, and numerous local pollens. Although the patient complied with the antihistamine and nasal steroid treatments, the cat remained in the house, carpets were left in the bedroom, and dust and mold controls were ignored.
Following an upper respiratory tract infection, the patient developed sinusitis. This was treated with antibiotics. Chronic sinusitis ensued, and the patient was referred to an otolaryngologist. A computed tomographic scan showed chronic sinusitis, and endoscopic sinus surgery was recommended. The physician advised the patient not to use any aspirin or nonsteroidal anti-inflammatory agents for at least two weeks before surgery. Three days before the operation, the patient attended an office party and had too much to drink. He took several aspirin-containing seltzer tablets for his dyspepsia.
The evening before surgery, the physician had two glasses of wine and went to bed at 10 o'clock. At 10:30 PM, he was called by the emergency department about a patient with epistaxis, and at midnight, after being called again, he went to the emergency department to control the nosebleed. He returned home at 2 AM and went to bed, but slept fitfully. He arose at 6 AM, still feeling tired.
The first three endoscopic surgeries of the day went well. A general surgical emergency delayed the fourth endoscopic sinus surgery, so the fourth operation began at 4 PM. A new anesthesiologist, a new scrub nurse, and a new circulating nurse, all unaccustomed to endoscopic sinus surgery, staffed the operation. The hospital, a managed care facility in southern California with financial difficulties, was not equipped with several state-of-the-art instruments, such as through-cutting forceps ($500 each) and an image-guided endoscopic sinus system ($125,000).
At surgery, the nurses and the anesthesiologist positioned the patient incorrectly by extending his head by 15 degrees, thereby changing the normal angle of operation. The surgeon, who was scrubbing, did not see this. The anesthesiologist, not understanding the importance of controlled systolic hypotension, maintained the patient's blood pressure at a systolic pressure of 120 mm Hg. The combination of the patient having taken aspirin and the level of the systolic blood pressure led to persistent oozing of blood throughout the operation. The physician's vision was, therefore, impaired.
While the physician was clearing the ethmoid cells from the roof of the anterior ethmoid, a vertical bar of bone was grasped with an upbiting forceps. When the bone was removed, a small piece of overlying cribriform was fractured and removed as well. Cerebrospinal fluid started leaking but was not noted because of the oozing of blood. The patient went home that evening. On the third postoperative day, the patient developed a mild headache. He called the emergency department and was told that this was not uncommon following nasal surgery and that he should take his prescribed pain medications. The next day, the patient was brought to the emergency department, where he was noted to have pain on cervical flexion and to be mildly obtunded. A computed tomographic scan showed a 1-cm hole in the anterior cribriform plate. A spinal tap was done, and a diagnosis of meningitis was made.
The patient was admitted to the hospital, intravenous antibiotics were given, and the leak of cerebrospinal fluid was repaired. The patient was discharged 30 days later, having sustained permanent brain damage that left him totally disabled and unable to work.
THE MALPRACTICE SUIT
A malpractice suit was filed. The plaintiff's attorney, who held doctor of medicine and doctor of jurisprudence degrees, had extensive medical malpractice success. The expert for the plaintiff, a 70-year-old retired physician, stated that he had performed “thousands” of ear, nose, and throat operations, and in the many nasal operations he had carried out, he had never created a leak of cerebrospinal fluid. None of his patients had developed meningitis after nasal surgery. It was his opinion that this event fell outside the standard of care. The expert for the defense, a young academic surgeon, explained the complexities of endoscopic sinus surgery and the potential complications. He stated that cribriform fracture and resultant meningitis were uncommon but known complications of endoscopic sinus surgery. This was, therefore, not a departure from the standard of care.
The jury of 11 people did not fully understand the science, the disease, the operation, or the complications. So deliberations were based on assessing conflicting expert opinions. The jury was unable to come to a decision regarding malpractice, but a man and his family were left disabled, and someone must pay. The jury handed down a judgment of guilty, and the plaintiff was awarded the maximum of the malpractice insurance policy.
