1 See, e.g., Banta & Thacker, Electronic Monitoring: Is it of Benefit?, 6 Birth & Fam. J. 237 (1979); Huddleston, Perlis & Harris, The Case for Electronic Fetal Monitoring, 25 J. Reprod. Med. 47 (1980); The Case for Electronic Fetal Monitoring, 26 J. Reprod. Med. 85 (1981) (letter to the editor).

2 See Brody, Routine Fetal Monitoring Is Termed Costly and Unsafe, N.Y. Times, Jan. 2, 1979, at C3, col. 1; Randal, Is Fetal Monitoring Safe? Widely Used Technique Needs More Testing, Wash. Post, Apr. 16, 1978, at B3, col. 1.

3 Obstetrical Practices in the United Stales: Hearing Before the Subcomm. on Health and Scientific Research of the Comm. on Human Resources, 95th Cong., 2d Sess. 226 (1978).

4 See J.T. Curran, Fetal Heart Monitoring (1975); see also Banta & Thacker, Assessing the Costs and Benefits of Electronic Fetal Monitoring, 14 Obstetrics & Gynecology Survey 627 (Supp. 1979); Goodlin, & Haesslein, , When is it Fetal Distress?, 128 Am. J. Obstet. & Gynecol. 440 (1977)CrossRefGoogle Scholar; Haverkamp, & Orleans, , An Assessment of Electronic Fetal Monitoring, 7 Women & Health 115 (1982)CrossRefGoogle Scholar; Hellegers, , Fetal Monitoring and Neonatal Death Rates, 299 New Eng. J. Med. 357 (1978)CrossRefGoogle Scholar.

5 See Paul & Hon,A Clinical Fetal Monitoring, 35 Obstetrics & Gynecology 161 (1970)Google Scholar.

6 See Banta & Thacker, supra note 4 (a 1976 survey reported that 278 of 279 obstetrics programs with residencies in obstetrics had EFM); see also Dilts, , Current Practices in Antipartum and Intrapartum Fetal Monitoring, 126 Am. J. Obstet. & Gynecol. 491 (1976)CrossRefGoogle Scholar.

7 See Banta & Thacker, supra note 4. The author strongly recommends a careful reading of this review.

8 See, e.g., Haverkamp, , Does Anyone Need Fetal Monitors?, 1 Compulsory Hospitalization 111 (1979)Google Scholar; Obstetric & Gynecological News, July 1, 1977, at 1 (scientific proof of fetal monitoring still lacking, but courts may dictate its use).

9 Banta & Thacker, supra note 4, at 627 (citing Quilligan, Summary of Fetal Monitoring Conference, 10 Int'l J. Gynecol. & Obstet. 163, 163-65 (1972)); see also Shearer, , Fetal Monitoring: For Better or Worse?, 1 Compulsory Hospitalization 99 (1979)Google Scholar.

10 External monitoring employs an ultrasound transducer to pick up the fetal heart rate and a tocodynamonometer to indicate frequency and duration of uterine contraction.

11 Internal monitoring employs electrodes attached directly to the presenting part of the fetus to monitor the fetal heart rate and a uterine catheter to monitor uterine contractions.

12 L.A. Cibils, Electronic Fetal-Maternal Monitoring 478 (1981); see also Haverkamp & Orleans, supra note 4; Shearer, supra note 9.

13 Banta & Thacker, supra note 4, at 627.

14 Id. at 627 (citing Edington, , Sibanda, & Beard, , Influence on Clinical Practice of Routine Intrapartum Fetal Monitoring, 3 Brit. Med. J. 341 (1975)Google Scholar) (a sample of blood is taken from the baby's scalp and analyzed for acid-base parameters, pH being the most widely accepted measure of fetal well-being). “This process is thought to be a necessary adjunct to EFM to reduce the overdiagnosis of fetal distress. The technique is difficult, awkward, uncomfortable for women, and technically difficult even with considerable experience.” Haverkamp & Orleans, supra note 4, at 119.

15 Some advocates of EFM have assumed that its use would decrease the incidence of Caesarean delivery for high-risk women. For a more detailed explanation of EFM, see, e.g., L.A. Cibils, supra note 12; Pillay, , Chik, , Sokol, & Zador, , Fetal Monitoring: A Guide to Understanding the Equipment, 22 Clinical Obstetrics & Gynecology 571 (1979)CrossRefGoogle Scholar [hereinafter cited as Pillay]; Sokol, , Stojkov, & Chik, , Maternal-Fetal Risk Assessment: A Clinical Guide to Monitoring, 22 Clinical Obstetrics & Gynecology 547 (1979)CrossRefGoogle Scholar; Young, , How to Read Fetal Monitoring Records, 44 Progress Clinical & Biological Research 133 (1980)Google Scholar.

16 A hand-held Doppler device, magnifying the fetal heart tones so that they are audible, can also be used. These techniques require personal attendance to the laboring woman and counting by the observer-attendant. See Haverkamp Sc Orleans, supra note 4.

17 Perinatal mortality decreased from 32.5 per thousand in 1950 to 20.1 in 1973 to 11.3 in 1979. See Haverkamp, & Orleans, supra note 4 at 122; see also Amato, , Fetal Monitoring in a Community Hospital, 50 Obstetrics & Gynecology 269 (1977)Google Scholar; Beard, , Edington, & Sibanda, , The Effects of Routine Intrapartum Monitoring on Clinical Practice, 3 Contributions to Gynecology & Obstetrics 14 (1977)CrossRefGoogle Scholar; Edington, , Sibanda, & Beard, , Influence on Clinical Practice of Routine Intrapartum Fetal Monitoring, 3 Brit. Med. J. 341 (1975)Google Scholar; Gabert, & Stenchever, , Electronic Fetal Monitoring as a Routine Practice in an Obstetric Service: A Progress Report, 118 Am. J. Obstet. & Gynecol. 534 (1974)CrossRefGoogle Scholar; Hedfond, , Walker, & Wade, , Do We Need Fetal Monitoring in a Community Hospital?, 43 Trans. Pac. Coast Obstet. & Gynecol. Soc. 25 (1976)Google Scholar; Huddleston, Perlis & Harris, 77ie Case for Electronic Fetal Monitoring, 25 J. Reprod. Med. 47 (1980)Google Scholar; Hughey, , Lapata, , McElin, & Lussky, , The Effect of Fetal Monitoring on the Incidence of Caesarean Section, 49 Obstetrics & Gynecology 513 (1977)Google Scholar [hereinafter cited as Hughey & Lapata]; Lee, & Baggish, , The Effect of Unselected Intrapartum Fetal Monitoring, 47 Obstetrics & Gynecology 516 (1976)Google Scholar; Mueller-Heuback, , MacDonald, , Joret, , Portman, , Edelstone, & Caritis, , Effects of Electronic Fetal Heart Rate Monitoring on Perinatal Outcome and Obstetric Practices, 137 Am. J. Obstet. & Gynecol. 758 (1980)CrossRefGoogle Scholar; Paul, , Gauthier, & Quilligan, , Clinical Fetal Monitoring, the Usage and Relationship to Trends in Caesarean Delivery and Perinatal Mortality, 59 Acta Obstetrica Et Gynocologica Scandinavica 289 (1980)CrossRefGoogle Scholar; Paul, , Huey, & Yeager, , Clinical Fetal Monitoring, Its Effect on Caesearean Section Rate and Perinatal Mortality: Five Year Trends, 61 Postgrad. Med. 160 (1977)CrossRefGoogle Scholar (describing perinatal mortality rates at around 50 per 1000 until 1969 when EFM was introduced, and a progressive fall to 21 per 1000 in 1974); Shenker, , Post, & Seiler, , Routine Electronic Monitoring of Fetal Heart Rate and Uterine Activity During Labor, 46 Obstetrics & Gynecology 185 (1975)Google Scholar; Tejani, , Mann, , Bhakthavathsalan, & Weiss, , Correlation of Fetal Heart Rate—Uterine Contraction Patterns With Fetal Scalp BloodpH, 46 Obstetrics & Gynecology 392 (1975)Google Scholar.

18 Methodological deficiencies include poorly matched or totally missing controls, and controls that were historical. The inclusion of antepartum stillbirths, infants with lethal malformations and infants of extremely low birth weight was not recognized as confounding either the allocation to EFM or the interpretation of “lives saved” by the procedure. See, e.g., Wood, , Renou, , Oats, , Farrell, , Beischer, & Anderson, , A Controlled Trial of Fetal Heart Rate Monitoring in a Low-Risk Obstetric Population, 141 Am. J. Obstet. & Gynecol. 527 (1981)CrossRefGoogle Scholar [hereinafter cited as Wood & Renou].

19 Declining infant and perinatal morbidity and mortality are cited as causal outcomes of the use of EFM and Caesarean section. However, Marieskind points out that although “[fjetal and neonatal rates are those most subject to change through Caesarean section, EFM, and … neonatal intensive care units … they would not seem to be declining at a pace comparable with the increase in Caesarean sections.” Marieskind, , Caesarean Section, 7 Women & Health 179, 189 (1982)Google Scholar. She adds that one community hospital, for example, noted in a 38 year review that its perinatal mortality rate had its major drop two years before a rapid increase in Caesareans and the introduction of EFM. Id. at 190 (citing Haddad, & Lundy, , Changing Indications for Caesarean Sections: A 38-Year Experience at a Community Hospital, 51 Obstetrics & Gynecology 133 (1978)Google Scholar).

20 See infra note 24.

21 See J. Wennberg, Presentation at the 25th Annual National Health Forum, New York (Mar. 23, 1977) (unpublished manuscript available from the author at Dartmouth Medical School Hanover, NH).

22 See R. Lubic, Fetal Electronic Monitoring v. Home Delivery, Presentation at the 25th Annual National Health Forum 15 (Mar. 23, 1977) (unpublished manuscript available from the author at the Maternity Center Ass'n, 48 East 92nd Street, New York, New York 10028). In addition, Banta & Thacker, supra note 4, note the concurrent increased availability of family planning practices such as the use of contraception and abortion, as well as better nutrition, better prenatal and obstetrical care, and increased patient education. These have led to fewer births and lower incidence of high risk factors such as multiparity, very young and very old pregnant women, and birth weights under 2500 grams. These authors further note obstetric practices such as amniocentesis and improved methods of resuscitation as factors in the improved mortality rates. Id. at 633. See also Chard, The Fetus at Risk, 1974 Lancet II 880; Goodlin & HaessIein.jM/ra note 4; Hughey & Lapata,supra note 17; Pakter, & Nelson, , Factors in the Unprecedented Decline in Infant Mortality in New York City, 50 Bull. N.Y. Acad. Med. 839 (1974)Google Scholar.

23 Doubt is also cast on the conclusions of these before-and-after reports because the study group populations were not comparable, nor was the quality of obstetric care explicitly described. In addition, it should be noted that data usually cited to show that EFM prevents death comes primarily from those institutions involved in the development of EFM testing. See Chalmers, , ZIosnik, , Johns, & Campbell, , Obstetric Practice and Outcome of Pregnancy in Cardiff Residents, 1965-1973, 1 Brit. Med. J. 735 (1976)CrossRefGoogle Scholar, in which the introduction of active management of labor and fetal monitoring did not lower the perinatal mortality rate nor reduce asphyxiation deaths. Also, in Dublin, there was a low death rate with a very low rate of monitoring. O'Drisco, , Coughlan, , Fenton, & Skelly, , Active Management of Labour: Care of the Fetus, 2 Brit. Med. J. 1415 (1977)Google Scholar.

24 Perinatal mortality is, of course, subject to numerous influences. During the time EFM was initiated and became widespread, perinatal mortality was also affected by myriad factors: use of contraceptives, better nutrition and patient education, better prenatal care, genetic counseling (which shifted some of what would have been perinatal deaths to abortion), and other changes in obstetrical practice. Haverkamp & Orleans, supra note 4, at 122. In addition, abortion increases have been demonstrated to affect perinatal mortality. Morris, , Udry, & Chase, , Shifting Age-Parity Distribution of Births and the Decrease in Infant Mortality, 65 Am. J. Pub. Health 359 (1975)CrossRefGoogle Scholar. All these factors, as well as less easily documented changes, such as shifts in socieconomic status, affect perinatal death rates.

Banta and Thacker suggest that EFM may have played some indirect and inadvertant part in reducing infant mortality. Given the newness of the EFM procedure, and physicians’ desires to make sure it was functioning properly, physicians using EFM undoubtedly paid greater attention during labor and delivery. The greater care exercised by the physicians in turn provided greater protection for pregnant women and reduced infant mortality during this era. See Banta & Thacker, supra note 4, at 632. In addition, the period is the most critical with regard to mortality occurrence. It could be that improved neonatal care by neonatologists has been most responsible for reducing neonatal death. Haverkamp & Orleans, supra note 4, at 122.

25 The advantages of controlled over retrospective trials include the following: (1) the increased likelihood of the monitored and control groups being similar; (2) the avoidance of other changes in obstetric care that would bias the results; and (3) the reduced risk of the staff biasing the results.

