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THE EFFECT OF CHANGES IN TORT LAWS ON CESAREAN SECTION RATES IN THE UNITED STATES by ALLISON JEAN TAYLOR BEVERLY A. MULVIHILL, COMMITTEE CHAIR MEREDITH L. KILGORE MICHAEL A. MORRISEY LEONARD J. NELSON III MARTHA SLAY WINGATE A DISSERTATION Submitted to the graduate faculty of The University of Alabama at Birmingham, in partial fulfillment of the requirements for the degree of Doctor of Public Health BIRMINGHAM, ALABAMA 2011
Transcript

THE EFFECT OF CHANGES IN TORT LAWS ON CESAREAN SECTION RATES IN THE UNITED STATES

by ALLISON JEAN TAYLOR

BEVERLY A. MULVIHILL, COMMITTEE CHAIR MEREDITH L. KILGORE MICHAEL A. MORRISEY LEONARD J. NELSON III

MARTHA SLAY WINGATE

A DISSERTATION

Submitted to the graduate faculty of The University of Alabama at Birmingham, in partial fulfillment of the requirements for the degree of

Doctor of Public Health

BIRMINGHAM, ALABAMA

2011

ii

THE EFFECT OF CHANGES IN TORT LAWS ON CESAREAN SECTION RATES IN THE UNITED STATES

ALLISON JEAN TAYLOR

MATERNAL AND CHILD HEALTH

ABSTRACT

“Defensive medicine”, medical practice decisions based on fear of malpractice

litigation and where risks may outweigh health and cost benefits, is a proposed

contributor to increasing cesarean rates in the U.S. Some studies suggest that changes in

laws governing medical malpractice actions may decrease the cesarean rate by relieving

pressures driving defensive medicine.

This study examined whether, in states that have adopted certain tort reform

measures, the probability of having a cesarean delivery is lower following

implementation of the reform measures. A database of state legislation and court

decisions and National Center for Health Statistics natality data files (1991-2004) were

used to model state and year fixed effects. Tort laws were grouped as those directly

affecting recovery in a legal action (non-economic damages caps, collateral source offset)

and those with an indirect effect (contingency fees limits, periodic payments, joint and

several liability rule, statutes of limitations, statutes of repose) and examined separately

as individual reforms. The analysis was limited to live singleton births and adjusted for

maternal age, race, education, marital status, diabetes, hypertension, tobacco use, pre-

natal care utilization, gestational age, birthweight, and non-vertex presentation.

Coefficients ranged from -0.01-0.03 for individual tort reforms. The effect was

slightly greater for direct than for indirect tort reforms, -0.009 compared to -0.004. Non-

iii

economic damages caps were associated with a small reduction in cesarean rates, with a

slightly greater effect shown for collateral source laws and statutes of limitations.

The findings may indicate that there is little effect of tort reform on defensive

medicine, for which cesarean was a marker. It is also possible that the minimal effect

observed is due to small numbers of tort law changes during the study period or that

unobserved time-varying factors influencing the decision to perform cesarean delivery

exerted a greater effect than tort reform. Based on findings of this study and several

others, tort reforms alone are likely insufficient to reduce defensive medicine. If tort

reforms do not contribute to reduction in cesarean rates, attention must be focused on

other approaches to influence clinical practice patterns and to achieve rate reduction

goals.

Keywords: tort reform, defensive medicine, cesarean, obstetric

iv

DEDICATION To my late father, Lincoln H. Taylor, Jr. The knowledge that it was very important to him that I complete this degree fueled my determination when I might otherwise have been inclined to consider abandoning this endeavor.

v

ACKNOWLEDGMENTS

I acknowledge the following persons for their assistance and guidance:

My committee chair, Dr. Beverly A. Mulvihill, and committee members, Dr. Michael A. Morrisey, Dr. Meredith L. Kilgore, Dr. Martha Slay Wingate, and Leonard J. Nelson III.

Dr. Donna Petersen and the late Dr. Greg Alexander for recruiting me to the Department of Maternal and Child Health and encouraging my research interests.

Steven Kazan, Esq., former boss and renowned trial lawyer, for whom I worked as a paralegal on medical negligence cases in Oakland, California for ten years.

Dr. Elizabeth Delzell, Dr. Philip Cole, and Dr. Gerald McGwin, UAB Department of Epidemiology, for their long-time mentorship.

My sister, Amy T. Fleury, for her wise counsel with respect to balancing priorities.

My parents, Lincoln H. Taylor, Jr. and Nancy B. Taylor, who instilled in me an appreciation for scientific thought and the value of education.

vi

TABLE OF CONTENTS

ABSTRACT……………….….…..…………………………………………………... iii

DEDICATION…………….…….……….……………………………………………. v

ACKNOWLEDGMENTS….…….…………………….……………………………… vi

LIST OF TABLES…………….….………………………………………….………… ix

LIST OF FIGURES……………….…………………………………………………… x

CHAPTER

1 INTRODUCTION……………..…………………..………..……………………….…1

2 BACKGROUND……..……………………………….………………………..………3

History of Cesarean Section ...................................................................................... 3 Increasing Cesarean Section Rates ............................................................................ 5 Risks of Cesarean versus Vaginal Delivery ............................................................... 7 Clinical Indications for Cesarean Delivery .............................................................. 11 Liability Pressure and Defensive Medicine ............................................................. 19 Literature on Tort Reform and Defensive Medicine ................................................ 28 Literature on Defensive Medicine in Obstetrics ....................................................... 35 Gaps in the Literature.............................................................................................. 37

3 METHODS ............................................................................................................... 44

Conceptual Framework ........................................................................................... 44 Research Questions ................................................................................................. 45 Subjects .................................................................................................................. 46 Geographic Units of Analysis ................................................................................. 46 Data Sets................................................................................................................. 46 Births ................................................................................................................. 46 Tort Reform ....................................................................................................... 47 Variables ................................................................................................................ 48 Dependent Variable............................................................................................ 48 Independent Variables ........................................................................................ 49 Confounders ........................................................................................................... 53 Maternal Demographic Characteristics ............................................................... 54 Maternal Medical History .................................................................................. 57

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Labor and Delivery Characteristics ...................................................................... 60 Infant Characteristics ........................................................................................... 61 Excluded Variables ................................................................................................... 63 Unmeasured Confounders ......................................................................................... 74 Tort Reform Analysis ............................................................................................... 76 Fixed Effects Modeling ........................................................................................ 76 Omitted Variable Bias and Endogeneity ............................................................... 77

4 RESULTS ................................................................................................................. 80

Descriptive Analyses............................................................................................ 80 Fixed Effects Analysis ......................................................................................... 89 5 CONCLUSIONS ...................................................................................................... 94

Strengths ............................................................................................................... 96 Limitations............................................................................................................ 96 Implications .......................................................................................................... 99

REFERENCES ............................................................................................................ 103

APPENDIX A: INSTITUTIONAL REVIEW BOARD APPROVAL FORM……..…112

viii

LIST OF TABLES

Table

1 Percent of Reported Pregnancy and Labor and Delivery Complications, U.S. Standard Certificate of Live Birth (1989 Revision), 1991-2002 ............................. 13 2 Key Defensive Medicine Literature............................................................................ 40 3 Variables Considered for Inclusion the Fixed Effects Models ..................................... 69 4 Variables Included in Descriptive and/or Econometric Analyses ................................ 70 5. Missing Values for Variables Included in Econometric Analyses ............................... 73 6 Numbers of Live Singleton Births Per Year, United States, 1991-2004 ...................... 79 . 7 Live Singleton Births by Delivery Method, United States, 1991-2004 ........................ 81 8 Cesarean Deliveries (Live Singleton Births) by State, Ordered by Rate, United States, 1991-2004 ............................................................................................... 82 9 Number of States with Tort Reforms in Effect by Year, 1991-2004 ........................... 84 10 Maternal Characteristics by Delivery Method, Live Singleton Births, United States, 1991-2004 ............................................................................................... 85 11 Infant Characteristics by Delivery Method, Live Singleton Births, United States, 1991-2004 ............................................................................................... 86 12 Cesarean Deliveries (Live Singleton Births) by State, 1991 and 2004 ..................... 87 13 Parameter Estimates for the Effect of Direct and Indirect Tort Reforms on Cesarean Delivery ..................................................................................................... 91 14 Alternative Model Specifications ............................................................................. 92 15 Parameter Estimates, Effect of Tort Reforms on Cesarean Delivery by Race ............ 93 16 Regression Coefficients, Effect of Tort Reforms on Cesarean Delivery by Maternal Educational Attainment and Marital Status ..................................................... 93

ix

LIST OF FIGURES

Figure Page 1 Relationship Among Several Branches of Tort Reform Literature .............................. 29

2 Percent of Cesarean Deliveries Among Live Singleton Births, United States, 1991-2004 ..................................................................................................................... 88

1

CHAPTER 1

INTRODUCTION

Cesarean section is the surgical delivery of an infant, a procedure once used solely

for emergencies threatening the life of the mother but more recently used to reduce the

likelihood of injury or death of either mother or infant. Cesarean rates have grown

dramatically over the past forty years, from 5.5 per 100 live births in 1970 (1) to 32.9 per

100 in 2009, (2) which has caused concern that infants may be sometimes delivered

surgically in cases where risks outweigh benefits in terms of both health and cost.

“Defensive medicine,” medical practice decisions based on fear of malpractice litigation,

has been posited as a contributor to this increase. Some studies (described in Chapter 2)

suggest that changes in certain laws governing medical malpractice actions may

contribute to decreasing the cesarean rate by relieving some of the pressures that drive

defensive medicine, but this question has not been fully resolved by empirical research.

Tort reform has received considerable media and legislative attention in recent

years, with physicians arguing in favor of reform and trial lawyers arguing against it. Tort

reform legislation is often proposed in response to a perceived “malpractice crisis”,

characterized by increasing malpractice insurance premiums or decreasing numbers of

malpractice insurance carriers. The debate on defensive medicine often centers on a

perceived contribution to rising healthcare costs. It has not been well-established that

defensive medicine exists, and, if it exists, whether reform of tort laws is effective in

reducing it. The importance of this study is in its contribution to determining whether tort

reform legislation is an effective approach to reducing defensive medicine and of

addressing rising cesarean delivery rates.

2

The purpose of this study was to investigate the effect of changes in tort law on

defensive medicine by examining changing patterns of cesarean section. This was done

by estimating the effects of changes in tort laws on cesarean section rates over the 1991

through 2004 period, taking advantage of recently collected information on state

legislation and court decisions over this period, nationwide birth certificate data, and

econometric techniques. Defensive medicine is a complex phenomenon, which has been

explored via research spanning several disciplines, including medicine, law, economics,

and policy. The present work draws on these disciplines while adding the perspective of

obstetrics, perinatal epidemiology, and maternal and child health.

3

CHAPTER 2

BACKGROUND

History of Cesarean Section

In generations past, death during childbirth and death of an infant were such

common experiences that a woman had little expectation of delivering a live, healthy

infant or of her own survival. Maternal deaths from complications of pregnancy

decreased by 99% during the last century, from 85 per 1,000 live births in 1900 to 7.5 in

1982 (no further decrease since that time). (3) In 1911, the infant mortality rate in the

United States was 135.0 per 1,000 live births (4) compared to 6.8 in 2007. (5) Improved

survival has resulted in changed expectations with respect to the birth experience and

fetal outcome.

For a thousand years, obstructed labor was managed by rotating the fetus so that

one foot, rather than the head, presented during delivery (referred to as a “footling

breech”). Delivery was accomplished by applying traction to the foot, and the head was

expelled via pressure on the maternal abdomen. (6) Before cesarean delivery came into

wide use for cephalopelvic disproportion (fetal head disproportionately large in relation

to the maternal pelvis), intervention to preserve the mother’s life often involved

craniotomy or cephalotripsy, cutting or collapsing of the fetal skull to allow passage

through the maternal pelvis. (7) Introduction of obstetric forceps in the mid-1800’s

reduced but did not eliminate the need for craniotomy. (8)

The first reported cases of cesarean performed on live women occurred in the 17th

century. (8) Prior to that time, cesarean delivery was a postmortem procedure intended to

save the infants of women who died late in pregnancy. (8) What is reportedly the first

4

cesarean delivery in the United States was performed in 1827 by Dr. Ephraim McDowell

in Newtown Ohio. (9) Cesarean in the United States began to evolve in the late 19th

century; however, according to one report of 100 cesarean deliveries performed in the

United States in 1878, 56% resulted in death of the mother. (8) These 100 cases were

drawn from among “lying-in” (maternity) hospitals, and other reports suggest that

mortality for cesarean in the community overall was higher.(8) Cesarean was a

procedure of last resort, used only in cases of cephalopelvic disproportion. (10) At that

time, CPD most often resulted from contracture of the maternal pelvis due to rickets, (11,

12) a condition which is rare in the United States today. Cesarean was recommended

only in cases where death of both mother and infant would be otherwise inevitable.

Whether it was preferable to perform a craniotomy on a live fetus, which would result in

death of the fetus, or attempt a cesarean, which carried high risk of death for the mother,

was a subject of controversy in the mid-1800’s. (8)

In the present day, the most common indications for which cesarean delivery is

performed are dystocia (failure to progress in labor), fetal distress, breech presentation,

and history of prior cesarean. (13) Dystocia can result from CPD, mal-position of the

fetus, or inadequate frequency and strength of maternal contractions. (11) These

indications are further described in a separate section below.

Several medical advances in the mid to late 19th century made cesarean delivery

more feasible and began to improve survival. Surgical anesthesia was first used in Boston

in 1847. First chloroform and then ether were introduced into obstetric practice.(8) The

germ theory of disease was advanced in the 1860’s, and Joseph Lister’s aseptic technique

utilizing carbolic acid spray was introduced into obstetrics in 1870. (6) Introduction of

5

antibiotics, sulfonamides in 1937 and penicillin in the 1940’s, (14) and safe blood

transfusions in the 1940’s (15) reduced maternal death from the two main causes,

infection and hemorrhage.

Two technological advances in the 1960’s, ultrasound and electronic fetal

monitoring (EFM) changed both the management of labor and delivery and the

perception of the fetus. Visualization of the fetus via ultrasound provides the clinician

with the opportunity to assess gestational age and to detect some types of fetal

abnormalities. Ultrasonography also provides the mother with an opportunity to view the

fetus, which was never before possible. EFM entails use of either an external or internal

device to detect heart rate patterns indicative of possible oxygen deprivation. Prompt

recognition of oxygen deprivation and delivery of the infant is thought to reduce the

likelihood of neurologic injury. Soon after its development, continuous EFM began to

replace intermittent auscultation by stethoscope to monitor the fetal heart rate. (16)

With advances in obstetric medicine and technology has come a perception that

reproductive outcomes can not only be predicted but controlled, leading to the

expectation of a perfect baby. (17) This belief can, in turn, lead to an assumption that an

imperfect outcome is the result of physician error and may lead to malpractice

lawsuits.(17) In sharp contrast with maternal expectations early in the last century,

advances in obstetric medicine have created the expectation of a problem-free delivery.

Increasing Cesarean Section Rates

Over the past four decades, cesarean births have increased as a percentage of all

births in the United States from 5.5% in 1970 to 32.9% in 2009 (preliminary data). (2)

6

Increases in the total rate reflect both increases in rates of primary cesarean and a sharp

drop in rates of vaginal delivery by women who have had a prior cesarean birth (VBAC).

