The medical and legal risks of the electronic fetal monitor.
The medical profession depends on the latest medical technologies to provide top quality care and to extend that care to a greater pool of patients. This dependence is all well and good where the method, drag, or device is tested in clinical trials that establish its efficacy and safety. But what happens when new technology diffuses rapidly into mainstream medicine well before it has been adequately tested?
The story of electronic fetal heart monitoring (EFM) reveals the problems posed to physicians and patients by the hasty acceptance of relatively unproven devices and techniques. When EFM was introduced in the 1960s, enthusiastic advocates promised that by enabling the continuous, electronic monitoring of the fetal heart rate during labor and delivery, EFM would enable physicians to detect dangerous heart rate patterns and to intervene more promptly than with intermittent auscultation, the long-employed technique of periodically monitoring fetal heart rate with an obstetrical stethoscope. Thus, announced EFM proponents, the device would reduce rates of neonatal illness and death. Based on these promises, EFM became the predominant form of fetal heart monitoring by the mid- to late 1970s.(1) However, experts now conclude that these promises remain unfulfilled and that EFM is, at best, a "disappointing story."(2) In the twenty-five years of its almost ubiquitous use, no randomized controlled trial has demonstrated that electronic monitoring does a better job of saving babies or improving infant health than intermittent auscultation.(3) Moreover, studies indicate that the inaccuracy of the technique prompts unnecessary interventions and contributes to the nation's excessively high rate of cesarean delivery, a major surgical procedure which places mother and infant at greater risk of injury and death than noncesarean delivery.(4) Despite the increased risks, the device remains employed in nearly all American delivery rooms. Continued high use of EFM is often attributed to physician concerns about medical malpractice liability and professional inertia. As one EFM critic has observed: "[Doctors] talk about [abandoning EFM] at conferences and at [medical] rounds and listen intently and all of that, but it's not measurable in terms of changes in behavior. Everybody's waiting for the next person to get brave."(5)
A quarter century of failure in clinical trials and striking new evidence documenting EFM's imprecision indicate that now is the ideal time for the obstetrical profession to "get brave." To ensure the safety of their patients and to preserve national confidence in the profession, obstetricians must abandon EFM and adopt safer, more effective monitoring methods such as intermittent auscultation. Close analysis of the legal and medical consequences of the use of EFM reveals that obstetricians have little to fear in discontinuing use of the technique. Not only is EFM an inferior diagnostic tool in the delivery room, but it fails to offer the courtroom protection obstetricians suppose. Moreover, a physician's decision to return to safer,, effective methods such as auscultation should not expose her to liability. In short, there are no excuses left to defend the continued use of EFM.
This note will first examine the medical inefficacy of EFM, including its poor performance in controlled trials, production of questionable data, potential to exacerbate patient dissatisfaction, high cost, and link to increased cesarean rates. Then it will analyze the implications of EFM use in a legal context, applying tort law's standard of care analysis to the technique and comparing obstetricians' perception of EFM's role in malpractice litigation to its actual function in a lawsuit. Finally, the note proposes that obstetricians create a new standard of care through definitive professional practice guidelines and consensus conferences, and recommends that obstetricians abandon EFM for intermittent auscultation.(6)
I. ELECTRONIC FETAL MONITORING IN THEORY AND PRACTICE
A. History and Theory Behind Fetal Heart Monitoring
For over 100 years, physicians have employed some form of fetal heart monitoring during the management of labor.(7) The purpose of fetal heart monitoring is to detect abnormal fetal heart rates, which indicate stress on the fetus. Not all stresses are considered a threat to the fetus.(8) Only when physicians find evidence of "fetal distress"--where the fetus appears incapable of handling stress to the heart--do they intervene to help the fetus.
Historically, one major cause of "fetal distress" indicated by fetal heart monitoring is deprivation of oxygen to the fetus. This condition, known as fetal asphyxia or hypoxia, results from poorly oxygenated blood in the mother or by an obstruction.(9) Fetal asphyxia or hypoxia may cause fetal neurological disorders, such as cerebral palsy, or even death. As such, intervention is required when physicians interpret the presence of fetal asphyxia or hypoxia.
Before the development of EFM, fetal heart rates were monitored through intermittent auscultation, the periodic monitoring of fetal heartbeats by stethoscope.(10) In 1960, the same presumption that generated the development of auscultation over 100 years ago--that early detection of abnormal heart rates indicating distress enabled physicians to prevent infant death and neurological disorders--inspired the development of EFM.(11) EFM improved upon auscultation, according to founders and enthusiasts, because continuous electronic monitoring allowed clinicians not only to detect abnormal heart rate but also abnormal heart rate patterns suggesting hypoxia and asphyxia.(12) By identifying fetal heart rate patterns that indicated fetal distress, EFM would alert clinicians to potential problems, enabling them to intervene more quickly and to prevent more fetal deaths and irreversible brain injuries than could be prevented with auscultation.(13)
B. Mechanics of the EFM Method
There are two EFM methods. The external method employs two wide belts which strap around a mother's abdomen, holding the monitor and electronic sensors in place. In the more invasive and more common internal method, an electrode is inserted through the vagina and attached to the fetal scalp.(14) The monitor generates a continuous paper tape that traces both the fetal heart rate and the mother's contractions, projecting this data upon a video monitor attached to the unit. Alarm sensors in the EFM device sound if the heart rate dips below or rises above "normal range."(15) In larger obstetrical units, clinicians typically monitor several EFM devices simultaneously from a "floor monitor" centrally situated within a labor and delivery unit.
In analyzing an EFM tracing for signs of asphyxia or hypoxia, physicians look for two things. First, they scrutinize heart rate patterns for multiple late decelerations--abnormal patterns involving a rapid fall in fetal heart rate.(16) Occasional or intermittent late decelerations are not uncommon during labor. But when they become persistent or severe, clinicians may determine that the fetus is in distress.(17) Second, clinicians interpreting EFM tracings look for "beat-to-beat variability"--moment-to-moment changes in fetal heart rate which are apparent in electronic measurements between heartbeats.(18) The tracing of a healthy fetal heartbeat demonstrates "short-term" variability-fairly rapid changes between heartbeats. Lack of short-term variability may indicate a range of normal fetal states, including sleep or the effects of medication administered to the mother.(19) Lack of variability may also have a more ominous significance, suggesting the beginnings of brain damage caused by hypoxia.(20) Confronting a pattern that may indicate one of two polar opposite conditions--a healthy fetus at rest or fetal distress--physicians often intervene.(21) Such intervention may take the form of an attempt to remove the cause of the perceived distress, or, more commonly, delivery via cesarean section.(22)
C. Expansion of EFM
EFM began its rapid diffusion into obstetrical practice in the early 1970s, soon after its development.(23) It was widely adopted for a number of reasons. Physicians perceived hypoxia as an important cause of neonatal mortality and morbidity,(24) and many expected that the technique would dramatically reduce the frequency of fetal death, cerebral palsy and other neurological disorders.(25) The technique appeared to offer benefits to physicians. In particular, it appeared easier to learn than auscultation, which obstetricians perceived as imperfect.(26) The device's fortuitous timing further augmented its already warm reception. EFM arrived upon the obstetrical scene during a period when the nation was poised to accept new technologies, and when great concern about perinatal mortality caused a shift in focus from maternal to infant health during delivery.(27)
Although founders intended the technique for use only in high-risk pregnancies, an increasing number of obstetricians came to favor the use of EFM in all pregnancies. By 1976, 278 of 279 obstetrics programs with residents used EFM.(28) By 1977, seventy-seven percent of physicians believed that EFM should be employed during every woman's labor.(29) By 1988, seventy percent of all births occurred under the surveillance of EFM monitors.(30) Today, according to the American College of Obstetrics and Gynecology (ACOG), clinicians employ EFM in eighty-three percent of all American births.(31) Thus, the technique has virtually eliminated older methods of fetal heartbeat monitoring.(32)
Critics have attacked EFM's rapid diffusion as precariously hasty because physicians practiced the technique in nearly all high- and low-risk births before anyone rigorously tested its efficacy and safety.(33) In particular, EFM's introduction and wide diffusion occurred well before randomized controlled trials were conducted. These trials offer the best way to test the efficacy of medical technology.(34) Critics began to question the monitoring device's effectiveness, cost, reliability, and safety in the late 1970s, following the preliminary results of several such trials, which indicated that EFM had not succeeded in reducing fetal mortality or morbidity rates.(35) These critiques, which arrived at the height of EFM's widespread diffusion into obstetrical practice, were arguably too late.
II. EVALUATING ELECTRONIC FETAL HEART MONITORING
A. Comparison Between Outcomes in Labors Monitored by EFM and Labors Monitored by Auscultation
The results of several randomized controlled trials(36) have demonstrated that EFM has proved to be, as one physician observed, at best a "disappointing store."(37) Not only has EFM failed to achieve the purposes for which it was designed--the reduction of fetal mortality and morbidity rates--but researchers have also discerned an eerie and substantial correlation between the high false positive rate of distress indicated by EFM and the alarming number of cesarean sections performed since its introduction.(38)
1. Near-birth deaths in infants monitored by EFM compared to those monitored by auscultation.
Twelve randomized controlled trials have evaluated the efficacy of EFM.(39) Several of these studies overwhelmingly concluded that EFM does not lower overall fetal mortality rates.(40) Only one trial demonstrated a significant decrease in rates of perinatal death as a result of EFM use.(41) None of the trials showed that EFM decreases the rates of stillbirth, neonatal death, or neonatal intensive care admissions.(42)
2. Incidence of cerebral palsy in infants monitored by EFM compared to those monitored by auscultation.
Particularly damaging to confidence in the EFM technique is the wealth of data mounted since the late 1970s challenging the very premise upon which EFM had been developed and embraced by the medical profession. Studies have suggested that "intrapartum" trauma (trauma during birth), and specifically asphyxia, only rarely caused fetal death and neurological disorder, including cerebral palsy. Most severely distressed infants survive without complications.(43) And although a small percentage of infants die as a consequence of events during birth, "survivors of even severe and prolonged asphyxia have no detectable neurological deficits."(44) Moreover, researchers have determined that cerebral palsy primarily occurs in fully grown, mature infants who did not display evidence of asphyxia during birth.(45) In the overwhelming majority of cases, the fetal heart abnormality and infant hypoxia reflect neurological damage sustained and maldevelopment begun well before labor. Thus, detection of fetal distress via EFM use and subsequent intervention can only rarely prevent such outcomes.