26 See Haverkamp, , Orleans, , Langendoerfer, , McFee, , Murphy, & Thompson, , A Controlled Trial of the Differential Effects of Intrapartum Fetal Monitoring, 134 Am. J. Obstet. & Gynecol. 399 (1979)CrossRefGoogle Scholar [hereinafter cited as Haverkamp, Orleans & Langendoerfer]; Haverkamp, , Thompson, , McFee, & Cetrulo, , The Evaluation of Continuous Fetal Heart Rate Monitoring in High-risk Pregnancy, 125 Am. J. Obstet. & Gynecol. 310 (1975)CrossRefGoogle Scholar [hereinafter cited as Haverkamp & Thompson]; Kelso, , Parsons, , Lawrence, , Arora, , Edmonds, & Cooke, , An Assessment of Continuous Fetal Heart Rate Monitoring in Labor, 131 Am. J. Obstet. & Gynecol. 526 (1978)CrossRefGoogle Scholar [hereinafter cited as Kelso, Parsons & Lawrence]; Renou, , Chang, , Anderson, & Wood, , Controlled Trial of Fetal Intensive Care, 126 Am. J. Obstet. & Gynecol. 470 (1976)CrossRefGoogle Scholar [hereinafter cited as Renou, Chang & Anderson]. Dr. Helen Marieskind, an author of an Hew sponsored research project, U.S. DEP't of Health, Education and Welfare, an Evaluation of Caesarean Section in the United States (1979) [hereinafter cited as U.S. Dep't of Health, Education and Welfare], noted that she had reviewed over 400 technical articles on EFM and only four of these were based on valid scientific modalities. See also Shearer, supra note 9; Wood & Renou, supra note 18.

27 See generally Haverkamp & Thompson, supra note 26.

28 See generally Haverkamp, Orleans & Langendoerfer, supra note 26.

29 Langendoerfer, , Haverkamp, , Murphy, , Nowick, , Orleans, , Pacosa, & Doorninck, , Pediatric Follow-up of a Randomized Controlled Trial of Intrapartum Fetal Monitoring Techniques, 97 J. Pediatrics 103 (1980)CrossRefGoogle Scholar (noting that no significant differences among the three groups were revealed as assessed by physical examination using Bayley Scales of Infant Development and Milani-Comparetti tests).

30 Kelso, Parsons & Lawrence, supra note 26.

31 Renou, Chang & Anderson, supra note 26.

32 In the auscultated group, four large-size term infants displayed significant neurological damage, but all four had experienced traumatic second stages during labor and were delivered with midforceps. Thus, it is possible that trauma rather than means of fetal surveillance was the causal factor. Haverkamp & Orleans, supra note 4, at 126.

33 See supra note 26.

34 Infant outcome was measured by a variety of methods, including Apgar scores, infant deaths, neurological examination of the baby, and course of delivery and aftercare. See generally Haverkamp, Orleans & Langendoerfer, supra note 26.

35 See Wood & Renou, supra note 18.

Id. at 532 (citations omitted). In addition, see Thompson, , Decision-analytic Determination of Study Size, The Case of Electronic Fetal Monitoring, 1 Med. Decision Making 165 (1981)CrossRefGoogle Scholar, in which the author estimates that two randomly assigned groups of 180,000 births each should be studied. This would achieve net expected societal benefits estimated at $118 million at a cost of about $22 million.

As Haverkamp and Orleans point out, “[t]he very size of the required groups casts doubt on the need for universal use of EFM, since obviously very low incidence problems are involved. Furthermore, the possible adverse effects resulting from the use of EFM would also warrant careful consideration.” Haverkamp 8c Orleans, supra note 4, at 121.

36 In addition to the Denver studies and the Kelso study above, see Banta & Thacker, supra note 4 and citations therein. Neutra applied multivariate analysis to data from a group of 15,846 live-born infants delivered in a large hospital over a seven-year period. The study gave evidence of some benefit of EFM in selected high-risk patients. However, non-EFM patients in the low-risk group had somewhat lower neonatal death rates than did EFM patients in the low-risk group. Neutra, Fienberg, Greenland & Friedman,Effect of Fetal Monitoring on Neonatal Death Rates, 299 New Eng.J. Med. 324, 324(1978) [hereinafter cited as Neutra & Fienberg].

Notably, significant benefits in terms of death averted could only be expected in infants of short gestation, the very group which was least likely to be monitored. Wood & Renou, supra note 18, at 531; see also Ballas, , Hornstein, , Jaffa, & Toaff, , Selective Versus Routine Intrapartum Monitoring: Comparison of Effects on Perinatal Outcome, 59 Acta Obsteticia & Gynocologica Scandinavica 301 (1980)CrossRefGoogle Scholar. “[This] study failed to demonstrate any significant improvement as a result of a four-fold increase in monitoring, either in intrapartum or in early neonatal mortality rates.” Id. at 303. This was a retrospective nonrandomized study which compared perinatal results of 7,604 deliveries in two successive years in which no obstetric department policy changes occurred other than a four-fold increase in electronic intrapartum monitoring. Id. at 301.

Neutra, evaluating the effect of EFM on Apgar scores using techniques of multivariate analysis, found EFM to be of benefit only in the highest risk group (7.4% of all the labors; there were four groups divided according to degree of risk). “Other groups showed a trend that suggested—but did not prove—possible negative effects on the 1-minute Apgar score, which, except in group 2, had largely disappeared by 5 minutes.” Neutra, , The Relationship Between Electronic Fetal Monitoring and Apgar Score, 140 Am. J. Obstet. & Gynecol. 440, 443 (1981)CrossRefGoogle Scholar.

37 There are serious questions about both the assumption that intrapartum anoxia is a cause of motor and intellectual ability and that EFM, by detecting anoxia earlier, can thereby prevent such disability. See Davies, & Stewart, , Low Birth-Weight Infants: Neurological Sequelae and Later Intelligence, 31 Brit. Med. Bull. 85 (1975)CrossRefGoogle Scholar; Goodlin & Haesslein,.si^)ra note 4; Haesslein, & Niswander, , Fetal Distress in Term Pregnancies, 137 Am. J. Obstet. & Gynecol. 245 (1980)CrossRefGoogle Scholar; Low, , Galbraith, , Murikilen, , Karchmar, & Campbell, , Intrapartum Fetal Asphyxia: Preliminary Report in Regard to Long-Term Morbidity, 130 Am. J. Obstet. & Gynecol. 525 (1978)CrossRefGoogle Scholar; Niswander, , Gordon, & Drage, , The Effect of Intrauterine Hypoxia in the Child Surviving to Four Years, 121 Am. J. Obstet. & Gynecol. 892 (1975)CrossRefGoogle Scholar. For a detailed discussion of the evidence regarding brain damage and EFM, see Banta & Thacker, supra note 4, at 634. See also Banta, & Thacker, , Electronic Monitoring: Is It of Benefit?, 6 Brrth & Fam. J. 237 (1979)CrossRefGoogle Scholar; Haverkamp & Orleans, supra note 4.

The only study which correlated abnormal fetal heart rate (FHR) patterns with neurological outcome was conducted by Painter. He found that ominous FHR patterns predicted abnormal neurological performances more accurately than did Apgar scores. However, an analysis of the second Denver trial found no correlation between ominous FHR patterns and abnormal neurological outcomes unless there were other contributing factors. “Many times EFM identifies infants who are already damaged by congenital or prepartum factors. Indeed, EFM may lead to the rescue of infants seriously ill with cerebral palsy or anomalies such as trisomy 18, which result in prolonged hospitalization, ending in inevitable death or lifetime disabilities.” Id. at 126.

38 “The continuous recording of the various pathophysiologic phenomena evolving during labor and delivery implies a number of manipulations and the use of the equipment … that may predispose to complication (physiological or psychological) … .” L.A. Cibils, supra note 12, at 472.

39 “The manipulations involved in setting up ‘direct’ monitoring carry with them the potential for infection; in particular the need to rupture membranes should be recognized as a most important possible drawback of the technique.” Id. at 479; see Hagen, , Maternal Febrile Morbidity Associated with Fetal Monitoring and Ceasarean Section, 46 Obstetrics & Gynecology 260 (1975)Google Scholar; Larsen, , Goldkran, , Hanson, & Miller, , Intrauterine Infection on an Obstetric Service, 43 Obstetrics & Gynecology 838 (1975)Google Scholar; Ledger, , Norman, , Gee, & Lewis, , Bacteremia on an Obstetric Gynecological Service, 121 Am. J. Obstet. & Gynecol. 205 (1975)CrossRefGoogle Scholar. However, Koszalka, Haverkamp, Orleans & Murphy, in The Effects of Internal Electronic Fetal Heart Rate Monitoring on Maternal and Infant Infections in High-Risk Pregnancies, 27 J. Reprod. Med. 661 (1982) [hereinafter cited as Koszalka & Haverkamp], found that although there was a trend toward more infection with invasive EFM (15% v. 8%), this was not significant. Id. at 663. Caesarean section was t he most significant factor associated with increased maternal puerperal infections and morbidity (13.75% Caesarean v. 3.9% vaginal) rather than EFM. Id. at 662. There was, however, a greater antibiotic usage in neonates where internal catheter usage longer than twelve hours and rupture of membranes had occurred. Id. at 663-64. In addition, in this study of 690 high-risk women, there were significantly more Caesarean sections in the EFM group than the auscultated group with no improved infant outcome. Id.

40 U.S. Dep't of Health, Education and Welfare, supra note 26, at 154.

41 Cibils discusses several maternal complications: “Careless manipulation at introducing the internal catheter may produce moderate to severe complications that may or may not be recognized at THE time they occur.” L.A. Cibils, supra note 12, at 472. It is possible to perforate the lower segment by catheter guide with subsequent development of a parauterine abscess requiring drainage. “Unrecognized perforations have been found at the time of Caesarean sections.” Id. He notes that perforations into the broad ligament may occur without bad effects. However,

Id. Further, Cibils points out that

Id. at 474; see also Chan, , Paul, & Toews, , Intrapartum Fetal Monitoring, Maternal and Fetal Morbidity and Perinatal Mortality, 41 Obstetrics & Gynecology 7 (1973)Google Scholar; Tutera, & Newman, , Fetal Monitoring: Its Effect on the Perinatal Mortality and Caeserean Section Rates and its Complications, 122 Am. J. Obstet. & Gynecol. 750 (1975)CrossRefGoogle Scholar. Fernandez also reports that a 7 cm. long fetal scalp electrode was found in the dome of a patient's bladder partly imbedded in its muscularis. Fernandez, Complications of Fetal Scalp Electrodes: A Case Report, 145 Am. J. Obstet. & Gynecol. 891, 891 (1983); see also Siddigi, & Taylor, , Necrotizing Fasciitis of the Scalp: A Complication of Fetal Monitoring, 136 A M. J. Diseases of Children 226 (1982)CrossRefGoogle Scholar.

42 Though Marieskind, in U.S. Dep't of Health, Education and Welfare, supra note 26, at 81, believes that “no one factor can be pinpointed as causing the increase in Caesarean section,” Haverkamp, as well as Banta and Thacker, supra note 4, believe that EFM has a role in the increase of unnecessary Caesarean sections over the last ten years or so. See, e.g., infra notes 46-50.

43 Haverkamp & Thompson, supra note 26, at 312-13.

44 Haverkamp, Orleans & Langendoerfer, supra note 26, at 403.

45 Kelso, Parsons & Lawrence, supra note 26, at 528-29.

46 Banta & Thacker, supra note 4, at 631.

Koszalka & Haverkamp, supra note 39, at 663 (citations omitted). Haverkamp and Orleans note that during the time that EFM was introduced and adopted, the Caesarean section rate increased more than three-fold, from 5% in 1970 to 16.5% in 1980. Haverkamp & Orleans, supra note 4, at 127.

Id. at 127 (citations omitted). The Caesarean section rate statistics

Id. at 128-29.

In addition, there are several studies involving minimally interventive care given to low-risk women in labor without EFM. In a study of 500 consecutive patients cared for in a tertiary hospital by nurse-midwives, without EFM, the Caesarean rate was 2.8%. Each patient was matched against the next normal low-risk laboring woman, cared for by usual hospital procedures, including EFM, and the primary Caesarean section rate rose to 9.2%. Goodlin & Haesslein, supra note 4, at 440-41.

Banta and Thacker also note that “technological factors including EFM were found to be associated with an increased CSR” and that “the increase in CSR reflects an interventionistic trend in obstetrics.” Banta & Thacker, supra note 4, at 631.

Neutra found that in 7132 multiparas with normal presentation, monitoring was associated with a two- to three-fold increase of Caesarean section. However, “[w]hen the effect in all eight subgroups [for study purposes] is summed up, the increases and decreases appear to balance each other out … . The net overall impact of Caesarean sections associated with monitoring is then … 1/362 patients monitored.” Neutra, , Greenland, & Friedman, , Effect of Electronic Fetal Monitoring on Caesarean Section Rates, 55 Obstetrics & Gynecology 175, 177 (1980)Google Scholar. The influence of fetal scalp blood sampling was negligible.

Id. at 177-78. The authors also note that the analysis of their nonexperimental study “has provided results at variance with the results for high-risk labors in the 2 studies by Haverkamp” and they discuss possible explanations for this variance. Id. at 179. One of the most plausible, and one which has widespread significance, is the following: “the EFM used to influence the decision to perform a CS may vary from hospital to hospital, both in the diagnosis of fetal distress, and indirectly with regard to the diagnosis of FPD.” Id.

