Eddy et al.
tients. There is a great deal of difficulty in looking at raw numbers. I have been asked to elaborate on our recommendation for radiation therapy before exenterative procedures in patients with Stage IV. It was remarkable that three patients with stage IVA who were treated with radiation were noted to have persistent disease at exenteration and all were cured. I think that this is probably due to good fortune. It was noteworthy that every patient treated for palliation didn't get very much and lived a relatively short period of time. This makes us more interested in being aggressive in considering exenteration in these patients. Another interesting subgroup are those with stage IVB, all of whom died in relatively short periods of time. They also received external therapy, as it was most difficult to give intracavitary therapy for "palliation." Three of these patients were classified as having stage IV disease, only
August 1991 Am J Obstet Gynecol
on the basis of positive inguinal nodes. I am tempted to recommend groin dissection and radiation therapy for such patients with consideration for exenteration in patients with persistent central disease. I know that this recommendation is controversial and not based on fact. How are patients with early-stage disease and prior radiation therapy treated ? We were fortunate in that most of our early-stage disease was stage I; some of these patients had microinvasive cancer that was diagnosed after colpectomy. Four of eight such patients were treated by colpectomy alone. Two patients were treated by external radiation therapy, one by external beam therapy and colpectomy, and one by intracavitary radium and external beam therapy. Those eight patients had local control of disease as a result of the therapy.
Analysis of 500 obstetric and gynecologic malpractice claims: Causes and prevention Charles J. Ward, MD Atlanta, Georgia Five hundred obstetric and gynecologic malpractice litigation claims were analyzed to determine the incidence of claims that could not be defended because of breach of standards of care, problems with documentation, or both. Of the 500 claims, 294 were obstetric and 206 were gynecologic. Of the obstetric claims,.79 (27%) were indefensible because of breaches of standards of care (71 %), problems with documentation (5%), or both (24%). Of the 206 gynecologic claims, 45 (22%) were indefensible because of breaches of standards of care (62%), problems with documentation (24%), or both (13%). The incidence of indefensible Obstetric and gynecologic claims was 25%. Indefensible claims were analyzed to determine the common medical and surgical problems that instigated the malpractice suits. Recommendations are made that should reduce the incidence of indefensible malpractice suits. (AM J OaSTET GYNECOl 1991 ;165:298-306.)
Key words: Breach of standards of care, documentation, malpractice
The malpractice crisis has had significant impact on obstetricians, gynecologists, and the women who seek their services. The 1990 American College of Obstetricians and Gynecologists (ACOG) Professional Liability Survey' reFrom the Department of Gynecology and Obstetrics, Emory University School of Medicine. Presented as Official Guest at the Fifty-third Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists, Hot Springs, Virginia, January 27-30, 1991, Reprint l'equests: Charles J. Ward, M D , 465 Winn Way, Suite 140, Decatur, GA 30030. 616130760
vealed that 78% of obstetricians and gynecologists have been sued at least once; 37% have been sued three or more times. The survey also revealed that 62% stopped practicing obstetrics before the age of 55 years and that 31 % discontinued obstetrics before the age of 45 years. Twenty-four percent of obstetricians have decreased their level of high-risk obstetrics. Another survey" revealed that 36% of obstetric residents have been sued while in training. The 1990 ACOG survey' noted that obstetric malpractice claims outnumbered gynecologic malpractice claims by 58% to 42%. In this study of 500 claims the
Malpractice claims analysis 299
Volume 165 Number 2
Table I. Analysis of 500 obstetric and gynecologic malpractice claims Reason indefensible
Obstetric Gynecologic TOTAL
No. of claims
No. defensible
No indefensible
294 206 500
215
79 45
161 376
124
Breach of standards No.
56 28 84
incidence of obstetric claims was 59% and gynecologic claims 41 %. I reviewed 500 obstetric and gynecologic claims to determine the causes of the claims and the percentage of indefensible claims. The indefensible claims were further analyzed to determine whether they were indefensible because of a breach in the standards of care, lack of documentation, or both. Recommendations are made that may significantly reduce further claims.
Material and methods Between 1983 and 1988, I reviewed 500 obstetric and gynecologic malpractice claims primarily from the southeastern United States. The 500 consecutive cases, which were supplied by several insurance companies and attorneys, are analyzed in this report. A case was categorized as indefensible when the treatment rendered was considered to be below the degree of care generally exercised by physicians under the same or similar circumstances. This standard of care was established after consultation of the following sources and references: (1) ACOG's Standards for Obstetric-Gynecologic Seroices, editions I through 6; (2) AGOC Technical Bulletins , 1968 through 1988; (3) articles indexed in the National Library of Medicine's MEDLARS database; and (4) ACOG Committee Opinions, Nos. 11 through 64. Deviation from these standards without reasonable explanation was classified as being indefensible. Methods of therapy and procedures that might be controversial but were documented as acceptable through literature searches were classified as defensible and not malpractice. A poor outcome, or "maloccurrence," was never classified as malpractice unless it resulted from a direct deviation from the established standards. In this review substandard care per se did not necessarily render a case indefensible unless a cause-and-effect relationship existed between the substandard care and the poor outcome.