In 1990, a comprehensive study conducted by Dr. Kirkwood Shy and his colleagues dealt a particularly forceful blow to theories that EFM reduces cerebral palsy rates. From the results of a randomized controlled trial, Dr. Shy reported a statistically significant increase in cerebral palsy among premature infants monitored electronically during labor.(46) Twenty percent of the infants in the EFM group were diagnosed with cerebral palsy, while only eight percent of infants in the auscultation group had the disorder.(47) The authors concluded that EFM use does not lead to improved neurological development in premature infants.(48) Although the reason for the increase in cerebral palsy in the EFM group remains unclear, physicians and researchers have speculated that the lower incidence of cerebral palsy in the auscultation group was due to the value of interpreting heart rate readings in the one-to-one, clinician-to-patient context that stethoscopic auscultation requires.(49) Other physicians and clinicians suggest that "medical management" (i.e., intervention including cesarean and forceps delivery), which increases with the employment of EFM, influences the risk of cerebral palsy on an already "distressed" infant.(50) At the very least, Dr. Shy's controlled trial confirmed EFM's inability to improve delivery outcomes and to prevent neurological disorders. The latest and most striking study of EFM's value in preventing neurological disorders also focused on cerebral palsy. Cerebral palsy itself remains a relatively rare outcome, afflicting approximately two out of 1000 full-term infants.(51) Researchers estimate that only three to twenty-one percent of those cases are the product of traumatic events that occur during birth.(52) Consequently, even assuming ideal conditions and performance in this small number of cases,(53) EFM would not significantly reduce the risk of intrauterine death and neurological disorders.(54) In the view most favorable to EFM, the method would spare only four of every 100,000 infants from cerebral palsy.(55) Meanwhile, unnecessary interventions would be administered to 9296 additional deliveries--2324 unnecessary interventions for each child in whom cerebral palsy was prevented.(56) Thus, the researchers determined, EFM's false positive rate was a whopping 99.8 percent.(57)
This study aroused researchers' concern that through extensive, misdirected focus on EFM's efficacy in predicting and preventing neurological disorders, clinical and research attention had been diverted from "an exploration of factors other than birth asphyxia that can contribute to maldevelopment or injury of the infant's brain."(58) Results of this dramatic study and the other controlled trials suggest that by exclusively employing EFM, the obstetrical profession pursues the goal of avoiding the rarely preventable negative outcome due to hypoxia at the expense of the overwhelming majority of mothers and infants.
3. Incidence of cesarean deliveries with EFM compared to auscultation.
For over a decade, critics of EFM have argued the existence of a strong cause-effect relationship between EFM and sky-high cesarean section rates in the United States. These detractors point to the correlation between EFM's rapid diffusion and a tripling of the cesarean rate from six percent in the period from 1970 to 1973 to twenty percent in the period from 1981 to 1983.(59) Nineteen-ninety-four marked the first year since EFM's development that the cesarean rate dipped.(60) The decline was due in part to a national scheme designed to reduce the number of cesarean procedures.(61) But the 1994 rate--twenty-two percent--is forty-seven percent greater than the National Institutes of Health target of fifteen percent for the year 2000.(62)
Several features of EFM contribute to its estimated 99.8 percent false positive rate and soaring U.S. cesarean rates. To begin, EFM was designed to detect distress as early as possible in the labor process, allowing clinicians to promptly remedy distress by forceps or delivery. Since intervention constitutes the main objective of the technique's design, logically, the ubiquitous use of EFM increases the likelihood of remedying distress by cesarean section.(63) Then there is the ambiguity of the tracings themselves. While EFM, which provides a continuous readout of fetal heartbeat, certainly produces more data than does intermittent auscultation, the quantity of information may come at the cost of clarity.(64) Confronting this ambiguity and their own perceptions of the current "medicolegal" environment, physicians often intervene when they are in doubt, primarily by performing cesarean delivery.(65)
The physical constraints imposed by the continuous use of EFM also increase the risk of intervention by cesarean delivery. Specifically, the technique's physical demands on the patient during monitoring appear to contribute to the development of fetal distress. For example, the procedure often requires that the mother remain in a supine position to keep sensors in place. Because continuous EFM surveillance severely restricts a woman's movement, it increases the risk of a slower labor process in women monitored by EFM as compared to women monitored by intermittent auscultation, because the latter group is allowed to remain ambulatory.(66) When labor is slowed or stopped, women are less able to tolerate it and therefore often require more sedation and the administration of labor-inducing drugs. This additional attention, in turn, causes changes in the fetal heart rate, which may prompt intervention.(67) Conversely, intermittent auscultation allows the patient freedom of motion, encourages a faster, more natural, and more comfortable birth process, and reduces the chance that the administration of additional therapies will affect the fetal heart rate.(68)
B. Clarity of EFM Readings
Some clinicians may perceive the continuous readout of fetal heart rate produced by EFM as an advantage during labor and delivery. "When you look at anything that has lights and a digital readout and a paper drum turning and an instanteous [sic] fetal heart rate recording ... it makes you feel like you're getting a lot of information," explained one physician, offering insight into many obstetricians' defense of the technique.(69) "There's a hell of a lot at stake [during delivery], and it goes way beyond what's legally at stake."(70) "It's reassuring," agrees another obstetrician who has practiced for fifteen years in settings that exclusively employed an electronic fetal monitor.(71) Well apprised of and concerned about study results that call into question the efficacy and safety of EFM, this physician concedes that continuous monitoring may be more psychologically comforting than practically helpful: "You have continuous, permanent monitor tape that shows all the subtleties and patterns. Is that better? It certainly seems to be, but maybe it's better not to see every nuance."(72)
The continuous nature of EFM readout proves as confusing as it is reassuring to obstetricians. The tape obscures the line between insignificant heart rate data, which reflect the normal stresses all infants undergo during the traumatic event of birth, and information indicating real, nontransient distress.(73) Physicians' tendency to determine that there is fetal distress and intervene when in doubt seems warranted when one considers that decreased beat-to-beat variability can indicate anything from fetal sleep to the effects of sedatives to hypoxia.(74)
Interpretation of EFM tracings remains more of an art than a science, and the definition of what pattern (or patterns) constitutes fetal distress is frequently disputed, even by EFM experts. Researchers reported that a survey of twelve obstetricians nationally recognized as EFM authorities showed considerable disagreement among physicians regarding the meaning of EFM tracings.(75) A survey of 118 board-certified obstetricians revealed that eleven physicians considered experts in the field gave lower estimates of the accuracy of their own diagnoses than did their 107 less nationally recognized counterparts.(76) These surveys suggest that although obstetricians might find EFM's continuous readings to be reassuring, the "patterns" they construe therein may be less indicative of fetal status than of the observer's particular perspective. As one set of critics has observed: "The extent of disagreement between these authorities is testimony to the subjective, qualitative nature of fetal heart rate monitoring interpretation."(77)
Despite EFM's promise to produce data superior in predictive value to that produced by auscultation, the randomized controlled trials discussed earlier provide the strongest proof to the contrary, revealing no difference in overall mortality or morbidity rates and a far lower false positive rate as a result of auscultation.(78) As one study revealed, auscultation may in fact be a safer method of monitoring infants.(79) More significantly, the technique's much lower false positive and cesarean delivery rates in controlled trials provide strong support for auscultation's greater clarity and accuracy, and therefore enhance its value as a diagnostic tool.(80) Auscultation produces a small number of significant records in a one-on-one, clinician-to-patient context, while EFM produces a large number of confusing, subtle, or anomalous readings that may endure only briefly before the fetus itself recovers.
C. Patient Satisfaction
In addition to EFM's technical inefficacy, high false positive rate, and links to unusually high cesarean delivery rates, EFM's design may also impede obstetrical care because of its tendency to foster patient dissatisfaction. At the outset, the method may produce counterproductive anxiety in the mother because it leads to confinement, a slower labor process, a greater need for sedation and labor-inducing drugs, and discomfort caused by the monitor's attachments. Moreover, many women may resent the lack of human attention and the impersonal medical care that use of the monitor promotes. Part of the purpose of EFM, after all, is efficiency--a reduction of the need for patient contact with health care personnel. By allowing clinicians to simultaneously monitor many women from a central floor monitor, and to rely primarily on tracings to provide information about a woman's labor progress, EFM greatly reduces clinician interaction with expectant mothers. Even when a clinician does enter the patient's room, the patient may still feel neglected by the care provider, whose attention may be focused on the EFM monitor tracings. One father explains the draw of the monitor:
"My wife looked like she was tied down, and no matter what I did, the machine kept drawing me to it. I just couldn't keep from watching the beeps. My wife would get angry every time I tried to say, `Here comes a contraction ...' I am not sure it was worth all of the trouble."(81)
By comparison, auscultation requires one-on-one interaction between clinician and patient. Thus, it may promote patient satisfaction and psychological readiness for the labor process. Moreover, the patient contact and close observation required by auscultation provide clinicians an important context in which to interpret readings, thereby augmenting the accuracy of diagnosis. This one-on-one dynamic is so important that observers have suggested that many of the apparent advantages of auscultation over EFM lie not in the technique itself but in the listening, personal attention, and interpretation of results that the procedure demands: "Intrapartum fetal death is not prevented by monitors; it is prevented by an alert nurse or doctor at the bedside of the laboring woman."(82)
EFM monitors provide no such interpretative context. Very often, clinicians observe multiple readings from floor monitors placed outside patients' rooms. However, this condition generally is not duplicated in controlled trials, in which nurses and doctors often supply more one-on-one attention to EFM patients than in typical EFM monitoring situations. The popularity of the EFM floor monitor in "real life" stems from the fact that it reduces the need for patient contact with personnel, which suggests that the true extent of the inefficacy of EFM may as of yet be undocumented.(83)
Clinicians who cite fear of malpractice as a primary reason for using EFM should not discount the patient alienation and decreased communication that EFM promotes. Poor physician-patient communication proves an important factor in a patient's decision to file a malpractice claim.(84) Current advice about reducing medical malpractice risk strongly emphasizes the establishment of good physician-patient rapport.(85) For example, defendants' malpractice attorneys often cite personal attention to patients and cultivation of trust as important ways of avoiding malpractice litigation.(86) Thus, the personal attention required for auscultation provides greater patient benefits in two important ways: first, it may reduce the risk of fetal distress and better enable clinicians to identify distress and respond appropriately, and second, it may foster patients' confidence and trust in clinicians, which reduces the risk of medical malpractice liability.