Following dramatic increases in cesarean births in the 1970’s and ‘80’s, rates declined

between 1989 and 1996. (18) During this period, rates of primary cesarean decreased

and VBAC increased. (19) Since 1996, the rate of primary cesarean has increased, and

the rate of VBAC has decreased (with the rate of repeat cesarean consequently

increasing).(18) In 2006, the rate of repeat cesarean was approximately 92%; (19)

however, 53% of the overall increase in cesarean rates 1991-2002 was attributable to

increases in primary cesarean delivery. (20) The greatest reported variation in cesarean

delivery rates has been in nulliparas (women who have not previously given birth) with

singleton vertex pregnancies (one fetus presenting head first). (21)

Although no ideal rate of cesarean delivery has been established, there is wide

agreement that rates have become too high. The World Health Organization (WHO)

Consensus Statement, published in 1985, recommended an ideal rate of 10-15%. (22)

This rate has been widely criticized as lacking a firm evidence base, and according

WHO’s 2009 Monitoring Emergency Obstetric Care: A Handbook, “Both very low and

very high rates of caesarean section can be dangerous, but the optimum rate is unknown.”

(23) In 1990, the U.S. Public Health Service set a Healthy People 2000 goal of reducing

the rate of cesarean deliveries to 12% for primary cesarean deliveries and 65% for repeat

cesareans, for a 15% reduction in cesareans overall. This goal was not achieved, and

Healthy People 2010 Objective 16-9 specifies reduction of cesarean section rates to 15%

among women giving birth for the first time and to 63% of women who have undergone a

prior cesarean birth. These goals were developed by a U.S. Department of Health and

7

Human Services working group and are based on the lowest 25% of state rates for

primary cesarean delivery rates and the highest 75% of state rates for VBAC as

determined from 1996 NCHS birth certificate data. (24) At the time of 22010’s release,

cesarean section rates were decreasing but then resumed their pattern of increase.(25)

These objectives were recently again modified for Healthy People 2020, with a target of

23.9% for primary cesarean and 81.7% for repeat cesarean deliveries. (26)

Risks of Cesarean versus Vaginal Delivery

With increasing cesarean rates, concern has arisen that many of these surgeries

may not be truly indicated, exposing both mother and fetus to unnecessary risk.

Childbirth has always posed a danger to both mother and fetus, and there are risks

associated with both vaginal and cesarean birth.

As previously described, before cesarean came into use, serious complications

resulted in high rates of fetal and maternal mortality and morbidity. In the present day,

the most common adverse maternal outcome of vaginal delivery is urinary stress

incontinence. Vaginal delivery may cause injury to the nerves, muscles and connective

tissue of the pelvic floor, resulting in urinary or anal incontinence or prolapse of the

bowel, bladder or reproductive organs. Third degree laceration into the anal sphincter,

which is most common in deliveries involving forceps or episiotomy, may also result in

incontinence. (21) Some of these complications may result in long-term dysfunction.

Among the risks of vaginal delivery for the fetus are neurologic injury due to hypoxia

(oxygen deprivation) or brachial plexus injury (stretching of the network of nerves that

run from the cervical spine to the shoulder, arm, and hand) that may result from difficulty

in delivering the shoulders.

8

Although the purpose of cesarean delivery is to prevent adverse outcomes, it

carries the inherent risks of major abdominal surgery. Maternal mortality, although very

low in the United States (12.7 per 100,000 live births in 2007), (27) is reportedly 3-7

times greater for cesarean than vaginal delivery. (21) These deaths are most commonly

caused by deep vein thrombosis or pulmonary embolism. (21) Surgical complications of

cesarean may include hemorrhage, injury to the urinary tract, (13, 21) and, occasionally,

the gastrointestinal tract. (21) The most common postoperative complication of cesarean

delivery is infection, with endomyometritis (infection of uterine tissues occurring after a

cesarean section), estimated to occur in anywhere from 10-50% of cesarean

deliveries.(21) Women who have undergone cesarean experience increased risk of

complications in future pregnancies, including a three-fold increased risk of placenta

previa (placenta obstructing the cervical opening), (21) a rare but serious complication.

Placenta previa may lead to placenta accreta, where the placenta detaches from the

uterine wall and causes severe hemorrhage. (21) Longer term consequences of cesarean

may include pelvic pain, bowel obstruction, and threats to future reproductive capacity.

(28)

Although cesarean delivery has contributed to an impressive decrease in perinatal

mortality rates over the last century, the surgery does pose some risk to the fetus.

MacDorman et al, used 1999-2002 linked U.S. birth and death data to examine

differences in infant mortality among low risk (no prior cesarean, singleton birth, term

gestation, no medical risk factors, no placenta previa) delivering vaginally and via

cesarean. An ‘‘intention-to-treat’’ methodology, where both vaginal deliveries and

unplanned cesareans (labor and delivery complications recorded on the birth certificate)

9

were treated as though the intention was to delivery vaginally, was used to compare

planned cesarean deliveries (no labor and delivery complications recorded on the birth

certificate) to planned vaginal deliveries, adjusting for socio-demographic and medical

risk factors. They reported an adjusted odds ratio for neonatal mortality of 1.69 (95% CI

1.35–2.11) for cesareans with no labor complications or procedures, compared with

planned vaginal deliveries. (29) Potential harm to the fetus may include surgical cuts,

respiratory distress, and development of childhood asthma. (28) While in utero, the fetal

lungs are filled with fluid. It is thought that the process of labor may assist in clearing this

fluid in preparation for birth. (30) Cesarean delivery interrupts this process. Also, some

cases of respiratory distress in neonates delivered via cesarean may be due to iatrogenic

prematurity, which occurs when the gestational age of the fetus was inaccurately

estimated prior to delivery, resulting in a premature birth. (30)

Between 1996 and 2004, the percentage of cesareans that were repeat, rather than

primary, surgeries increased from 71.7 to 90.8%. (31) This increase has been attributed to

the decrease in vaginal birth after cesarean (VBAC) in response to concern over reported

risks. Risks associated with repeat cesarean are similar to those for primary cesarean;

however, there are some additional risks. Maternal morbidity (placenta accreta, bowel or

bladder injury), postoperative ventilation, intensive care unit admission, hysterectomy,

blood transfusion requiring four or more units, duration of surgery, and length of hospital

stay, increase progressively with the number of cesarean deliveries. (32) Menacker et al.

report an adjusted odds ratio for neonatal mortality for repeat cesarean delivery compared

with VBAC of 1.36 in low risk (singleton, term, vertex presentation) pregnancies 1998-

10

2002, with rates of repeat cesarean delivery for low risk pregnancies comparable to rates

of repeat cesarean overall. (33)

The decreasing rate of vaginal birth after cesarean (VBAC) was influenced by the

risk of uterine rupture. This risk may have been overstated in some past reports; however,

uterine rupture remains a serious (although rare) complication. Guise et al., (34) in a

recent systematic review, found that a number of studies used a broad definition of

“rupture” that included separation of the uterine scar without symptomatic rupture, over-

estimating the incidence of uterine rupture. Excluding those studies, Guise et al. (34)

reported the rate of uterine rupture among women undergoing a trial of labor as 0.47%

and for elective repeat cesarean as 0.30%, with the difference reaching statistical

significance. They also reported significantly greater perinatal mortality (0.13%) for trial

of labor compared to elective repeated cesarean (0.05%). Rates of maternal hysterectomy,

hemorrhage, and transfusion did not differ significantly between the two procedures.(34)

Several factors are believed to have influenced trends in cesarean section. The

increase in rates between the mid-1960s and the late 1980s has been attributed to

changing maternal characteristics (older maternal age, reduced parity), increasing

incidence of risk factors (maternal obesity and diabetes, macrosomia), (35) changes in

obstetric practice (increased use of epidural anesthesia, fetal monitoring, cesarean

delivery for breech presentation, and reduced use of forceps), (35) and social factors

(malpractice litigation and socioeconomic factors). (35) However, recent dramatic

increases, particularly since the mid-1990s, are less understood. There have been widely

conflicting reports with respect to the extent of maternal preference for cesarean and its

contribution to rising cesarean rates, with much of the evidence anecdotal. Maternal

11

request cesarean is difficult to quantify, (36) and many studies purporting to examine

“maternal request” cesarean include no measure of intent but rather examine cesarean

with no documented medical indication. (18) Cesarean section rates vary substantially by

geographic location within the United States. Some of this variation is explained by

differing patient characteristics, provider density, and other aspects of local health care

delivery; however, otherwise unexplained variation has been attributed to local variation

in physician practice style. (37)

Clinical Indications for Cesarean Delivery

A “high risk” pregnancy is a pregnancy at greater than normal risk of

complications, either of pregnancy or labor and delivery. A pregnancy may be considered

high risk if one or more of a number of medical conditions are present, including renal,

cardiac or endocrine disease, fetal anomalies, history of pre-term delivery, incompetent

cervix, RH incompatibility between mother and fetus, mother is a carrier of a genetic

disorder, multiple gestation, placenta previa after 28 weeks, prior fetal death,

hypertension, diabetes, asthma, or third-trimester bleeding. The majority of these

conditions are included among the check-box items on the birth certificate. (38) In

pregnancies at high risk for fetal loss, tests of fetal well-being may be performed

beginning at 28 to 32 weeks gestation. Testing is often performed in the presence of

decreased fetal movement, fetal growth restriction, or a post-term pregnancy, as well as

in the presence of hypertension, diabetes, multiple gestation with discordant fetal growth,

oligohydramnios (diminished amniotic fluid volume) or polyhydramnios (excess

amniotic fluid volume), post-term pregnancy, or prior loss or stillbirth. (38) This testing

12

may entail either cardiac stress or non-stress testing employing an electronic fetal monitor

and ultrasonography. (38)

The majority of primary cesarean deliveries are performed because of dystocia,

non-reassuring fetal heart rate, or breech or other malpresentation. (12) (ACOG has

recommended that the term “fetal distress” be replaced by “non-reassuring fetal heart

rate,” which is more specific.) (39) Another 3% of cesarean deliveries were performed as

a result of unsuccessful trial of forceps or vacuum extraction. All other indications

combined account for just 15% of cesareans. (12) Because many repeat cesareans are

performed because a cesarean for dystocia was performed in a previous pregnancy, 60%

of cesareans are directly or indirectly attributable to dystocia. (40) Table 1 below

presents complications of pregnancy and of labor and delivery according to the

percentage occurring in all singleton births, in singleton cesarean births, and the

percentage of cesarean births in which each complication occurs, 1991-2002. For

example, although cephalopelvic disproportion is reported in just 2% of all singleton

births and in 10% of singleton cesarean births, cesarean delivery is reported for 97% of

singleton births for which cephalopelvic disproportion is recorded as a complication.

Note that labor and delivery complications are likely underreported in the birth certificate

data. (41) This underreporting is further discussed in Chapters 2 and 3. Additionally,

more than one complication may be reported per birth, and co-occurring complications

may be associated with each other.

13

Table 1. Percent of Reported* Pregnancy and Labor and Delivery Complications, U.S. Standard Certificate of Live Birth (1989 Revision), 1991-2002**

Percent of Live

Singleton Births with

Complication Reported

Percent of Singleton

Cesarean Births with

Complication Reported

Percent of Singleton

Births with Complication Reported that

were Delivered by Cesarean

Pregnancy complications Pregnancy-associated hypertension 3.27 5.59 36.03 Diabetes 2.64 4.49 35.92 Hydramnios/Oligohydramnios 1.11 1.95 37.00 Anemia 2.06 2.14 21.89 Herpes 0.79 1.37 36.41 Chronic hypertension 0.69 1.31 40.17 Previous infant > 4000 g 1.04 1.28 26.09 Previous preterm infant 1.14 1.23 22.66 Lung 0.82 0.96 24.71 Eclampsia 0.31 0.70 47.89 RH sensitization 0.63 0.65 21.82 Cardiac 0.47 0.55 24.83 Incompetent cervix 0.23 0.32 29.51 Renal disease 0.26 0.31 25.15 Hemoglobinopathy 0.07 0.08 25.07 Labor and Delivery Complications Breech 3.18 12.90 85.51 Fetal distress 3.67 9.97 57.40 Cephalopelvic disproportion 2.27 10.33 97.01 Dysfunctional labor 2.82 8.75 65.95 Meconium 5.65 5.65 21.09 Premature rupture of membranes 2.68 3.14 24.67 Febrile 5.65 5.65 21.09 Abruptio placenta 0.54 1.50 58.18 Prolonged labor 0.86 1.47 36.34 Placenta previa 0.32 1.25 81.47 Excessive bleeding 0.55 0.75 28.69 Seizures 0.04 0.08 48.71 Cord prolapse 0.20 0.61 64.94 * As sensitivity for some variables is reportedly less than 40%, figures presented for some complications may be extreme underestimates. ** As reported on the Unrevised (1989) U.S. Standard Certificate of Live Birth. In 2003, 2 states (Pennsylvania, Washington) began using the 2003 revised birth certificate. In 2004, the 2003 births certificate was in use by an additional 7 states (Idaho, Kentucky, and New York, excluding New York City, South Carolina, Tennessee, Florida, and New Hampshire), accounting for 20% of all live births. The majority of complications are not comparable across birth certificate revisions. We have therefore presented these data for the years 1991-2002 only.

14

Complications of pregnancy that contribute to the risk of undergoing a cesarean

delivery include hypertensive disorders (chronic hypertension, pregnancy-associated

hypertension, preeclampsia, and eclampsia), hemorrhage (bleeding from the site of

placental attachment or from the genital tract), pre- or post-term pregnancy, fetal growth

retardation, twins or higher order multiples, and fetal abnormalities. Preeclampsia is the

development of hypertension plus proteinuria or generalized edema during pregnancy and

may progress to eclampsia, which is characterized by convulsions. Hypertension

increases the risk of abruptio placenta and of fetal growth retardation and intrauterine

death.

Estimates of the proportion of deliveries attributable to these indications vary. The

recent literature on cesarean emphasizes the practical and ethical implications of VBAC

and maternal choice cesarean, and there has been little published in the last decade on the

indications for cesarean section. The majority of published papers describing population-

based estimates of cesarean rates by indication and risk factors are ten or more years old

and are based on data now 15 or more years old. It is therefore difficult to assess trends

in indications and risk factors for cesarean over time. A limited analysis based on birth

certificate data is presented in Table 1.

“Dystocia” is used to describe abnormal labor, specifically, prolonged or arrested

cervical dilation or arrested fetal descent. The diagnosis of dystocia increased over time

and, according to some reports, accounts for approximately 60% of primary cesarean

deliveries. (12) Increasing use of epidural anesthesia, (12) the increasing prevalence of

maternal obesity, (42) and inadequate use of oxytocin augmentation in women failing to

progress in labor (12) may have contributed to the increase in dystocia; however, there is

15

a widespread belief that dystocia is over diagnosed. (12) This over-diagnosis has been

attributed in part to misdiagnosis and variability in the criteria for diagnosis but also to

fear of litigation. (12) Gifford et al. (2000) reported that despite ACOG’s

recommendation that dystocia not be diagnosed until cervical dilation reaches 3-4 cm,

25% of cesarean deliveries for dystocia were performed at 3 cm or less. According to

ACOG, “there is much uncertainty about the definition of the latent phase of labor.”