Results The 500 claims were divided into 294 obstetric claims and 206 gynecologic claims (Table I). Of the obstetric claims, 79 (27%) were classified as
I
Lack of documentation
%
No.
71
4 11
62
68
15
I
Combination
%
No.
5 24 12
19 6
25
I
%
% Indefensible
24
27
13
20
22 25
indefensible. Of these, 56 (71%) breached the standards of care, 4 (5 %) had inadequate documentation, and 19 (24%) had both problems. Of the gynecologic claims, 45 (22%) were classified as indefensible. Of these, 28 (62 %) breached the standards of care, II (24%) had inadequate documentation, and 6 (13 %) had both deficiencies. Obstetric cases. Many of the obstetric claims comprised several clinical problems, making classification difficult. These cases were categorized according to the problem that instigated the malpractice suit (Tables IIA through lID) . Several problems common to the indefensible obstetric claims involved cord-placental problems, stillbirths, presence of meconium, fetal distress, dystocia of labor, abnormal presentations other than breech, cephalopelvic disproportion, brain damage, perinatal deaths, infant trauma, and vaginal birth after cesarean section. These claims could not be defended because of failure to (I) appropriately monitor or record the fetal heart rate with auscultation or electronic fetal heart monitoring, (2) recognize and act on potentially ominous fetal heart rate tracings, (3) recognize and appropriately manage dystocia of labor, (4) administer oxytocin according to ACOG guidelines, (5) have cesarean capabilities within 30 minutes without a reasonable explanation for the delay, (6) properly resuscitate the newborn, (7) respond to nurses' calls in a timely and appropriate manner when notified of potential problems, or (8) notify a physician when a nurse midwife encountered a high-risk situation during labor. The postmaturity claims that could not be defended were caused by problems related to the use and misuse of antepartum fetal surveillance. The indefensible cases of shoulder dystocia were so classified because the obstetricians ignored the risk factors of maternal diabetes, obesity, and fetal macrosomia coupled with dystocia of labor. Breech deliveries were judged to be indefensible when there was improper use of oxytocin and failure to recognize dysfunctional labor. In the indefensible forceps-vacuum extractor cases, physicians failed to evaluate and recognize d ystocia of labor and attempted midforceps procedures that resulted in significant infant morbidity.
300
August 1991 Am J Obstet Gynecol
Ward
Table IIA. Anqlysis of obstetric cases: Prenatal labor and delivery Reason indefensible Cause
No. of claims
No. defensible
No. indefensible
Cord-placenta problems Abruptio placentae Prolapse of cord Cord accidents Placenta problems Stillborn Problems involving meconium Postmaturity Shoulder dystocia Premature rupture of membranes Breech Fetal distress Forceps-vacuum extractors Prematurity Pregnancy-induced hypertension Oxytocin Twins Miscellaneous delivery problems Anesthesia Dystocia of labor Chorioamnionitis Abnormal presentation Cephalopelvic disproportion Premature labor
10 5 3 1 14 13 II II 10 10 9 8 7 7 6 5 5 5 3 2 2 1 1
9 4 3 1 9 7 5 8 10 4 4 5 7 5 0 5 5 5 I 2
1 1 0 0 5 6 6 3 0 6 5 3 0 2 6 0 0 0 2 0 1
I
1 1
Breach of standards
1
1
Lack of documentation
Combination
5 4 5 2 5 5 3
1 2
I 4
I
0
Table lIB. Analysis of obstetric cases: Problems in newborn Reason indefensible Cause
Brain damage Congenital anomalies Neonatal seizures Circumcision Infections in newborn Herpes Miscellaneous Perinatal death Infant trauma Respiratory distress
No. defensible
No. indefensible
Breach of standards
8 I 0
4
6 6
16 8 6 2
3 3 3 3 2
3 3 2 2 2
No. of claims
24 9
When nurses failed to notify the physician or the physician failed to respond in a timely and appropriate manner to the obvious signs and symptoms of pregnancy-induced hypertension, the claims could not be defended. Failure to diagnose a major congenital anomaly on a mid pregnancy ultrasonogram by a physician who implied he possessed such diagnostic skills rendered one claim indefensible. Circumcision claims became indefensible when electrocautery machines were improperly used or proper consent forms had not been signed. In cases of abortion, indefensible claims arose from physicians' failure to adequately inform patients as to the signs and symptoms of infection, failure to recog-
4
I
Lack of documentation
I
Combination
4
I
3
0 0 I I
0
nize and appropriately treat the postoperative complications of infection resulting in serious morbidity and extensive surgery, and allowing physician's assistants to manage serious complications without adequate physician supervision. Maternal death claims could not be defended because the physicians failed to recognize and appropriately treat sepsis; administer a general anesthetic and monitor the patient properly, resulting in an unrecognized gastric aspiration; administer oxytocin properly, resulting in hyperstimulation, abruptio placentae, and disseminated intravascular coagulation; and deliver a known high-risk obstetric patient in a hospital setting (the patient was delivered in a birthing center). Claims related to x-ray examinations and drugs taken
