E.LSEVIER
The Doctor’s Docket Speaking for Itself: The Doctrine Res Ipsa Loquitur in a Case of Pediatric Anesthesia
of
Bryan A. Liang, MD, PhD, JD* Pepperdine
University School of Law, Malibu, CA
Commentary
Facts JR, age 2 months, was scheduled for a craniectomy at Medical Center. Dr. A, a specialist in pediatric anesthesiology, anesthetized JR with halothane and nitrous oxide. Once JR was asleep, Dr. A passed an endotracheal tube into her trachea for the administration of oxygen. Dr. A checked the tube for proper placement and then connected it to a ventilator designed to perform the breathing process. Dr. A next established an intravenous (IV) line for the administration of fluids and medications into JR’s bloodstream during surgery. He was assisted by a surgical nurse. The IV line was assembled prior to surgery and filled with fluid by the nurse for Dr. A. Both Dr. A and the nurse testified that while observing fluid dripping through the IV line they carefully inspected the tubing for air bubbles. Observing no air in the line, Dr. A connected the tubing to a catheter in JR’s foot.
*Assistant Professor of Law iProfessor of Anesthesia Medical School
and Pediatrics,
Northwestern
Address correspondence to Dr. Liang at the Pepperdine School of Law, Malibu, CA 90263, USA. Received for publication June 13, 1995; revised manuscript for publication February 22, 1996.
Journal of Clinical Anesthesia 8:398-401, 1996 0 1996 by Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010
University University accepted
by Charles J. Cot+, MDT
Within minutes after completing these procedures and before the actual surgery began, JR suffered a cardiac arrest, which lasted approximately 23 minutes. At the onset of the cardiac arrest, Dr. A noted loud heart tones and a heart murmur. He first checked the position of the endotracheal tube and determined that it was appropriately placed. Dr. A next turned off the anesthesia, suspecting that JR was suffering from a cardiac depression caused by the anesthetic agents. The IV line was also reexamined and was found to be functioning properly. Although JR was ultimately resuscitated, she sustained serious permanent injury, including cerebral palsy, spastic quadriplegia, and seizures. JR’s parents subsequently brought suit against Dr. A for negligent administration of anesthesia to JR under the doctrine of res ipsa loquitur. At trial, JR’s parents presented expert testimony of Dr. Z, who indicated that JR’s cardiac arrest stemmed either from unremoved venous air in the IV line or a relative overdose of anesthetic drugs. However, Dr. Z also testified that defendant Dr. A’s care, if rendered as described and recorded, complied with the appropriate standard of care. Dr. A also presented expert testimony by Dr. S. Dr. S testified that Dr. A complied in all respects with the appropriate standard of care expected of a pediatric anesthesiologist. Dr. S indicated that the most likely explanation for JR’s cardiac arrest was a profound myocardial depression resulting from abnormal response to the combination of anesthetic drugs used. He testified that the loud heart sounds Dr. A noted were typical of those preceding pro-
0952-8180/96/$15.00 PI1 SO952-8180(96)00088-8
The doctrine of res ipsa loquitur in pediattic anesthesia: Lang
found depression of the heart. Further, Dr. S. testified that an air embolism was not a possible explanation of JR’s cardiac arrest and that air in the bloodstream causes damage that would have produced objective signs that were not present in JR’s case (eg, thrombocytopenia, pulmonary edema). Dr. A also relied on testimony of Dr. M, who stated that it would take 16 or more cubic centimeters of air to cause a cardiac arrest in a patient of JR’s size when administered in an IV line; however, the entire volume contained in the IV tubing only contained 13 cubic centimeters. Thus, the trial court recognized that “ [a] cardiac arrest after induction of anesthesia which leads to an injury such as UR] sustained in this case can and does occur in the absence of negligence and even with the best of care.” The court continued, “there are alternative plausible explanations for the cause of the cardiac depression in this case which are not related to any negligence on the part of Defendant [Dr. A].” Based on these findings, the trial court refused JR’s counsel’s demand to apply the doctrine of res $~a Zoquitur. The court then determined that Dr. A “clearly complied with the applicable standard of medical care in his treatment and care of UR]” and held for Dr. A. JR’s parents’ appealed and argued that the doctrine of res ijm Zoquitur applied to Dr. A’s treatment and care and that the trial court erred in refusing to apply the doctrine.