There is, however, agreement that the active phase begins when cervical dilation is

between 3 and 4 cm, (40) and that it is not possible to diagnose dystocia until labor

progresses from the latent to the active phase. (42)

The second most common reason reported for performing a cesarean is non-

reassuring fetal heart rate (fetal distress), (13, 43) which is diagnosed primarily via

electronic fetal monitoring (EFM). EFM entails use of either an external or internal

device to detect heart rate patterns indicative of possible oxygen deprivation. Prompt

recognition of oxygen deprivation and delivery of the infant is thought to reduce the

likelihood of neurologic injury of the fetus, particularly cerebral palsy. EFM use

increased from 45% of pregnant women in labor in 1980 to 85% in 2002. (13, 43) A

diagnosis of fetal distress based on EFM is subject to many false positives, and there is

substantial intraobserver variability in obstetricians’ interpretation of fetal heart rate

patterns.(44), (45) Despite the increase in EFM and in cesareans, rates of cerebral palsy

have remained constant over time at approximately 2.0 per 1,000 live births. (44)

Williams’ Obstetrics refers to diagnosis of fetal distress based on fetal heart rate patterns

as “imprecise and controversial.” (46) Additionally, according Bassett et al., significant

16

reversible hypoxia, which EFM is intended to identify, is rare, occurring in just 1-2% of

births. (43)

Conventional wisdom for many years dictated that following a cesarean, all

subsequent pregnancies be delivered via cesarean. Evidence began to accumulate that a

trial of labor might be appropriate for some women with a history of cesarean. It became

increasingly common to allow women who had previously undergone a cesarean to

proceed with a “trial of labor.” These attempts at vaginal delivery were mandated by

some insurance carriers, and physicians were reportedly pressured to allow trials of labor

for unsuitable patients. Between 1985 and 1996, VBAC rates increased from 5% to 28 %.

(47, 48) VBAC carries a risk of rupture of the uterine scar. Although this risk is

extremely small the consequences can be catastrophic, and may result in the mother’s

undergoing a hysterectomy or in death or neurologic injury to the infant. (48) As VBAC

rates increased, an increase in cases of uterine rupture occurred, and in some of these

cases, malpractice lawsuits were filed. Following publication of a number of articles (33)

and an influential 2001 editorial recommending against VBAC, (49) rates again began to

drop. In 2002, the VBAC rate was 8.5%. (47), and for 2006, the rate was 7.6% among the

31 states using the 1989 U.S. Standard Birth Certificate and 8.5% among the 19 states

using the 2003 revised certificate. (19) (VBAC is not comparable across birth certificate

revisions.) (19) ACOG’s 2004 guidelines recommended that VBAC be permitted only

under circumstances where emergency cesarean was available within 30 minutes of a

decision to perform surgery. These guidelines were narrowly construed, and many

hospitals and insurance companies ceased allowing VBAC. (50) Recent research has

17

challenged the preference for repeat cesarean over VBAC for certain low risk women. In

August of 2010, ACOG issued a revised guideline providing clarification. (47)

A number of the risk factors and complications that would influence the decision

to perform a cesarean section have changed in either incidence or prevalence over time.

Increasing numbers of women have delayed motherhood until after age 35, which carries

increased risk of delivering a preterm or low birthweight infant. (51) Birthweight has

increased over time, resulting in increases in the incidence of macrosomia (birthweight >

4,000 grams). (51) Prevalence of type II diabetes, (52) gestational diabetes (53, 54) and

hypertension (52) have increased in recent decades . The prevalence of obesity in the

United States has increased dramatically over the past 30 years, (55) and currently nearly

50% of women of childbearing age in the United States are overweight or obese. (56) A

number of studies have suggested that being overweight or obese increases a woman’s

risk of prolonged labor (57, 58) and dystocia, even in the absence of other complications.

(42) Other obstetric complications more common among pregnant women who are

overweight or obese are hypertensive disorders and diabetes.(19) Rates of pre-term birth

have risen 20% (14% among singleton births) and low birthweight 10% since 1990. (59)

Twins and higher order multiples, the occurrence of which has increased in recent

decades, are more likely to be delivered by cesarean section. (60) Nevertheless, studies

have concluded that changes in the medical risk profile over time are not the major

contributors to the increase in rates. (61)

There have been dramatic changes over time in the percentage of infants delivered

via cesarean section, with substantial geographic variation. (37) Practice variation

specific to cesarean had not been well-explained; however, there been considerable

18

research on physician practice variation generally. According to Eisenberg, (62) practice

variation results from a complex set of factors, which can be categorized as those

benefitting the physician, those benefitting patients, and those benefitting society overall.

(One factor that drives variation is underlying uncertainty about best practices. To non-

clinicians, many medical decisions may appear to be clear-cut and based on firmly

established diagnostic and treatment criteria; however, health services research

demonstrates that there is a great deal of uncertainty involved in the practice of medicine.

This uncertainty occurs because scientific evidence may be ambiguous, incomplete, or

conflicting. (63, 64) Procedures for which there is consensus among physicians and broad

scientific support in the literature are associated with little variation in practice; however,

for many procedures, norms are not well-defined. (63) Practice variations also result

from differences in observation and interpretation of tests and of clinical signs and

symptoms among individual physicians. (64) Provision of medical services is based on

science but is also influenced by subjective factors, including physician attitudes,

opinions, and personal experience in the practice of medicine. Wennberg, a preeminent

researcher in the area of physician practice variation, refers to these influences as the

“practice style factor.” (63) The daunting task of synthesizing complex, conflicting, and

ambiguous information and determining how best to apply that information to the clinical

circumstances of an individual patient may lead to oversimplification and to broad

application of rules of thumb. (64) In the face of uncertainty about approach to

management of a particular condition, a physician often follows a course consistent with

that of other physicians in the community in which he or she practices, which becomes

the standard for the community. (64) This may in some cases cause defensive medicine to

19

effectively become the standard of care. (65) Differences in standards across

communities exist, because there is insufficient evidence to clearly support one course of

action and different conclusions with respect to best practices are drawn. (64)

In the case of obstetrics, many guidelines, best practices based on a thorough

review of the available scientific evidence, are established by ACOG. How those

guidelines are interpreted and implemented may differ among institutions and among

geographic areas, resulting in practice variations. The significant disparity in

interpretation of the 1998 and 2004 ACOG VBAC guidelines with respect to immediate

availability of emergency care is an example.

Whereas empirical studies treat the decision to perform a cesarean as one based

on a checklist of evidence-based indicators, many clinicians argue that the emphasis on

rigid criteria ignores the role of individual clinical judgment with regard to the most

beneficial course for an individual patient. (66) The literature on medical uncertainty and

practice variation, the role of individual clinical judgment, and the influence of changing

thresholds for some labor and delivery complications suggest that the gray area between

“necessary” and “unnecessary” cesarean may be larger than widely perceived. Therefore

empirical studies categorizing cesareans as “necessary” or “unnecessary” are inherently flawed.

Those using birth certificate data, for which many of the indications are poorly reported, are even

more so.

Liability Pressure and Defensive Medicine

Medical negligence is an act or omission by a health care provider that deviates

from the standard of care in the relevant medical community as defined by state laws. If

the negligence results in injury to the patient, there is a breach of professional duty

20

actionable under tort law. Physicians are expected to conform to a standard defined by

the “degree of skill and care that a physician or surgeon of the same medical specialty

would use under similar circumstances.” (67) The standard of care “in the community” is

generally construed to refer to local practice patterns; however, legal rulings have left

some uncertainty as to the geographic scope of a community. (68)

Most medical malpractice claims sound in tort (have their basis in tort law). A tort

is defined as a private or civil wrong resulting from breach of a legal duty. (69) Such a

wrong may be redressed via a lawsuit leading to an award of damages. The injured party

may be compensated for economic (e.g., past and future medical expenses and past and

future lost wages) and non-economic (e.g., pain and suffering) damages). (70) Torts are

classified as intentional, negligent, or strict liability (i.e., liability for defective products)

torts. Negligence is typically defined as the “failure to behave with the level of care that

someone of ordinary prudence would have exercised under the same circumstances,” and

can consist either of acts or omissions. (70) To establish negligence, the five elements of

the “negligence rule” must be demonstrated. There must be: 1) a duty to exercise

reasonable care; 2) an act or omission that breaches that duty; 3) the act or omission must

be the cause of the harm (actual cause); 4) the act or omission must be fairly closely

related to the harm, rather than a remote consequence, (proximate cause); and, 5) the

harm must have monetary value (damages). (70)

Most medical malpractice tort claims sound in negligence, but traditionally

medical malpractice claims have been treated differently than other negligence claims.

Instead of using the reasonable prudent person standard, courts have traditionally used a

customary standard whereby the conduct of the defendant physician is compared to

21

accepted practices in the profession. The jury in a medical malpractice case is charged

with determining what is customary practice and whether the physician was in

compliance with that practice, rather than whether the physician acted in a reasonable

manner. (71) Physicians are held to this alternative standard because of their unique

training and expertise, (72) which has over the past century been rewarded with deference

and special privilege. (71) The custom-based standard arose, because it was believed that

a lay jury would have insufficient knowledge to assess reasonableness of medical care

and because it was believed inappropriate to compare the actions of physicians, who are

ethically bound to hold the interests of their patients first, with for-profit endeavors or the

actions of persons otherwise acting in their own interest. (72)

From the custom standard have arisen a number of doctrines bearing on

malpractice actions. In a medical malpractice case, each side, plaintiff and defendant,

endeavor to prove their cases via testimony of expert witnesses who educate the jury

about customary medical practice and address whether or not the defendant’s practices

were consistent with the applicable “standard of care.” The standard of care is not

limited to one medical custom but is rather subject to a “two schools of thought” or

“respectable minority” rule, which allows physicians to choose between conflicting but

respectable approaches to treatment when medical opinion is divided. (71) The standard

of care has been traditionally defined according to medical custom at the local level, and

expert witness testimony was subject to a “locality rule,” requiring the expert to be

familiar with customary practices specific to the community in which the defendant

physician practiced. Beginning in the 1970’s there was gradual dismantling of the

locality rule. The rule had been established in part to protect rural physicians against

22

being held to the same standard as their urban counterparts who had greater access to

state of the art knowledge and better conditions in which to practice; (72) however,

plaintiffs found it difficult to retain expert witnesses willing to testify against their local

peers. (72) There has been a gradual shift toward reliance on nationwide medical custom,

particularly for specialists

More recently, it has been argued that many courts have shifted from the

customary standard to a reasonable prudent physician standard. (71, 72) This shift in

judicial interpretation of malpractice law began in the 1970’s. (71) Multiple court

decisions, beginning with a 1965 Illinois Supreme Court case (Darling v. Charleston

Community Memorial Hospital), have taken the position that adherence to custom should

not be considered conclusive evidence in support of appropriate care, because the custom

itself could be unreasonable or negligent. (71) Courts rejecting the custom standard have

opined that an industry should not be permitted to establish its own standard of care, (71)

reflecting a gradual decline in deference toward physicians by both the lay public and the

judiciary. (71) Another criticism of the custom-based standard is that physicians do not

know how other physicians practice medicine. (72) As such, the testimony of expert

witnesses is typically about the care they would have provided under similar

circumstances, (72) what they believe to be reasonable, rather than what is truly

customary. Over time some states have rejected the custom-based or begun to apply it

more loosely. Among the implications of this shift is that expert testimony demonstrating

the defendant physician’s compliance with accepted practice is no longer a complete

defense, and there is increasing uncertainty regarding the standard of care. This

uncertainty may lead to an increase in defensive medicine. (71)

23

The principal goals of the tort system are to deter negligent conduct and

compensate the injured parties. In addition, corrective justice has been identified as a

third goal of tort law. The purpose of tort liability in the context of medical malpractice is

to provide incentives for the optimal level of precaution and to limit inappropriate or

negligent care, (73) thus exerting “liability pressure.”

Although physicians’ legal expenses (settlement, judgment, attorneys’ fees, court

costs) are for the most part covered by insurance, non-monetary costs of a malpractice

lawsuit may be substantial, including time spent (e.g., responding to interrogatories,

undergoing depositions, attending court appearances) adverse publicity, a blemished

reputation, and significant personal distress. (74, 75) Ideally, the tort system should exert

some optimum level of liability pressure, which would maximize social benefit. If

liability pressure is too low, physicians may provide too low a level of care. If the level of

malpractice pressure is too high, doctors may take excessive precautions. The marginal

cost to society of these precautions may exceed the marginal benefits, which is referred to

as “defensive medicine.”

Defensive medicine, as defined by the U.S. Office of Management and Budget,

“occurs when doctors order tests, procedures or visits, or avoid high risk patients or

procedures primarily (but not necessarily solely) to reduce their exposure to medical

malpractice liability.” (76) These tests, procedures or visits may be appropriate and

reasonable, but if they are intended primarily to benefit the physician by protecting

against liability they are considered defensive. (77) Defensive medicine may benefit both

the physician and the patient, and may result in enhanced health care for the patient;

however, in economic terms, the marginal cost of the procedure exceeds the marginal

24

benefits. Klingman et al., in the belief that labeling of care as unnecessary or unjustified

indicates clearer delineation between appropriate or inappropriate care than actually

exists, proposed that defensive medicine be defined as “actions taken to minimize the

chance of being wrong when the medical and legal consequences of being wrong are

severe.” (78) They further refine their definition by dividing defensive medicine into

four categories, procedures that raise costs while reducing quality, those that raise costs

while raising quality, those that reduce costs while reducing quality, and those that raise

costs while reducing quality. (78)

Defensive medicine occurs in two forms, “positive defensive medicine,” the use

of additional tests or procedures, and “negative defensive medicine,” avoidance of tests,

procedures, or groups of patients that may be associated with a high risk of adverse

outcome in order to minimize liability risk. (76, 79) In a survey of physicians practicing

in several high-liability specialties (emergency medicine, general surgery, orthopedic

surgery, neurosurgery, obstetrics/gynecology, and radiology), conducted by Studdert et

al., 93% reported performing additional tests, diagnostic procedures and referrals for

consultation to minimize the possibility of litigation. (80) In a survey conducted by

Carrier et al. of a nationwide sample of physicians, 67.7% of respondents reported

concern over malpractice risk and 62% reported engaging in defensive medicine. Among

obstetrician/gynecologists, these percentages were 81.0% and 68.5%. (81) Physicians

also report negative defensive or avoidance behavior. In the study by Studdert et al., (80)

of high risk specialists, 46% of obstetrician/gynecologists reported that they avoid caring

for high risk patients and 38% reported that they avoid certain procedures or

interventions.

25

Mailed surveys are subject to both selection and reporting bias, as there is a

tendency for those who respond to be those motivated by strong opinions, and there is a

tendency to respond to questions in socially desirable ways. (82) Consequently, physician

surveys may overstate the extent of defensive medicine, with those favoring tort reform

over-represented among respondents and, consciously or unconsciously, over-reporting

their practice of defensive medicine. (83) Studies that query physicians on how they

would address each of a series of specific clinical scenarios have reported markedly

lower percentages of physicians practicing defensive medicine. Klingman et al. employed

a mailed survey describing nine clinical scenarios to assess defensive medicine practices

in a random sample of U.S. cardiologists, surgeons, and obstetrician/gynecologists.