D. Costs Analysis
Proponents often defend EFM on the basis of cost and practicality. They argue that auscultation is impractical, imposing excessive demands upon the hospital staff because of the one-on-one personnel to patient care required.(87) Auscultation's primary cost does lie in the provision of personnel. However, auscultation may demand no more personnel than EFM.(88) In fact, when one considers the costs and labor involved in the maintenance of EFM equipment--including cleaning, sterilization, and periodic maintenance by EFM technicians--EFM requires more personnel and labor than auscultation, which requires only minimal maintenance of the obstetrical stethoscope. In a study performed by the National Institutes of Health consensus development conference, researchers concluded that "[electronic] fetal monitoring appears not to substitute equipment for labor expenses.... [It] seems to increase requirements for nurses and maintenance personnel to operate and maintain the equipment."(89)
Economic comparisons between EFM and auscultation also must not discount the cost of the EFM monitor itself, the price of which can approach $16,000.(90) Central floor monitors, which are larger and more expensive than individual monitors, add considerably to the total price of EFM. Finally, estimates of EFM's costs should also include the cost of the electricity required to generate the monitors. By comparison, intermittent auscultation employs only obstetrical stethoscopes--instruments of minor expense--which require no electricity and only minimal maintenance.
Of course, EFM's most significant expense lies not in the cost of its equipment or maintenance but in its consequential costs. As noted, EFM significantly increases the likelihood of active management of labor, often through the administration of labor-inducing drugs and costly cesarean sections. In 1979, the estimated cost of EFM to United States consumers was $411 million.(91) A more recent update, following studies linking EFM and cesarean delivery, estimated the national annual cost of EFM at $1.09 billion.(92) The expense of cesarean deliveries explains in part why auscultation, with its much lower incidence of such deliveries, is the more cost-efficient procedure. One 1988 Boston study of the cost of cesarean delivery found a $4000 to $5000 average cost differential between cesarean section and uncomplicated vaginal birth deliveries, prompting predictions that if physicians could reduce the national cesarean rate by five percent, they would produce a national savings of between $700 and $900 million dollars per year.(93) As health management and insurance organizations apply greater pressure upon obstetricians to reduce the number of cesarean sections, clinicians and hospitals alike may soon be required to re-evaluate the cost of EFM and to reconsider auscultation.
Users and potential users of EFM must also consider the high opportunity costs of time and resources expended to train clinicians in the interpretation of monitor tracings. These are, in fact, wasted costs. The ambiguity of tracings and the inability of training to improve the accuracy of interpretation suggest that the quest for EFM expertise may be futile.(94) Discernible patterns of fetal distress may in fact not ever be knowable, much less teachable. Nonetheless, new clinicians labor to master the "skill" of pattern interpretation and grapple with the extraordinarily high false positive rate that EFM readings produce. By pursuing mastery of the elusive art of EFM interpretation, physicians waste time, money, and resources, sacrificing patient care and opportunities to learn more effective practices and procedures.
III. EFM AND THE LAW
Due to EFM's poor performance in randomized controlled trials and its strong correlation to high cesarean rates, one might expect the medical profession to have replaced the device with safer, more accurate methods such as intermittent auscultation. Surprisingly, however, EFM's place in the birthing room appears uncompromised: The ACOG reports that between 1992 and 1994, clinicians used the device to monitor over seventy-nine percent of all births.(95)
To explain the discrepancy between sound medical policy on the one hand and the professional use and defense of EFM on the other, obstetricians have blamed plaintiffs' lawyers, a litigious national climate necessitating "defensive medicine" strategies, and patients' desire for a perfect outcome guarantee.(96) Physicians may argue that they are obliged to employ EFM in order to document and defend a decision to intervene or not to intervene in a pregnancy.
Perhaps the most striking example of physicians' reliance on legal justifications to support EFM issues comes from the authors of the latest and arguably most damning of the twelve trials confirming EFM's inefficacy. As discussed above, researchers not only confirmed EFM's failure to decrease mortality and morbidity rates, but also estimated EFM's false positive rate to be 99.8 percent.(97) Nonetheless, the authors refused to rise to their colleague's challenge to take an "unambiguous" position against EFM, explaining that "medicolegal pressures can influence physicians' decisions."(98)
While patients, expectant parents, and plaintiffs' lawyers should be educated about EFM's medical failures, obstetricians and the medical profession in general must be educated about the failures of the legal justifications for EFM. Two largely erroneous suppositions premise obstetricians' legal justification for their use of EFM: first, that because it is customary practice to use EFM, failure to employ the device will result in liability, and second, that EFM insulates the obstetrician from liability by supporting her decision to intervene or not to intervene with a permanent record indicating visible patterns of fetal distress or the lack thereof.
The surge of medical malpractice claims accompanying the adoption of the EFM technique substantially undermines these presumptions, suggesting what close analysis confirms: Use of EFM does not insulate the obstetrician from liability. It may in fact expose her to greater malpractice risk.(99) Moreover, legal analysis indicates that a return to intermittent auscultation will not result in increased liability. In light of its superior performance in clinical trials and endorsement by considerable authority, intermittent auscultation is at the very least an equally effective, equally acceptable alternative to EFM.
A. Risk of Malpractice for Obstetricians: Perceptions, Reputation, and Litigation
To understand obstetricians' defense of EFM as legally necessary, it is essential to understand the perceived "crisis culture" of medical malpractice and the particular legal concerns of obstetricians. Few other medical professionals perceive the malpractice crisis as acutely as obstetricians: More than seventy-three percent reported in 1988 that they have been sued at least once.(100) However, litigation data indicate that obstetricians may have less to fear from plaintiff success rates than from the size of jury awards when plaintiffs do prevail. From 1988 to 1994, the average plaintiff recovery rate for all physician and medical malpractice was thirty-nine percent.(101) The recovery rate in malpractice cases involving childbirth was forty-five percent.(102) Similarly, a Harvard Risk Management Foundation study analyzing the 230 claims related to obstetrics and gynecology (ob/gyn) from 1980 to 1993 reported the "good news" that obstetrician/gynecologist defendants do well in court: Twenty of the twenty-nine cases that went to trial resulted in defense verdicts.(103) However, the bad news is that when plaintiffs do succeed in claims involving labor and delivery, the result is costly. Recovery rates for ob/gyn claims dominated the overall plaintiff recovery rate for medical malpractice, comprising twenty-one percent of total medical malpractice losses, or $64 million.(104) Moreover, there is a great disparity between the median awards for obstetrical malpractice claims and medical malpractice awards generally. This disparity appears most strident when one compares the general median award to the median award in so-called "bad baby" cases, cases involving infant brain damage, neurological disorder, or other serious injury allegedly incurred during labor and delivery. From 1988 to 1994, the median award for all medical malpractice claims was $383,150.(105) However, the median award for claims involving brain injury, which is significantly more likely to be the primary allegation in obstetrical malpractice claims than in any other medical malpractice claim, was $2.5 million.(106) While the Harvard study did not provide specific details of the median award for labor and delivery claims, it revealed that ob/gyn claims represent one quarter of all "large" claims, defined as claims resulting in defense losses of over $500,000.(107) Further, the study found that cases involving cerebral palsy and neurological damage in infants represent half of these large obstetrical claims.(108)
Although maternal injury, maternal death, fetal death, neurological disorder, or other serious injury resulting from birth trauma are the exception given today's advancements in obstetrical practice, malpractice litigation has increased along with the number of successful deliveries.(109) This result most likely occurs because advanced obstetrics allows more premature and otherwise impaired infants to survive. Thus infant births that would formerly have been part of the mortality rates become part of morbidity rates. Yet an infant's birth with cerebral palsy or other neurological conditions is often serious, costly, and heartbreaking. As such, obstetricians and obstetrical nurses may fear that judges and jurors will inevitably side with the plaintiffs. Many physicians, especially obstetricians, perceive that juries do not decide malpractice cases rationally,(110) and Otis Bowen, former Secretary of Health and Human Services, has lamented that "[the tort system] has become more a lottery than a rational system of compensating the injured."(111)
Despite the fact that defendants prevail in the majority of both medical and obstetrical malpractice claims,(112) the frequency with which labor and delivery claims are alleged, the severity of infant injury involved, and the resulting high awards in successful cases, encourage the perception that juries are more likely to make decisions based on emotion rather than fault. "It's natural for jurors to sympathize with the plaintiff," explains one physician.(113) "They see a disabled child and they rightfully feel pity and that the child should get something out of this. And that child should get something--but not through the court system, not by wrongly blaming a physician for an unpreventable outcome, something he didn't have any control over.(114) Anxious to avoid drawn-out legal hassles, and the substantial personal and professional expense that defending a lawsuit often entails, many obstetricians are unwilling to endure looming litigation, or to trust jurors to reach the right result. Settlement is often the inevitable outcome.
Fear of malpractice suits and their personal and professional consequences in part explains the pervasiveness of EFM in the birthing room, and its tenacity in the face of significant evidence challenging its efficacy and safety. However, careful study of the way in which plaintiffs have used EFM in the courtroom reveals that EFM tracings prove less a friend than a foe to the conscientious clinician. Specifically where cesarean delivery is involved, the controlled trials documenting EFM's high false positive rate and link to cesarean interventions suggest that EFM use increases physicians' risk of incurring liability. Analysis of the use of EFM and auscultation under tort law's standard of care analysis should assure physicians of the legal soundness of choosing an appropriate, safe alternate method such as auscultation. Just as no sound medical reasoning supports the use of EFM, no legal justification sustains its continued employment.