Malpractice claims analysis 301
Volume 165 Number 2
Table IIC. Analysis of obstetric cases: Surgical problems Reason indefensible Cause
Abortion Postpartum hemorrhage Cesarean section Bladder injuries Postoperative infections Rupture of uterus Surgery in pregnancy Vaginal birth after cesarean section Episiotomy complications
No. defensible
No. of claim5
No. indefensible
25
22
5
o
4 3 3 3 3 2
2 2
2
5
Lack of documentation
I
I
3
Combination
2
1
o
3 3 3
o o
1
1
o
2
2
Breach of standards
Table lID. Analysis of obstetric cases: Medical problems Reason indefensible Cause
Maternal deaths X-ray examinations and drugs in pregnancy Miscellaneous Amniotic fluid embolism Postpartum cerebrovascular accident Disseminated intravascular coagulation defect
No. of claims
13 14
5 2
1
No. defensible
No. indefensible
7 10
6
6
4
4
5
0 0 0
2 1
during pregnancy were classified as indefensible when there was no evidence that the physician had attempted to ascertain whether the patient was pregnant before ordering x-ray examinations or prescribing medications contraindicated in pregnancy. Gynecologic cases. The leading gynecologic claim (Tables lilA and lIIB) was unsatisfactory sterilization. When a physician failed to carry out a recognized surgical sterilization procedure properly and the patient became pregnant, the claim could not be defended. Failure to obtain signed consent forms for sterilization also contributed to indefensible suits. Although injury to the genitourinary tract was the second major gynecologic malpractice claim, it accounted for the highest number of indefensible gynecologic claims. The claims were indefensible not because of the original injury but because the physician failed to recognize the signs and symptoms of the injury and therefore failed to bring about a timely repair of the irtiury, leading to permanent damage in two cases. Three of the claims were rendered indefensible because of lack of documentation in either the office or hospital records to justify the original surgery. When a nurse failed to notify a physician of signs and symptoms of wound infection, or the physician failed to respond in a timely manner, the claim was
Breach of standards
I
Lack of documentation
I
Combination
0
judged indefensible. In one postoperative complication case, an irrigation needle was lost in the abdomen during a microsurgical procedure, resulting in an injury to the bowel and a need for further surgery. The indefensible ectopic pregnancy claims resulted from several different problems. When the patient was initially seen with the classic signs of ectopic pregnancy and an appropriate investigation was not conducted, the case was deemed malpractice. When an elective abortion was attempted, and the tissue obtained was not diagnostic of an intrauterine gestation, and no further evaluation was conducted, the claim could not be defended. A prolonged vaginal procedure, during which the patient was unfavorably positioned in the stirrups, resulted in bilateral foot drop and an indefensible claim of nerve injury. Intrauterine contraceptive device (IUD) claims that could not be defended involved insertion of an IUD even though it was contraindicated for medical reasons, failure to investigate a lost IUD string, and failure to explain the potential risks of using an IUD. Failure to diagnose breast cancer has become a more frequent claim. The cases in this series could not be defended because of physician failure to evaluate obvious breast masses with mammogram, surgical con-
302
Ward
August 1991 Am J Obstet Gynecol
Table IlIA. Analysis of gynecologic cases: Surgical Reason indefensible Cause Sterilization Injury to genitourinary tract Ureter Vesicovaginal fistula Urethra Bladder Postoperative complications Wound infection Foreign body Death Wound dehiscence Adhesions Miscellaneous Ectopic pregnancy Laparoscopy complications Bowel injury Miscellaneous Curettage Nerve injury Appendicitis Rectovaginal fistula Bowel injury Miscellaneous surgical problems
No. of clairns
No. defensible
No. indefensible
30
26
4
11 9 4 3
8 7 3 2
3 2 1 1
8 6 3 2 2 1 17
6 2 3 2 2 1 14
2 4 0 0 0 0 3
8 7
5
3 0 0 1 0 0 2 4
11 6 5 5 3 18
7
11 5 5 5 1 14
sultation, or both; failure to follow up on a suspicious mammogram report; and failure to perform a breast examination during the patient's annual physical examination. The improper management of cervical pathologic findings noted on Papanicolaou smears led to claims of malpractice. When the pathologist suggested or the findings of the Papanicolaou smear warranted colposcopic examination and it was not performed, the defense of invasive cancers of the cervix was impossible. The miscellaneous indefensible medical problem involved the misfiling of a laboratory report by office personnel. The physician did not discover that a patient had had positive test results for gonorrhea until after a full-blown case of pelvic inflammatory disease developed. The physician was held liable for the error.