Among 54 clinical actions that the survey proposed in response to the scenarios, 8%

(median) were selected primarily to minimize malpractice risk. (78) Results of clinical

scenario studies may be more reliable than direct surveys but are less generalizeable. (78)

If defensive medicine is practiced in response to liability pressure, we would

expect to see this manifested in obstetric practice, as obstetricians are sued more

frequently and are charged higher premiums for malpractice insurance than physicians in

other medical specialties. (84) Among respondents to the 2009 American College of

Obstetricians and Gynecologists (ACOG) Survey on Professional Liability, 90.5%

reported at least one professional liability claim during their careers. (85) Accordingly,

one would expect that obstetricians are more attuned to the potential impact of increases

in premiums and the potential for litigation than practitioners of other specialties and to

react defensively. Also among 2009 ACOG survey respondents, 30.2% reported

decreasing the number of high-risk obstetric patients in their care, 29.1% reported

26

increasing the number cesarean deliveries they perform, and 25.9% reported that they

have stopped performing VBAC. (85)

What is often described as the “malpractice crisis,” characterized by dramatic

increases in malpractice insurance premiums and/or the exit of firms from the malpractice

insurance market, has come in three waves, beginning in the mid-1970’s. Each wave has

spurred enactment of changes in tort laws, referred to hereinafter as “tort reforms,” in

many states. The term “tort reform” is sometimes associated with advocacy but used here

to conform to the language of other academic papers on this topic. The primary intent of

these tort reforms has been to constrain the growth of malpractice premiums by reducing

the number of lawsuits and the size of judgments. It has also been argued that reforms

will increase access to care by increasing physician supply and willingness of physicians

to perform riskier procedures and take on higher risk patients, reducing the practice of

negative defensive medicine. Moreover it has typically been argued that tort reform will

reduce costs by reducing positive defensive medicine. The debate on health care reform

often includes discussion of tort reform, based on a belief by some that costs of the

medical liability system generally, and specifically defensive medicine, are major

contributors to rising health care costs. (86) The Congressional Budget Office (CBO)

has estimated that malpractice-related costs (insurance premiums, settlement awards,

administrative costs not covered by insurance) comprise approximately 2% of total health

care expenditures in the United States. (87) They propose that a package of tort reforms

would reduce health care spending by 0.5%, comprised of a 0.2% reduction in direct

costs, such as malpractice insurance premiums, and 0.3% in indirect costs, such as

reduced defensive use of medical tests and procedures. (87) Some studies have reported

27

findings that conflict with those of the CBO, such as Avraham et al., (88) who reported

that tort reform reduced health care costs, and Morrisey et al., (89) who reported that

savings from reducing medical liability insurance premiums were not passed on to

consumers or employers in lower health insurance costs.

Although tort reform in many states has been enacted in response to perceived

crises in medical malpractice, medical malpractice actions comprise just 15% of tort

litigation, with litigation related to automobile crashes accounting for 53% (based on

numbers of tort trials in 75 largest U.S. counties in 2001). (90) Tort reforms enacted in

some states, particularly non-economic damages caps, are limited to medical malpractice

actions. (90)

The standard menu of tort reforms adopted by many state legislatures as a

response to the recurring medical liability insurance crises are intended to reduce

excessive compensation for plaintiffs and deter the filing of frivolous claims. (73)

Although the specific measures have differed across states, many states have modeled

their reforms after California’s Medical Injury Compensation Reform Act (MICRA)

enacted in 1975, adopting some its components but not others. Among the provisions of

MICRA are a cap on non-economic damages ($250,000), modification or abrogation of

the collateral source rule to permit the defendant to introduce evidence of collateral

source payments, limits on plaintiff attorney’s fees, periodic payment of future damages

awards of $50,000 or greater, strict time limitations for presentation of a claim (statute of

limitations), and a provision for binding arbitration (California Code of Civil Procedure).

In states that have not enacted liability-reducing tort reforms, there are few

disincentives to file suit and the amount of recovery is theoretically unlimited. If fear of

28

lawsuits and their economic, social and psychological consequences are an incentive to

practice defensive medicine, one would expect to see a decrease in certain tests and other

medical procedures following implementation of tort reform in those states that have

implemented it, and no decrease in states that have not implemented tort reform.

By studying the effect of these reforms, defensive medicine can be studied more directly

than by using premiums or claims history as measures of liability pressure.

Literature on Tort Reform and Defensive Medicine

Tort reforms reduce the number and size of damage awards, (90-92) with some

reforms directly affecting the amount of recovery and others having an indirect effect by

reducing the number of lawsuits. Research has examined the effect of tort reforms on a

number of outcomes related to medical malpractice, among them claims frequency and

cost, medical liability system overhead costs, providers’ liability costs, defensive

medicine (including health care utilization and spending and medical outcomes),supply

of health care services (including physician supply and patient health insurance

coverage), and quality of care. (93) This has resulted in a wide body of literature, which

will be only selectively reviewed here. The figure below, adapted from Morrisey et al.

(89), is a depiction of the effect of tort reforms and the relationship among several the

branches of literature on tort reforms and medical malpractice presented.

The discussion to follow will focus on tort reform and defensive medicine but

briefly describe research that has been conducted on the effect of tort reforms on

malpractice insurance premiums and on physician supply. It will also describe research

on physician history of insurance claims and of lawsuits on defensive medicine.

29

Figure 1. Relationship Among Several Branches of Tort Reform Literature

Early empirical studies of defensive medicine measured liability pressure via

malpractice premiums, insurance claims history, history of malpractice lawsuits, and

perceived risk of lawsuits obtained via physician survey. Several studies conducted after

the first malpractice crisis examined the effect of liability pressure on cesarean rates.

Rock (94) examined the effect of malpractice insurance premiums for obstetricians on

cesarean rates in New York and Illinois and reported a statistically significant correlation

between differences in cesarean rates and differences in liability premiums for insurance

territories in each state. Localio et al. (95) used hospital discharge data linked with

physician and hospital malpractice claims records using a stratified random sample of

hospitals in New York State, controlling for clinical risk of cesarean, patient

socioeconomic status and physicians and hospital characteristics. They reported positive

associations between malpractice claims risk and cesarean rates and between physicians’

perceived risk of suit and cesarean rates. No significant association between odds of

cesarean and claims history of physicians was found. Baldwin et al. (96) examined the

effect of malpractice claims for a random sample of obstetricians and family physicians

Tort Reforms

Number & Size of Awards

Defensive Medicine

Malpractice Insurance Premiums

Physician Supply

30

during a one-year period on several obstetric care measures (ultrasound , referral and

consultation, prenatal care, cesarean) for low risk patients and found no increase in

resource use by physicians with a history of malpractice claims or in counties with high

rates of malpractice litigation. Tussing et al. (97) investigated the effect of malpractice

lawsuits on use of electronic fetal monitoring, diagnosis of fetal distress, and cesarean

section in New York State and found malpractice exposure to be associated with each of

the outcomes.

A limitation common to these studies four studies examining cesarean delivery

rates is use of data from one or two states and just a few years to estimate the effects of

malpractice liability. This limits their generalizability to other geographic areas and time

periods, as cesarean section rates and a broad range of economic, political and

demographic factors have varied considerably by state and over time. (98)

Several later studies (Table 2) also examined liability pressure via either

malpractice premiums or claims, each reporting some evidence of defensive medicine.

Grant and McGinnis (99), using 1992-95 Florida hospital discharge and insurance claims

data, concluded that exposure to medical malpractice liability led to a 1% increase in the

risk-adjusted cesarean section rate. Baicker and Chandra (2005) (98) examined the

effects of changes in malpractice premiums, the state-level effects of claims payments on

premiums, and the effect of malpractice liability on the physician workforce and on

several medical procedures, including cesarean, and reported a decrease in cesarean

section in response to increased premiums. Kim (2007) (100) used 1992-98 NCHS

natality data (1992-98) and malpractice claim information from National Practitioners

Data Bank to investigate the effect of malpractice risk on use of several obstetric and

31

gynecologic procedures, including cesarean section. Kim found that doctors’ procedure

choices were generally insensitive to malpractice risk, although there was a small but

statistically significant association between increased malpractice risk and use of

amniocentesis. Dranove and Gron (101) explored negative defensive medicine by using

Florida hospital inpatient data to examine physician activity and patient access with

respect to craniotomy and for cesarean section with complications. They compared

periods before and after a dramatic increase in insurance premiums (1997-2000, 2000-

2003) and found decreases in the number of physicians performing craniotomies, in the

number of physicians performing high risk deliveries, and in the number of craniotomies

performed by high volume neurosurgeons. For both neurosurgery and obstetrics, they

found low-volume providers decreased or ceased performing craniotomies or high risk

deliveries. The authors attribute these findings to increases in malpractice premiums

Baicker et al. (2006) used NCHS linked birth and death data pooled across 1995-98 to

calculate a probability, based on the patient’s pre-birth characteristics and removing the

effect of area characteristics unchanging over time, that a typical obstetrician would

perform a cesarean delivery. For each county, a risk-adjusted probability of receiving a

cesarean delivery was calculated. They reported that that average birth via cesarean has a

systematically lower predicted probability in areas that do more cesarean sections. The

authors conclude that counties with higher rates of cesarean may perform a greater

number of unnecessary cesareans; however, it is possible that important predictors were

omitted or inaccurately measured.

The incentive to practice defensive medicine is fear of liability. Tort reform

reduces the likelihood of suit (90) and the amount of any potential award, (90, 92) which

32

should reduce the fear of liability and the practice of defensive medicine. Response to tort

reform is a more direct measure of defensive medicine than insurance premiums

The first study to use changes in tort law to examine defensive medicine is

described in the seminal 1996 paper by Kessler and McClellan. (102) The authors

evaluated the effects of two sets of tort reforms, direct reforms (caps on non-economic

damages, caps on or elimination of punitive damages awards, elimination of mandatory

prejudgment interest, collateral source offset) and indirect reforms (limits on contingency

fees, periodic payment of awards, modification of the joint and several liability rule,

patient compensation fund, statutes of limitations or repose) on hospital expenditures

among Medicare beneficiaries following hospitalization for acute myocardial infarction

(AMI) or ischemic heart disease, 1-year survival, and experiencing a subsequent AMI or

heart failure. Direct and indirect tort reforms were used, because previous studies have

shown different effects of these two groups of reforms on claims payments and

frequency. Kessler and McClellan found that direct tort reforms reduced medical

expenditures 5-9% but found no effect on survival or on subsequent hospitalizations for

AMI or heart failure. Kessler and McClellan’s work has many strengths and has been

cited extensively by other authors, but it has also been argued that their findings are not

generalizable to settings outside the hospital, to medical conditions other than heart

disease, or to younger patients. (103, 104)

Since publication of the Kessler paper, several additional studies, summarized in

Table 2, have investigated the effect of tort reform on health outcomes. (104) Dubay et al.

(1999), (105) in the first national study to examine the effect of malpractice claims risk

on cesarean section and birth outcomes, investigated the effect of malpractice premiums

33

on cesarean rates, using six tort reforms as instrumental variables. They reported that an

increase in premiums resulted in an increase in cesareans but not an improvement in birth

outcomes (Apgar scores). For unmarried women of lower educational attainment,

increased premiums resulted in lower Apgar scores. They then estimated the effect of

tort reforms on malpractice premiums and estimated that a damage cap results in a 58%

reduction in annual premiums, which would result in a 0.48% decrease in cesarean

sections. Currie et al. (106) examined effects of four direct reforms, any punitive

damages cap, and non-economic damages cap, joint and several liability reform, and

common law collateral source rule in 25 states with changes in tort law (1989-2001) and

found that joint and several liability reform significantly reduced probability of cesarean

and damage caps increased it. Sloan et al. (104) building on the work of Kessler and

McClellan), (102) assessed the effects of tort reforms on Medicare payments for hospital

admission for AMI, stroke, breast cancer, diabetes and the probability of survival

following the index event. Rather than Medicare payments to hospitals, as used by

Kessler and McClellan, Sloan et al. used total inflation-adjusted Medicare payments in

order to include outpatient care. They used 15 years of data (compared to Kessler and

McClellan’s three), and they expanded upon Kessler and McClellan’s list of medical

diagnoses. They found no reduction in inpatient medical expenditures and that both direct

and indirect reforms reduce payments for AMI or ischemic heart disease hospital care,

with no effect for other outcomes studied, and neither direct nor indirect tort reforms

effected survival probability, thus no evidence for defensive medicine.

Among studies using changes in tort law to examine defensive medicine, those

that have found an effect have more often found an effect of damages caps than other tort

34

reforms. Currie et al. (106) reported that reform of the joint and several liability rule

reduced complications of labor and procedure use, while caps on non-economic damages

increased complications of labor and procedure use, and Yang et al. (107) reported that

caps on non-economic damages increased VBAC rates and decreased cesarean rates, the

effect increasing with the stringency of cap. Kilgore et al. (106) estimated the effects of

changes in state tort law on malpractice premiums, rather than defensive medicine, and

reported a dose-response effect of inflation-adjusted damage caps. We hypothesize that,

similarly, a dose-response effect of damage caps on defensive medicine exists.

Studies evaluating the association between tort reform and defensive medicine

have used several sources of data on tort reforms. Currie et al. opined that studies of tort

reform and cesarean section may have shown mixed results because some have relied on

flawed information with respect to tort reforms.(108) Avraham found that existing

compilations contained omissions and miscoding (109) and developed a compilation, first

made available in 2006, (110) cross-referencing his own review of tort reform legislation

and court cases with existing tort reform compilations. The recent study by Yang et al.

(107) created a new compilation from several sources that was confirmed for accuracy

with the Avraham database. (110) The present study uses data on malpractice tort reform

from a recently completed Robert Wood Johnson Foundation (RWJF) project that

reviewed all state laws and court decisions for the 1975-2004 period, identifying the

elements of the reforms and their effective dates. This compilation has also been used by

Sloan et al. (104) and by Kilgore et al. (111)

The effects of ten tort reform variables will be examined in this study. Literature

on the association between tort reform and medical outcomes has investigated nine

35

separate tort reforms, and the tort reform database that will be used in this study includes

data on eight of these nine reforms. Several studies have combined reforms into two

groups, direct reforms, which limit the amount that can be recovered in a malpractice

action, and indirect reforms, which operate primarily by providing disincentives to file

suit. (102, 104) Studies have largely analyzed these reforms according to whether a

particular reform is present or absent. Currie et al. (108) criticize the categorization of

reforms into direct and indirect, suggesting that this strategy may reduce any observed

effect, as some reforms work in opposite directions; however, Sloan et al. (104) reported

that results of reforms considered separately were difficult to interpret due to

multicollinearity among reforms. In the present study, reforms were analyzed

individually and combined as direct and indirect.

Literature on Defensive Medicine in Obstetrics

It has long been speculated that the increasing rate of cesarean delivery and the

wide variation in rates in the U.S. are related to defensive medicine. However, the

research has been limited and conflicting. The majority of these studies have examined

the effect of increasing medical malpractice insurance premiums, (94, 95, 98, 105, 107)

or the effect of medical negligence claims experience (96, 97, 100, 112) on cesarean

section rates. Two studies have looked at the effect of tort reform on cesarean (Currie et

al. Yang et al. 2009). (106, 107) and one looked at the effect of malpractice premiums

on cesarean while using tort reform as an instrumental variable (Dubay 1999). (105)

Yang et al. (107) observed VBAC rates significantly higher and cesarean delivery

rates significantly lower in states with caps on noneconomic damages and found no effect

of other tort reforms. Currie et al. (106) found that induction and stimulation of labor,

36

cesarean delivery, and complications of labor were significantly decreased in the

presence of joint-and-several liability reform while in the presence of damages caps,

each were increased. Few studies examining validity of birth certificate data elements

have included induction and stimulation of labor; however, two state-level analyses

reported poor sensitivity for these two variables, one reporting 71.7% sensitivity for a

combined “induction or augmentation” variable (113) and the other 42.5% for induction

and 25.7% for stimulation. (114) Poor sensitivity is also reported among labor

complications variables. (113, 115, 116) Findings by Currie et al. of opposite effects of

two tort reforms on these variables are therefore difficult to interpret.