Banta presented further evidence as a participant in the NICHD Consensus Development Task Force on Predictors of Intrapartum Fetal Distress [hereinafter cited as NICHD Task Force], citing a recent study of 315 California hospitals that had widely varying Caesarean section rates. Monitoring was one of the most powerful predictors of the increased rate in these hospitals. Banta & Thacker, supra note 4, at 631. Another NICHD Task Force member, Dr. Mortimer Rosen, director of obstetrics and gynecology at Cleveland Metroplitan General Hospital, noted that the way the monitor is used may determine its effect on the Caesarean section rate. Check, Electronic Fetal Monitoring: How Necessary?, 241 J. A.M.A. 1772, 1774 (1979)CrossRefGoogle Scholar; see also Bottoms, , Rosen, & Sokal, , Current Concepts: The Increase in the Caesarean Birth Rate, 302 New Eng. J. Med. 559 (1980)CrossRefGoogle Scholar.

47 See, e.g., de la Fuente, , Hernandez-Garcia, , Escalante, & Vsandizaga, , Caesarean Operation: Indications and Maternal and Fetal Mortality, 3 Contributions to Gynecology & Obstetrics 135 (1977)CrossRefGoogle Scholar; Edward, & Gold, , Caesarean Section and Maternal Mortality in Rhode Island, 50 Obstetrics & Gynecology 594 (1977)Google Scholar; Marieskind, supra note 19, at 186; Petitti, , Cefalo, , Shapiro, & Whalley, , In-Hospital Maternal Mortality in the United States: Time Trends and Relations to Methods of Delivery, 59 Obstetrics & Gynecology 6 (1982)Google Scholar (the authors conclude that Caesarean section is probably neither less than two nor more than four times more hazardous than vaginal delivery); see also U.S. Dep't of Health, Education and Welfare, supra note 26; Banta & Thacker, supra note 4.

48 Evrard & Gold, supra note 47, at 595.

49 Banta & Thacker report that:

Banta & Thacker, supra note 4, at 635 (citations omitted).

50 Doering, , Unnecessary Caesareans: Doctor's Choice, Patients Dilemma, 1 Compulsory Hospitauzation 145, 149 (1979)Google Scholar. Other researchers report shock, deep disappointment, feelings of failure, and other negative postpartum emotions. See, e.g., U.S. Dep't of Health, Education and Welfare, supra note 26 (citing Alfonso, & Stickler, , Exploratory Study of Women's Reactions to Having a Caesarean Birth, 5 Birth & Fam. J. 88 (1978)CrossRefGoogle Scholar); Brody, Personal Health, N.Y. Times, Mar. 8, 1978, at CIO, col. 4.

51 Doering, supra note 50, at 149.

52 In addition, see Cohen, Klapholz, Mee 8c Thompson, , Electronic Fetal Monitoring and Clinical Practice: A Survey of Obstetric Opinion, 2 Med. Decision Making 79 (1982)Google Scholar, in which the authors reported on interviews with 12 obstetricians recognized for their scientific and clinical contributions in the use of electronic fetal monitoring. Even among these most highly educated, trained and experienced clinicians there were notable areas of disagreement in the interpretation and response to EFM tracings. For a more detailed discussion of the predictive value of EFM, see Banta & Thacker, supra note 4, at 630.

53 Shearer, supra note 9, at 101.

54 Id. (citing Edington, , Sibanda, & Beard, , Influence on Clinical Practice of Routine Intrapartum Fetal Monitoring, 3 Brit. Med. J. 341 (1975)Google Scholar).

55 Banta & Thacker, supra note 4, at 630. EFM cannot always “distinguish the difference between stress and distress of the fetus. Only 30% to 40% of the time, with ominous fetal heart rate patterns, are the infants actually acidotic. There is a tendency to overcall fetal distress based on a fetal heart rate pattern, which, on review, is not ominous at all.” Haverkamp & Orleans, supra note 4, at 130. In other words, 60%-70% of the infants are normal. Even amcomputerized systems will not now alleviate interpretation problems. See, e.g., Pillay, supra note 15.

Id. at 572. Labor management in practice is based on a very complicated analysis that is difficult to computerize. Id. at 579. Nor is it likely computers will alleviate the problem of false positives in the near future. See, e.g., Chik, , Sokol, , Rosen, , Pillay, & Jarrell, , Trend Analysis of Intrapartum Monitoring Data: A Basis for a Computerized Fetal Monitor, 22 Clinical Obstetrics & Gynecology 665 (1979)CrossRefGoogle Scholar [hereinafter cited as Chik & Sokol].

Id. at 665-66. The authors note at least two problems in the clinical interpretation of fetal monitoring tracings.

Id. at 667 (citations omitted). In addition, patient agitation or movement may cause interference and produce unreliable tracings. Laverson, Hochberg & George, Evolution of the Accuracy of a New Ultrasonic Fetal Heart Rate Monitor, 125 Am.J. Obstet. & Gynecol. 1125, 1128(1977). Maternal and fetal heart rates have been added, producing spurious tachycardia. Tivy-Jones, , Kenney, & deVere, , False Interpretation of Fetal Heart Monitoring, 4 Brit. Med. J. 552, 552 (1973)CrossRefGoogle Scholar.

56 See, e.g., L.A. Cibils,supra note 12, at 478; Haverkamp & Orleans,supra note 4, at 130; James, , The Effect of Pain Relief for Labor and Delivery on the Fetus and Newborn, 21 Anesthesiology. 405 (1960)CrossRefGoogle Scholar; Shearer, supra note 9, at 103; Ueland, & Hansen, , Maternal Cardiovascular Dynamics: Posture and Uterine Contractions, 103 Am. J. Obstet. & Gynecol. 1 (1969)CrossRefGoogle Scholar.

The use of telemetric monitoring may alleviate some of the problems involved; however, amniotomy must still be done, and it is not appropriate for many laboring women. See, e.g., Kelly, Flynn & Hollins, Ambulant Fetal Monitoring, 24(5) Brit. J. Hosp. Med. 449 (1980); lipshitz, , Wade, , Anderson, & Sibic, , Evaluation of Corometrics 315 Telemetry System for Fetal Monitoring, 139 Am. J. Obstet. & Gynecol. 199 (1981)CrossRefGoogle Scholar; MacLennan, & Green, , Fetal Heart Rate Monitoring During Ambulant Labour Using a Modified Adult Radiotelemetry System, 19 Austl. & N.Z. J. Obstet. & Gynecol. 135 (1979)CrossRefGoogle Scholar.

57 See generally Huch, & Huch, , Transcutaneous, Noninvasive Monitoring of P02, 11 (6) Hosp. Prac. 43 (1976)CrossRefGoogle Scholar; Huch, Huch, Schneider & Roth, Continuous Transcutaneous Monitoring of Fetal Oxygen Tension During Labour, 84 Brit. J. Obstet. & Gynecol. (Supp. I 1977) (showing effects on fetus of maternal supine position).

58 Jarzembski, , Benefits, Limitations, Fallacies and Hazards of Electronic Monitoring of the Human Body, 1 Compulsory Hospitalization 117, 120 (1979)Google Scholar.

59 Id. at 120.

60 See, e.g., Banta & Thacker, supra note 4, at 635; Caldeyro-Barcia, Schwarcz, Belzian, Martell, Nieto, Sabatino & Temer, Adverse Perinatal Effects of Early Amniotomy During Labor, in Mod. Perinatal Medicine. 431 (Gluck ed. 1974); Gabbe, , Ettinger, , Freeman, & Martin, , Umbilical Cord Compression Associated With Amniotomy: Laboratory Observations, 126 Am. J. Obstet. & Gynecol. 353 (1976)CrossRefGoogle Scholar [hereinafter cited as Gabbe].

Shearer, supra note 9, at 103.

62 Haverkamp, Orleans & Langendoerfer, supra note 26, at 410.

63 Haverkamp & Orleans, supra note 4, at 130. See also Haverkamp, Orleans & Langendoerfer, supra note 26, at 410-11 (citing Sokol, , Zador, & Rosen, , Slowing of Active Labor Associated with Internal Fetal Monitoring, 124 Am. J. Obstet. & Gynecol. 764 (1976)CrossRefGoogle Scholar). Cibils explains:

L.A. Cibils, supra note 12, at 478.

64 Summarizing the risks of EFM to the fetus, Banta and Thacker note that

Banta & Thacker, supra note 4, at 635. For other reports of complications, see Brook, , Osteomyelitis and Bacteremia Caused by Bacteroides Fragilis: A Complication of Fetal Monitoring, 19 Clinical Pediatrics 639 (1980)CrossRefGoogle Scholar (the writer felt that factors predisposing a monitored infant to scalp abscess are: duration of monitoring [in the reported case, five hours], ruptured membranes, and presence of amnionitis); Hegde, , Infected Cephalhematoma Associated with Placement of Scalp Electrode, 122 Can. Med. Ass'n J. 876 (1980)Google Scholar (involving ten days of antimicrobial therapy); Lauritsen, , Skalpabscesser hos spaedbarn sehundaert til retineret caputekktrodestyhke, 140 Ugeskrift for Laeger 2445 (1978)Google Scholar (Engl. abstr.); Reveri, & Krishnamurthy, , Gonococcal Scalp Abscess, 94 J. Pediatr. 819 (1980)CrossRefGoogle Scholar; Thoulan, & Gonnet, , Les Accidents de I'eUctrocardiographicfoetale directe (a propos d'unefracture de Velectrode de scalp), 7 J. Gynecol. Obstet. Biol. Reprod. 1257 (1978)Google Scholar (Engl. abstr.); Turbeville, & McCaffree, , Fetal Scalp Electrode Complications: Cerebrospinal Fluid Leak, 54 Obstetrics & Gynecology 469 (1979)Google Scholar; see also L.A. Cibils, supra note 12, at 472.

Id. at 472-73 (citations omitted).

Id. at 474-75 (citations omitted).

On the topic of fetal scalp abscesses, Cibils notes that the majority are seen when the infant is about four days old (incubation periods range from two to ten days) and that these are usually superficial. However, osteomyelitis may rarely occur. Id. at 475.

Id. at 475 (citations omitted).

Id. (citations omitted); see also Obstetrical Practices in the U.S.: Hearings Before the Subcomm. on Health and Scientific Research of the Senate Comm. on Human Resources, 95th Cong., 2d Sess. 9-49 (1978) (statement of Donald Kennedy, Comm'r FDA); Cordero, , Anderson, & Zuspan, , Scalp Abscess: A Benign and Infrequent Complication of Fetal Monitoring, 146 Am.J. Obstet. & Gynecol. 126 (1983)CrossRefGoogle Scholar.

65 See generally Gabbe, supra note 60; Hughey & Lapata, supra note 17, at 513; Simkin, , Amniotomy, 7 Women & Health 103 (1982)CrossRefGoogle Scholar.

66 Intact membranes provide some protection from infection in two ways: through the intrinsic opsonic and antimicrobial properties of amniotic fluid and as a barrier to outside sources of infection. Simkin, supra note 65, at 103. When the membranes are ruptured there is a sense of urgency and a time limit for delivery because of the increased risk of likelihood of infection. Intact membranes serve other protective purposes:

Id. at 104 (citation omitted).

In addition, Simkin reports evidence that “[i]n occasional difficult births, the presence of the bag of waters could conceivably afford enough protection to prevent subdural hemorrhage or other cerebral lesions.” Id. at 107.

Another group of investigators found evidence of better uteroplacental circulation in a group in which there was late rupture of membranes, compared with early amniotomy, all in low-risk women. Martell, , Belizan, , Nieto, & Schwarcz, , Blood Acid-Base Balance at Birth in Neonates from Labors with Early and Late Rupture of Membranes, 89 J. Pediatrics 963 (1976)Google Scholar. See Caldeyro-Barcia, , Noriega-Guerra, , Cibils, , Alvarez, , Poseiro, , Pose, , Sica-Blanco, , Mendez-Bauer, , Fielitz, & Gonzalez-Panizza, , Effects of Position Changes on the Intensity and Frequency of Uterine Contractions During Labor, 80 Am. J. Obstet. & Gynecol. 284 (1960)CrossRefGoogle Scholar; Schwarcz, , Althabe, , Belitzsky, , Canchares, , Alvarez, , Berdaguers, , Capurro, , Belizan, , Sabatino, , Abusleme, & Caldeyro-Barcia, , Fetal Heart Rate Patterns in Labors with Intact and With Ruptured Membranes, 1 J. Perinatal Med. 153 (1973)CrossRefGoogle Scholar. Koszalka, Haverkamp and co-workers also warn of a “possible association between scalp puncture and the later development of infant meningitis.” Koszalka & Haverkamp, supra note 39, at 664.

67 U.S. Dep't of Health, Education and Welfare, supra note 18 (citing Report, Supine Called the Worst Position for Labor and Delivery, 5 Fam. Prac. News 11 (1975)Google Scholar).