Comment This review confirms that documentation is a significant problem in medical recordkeeping. Twenty-four percent of the gynecologic cases and 5 % of the obstetric cases were found indefensible solely because of failure to document records in a complete and contemporaneous manner. Failure to document records adequately was an important factor in another 24% of obstetric cases and 13% of gynecologic cases (Table I). In a courtroom the finest care rendered under the best circumstances may be difficult or impossible to defend if it is not documented. An altered record also will make a
Breach of standards
I
Lack of docurnentation
I
Cornbination
3 2 1
1 3
2
3
2 3
case impossible to defend. In front of a jury a physician's credibility can easily be destroyed. When faced with a difficult obstetric or gynecologic problem, a physician should write out a plan of therapy or get consultation. It is easier to defend the judgment of two physicians even if the outcome is bad. Juries generally accept such judgments over those of experts who never attended the patient. It must be stressed that judgmental decisions, even if they result in maloccurrence, are defensible and do not constitute malpractice. Several specific areas in the obstetric cases need to be addressed. Oxytocin was frequently a primary or contributing factor in the obstetric malpractice claims. The ACOG Standards for Obstetric-Gynecologic Services and the ACOG Technical Bulletin No. 110, offer quite specific guidelines that, if followed, would have made many claims defensible. At its best, electronic fetal heart monitoring has serious limitations. 5°' In this study the m~or problems relating to the electronic fetal heart monitor were failure to recognize and properly classify decelerations, respond to calls from nurses concerning potentially ominous patterns, form a resonable management plan when potentially ominous patterns were observed, and obtain a reasonably acceptable or readable tracing. Two cases in this retrospective analysis were claims involving infants with neurologic impairments that were successfully defended by evidence gained through examination of the cord and placenta. Recent research 6
Malpractice claims analysis 303
Volume 165 Number 2
Table IIIB. Analysis of gynecologic cases: Medical Reason indefensible Cause IUD Failure to diagnose breast cancer Pelvic inflammatory disease Management of cervical pathologic findings Management of endometriosis Medical errors Management of human papillomavirus infections Miscellaneous medical problems
No. of claims
No. defensible
No. indefensible
Breach of standards
11 9 7 3
6 5 5
4
5
I
2 2
5 4
3
2 I
3 I I
0 I 0
II
lO
has demonstrated that neurologic impairment in an infant is not prima facie evidence of substandard care or negligence by the obstetrician at birth. Rather, pathologic conditions of the cord and placenta are increasingly recognized as the major cause of neurologic impairment. 7 These conditions often develop during the prenatal period long before labor and delivery; although they cannot be prevented by the best of obstetric care, they can be identified by examining the placenta. If there is a maternal, fetal-newborn, or placentaumbilical cord condition that warrants study (Table IV), the attending physician should arrange for a placental examination. If the pathologist is not well versed in placental pathology, he or she can still help by recording measurements, taking photographs, and making slides that can be reviewed by a placental pathologist. Placental examination often reveals the cause of preterm labor, premature rupture of the membranes, intrauterine growth retardation, and antenatal hypoxia. Failure to recognize dystocia of labor was a complicating factor in several indefensible claims. Labor records that use the Friedman curveS would facilitate early recognition of the problem. Before medication contraindicated in pregnancy is prescribed or x-ray studies to evaluate gastrointestinal complaints are ordered, it is sensible to at least list the patient'S last menstrual period. If a question of pregnancy exists, it is imperative to test the patient for pregnancy before taking further action. Sterilization failures accounted for the largest number of gynecologic malpractice claims. The m~ority of these claims might have been prevented if the physician had given the patient printed material, such as an ACOG pamphlet on sterilization, that outlines the risks, complications, and failure rate of sterilization procedures. It should be stressed that pregnancy can occur after the procedure, and it should be documented in the patient's chart that this information was given and discussed.