Studies of malpractice insurance premiums on cesarean delivery rates have

consistently found statistically significant associations between liability premiums and

cesarean delivery rates. (94, 95, 98, 105, 107) Among those examining the effect of

medical negligence claims experience, Grant et al. (112) found that physicians

experiencing high payout claims increased cesarean rates by 1%, while others have found

no effect of claims experience on cesarean rates. (96, 100, 117) Generally, studies of tort

reform have had mixed results, while studies of malpractice premiums have found an

association with cesarean delivery rates and studies of claims experience have not.

The most recent paper to examine the effects of liability reform on obstetric

practice (Yang et al.) (107) used data from Medical Liability Monitor Annual Rate

Survey and from National Center for Health Statistics (NCHS) Natality Detail file. They

found effects of non-economic damage caps on VBAC and cesarean and found an effect

of pretrial screening on VBAC but no significant associations for other reforms.

37

Gaps in the Literature

Despite several studies examining malpractice premiums and cesarean delivery

and tort reform and cesarean delivery, there are several remaining gaps in the literature

that this work is intended to fill. This study uses nationwide data, covers a greater span

of years (14) than the majority of prior studies and includes more recent data (1991-

2004). Many of the older studies of tort reform and cesarean delivery used unreliable

sources of tort reform data. This study will use a recent, thorough, and detailed

compilation that includes information on damage cap levels.

Studies using birth certificate data to examine cesarean delivery in the context of

defensive medicine have included maternal medical history and complications of labor

and delivery variables from the birth certificate in their analyses to control for underlying

medical risk. (37, 95, 96, 105-107, 118) Birth certificate data elements are subject to

varying degrees of reliability and validity. Validation studies have found concordance

between birth certificates and hospital discharge data, as well as sensitivity and positive

predictive value for method of delivery (vaginal versus cesarean) to be nearly 100%;

however, reliability of data elements for some maternal risk factors and complications is

fair to poor. (115) These data are useful for many types of comparisons, such as

monitoring trends in complications over time but some of these variables are not suitable

for inclusion in the models used for this study. The models include only those variables

shown by validity studies to have a high degree of sensitivity, and the outcome of interest

is total cesarean deliveries. VBAC and primary versus repeat cesarean are important

outcomes but not well-captured by the birth certificate data. Justification for inclusion or

exclusion of each variable is discussed in Chapter 3.

38

A recent study (Yang 2009) (107) has explored the effects of tort reforms on

obstetrical outcomes. The present study differed from that of Yang et al. in several ways.

The outcomes explored by Yang include VBAC, primary cesarean and total cesarean.

When births are categorized as vaginal versus cesarean, reliability has been found to be

very high; (115, 119) however, poor sensitivity has been reported for VBAC (115, 116,

119) and for primary cesarean and repeat cesarean. (116) Thus, this analysis categorized

delivery method as cesarean versus vaginal only. The natality dataset contains no reliable

mechanism for linking multiple births to one delivery event. In order to avoid the

possibility of over-counting cesarean births, this study examines singleton births only.

Yang controlled for 14 clinical risk factors for cesarean, addressing the high level of

colinearity by collapsing them into 4 principle components. This analysis includes four

of those 14 risk factors that are of reportedly high reliability, and they are included as

individual-level variables. Yang also adjusts for obesity and insurance status, using state-

level data. Rather than employing a mixed effects model and adjusting for various state-

level factors, this analysis controls for factors varying among states via fixed effects

modeling.

This study investigated whether there is a dose-response effect between damage

caps and cesarean delivery rates for both caps on non-economic damages and caps on

punitive damages. Four levels were examined for each cap (<$250,000, $250,000 to

<$500,000, $500,000 to < $750,000, and > $750,000). Yang et al. also investigated the

effect of damage caps on delivery methods, examining three levels of caps on non-

economic damages (< $250,000, $250,001 - $500,000, and > $500,000). The cap

39

variable was also modeled as a dichotomous yes/no variable and as a continuous variable

to examine differences in effect.

Studies of the effect either of malpractice premiums or tort reforms have not

considered whether the effect on cesarean delivery rates differs by race, marital status and

maternal educational attainment. There is, however, strong evidence that these factors

plus socioeconomic status affect the likelihood of undergoing a cesarean. (120, 121)

Also, Dubay et al. found the effect of malpractice premiums on cesarean rates and birth

outcomes to differ by maternal marital status and educational level. (105)

This work contains several new elements and, through methodological

refinements and other subtle improvements, builds on the work of others to inform the

ongoing debate on the existence of defensive medicine. This study takes advantage of

the richness of national birth certificate information as a data source while recognizing

and accounting for its limitations. Additionally, a multi-disciplinary approach brings new

perspective to the analysis and to interpretation of the findings.

40

Table 2. Key Defensive Medicine Literature

Authors Outcome Data Sources Years Geography Key Findings Rock 1988 (94) Malpractice

premiums Cesarean -Hospitals (NY)

-Dept. of Public Health (IL)

1981, 1983 New York Illinois

Statistically significant correlation between differences in cesarean section rates and differences in liability premiums for insurance territories within both New York and Illinois.

Localio 1993 (95) -Malpractice premiums

-Perceived risk of claim

-Rates of paid claims

Cesarean Hospital discharge data

1984 New York Malpractice premiums and physician perceived risk of suit associated positively with cesarean. No significant association between cesarean and physician claims history.

Baldwin 1995 (96) Malpractice claims

experience and exposure

-Obstetric ultrasound use -Referral and consultation -Prenatal care use -Cesarean

-Physician survey -Chart review -insurance databases

9/88-8/89 Washington No statistically significant association found for any of the outcome measures.

Kessler, McClellan 1996 (102)

Tort reforms Serious heart disease (hospital expenditures, mortality, and complications)

-Medicare data -Tort reform compilation

1984,1987,1990

United States -Direct tort reforms associated with reduced hospital expenditures of 5-9% within 3-5 years of adoption. -Indirect tort reforms not associated with expenditures or health outcomes. -Neither direct nor indirect reforms associated with differences in mortality or complications.

Tussing 1997 (118) Malpractice lawsuits

Use of EFM* Fetal distress Cesarean

-Vital records -Hospital discharge data

1986 New York Malpractice exposure is associated with each of the outcomes.

41

Table 2. Key Defensive Medicine Literature

Authors Outcome Data Sources Years Geography Key Findings Dubay 1999 (105) -Malpractice

premiums -Tort reforms

-Cesarean -Apgar

NCHS natality data 1990-1992 United States - Cesarean section rates increase in response to increased malpractice premiums. - Higher premiums do not lead to improved 5-minuteApgar scores. -Among mothers of lower SES, decrease in Apgar scores in response to higher premiums

Dubay 2001 (99) -Malpractice premiums -Malpractice liability concerns

-Prenatal care utilization -Low birthweight -Low Apgar

NCHS natality data 1990-92 United States -Increases in malpractice premiums associated with later initiation of prenatal care and fewer prenatal care visits. -No association with low birthweight or low Apgar.

Grant 2004 (112) Malpractice claims

Cesarean -Hospital discharge data - Insurance claims data

1992-1995 Florida Physicians experiencing high payout claims increased cesarean rates by 1%.

Currie 2008(106) Tort reforms Induction and stimulation of labor, cesarean and complications of labor and delivery.

-Compilation of tort reforms -NCHS natality data, 10% random sample

1989-2001 United States Joint and several liability reform significantly reduced and damage caps increased probability of cesarean.

Kilgore 2006 (111) Tort reforms Malpractice premiums

-Compilation of tort reforms -Medical Liability onitor -Area Resource File

1991-2004

United States Damage caps and statutes of repose associated with reduction in premiums.

42

Table 2. Key Defensive Medicine Literature

Authors Outcome Data Sources Years Geography Key Findings Baicker 2005 (98) -Payment on

claims -Malpractice liability -Malpractice premiums

-Malpractice premiums -Physician workforce -Cesarean, six other medical procedures -Medicare expenditures

-Medical Liability Monitor -National Practitioners Data Bank -Area Resource File -NCHS -Dartmouth Atlas of Healthcare

Payments: 1992-94, 2000-02 Premiums: 1992-93, 2001-02 Physician data: 1989 , 1995 Treatments: 1992-93, 1998-2001

United States -Malpractice payments did not affect premiums. -Increases in malpractice costs did not affect the size of the physician workforce. -Increases in malpractice costs did not result in increased use of medical procedures of interest.

Baicker 2006 (37) -Payment on claims -Malpractice premiums

Cesarean -Medical Liability Monitor -National Practitioners Data Bank

-NCHS linked birth and death data

1995-98

198 U.S. counties with populations > 250,000

Counties whose risk-adjusted rates are higher than unadjusted rates have cesarean usage that is more intensive than what would be predicted using observable characteristics. -Average birth through cesarean has a systematically lower predicted probability of cesarean birth in areas that do more cesarean sections.

Kim 2007 (100) Malpractice claims

Cesarean -NCHS natality data National Practitioner Data Bank

1992-98

1990-2005

United States Cesarean rates insensitive to malpractice risk.

Sloan 2009 (104) Tort reforms Serious heart disease (Medicare payments,

National Long-Term Care Survey merged with Medicare claims

1985-2000 United States Neither direct nor indirect reforms had a significant effect on health outcomes.

43

Table 2. Key Defensive Medicine Literature

Authors Outcome Data Sources Years Geography Key Findings survival probability)

and other data

Yang, 2009 (107) -Tort reforms --Malpractice premiums

VBAC c-section repeat c-section

NCHS natality detail file Medical Liability Annual Rate Survey National Conference of State Legislatures, American Tort Reform Association, unnamed internet database

1991-2003

United States VBAC rates significantly higher and c-section rates significantly lower in states with caps on noneconomic damages, effect increased with stringency of cap. No other tort reforms significantly associated with rates of these delivery methods.

*Electronic fetal monitoring.

44

CHAPTER 3

METHODS

Conceptual Framework

Conceptual Framework for investigating the association of tort reform with

cesarean and other delivery methods.

Policy

Direct Tort Reforms Caps on non-economic damages Collateral source offset

Indirect Tort Reforms Caps on contingency fees Periodic payments Modification of joint and several Liability rule Statutes of limitations Statutes of repose

Practice

Cesarean Section

Confounders Maternal characteristics age race Hispanic ethnicity foreign-born education marital status parity diabetes hypertension tobacco use pre-natal care utilization

Fetal characteristics gestational age birthweight non-vertex presentation Unobservable social, legal, political, economic factors that vary by state.

45

Research Questions

1. Are “direct” tort reforms, “indirect” tort reforms or any of seven tort reform measures

associated with changes in rates of cesarean delivery?

Hypothesis 1: The presence of direct tort reforms is associated with a decrease in cesarean delivery rates. Hypothesis 2: The presence of one or more of seven tort reforms is associated with a decrease in cesarean delivery rates. Hypothesis 3: The presence and magnitude of damage caps, alone or in combination with other tort reforms, is associated with a decrease in cesarean delivery rates. Hypothesis 4: There is a dose-response relationship between the level of damage caps and decrease in cesarean delivery rates.

2. Are the effects of “direct” tort reforms, “indirect” tort reforms or any of seven tort

reform measures associated with differential rates of cesarean delivery by race, marital

status or maternal educational attainment as recorded on the infant’s birth certificate?

Hypothesis 1: The effect of tort reforms on cesarean delivery rates differs by the maternal demographic characteristics of race, marital status and educational attainment. For this study, it was necessary to frame the hypotheses in a form testable using

econometric methods. “Other things equal” is economics parlance for an assumption that

everything remains constant except the variables of interest.

Testable hypothesis:

Other things equal, in states that that have adopted certain tort reform

measures, the probability of having a cesarean delivery is lower following

implementation of the reforms

46

Subjects

Included as subjects were all singleton infants born in the United States, 1991-

2004 (n=54,445,327). Although multiple births are known to increase the likelihood of

cesarean delivery, there is no mechanism available, when using birth certificate data, for

linking multiple births to each other as products of the same delivery. To avoid counting

the same delivery multiple times, which may have resulted in over-counting of the

number of cesarean deliveries, this study is limited to singleton births.

Geographic Units of Analysis

This study examined the effect of state tort laws on cesarean delivery rates.

Data Sets Births

The principal data used in these analyses were the U.S. birth certificate data from

the National Center for Health Statistics (NCHS) public use birth files. The United States

Standard Certificate of Birth was modified in 1989 and again in 2003. Although data on

method of delivery was collected on birth certificates beginning in 1989, it was not until

1991 that all states and the District of Columbia were reporting this information. Data

prior to 1991 were therefore not included in the analysis. Data for some variables are not

comparable between the 1989 and 2003 birth certificate revisions. States began adopting

the 2003 Revised Standard Certificate of Live Birth in 2003, and by the end of 2004, it

was in use in nine states. (19 states by 2009), (27) further complicating comparability

across states and years. The public use data files do not contain geographic identifiers for

years after 2004, precluding state-level analyses. The analysis therefore included the

47

years 1991-2004, using bridged and recoded variables when appropriate and excluding

variables that cannot be compared across years.

The birth certificate data files contain information on the state of birth, the method

of delivery, and other variables related to maternal demographic characteristics, maternal

health, infant health, and risk factors associated with the pregnancy and delivery. Among

the maternal risk factors for which data are available are age, education, race, marital

status, parity, plurality, presence of diabetes, hypertension, eclampsia, previous preterm

and low birthweight births, tobacco and alcohol use, and weight gain. Among the fetal

risk factors are gestational age, prenatal care utilization, induction of labor, stimulation of

labor, premature rupture of membranes, precipitous labor, prolonged labor, dysfunctional

labor, breech presentation, and cord prolapse. These variables are subject to varying

levels of reliability and many are exclusive to either the 1989 or the 2003 birth certificate.

Justification for use or omission of each variable is presented below. Variables

considered for inclusion in the fixed effects analysis are presented in Table 3, and those

actually used in the analysis and how they were coded are presented in Table 4.

Tort Reform

A complete compilation of state-by-state reforms for the period 1975 through

2004 were used to examine the impact of tort reform on cesarean delivery. (89, 111) A

team of law students, under the supervision of a law professor, prepared summaries of

tort reform for each state, including statutes and case rulings related to eleven reforms

enacted since 1975. Laws and court actions on eleven tort law provisions were

examined. The database’s coding scheme includes dichotomous variables for most

provisions, number of years for statutes of limitations and repose, and dollar amounts for

48

caps on noneconomic damage awards. The set of codes has been thoroughly documented

and validated, reflecting the tort provisions in effect in each state for each year 1975

through 2004. (111) The variables in the tort reform database and their coding are

presented in Table 4. Damage caps are coded according to levels. All other tort variables

are coded as absent or present (0/1).

Variables

Each tort reform and birth certificate variable employed by investigators

conducting similar research was examined for possible inclusion in our analyses (Table

3). This section first addresses variables selected for inclusion in the analyses, followed

by discussion of excluded variables and by discussion of unobserved and unmeasurable

confounding variables. Tables 3 and 4 list the variables addressed by this discussion.