B. Standard of Care Analysis
In medical malpractice suits, courts generally hold physicians to one of three standards in determining whether they have breached a duty to act with reasonable care: customary practice, the specific duty to keep abreast of developments in their field and to use one's "best judgment," and ordinary negligence. A customary practice review remains the traditional and most common approach.
1. Custom in medical malpractice suits.
In ordinary negligence cases, proof that a defendant acted in compliance with the customary practices of her profession is not dispositive, but is extremely important in evaluating the reasonableness of the physician's actions.(115) Traditionally, courts have evaluated the reasonableness of physician conduct and decision-making by employing a customary practice rule that looks to the practices actually employed by members of the profession.(116) Much controversy swirls about this customary practice standard, primarily because it grants the medical profession the discretion to set its own legal standards of conduct, a privilege generally not conferred upon other professions.(117) This deference to the medical profession stems at least in part from courts' "reluctance to overburden [the medical profession] with liability based on uneducated judgment."(118) Another reason for distinguishing medical malpractice cases from ordinary negligence lies in courts' fears of the possibility that a judge or jury might reach an erroneous determination of fault,(119) Courts may especially want to avoid a legally-dictated standard of care rather than a physician-created one, because of the potential physical and economic harm to patients caused by legally-defensible but inferior or unsafe medicine.(120)
Just as the law recognizes the hazards of a legally-dictated standard of care, it acknowledges the great complexity of the medical profession and the division of authority regarding a number of available, acceptable techniques and procedures. Thus the law allots to physicians a good deal of discretion and does not penalize them for following a course approved by a respectable segment of the profession. Where different schools of medical thought favor alternative methods of acceptable treatment, courts generally hold that the dispute cannot be settled by the law, and the physician's conduct is judged according to the tenets of the school of thought the physician follows.(121) In order to accommodate differences of opinion among schools of thought, most courts apply the "respectable minority" rule, which holds that the decision to use a particular method of treatment as opposed to other alternatives, where there is a reasonable doubt as to which method to choose, is not a breach of duty.(122) Consequently, "a physician does not incur liability merely by electing to pursue one of several recognized courses of treatment."(123) Elaborating upon the need to accept professional, substantiated divergences of medical opinion, the Sixth Circuit noted in Chumbler v. McClure(124) that "[t]he test for malpractice ... is not to be determined solely by a plebiscite."(125)
In jurisdictions applying standards related to the respectable minority rule, a physician does not incur liability where she follows a course of action approved by a "considerable number" of physicians(126) or, under a still more flexible standard, when "reasonable physicians disagree" as to the proper course of treatment.(127) Thus, even jurisdictions adopting the customary practice rule do not require physicians to comply with a single, dominant practice. The respectable minority rule preserves physicians' discretion by allowing physicians to rely on reasonable, accepted alternatives.
2. Physicians' duty to keep abreast of current developments and to use their best judgment.
In medical malpractice cases, several courts have indicated that a physician has a specific duty to "keep abreast of progress" in her field and to use her "best judgment." Such duties obligate physicians to read, interpret, and apply the latest research regarding the drugs, techniques, and procedures employed in their specialties. In several cases, courts have found physicians liable for breach of these special duties. In Incollingo v. Ewing,(128) a Pennsylvania state court held that the defendant physicians could not rely solely on conformity with custom to establish due care.(129) In that case, two physicians prescribed a drug believed to have caused the patient's death. Despite evidence that it was customary practice in the particular locale to prescribe the drug somewhat liberally, the court found liability because warnings accompanying the drug cautioned that it was inappropriate for treatment of minor infections.(130) Similarly, in Burton v. Brooklyn Doctors Hospital,(131) a New York state court upheld liability against a staff physician instructor and hospital in the death of a premature infant for whom the instructor ordered increased oxygen, the administration of which was customary practice, despite his knowledge of the danger of increased oxygen and of the child's satisfactory progress on the existing lower dose of oxygen.(132) Clearly, rigid adherence to customary practice where that practice proves unsafe or otherwise inappropriate may not insulate physicians from liability.
3. The Helling "ordinary negligence" standard.
The history of American medicine abounds with examples of procedures, pharmaceuticals, and devices employed in "customary practice" well before their efficacy or safety has been effectively established. The premature and widespread acceptance of DES, the Dalkon shield, and the administration of oxygen to premature infants punctuate arguments that customary practice is not always equivalent to medical soundness. They further indicate that the customary practice rule's grant of unusual discretion to the medical profession to set its own standard of care may allow monetary and other nonmedical incentives to dictate that standard of care.(133) A trend in the disposition of medical malpractice cases reflects several courts' unwillingness to accept customary practice as conclusive on the issue of due care. An increasing number of courts have implicitly or explicitly rejected the customary practice standard in favor of a reasonable care or reasonably prudent doctor standard.(134) Refusing to insulate physicians from liability merely because their actions complied with dominant practices, several courts have applied "ordinary negligence" standards to medical malpractice cases. Under an ordinary negligence standard, proof of medical custom becomes merely relevant to, but not conclusive on the issue of due care, consistent with the general tort law rule.(135)
The seminal case of Helling v. Carey(136) broke with the traditional customary practice rule when the court found a medical custom itself to be negligent. In Helling, the defendant opthamologist did not administer a glaucoma pressure test to a patient in whom he did not suspect glaucoma, in light of a standard practice among opthamologists that did not include giving routine pressure tests to patients who were under forty years of age.(137) The patient later developed glaucoma. The court rejected the standard practice, holding that reasonable prudence required the use of the pressure test on persons under the age of forty as well as those over forty.(138)
Following Helling, Washington courts have continued to apply a "reasonable prudence" standard, codified by statute, to find malpractice liability even where a physician has employed a customary practice. Gates v. Jensen(139) also involved an opthamologist's failure to detect plaintiff's glaucoma. In Gates the court applied the Helling doctrine, holding that the plaintiff was entitled to instruct the jury that if reasonable prudence under the circumstances required the physician to perform additional diagnostic tests, failure to perform such tests constituted negligence even if defendant had met the applicable standard of care followed by practicing opthamologists.(140) Following Helling, physicians who follow customary practice despite sufficient evidence suggesting its risks or inferiority may incur malpractice liability.
C. EFM and the Standard of Care
Obstetricians may feel compelled to employ EFM despite the evidence of its inefficacy largely because its own ubiquity suggests that it is the exclusive standard of care. However, the research documenting EFM's inefficacy confirms the erroneousness of this assumption and suggests the danger of relying on it. In the wake of the controlled trials confirming that EFM is no more effective than auscultation in preventing fetal mortality and morbidity,(141) it is very unlikely that any jurisdiction would accept EFM as the exclusive customary practice. It is still more unlikely that a court would reject intermittent auscultation as customary practice or a practice accepted by a respectable minority. Moreover, it is difficult to imagine a court that would find that a decision to employ auscultation rather than EFM was the actual and proximate cause of fetal injuries, proof of which would be very onerous in light of EFM's performance in the controlled trials. Finally, in light of EFM's documented high false positive rate(142) and correlation with increased cesarean section rates,(143) physicians should note that EFM will not insulate them from liability in jurisdictions that have rejected a standard of care based solely on custom.
1. EFM and customary practice.
Although EFM remains the dominant "customary practice," ACOG's endorsement of auscultation, the results of the twelve EFM trials conducted since EFM's diffusion, and the substantial professional support for auscultation(144) confirm that respectable medical opinions differ considerably as to the best monitoring technique, such that a physician's decision to auscultate merits some deference by the courts. In fact, the substantial divergence of authority as to monitoring practices and the adoption of the respectable minority rule and related malpractice liability standards strongly support a clinician's choice to auscultate. At the very least, there is a reasonable doubt as to which form of monitoring is safer and more effective.
Auscultation clearly qualifies as a "recognized" course of treatment, endorsed by recognized authorities such as ACOG and a host of monitoring experts, including authors of the controlled trials comparing the two monitoring methods. The respectable minority rule preserves physicians' discretion to rely on reasonable, accepted alternatives. Accordingly, no breach of duty should result from an obstetrician's decision to use intermittent auscultation. Even in the unlikely event that a court rejected auscultation as an acceptable alternative to EFM, a plaintiff attempting to establish liability for the decision to auscultate must still prove that the choice to auscultate was the actual and proximate cause of injury. This task proves especially onerous in light of new evidence refuting a significant link between intrapartum trauma and fetal morbidity and mortality and the substantial evidence garnered from clinical trials documenting the comparative safety and effectiveness of auscultation.
2. EFM and the "best judgment" and duty to "keep abreast" rules.
Employing EFM may expose the obstetrician to liability in jurisdictions in which the standard of care includes a physician's obligation to apply her best judgment, and to keep abreast of professional knowledge about techniques, drugs, and procedures used in her specialty. In light of twenty-five years of studies indicating that EFM is no more effective than auscultation and recent studies documenting its unreasonably high false positive rate, a physician may be held liable when injuries result from an intervention caused by a false positive EFM reading. Where the standard of care mandates that a physician has a duty not to follow customary practice when she believes that such practice is overly risky or otherwise inappropriate, a physician would be liable where the decision to use EFM was not considered to be her "best judgment,"(145) An obstetrician may not avail herself of a defense of compliance with customary medical practice when a number of studies have indicated that EFM is unnecessary (because auscultation is an equally or more effective monitoring technique) and unsafe (because it increases the risk of injury and death to mother and child during cesarean section).(146) Thus an obstetrician should not discount the possibility that use of EFM and subsequent injury to a patient during cesarean section will result in malpractice liability.
3. EFM and the Helling "ordinary negligence" standard.
In the increasing number of jurisdictions that apply an ordinary negligence standard, a court may find that the decision to use EFM violates the standard of care. In these jurisdictions, a physician's compliance with the customary practice of EFM use is not dispositive of due care and will not insulate the physician from liability if injuries result from intervention. Under Helling's "reasonable prudence" standard, an obstetrician may incur liability if a plaintiff shows that use of EFM, although customary, was negligent and that auscultation was a safer technique.(147) The latest of the randomized controlled trials documenting EFM's inefficacy and its correlation to an increased risk of cesarean section,(148) combined with the increasing frequency with which courts apply an ordinary negligence standard of care, increase a plaintiff's likelihood of success in proving that a physician inappropriately employed EFM and improperly intervened, causing her injuries.