68 Shearer, supra note 9, at 103.

69 See, e.g., Timor-Tritsch, , Gergely, , Abramovici, & Brandes, , Misleading Information From Fetal Monitoring in a Case of Intrapartum Fetal Death, 43 Obstetrics & Gynecology 713 (1974)Google Scholar; see also Low, , Cox, , Karchmar, , McGrath, , Pancham, & Piercy, , The Prediction of Intrapartum Fetal Metabolic Acidosis by Fetal Heart Rate Monitoring, 139 Am. J. Obstet. & Gynecol. 299 (1981)CrossRefGoogle Scholar [hereinafter cited as Low]. The authors state that at some stage, the fetus in all at-risk pregnancies should have an acid base assessment “in view of the 17% of high risk patients in whom the fetus exhibits evidence of a significant metabolic acidosis with no preceding fetal heart rate decelerations.” Low, supra, at 304. In Haesslein & Niswander, supra note 37, ten infants had a low Apgar score, but with no evidence of fetal distress on electronic fetal monitoring and with no evidence of delivery-induced asphyxia. The authors of this study also found that:

Id. at 248.

70 See supra notes 43-46 and accompanying text.

71 For a detailed discussion of these risks, see Banta & Thacker, supra note 4, at 635. These risks center on Respiratory Distress Syndrome (RDS) and hyaline membrane disease. Although, as is the case for Caesarean delivered infants who were electronically monitored, labor decreases the risk of RDS, it does not entirely eliminate such risk associated with Caeserean section. Id. As is noted by Banta and Thacker, much of the increase in Caesarean sections (some of which is caused by the use of EFM) occurs in young women and in primagravidas, women who are a likely population to bear subsequent infants. Id. Because of the still widespread practice of routine Caeserean delivery among women who have had previous Caesareans, their subsequent children will be at greater risk of RDS. Id.

72 See Kennedy, Obstetrical Practices in the U.S.: Hearings Before the Subcomm. on Health and Scientific Research of the Senate Comm. on Human Resources, 95th Cong., 2d Sess. 9 (1978); Amnazi, , Bryan, & Marnagola, , UUrasonography in Obstetrics, Gynecology, and Clinical Applications, 8 CRC Critical Review of Clinical Radiological Nuclear Med. 153 (1976)Google Scholar. Clinical opinion is that ultrasound is of no risk to mother or infant at clinical levels. Jarzembski, Associate Professor of biomedical engineering and computer medicine at Texas Technical University, agrees. See Jarzembski, supra note 58. However, he points out that research on ultrasound continues. He also mentions other research which may be cause for concern:

Id. at 129-30. Barrett & Anderson indicated that diagnostic levels of ultrasound have been shown in animal studies to disrupt the spleen's ability to produce antibodies. Anderson & Barrett, Ultrasound: A New Immunosupressant, 14(1) Clinical Immunology and Immunopathology 18, 27-28 (1979).

The delayed, long-range effects of electronic or ultrasonic fetal monitoring on offspring exposed in utero are unknown. Doris Haire, reporting on the International Congress of Obstetricians and Gynecologists in Mexico City, October, 1976, spoke of Dr. Susuki of Japan, one of the world's most prominent specialists in irradiation. When questioned about the safety of ultrasound, Dr. Susuki replied that ultrasound exposure would probably not harm the fetus, although there was no proof of safety in regard to delayed effects. He did express concern over possible delayed, long-range effects of ultrasound on the ovum of the female fetus. There is no way to know the long-term consequences of routinely irradiating with ultrasound the ovum of the female fetus, and the effects cannot be known until the next generation is born. Haire, , The Cultural Unwarping of Childbirth: How Can It Be Accomplished?, 1 2 1st Century Obstetrics Now! 567, 572 (1976)Google Scholar.

73 N.Y. Times, Feb. 9, 1984, at Al, col. 1.

74 That is, the physician's “unreasonable” conduct must be shown to have caused the injury. See D. Louisell & H. Williams, Medical Malpractice § 8.07 (1973); McCoid, , The Care Required of Medical Practitioners, 12 Vand. L. Rev. 549 (1959)Google Scholar; Pearson, , The Role of Custom in Medical Malpractice Cases, 51 Ind. L.J. 528 (1976)Google Scholar.

75 The standard of care for a specialist—and an obstetrician-gynecologist is considered a specialist—is “that of a reasonable specialist practicing medicine in the light of present-day scientific knowledge.” Naccarato v. Grob, 384 Mich. 248, 254, 180 N.W.2d 788, 791 (1970). It is a national standard. See, e.g., White v. Edison, 361 So. 2d 1292 (La. Ct. App. 1978), cert, denied, 363 So. 2d 915 (La. 1978); Francisco v. Parchment Med. Clinic, 407 Mich. 325, 328,285 N.W.2d 39, 41 (1979); Gilmore v. O'Sullivan, 106 Mich. App. 35, 38-39, 307 N.W.2d 695, 697 (1981); Pearson, supra note 74, at 536.

76 See Restatement (Second) of Torts §§ 295A, 299A (1965); W. Prosser, Handbook of the Law of Torts § 32, at 161-63 (4th ed. 1971); McCoid, supra note 63, at 558; see also Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974).

77 See Pikev. Honsinger, 155 N.Y. 201, 210, 49 N.E. 760,762(1898); Regan, Doctor and Patient and the Law 41 (3d ed. 1956).

McCandless v. McWha, 22 Pa. 261, 269 (1853); see also McCarthy v. Boston City Hosp., 358 Mass. 639, 266 N.E.2d 292 (1971); Naccarato v. Grob, 384 Mich. 284, 180 N.W.2d 788 (1970); Gielskie v. State, 9 N.Y.2d 834, 175 N.E.2d 455, 216 N.Y.S.2d 85 (1961); Stone v. Goodman, 241 A.D. 290, 271 N.Y.S. 500 (1934); Alteresko v. Phillips, 208 A.D. 171, 203 N.Y.S. 198 (1924); Richardson v. Doe, 176 Ohio St. 370, 199 N.E.2d 878 (1964) (qualifying custom by requiring due regard for “the present state of medical science“); Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971).

78 See, e.g., Toth v. Community Hosp., 22 N.Y.2d 255, 239 N.E.2d 368 (1968) (this language is frequently part of the standard of care formulation); J. Waltz & F. Inbau, Medical Jurisprudence 42-43 (1971).

79 McCoid, supra note 74, at 558; see also W. Prosser, supra note 76, at 150-51; Restatement (Second) of Torts §§ 295A, 299A (1965).

80 W. Prosser, supra note 76, at 161-63; 2 J. Wigmore, Evidence § 461, at 499 (3d ed. 1940); McCoid, supra note 74, at 605 (citing 2 F. Harper & F. James, Torts 977 (1956)).

81 W. Prosser, supra note 76, § 33, at 166-68.

82 Texas & Pa. Ry. v. Behymer, 189 U.S. 468 (1903). See McCoid, supra note 74, at 606 n.264 for a list of other cases.

83 See generally Morris, , Custom and Negligence, 42 Colum. L. Rev. 1147 (1942)CrossRefGoogle Scholar.

84 The T.J. Hooper, 60 F.2d 737, 740 (2d Cir. 1932), cert, denied, 287 U.S. 662 (1933). A custom may be considered negligent if by common knowledge it appears that safer conduct could have been feasible, or if expert evidence shows that there was a way scientifically demonstrated to be safer. See generally Ward v. Hobart Mfg. Co., 450 F.2d 1176 (5th Cir. 1971); Afran Trans. Co. v. The Bergechief, 274 F.2d 469 (2d Cir. 1960) (two tankers collided in deep fog where it was not customary for tankers to have radar); Dannign Warehouse Co. v. Widener, 172 F.2d 910 (10th Cir. 1949) (custom among broomcorn warehousemen was not to hire watchmen).

85 6 0 F.2d 737 (2d Cir. 1932), cert denied, 287 U.S. 662 (1933).

86 This may be true in the case of EFM. In dealing with the complex natural process of labor and childbirth, it is especially important not to accept without evaluation new procedures and technologies that significantly affect or alter the process. Unfortunately, as David Birnbaum says, there seems to be a premise “that if something natural can be done medically, intervention is the choice if the natural course can't be proven better, or the medical course proven worse.” Birnbaum, , The Iatrogenesis of Damaged Mothers and Newborns, 1 21st Century Obstetrics Now! 105, 110 (1977)Google Scholar. He feels that the medical profession must rid itself of the “dogma“: “Common sense indicates that if natural delivery can't be proven better, or medical delivery worse, then natural delivery can't be proven worse or medical delivery better. It is far more likely that we will continue to find more and more ill effects of enlightened modern medicine.” Id. at 111 (citing from the Hippocratic Oath, “Primum non nocere“—first do no harm).

87 Pearson, supra note 74, at 534. Pearson notes that “courts, in the context of negligence actions, function as a substitute for the market forces which might, but did not, operate to insure the optimal level of safety.” Id. at 534-35.

88 See supra notes 74-78 for exposition of the general negligence standard. See also Schwartz, & Komesar, , Doctors, Damages and Deterrence: An Economic View of Medical Malpractice, 298 New Eng. J. Med. 1282, 1283 (1978)CrossRefGoogle Scholar.

89 This holds except in cases in which “the results of medical treatment are so patently bad as to be manifest to lay persons.” Collins v. Meeker, 198 Kan. 390, 394, 424 P.2d 488, 493 (1967).

90 See, e.g., McCoid, supra note 74; Morris, supra note 83. “Whether anticoagulant drugs should have been administered … is a question beyond the knowledge and competence of lay jurors.” Haase v. Garfinkel, 418 S.W.2d 108, 113 (Mo. Sup. Ct. 1967). The physician must possess (1) a reasonable or ordinary degree of skill and learning; (2) commonly possessed and exercised by members of the profession; (3) who are of the same school or system as the defendant; (4) and who practice in the same or similar localities; (5) and exercise of the defendant's good judgment.

McCoid, supra note 74, at 559. Keeton similarly states that the “principal reason” for the use of a “customary practice standard is the infeasibility of permitting the jury to evaluate the ethical quality of the trade-offs that a doctor must make“—i.e., the education of the jury of the risks and dangers of an alternative course “would be a formidable task.” Keeton, , Medical Negligence—The Standard of Care, 10 Tex. Tech. L. Rev. 351, 359 (1979)Google Scholar.

91 For example, in a case in which the jury must weigh the danger involved in the use of a product as designed, the jury must also determine the feasibility under the state of the art of the design engineer to design a safer product. Such social and economic tradeoffs are similar to those a physician must make in diagnosing and treating patients. Keeton, supra note 90, at 359 n.17.

92 See King, , In Search of a Standard of Care for the Medical Profession: The “Accepted Practice” Formula, 28 Vand. L. Rev. 1213, 1249 (1975)Google Scholar; Note, An Evaluation of Changes in the Medical Standard of Care, 23 Vand. L. Rev. 729, 743 (1970)Google Scholar [hereinafter cited as Note, An Evaluation of Changes]. See generally Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974) (which relied on expert testimony regarding the simplicity, expense, and definiteness of the glaucoma test).

93 McCoid, supra note 74, at 608.

94 Id.

95 Note, An Evaluation of Changes, supra note 92.

96 See Pearson, supra note 74, at 536.

97 Schwartz & Komesar, supra note 88.

98 Pearson, supra note 74, at 536.

99 Id. at 537.

100 Pi-ofesSor Morris has said, “Doctors as a class may be more likely to exert their best efforts than drovers, railroads, and merchants; but they are human and subject to the temptations of laziness and unthinking acceptance of traditions.” Morris, supra note 83, at 1164. Doctors may also be lulled into the unthinking acceptance of the notion that new techniques and technologies are better and safer.

The rapid spread and diffusion of EFM into virtually every obstetric setting, see text accompanying note 7, is an example of the “tradition” that new techniques and technologies are assumed to be progressive per se by many. Speaking of EFM, Banta and Thacker, state:

Banta & Thacker, supra note 4, at 637.

101 King, supra note 92, at 1237. That commentator argued for an “accepted practice” formulation of the standard of care which would afford due consideration for the obligation on the part of the medical community to keep abreast of scientifically valid research.

102 Id.

103 Id.

104 Shearer, supra note 9, at 100.

105 Id.

106 Id.

107 See, e.g., Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974).

108 Schwartz & Komesar, supra note 88.

109 83 Wash. 2d 514, 519 P.2d 981 (1974).

110 Lundahl v. Rockford Memorial Hosp. Ass'n, 93 111. App. 2d 461, 235 N.E.2d 671 (1968). In Lundahl, the court said: “[T]he fact that the treatment given was ‘usual’ or ‘customary’ procedure would not, of itself, preclude the possibility of either negligence or want of skill. It is entirely possible … that what is the usual or customary procedure might itself be negligence.” Id. at 465, 235 N.E.2d at 674. See Favalora v. Aetna Casualty & Surety Co., 144 So. 2d 544 (La. App. 1962). In Favalora, a patient became dizzy during X-ray session and fell. The radiologist had not seen the patient's medical history (which would have warned of the dizzy spells so that precautions could have been taken) because it was not customary for radiologists to review the history before X-ray. The court indicated that it is unreasonable and arbitrary to grant immunity for failure to take such a precaution just because others in the profession fail to exercise due care. Id. at 550-52. See also Darling v. Charleston Community Memorial Hosp., 33 111. 2d 326, 211 N.E.2d 253 (1965), cert, denied, 383 U.S. 946 (1966); Morgan v. Sheppard, 91 Ohio L. Abs. 579, 188 N.E.2d 808 (1963) (the defendant was in charge of the patient after a partial gastrectomy but did not visit him until twelve hours after receiving notice that the patient was in shock); Pederson v. Dumouchel, 72 Wash. 2d 73, 431 P.2d 973 (1967); see also Note, An Evaluation of Changes, supra note 92, at 745-46.