Dependent variable Cesarean delivery: Cesarean delivery is the primary outcome to be examined, as the

purpose of the study is to examine whether cesarean rates change in response to tort

reform. Twelve of the papers presented in Table 2 included cesarean delivery among the

outcome variables. (37, 100), (94-96), (98), (99), (105, 106, 112, 118) Six of these

papers, those by Dubay et al., (99, 105) by Currie et al., (106) by Baicker et al., (37, 98)

and by Yang et al. (107) used NCHS natality data, with the others employing other data

sources. Among the studies using NCHS data to examine delivery method as an outcome

measure, Dubay, Currie, and Kim used cesarean only, while Yang also looked at VBAC

and primary cesarean delivery. When births are categorized as vaginal versus cesarean,

sensitivity has been found to be very high; (115, 119) however, poor sensitivity has been

reported for VBAC (115, 116, 119) and for primary cesarean and repeat cesarean. (116)

49

Recording of a delivery as primary, repeat or VBAC is likely poor, because it requires

knowledge of prior deliveries, whereas recording a delivery of vaginal versus cesarean

requires knowledge only of the current delivery.) Thus, for the present analysis, delivery

method is categorized as cesarean versus vaginal only (Table 4).

Independent Variables

Tort reforms adopted by states include caps on non-economic damages, caps on

or elimination of punitive damage awards, elimination of mandatory prejudgment interest

(interest accrued between the date of injury and entry of the judgment), collateral source

offset, caps on contingency fees, periodic payments, modification of joint and several

liability rule, patient compensation fund, statutes of limitations/repose, pre-trial

screening, and mandatory pre-judgment interest. These terms are explained in the

discussion which follows. Pre-trial screening was not included in this analysis, because

no changes were made during the study period. Elimination of mandatory prejudgment

interest was not included, because this information is not included in the database of tort

reforms used for this project.

The effects of nine tort reform variables will be examined in this study, consisting

of seven reforms and two variables that group the seven reforms as either direct or

indirect. Caps were coded as absent or present (0/1) and in a series of levels. Other tort

reforms were coded as absent or present (0, fraction of year reform was in effect) in each

of the 14 years under study.

Several studies examining the effects of tort reform on medical outcomes have

incorporated a “lag time” into their analysis (105, 107) on the supposition that there

would be a delay from the time legislation is enacted until this legislation is reflected in

50

changes in clinical practice. It should be noted that Dubay et al.’s use of a lagged analysis

was to account for the delay in tort reforms impacting insurance premiums, rather than

medical practice. (105) Currie et al. did not employ a lagged analysis in the belief that

tort reforms would affect the filing of lawsuits without a lag, whereas there would be a

lag in the effect of tort reforms on premiums.(106) Sloan et al. have reported that

physicians are generally aware of tort reforms prior to their implementation, (122, 123)

likely via news outlets, professional organizations, and colleagues. Their defensive

response, if any, would therefore likely take effect immediately. Using this rationale,

lagged analysis was not employed in the present study. Tort reforms to be included as

independent variables are caps on non-economic damages, collateral source offset, caps

on contingency fees, periodic payments, modification of joint and several liability rule,

patient compensation fund, statutes of limitations/repose. Additionally, these seven

reforms were grouped into two categories, direct tort reforms (caps on non-economic

damages, collateral source offset) and indirect tort reforms (caps on contingency fees,

periodic payments, modification of the joint and several liability rule, patient

compensation fund, and statutes of limitations/repose). These nine variables are

operationalized as presented in Table 4.

Direct Tort Reforms: This variable groups reforms that directly limit the amount of

recovery. This includes caps on non-economic damages and, and collateral source offset.

Others have also included caps on or elimination of punitive damages in this category.

(102, 107, 123)

Indirect Tort Reforms: This variable groups reforms with an indirect effect on reducing

awards by providing disincentives to file suit: caps on contingency fees, periodic

51

payments, modification of the joint and several liability rule, patient compensation fund,

and statutes of limitations/repose.

Caps on non-economic damages: Caps on non-economic damages limit recovery for

pain and suffering, which is often sought in addition to compensation for economic

damages, which are monetary losses, such as medical expenses and lost wages. Several

researchers examining defensive medicine and tort reform have included non-economic

damages caps as either present or absent, (102, 105, 106, 123), while Kilgore et al. (111)

and Yang et al., (107) examined cap levels. In this analysis, caps are categorized as <

250,000, > $250,000 and < 500,000, > $500,000 and < 750,000, and > $750,000. Caps

will also be coded as a dichotomous (yes/no) variable and a continuous variable in

alternate model specifications.

Non-economic damages caps were adjusted to year 2004 dollars. For example,

throughout the study period, California had in place a $250,000 cap on non-economic

damages. Due to inflation, the purchasing power of a dollar decreases each year, so that

$250,000 cap in 2004 would have been worth $344,347 in 1991, $281,513 in 1997 and so

on. This adjustment of the cap amount more accurately reflects its effect on damages

awards than using the flat statutory cap amount. Some states include a provision for

inflation in their statutory cap.

Modification of the joint and several liability rule: The joint and several liability rule

defines the way in which liability is apportioned among defendants. Modification of the

rule is intended to deter filing of lawsuits by preventing assignment of a larger share of

liability to a “deep pocket” defendant. Currie et al. reported a finding that JSL reduced

the effect of preventable complications of labor and delivery.

52

Collateral source offset: A collateral source offset requires the plaintiff to disclose

amounts received from collateral sources (e.g., medical insurance, disability payments),

and economic damages are offset by this amount. The intent is to prevent “double

dipping.”

Caps on contingency fees: Limiting attorneys’ fees reduces profitability and thus the

likelihood of filing suit.

Periodic payment provisions: This reform adds a requirement that payment of a

judgment for future damages be paid over time in the form of an annuity, rather than as a

lump sum.

Statutes of Limitations and Repose: Changing the time limits for filing suits presumably

reduces the number of claims filed. Both statutes of limitations and statutes of repose are

time limits beyond which legal action cannot be brought. In most states, the time limit

specified for a statute of limitations is counted from the date the plaintiff discovered or

should have discovered that an injury occurred (often but not always the actual date of

injury). The justification for statutes of limitations is that there should be point in time

when a potential defendant no longer needs to worry about being sued.(69) A statute of

repose differs from a statute of limitations in that the time limit it imposes is tied to some

event other than an injury (e.g., date of construction, date of manufacture, date of

treatment) and may run out before an injury occurs. For example, a woman in Florida

who had received a blood transfusion in 1986 learned in 1990 that she had contracted

HIV infection; however, the discovery date was beyond Florida’s four-year statute of

repose, and legal action was barred. (124)

53

Confounders

The association between tort reform and choice of delivery method is potentially

confounded by maternal demographic characteristics, maternal risk factors, labor and

delivery complications, fetal characteristics, and a variety of social, legal, political, and

economic factors that vary with geography .A number of maternal demographic

characteristics, maternal risk factors, labor and delivery complications, and fetal

characteristics are captured by the birth certificate data; however, among them are

variables that are subject to significant under-reporting. In order to avoid introducing

bias, variables with poor reliability were excluded from the analysis. Studies have shown

some variables to be of poor or moderate reliability, with sensitivity for some labor and

delivery complications of 30% or less. Other studies have suggested that this

underreporting may be differential according to maternal characteristics (e.g., unwed

mother, low educational attainment, Hispanic ethnicity) for some variables (116, 125,

126) or characteristics of the pregnancy or birth (e.g., preterm birth, birth injury). (127)

Other researchers addressing similar questions have included many or most of the

birth certificate variables in their models without considering the impact of data quality.

The discussion below explains why we believe it is appropriate or inappropriate to

include each variable in the models used in the present study. The final list of

confounders consists of the maternal characteristics of age, race, education, marital

status, diabetes, hypertension, tobacco use, pre-natal care utilization and the fetal

characteristics of gestational age, birthweight, and non-vertex presentation. Several

important predictors of cesarean delivery that are not recorded on the birth certificate, and

54

hence not included in this analysis, are measures of socio-economic status, insurance

status and type of insurance.

Confounders that are unknown or cannot be measured, “unobserved” but fixed

confounders, were accounted for via fixed effects modeling. Kessler et al., while using

fixed effects modeling, controlled separately for several time-varying state-specific

covariates, including the political party of each state’s governor, the majority political

party of each house of each state’s legislatures, and lawyers per capita. (102) These

variables were not added, as adequate control was achieved via fixed effects modeling.

Maternal Demographic Characteristics

We examined rates of cesarean delivery by maternal race and ethnicity, marital

status and educational attainment, because rates of cesarean delivery differ according to

each of these factors. (128) Most demographic variables are considered to be very

reliably reported in the birth certificate data. (18) Dubay et al. found that higher

malpractice claims risk results in increased use of cesarean section among unmarried

women with less than a high school education, which she used as a measure of SES, as

marital status and education are often correlated with income and insurance coverage.

(105)

Maternal Race: Cesarean rates vary by race and are highest for non-Hispanic black

women, (18) Several studies of defensive medicine and cesarean delivery have

controlled for race as a dichotomous Black and Other variable. (105-107) None have

separately stratified by race and ethnicity. The 2003 revision of the U.S. Standard Birth

Certificate uses an expanded classification scheme for race that includes multiple race

categories; however, data for states using the new categories has been bridged to single

55

race categories to facilitate comparability among states. For the present analyses, race

was categorized as White, Black, Native American, and Asian.

Hispanic ethnicity of mother: The cesarean rate has increased over time among all racial

and ethnic subpopulations, including Hispanic women. (19, 129) Hispanic ethnicity was

coded as yes/no.

Foreign-born mother: Dubay et al. (105) controlled for foreign birth of the mother in

their study of the effect of malpractice premiums on cesarean section rates. Literature is

sparse on the effect of foreign birth on cesarean; however, two studies report higher rates

of cesarean delivery among foreign-born mothers. Forma et al., (130) in a study of 50,000

deliveries at Grady Memorial Hospital in Atlanta, found a higher rate of cesarean

delivery among foreign-born women from Africa but not for foreign-born women overall,

and a study of Latina women in San Diego found that foreign-born primiparas (women

experiencing a first birth) were twice as likely to have undergone a cesarean as their U.S.-

born counterparts. (131)

Maternal Age: Pregnancy risk is increased at either end of the age spectrum. Births to

older women and to very young women have become more common during the time

period under study. Cesarean rates have been shown to increase with maternal age. (61)

Among the contributing factors may be the association of dystocia with increasing

maternal age. (42) In 2007, the cesarean rate for mothers aged 40–54 years in 2007 was

more than twice the rate for mothers under age 20 (48% and 23%, respectively).(132)

For this analyses, maternal age was categorized as <20, 20-24, 25-29 30-34, 35-39, 45-

54, consistent with categories used by Menacker et al. (132)

56

Maternal Education: Cesarean rates have been shown to increase with increasing

educational attainment. (18) Data on maternal educational attainment are not considered

comparable across birth certificate revisions, as the 2003 Certificate asks for the highest

degree or level of school completed (e.g., high school diploma, some college credit but

no degree, bachelor’s degree) and the 1989 Certificate asks for the highest grade of

school completed (years of grade school, years of high school or years of college).

Variables were re-coded to form three categories of educational attainment based roughly

on the work of Dubay et al. (1999), 0-11 years, 12 -15 years, and four or more years of

college.

Including adolescents in these educational categories produces misleading results,

as persons under 19 years of age have not had the same opportunity to complete

schooling as an adult. Mothers in this younger age group represent 10.4% of all births

(2006 data). Some studies have excluded adolescents to avoid this comparability

problem; however, most do not account for it. Studies focusing on adolescents have used

an “education for age” approach; (133) however, there appears to be little support for

such a strategy across age groups. This analysis includes adolescents, and, consistent

with other reports based on NCHS birth data, (31) make no special provision for years of

education for age.

Marital Status: Associations have been reported for unmarried status and low birth

weight, preterm birth, and small for gestational age birth. (134) Dubay et al. (105) used

mother’s marital status and educational attainment as proxies for socioeconomic status.

Currie et al. (106) and Baicker et al. (37) also controlled for marital status in their

57

analyses. The present analysis included marital status as a dichotomous variable,

unmarried, married.

Plurality: Multiple gestation pregnancies are more likely to be delivered via cesarean;

however, birth certificate data do not allow the linking of multiple births to the same

delivery event. The 2003 revision of the U.S. Standard Birth Certificate includes a

matching number for plural births. The present analysis includes the years 1991-2004,

and by the end of 2004 just nine states had adopted the new birth certificate. The analysis

is limited to singleton deliveries to avoid potentially over-counting of the number of

cesarean deliveries and because single and multiple births differ in the types of medical

complications they experience. Among studies using birth certificate data to examine

defensive medicine and cesarean delivery, Dubay et al.(105) limited their analysis to

singleton births and Currie et al. (106) and Yang et al. included multiple births,

controlling for them in the analysis. (107) Baicker et al. (37) did not address plurality.

Kim (135) performed a separate sub-analysis of multiple births but did not account for

them in the main analysis. Multiple births were excluded from this analysis.

Maternal Medical History

Several maternal medical history variables included by other researchers in their

analyses were not included in the present analysis, primarily because validation studies

report poor reliability. Variables included in the analyses are discussed below. Variables

used by others but excluded from this analysis are presented in a separate section.

Included and excluded variables are listed in Tables 3 and 4.

58

Parity: Associations have been reported between the number of times a woman has given

birth and certain obstetric complications. Some of these complications, such as

preeclampsia (136) and dystocia (42) are more common in nulliparous women, whereas

others, such as placenta previa (137) are more common in multiparous women. Overall, a

first birth carries a higher risk of complications and of cesarean delivery. Among papers

examining defensive medicine and cesarean, only Currie et al. controlled for parity in

their analysis. The present analysis includes parity as a dichotomous variable,

(primiparous/multiparous). The term “primiparous,” rather than “nulliparous” is used

because the analysis uses birth certificate data, which was collected following the birth.

During labor and delivery, the same woman would be correctly described as nulliparous.

Maternal Tobacco Use: Smoking during pregnancy increases the risk of pregnancy

complications, including premature rupture of membranes, abruptio placenta, and

placenta previa, as well as increasing the risk of delivering a premature and/or low

birthweight infant. Infants born to mothers who smoke during pregnancy have about

30% higher odds of being born prematurely than infants born to mothers who do not

smoke. (138) Maternal tobacco use is of moderate sensitivity.(115, 125) This was coded

as a dichotomous (yes/no) variable.

Diabetes: Diabetes is a chronic metabolic disorder characterized by insulin deficiency,

which results in elevated blood sugar (hyperglycemia). Glucose transported across the

placenta puts the fetus at risk for intra-uterine hyperglycemia, (139) hypoglycemia, or

other metabolic disturbances. (140) The fetus’s responds to maternal diabetes with

increased insulin production and accelerated fetal metabolism, which can result in excess

fetal growth and macrosomia (gestational weight > 4,000 grams). Macrosomia increases

59

the risk of shoulder dystocia (impeded delivery of the shoulders often accompanied by

nerve injury), clavicle fracture, and other birth injuries. (140) Prophylactic cesarean has

been recommended when fetal weight is estimated at 4,500 grams or more. (140)

Diabetes is associated with chronic and gestational hypertension (140) and with obesity.

(141) For this analysis, diabetes is a combined variable including both pre-pregnancy

(chronic) and gestational diabetes and was coded as a dichotomous (yes/no) variable.

Hypertension: Hypertension, although not a direct indication for cesarean, may co-occur

with other risk factors, such as obesity, and may be a precursor to more serious

pregnancy complications. Preeclampsia is the development of hypertension plus

proteinuria or generalized edema during pregnancy and may progress to eclampsia, which

is characterized by convulsions. Hypertension increases the risk of abruptio placenta and

of fetal growth retardation and intrauterine death, (13) and pregnancy-induced

hypertension is among the leading causes of maternal mortality. (3)

Pre-pregnancy (chronic) was coded as a dichotomous (yes/no) variable.

Gestational was coded as a dichotomous (yes/no) variable.