Legal Analysis The lower trial court’s decision for Dr. A was affirmed by the appeals court [Robb ‘u.Anderton, 863 P.2d 1322 (Utah App.Ct. 1993)]. In a medical malpractice claim a plaintiff must prove (1) the standard of care (preexisting duty), (2) breach of that duty, (3) that causes (4) damages.’ However, in exceptional circumstances a plaintiff may use the doctrine of res @a Zoquitur (literally, “the thing speaks for itself ‘) to carry the burden of establishing breach of duty and causation. Since a preexisting duty (eg, through Dr. A and JR’s physician-patient relationship) and damages (eg, through the harm suffered by JR) are usually established, res @a loquitur is thus an evidentiary doctrine that establishes an inference of negligence from the circumstances surrounding the medical treatment. To establish a proper foundation for res ipsa Zoquitur, the malpractice plaintiff must establish three elements: the accident was of a kind which, in the ordinary course of events, would not have happened had the defendant physician used due care; the agency or instrumentality causing the accident was at the time of the accident under the exclusive management or control of the defendant; and the plaintiffs own use or operation of the agency or instrumentality was not primarily responsible for the accident. The trial court and appellate court agreed that JR’s family failed to establish that the injury in this case was of a kind which, in the ordinary course of events, would not
and Cotd
have occurred had the physician used due care (element one above). Critical in this determination was the expert testimony presented at trial. The appellate court noted that Dr. Z, who was plaintiffs own expert, testified that an adverse reaction to anesthetic drugs could produce a cardiac arrest and even death, even when “careful and appropriate care” was rendered. Furthermore, the court recognized defendant’s expert Dr. S’s testimony that an air embolism was not a possible explanation for JR’s cardiac arrest, and that an abnormal response to the combination of anesthetic drugs used provided an alternative explanation for JR’s cardiac arrest. The appellate court thus found no error in the trial court’s refusal to apply the doctrine of res ipa Zoquitur. Indeed, the appellate court noted, even if the trial court had invoked the doctrine of res $~a Zoquitur, it was not obligated to find Dr. A negligent. The appellate court noted that because res ipsa Zoquitur “raises only an inference and not a presumption of negligence, the fact finder may choose either to accept or reject that inference.“’ The appellate court indicated that in this case, the trial court simply chose to reject the inference on negligence because, according to the trial court: Even if the doctrine of res ipsa Zoquiturwere applicable in this case, giving rise to an inference of negligence, that inference would not overcome the persuasive force of the evidence provided by the defense and Plaintiff would still not have carried his burden of proof to establish that Defendant was negligent in his treatment and care of UR].
Thus, the appellate properly refused to because JR’s parents kind which, in the have happened had trial court’s decision
court concluded that the trial court apply the doctrine of res ipsu Zoquitur failed to prove JR’s accident was of a ordinary course of events, would not Dr. A used due care and affirmed the for Dr. A.
Commentary This case is a very good example of how differently physicians and lawyers can view the same data. Lawyers look at the technical issues; physicians look for the truth of what happened medically and then ask, “Was this preventable?” This case indicates that the legal system can work in favor of the physician despite what some might consider to be less than ideal anesthetic management. Regardless of the actual management, it is good for physicians to gain insight into the lawyer’s viewpoint. Without benefit of review of the medical records or the depositions surrounding this case, the brief outline provided suggests a number of concerns regarding the anesthetic management, some possible “take home caveats,” as well as possible ramifications from a recently described fatal case report3; it also points out how change in anesthetic practice might have contributed to this problem.
Was This A Preventable The infant underwent
Mishap?
was an apparently healthy P-month-old who a gaseous induction with halothane and niJ. Clin. Anesth., vol. 8, August 1996
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The Doctor’s Docket
trous oxide. It appears that the child was deeply anesthetized to allow placement of the endotracheal tube prior to insertion of an IV catheter. Although this is a practice that has been a common one for many years, this is also a practice fraught with potential disaster. The first concern regarding anesthetic management is that in an infant, one is walking a fine line between adequate depth of anesthesia to allow passage of the endotracheal tube, while at the same time balancing the anesthetic depressant effects on an immature heart. The infant also may be somewhat volume-depleted from an unknown period of fasting; we do not know what happened to this patient’s blood pressure during the early part of the anesthetic. The next concern is that after checking the proper placement of the endotracheal tube, the patient was placed on a ventilator, again with an unknown concentration of anesthetic drug. This also might have presented a source of error in this fragile patient. If infants are breathing spontaneously, generally, they will “autoregulate” their depth of anesthesia; that is, the more deeply anesthetized they become, the more shallowly they breathe, the less anesthetic drug is taken up. However, if the patient is placed on controlled ventilation, such autoregulation of depth of anesthesia is eliminated; should the inspired concentration of drug not be turned back to a low value or if the system contains residual high anesthetic concentration, an anesthetic overdose may result. A third concern is that there is no mention of the frequency of blood pressure determination, whether a precordial stethoscope was used continuously (and attached to the anesthesiologist’s ear), and whether the earliest of anesthetic depth monitors (ie, the quality of heart tones and the “muffling” of those heart tones as a result of anesthetic-induced myocardial depression) may have occurred. A murmur and loud heart tones were noted, which are not consistent with hypotension and anestheticinduced myocardial depression. A fourth concern is that when the problem was recognized, the first response was to check for position of the endotracheal tube rather than to shut off anesthetic drug; and then check position of the endotracheal tube.