111 See, e.g., Toth v. Community Hosp., 22 N.Y.2d 255, 239 N.E.2d 368 (1968); Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971). See discussion of these cases infra notes 128-135 and accompanying text.

112 Schwartz & Komesar, supra note 88.

113 83 Wash. 2d at 519, 519 P.2d at 983. In response to Helling, the Washington State Legislature revised the Washington Code of Civil Procedure:

Wash. Rev. Code § 4.24.290 (Supp. 1984).

In 1976, the Washington Court of Appeals (Division 2) suggested that Helling's holding “was intended to be restricted to its own ‘unique’ facts.” Meeks v. Marx, 15 Wash. App. 571, 577, 550 P.2d 1158, 1162 (1976).

The Washington Supreme Court in 1979 held that Code Section 4.24.290 was not inconsistent with Helling because the original bill would have established the standard of care as that skill and care practiced by others in the same profession and speciality. But the bill that passed required physicians to exercise the skill, care, and learning possessed by others in the same profession, which the court considered a much broader standard. Gates v. Jensen, 92 Wash. 2d 246, 254, 595 P.2d 919, 924 (1979). Subsequent Washington cases which discuss Helling include: Keogan v. Holy Family Hosp., 24 Wash. App. 583, 584, 601 P.2d 1303, 1304 (1979) (mentions Helling and notes that it was reaffirmed in Gates), rev'd on other grounds, 95 Wash. 2d 306, 622 P.2d 1246 (1980) (reaffirmed Helling doctrine of reasonable prudence). In 1983, The Washington Supreme Court was again faced with the issue of “whether the conduct of a Health care provider is to be measured against the standard of care practiced by the profession or against a standard of reasonable prudence.” Harris v. Groth, 99 Wash. 2d 438, 439, 663 P.2d 113, 114 (1983).

That court held that “as enacted by the Legislature, the standard of care imposed upon Health care providers is one of reasonable prudence and that nonphysicians, if otherwise qualified, may give expert testimony in a medical malpractice case.” Id. After an extensive discussion of Helling, the legislative “reaction,” and the controversy aroused in general, the Washington Supreme Court, en bane stated the following:

Id. at 451, 663 P.2d at 120 (emphasis added).

A California appellate court in Barton v. Owen, 71 Cal. App. 3d 484, 506, 139 Cal. Rptr. 494, 506 (1977) did not follow Helling to the extent it decided that expert testimony was necessary when matters of treatment and diagnosis were at issue. However, the Barton court held that where an issue to be determined was within the “common knowledge” of the trier of fact, expert testimony was not necessary. The California Supreme Court discussed Helling briefly in Truman v. Thomas, 27 Cal. 3d 285, 295-96, 611 P.2d 902, 908, 165 Cal. Rptr. 308, 314 (1980) (distinguished Helling on its facts).

114 Helling, 83 Wash. 2d at 519, 519 P.2d at 983 (citing The T.J. Hooper, 60 F.2d 737 (2d Cir. 1932), cert, denied, 287 U.S. 662 (1933)). Had the test been administered earlier than the 40 year customary age, the glaucoma presumably would have been discovered and its progress arrested.

115 83 Wash. 2d at 518-19, 519 P.2d at 983.

116 Id. The appellate court weighed the cost of the test (“inexpensive” and “harmless“) against the probability that glaucoma could develop in a young person (“one in 25,000“) and the magnitude of the loss (blindness). The court concluded that “reasonable prudence” required the test and faulted the profession for not routinely carrying out tonometry in patients under that age of forty. Here, custom did not meet the standard of efficiently allocated resources; the court measured custom against the Hand standard and set custom aside. This decision, when expressed quantitatively, yields a result consistent with the Learned Hand Rule. See also discussion of defensive medicine, infra note 200 and accompanying text.

117 33 111. 2d 326, 330-33,211 N.E.2d 253, 256-58 (1965),cerf. denied, 383 U.S. 946 (1966).

118 Pearson, however, notes that hospitals are less likely to enjoy the benefits of the medical custom rule than are physicans. Pearson, supra note 74, at 531.

119 Petras & Scarpelli, Computers, Medical Malpractice, and the Ghost of The T.J. Hooper, 5 Rutgers J. Computers & Law 15, 36 (1975).

120 See, e.g., Pike v. Honsinger, 155 N.Y. 201, 210, 49 N.E.760, 762 (1898); McCandless v. McWha, 22 Pa. 261, 269(1853); L. Regan, Doctor and Patient and the Law 41, 47 (3d ed. 1956).

121 See Naccarato v. Grob, 384 Mich. 248, 180 N.W.2d 788 (1970); Gielskie v. State, 9 N.Y.2d 834, 175 N.E.2d 455, 216 N.Y.S.2d 85 (1961); Pike, 155 N.Y. 201, 49 N.E. 760; Alteresko v. Phillips, 208 A.D. 171, 203 N.Y.S. 198 (1924); Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971).

122 W. Silverman, Retrolental Fibroplasia: A Modern Parable (1980) (describes iatrogenic diseases and deaths in newborn infants resulting from the hasty adoption of new therapies in neonatal intensive care). Beginning after World War II, mobilization of national resources was undertaken in medicine. Enthusiasm and optimism characterized attitudes toward new medical techniques, both in medicine and in the lay press.

One innovation, the use of a “mist-nevulizer,” which forced humidified air with a detergent-like substance into incubators, was shown by randomized trials to be of no benefit. When results were publicized the manufacturer of the preparation told one of the two authors of the studies, “It won't hurt our sales.” He was right. Id. at 75.

123 Silverman does not obscure the difficulty of conducting such clinical trials. But to introduce an inadequately evaluated procedure is to experiment upon all on whom it is performed, with a lesser likelihood that side effects and long-term complications may be detected. Id. at 152-153.

124 See generally Note, DES and a Proposed Theory of Enterprise Liability, 46 Fordham L. Rev. 963 (1978)Google Scholar.

125 Morrow, Women's Health Care and Informed Consent: Who Should Decide What is Best for Women—Patients or Doctors?, 9 Golden Gates 553, 554-55 (1979). See generally Van Dyke, , The Dalkon Shield: A “Primer” in IUD Liability, 6 W. St. U. L. Rev. 1 (1978)Google Scholar. McCoid, writing in 1959, cites a further cogent example of the dangers involved in indiscriminately following the most recent developments in medicine: “the administration of antibiotics for any and all ailments may prove to be dangerous and not in accord with accepted medical practice as evidence develops that these drugs may develop undesirable tolerances in the patient so that their use in case of serious infection is valueless.” McCoid, supra note 74, at 580.

126 W. Silverman, supra note 122, at 85.

127 Donaldson v. Maffucci, 397 Pa. 548, 554, 156 A.2d 835, 838 (1959).

128 Pearson, supra note 74, at 532.

129 444 Pa. 263, 277, 282 A 2d 206, 217 (1971).

130 Id.

131 Id.

132 22 N.Y.2d 255, 239 N.E.2d 368 (1968).

133 Id. at 263, 239 N.E.2d at 373. This language is frequently part of the standard of care formulation. See J. Waltz & F. Inbau, supra note 78, at 42.

134 Toth, 22 N.Y.2d at 263, 239 N.E.2d at 373.

135 while the Toth decision has been criticized, there is nothing revolutionary in it. That a doctor has to do the best job he can and has to use any special knowledge he possesses has always been New York law. It would be poor social policy not to require a doctor who knows better to do better. It is only in the avoidance of slavish adherence to the “custom and practice” rule that the Toth case may state a new departure, and it applies only if the doctor has reason to question the existing practice.

Reingold & Davey, Standard of Care in Medical Malpractice Cases, in Modern Trends in Medical Malpractice (R.L. Conason ed. 1974).

136 W. Prosser, supra note 76, § 32 at 165 (citation omitted).

137 Banta & Thacker, supra note 4, at 627.

138 In any case of injury to mother or baby, the issue of due care would involve an examination of all relevant behavior and procedures which occurred. Whether or not EFM was used would be one of possibly many issues. In addition, it would have to be shown that failure to use EFM in some cases caused the injury. W. Prosser, supra note 76, § 30 at 143-44.

It is of course possible that negligent performance of any of the procedures involved in applying and maintaining electronic fetal monitoring, if injury resulted, could give rise to a malpractice claim. Dr. David Rubsamen, speaking at the 1977 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, observed, however, that law suits would not be brought based on direct injuries sustained from EFM. He noted that no scalp abscess cases had reached the courts, “although maternal infection might well lead to a malpractice suit.” Obstetric & Gynecological News, July 1, 1977, at 26, col. 3. Scientific proof of fetal monitoring value is still lacking but courts may dictate its use. Id.

In a case where injury to mother or baby occurred, it is also possible that equipment malfunction or staff or doctor inattention to or incorrect interpretation of EFM readouts might be alleged as malpractice against the attending physicians, staff and/or the hospital. It should also be noted that the NICHD Consensus Development Task Force on Predictors of Intrapartum Fetal Distress emphasized that “intermittent and continuous fetal heart rate assessment are screening, rather that diagnostic techniques. Failure to appreciate this limitation may lead to inappropriate clinical decisions.” Zuspan, Quilligan, lams 8c van Geijn, , NICHD Consensus Development Task Force Report: Predictors of Intrapartum Fetal Distress—The Role of Electronic Fetal Monitoring, 95 J. Pediatrics 1026, 1027 (1979)Google Scholar [hereinafter cited as Zuspan]. However, failing to act on ominous EFM tracings and to keep track of and heed other clinical indications may lead to injury for which a physician may be liable. For example, in Haught v. Maceluch, 681 F.2d 291 (5th Cir. 1982), the mother arrived at the hospital at 10:30 p.m.; her doctor was so informed by phone. At 3 a.m. her amniotic sac ruptured, revealing dark green meconium stained fluid. Since meconium staining can be a sign of fetal distress, the night supervisor called the doctor again. At 4 a.m., Dr. Maceluch, who had still not come to the hospital, called and ordered external EFM as well as the administering of Pitocin. At 5 a.m., the nurse called him to report continued meconium staining and, in her reading of the EFM tracings, a loss of “beat to beat variability” in relation to contractions. The doctor, however, did not go to the hospital until 7 a.m., when he observed gross meconium staining and ordered internal EFM and a doubling of the Pitocin dosage. The mother was only 1 cm dilated, and the baby's head was not yet engaged. At 8 a.m., nurses noted the first sure sign of fetal heart deceleration. At 9:26 a.m., the doctor performed a Caesarean section. The umbilical cord was wrapped around the baby's neck three or four times. A neonatologist diagnosed severe perinatal asphyxia with a prognosis that the child's life would be limited by severe handicaps. The court found that defendant doctor breached the standard of care by failing to recognize meconium staining and the loss of “beat to beat variability” as danger signs early enough. In addition, the 1978 Physician's Desk Reference specifically contraindicated the use of Pitocin when fetal distress is suspected—for example, when the above two symptoms exist. The court found that failure to perform a Caesarean section earlier and administering Pitocin proximately caused the baby's injuries.

In another case which yielded a large settlement for the plaintiff, the mother was monitored electronically, and the fetal monitor strip provided the crucial evidence in the action. Although the strip showed signs of fetal distress and the mother was five weeks overdue, no action was taken by the staff or the doctors to determine the nature and extent of this distress for three hours, until a fetal scalp sample revealing anoxia was done. A Caesarean section was performed. Also significant was the fact that a 40 minute segment of the fetal monitor strip was missing from the plaintiff's medical records. Tyler Blair, a Minor, by his Guardian Ad Litem Joseph T. Blair vs. Regents of the University of California, 24(15) Jury Verdicts Weekly 7 (Apr. 11, 1980); see supra notes 137-38 and accompanying text.

139 See notes 39-71 and accompanying text for a discussion of the risks of EFM.

140 See, e.g., Fatovic v. Nederlandsch-Ameridaansche Stoomvart, Maatschappij, 275 F.2d 188 (2d Cir. 1960) (defendant's work safety measures conformed to those of its industry and plaintiff did not prove that safer methods were known or available; directed verdict for defendant affirmed); see also Petras & Scarpelli, supra note 119, at 23.

141 Petras & Scarpelli, supra note 119, at 23 (citing Kiesel v. American Trading & Prod. Corp., 347 F. Supp. 673 (D. Md. 1972)).

142 Morris has pointed out that evidence of compliance or noncompliance with custom in an ordinary negligence action is relevant in the following determinations: (a) whether an imposition of liability on the defendant will unduly disrupt existing business practices; (b) whether some other safety measures or precautions than those taken by defendant are feasible or practicable; and (c) whether defendant had an opportunity to know of other safety measures or precautions from existing practices of others. Morris, supra note 83, at 1147-55; see also Dempsey v. Addison Crane Co., 247 F. Supp. 584 (D.D.C. 1965) (defendant crane renters were negligent because alternate means offered greater safety and the alternative component parts were available and inexpensive); Marietta v. Cliffs Ridge, Inc., 385 Mich. 364, 189 N.W.2d 208 (1971) (saplings as gate markers at ski resort not adequate when safer fiberglass or bamboo markers available; jury verdict against defendant upheld); Welsh v. Kleiderer, 440 Pa. 47, 269 A.2d 746 (1970) (although machinery complied with customary standards of the trace, failure to equip with inexpensive safety switch presented a question of negligence for the jury).