D. EFM and the Realities of Tort Litigation
Contrary to the supposition that failure to use EFM exposes obstetricians to malpractice liability, the significant rise in filed malpractice claims accompanying the diffusion of EFM strongly suggests a causal relationship between the advent of EFM and the current malpractice crisis. Obstetrical litigation statistics confirm that since its introduction, EFM has played a significant role in a large number of malpractice claims. A study by the Harvard Risk Management Foundation revealed that over a ten-year period following EFM's arrival on the obstetrical scene, allegations of failure to diagnose or treat fetal distress pervaded the most serious medical malpractice claims in obstetrics.(149) Of the cases examined by the Foundation between the 1976 and 1986, almost two-thirds of the losses involved alleged problems with fetal monitoring or related documentation.(150) Many of the claims involved the alleged failure to properly interpret the electronic fetal monitor readings, or the alleged loss or accidental destruction of the monitoring strips themselves.(151)
A 1987 ACOG survey of claims against about 2000 of its members found that the use of EFM was cited forty-six percent more frequently than any other characteristic.(152) A similar 1994 ACOG study of malpractice complaints reported that plaintiffs referenced EFM tape 50.1 percent more often than any other characteristic.(153) Both studies reported that the great majority of cases settled out of court.(154) Clearly, obstetricians should not: reassure themselves that employing EFM will diminish their chances of being sued, even in jurisdictions that follow the general rule of customary practice.
1. Plaintiff's use of EFM tape during litigation.
Since the advent of EFM, EFM tracings and the debate surrounding their interpretation have proved more valuable to plaintiffs' lawyers than to physicians seeking potential patterns of fetal distress. The same ambiguity in EFM tracings that has plagued the obstetrician has assisted the lawyer, who could, until recently, present the confusing record of fetal heart patterns to a factfinder and convince her that the negligent obstetrician ignored "clear" signs of distress.
Before EFM's introduction, when obstetricians employed auscultation, the litigation story was markedly different. In Galileo's Revenge, Peter Huber explains that:
In court a year or two after a child had been delivered, all the speculation in the world from the plaintiff's expert witness might be countered by the defending doctor's simple, confident recollection that there had been no evident fetal distress, and therefore no cause either to slow or to accelerate delivery.(155)
But EFM transformed the plaintiff's case by supplying a paper chart for the record: "Another doctor could now deliver the baby a second time, in court. More successfully, of course."(156) Following EFM's diffusion, plaintiffs' theories remained similar to those offered when auscultation was the dominant monitoring practice. However, EFM's production of a permanent visual record undoubtedly convinced more juries and plaintiffs themselves of the legitimacy of their complaints and increased pressure upon physicians to settle such claims.(157) Plaintiffs' lawyers could direct jurors' attention to a nebulous pattern on the tape and present the expert testimony of obstetricians who claim that they would have interpreted the tracing as distress and intervened or acted more promptly.(158) Had the physician correctly interpreted the tracings, he could have intervened or intervened sooner, the argument proceeds, and the child would have been spared cerebral palsy, neurological impairment, or other permanent, disabling conditions.(159)
Following the advent of EFM, the loss of or damage to EFM tape prior to litigation severely jeopardized the defense's case. While EFM tape may have offered defendants very little protection from liability, failure to produce the tape significantly increased the likelihood of settlement or a plaintiff's verdict. Missing or altered tapes permitted the plaintiff to speculate and to charge that the defense had purposefully concealed or destroyed the tape because it contained damaging evidence revealing the defendant's negligence.(160)
The reality of plaintiff use of EFM tracings in malpractice litigation substantially undermines physician arguments that the risk of medical liability compels the use of EFM. Analysis of courtroom use of EFM tracings reveals that EFM has historically been more of a tool for plaintiffs' lawyers than a safe harbor for the defense.
The new evidence refuting the presumed correlation between asphyxia and intrapartum mortality and morbidity will considerably assist the defense of medical malpractice claims based on a theory of failure to intervene.(161) Such data significantly weakens plaintiffs' claims that failure to interpret fetal distress in EFM tracings and subsequent failure to intervene or to intervene promptly caused injuries to infants during delivery.
It remains foreseeable, however, that plaintiffs' lawyers may soon use this new data to dispute the diagnostic precision of EFM to their advantage under new liability theories. Allegations involving maternal and fetal injury and death during the performance of cesarean section already constitute a significant proportion of the total number of obstetrical claims.(162) Claims involving cesarean delivery are frequently serious, involving issues of infant cerebral palsy and/or neuromuscular development problems, infant death, maternal hemorrhage, coma, paralysis, death, perforation or laceration of the mother's anatomical structure, and laceration to the infant's scalp and face.(163) Plaintiffs may now choose from two additional theories to argue that physician cesarean section or other intervention was erroneous and unnecessary: first, that although the EFM tracing pattern failed to signal fetal distress, the physician interpreted the tape as signaling distress, or second, that the physician negligently employed EFM in the first place despite his knowledge of evidence of its high false positive rate.(164) Where plaintiffs' lawyers previously used the ambiguity of EFM tracings to argue that physicians failed to intervene where tracings "clearly" indicated potential distress, they may
now use the ambiguity of tracings and the evidence disputing a link between fetal neurological disorder and intrapartum trauma to argue that the physician intervened via cesarean section where action was unwarranted. Evidence of EFM's 99.8 percent false positive rate(165) and strong link to cesarean delivery(166) substantially enhances malpractice theories alleging that obstetricians negligently employed EFM or negligently interpreted its tracings, and performed unnecessary cesarean deliveries resulting in maternal and fetal injury or death.
For defendant obstetricians and expectant mothers, EFM proves a clear failure in the delivery room and in the courtroom. Beyond its inaccuracy, inefficacy, and undue promotion of cesarean section interventions, use of the monitor fails to defend physicians from medical liability. Legal analysis reveals that the law is on the side of obstetricians who provide their patients with the best care, including safer, more effective methods of monitoring fetal heart rate during labor and delivery. Employment of the EFM technique fails to further this objective. Instead, it jeopardizes outcomes for both mothers and infants by causing unnecessary interventions.
As the authors of the latest study to document EFM's inefficacy have suggested, medicolegal pressures can influence a physician's decisions.(167) Yet obstetricians must remember that the reverse is true to a far greater degree: Physicians' decisions influence medicolegal pressure. The law generally grants great deference to physicians' professional expertise and invests in them the autonomy to determine the standard of care according to what is best for their patients. The obstetrical profession should not perpetuate abuse of this authority by encouraging the continued employment of an ineffective, unsafe fetal monitoring method, and it should not permit obstetricians to duck behind the shield of "defensive medicine" to support an inferior technique. After all, by choosing to employ EFM and to flout extensive evidence contravening the soundness of this choice, obstetricians prolong the notion among patients and plaintiffs' lawyers that EFM is a safe, effective, necessary monitoring technique.
Patients can no longer wait for individual physicians to "get brave."(168) Obstetricians must devise a new standard of care which ensures the employment of the safest and most effective monitoring techniques. The obstetrical profession should accept the responsibility to clearly establish intermittent auscultation as the standard of care and to organize reform of the policy and practice of EFM use. This process of reform involves revising practice guidelines, conducting consensus conferences, emphasizing auscultation in teaching programs, and adopting, via professional organizations; such as ACOG, a clear, definitive stance against the EFM technique as it is currently employed. The profession must educate obstetricians about the medical and legal realities of the EFM technique in order to remove "defensive medicine" as a priority consideration in medical decision-making. Finally, it must restore quality patient care as the central objective of employing obstetrical procedures.
(1.) See Stephen B. Thacker, The Impact of Technology Assessment and Medical Malpractice on the Diffusion of Medical Technologies: The Case of Electronic Fetal Monitoring, in 2 MEDICAL PROFESSIONAL LIABILITY AND THE DELIVERY OF OBSTETRICAL CARE 9, 10 (Victoria P. Rostow & Roger J. Bulger eds., 1989) (noting that by 1969 EFM had begun to diffuse rapidly) [hereinafter MEDICAL PROFESSIONAL LIABILITY].
(2.) Betsy A. Lehman, Doubts Growing Over Fetal Monitors, BOSTON GLOBE, Oct. 8, 1990, at 59 (quoting Dr. Roger Freeman's March 1990 editorial in The New England Journal of Medicine).
(3.) See notes 36-58 infra and accompanying text.
(4.) See Diane B. Petitti, Robert C. Cefalo, Sam Shapiro & Peggy Whalley, In-Hospital Maternal Mortality in the United States: Time Trends and Relation to Method of Delivery, 59 OBSTETRICS & GYNECOLOGY 6, 11 (1982) (estimating that cesarean delivery places the mother at no less than two and no more than four times the risk of death than vaginal delivery); see also Benjamin P. Sachs, Is the Rising Rate of Cesarean Sections a Result of More Defensive Medicine?, in 2 MEDICAL PROFESSIONAL LIABILITY, supra note 1, at 27, 34 (explaining that cesarean deliveries place mothers at far greater risk of morbidity, including increased incidence of maternal infection, longer hospitalization, problems in bonding with the infant, and rarer complications).
(5.) Lehman, supra note 2, at 59 (quoting Dr. Fredric D. Frigoletto, Jr.).
(6.) For a review of liability for the use of or failure to use EFM before 1984, see generally Myra Gerson Gilfix, Electronic Fetal Monitoring: Physician Liability and Informed Consent, 10 AM. J.L. & MED. 31 (1984). This note updates Gilfix's article, incorporating the results of later controlled trials that further document EFM's failure as a diagnostic tool, and includes new studies tracing EFM's strong link to cesarean delivery.
(7.) See Dermot MacDonald, Cerebral Palsy and Intrapartum Fetal Monitoring, 334 NEW ENG. J. MED. 659, 659 (1996) (discussing the history of fetal heart monitoring).
(8.) See AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS, TECHNICAL BULL. NO. 207, FETAL HEART RATE PATTERNS: MONITORING, INTERPRETATION, AND MANAGEMENT 4 (1995) [hereinafter 1995 ACOG BULL.] (explaining that periodic changes in fetal heart rate are common in labor, occurring in response to contractions and fetal movement).