Adequacy of Prenatal Care: Adequacy of prenatal care will be measured via the Revised

Graduated Index of Prenatal Care Utilization (R-GINDEX) proposed by Alexander and

Kotelchuck. (142) The R-GINDEX is a graduated index using six categories of care

(intensive, adequate, intermediate, inadequate, no-care, and missing/unknown), that

improves upon on the Graduated Index of Prenatal Care Utilization (GINDEX) described

by Alexander and Cornely. (143) Early indices, such as the Kessner Index and the

GINDEX rely on a 1972 Institute of Medicine Report and are considered flawed, while

more recently developed indices, such as the Adequacy of Prenatal Care Utilization

60

(APCNU) index and R-GINDEX, incorporate 1989 ACOG prenatal care

recommendations and are thought to better reflect adequacy of care. (143)

These categories were used for the descriptive analysis. For the fixed effects analysis, the

inadequate and no care categories were combined and a dichotomous (yes/no)

“inadequate or no care” variable was created. Baicker et al. included prenatal care use in

the index of patient-level characteristics developed for use in their models, using the

Kessner index (adequate, intermediate, or inadequate). Kim (100) examines prenatal care

as an outcome, evaluating the effect of malpractice risk on the number of visits (not

accounting for gestational age at birth).

Labor and Delivery Characteristics

Many labor and delivery variables included by other researchers in their analyses

were not included in the present analysis, primarily because validation studies report poor

reliability. Variables included in the analyses are discussed below. Variables used by

others but excluded from this analysis are presented in a separate section.

Non-vertex presentation: ACOG’s 2006 opinion on delivery of a term singleton breech

birth was that a decision to attempt vaginal delivery should depend on the experience of

the health care provider, acknowledging that cesarean delivery be the preferred delivery

mode for most physicians. (144) This is a departure from the 2002 opinion that patients

with a singleton in persistent breech presentation or a second twin in non-vertex

presentation should undergo a planned cesarean. (145) Cesarean is the method of

delivery for 85% of breech births. On the 1989 revision of the U.S. Standard Birth

Certificate, presentation is categorized as vertex, breech, or other malpresentation. The

61

2003 birth certificate classifies all malpresentations as non-vertex. For this analysis,

breech and other malpresentation have been combined to allow comparability. Among

labor and delivery characteristics, only non-vertex presentation is sufficiently reliable for

inclusion in the analysis. The following variables are therefore excluded from the

analysis due to poor, (115) (125) and possibly differential, reporting. Non-vertex

presentation was recorded for 3.18% of singleton births 1991-2002 (12.9% of cesarean

deliveries) and has been constant over time.

Infant Characteristics

Gestational Age: In 2005, 46.8% of singleton births of less than 32 weeks gestation were

delivered via cesarean. (61) For this analyses, gestational age was categorized as < 32

weeks (extremely premature), > 32 weeks, < 36 (premature), > 37 weeks and < 41

weeks (normal), and > 41 weeks (postmature). Gestational age was based on last

menstrual and period, rather than clinical gestational age. Wingate et al., (146) using

NCHS natality files for 2000-2002, found perfect agreement between last menstrual

period and the clinical estimate for just 53.8-57.0% (differing according to demographic

characteristics) of records. The last menstrual period measure is reportedly less subject to

systematic error and is therefore preferable for use in population-based analyses. (146)

Wingate et al. also reported that the greatest discordance between last menstrual period

estimate and clinical estimate occurred at 32–33-weeks’ gestation, and the

proportion of cases with their clinical estimates of gestational age two or more weeks

higher than the last menstrual period estimate was greatest between 32 and

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35 weeks. (146) As pre-term birth is defined as birth at less than 37-weeks’ gestation, use

of the clinical estimate could result in a substantial under-estimate of the number of pre-

term births, affecting our ability to control for pre-term birth in the analysis.

Birthweight: The association between low birthweight and cesarean delivery is well-

recognized; however, high birthweight infants are also often delivered via cesarean.

Other factors associated with macrosomia include a previous infant > 4,000 g and post-

maturity. Over time, there has been an increased tendency toward larger babies (in the

presence or absence of obesity and diabetes) (51) (147) Boulet et al. (2005) report that

rates for cesarean delivery of macrosomic infants showed a pattern of increase between

1989 and 2000. (148) Boulet et al. (2003) also report that 25.5% of infants weighing

4,000 -4,499 grams , 35.6% of infants weighing 4,500-4,999, and 50.6% of infants

weighing in excess of 5,000 grams were delivered via cesarean while the percentage of

normal weight (300—3999 grams) infants delivered via cesarean during the same period

was 18.0%. (149) For these analyses, birthweight was categorized as < 2500 g (LBW),

> 2500 but < 4000 (normal birthweight), and > 4000 (high birthweight).

Table 4 presents the variables selected for inclusion in the analysis and describes

how they will be operationalized. The confounders for which we will adjust are the

maternal characteristics of age, race, education, marital status, parity, diabetes,

hypertension, tobacco use, pre-natal care utilization and the fetal characteristics of

gestational age, birthweight, and non-vertex presentation. The “NCHS Variable Name”

column lists the variables from the NCHS public use natality datasets from which our

variables were derived. The analysis uses data from fourteen NCHS datasets from the

years 1991-2004. During the earlier years, the 1989 revision of the U.S. Standard Birth

63

Certificate was in use. The birth certificate was revised in 2003. Just a few states adopted

the new certificate in 2003, and it came into use in additional states in 2004. As a result,

during 2003 and 2004 states were using two different versions of the birth certificate. The

2003 and 2004 datasets include sets of variables for both revisions. Most variables

included in the dataset used for this analysis were re-coded from multiple variables to

allow comparability among states and across years.

Excluded Variables

The following section describes variables excluded from the analysis, with

reasons for exclusion provided. This section is provided to explain why variables used in

similar research were excluded from the present analysis. Table 3 lists variables included

and excluded from the analysis.

Tort Reform Variables

Two tort reforms included by some other researchers were excluded from this analysis.

Caps on or elimination of punitive damages awards: These caps place limits on awards

intended to punish a defendant for willful egregious conduct. Punitive damages are most

often awarded in contract and intentional tort cases and rarely in medical malpractice

actions. (150) Because this reform is rarely adopted by states and is not included in the

database used this study; it was not considered in this analysis.

Patient compensation funds: A patient compensation fund is a state-sponsored excess

insurance pool for medical malpractice liability, often financed via a tax on malpractice

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insurance premiums, which pays for judgments or settlements in excess of an amount

specified by statute. This reform is not included in the database used for this study.

Birth Certificate Variables

Weekend birth: Patterns of birth by day of week and delivery method have not been

well-described in the literature. Goodman et al., however, report that weekend births,

Sunday more so than Saturday, have shown a progressive decrease since the 1950’s and

opine that this decrease may be related to increasing use of cesarean delivery. (151)

Martin et al. report that, based on U.S. birth certificate data, the average number of births

by day of the week is lower on Saturday and Sunday than for weekdays for both vaginal

and cesarean births. Weekend cesarean births showed a pattern of decrease between

1990 and 2006. (19) Dubay et al. (105) controlled for weekend birth in their analysis.

Others using birth certificate data to examine cesarean delivery in the context of

defensive medicine have not considered day of the week. This variable was included in

the descriptive analysis but not in the tort reform analysis.

The following maternal medical history and labor and delivery complications

variables were excluded from the fixed effects analysis, because of poor reliability.

Studies have reported low sensitivity (<40%) for incompetent cervix and extremely low

sensitivity (< 20%) for eclampsia, previous infant 4000 + grams, previous preterm or

small for gestational age infant in the birth certificate data (115), (125). Dubay et

al.(105) controlled for eclampsia (percent in each county with eclampsia recorded as a

complication on the birth certificate). Baicker et al. (37) included indicators for the

presence of each medical risk factor variables from the birth certificate in an index of

65

characteristics, which was used as a control variable in their models. Currie et al. (106)

included each of these variables in their “high risk” categorization for identifying

preventable and unpreventable cesareans. These four variables were among the 14

collapsed into four principle components by Yang et al. (107) to control for clinical risk

factors for cesarean in their analysis.

Maternal Alcohol Use: Alcohol use during pregnancy is associated with fetal alcohol

syndrome and several types of birth defects.(106) Because of its association with

premature birth, it is a risk factor for cesarean delivery. Sensitivity of maternal alcohol

consumption during pregnancy recorded in birth certificate data has been reported as less

than 25% (115) and will be excluded from this analysis.

Incompetent cervix: Incompetent cervix is a condition that occurs when the cervix begins

to open early in pregnancy in response to pressure from the developing fetus. The

condition may result in premature birth or fetal loss. Treatment may entail use of a suture

to hold the cervix, which is removed late in pregnancy. Among singleton births 1991-

2002, incompetent cervix was recorded on 0.23% of birth certificates.

Eclampsia: Eclampsia (formerly known as “toxemia”) is a life-threatening condition

characterized by seizures and accompanied by high blood pressure. Eclampsia may be

associated with diabetes, high blood pressure, or kidney disease and may result in

abruptio placenta. (152) Eclampsia was recorded for 0.31% of singleton births 1991-

2002.

Previous preterm or small for gestational age infant: Birth of a preterm or small for

gestational age infant is a risk factor for birth of subsequent preterm or small for

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gestational age infants. (12) This history was recorded for 1.14 % of singleton births

1991-2002.

Previous infant 4000 + grams: Birth of a macrosomic infant is a risk factor for

subsequent macrosomic infants. (149) History of a prior macrosomic infant was recorded

for 1.04% of singleton births 1991-2002.

Dystocia: Dystocia (dysfunctional labor) can result from abnormalities of the expulsive

forces, of fetal presentation, positioning or development, of the maternal pelvis or of the

maternal soft tissues. (12) Dystocia is the most commonly reported indication (43%-70%)

for cesarean delivery (35, 43); however, studies have reported less than 20% sensitivity

for this birth certificate variable. There is broad agreement that dystocia is over-

diagnosed, but the reasons are unclear. Variability in diagnostic criteria, diagnosis made

without an adequate trial of labor, failure to utilize oxytocin stimulation for slow labor,

and fear of litigation are among the hypothesized reasons. (12) Dystocia was recorded for

2.82% of singleton births 1991-2002 (8.75% of cesareans).

Fetal distress: Fetal distress is a condition involving hypoxia (oxygen deprivation) and

metabolic acidosis (elevated blood level of lactic acid). The contractions of normal labor

result in a series of acute hypoxic events, which lead to some degree of acidosis;

however, severe oxygen deprivation (asphyxia) and acidosis can lead to neurologic

impairment or death. The fetal heart rate is monitored via intermittent examination with

a stethoscope or via continuous electronic monitoring. Certain fetal heart rate patterns are

believed to portend an adverse outcome, and the threshold for intervention is subject to

subjective clinical judgment. (12) Fetal distress is the second most commonly reported

indication for cesarean (14-20 % of cesarean deliveries) (35, 43) has a reported

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sensitivity in the birth certificate data of less than 40%. Fetal distress was recorded for

3.67% of singleton births 1991-2002 (9.97 % of cesareans).

Prolonged labor (> 20 hours): There is a strong association between prolonged labor and

cesarean delivery. (153-155) Associations have been reported between prolonged labor

and maternal morbidity, specifically, prolonged first stage of labor (155) and infection

and between prolonged second stage, which is more often cited as an indication for

cesarean delivery, and postpartum hemorrhage, infection, and severe obstetric

lacerations. (154, 155) Prolonged labor was recorded among 0.86 % of singleton births

1991-2002 (1.47 % of cesareans).

Cephalopelvic disproportion: Cephalopelvic disproportion occurs when the either the

fetal head too large to pass through the maternal pelvis, because of the size of the fetal

head, the size of the maternal pelvis, or both. There is no reliable way using current

radiographic or ultrasound techniques to predict cephalopelvic disproportion, and the

diagnosis is often made following arrest of labor. (12) Cephalopelvic disproportion was

recorded among 2.27 % of singleton births 1991-2002 (10.33 % of cesareans).

Abruptio placenta: Abruptio placenta is separation of the placenta from the uterine

implantation site before delivery of the fetus. Some risk factors include diabetes,

hypertension, advanced maternal age, and alcohol or cigarette use during pregnancy.

Treatment entails IV fluids and blood transfusion, and emergency cesarean delivery may

be indicated. (152) Abruptio placenta was recorded among 0.54 % of singleton births

1991-2002 (1.50 % of cesareans).

Cord prolapse: Cord prolapse is a rare complication that occurs when the umbilical cord

drops through the cervix into the vagina ahead of the descending fetus. Due to the risk of

68

fetal oxygen deprivation, it is considered an emergency. Attempts must be made to

elevate the presenting part of the fetus in order to prevent cord compression. Immediate

delivery is required, typically via cesarean. Cord prolapse was recorded among 0.20 %

of singleton births 1991-2001 (0.61 % of cesareans).

Excessive bleeding: Excessive bleeding is responsible for the majority of maternal deaths

during childbirth in the United States. Excessive bleeding during labor is not clearly

defined, as most criteria for defining obstetric hemorrhage refer to postpartum, rather

than intrapartum bleeding. (156) Significant bleeding compromises both mother and fetus

and is often an indication for cesarean delivery. Causes of excessive bleeding during

labor may include placenta previa (placenta across the cervix), placenta accreta (abnormally

deep attachment of the placenta), abruptio placenta (premature detachment of the placenta

from the uterine wall), or uterine rupture. (156) A condition which may result excessive fetal,

rather than maternal, bleeding during labor is vasa previa, a condition in which fetal blood

vessels run in close proximity to the cervix. Rupture of the maternal membranes may result in

rapid exsanguination of the fetus. (156) Excessive bleeding was recorded for 0.55 % of

singleton births 1991-2002 (0.75 % of cesareans).

Placenta previa: Placenta previa is a complication of pregnancy in which the placenta

grows across the opening of the cervix, creating a risk of hemorrhage. Placenta previa

was recorded for 0.32 % of singleton births 1991-2002 (1.50 % of cesareans).

Premature rupture of membranes: Premature rupture of membranes (prior to

commencement of labor) occurs in approximately 8% of pregnancies. (12) Attempts are

made to induce labor by administering oxytocin, a hormone ordinarily produced by the

mother during labor. If this fails to induce sufficient contractions, cesarean delivery is

69

indicated. Premature rupture was recorded for 2.68 % of singleton births 1991-2002 (3.14 %

of cesareans).

Meconium staining: Meconium staining indicates that fetal bowel contents have passed

into the amniotic fluid. There has been a long-held belief that meconium is passed in

response to hypoxia, and its presence is a sign of fetal distress. More recent research

suggests that in some cases it is a normal physiological process. (12) Aspiration of

meconium can result in fetal lung damage.(12) Meconium staining was recorded for 5.65

% of singleton births 1991-2002 (percentage was also 5.65 for cesareans).

Table 3. Variables Considered for Inclusion the Fixed Effects Models*

Included Excluded Tort Variables

Caps on non-economic damages Collateral source offset Caps on contingency fees Periodic payments Modification of joint and several liability rule Patient compensation fund Statute of Limitations Statute of Repose Direct Tort Reforms Indirect Tort Reforms

Caps on or elimination of punitive damages awards Patient compensation funds

Birth Certificate Variables

Cesarean Birth Year State of Occurrence Maternal age Marital status Race Hispanic ethnicity Foreign-born mother Maternal education Parity Tobacco Diabetes Hypertension Adequacy of pre-natal care Breech or other malpresentation Gestational age Birthweight

Weekend birth Maternal Alcohol Use Incompetent cervix Eclampsia Previous preterm or small for gestational age infant Previous infant 4000 + grams Dystocia Fetal distress Prolonged labor (> 20 hours) Cephalopelvic disproportion Abruptio placenta Cord prolapse Excessive bleeding Placenta previa Premature rupture of membranes Meconium staining

* Table 4 contains several additional variables that were used in the descriptive analysis only.