143 See supra notes 39-71 and accompanying text, in which a review of THE literature indicates risks of EFM exist in a context of doubtful benefits as compared with auscultation. Another allegation might be—rather than that EFM should not have been used—that the act of placing the scalp electrode was done negligently, or that negligent contamination occurred. Still another hypothetical was raised by Chik, who described one of two types of problems with EFM occurring in the clinical setting: “[c]linical interpretation of fetal monitoring data obtained during labor” not infrequently does not correspond with the observed outcome, for example, when Caesarean is performed for “fetal distress diagnosed from the FHR intrauterine pressure tracing and the infant has an Apgar score of 9 at 1 min.” Chik & Sokol, supra note 55, at 665.

For an alternate and additional theory of liability on the part of the physician, see Katz, , Electronic Fetal Monitoring and the Law, 6 Birth & Fam. J. 251 (1979)CrossRefGoogle Scholar. Katz discusses the possibility of an action brought by an aggrieved patient who is economically injured due to overdiligence by the physician: “[a] physician who recommends a procedure to the patient may be held responsible for the ensuing charges when that procedure is found to have been unnecessary to the patient's welfare.” Id. at 255. This theory might also be invoked where a “low-risk” electronically monitored patient suffers what, according to available medical evidence, turns out to be an unnecessary Caesarean section.

144 This and the following questions are paraphrased from an article in which the authors, examining computer use in medicine, considered a hypothetical negligence charge based on the failure to use a computer (setting aside the role of custom in medical malpractice). Petras & Scarpelli, supra note 119, at 23-24.

145 Haverkamp & Thompson, supra note 26; Haverkamp, Orleans & Langendoerfer, supra note 26.

146 Haverkamp, Orleans & Langendoerfer, supra note 26. Banta and Thacker state that “[i]t is a sad commentary on the quality of obstetric services in this country if we are unable to provide human support for all women in labor.” Banta & Thacker, supra note 4, at 638.

Haverkamp, Orleans & Langendoerfer, supra note 26, at 407.

148 A recent study yielded results that suggest that there may be major perinatal benefits of constant human support during labor. Length of time from admission to delivery was shorter in the experimental (human supported) group (8.8 v. 19.3 hours, P less than 0.0001). Mothers in this group slept less after delivery (P less than 0.02) and it appeared that bonding was facilitated in the experimental group (mothers stroked (P less than 0.001), smiled at (P less than 0.009) and talked to (P less than 0.002) their babies more than the control mothers). Sosa, Kennell, Klaus, Robertson & Urrutia, The Effect of a Supportive Companion on Perinatal Problems, Length of Labor, and Mother-Infant Interaction, 303 New Eng. J. Med. 597, 597-600 (1980).

149 Haverkamp, supra note 8, at 114. Nursing chores are not small with regard to EFM. For example, in one study, the author explained that standard nursing procedure for care and maintenance of monitoring devices includes disassembly and drying of the transducer after each use. “However, time constraints have precluded initiating suggested sterilization processes. Time interval between use varied from several minutes to several days … . [W]aterborne contamination of pressure transducers does occur in the interval between patient use despite disassembly and drying of transducer.” Baker, , Mead, , Gallant, , Hayward, & Hamel, , Water-borne Contamination of Intrauterine Pressure Transducer, 133 Am. J. Obstet. & Gvnecol. 923, 924 (1979)Google Scholar.

Speaking of the possibility of computerizing EFM, researchers note that even a detailed computer analysis “does not begin to match the complexity of visual pattern recognition methods used every day by clinicians.” Chik & Sokol, supra note 55.

150 NICHD conferences have been established to address broad recent developments in medical practices and research. Task Force participants, chosen from outside NIH, are asked to provide a comprehensive review of the state-of-the-art, including recommendations for current clinical practice and future research in a particular area of medicine.

151 Check, supra note 46. Conference chairman Kenneth Ryan [chief of staff at Boston Hospital for Women] expressed concern at the notion that EFM could provide high quality care for all patients at lower cost: “I am appalled,” he said,” by the suggestion that the monitor be used as an electronic nurse.” Id. Another Task Force member [director of the American Academy of Husband-Coached Childbirth], Jay Hathaway, contended that in the absence of clear-cut data on efficacy and cost savings, technology should not be allowed to interfere with the childbirth experience. Id.

152 Mehl, , Options in Maternity Care, 29 Women & Health 29 (1978)Google Scholar. Alternative birth centers, such as The Birth Place in Menlo Park, California, and others throughout the country, also provide continuous, cost-effective nursing care to laboring women. For example, at the Mendocino Coast Hospital in Fort Bragg, California, nurses come to the hospital when a woman in labor enters and follow her throughout labor, providing monitrice type of care. “The use of obstetrical medication has been decreased and labor lengths are shorter.” Id.

Another hospital mentioned by Mehl is the Manchester Memorial Hospital which in April of 1969 established a labor-delivery room in which parents could give birth to their babies. In that set-up, fourteen obstetrical nurses trained in the LaMaze method of prepared childbirth provided continuous emotional and physical one-to-one support throughout labor and delivery. “Eight of these monitrices also taught childbirth education classes for couples, combining their experience in obstetrics and support in labor to make their childbirth more effective and relevant.” Id. at 31. The nurses are on 24-hour call. They bill the patient directly with fees of approximately $50 for support during labor and delivery, or $35 plus $3 per half hour. Id.

In this context it is important to note that certified nurse-midwives provide excellent prenatal and intrapartum care that is economically beneficial as well. Yet certified nurse midwives use expensive technology and medication selectively rather than routinely despite the fact that not all their patients are low-risk. For example, at North Central Bronx Hospital, all patients—including 30% at high-risk—receive certified nurse-midwife care; electronic fetal monitoring is used for less than 50% of the women, and frequently only intermittently. The Caesarean section rate was 9% and the perinatal mortality rate was lower than the overall rate for New York City.

As stated by staff who were involved in the Denver studies:

Applegate, Haverkamp, Orleans & Taylor, Electronic Fetal Monitoring: Implications for Obstetrical Nursing, 28 Nursing Research 369, 370-71 (1979).

153 Mehl, supra note 152, at. 31.

154 Telephone interview with sales representative of Hewlett-Packard, manufacturer of EFM equipment (July 10, 1984).

155 “Unfortunately the necessary in-depth education of all those in charge of interpreting the tracings and managing the cases has not kept pace with the rapidly increasing use of EFM. Hazards created by this lack of education may have detrimental effects on the outcome of some pregnancies.” Lubic, supra note 26, at 5.

156 Sec Marieskind, supra note 19, at 187.

157 Shearer, supra note 9, at 104. Lee & Baggish, supra note 17, at 517, reported: “The cause of the only case of intrapartum death among the monitored group was a cord accident. On reviewing that case retrospectively, the patient's monitor pattern revealed a long strip of unsatisfactory tracing during external monitoring, presumably due to the movements of both the mother and the baby.“

Goodlin, a pioneer in monitor research 10 years ago, said in 1977 that he had given up trying to get monitor companies to produce an accurate machine:

Goodlin & Haesslein, supra note 4, at 442 (emphasis added).

Other researchers comment: “Apparently we are not alone in our feelings about the effects of staff versus the machine.” Ballas, , Hornstein, , Jaffa, & Toaff, , Selective Versus Routine Intrapartum Monitoring: Comparison of Effects on Perinatal Outcome, 59 Acta Obsteticia & Gynocologica Scandinavica 301, 303 (1980)CrossRefGoogle Scholar. They quote Haverkamp & Thompson, supra note 26, with agreement: “The over-all findings … make it appear that it may be THE staff, both nursing and medical, and the facilities that are important in achieving an optimal outcome rather than the use of electronic monitoring per se.” Id. at 317.

158 See infra notes 212-20 and accompanying text on risks of EFM use.

159 Molfese, , Sunshine, & Bennett, , Reactions of Women to Intrapartum Fetal Monitoring, 59 Obstetrics & Gynecology 705 (1982)Google Scholar.

160 Note that in the Denver studies, all of t he study subjects were women in a “high-risk” category. They were not “routine” or “low-risk” labors.

161 Jarzembski, supra note 58, at 130.

162 Id.

163 Brewer, & Hodin, , Why Women Must Meet the Nutritional Stress of Pregnancy, 221 St Century Obstetrics Now! 387 (1977)Google Scholar.

164 Id. at 388-89.

165 One of the participants at the Hastings Center conference on childbirth technology put it another way:

Steinfels, , New Childbirth Technology: A Clash of Values, Report From a Hastings Center Conference, 8 The Hastings Center Rep. 9, 10 (1978)CrossRefGoogle Scholar (statement of Nancy Amidei of Hew).

In their administrative petition to reduce the incidence of low birth weight and resultant infant mortality, the Public Advocates emphasized to the U.S. Department of Health and Human Services the hazards of low birth weight. Small infants have high mortality rates and those surviving often suffer mental and physical disabilities.

The overall infant mortality rates dropped from 26.0% in 1960 to 13.1% in 1979. However, little change has occurred in the percentage of low birth weight babies born, low birth rate being the major factor contributing to infant deaths.

Early conprehensive prenatal care, as documented time and again in the medical literature and in government studies does increase birth weight and reduce infant mortality. Id. at 3. The chances of having a low birth weight baby are three times as great when an expectant mother receives no prenatal care. Id. at 37. Unfortunately,

Id. at 47-48. This approach has proven extremely costly.

166 Jarzembski, supra note 58, at 130.

167 Id.; see also Goodlin, Low Risk Obstetric Care for Low-Risk Mothers, 1980 Lancet I 1017.

168 Jarzembski, supra note 58, at 130.

169 See supra notes 43-47 and accompanying text.

170 Banta and Thacker point out that whereas “supervision of active labor alone might reduce perinatal mortality rates by only 3 per 1000 live births, assuming the ability to effectively diagnose and intervene in all cases, the management of maternal disease, fetal malnutrition, RDS, and infections can diminish the rates by 6.6 per 1000 live births.” Banta & Thacker,supra note 4, at 633-34 (emphasis added); see also supra notes 144-48.

171 Given the risks apparently involved in the use of EFM, and the dubious benefits, one might ask why the procedure has become so widespread.

In the case of EFM, on a broader scale, the production of electronic fetal monitors is a business like any other. Jarzembski, a biomedical engineer, points out another concern which should call more attention to the practice of medicine and its interrelationship with technological industry. His concern is that “little if any attention [is paid] to the education and credentials of those who make important life or death decisions as to the design, testing and maintenance of the apparatus used by the physician.” Jarzembski, supra note 58, at 130.

With some alarm he notes that although virtually every state has laws which require proof of professional competence in order to become licensed to practice engineering, “most of these laws specifically exempt those who design medical apparatus under a blanket manufacturing exemption.” Id.

Banta and Thacker, who did an extensive review of the literature on EFM, speak of the fact that private firms have invested in the development of EFM:

H.D. Banta & S. Thacker, The Premature Delivery of Medical Technology: A Case Report 7 (unpublished manuscript) (available from the authors at Office of Technology Assessment, Congress of the United States, Wash. D.C. 20510).

It has been reported that Dr. E.H. Hon, a developer of EFM and major researcher in the field, owns stock in and is a consultant to Corometrics, a subsidiary of American Home Products which is the largest manufacturer of EFM equipment. U.S. DEP't of Health, Education and Welfare, supra note 26, at 155 (citing Randal, Is Fetal Monitoring Safe? Widely Used Technique Needs More Testing, Wash. Post, Apr. 16, 1978, at B3, col. 1). Dr. R.H. Paul, another developer and major researcher of EFM, is a stockholder and consultant to Corometrics and the Hewlett-Packard and Bio-Berkeley Engineering. Id. (citing a personal communication with Dr. Paul).

A survey done in 1975 of 563 institutions known to use EFM revealed that 142 of the 344 responding (46.3%) charged a separate fee for its use. Such a fee could be the most important policy encouraging the use of EFM. H.D. Banta & S. Thacker, supra at 11. In addition, Banta and Thacker note that third party payment for EFM is likely to be “readily available.” Id.

There is, then, a substantial economic commitment to the use of EFM that cannot be discounted. Banta & Thacker, supra note 4, at 636-37.

172 Toth, 22 N.Y.2d at 255, 239 N.E.2d at 368. The Toth decision is considered to a be “a significant [one] on custom and practice” with impact “beyond New York's borders.” Rheingold & Davey, supra note 135.

173 See supra note 46 and accompanying text.

174 Banta & Thacker, supra note 4.

175 Given that adequate nursing care is necessary for auscultation (as well as for employing EFM), a hospital may be held directly liable for harm to a patient that could have been prevented by having an adequate number of trained personnel. See, e.g., Darling v. Charleston Community Memorial Hosp., 50 111. App. 2d 253, 200 N.E.2d 149 (1964), off'd, 33 111. 2d 326, 211 N.E.2d 253 (1965), cert, denied, 383 U.S. 946 (1966). A hospital owes a duty of reasonable care to its patients. See, e.g., Mercy Hosp. Inc. v. Larkins, 174 So. 2d 408 (Fla. Dist. Ct. App. 1965). Hospitals, thus, have been found to have a duty to exercise due care in the provision of a safe and habitable place for the patient, Tulsa Hosp. Ass'n v. Juby, 73 Okla. 243, 175 P. 519 (1918), and in the selection of hospital employees, Hipp v. Hospital Auth. of Marietta, 104 Ga. App. 174, 121 S.E.2d 273 (1961). See also Mauer v. Highland Park Hosp. Found., 90 111. App. 2d409, 232 N.E.2d 776(1967) (hospital has a duty to exercise due care in selection of medical staff).