I
Lack of documentation
I Combination
I
2
Table IV. Indications for placental examination Maternal Diabetes mellitus Pregnancy-induced hypertension Premature rupture of the membranes Preterm delivery «36 weeks) Postterm delivery (>42 weeks) Unexplained fever Poor obstetric history History of drug use or abuse Fetus-newborn Stillborn Neonatal death Multiple gestation Intrauterine growth retardation Congenital anomalies Erythroblastosis fetalis Transfer to neonatal intensive care unit Ominous fetal heart tracing Presence of meconium Apgar score
tients. There is a great deal of difficulty in looking at raw numbers. I have been asked to elaborate on our recommendation for radiation therapy before exenterative procedures in patients with Stage IV. It was remarkable that three patients with stage IVA who were treated with radiation were noted to have persistent disease at exenteration and all were cured. I think that this is probably due to good fortune. It was noteworthy that every patient treated for palliation didn't get very much and lived a relatively short period of time. This makes us more interested in being aggressive in considering exenteration in these patients. Another interesting subgroup are those with stage IVB, all of whom died in relatively short periods of time. They also received external therapy, as it was most difficult to give intracavitary therapy for "palliation." Three of these patients were classified as having stage IV disease, only
August 1991 Am J Obstet Gynecol
on the basis of positive inguinal nodes. I am tempted to recommend groin dissection and radiation therapy for such patients with consideration for exenteration in patients with persistent central disease. I know that this recommendation is controversial and not based on fact. How are patients with early-stage disease and prior radiation therapy treated ? We were fortunate in that most of our early-stage disease was stage I; some of these patients had microinvasive cancer that was diagnosed after colpectomy. Four of eight such patients were treated by colpectomy alone. Two patients were treated by external radiation therapy, one by external beam therapy and colpectomy, and one by intracavitary radium and external beam therapy. Those eight patients had local control of disease as a result of the therapy.
Analysis of 500 obstetric and gynecologic malpractice claims: Causes and prevention Charles J. Ward, MD Atlanta, Georgia Five hundred obstetric and gynecologic malpractice litigation claims were analyzed to determine the incidence of claims that could not be defended because of breach of standards of care, problems with documentation, or both. Of the 500 claims, 294 were obstetric and 206 were gynecologic. Of the obstetric claims,.79 (27%) were indefensible because of breaches of standards of care (71 %), problems with documentation (5%), or both (24%). Of the 206 gynecologic claims, 45 (22%) were indefensible because of breaches of standards of care (62%), problems with documentation (24%), or both (13%). The incidence of indefensible Obstetric and gynecologic claims was 25%. Indefensible claims were analyzed to determine the common medical and surgical problems that instigated the malpractice suits. Recommendations are made that should reduce the incidence of indefensible malpractice suits. (AM J OaSTET GYNECOl 1991 ;165:298-306.)
Key words: Breach of standards of care, documentation, malpractice
The malpractice crisis has had significant impact on obstetricians, gynecologists, and the women who seek their services. The 1990 American College of Obstetricians and Gynecologists (ACOG) Professional Liability Survey' reFrom the Department of Gynecology and Obstetrics, Emory University School of Medicine. Presented as Official Guest at the Fifty-third Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists, Hot Springs, Virginia, January 27-30, 1991, Reprint l'equests: Charles J. Ward, M D , 465 Winn Way, Suite 140, Decatur, GA 30030. 616130760
vealed that 78% of obstetricians and gynecologists have been sued at least once; 37% have been sued three or more times. The survey also revealed that 62% stopped practicing obstetrics before the age of 55 years and that 31 % discontinued obstetrics before the age of 45 years. Twenty-four percent of obstetricians have decreased their level of high-risk obstetrics. Another survey" revealed that 36% of obstetric residents have been sued while in training. The 1990 ACOG survey' noted that obstetric malpractice claims outnumbered gynecologic malpractice claims by 58% to 42%. In this study of 500 claims the
Malpractice claims analysis 299
Volume 165 Number 2
Table I. Analysis of 500 obstetric and gynecologic malpractice claims Reason indefensible
Obstetric Gynecologic TOTAL
No. of claims
No. defensible
No indefensible
294 206 500
215
79 45
161 376
124
Breach of standards No.
56 28 84
incidence of obstetric claims was 59% and gynecologic claims 41 %. I reviewed 500 obstetric and gynecologic claims to determine the causes of the claims and the percentage of indefensible claims. The indefensible claims were further analyzed to determine whether they were indefensible because of a breach in the standards of care, lack of documentation, or both. Recommendations are made that may significantly reduce further claims.
Material and methods Between 1983 and 1988, I reviewed 500 obstetric and gynecologic malpractice claims primarily from the southeastern United States. The 500 consecutive cases, which were supplied by several insurance companies and attorneys, are analyzed in this report. A case was categorized as indefensible when the treatment rendered was considered to be below the degree of care generally exercised by physicians under the same or similar circumstances. This standard of care was established after consultation of the following sources and references: (1) ACOG's Standards for Obstetric-Gynecologic Seroices, editions I through 6; (2) AGOC Technical Bulletins , 1968 through 1988; (3) articles indexed in the National Library of Medicine's MEDLARS database; and (4) ACOG Committee Opinions, Nos. 11 through 64. Deviation from these standards without reasonable explanation was classified as being indefensible. Methods of therapy and procedures that might be controversial but were documented as acceptable through literature searches were classified as defensible and not malpractice. A poor outcome, or "maloccurrence," was never classified as malpractice unless it resulted from a direct deviation from the established standards. In this review substandard care per se did not necessarily render a case indefensible unless a cause-and-effect relationship existed between the substandard care and the poor outcome.