This is not a true story but a simulated case that represents what can happen after an adverse medical outcome. But is this, in fact, a single technical error or a more complex problem? There is a science that permits a more thorough analysis. The following analysis is based on principles used by the transportation industry to investigate major accidents.1,2
CASE ANALYSIS
A detailed analysis of the events leading up to the accident shows many compounding problems. “Accident” is defined by Webster's Third International Dictionary (1986) as “an event or condition occurring by chance or arising from unknown or remote causes.” Accident does not infer causation or responsibility. The patient, to a large degree, was responsible for his illness because he and his family ignored environmental control, allowing his allergic rhinitis to develop into chronic sinusitis. Despite being advised not to take any aspirin before surgery, three days before, the patient took several aspirin-containing seltzer tablets. The patient's actions contributed to the bleeding that hampered the surgeon's ability to see the surgical field well during the operation.
The physician was impaired by the lack of sleep due to the calls from the emergency department. The effect of two glasses of wine is not known. Pilots are prohibited from drinking alcohol for 24 hours before flying and are restricted in the number of hours they can fly. No similar guidelines exist for medicine.
The hospital contributed to the accident. The usual operating team had gone home and an anesthesiologist and a nurse who were unaccustomed to endoscopic sinus surgery were called upon to perform the emergency operation. The anesthesiologist failed to maintain a moderated systolic hypotension and the nurses and anesthesiologist improperly positioned the patient. The physician, who was not well rested, was interrupted in the operating room by telephone calls and pages and was distracted by annoying background music. Bleeding at the time of surgery obscured the normal, clear operating field. The lack of an upbiting, through-cutting forceps required the physician to use a standard upbiting forceps. Instead of cutting the vertical bar of ethmoid, the bone was fractured and resulted in the cranial fossa hole. Without the benefit of multiplanar image guidance, the physician did not realize the immediate proximity of the cribriform plate.
The trial was flawed by several factors. The plaintiff's physician-attorney was more skilled than the less experienced (and not medically qualified) defense attorney. The expert for the plaintiff was a retired physician who had never performed endoscopic sinus surgery; nevertheless, he proved to be a master of presentation. The expert for the defense was a young academic surgeon. The court made no attempt to perform an independent analysis. The jury was unable to make an informed opinion regarding causation, but felt that the operating surgeon had to be responsible and so handed down a guilty verdict. Whether the judge fully understood the complexity of the case, he accepted the verdict and awarded the full amount of the insurance policy.
A review of the literature indicates that this kind of accident is caused by a series of errors, some in the system and some as a result of human factors. According to Wagenaar and Groeneweg, Dutch psychologists,1
Accidents appear to be the result of highly complex coincidences which could rarely be foreseen by the people involved. The unpredictability is caused by the large number of causes and by the spread of information over the participants...accidents do not occur because people gamble and lose, they occur because people do not believe that the accident that is about to occur is at all possible.
Reason describes several important concepts.2 First, he distinguishes between active and latent failures. Latent failures are those intrinsic to the healthcare system. Examples of latent failures might include inadequate resources to staff an operating room for emergencies, poorly designed instruments, and an insufficient volume of a given procedure to have multiple layers or teams of persons available to perform operations. Active failures are the errors of commission. For surgeons, these are generally anatomic. For organizations, these are the differences between the ideal and the real, commonly the balance between production and protection. Production is the most efficient use of available resources. Protection is the investment in personnel, technology, and safety.2
Reason writes, “With hindsight, it is nearly always possible to identify prior to a disaster, the presence of warning signs which, if heeded and acted upon, could have thwarted the accident sequence. The question that often arises after the event is: How could these warnings have been missed or ignored at the time? There are a number of possible reasons why this happens, but most of them have to do with the fact that after the fact observers armed with “20/20” hindsight view events quite differently from the active participants who possess only limited foresight. Knowing how the events turned out—what psychologists have called outcome knowledge—profoundly biases our judgment of the actions of those on the spot.”2
The medical accident was the fracture of the cribriform, which set the stage for the resultant meningitis. The oozing of blood was not sufficient for the surgeon to abort the operation. However, it hampered the physician's ability to recognize that the cribriform rupture had occurred. Had the emergency department physician evaluated the headache a day earlier, the meningitis would have been diagnosed and treated 24 hours earlier, thereby reducing the effect of the brain injury.