There may also be implications for the duty to provide informed consent if the hospital or physician claims that there is not adequate nursing staff to provide auscultation and direct clinical attendance for laboring women. Sec infra note 219 and accompanying text.

176 See King, Ji^ra note 92, at 1236-44. King proposed an “accepted practice” formulation of the standard of care: “While the customary practice standard, taken literally, looks to the historical conduct of the profession, the accepted practice approach would focus on the ‘best standards of the day'—the reasonable expectations of the profession as to how its members should manage the care of a patient.” Id. at 1238 (citation omitted). The author notes that the:

Id. at 1243; see also Keeton, supra note 90, at 363-67. Keeton notes that despite the language used in opinions, “many courts have in reality allowed expert witnesses to testify in terms of what the defendant doctor should have done under the circumstances rather than what would have been customary. “ Id. at 363 (citing Webb v. Jones, 488 S.W.2d 407 (Tex. 1976) and Speed v. State, 240 N.W.2d 901 (Iowa 1976)). Keeton observed that the Webb “court seems to allow the witnesses to testify in terms of what is generally recognized to be acceptable medical practice rather than what is customary.” Id. at 363 n.27.

Further, under this approach, the expert “would look to the best of available medical literature … .” King, supra note 92, at 1243. An accepted practice standard would be “likely to encourage practitioners to stay abreast of sound medical technique.” Id. Presumably, “sound” techniques would not necessarily be the most technological. In addition, “[w]hen the negative aspects of a medical technique have been demonstrated by systematic and reliable studies, the accepted practice standard would probably compel repudiation of the untoward practice.“Id. at 1251.

177 They may also be pressured by their malpractice insurers to use EFM routinely. This is because, as discussed infra, a plaintiff will allege every possible contributing factor to a bad outcome, including the non-use of EFM. Insurance companies act on this allegation, even though the issue has not been litigated, and even though the use or non-use of EFM would be but one factor among many in a malpractice suit. Most cases are settled out of court. Therefore, the insurance companies are acting on unsubstantiated fears. For example, in the March, 1982 issue of Oakland Association of Insurance Agents, Inc. Association News, it is noted that some plaintiffs’ attorneys allege that electronic fetal heart monitors should have been used. The newsletter, however, further points out that physicians are divided regarding the benefits and risks to patients of EFM.

178 83 Wash. 2d 514, 519 P.2d 981 (1974); see also The discussion of defensive medicine at notes 199-215 infra.

179 See D. Louiseix & H. Williams, Medical Malpractice § 8.04, at 204 (1973); Chumbler v. McClure, 505 F.2d 489, 4 92 ( 6 th Cir. 1974); DiFilippo v. Preston, 53 Del. 539, 173 A.2d 333 (1961); Downer v. Veilleux, 322 A.2d 82 (Me. 1974). These are cases in which There was evidence that there were an appreciable number of physicians who disagreed with the basis for the approved procedure and the courts allowed either school of thought to be followed.

180 Sim v. Weeks, 7 Cal. App. 2d 28, 37, 45 P.2d 350, 354-55 (1935). See also Leech v. Bralliar, 275 F. Supp. 897, 902 (D. Ariz. 1967) (mode of treatment adopted by 65 physicians in county held to constitute respectable minority); Baldor v. Rogers, 81 So. 2d 658, 660 (Fla. 1954) (difference in medical opinion in treatment of cancer); Dahl v. Wagner, 151 P. 1079, 1080 (Wash. 1915) (difference in medical opinion regarding treatment of bone dislocation).

181 See, e.g., Fritz v. Parke Davis & Co., 277 Minn. 210, 213, 152 N.W.2d 129, 131 (1967) (difference of medical opinion in treatment of epilepsy); Duckworth v. Bennett, 320 Pa. 47, 51, 181 A. 558, 559 (1935) (competent medical authority divided as to treatment of patient's hip injury); Gresham v. Ford, 192 Tenn. 310,315,241 S.W.2d 408, 411 (1951) (difference of medical opinion as to proper treatment of injured arm). In Schueler v. Strelinger, 43 N.J. 330, 346, 204 A.2d 577, 585 (1964), the court held the test to be whether the form of treatment adopted had “substantial support … by the medical profession.“

182 Sec, e.g., Graham v. Alcoa S.S. Co., 201 F.2d 423, 426 (3d Cir. 1953), cert, denied, 346 U.S. 832 (1953)(disagreement as to proper treatment of hernia); Rickettv. Hayes, 511 S.W.2d 187, 194 (Ark. 1974) (disagreement regarding proper treatment of fractured jaw); Haase v. Garfinkel, 418 S.W.2d 108 (Mo. 1967) (disagreement among doctors in treatment of heart disease).

183 554 S.W.2d 160 (Tex. 1977).

184 Id. at 162.

185 The Texas Court of Civil Appeals held that the defendant physicians would not be liable if the procedure was considered acceptable by a respectable minority, even though the mainstream medical profession considered it ineffectual. Allowing physicians to exercise their professional judgment in selecting a method of treatment was important to the court. Id. at 165.

On appeal, the Texas Supreme Court expressed concern that the usual “respectable minority” and “considerable number” standards might indicate that malpractice is to be determined by a poll of the medical profession. Id. That notion would allow a physician to use a mode of treatment that has either been rejected by the profession or has become outmoded—so long as a respectable minority of physicians follow the same procedure. Id.; see also Dahl v. Wagner, 151 P. 1079, 1080 (Wash. 1915); Comment, Unnecessary Surgery: Doctor and Hospital Liability, 61 Geo. L.J. 807, 813-14 n.39 (1973) [hereinafter cited as Comment, Unnecessary Surgery],

186 Hood, 554 S.W.2d at 165; see also Webb v. Jorns, 488 S.W.2d 407, 411 (Tex. 1972) (rural doctor not required to possess the resources of sophisticated clinic). The locality rule is not abandoned, but rather, as done in other jurisdictions, is only one factor to be considered in applying standard of care. See, e.g., Brune v. Belinkoff, 354 Mass. 102, 108, 235 N.E.2d 793, 798 (1968); Tallbull v. Whitney, 172 Mont. 326, 333,564 P.2d 162, 165-66 (1977); Pederson v. Dumouchel, 72 Wash. 2d 73, 79, 431 P.2d 973, 978 (1967).

187 Hood, 554 S.W.2d at 165.

188 Id.; see Naccarato v. Grob, 384 Mich. 248, 180 N.W.2d 788 (1970) (practicing specialist must treat patients “in light of present day scientific knowledge“); Smith v. Yohe, 412 Pa. 94, 96, 194 A.2d 167, 170 (1963) (failure to take X-rays in treatment of a fractured hip); Hodgson v. Bigelow, 335 Pa. 497, 501, 7 A.2d 338, 342 (1939) (failure to administer tetanus shot to patient who had sustained a cut). None of the foregoing cases involved an issue of unskilled or negligent performance of a particular procedure, nor of an improper diagnosis.

189 See, e.g., Toth, 22 N.Y.2d at 255, 239 N.E.2d at 368.

190 See, e.g., Hood, 554 S.W.2d at 165.

191 For example, “[t]here are diverse views on when to monitor—universally, selectively, or never.” Wood & Renou, supra note 18, at 532.

Many physicians also believe that there should be specific indications for rupture of the membranes and placement of an electrode, “especially so for low-risk term pregnancies, where there is no evidence that electronic fetal monitoring improves infant outcome… .” Koszalka, , Haverkamp, & Orleans, , The Effects of Internal Electronic Fetal Heart Monitoring on Maternal and Infant Infections in High-Risk Pregnancies, 27 J. Reprod. Med., 661 (1982)Google Scholar. Goodlin & Haesslein, supra note 4, also call into question the overuse of EFM.

Among the conclusions of the National Institutes of Child Health and Human Development Consensus Development Conferences Task Force on Predictors of Intrapartum Fetal Distress was the following:

Zuspan, supra note 138, at 1026-27.

The Task Force recommendation included the following: “Periodic auscultation of the fetal heart rate is an acceptable method of assessment of fetal condition… . Interpretation of auscultated fetal heart rate data should include an understanding of the relationship of fetal heart rate changes to uterine contractions.” Id. at 1028.

192 Bovbjerg, The Medical Malpractice Standard of Care: HMOs and Customary Practice, 1975 Duke L.J. 1375, 1404.

193 Id. at 1404 n.92.

194 Hood, 554 S.W.2d at 165.

195 The T.J. Hooper, 60 F.2d at 737.

196 See Petras & Scarpelli, supra note 119, at 40.

197 See supra note 191 and accompanying text.

198 In cases in which the sufficiency of monitoring was an issue, courts have recognized the acceptability of monitoring fetal heart tones by auscultation. For example, in Williams v. Lallie Kemp Charity Hospital, 428 So. 2d 1000 (La. Ct. App. 1983), the plaintiff baby, born in 1979, was profoundly retarded, brain damaged, deaf and almost totally blind. The record indicated that fetal heart tones were taken only twice in three hours. Though the court noted that EFM was available, but not used, the opinion stated that “[t]he evidence showed that such monitoring could be done manually or with an electronic monitoring device.” Id. at 1005. The expert witness “agreed that the fetal heart rate should be taken and recorded at least every thirty minutes in the first stage of labor and every five minutes in the second stage … .” Id.

Another court decision has determined that a jury could find that failure to auscultate fetal heart tones at least every 1/2 hour where there was stained amniotic fluid, and the mother had a sudden pain and called for the nurse, was a substantial factor in causing the death of the plaintiff baby. (In addition, the baby was six weeks and five days overdue.) Libbee v. Permanente Clinic, 268 Or. 258, 518 P.2d 636 (1974), reh'g denied, 520 P.2d 361 (1974).

199 Keeton, supra note 90, at 368.

200 Id. Keeton notes that “[t]ypically, ‘defensive medicine’ involves the increased use of medical services, such as extra diagnostic tests … [and that it] is to be discouraged because of the consequences of unnecessarily prolonged hospitalization and increased cost of medical care.” Id. (citation omitted).

201 See supra notes 107-19 and accompanying text.

202 U.S. Dep't of Health, Education and Welfare, supra note 26, at 82.

203 Id.

204 Id.

205 Id. at 83.

206 Id.

207 See supra notes 138, 183.

208 Sec notes 177-97 and accompanying text.

209 Findings reported by the Hew evaluation of Caesarean section in the United States illustrated this point:

4 National Ass'n of Ins. Comm'r, Malpractice Claims (Closed Claims Study) (1977); see id. at 85, table 20 (provides a detailed list of cause and indemnity paid in each case); see also U.S. Dep't of Health, Education and Welfare, supra note 26, at 83-87.

210 U.S. Dep't of Health, Education and Welfare, supra note 26, at 86. Also, a recent survey done by ACOG's (American College of Obstetricians and Gynecologists) District II (New York State) for the first two years (July, 1975 to June 30, 1977) of their new mutual company showed that there were 26 suits relating to Caesareans, out of a total of 2,193. Because the cases were filed relatively recently, most are still open and an updated study is not yet available. Eight of the suits related to maternal death from Caesarean Section, three to other anesthesia complications, three hernia, two endometritis, two hematoma, two unnecessary Caesareans, one abdominal distention, one phlebitis, one lap pad, one pack in vagina, one bleeding and one perforation of small bowel. Id. at 86-87.

211 Haverkamp & Orleans, supra note 26, at 412.

212 For example, the NICHD Task Force, basing its conclusions on available information, stated that “[cjourts of law should recognize that intrapartum hypoxia is only one of many potential factors involved in the development of handicaps and perinatal death, and that current research and clinical data do not allow comprehensive definition of antepartum … risk of adverse outcome.” Zuspan, supra note 138, at 1028.

In a recent study, researchers reported that ten infants in the population (all were monitored by EFM) had five-minute Apgar scores of less than seven without changes in fetal monitoring tracings. That was two-thirds the number of infants born with a low Apgar score, but who had not been prenatally diagnosed as having fetal distress. As the authors suggest:

Haesslein & Niswander, supra note 37, at 248.

Haesslein and Niswander also found that FSBS (fetal scalp blood sampling) as a confirmatory diagnostic technique of in utero fetal asphyxia is less precise than is usually thought. They found that there was evidence of chronic intrauterine distress in five of six of the neurologically damaged infants in the study. “It would appear, therefore, that the critical factor is not how long an abnormal fetal heart rate pattern is watched prior to delivery, but rather, whether factors associated with chronic distress were present in addition to an abnormal EFM pattern.” Id, at 249.