(9.) See id. (noting that "fetal distress" is a somewhat "imprecise and inaccurate" term generally applied to abnormal heart rate patterns in labor suggestive of fetal trouble, including asphyxia and hypoxia, that requires physician intervention).
(10.) See MacDonald, supra note 7, at 659 (discussing the history of auscultation).
(11.) See Thacker, supra note 1, at 9-11 (discussing the development and diffusion of EFM).
(12.) While obstetrical stethoscopes are capable of detecting fetal abnormal heart rates, continuous monitoring was capable of taking the next important step: detecting abnormal patterns. See Stanely Tessel, Liability--Fetal Distress, in LITIGATION 1989, at 31, 34 (PLI Litig. & Admin. Practice Course Handbook Series No. 376, 1989) (suggesting that observation of such patterns is particularly important for the diagnosis of hypoxia).
(13.) See 1995 ACOG BULL., supra note 8, at 3 ("With the advent and liberal use of electronic FHR monitoring in the 1970s, there was great hope that intrapartum fetal death and morbidity associated with intrapartum asphyxia could be virtually eliminated.").
(14.) See Dale E. King, Electronic Fetal Monitoring, 12 INT'L J. CHILDBIRTH EDUC. 28, 28 (1997); 1995 ACOG BULL., supra note 8, at 2 (noting that obstetricians often confirm a diagnosis made using EFM by analyzing the acid-base of a sampling of fetal scalp-blood, obtained by making a small wound in the fetal scalp).
(15.) A normal range is 120 to 160 beats per minute. See 1995 ACOG BULL., supra note 8, at 2.
(16.) See id. at 4.
(17.) See id. ("Only when [heart rate patterns] become persistent, progressively deeper, and longer lasting are they considered nonreassuring.").
(18.) See Barry S. Schifrin, Antenatal Fetal Assessment: Overview and Implications for Neurologic Injury and Routine Testing, 38 CLINICAL OBSTETRICS & GYNECOLOGY 132, 135 (1995) (explaining the significance of variability and other features of diagnosis of fetal hypoxia and neurological handicap).
(19.) See id. (noting that sleep and other behaviors "may pose problems of [EFM] interpretation for the unwary").
(20.) See id.
(21.) See id. (noting that EFM may produce "a seemingly bewildering array of fetal heart rate patterns" that thwarts ready interpretation because it focuses on decelerations and not behavior); see also Sachs, supra note 4, at 31 (explaining that several features of EFM contribute to the likelihood that physicians will intervene via unnecessary cesarean deliveries, including EFM's low predictive value and the current "medical-legal" environment that predisposes physicians to "overread" tracings).
(22.) See Sachs, supra note 4, at 31.
(23.) See Thacker, supra note 1, at 17.
(24.) See id.
(25.) See MacDonald, supra note 7, at 659 (noting that proponents of EFM suggested that it would lower the incidence of cerebral palsy and mental retardation by as much as 50%).
(26.) See Thacker, supra note 1, at 17 (noting that new obstetricians had little experience using auscultation).
(27.) See id.
(28.) See id. at 10.
(29.) See id.
(30.) See Fredric D. Frigoletto, Jr. & Allan S. Nadel, Electronic Fetal Heart Rate Monitoring: Why the Dilemma ?, 31 CLINICAL OBSTETRICS & GYNECOLOGY 179, 179 (1988).
(31.) In 1996, 3,184,945 American births--approximately 825.3 per 1000 births--were monitored by EFM. See Stephanie J. Ventura, Joyce A. Martin, Sally C. Curtin & T.J. Matthews, Report of Final Natality Statistics, 1996, in NAT'L CENTER HEALTH STAT. 71 tbl.36 (1998).
(32.) The two primary older methods were intermittent auscultation and the hand-held Doppler probe, a method of detecting fetal heartbeat developed in 1964. See MacDonald, supra note 7, at 659 (discussing the history of various forms of monitoring).
(33.) See, e.g., PETER W. HUBER, GALILEO'S REVENGE 78 (1991) (reviewing the spread of EFM use in the 1970s).
(34.) See Karin B. Nelson, James M. Dambrosia, Tricia Y. Ting & Judith K. Grether, Uncertain Value of Electronic Fetal Monitoring in Predicting Cerebral Palsy, 334 NEW ENG. J. MED. 613, 613 (1996); see also HUBER, supra note 33, at 78 (explaining that EFM became widely used before anyone methodically tested its efficacy, and that although there were "numerous reports" indicating that EFM-monitored fetuses did better than those undergoing auscultation, the reports proved largely anecdotal).
(35.) See generally Robert C. Goodlin & Hanns C. Haesslein, When Is It Fetal Distress?, 128 AM. J. OBSTETRICS & GYNECOLOGY 440 (1977) (analyzing reports calling EFM use into question); see also Albert D. Haverkamp, Does Anyone Need Fetal Monitors?, 1 COMPULSORY HOSPITALIZATION 135, 135-39 (1979) (reviewing the results of two early studies that identified problems stemming from EFM use).
(36.) For a comprehensive discussion of the twelve controlled trials of EFM, see Stephen B. Thacker, Donna F. Stroup & Herbert B. Peterson, Efficacy and Safety of Intrapartum Electronic Fetal Monitoring: An Update, 86 OBSTETRICS & GYNECOLOGY 613, 613-19 (1995).
(37.) Lehman, supra note 2, at 59.
(38.) For a discussion of EFM's link to the rise of cesarean rates in the United States, see notes 59-68 infra and accompanying text; see also Frigoletto & Nadel, supra note 30, at 180 (lamenting that in an effort to avoid the rare but devastating cases of false-negative intervention, the obstetrical profession had interpreted "abnormalities" in fetal heart rate tracings too liberally, and had intervened unnecessarily).
(39.) See Thacker et al., supra note 36, at 614.
(40.) See 1995 ACOG BULL., supra note 8, at 3 (reporting that seven trials compared EFM to intermittent auscultation and found no difference in fetal death rates during birth).
(41.) See 1995 ACOG BULL., supra note 8, at 3. The ACOG study explained that although a trial conducted by A.M. Vintzileos and colleagues, published in 1993, showed a significant decrease in perinatal death associated with fetal asphyxia, the reason for the results' lack of correlation with the results of the other trials was unknown. ACOG concluded that the substantial body of evidence amassed in clinical trials disproves the hypothesis that EFM would reduce fetal morbidity.
(42.) See Thacker et al., supra note 36, at 613-19. Thacker concluded that the only clinically significant benefit from the routine use of EFM was the reduction of neonatal seizures, which was statistically significant in one of the controlled trials. The trial, performed in Dublin, suggested that EFM may reduce the rate of seizures in newborns, but that the reduction does not persist into late childhood. See id. at 619. Follow-up of the thirty-nine Dublin infants with seizures who survived the neonatal period showed no difference in outcomes between the auscultation and EFM groups at one year of age, suggesting that the Dublin study may have used more sensitive diagnostic criteria. See id. at 618.
(43.) See Schifrin, supra note 18, at 134 (concluding that the obstetrical profession has overemphasized the severity of asphyxia in trying to relate obstetrical events to neurological handicap).
(44.) Frigoletto & Nadel, supra note 30, at 179-80.
(45.) See id. at 180 (citing a 1986 epidemiologic study in which the authors concluded that only a minority of cases of cerebral palsy can be attributed to intrapartum events and that a considerable percentage of cerebral palsy cases may be due to prenatal rather than perinatal events).
(46.) See Kirkwood K. Shy, David A. Luthy, Forrest C. Bennett, Michael Whitfield, Eric B. Larson, Gerald van Belle, James P. Hughes, Judith A. Wilson & Morton A. Stenchever, Effects of Electronic Fetal-Heart-Rate Monitoring, as Compared with Periodic Auscultation, on the Neurologic Development of Premature Infants, 322 NEW ENG. J. MED. 588, 590 (1990).
(47.) See id.
(48.) See id. at 592-93.
(49.) Cf. Leslie Iffy & Joseph J. Apuzzio, 323 NEW ENG. J. MED. 345, 345 (1990) (asserting that electronic monitoring is no substitute for the experienced judgment of an obstetrician); see also Michael Shearer, Fetal Heart Monitoring: For Better or For Worse?, 1 COMPULSORY HOSPITALIZATION 121, 127 (1979) (speculating that personal attention of an alert nurse or doctor may be the most important factor in preventing intrapartum fetal death).
(50.) See Barry S. Schifrin & Stephen Myers, 323 NEW ENG. J. MED. 346, 346 (1990).
(51.) See MacDonald, supra note 7, at 660.
(52.) See Karin B. Nelson, What Proportion of Cerebral Palsy is Related to Birth Asphyxia, 112 J. PEDIATRICS 572, 573 (1988).
(53.) In other words, assume here that EFM properly indicated fetal distress, and that clinicians properly and timely "managed" delivery through cesarean or forceps delivery.
(54.) See 1995 ACOG BULL., supra note 8, at 3 (noting that the substantial body of evidence amassed from clinical trials refutes the argument that EFM would reduce neurological injuries in newborn babies, and that EFM has been no more effective in reducing long-term neurological morbidity than auscultation). For a discussion of the most recent study evaluating EFM's efficacy in preventing cerebral palsy, see Nelson et al., supra note 34, at 613-17.
(55.) See Nelson et al., supra note 34, at 617. Note that this figure assumes the view most favorable to EFM: that 20% of cases of cerebral palsy are due to intrapartum events. See id.
(56.) See id.
(57.) See id. at 616. The researchers estimated that among 100,000 singleton (i.e., not twins) children, 9.3% or 9300 would be expected to exhibit signs of distress--multiple late decelerations or decreased beat-to-beat variability. See id. at 617. About 18 of the children would be expected to have cerebral palsy. See id. If asphyxia was one cause of cerebral palsy in 20% of these children, and if there were some intervention that could prevent asphyxia-related cerebral palsy, then approximately four of the original 100,000 infants might benefit. However, physicians would also intervene in 9296 additional deliveries. See id.
(58.) Id. (citation omitted).
(59.) See Sachs, supra note 4, at 31.