relatively slow progression from sinus rhythm to complete heart block. A recently published case with a similar result has been reported.3 Thus, the anesthesiologist, despite diligence and practice within the standard of care, may still have an adverse event take place that could result in morbidity or mortality. For the 2-month-old in this case, one questions what took so long to resuscitate a child who sustained a witnessed cardiac arrest. One suspects that something other than simple anesthetic overdose was a contributory factor if cardiopulmonary resuscitative (CPR) efforts were unsuccessful. Abnormal cardiac function such as that associated with myocarditis can result in sensitivity to anesthetic drugs, resistance to drugs administered for resuscitation, and malignant arrhythmias. Since this child apparently did not have a cardiac biopsy to determine this situation, we will never know whether this patient in fact represented an idiosyncratic reaction to anesthetic, a relative overdose of anesthetic drug due to the changeover from spontaneous to controlled ventilation, or an unrecognized myocarditis presenting in a patient undergoing an elective operative procedure. It would be helpful for our profession, perhaps with the closed-claims study methods, to investigate more carefully the incidence of such cases that are a result of unrecognized (ie, prior to the event) viral-induced myocarditis. Hypersensitivity to potent anesthetic drugs due to this cause is a disaster. Because patients with viral myocarditis often present with a history of a viral infection a week or two prior to the onset of myocarditis,‘” and because so many children are anesthetized having recently had, or currently suffering from, a mild upper respiratory tract infection, it is surprising that more children have not been reported to have suffered cardiac arrest during induction of anesthesia. Unfortunately, this is an extremely difficult area to study because of the rarity of the event in modern anesthetic practice. However, this is an important area of investigation because cardiac dysfunction as a result of myocarditis is one of the most common causes of sudden death in children and, at present, it may be one of the causes of cardiac arrest/malignant ar“unexplained” rhythmias in children given anesthesia with potent anesthetic drugs.
Are All Bad Outcomes Preventable? Lessons for the Practitioner Another possibility, unrelated to anesthetic management, is that this patient may have suffered from an unrecognized myocarditis that may have made the patient particularly vulnerable to the effects of anesthetic drugs, arrhythmias, and sudden death. Such sudden unexpected deaths obtain much publication when they involve athletes but myocarditis may involve the entire population, including infants.+13 Recent experience with a case on which I consulted revealed unsuspected myocarditis in a young patient scheduled for an esophageal dilatation, who suffered bradycardia progressing to cardiac arrest and death. Anesthetic concentrations were measured by mass spectroscopy and oxygen saturation was normal until arrest. The changes in vital signs were consistent with an anesthetic overdose or sensitivity to potent anesthetic drugs, that is a 400
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The legal facts of this case are that experts for both sides stated that cardiac arrest may occur in infants as a result of myocardial depression due to an “abnormal response” to ordinary concentrations of anesthetic drugs. Certainly, this is true and likely saved the day regarding medical liability in this case. The court in this case correctly identified the fact that experts on both sides described the anesthetic care delivered as being within the standard of care. The defense provided expert testimony that refuted another possible cause (ie, venous air embolism). Thus, as the legal analysis points out, the plaintiffs malpractice attorneys were not able to establish proper foundation for res ipsa loquitur.
The “take home”
lesson from this case, in addition
to
The doctrine of res @a loquitur in pediatric anesthesia: Liang and Coti
the concerns mentioned at the beginning are that (1) careful contemporaneous timing and sequence of all events in the anesthetic record are essential in establishing a standard of care; (2) the physician must be able to document that he/she proceeded “in a reasonable fashion”; (3) documentation of preoperative assessment, monitoring, selection of anesthetic techniques and drug dose, proper preparation, and appropriate and timely response to the emergency are essential.
Did the Fear of Litigation
Contribute to this Case?