Results The 500 claims were divided into 294 obstetric claims and 206 gynecologic claims (Table I). Of the obstetric claims, 79 (27%) were classified as
I
Lack of documentation
%
No.
71
4 11
62
68
15
I
Combination
%
No.
5 24 12
19 6
25
I
%
% Indefensible
24
27
13
20
22 25
indefensible. Of these, 56 (71%) breached the standards of care, 4 (5 %) had inadequate documentation, and 19 (24%) had both problems. Of the gynecologic claims, 45 (22%) were classified as indefensible. Of these, 28 (62 %) breached the standards of care, II (24%) had inadequate documentation, and 6 (13 %) had both deficiencies. Obstetric cases. Many of the obstetric claims comprised several clinical problems, making classification difficult. These cases were categorized according to the problem that instigated the malpractice suit (Tables IIA through lID) . Several problems common to the indefensible obstetric claims involved cord-placental problems, stillbirths, presence of meconium, fetal distress, dystocia of labor, abnormal presentations other than breech, cephalopelvic disproportion, brain damage, perinatal deaths, infant trauma, and vaginal birth after cesarean section. These claims could not be defended because of failure to (I) appropriately monitor or record the fetal heart rate with auscultation or electronic fetal heart monitoring, (2) recognize and act on potentially ominous fetal heart rate tracings, (3) recognize and appropriately manage dystocia of labor, (4) administer oxytocin according to ACOG guidelines, (5) have cesarean capabilities within 30 minutes without a reasonable explanation for the delay, (6) properly resuscitate the newborn, (7) respond to nurses' calls in a timely and appropriate manner when notified of potential problems, or (8) notify a physician when a nurse midwife encountered a high-risk situation during labor. The postmaturity claims that could not be defended were caused by problems related to the use and misuse of antepartum fetal surveillance. The indefensible cases of shoulder dystocia were so classified because the obstetricians ignored the risk factors of maternal diabetes, obesity, and fetal macrosomia coupled with dystocia of labor. Breech deliveries were judged to be indefensible when there was improper use of oxytocin and failure to recognize dysfunctional labor. In the indefensible forceps-vacuum extractor cases, physicians failed to evaluate and recognize d ystocia of labor and attempted midforceps procedures that resulted in significant infant morbidity.
300
August 1991 Am J Obstet Gynecol
Ward
Table IIA. Anqlysis of obstetric cases: Prenatal labor and delivery Reason indefensible Cause
No. of claims
No. defensible
No. indefensible
Cord-placenta problems Abruptio placentae Prolapse of cord Cord accidents Placenta problems Stillborn Problems involving meconium Postmaturity Shoulder dystocia Premature rupture of membranes Breech Fetal distress Forceps-vacuum extractors Prematurity Pregnancy-induced hypertension Oxytocin Twins Miscellaneous delivery problems Anesthesia Dystocia of labor Chorioamnionitis Abnormal presentation Cephalopelvic disproportion Premature labor
10 5 3 1 14 13 II II 10 10 9 8 7 7 6 5 5 5 3 2 2 1 1
9 4 3 1 9 7 5 8 10 4 4 5 7 5 0 5 5 5 I 2
1 1 0 0 5 6 6 3 0 6 5 3 0 2 6 0 0 0 2 0 1
I
1 1
Breach of standards
1
1
Lack of documentation
Combination
5 4 5 2 5 5 3
1 2
I 4
I
0
Table lIB. Analysis of obstetric cases: Problems in newborn Reason indefensible Cause
Brain damage Congenital anomalies Neonatal seizures Circumcision Infections in newborn Herpes Miscellaneous Perinatal death Infant trauma Respiratory distress
No. defensible
No. indefensible
Breach of standards
8 I 0
4
6 6
16 8 6 2
3 3 3 3 2
3 3 2 2 2
No. of claims
24 9
When nurses failed to notify the physician or the physician failed to respond in a timely and appropriate manner to the obvious signs and symptoms of pregnancy-induced hypertension, the claims could not be defended. Failure to diagnose a major congenital anomaly on a mid pregnancy ultrasonogram by a physician who implied he possessed such diagnostic skills rendered one claim indefensible. Circumcision claims became indefensible when electrocautery machines were improperly used or proper consent forms had not been signed. In cases of abortion, indefensible claims arose from physicians' failure to adequately inform patients as to the signs and symptoms of infection, failure to recog-
4
I
Lack of documentation
I
Combination
4
I
3
0 0 I I
0
nize and appropriately treat the postoperative complications of infection resulting in serious morbidity and extensive surgery, and allowing physician's assistants to manage serious complications without adequate physician supervision. Maternal death claims could not be defended because the physicians failed to recognize and appropriately treat sepsis; administer a general anesthetic and monitor the patient properly, resulting in an unrecognized gastric aspiration; administer oxytocin properly, resulting in hyperstimulation, abruptio placentae, and disseminated intravascular coagulation; and deliver a known high-risk obstetric patient in a hospital setting (the patient was delivered in a birthing center). Claims related to x-ray examinations and drugs taken