CONTRIBUTING FACTORS
When the substantial contributing factors are analyzed, the patient is seen to play an important role. He developed the disease, failed to comply with medical therapy, over-imbibed, and, contrary to his physician's advice, took medicine that contained aspirin. The surgeon contributed by consuming alcohol the night before the operation, having his sleep interrupted, and failing to recognize that the late afternoon surgery had sufficient problems that it should have been delayed. He also failed to recognize the extended head position, performed the operation with instruments that were less than optimal, and failed to recognize the cribriform rupture and the resultant leak of cerebrospinal fluid when they occurred. The environment of the operating room has evolved over time. Music, telephones, and beepers are all distracting factors. Health care professionals have become so accustomed to these environmental intrusions that they are no longer questioned. However, consider the cockpit of a jetliner. Intrusions like music, pages, and telephone calls that are permitted in the operating room are not permitted in other “dangerous” environments.
Staffing and hospital decisions contributing to the accident are based on the production/protection issues. Society and physicians, striving to maximize their production, push themselves beyond optimal workloads. Inadequate staffing of nurses and anesthesiologists fully trained for each operation represents a problem of production versus protection. Again, comparison with the aviation industry is valuable. Does a flight attendant trained in one airplane have the skills to switch to a different plane? The airline industry says no. A pilot trained on one aircraft is not permitted to fly an alternate plane without going through extensive training.
New and better instruments are constantly being developed and are expensive. Not every hospital can have every technologic advancement. Many of these issues could be addressed by identifying areas of expertise—that is, if one hospital and one set of physicians agree to do ears, nose, and throat surgery, perhaps a neighboring hospital could be responsible for general surgery. These kinds of agreements run counter to today's competitive environment. Lack of volume is a substantial contributing factor.
The emergency department physician was not named in the malpractice suit and was not considered a substantial contributing factor. While he or she may not have caused the accident, the damages may have been ameliorated had the meningitis been diagnosed earlier.
The result of the medical accident is multiple, the most obvious being an injured, disabled person. His family is also affected for they lose a husband, a father, and a provider. Another casualty is the medical system. The malpractice suit will permanently taint the physician's attitudes toward the practice of medicine. The physician will need to pass on the costs of his malpractice insurance to his patients. Adams writes,3
Fear of being sued for malpractice is one of the greatest tragedies of modern medicine. This thief of the joy of medical practice has stolen the physician's humanity. Our society is saying that we don't have the right to make mistakes. We must have the right to make mistakes. Medical science is so imperfect that it is impossible to know for certain, before treating a patient, what the outcome will be.
Our adversarial judicial system, alleged to be the finest in the world, is filled with latent error. Today's technologic world can no longer be reasonably evaluated by a lay jury. The O J Simpson trial 4 clearly demonstrated the deficiencies of a lay jury. The self-proclaimed medical experts have no qualifications other than their own representations. Impartial investigation is neither available nor required.
Society must accept some responsibility. Society does not wish to pay for the full cost of today's medical practice. Yet, it wishes to reap all the benefits. The practice of medicine is not the same as the production and sale of widgets. A defective hula hoop is not the same as a fulminant meningitis with resultant long-term disability. Many industries are regulated, a classic example being the aviation industry. Physicians have successfully resisted this intrusion, but they seem unable to regulate themselves. Perhaps the time has come for external oversight.
How might the risk of such accidents in the future be reduced? First, strict protocols should be developed for all serious medical intrusions. The aviation industry operates “by the book.” It has protocols and checklists, and each and every step is performed and checked off before moving to the next. Even airline maintenance runs by protocol and checklist. The same is possible for medical activities.
Second, medicine has not learned from its accidents and near misses. Physicians conduct morbidity and mortality conferences and have scientific study, but medicine does not use the rigorous accident analysis that is applied to other industries, specifically the transportation industries and the nuclear reactor industries. If impartial accident analysis became routine, substantial contributing problems could be identified and possibly decreased.
CONCLUSIONS
Medical accidents are inevitable. Society and the medical profession should begin to use the science of accident analysis to understand and prevent some of them.
Competing interests: None declared
References
- 1.Reason J. Human error. Cambridge (England): Cambridge University Press; 1990, p 216
- 2.Reason J. Managing the risks of organizational accidents. Brookfield (VT): Ashgate Publishing Co; 1997, p 38
- 3.Adams P, Mylander M. Gesundheit: bringing good health to you, the medical system, and society through physician service, complementary therapies, humor, and joy. 2nd ed. Rochester (VT): Healing Arts Press; 1998, p 43.
- 4.Schmalleger F. Trial of the century: People of the State of California vs. Orenthal James Simpson. Upper Saddle River (NJ):Prentice Hall Career and Technology, 1996. ISBN 0-13-235953-7.