A final concern here is that with the establishment of monitoring standards and the availability of pulse oximetry and expired carbon dioxide monitoring, the two major sources of anesthetic mishaps (ie, unrecognized hypoxemia and unrecognized problems with maintaining a patent airway) have virtually disappeared from the malpractice venue.14,15 However, anesthetic overdose, whether real or relative (ie, sensitivity to anesthetic drugs), as demonstrated by the patient’s response, are still making their way into the courts as a source of malpractice. In the past, in the United States, intramuscular (IM) succinylcholine was often administered after induction, the level of anesthesia lightened, and an endotracheal tube passed; the patient was placed on a ventilator with low concentrations of inhalation drug, and the IV was then inserted.16’17 The recent cases of rhabdomyolysis associated with IV and IM succinylcholine, and the change in label prohibiting the routine use of IM succinylcholine, has changed the practice of many anesthesiologists in that this practice can no longer be considered routine.“-** One must wonder if this P-month-old represents a casualty of changing this practice in an attempt to avoid the use of succinylcholine. I hope that shorter acting nondepolarizing relaxants will be developed that can be administered IM. At present, only rocuronium appears to be a viable alternative, but the price paid is prolonged during of action.23
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4. Futterman LG, Lemberg L: Sudden death in athletes. Am J Chit Care 1995;4:239-43. 5. Shephard RJ, Shek PN: Infectious diseases in athletes: new interest for an old problem. J Sports Med Phys Fitness 1994;34:11-22. 6. Khoury Z, Keren A, Benhorin J, Stern S: Aborted sudden death in a. young patient with isolated granulomatous myocarditis. Eur Heart J 1994;15:39%9. 7. Lecomte D, Fornes P, Fouret P, Nicolas G: Isolated myocardial fibrosis as a cause of sudden cardiac death and its possible relation to myocarditis. JEorensic Sci 1993;38:617-21. 8. Kenny A, Shapiro LM: Sudden cardiac death in athletes. Br Med Bull 1992;48:53445. 9. Smith NM, Bourne AJ, Clapton WK, Byard RW The spectrum of presentation at autopsy of myocarditis in infancy and childhood. Pathology 1992;24:129-31. 10. Wailer BF, Catellier MJ, Clark MA, Hawley DA, Pless JE: Cardiac pathology in 2007 consecutive forensic autopsies. Clin Curdiol 1992;15:760-5. 11. See DM, Tilles JC: Viral myocarditis. Rev InfectDis 1991;13:951-6. 12. Shen WK, Edwards WD, Hammill SC, Bailey KR, Ballard DJ, Gersh BJ: Sudden unexpected nontraumatic death in 54 young adults: a 30-year population-based study. Am J Cardiol 1995;76: 148-52. 13. Drory Y, Turetz Y, Hiss Y, et al: Sudden unexpected death in persons less than 40 years of age. AmJ Card& 1991;68:1388-92. 14. Eichhorn JH: Documenting improved anesthesia outcome. J Clin Anesth 1991;3:351-3. 15. Eichhorn JH: Pulse oximetry as a standard of practice in anesthesia. Anesthesiology 1993;78:423-6. 16. Mazze RI: Intralingual succinylcholine administration in children: an alternative to intravenous and intramuscular routes? Anesth Analg 1968;47:605-15. 17. Liu LMP, DeCook TH, Goudsouzian NG, Ryan JF, Liu PL: Dose response to intramuscular succinylcholine in children. Anesthesiology 1981;55:599-602. 18. Rosenberg H, Gronert GA: Intractable cardiac arrest in children given succinylcholine [Letter]. Anesthesiology 1992;77:1054. 19. Farrell PT: Anaesthesia-induced rhabdomyolysis causing cardiac arrest: case report and review of anaesthesia and the dystrophinopathies. Anaesth Intensive Care 1994;22:597-601. 20. Badgwell JM, Hall SC, Lockhart C: Revised label regarding use of succinylcholine in children and adolescents [Letter]. Anesthesiology 1994;80:243-5. 21. Lerman J, Berdock SE, Bissonnette B, et al: Succinylcholine warning [Letter]. Can JAnaesth 1994;41:165. 22. Katz L, Wright C, Harter J, Zung M, Scally D, Spyker D: Revised label regarding use of succinylcholine in children and adolescents: II. Anesthesiology 1994;80:243-244. 23. Reynolds LM, Lau M, Brown BS, Luks A, Fisher DM: Intramuscular rocuronium in infants and children: dose-ranging and tracheal intubating conditions. Anesthesiology 1996 (in press).
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