Malpractice claims analysis 301
Volume 165 Number 2
Table IIC. Analysis of obstetric cases: Surgical problems Reason indefensible Cause
Abortion Postpartum hemorrhage Cesarean section Bladder injuries Postoperative infections Rupture of uterus Surgery in pregnancy Vaginal birth after cesarean section Episiotomy complications
No. defensible
No. of claim5
No. indefensible
25
22
5
o
4 3 3 3 3 2
2 2
2
5
Lack of documentation
I
I
3
Combination
2
1
o
3 3 3
o o
1
1
o
2
2
Breach of standards
Table lID. Analysis of obstetric cases: Medical problems Reason indefensible Cause
Maternal deaths X-ray examinations and drugs in pregnancy Miscellaneous Amniotic fluid embolism Postpartum cerebrovascular accident Disseminated intravascular coagulation defect
No. of claims
13 14
5 2
1
No. defensible
No. indefensible
7 10
6
6
4
4
5
0 0 0
2 1
during pregnancy were classified as indefensible when there was no evidence that the physician had attempted to ascertain whether the patient was pregnant before ordering x-ray examinations or prescribing medications contraindicated in pregnancy. Gynecologic cases. The leading gynecologic claim (Tables lilA and lIIB) was unsatisfactory sterilization. When a physician failed to carry out a recognized surgical sterilization procedure properly and the patient became pregnant, the claim could not be defended. Failure to obtain signed consent forms for sterilization also contributed to indefensible suits. Although injury to the genitourinary tract was the second major gynecologic malpractice claim, it accounted for the highest number of indefensible gynecologic claims. The claims were indefensible not because of the original injury but because the physician failed to recognize the signs and symptoms of the injury and therefore failed to bring about a timely repair of the irtiury, leading to permanent damage in two cases. Three of the claims were rendered indefensible because of lack of documentation in either the office or hospital records to justify the original surgery. When a nurse failed to notify a physician of signs and symptoms of wound infection, or the physician failed to respond in a timely manner, the claim was
Breach of standards
I
Lack of documentation
I
Combination
0
judged indefensible. In one postoperative complication case, an irrigation needle was lost in the abdomen during a microsurgical procedure, resulting in an injury to the bowel and a need for further surgery. The indefensible ectopic pregnancy claims resulted from several different problems. When the patient was initially seen with the classic signs of ectopic pregnancy and an appropriate investigation was not conducted, the case was deemed malpractice. When an elective abortion was attempted, and the tissue obtained was not diagnostic of an intrauterine gestation, and no further evaluation was conducted, the claim could not be defended. A prolonged vaginal procedure, during which the patient was unfavorably positioned in the stirrups, resulted in bilateral foot drop and an indefensible claim of nerve injury. Intrauterine contraceptive device (IUD) claims that could not be defended involved insertion of an IUD even though it was contraindicated for medical reasons, failure to investigate a lost IUD string, and failure to explain the potential risks of using an IUD. Failure to diagnose breast cancer has become a more frequent claim. The cases in this series could not be defended because of physician failure to evaluate obvious breast masses with mammogram, surgical con-
302
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August 1991 Am J Obstet Gynecol
Table IlIA. Analysis of gynecologic cases: Surgical Reason indefensible Cause Sterilization Injury to genitourinary tract Ureter Vesicovaginal fistula Urethra Bladder Postoperative complications Wound infection Foreign body Death Wound dehiscence Adhesions Miscellaneous Ectopic pregnancy Laparoscopy complications Bowel injury Miscellaneous Curettage Nerve injury Appendicitis Rectovaginal fistula Bowel injury Miscellaneous surgical problems
No. of clairns
No. defensible
No. indefensible
30
26
4
11 9 4 3
8 7 3 2
3 2 1 1
8 6 3 2 2 1 17
6 2 3 2 2 1 14
2 4 0 0 0 0 3
8 7
5
3 0 0 1 0 0 2 4
11 6 5 5 3 18
7
11 5 5 5 1 14
sultation, or both; failure to follow up on a suspicious mammogram report; and failure to perform a breast examination during the patient's annual physical examination. The improper management of cervical pathologic findings noted on Papanicolaou smears led to claims of malpractice. When the pathologist suggested or the findings of the Papanicolaou smear warranted colposcopic examination and it was not performed, the defense of invasive cancers of the cervix was impossible. The miscellaneous indefensible medical problem involved the misfiling of a laboratory report by office personnel. The physician did not discover that a patient had had positive test results for gonorrhea until after a full-blown case of pelvic inflammatory disease developed. The physician was held liable for the error.