213 Goodlin & Haesslein, supra note 4, at 444 (citations omitted).

214 Claims department manager Joseph H. De Roma of the Los Angeles Office of the Travelers Insurance Companies stated that, to his knowledge, from 1974 through 1978, they “never had to defend against an allegation that electronic fetal monitoring should have been done in a case where perhaps less exotic modalities have been used.” Letter from J.H. De Roma to M.G. Gilfix (Oct. 6, 1980). When EFM had been used in the few obstetrical cases they handled, allegations were sometimes made that (1) there was failure to monitor tracings frequently enough or to act quickly enough on ominous tracings, and (2) there was failure to observe clinical danger signs in mother or baby other than EFM tracings. He also noted that liability issues are complex and “often entail analysis of the whole spectrum of medical care that might have a bearing on the patient/plaintiff's final result … . In the cases we have seen, the issues arising from electronic monitoring have been only one of many issues and never the primary issue in any one case.” Id.

215 Goodlin & Haesslein, supra note 4, at 442. The NICHD Task Force stated: “The electronic fetal monitor or any other technology should never be substituted for clinical judgment.” Zuspin, supra note 138, at 1028 (from the Task Force's Recommendations for Current Clinical Practice). The Task Force also cautioned, “The use of all forms of monitoring should be accompanied by supportive and knowledgeable personnel who are attentive to the patient's expectations regarding the conduct of her labor.” Id. Misreadings of EFM tracings can and do occur. See, e.g., Haesslein & Niswander, supra note 37, at 247.

216 Indeed, as one physician stated with regard to EFM: “The value of this technology is probably The most controversial and ardently discussed topic in our specialty today.” Haesslein & Niswander, supra note 37, at 250.

217 In Cobbs v. Grant, the California court thus outlined the doctrine of informed consent: “we hold, as an integral part of the physician's overall obligation to the patient, there is a duty of reasonable disclosure of the available choices with respect to proposed therapy and of the dangers inherently and potentially involved in each.” Cobbs v. Grant, 8 Cal. 3d 229, 243, 502 P.2d 1, 10, 104 Cal. Rptr. 505, 514 (1972).

Although the majority of jurisdictions require “a physician to disclose facts which a reasonable medical practitioner in a similar community and of the same school of medical thought would have disclosed to his patient regarding the proposed treatment,” Karp v. Cooley, 493 F.2d 408, 419 n.l 1 (5th Cir. 1974), physicians and their patients are afforded the greatest protection under the minority view, exemplified by Cobbs, Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), and Scott v. Bradford, 606 P.2d 554 (Okla. 1979). In Scott, the Oklahoma Supreme Court required the finder of fact to determine what risks were or were not material to the particular patient-plaintiff's decision with respect to treatment received or not received. For a full discussion of majority and minority tests, see Trichter & Lewis, Informed Consent: The Three Tests and a Modest Proposal for the Reality of the Patient as an Individual, 1980 S. Tex. L.J. 155; see also Slater v. Kehoe, 38 Cal. App. 3d 819, 825, 113 Cal. Rptr. 790, 794 (1974); Sard v. Hardy, 281 Md. 432, 439, 379 A.2d 1014, 1019 (1977); Cornfeldt v, Tongen, 262 N.W.2d 684, 702 (Minn. 1977); Shack v. Holland, 89 Misc. 2d 78, 389 N.Y.S.2d 988 (1976) (doctor not entitled to summary judgment in an action by twenty-two year old son alleging injury as the result of doctor's failure to sufficiently inform his mother of the risks, hazards, and alternatives to the delivery procedure administered. A conditional prospective liability was created at the time the mother was not informed and attached to the child at birth as a cause of action for lack of informed consent); Scott, 606 P.2d at 559 (the “basic right to know and decide is the reason for the full-disclosure rule“); Scaria v. St. Paul Fire & Marine Ins. Co., 68 Wis. 2d 1, 12, 227 N.W.2d 647, 653 (1975) (“[t]he right to be recognized and protected is the right of the patient to consent or not to consent to a proposed medical treatment or procedure“), U.S. Dep't of Health, Education and Welfare, Pub. NO. 05 73-88, Report of the Secretary's Commission on Medical Malpractice 29 n.9 (1973); R. Goodman & L. Goldsmith, Modern Hospital Liability—Law and TACTICS 355-416(1974 ed.); Annot., 69 A.L.R.3d 1250 (1976).

218 See, e.g., A. Holder, Medical Malpractice Law 225 (2d ed. 1978); Note, Informed Consent Liability, 26 Drake L. Rev. 696 (1976-77).Google Scholar An integral part of a physician's duty to use reasonable care extends to disclosure of information to the patient in order to obtain from the patient what has been designated “informed consent.” The physician's liability under the doctrine of informed consent may attach irrespective of whether the physician has exercised the care required of medical practitioners in diagnosis or treatment, and even though the purpose of the particular therapy has been successfully realized. Id. (citations omitted).

A physician may be liable in tort for damages (under either a battery theory or a negligence theory) unless legally adequate consent is obtained. Consent may not be adequate or effective for several possible reasons: (1) the physician may have misrepresented the purported treatment; (2) the physician may exceed the limits of the obtained consent; (3) the physician may fail to provide the patient with enough information as to risks of or the potential alternatives to the proposed therapy or procedure. See, e.g., Funke v. Fieldman, 212 Kan. 524, 512 P.2d 539 (1973) (anesthesiologist's disclosure to patient that headaches were the only risk involved in administration of spinal anesthesia was misleading since the anesthesiologist knew of the risk of paralysis); Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093 (1960) (physician's failure to inform patient-plaintiff of risks involved in cobalt irradiation therapy was a breach of his duty of disclosure); Bang v. Charles T. Miller Hosp., 251 Minn. 427, 88 N.W.2d 186 (1958) (plaintiff was not informed that prostate gland operations necessitated severence of his spermatic chords); Gray v. Grunnagle, 423 Pa. 144, 223 A.2d 663 (1966) (defendant surgeons attempted a corrective procedure during what plaintiff was told would be an exploratory operation). A battery theory has been the court's general approach in the first two situations; a negligence theory has been applied in the latter situation. For a full discussion on the distinction between these theories of liability, see Note, Informed Consent Liability, supra note 218, at 699-706.

219 Trichter, , Informed Consent: The Patient as an Individual, 15 Forum 455, 463 (1980)Google Scholar. This author suggested:

Id. at 462 (citing Medical Malpractice: The Patient Versus the Physician, A Study by the Subcomm. on Executive Reorganization, S. Doc. No. 20, 91st Cong., 1st Sess. (1969); Medical World News, Nov. 16, 1973, at 80; 5 The Hastings Center Report 19 (April 1, 1975); Goldsmith, The Myth About Informed Consent, 3 J. Leg. Med., Sept. 1975, at 17.

Conversely, Shearer found in examining them that “[t]he most common thread uniting the California OB-GYN malpractice verdicts of 1975 was that the plaintiff contended that the risks of the procedure were not explained beforehand.” Shearer, , Raphael, & Cattani, , A Survey of California OB-GYN Malpractice Verdicts in 1975 With Recommendations for Expediting Informed Consent, 3 Birth & Fam. J. 59, 64 (1976)CrossRefGoogle Scholar.

220 Trichter, supra note 219, at 462; see also Bachman, Doctors: Move Closer to your Patient?, 11(3) Trial no. 3, May/June 1975, at 25.

221 See, e.g., Goodlin, Low-Risk Obstetric Care for Low-Risk Mothers, 1980 Lancet I, 1017, 1018.

222 See generally Goldsmith, supra note 219.

223 Established by the National Institute of Child Health and Human Development. See supra note 138.

224 Zuspan, supra note 138, at 1028.

225 See, e.g., Capron, , Informed Consent in Catastrophic Disease Research and Treatment, 123 U. Pa. L. Rev. 340 (1974)CrossRefGoogle Scholar; Comment, Informed Consent: From Disclosure to Patient Participation in Medical Decisionmaking, 76 Nw. U.L. Rev. 172 (1981)Google Scholar [hereinafter cited as Comment, Patient Participation],

226 Comment, Patient Participation, supra note 225, at 174. “Studies of German concentration camps and Southern slave plantations indicate that the ultimate dehumanization is achieved through reducing persons to the status of dependent children, without the power to make decisions affecting their lives. See S. Elkins, Slavery: A Problem in American Institutional and Intellectual Life (rev. ed. 1976).“Id. at 175 n.17. Other benefits accruing to the doctor-patient relationship and treatment decisions include the following: (1) increasing rational decision-making, J. Katz & A. Capron, Catastrophic Diseases: Who Decides What? 79, 88-90 (1975); (2) diminishing the potential for duress, id. at 85-87; (3) encouraging the self-scrutiny of medical professional, id. at 87-88; (4) increasing the potential for positive patient participation in and response to therapy, id. at 79-115 (“A well-informed patient, after all, is more alert to facts about his own condition that may be of great significance to the investigator, and he also feels freer about reporting what he experiences to his physician, without fear of upsetting him or losing his support.” Id. at 89); and (5) enabling the patient to prepare psychologically for the treatment. I. Janis, Psychological Stress 352-53 (1958). The benefits for physicians are also described in Trichter & Lewis, supra note 217, at 166-68.

227 Chez, , Fox, , Hobbins, , Peckham, & Peske, , Monitor Every Patient in Labor?, 12 Patient Care 136, 148 (1978)Google Scholar.

228 This occurs despite the fact that the American Hospital Association presented a Patient's Bill of Rights which recognizes the benefits and affirms existing legal rights:

Comment, Patients’ Rights and Informed Consent: An Emergency Case for Hospitals?, 12 Cal. W. L. Rev. 406, 407 n.7 (1976).

229 L.A. CIBILS, supra note 12, at 478.

230 U.S. Dep‘t of Health, Education and Welfare, supra note 26, at 170. “[WJhen women make choices concerning medical intervention they are likely to be accused of jeopardizing the lives and well-being of their infants.” Steinfels, supra note 165, at 10; see also L.A. Cibils, supra note 12, at 478.

231 Scanlon, , Routine Neonatal Procedures: Risk/Benefit Calculation and Informed Consent, 7 Birth & Fam. J. 219, 221 (1980)CrossRefGoogle Scholar. He also noted that blanket consent forms are legally ineffective. Id. at 222.

232 Shearer, Rapahel & Cattani, supra note 220, at 64.

233 Id.

234 Id.

235 See supra notes 39-73 and accompanying text. One commentator has offered a detailed list of guidelines for the physician to ensure that enough information is exchanged and is in a manner comprehensible to the patient. Comment, Patient Participation, supra note 225, at 192-95. Among these guidelines are the following: “The physician should describe the proposed treatment, including the actual procedures to be followed, in detail… . [He should also describe the] potential benefits of the treatment and explain the treatment's efficacy in bringing about those benefits … . [and] the alternative methods of treating the patient's condition … .“Id. at 192-93. The author notes that “this requirement will compel the physician to engage in a degree of self-scrutiny with respect to the necessity for the proposed treatment… . Increased self-scrutiny on the physician's part will reduce the risk that the proposed treatment is unnecessary or inappropriate for the patient.” Id. at 193 n.3.

Id. at 193; Shearer, Raphael & Cattani suggest another means of imparting information and encouraging questions: the use of group classes. Shearer, Raphael & Cattani, supra note 219, at 64. Patients, however, are not obligated to ask for information about medical procedures; it is the physician's legal duty to take the initiative in making the disclosure. Meisel & Roth, Toward an Informed Discussion of Informed Consent: A Review and Critique of the Empirical Studies, 25 Ariz. L. Rev. 265, 275(1983).

The physician should inform the patient that he or she has the right to refuse treatment or choose one of the alternatives which has been discussed at the session.

The physician's willingness to perform any alternative treatment that the patient chooses, or to help the patient find a specialist qualified to perform the chosen alternative, should also be conveyed. Compliance with this guideline should alert the patient to his or her full freedom to choose one of the alternatives discussed at the session, without the patient having to rely solely upon his or her own resources in locating a physician willing to perform the preferred alternative.

Comment, Patient Participation, supra note 225, at 194.

236 Brody, & Thompson, , The Maximum Strategy in Modern Obstetrics, 12 J. of Fam. Pract. 977, 978 (1981)Google Scholar.

237 Id. at 979.

238 In general, nurse-midwives’ philosophies expressed in the American College of Nurse-Midwives Functions, Standards & Qualifications (revised and approved April, 1983), is that the woman and her family should be encouraged to participate in Health care decision-making throughout the pregnancy and birth.

Note, Childbearing and Nurse-Midwives: A Woman's Right to Choose, 58 N.Y.U. L. Rev. 661, 668 (1983)Google Scholar (citation omitted). A recent study suggests significant benefits of “low-risk” obstetrical care for low-risk mothers who were encouraged to participate in decisions concerning their intrapartum care. Outcomes of 500 births at the alternative birth center (ABC) at the University of California, Davis Medical Center were compared with low-risk pregnancy outcomes and delivery rooms. In the ABC, there was very little obstetric intervention. Policies included maternal choice of position for giving birth, no IV fluids, eating and drinking as desired, inclusion of siblings over four years, no EFM, minimal narcotics (i.e. 75 mg. pethidine) used by six percent of the women, and other policies encouraging a relaxed atmosphere and patient choice.

In the standard labor and delivery room, all mothers had IV fluids, 81% had EFM, 29% had epidural anesthesia, 69% had more than 75 mg. pethidine. Goodlin states that the good condition of the ABC infants without EFM and special obstetric care was unexpected. He believes that the tranquil atmosphere and family support may have enhanced mothers’ relaxation and thus improved uterine blood flow. Goodlin, supra note 221, at 1018.

239 See Goodlin, supra note 221, at 1018.