(60.) See Nicette Jukelevics, Reducing Cesarean Rates While Improving Maternal and Infant Outcomes, 12 INT'L J. CHILDBIRTH EDUC. 30, 30 (1997).
(61.) See id. (reporting on a national congress convened to raise awareness of the need to reduce cesarean rates).
(62.) See id.
(63.) See Sachs, supra note 4, at 31 (listing reasons why the widespread use of EFM has contributed to an increase in cesarean sections performed).
(64.) See notes 69-80 infra and accompanying text.
(65.) See Sachs, supra note 4, at 31 (arguing that the current medical-legal environment accounts for clinicians' tendency to "overread" tracings, which leads to more cesarean deliveries).
(66.) See id. (ascribing the higher incidence of dystocia among women who are monitored by EFM to the fact that such women are unable to walk during labor, which renders them less able to tolerate labor and leads them to require more sedation).
(67.) See id. (explaining that "fetal monitoring by itself will increase the rate of intervention").
(68.) Cf. Charles S. Mahan, Roundtable Discussion: Should the Electronic Fetal Heart Monitor Always Be Used for Women in Labor Who Are Having a Vaginal Birth After a Previous Cesarean Section, 19 BIRTH 34, 34 (1992). Mahan recommends auscultation rather than EFM even for women who have had a previous cesarean section. He notes that "unnecessary" EFM monitoring may not only increase costs but may decrease the success of a woman's "trial of labor" (attempt at nonoperative delivery by woman who previously has had a cesarean delivery) by confining her to bed, "thereby losing the labor-enhancing effects of mobility." Id. at 35.
(69.) Lehman, supra note 2, at 61 (quoting Dr. Fredric D. Frigoletto, Jr.).
(71.) Interview with Dr. Judith Levinson, M.D., attending physician, Santa Clara Valley Medical Center, San Jose, CA (Dec. 17, 1996).
(73.) See notes 18-22 supra and accompanying text.
(74.) See id.
(75.) See Alan B. Cohen, Henry Klapholz & Mark S. Thompson, Electronic Fetal Monitoring and Clinical Practice: A Survey of Obstetric Opinion, 2 MED. DECISION MAKING 79, 83-84 (1982) (noting an average agreement rate of 68%, resulting from very sharp disagreement in some areas and "near-perfect" or perfect agreement in other areas).
(76.) See Mark Helfand, Keith Marton & Kent Ueland, Factors Involved in the Interpretation of Fetal Monitor Tracings, 151 AM. J. OBSTETRICS & GYNECOLOGY 737,740 (1985).
(77.) Frigoletto & Nadel, supra note 30, at 180.
(78.) See notes 40 & 54 supra and accompanying text.
(79.) See Shy et al., supra note 46, at 588.
(80.) Researchers of randomized controlled trials comparing EFM and auscultation consistently reported that while there was no measurable difference between the techniques in terms of fetal mortality and morbidity, cesarean sections were performed with far significantly greater frequency in the EFM group. See Thacker et al., supra note 36, at 618.
(81.) See Robin Elise Weiss, Monitoring FAQ (visited Dec. 2, 1996) <http://www.childbirth.org/articles/efmfaq.html>.
(82.) Shearer, supra note 49, at 127.
(83.) See Gilfix, supra note 6, at 69 (noting that reliance on electronic equipment instead of human monitoring may lead to greater risk of injury or death).
(84.) See G. Eric Knox, Samuel Hohman & Emanuel Gaziano, Obstetrical Clinical Risk Modification: Are Medical Malpractice Lawsuits Inevitable?, FORUM, May 1994, at 6-7.
(85.) See Marva West Tan & Anne Feierstein, Ob/Gyn Claims: Analysis and Advice, FORUM, May 1994, at 1, 5 (stating that a strong relationship with patients may be a physician's best protection against liability).
(86.) See JAMES E. SCHUTTE, PREVENTING MEDICAL MALPRACTICE SUITS: A HANDBOOK FOR DOCTORS AND THOSE WHO WORK FOR THEM 7 (1995) (emphasizing communication with and personal attention to patients as two important ways to minimize lawsuit risk).
(87.) See Albert D. Haverkamp, Miriam Orleans, Sharon Langendoerfer, John McFee, James Murphy & Horace E. Thompson, A Controlled Trial of the Differential Effects of Intrapartum Fetal Monitoring, 134 AM. J. OBSTETRICS & GYNECOLOGY 399, 407 (1979) (noting the weakness of the proponents' argument that EFM is less costly than auscultation).
(88.) For a thorough discussion of factors affecting the cost of EFM as compared to auscultation, see Gilfix, supra note 6, at 66-69.
(89.) William A. Check, Electronic Fetal Monitoring: How Necessary?, 241 JAMA 1772, 1774 (1979) (quoting the conclusions of a National Institutes of Health task force).
(90.) A "basic" intrapartum monitor, without accoutrements, is $10,755. Telephone interview with Deb Fogg, Sales Support Division, Space Labs (Mar. 5, 1999). An intrapartum monitor with accoutrements ranges in price from $12,000 to $15,600. Telephone interview with Pat Graf, Customer Service Service Division, Corometrics (Mar. 5, 1999).
(91.) See H. David Banta & Stephen B. Thacker, The Case for Reassessment of Health Care Technology: Once is Not Enough, 264 JAMA 235, 238 (1990).
(92.) See id.
(93.) See Sachs, supra note 4, at 36.
(94.) Surveys demonstrate that even experts struggle to interpret EFM readings and disagree widely with regard to their significance. See notes 75-77 supra and accompanying text.
(95.) Telephone interview with ACOG representative (Dec. 2, 1996); see also Banta & Thacker, supra note 91, at 238 (noting that despite technology reassessment of EFM by the National Institutes of Health and ACOG's endorsement of auscultation following EFM's failure in randomized controlled trials, the "practice apparently goes on with little modification").
(96.) See, e.g., Emanuel A. Friedman, The Obstetrician's Dilemma: How Much Fetal Monitoring and Cesarean Section is Enough?, 315 NEW ENG. J. MED. 641, 641 (1986) (citing the legal system and consumer groups as "buffeting forces" that today's obstetricians are expected to endure and suggesting that the demand for the "perfect product every time" may compel both the use of EFM and cesarean delivery).
(97.) See notes 40, 54-57 supra and accompanying text.
(98.) Karin B. Nelson & Judith K. Grether, 335 NEW ENG. J. MED. 287, 287-88 (1996) (responding to Dr. Jay A. Gold's letter questioning why the authors did not endorse the abandonment of EFM or at least adopt a stronger position against EFM following their dramatic study).
(99.) See notes 141-148 infra and accompanying text.
(100.) See Otis R. Bowen, Keynote Address, in 2 MEDICAL PROFESSIONAL LIABILITY, supra note 1, at 1.
(101.) See BRIAN SHENKER, TRENDS IN HEALTH CARE PROVIDER LIABILITY II 32 tbl. (1994).
(102.) See id. at 64.
(103.) See Tan and Feierstein, supra note 85, at 1.
(104.) See id.
(105.) See SHENKER, supra note 101, at 14.
(106.) See id. at 64; Thacker, supra note 1, at 23 (citing a 1987 ACOG study reporting that brain damage to the infant was 31% more likely to be the primary allegation in obstetrical malpractice claims than in any other malpractice claims).
(107.) See Tan & Feierstein, supra note 85, at 2
(108.) See id. at 2.
(109.) Between 1975 and 1985, the number of claims per 100 physicians more than doubled, while between 1976 and 1981, the number of claims against obstetricians and gynecologists tripled. See Peter B. Jacobson, Medical Malpractice and the Tort System, 262 JAMA 3320, 3321 (1989); see also Stephen Daniels & Loft Andrews, The Shadow of the Law: Jury Decisions in Obstetrics and Gynecology Cases, in 2 MEDICAL AND PROFESSIONAL LIABILITY 161, 161-64 (1990) (noting that patients have come to demand perfect results).
(110.) See Daniels & Andrews, supra note 109, at 162 (arguing that many physicians perceive jury verdicts to be irrational).
(111.) Medical Liability and Malpractice: Hearings on S. 1804 Before the Senate Comm. on Labor and Human Resources, 99th Cong. (1986) (statement of Otis R. Bowen, Secretary of Health and Human Services), reprinted in 257 JAMA 816, 818 (1987); see also Kirk B. Johnson, Beyond Tort Reform, 257 JAMA 827, 827-28 (1987) (describing the increased costs and inefficiencies of the medical malpractice system).
(112.) See Tan & Feierstein, supra note 85, at 1 (reporting that ob/gyn defendants do well in court, prevailing in 20 of 29 trials examined by the Risk Management Foundation between 1980 and 1993); see also notes 101-103 supra and accompanying text.
(113.) Interview with Dr. Judith Levinson, supra note 71.
(115.) See W. PROSSER, HANDBOOK OF THE LAW OF TORTS [sections] 32, at 161-63 (4th ed. 1971); see also W. PAGE KEETON, DAN B. DOBBS, ROBERT F. KEETON & DAVID G. OWEN, PROSSER AND KEETON ON THE LAW OF TORTS [sections] 32, at 189, 195 (5th ed. 1984).
(116.) FOWLER V. HARPER, FLEMING JAMES, JR. & OSCAR S. GRAY, THE LAW OF TORTS [sections] 17.3, at 583 n.6 (2d ed. 1956); see also KEETON ET AL., supra note 115, [sections] 32, at 189 ("The standard of conduct becomes one of `good medical practice,' which is to say, what is customary and usual in the profession.").
(117.) Patricia Danzon argues that rigid adherence to customary practice rules may imperil the practice of medicine because it tends to legally formalize consumer misperceptions and "the distortions induced by health insurance," which she thinks could lead to the threat of malpractice liability for the exercise of more cost-effective medicine. See PATRICIA M. DANZON, MEDICAL MALPRACTICE: THEORY, EVIDENCE, AND PUBLIC POLICY 149 (1985). Accordingly, Danzon argues that courts should "retain the right to override custom in specific cases in favor of a reasonable-man test or an explicit cost-benefit calculus." Id. Harper counters that the great discretion granted to the medical profession under the customary practice rule protects against such a result. Accordingly, Harper reaches a conclusion exactly opposite that of Danzon, theorizing that the standard of custom will protect the cost-efficient practitioner who can establish that his decision conforms with the views of a respectable minority of other practitioners "and is likely to do so more reliably than any test that permits either courts or juries to second-guess professional standards." HARPER ET AL., supra note 116, [sections] 17.3, at 120-21 n.6 (5th ed. Supp. 1994).