Comment This review confirms that documentation is a significant problem in medical recordkeeping. Twenty-four percent of the gynecologic cases and 5 % of the obstetric cases were found indefensible solely because of failure to document records in a complete and contemporaneous manner. Failure to document records adequately was an important factor in another 24% of obstetric cases and 13% of gynecologic cases (Table I). In a courtroom the finest care rendered under the best circumstances may be difficult or impossible to defend if it is not documented. An altered record also will make a
Breach of standards
I
Lack of docurnentation
I
Cornbination
3 2 1
1 3
2
3
2 3
case impossible to defend. In front of a jury a physician's credibility can easily be destroyed. When faced with a difficult obstetric or gynecologic problem, a physician should write out a plan of therapy or get consultation. It is easier to defend the judgment of two physicians even if the outcome is bad. Juries generally accept such judgments over those of experts who never attended the patient. It must be stressed that judgmental decisions, even if they result in maloccurrence, are defensible and do not constitute malpractice. Several specific areas in the obstetric cases need to be addressed. Oxytocin was frequently a primary or contributing factor in the obstetric malpractice claims. The ACOG Standards for Obstetric-Gynecologic Services and the ACOG Technical Bulletin No. 110, offer quite specific guidelines that, if followed, would have made many claims defensible. At its best, electronic fetal heart monitoring has serious limitations. 5°' In this study the m~or problems relating to the electronic fetal heart monitor were failure to recognize and properly classify decelerations, respond to calls from nurses concerning potentially ominous patterns, form a resonable management plan when potentially ominous patterns were observed, and obtain a reasonably acceptable or readable tracing. Two cases in this retrospective analysis were claims involving infants with neurologic impairments that were successfully defended by evidence gained through examination of the cord and placenta. Recent research 6
Malpractice claims analysis 303
Volume 165 Number 2
Table IIIB. Analysis of gynecologic cases: Medical Reason indefensible Cause IUD Failure to diagnose breast cancer Pelvic inflammatory disease Management of cervical pathologic findings Management of endometriosis Medical errors Management of human papillomavirus infections Miscellaneous medical problems
No. of claims
No. defensible
No. indefensible
Breach of standards
11 9 7 3
6 5 5
4
5
I
2 2
5 4
3
2 I
3 I I
0 I 0
II
lO
has demonstrated that neurologic impairment in an infant is not prima facie evidence of substandard care or negligence by the obstetrician at birth. Rather, pathologic conditions of the cord and placenta are increasingly recognized as the major cause of neurologic impairment. 7 These conditions often develop during the prenatal period long before labor and delivery; although they cannot be prevented by the best of obstetric care, they can be identified by examining the placenta. If there is a maternal, fetal-newborn, or placentaumbilical cord condition that warrants study (Table IV), the attending physician should arrange for a placental examination. If the pathologist is not well versed in placental pathology, he or she can still help by recording measurements, taking photographs, and making slides that can be reviewed by a placental pathologist. Placental examination often reveals the cause of preterm labor, premature rupture of the membranes, intrauterine growth retardation, and antenatal hypoxia. Failure to recognize dystocia of labor was a complicating factor in several indefensible claims. Labor records that use the Friedman curveS would facilitate early recognition of the problem. Before medication contraindicated in pregnancy is prescribed or x-ray studies to evaluate gastrointestinal complaints are ordered, it is sensible to at least list the patient'S last menstrual period. If a question of pregnancy exists, it is imperative to test the patient for pregnancy before taking further action. Sterilization failures accounted for the largest number of gynecologic malpractice claims. The m~ority of these claims might have been prevented if the physician had given the patient printed material, such as an ACOG pamphlet on sterilization, that outlines the risks, complications, and failure rate of sterilization procedures. It should be stressed that pregnancy can occur after the procedure, and it should be documented in the patient's chart that this information was given and discussed.
I
Lack of documentation
I Combination
I
2
Table IV. Indications for placental examination Maternal Diabetes mellitus Pregnancy-induced hypertension Premature rupture of the membranes Preterm delivery «36 weeks) Postterm delivery (>42 weeks) Unexplained fever Poor obstetric history History of drug use or abuse Fetus-newborn Stillborn Neonatal death Multiple gestation Intrauterine growth retardation Congenital anomalies Erythroblastosis fetalis Transfer to neonatal intensive care unit Ominous fetal heart tracing Presence of meconium Apgar score