(118.) KEETON ET AL., supra note 115, [sections] 32, at 189. Keeton states that such deference is "closely tied in with the layman's ignorance of medical matters and the necessity of expert testimony, since, when juries are considered competent to do so, they are permitted to find that a practice generally followed by the medical profession is negligent." Id.
(119.) See HARPER ET AL., supra note 116, [sections] 17.3, at 583 n.6.
(120.) Specifically, concern centers on the administration of unnecessary procedures and the retardation of medical progress, including the development and use of new procedures, pharmaceuticals, and medical devices.
(121.) See KEETON ET AL., supra note 115, [sections] 32, at 187.
(122.) See, e.g., Sprowl v. Ward, 441 So. 2d 898,900 (Ala. 1983) (affirming jury's decision not to find malpractice in situation where dentist used skill and judgment to choose one recognized course of treatment over another).
(123.) Downer v. Veilleux, 322 A.2d 82, 87 (Me. 1974); see also Roberts v. Tardif, 417 A.2d 444, 44849 (Me. 1980) (applying the respectable minority rule to hold that "a doctor is not liable for injury to a patient when he pursues one of several acceptable courses of treatment meeting the applicable standard of care in the circumstances, even though an alternative procedure also meeting that standard might have avoided the injury").
(124.) 505 F.2d 489 (6th Cir. 1974).
(125.) Id. at 492.
(126.) For examples of the application of the "considerable number" standard, see Fritz v. Parke Davis and Co., 152 N.W.2d 129, 131 (Minn. 1967) (holding that there is no negligence where a considerable number of physicians in the community used the disputed treatment); Gresham v. Ford, 241 S.W.2d 408, 410-11 (Tenn. 1951) (holding that there is no negligence where experts might have chosen a different treatment, but doctor still used a treatment followed by many others in the community).
(127.) For examples of the application of the "reasonable physicians disagree" standard, see Rickett v. Hayes, 511 S.W.2d 187, 194 (Ark. 1974) (acknowledging the divergence of opinion between oral surgeons and plastic surgeons as to proper treatment for a fractured jaw); Haase v. Garfinkel, 418 S.W.2d 108, 114 (Mo. 1967) (holding that there is no negligence where there is "an honest difference of opinion" among physicians); Graham v. Alcoa S.S. Co., 201 F.2d 423, 426 (3d Cir. 1953), cert. denied, 346 U.S. 832 (1953) (acknowledging the divergence of opinion as to proper course of treatment for hernia).
(128.) 282 A.2d 206 (Pa. 1971).
(129.) See id. at 212-18.
(130.) See id.
(131.) 88 A.D.2d 217 (N.Y. 1982).
(132.) See id. at 223; see also Toth v. Community Hospital, 239 N.E.2d 368, 373 (N.Y. 1968) (ruling that physicians may be liable for failure to apply "best judgment" where they have particular knowledge of the risks associated with a customary practice, but nonetheless employ the practice in treating a patient).
(133.) See DANZON, supra note 117, at 149-50 (discussing the ability of customary practice to increase social costs, specifically costs to the consumer).
(134.) See HARPER ET AL., supra note 116, at 163 (citing Kalsbeck v. Westview Clinic, 375 N.W.2d 861 (Minn. 1985) and Brown v. Dahl, 705 P.2d 781 (Wash. 1985) as examples of courts' application of the "reasonably prudent practitioner" standard).
(135.) See KEETON ET AL., supra note 115, [sections] 32, at 195.
(136.) 519 P.2d 981 (Wash. 1974) (en banc).
(137.) See id. at 983.
(138.) See id.
(139.) 595 P.2d 919 (Wash. 1979) (en banc).
(140.) See id. at 924. Rejecting an argument that a statute passed after Helling had overruled the case, the court determined that the Washington state legislature had intended to establish a "reasonable prudence" standard of care by statute. Thus, the court found that Helling was still good law because the statute provided that a physician must "exercise the skill, care, and learning possessed by others in the same profession," not simply practiced by others in the same profession. See id. (emphasis added); see also Harris v. Groth, 663 P.2d 113, 118 (Wash. 1983) (holding that the plaintiff was entitled to a reasonable prudence instruction setting forth her theory that the defendant physician should have performed a pressure test for glaucoma). In Harris, the Washington Supreme Court once again affirmed its conclusion that the state legislature had intended to adopt a reasonable prudence standard of care. See id.
(141.) See Thacker et al., supra note 36, at 618.
(142.) See note 57 supra and accompanying text.
(143.) See notes 59-62 supra and accompanying text.
(144.) For a sample of the professional debate, see the letters to the editor in Electronic Fetal Monitoring in Predicting Cerebral Palsy, 335 NEW ENG. J. MED. 287, 287-88 (1996). See also generally Banta & Thacker, supra note 91.
(145.) Cf. Toth v. Community Hosp., 239 N.E.2d 368, 373 (N.Y. 1968) (ruling that a pediatrician could be held liable for administering oxygen to a premature infant, even if this was a customary practice, if she was aware of the fact that such treatment entailed risk of injury).
(146.) Cf. Burton v. Brooklyn Doctors Hosp., 88 A.D.2d 217, 223 (N.Y. 1982) (finding that a doctor charged with malpractice for administering oxygen to an infant cannot use the defense of acceptable medical practice when a number of studies, including his own, have found the procedure unnecessary and dangerous).
(147.) See Helling v. Carey, 519 P.2d 981, 983 (Wash. 1974) (establishing this standard).
(148.) See MacDonald, supra note 7, at 659.
(149.) See James S. Holzer, Linda Paulson & Elizabeth A. Bowyer, Fetal Monitoring and Documentation Problems Associated with the Most Serious OB Claims, FORUM, Sept.-Oct. 1986, at 3 (discussing the results of the Harvard study).
(150.) The foundation reported that claims that alleged failure to identify and appropriately treat fetal distress accounted for 28% of the obstetrical files reviewed but represented 64.5% of the total losses within the specialty. See id.
(151.) See id.
(152.) See Thacker, supra note 1, at 23.
(153.) Telephone interview with ACOG representative, supra note 95.
(154.) See Thacker, supra note 1, at 23; Telephone interview with ACOG representative, supra note 95.
(155.) HUBER, supra note 33, at 78-79.
(156.) Id. at 79.
(157.) Although neither the ACOG study nor the Harvard study specifically examined the link between EFM, plaintiff success, and settlement rates, the link can be seen in the correlation among a number of factors: the consistently high percentage of allegations involving EFM since its diffusion, the significantly greater number of obstetrical malpractice claims brought since EFM's advent, the predominance of claims involving allegations of brain damage sustained during delivery since EFM's diffusion, the increased plaintiff recovery and settlement rates in obstetrical malpractice suits since the advent of EFM, and the significant increase in the median award in obstetrical claims since the advent of EFM. See generally SHENKER, supra note 101.
(158.) For an example of a plaintiff's use of EFM tracings in a case alleging failure to treat fetal distress where the infant suffered permanent brain damage, see Frigoletto & Nagel, supra note 30, at 181-82 (summarizing a case brought prior to 1988 in which the plaintiff successfully used expert testimony to show that ambiguous fetal heart tracings indicated fetal distress). In this case, the plaintiff's lawyer argued that clinicians either failed to identify or failed to respond promptly to the EFM tracings by intervening during delivery. Frigoletto concludes that "the point remains that subjectivity, frequently influenced by the knowledge of a poor outcome" constitutes the fundamental problematic difference between legal hindsight interpretation of tracings by plaintiffs' lawyers and expert witnesses, and clinicians' medical interpretation of tracings during labor and delivery. See id. at 181. The case was settled on terms favorable to the plaintiff. See also HUBER, supra note 33, at 79-80 (describing a case where plaintiffs alleged that an obstetrician's failure to correctly interpret fetal distress in an EFM tracing resulted in the infant plaintiff's cerebral palsy, and where defendant eventually settled for $2.5 million).
(159.) For examples of typical malpractice allegations involving EFM, see HUBER, supra note 33, at 80 (describing several EFM-related liability "formulas" including clinicians' failure to see clear signs of fetal distress in the tracings, failure to accurately analyze and act upon warning signs indicated by the fetal heart monitor, ignoring fetal distress for a significant time period during labor, failure to accurately read an EFM tracing, and failure to notice that an EFM tracing showed the unborn infant was receiving enough oxygen).
(160.) See Holzer et al., supra note 149, at 3 (reporting that many fetal monitoring claims examined in the Harvard study involved the loss or accidental destruction of the monitoring strips). The authors reported that one malpractice case was settled for $250,000 after a claims investigation revealed that the fetal monitor strips which were critical to the defense had not been preserved at the hospital. See id.
(161.) See Tan and Feierstein, supra note 85, at 1 ("Defense of difficult cerebral palsy claims is aided by current medical research.").
(162.) See id. at 2 (reporting that 43 of the 111 obstetrical claims examined by the Risk Management Foundation between 1980 and 1993 involved cesarean delivery whereas 42 involved vaginal delivery).
(163.) See id. at 3 tb1.
(164.) See text accompanying notes 145-148 supra for a discussion of potential malpractice liability for employing EFM in jurisdictions that apply "best judgment" and ordinary negligence standards of care; see also Thacker, supra note 1, at 22 (cautioning that the use of EFM may not protect physicians against liability in suits brought because of complications arising from cesarean delivery when the use of an acceptable alternative, such as intermittent auscultation, was not likely to have led to cesarean delivery).
(165.) See note 57 supra and accompanying text.
(166.) See notes 59-62 supra and accompanying text.
(167.) See note 98 supra and accompanying text.
(168) See note 5 supra and accompanying text.
Margaret Lent, Associate, Davis Wright Tremaine, Seattle, Washington. J.D., Stanford Law School, 1998. The author would like to thank Professor Hank Greely for his excellent instruction and assistance with this note.
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|Date:||Apr 1, 1999|
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