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Table 4. Variables Included in Descriptive and/or Econometric Analyses

Variables and Description NCHS Variable

Name

Category Classification

Caps on non-economic damages

N/A

Independent 1=Cap < 250,000 2=$250,000 < Cap < 500,000 3=$500,000 < Cap < 750,000 4=Cap > $750,000 (89) 0=absent 1=present

Collateral source offset

N/A Independent Continuous (fractions of a year in effect)

Contingency fees

N/A Independent Continuous (fractions of a year in effect)

Periodic payments

N/A Independent Continuous (fractions of a year in effect)

Modification of JSL N/A Independent Continuous (fractions of a year in effect)

Statute of Limitations N/A Independent Time limit in years Statute of Repose N/A Independent Time limit in years Direct Tort Reforms

N/A Independent 0=absent 1=present

Indirect Tort Reforms

N/A Independent 0=absent 1=present

Delivery Method

DELMETH5 UME_VAG UME_VBAC UME_PRIMC UME_REPEC

Dependent 1= vaginal (excludes VBAC) 2= VBAC 3= primary cesarean 4= repeat cesarean

Cesarean DELMETH5 UME_PRIMC UME_REPEC

Dependent 0=no 1=yes

Birth Year DATAYEAR DOB_YY

1991-2004

State of Occurrence STATENAT OSTATE

01-51

Day of week WEEKDAY DOB_WK

Confounder 1-7

Maternal age

DMAGE MAGER

Confounder 1= <20 2=20-24 3=25-29 4=30-34 5=35-39 6=40-45 7=45+

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Table 4. Variables Included in Descriptive and/or Econometric Analyses

Variables and Description NCHS Variable

Name

Category Classification

Marital status DMAR MAR

Confounder 0=married 1=unmarried

Race MRACE MBRACE

Confounder 1= white 2 =black 3= Native American 4= Asian

Hispanic ethnicity ORMOTH UMHISP

Confounder 0=not Hispanic 1=Hispanic

Foreign-born mother MPLBIR UMBSTATE

Confounder 0=not foreign-born 1=foreign-born

Maternal education DMEDUC MEDUC6

Confounder 1= 0-8 years 2= 9-11 3= 12 (hs grad) 4= 13-15 y 5= 16 +

Parity DLIVORD LBO

Confounder 1=primiparous 0=multiparous

Tobacco TOBACCO TOBUSE

Confounder 0= does not smoke 1=smokes

Diabetes DIABETES URF_DIABETES

Confounder 0=absent 1=present

Hypertension CHYPER PHYPER URF_CHYPER URF_PHYPER

Confounder 0=absent 1=present

Adequacy of pre-natal care

PCV MONPRE NPREVIST MBCB PRECARE UPREVIS

Confounder 0=adequate, intermediate or intensive. 1=inadequate or no care

Breech presentation

BREECH ULD_BREECH

Confounder 0=absent 1=present

Gestational age

DGESTAT COMBGEST

Confounder < 32 wks (extremely premature) > 32 wks and < 36 (premature) > 37 wks and < 41 weeks (Term) > 41 wks (postmature)

Birthweight

DBIRWT DBWT

Confounder < 2500 g (LBW) > 2500 but < 4000 (NBW) > 4000 (high birthweight)

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Table 5 lists numbers and percent missing for variables included in the fixed

effects analysis. For approximately 1% of births no delivery method was reported, and

for the tort reform variables, there were no missing variables. For most confounders, the

percent missing was less than 2%, however, the percentages were higher for receipt of

prenatal care (7.51%), maternal education (13.52%) and for smoking status (19.42%).

The percent missing data for race, age, and marital status of mother on birth certificates is

very small and values are imputed by NCHS. (31) Missing data for gestational age may

be more common for some subpopulations and for pre-term births. For computation of

gestational age, weeks of gestation were imputed for records with missing day of last

menstrual period when there is a valid month and year. (157) Missing information on

educational attainment varies by state, but, overall, according to the National Center for

Health Statistics, information was missing for just 2% of records in 2004. (157) The

educational attainment variables are not directly comparable across birth certificate

revisions. (31) Because maternal educational attainment is an important predictor of

cesarean delivery, it was included in the models. In re-coding, a decision was made to

lose, rather than misclassify observations. PROC GLM in SAS addresses missing values

via listwise deletion, deleting observations for which there is a missing value, which may

be a non-trivial number. Nevertheless, when the problem of missing data for a particular

variable does not depend on the dependent variable, listwise deletion produces generally

unbiased estimates and may be preferred over more complex statistical approaches, such

as maximum likelihood or imputation. (158)

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Table 5. Missing Values for Variables Included in Econometric

Analyses Variable

(Recoded from Originals)

Original Birth Certificate Variables

Variable Names % Missing or Coded

“Not Stated” Delivery Method Delivery

Method DELMETH5 UME_VAG UME_VBAC UME_PRIMC UME_REPEC

0.99

Race Race MRACE MBRACE

1.57

Hispanic Ethnicity

Hispanic Ethnicity

ORMOTH UMHISP

1.13

Age Age DMAGE MAGER

0.00

Education Education DMEDUC MEDUC6

13.52

Unmarried Marital status DMAR MAR

0.00

Foreign birth of mother

Foreign birth of mother

MPLBIR 0.12

Primipara/parity Live birth order

DLIVORD LBO

0.00

Diabetes Diabetes DIABETES URF_DIABETES

1.55

Hypertension Hypertension CHYPER PHYPER URF_CHYPER URF_PHYPER

1.55

Smoking Smoking TOBACCO TOBUSE

19.42

Inadequate Prenatal Care

Receipt of prenatal care

PCV MONPRE NPREVIST MBCB PRECARE UPREVIS

7.51

LBW, VLBW, HBW

Birthweight BW DBIRWT DBWT

0.10

Very Pre-term, Preterm, Postmature

Gestational age

DGESTAT COMBGEST

1.01

Breech Breech BREECH ULD_BREECH

0.04

74

Unmeasured confounders

There are several important confounders for which there are no data available

from the NCHS natality files.

Insurance status: Women who have private medical insurance are more likely to have a

cesarean delivery than those insured by a health maintenance organization or by public insurance

or without insurance. (21) (159) There is also a perception that patients with public

insurance (e.g., Medicaid) are more likely to bring suit, (160) This information is not

collected on the birth certificate. Yang et al. (107)adjusted for insurance status using

state-level data from the U.S. Census Bureau. Dubay et al. (105) used mother’s marital

status and educational attainment as proxies for both socioeconomic status and insurance

coverage. Yang et al. (107) used U.S. Census state-level data for each year on insurance

status (Medicaid, private, uninsured) among women to measure SES.

Socio-economic status: Studies have reported associations between cesarean delivery

and socioeconomic status that cannot be explained by maternal age, parity, birth weight,

race, ethnicity, or complications of pregnancy or childbirth. (161) Birth certificate data

provides no direct measure of socioeconomic status. Dubay al. (105) used mother’s

marital status and educational attainment as a proxies’ defensive responsive to

malpractice claims risk includes performing more cesarean deliveries on women in the

lower categories of socioeconomic status. Others have used educational attainment, Kim

using high school education or less than high school and Yang et all using college

education or less than college to represent socioeconomic status as a control variable in

their models. The present analysis will examine the effect of tort reform on cesarean

75

delivery, stratified by age, race, and educational status but not attempt to measure

socioeconomic status directly.

Maternal obesity: Maternal obesity is associated with several complications of

pregnancy, including macrosomia, gestational hypertension, preeclampsia, and

gestational diabetes. (135) and consequently with higher cesarean rates. Obesity among

the U.S. population, including women of childbearing age, has increased dramatically

over time. Although it is not possible to measure obesity, data are available for several

risk factors often associated with obesity, including hypertension and both pre-pregnancy

and gestational diabetes, which will be controlled for in the analysis. In order to control

for obesity in their study of tort reform and delivery method, Yang et al. (107) used data

on females (all ages) from the Behavioral Risk Factor Surveillance System (BRFSS) to

calculate state-level obesity rates.

Insurance carrier prohibition of VBAC: If insurance companies’ failure to cover VBAC

is a substantial contributor to cesarean rates, this will confound the association between

tort reform and physician decision to perform a cesarean. This could be controlled by

limiting the analysis to primary cesarean deliveries; however, it is not possible to reliably

distinguish between primary and repeat cesareans using birth certificate data.

Tort Reform Analysis

Panel data consists of “repeated measures” on an individual. Although this study

used individual-level data for 54 million singleton births, the unit of observation was the

state, rather than the individual birth, as tort reforms operate at the state level. For each

state, cesarean delivery (yes/no) was measured for each of the 14 years under study.

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Fixed Effects Modeling

An “effect” (each term in a statistical model) is either “random” or “fixed.” A

fixed effect is an effect that is assumed to be constant for each unit of observation (in this

case a state) for each measurement (in this case each of 14 years), while a random effect

is one that is not fixed. Models in which all effects are fixed are called “fixed-effects”

models, and those in which all the effects are random are called “random-effects”

models. A hybrid, containing both, is called a “mixed-effects” model.

There is considerable state-to-state variability in cesarean rates. For each state, the

cesarean rate is likely affected by a set of factors, some measureable and some not,

unique to that state. Thus, changed in cesarean rates within states over time was

measured. Fixed effects modeling was used to reduce “unobserved variable bias,” a term

used in economics to describe the effect of unknown confounders, at the state and year

level. This controls for omitted but fixed variables at the state level, those that either are

unidentified or cannot be measured. In the absence of tort law change, cesarean rates are

determined by the sum of a state effect that is stable over time and a year effect that is

common across states.

“Differences in differences” is fixed effects methodology for aggregated data that

is similar to a pre-test, post-test experiment. It is often specifically used to estimate the

impact of state-level policy change. “Other things equal” (ceteris paribus) is an

assumption that everything, apart from the variables of interest and variables for which

control can be achieved, remains the same. Therefore, the unobserved differences

between the two groups are the same over time. It is also assumed that, were it not for the

implementation of tort reforms, the general trend in rates would be the same for the group

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of states that has implemented reforms and that which has not. In this case, states that did

not implement reforms act essentially as a control group for those that did implement

reforms. The present analysis compares probability of cesarean delivery before and after

tort reform for states that implemented tort reform (essentially the “treatment” group)

with changes in occurrence for states that did not implement tort reforms (“control”

group). This approach accounts for differences in outcomes between the states that

existed before implementation of the tort reforms. Other things equal, in states that that

have adopted certain tort reform measures, the probability of having a cesarean delivery

is lower following implementation of the reform measures.

In an ecologic analysis, it is not possible to be sure that any observed changes in

occurrence of cesarean delivery were due to changes in tort law. It is, however, possible to be

sure that the changes were due to some factor that changed over time within each state and that

changes in cesarean delivery were not due to characteristics within the states that were fixed over

time, because the fixed effects analysis controls for these characteristics. What is often cited as a

limitation of fixed effects methodology is an increase in sampling variability. (162) Of course,

that limitation does not apply to this study, which utilizes a 100% sample.

Omitted Variable Bias and Endogeneity

“Omitted variable bias” is bias in a parameter estimate in a regression analysis

that occurs when a variable that should be in the model has been omitted. Despite the use

of fixed effects modeling to reduce the likelihood of omitted variable bias, there were

several possible confounders that could not be measured using birth certificate data.

Individual-level variables that could not be measured included insurance status, socio-

economic status, and maternal obesity. Additionally, within-state local area patterns of

78

medical practice and insurance company practices, such as prohibition of VBAC, that

may influence cesarean delivery, could not be measured.

An “endogenous” variable is one whose value is determined by other variables in

the model, as opposed to an “exogenous variable,” the value of which is unrelated to the

variables in the model. Endogeneity was of concern in this analysis, because tort reforms

in some states may have been enacted in response to a perceived malpractice crisis,

characterized by increases in malpractice insurance premiums, malpractice lawsuits, and

and/or damage awards. In some states, tort reform has been limited to medical

malpractice cases in response to a perceived crisis specifically in medical malpractice

cases. Obstetrics is the most common specialty involved in malpractice suits, and

negligent failure to perform a cesarean is a common cause of action in those lawsuits.

Cesarean rates may therefore, in some cases, have an influence on enactment of some tort

reforms. Endogeneity could result in an underestimate of the effect of tort reforms if

reforms were adopted in response to increasing cesarean delivery rates. If both adoption

of tort reforms and increasing cesarean rates are associated with an omitted variable, an

overestimate of the effect could result.

Data analysis was performed using SAS (SAS, Inc., Cary, NC). The SAS

procedure employed will be PROC GLM, with dummy variables for each year and for

each state. PROC GLM (generalized linear models) is a procedure used to perform

analysis of variance for repeated measures and is particularly useful for fixed effects

modeling that uses a large number of dummy variables. Adding the “solution” option in

PROC GLM produces a table of parameter estimates.

79

Ordinarily PROC GLM would not be used with a dichotomous outcome variable,

as it uses ordinary least squares regression, which, when used with a categorical variable,

may cause an “incidental parameters problem.” This occurs in repeated measures when

the number of observations increases with the number of measurements, and results in

parameter estimates that are biased upwards. (162) The annual number of births remained

relatively constant across the 14-year study period (Table 6), with a mean of 3,873,208 ,

and all 50 states were observed for each of the 14 years. For this reason, incidental

parameters should not be a problem. Some texts recommend use of the PROC PHREG

procedure, ordinarily used for survival analysis, for fixed effects analysis with a

dichotomous outcome; however, the procedure is not appropriate for use with the large

number of dummy variables needed for this analysis. (163)

Table 6. Numbers of Live Singleton Births Per Year, United States, 1991-2004

Year Number 1991 4,115,342 1992 4,069,428 1993 4,004,523 1994 3,956,925 1995 3,903,012 1996 3,894,874 1997 3,884,329 1998 3,945,192 1999 3,963,465 2000 4,063,823 2001 4,031,531 2002 4,027,376 2003 4,096,092 2004 4,118,907

Confounders that were known, could be measured, and for which data are

available, were included as variables in the models. Confounders that were unknown or

not measurable, “unobserved” but fixed confounders, were accounted for via fixed the

effects modeling.

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CHAPTER 4

RESULTS Descriptive Analyses

Between 1991 and 2004, there were 54,445,327 (approximately 3, 900,000 per

year) live singleton births in the United States, 74.9% delivered vaginally, and 21.8%

delivered via cesarean. (Table 7) The rate of cesarean delivery varied by state from 16.0

per 100 live singleton births (16.0%) in Alaska to 27.3 in Louisiana. (Table 8)

Changes in tort law between 1991 and 1994 by state are summarized in Table 9.

Non-economic damages caps were in effect in 29 states over the 14-year study period,

and eight states underwent changes in caps, either adopting, removing, or changing the

cap amount. Removal of a cap may result from either legislative or judicial actions, such

as invalidating a cap under a state’s constitution. Laws requiring disclosure of collateral

sources were in effect in 30 states, with 3 making changes in their laws during the study

period. The number of states with joint and several liability reforms in place increased

from 25 to 30 over the study period. Periodic payment requirements were in effect in 33

states. All states had statutes of limitations in effect throughout the 14-year period, which

varied in length by state. Statutes of limitations ranged from 1 year to 4 years, with a

mean of 2.2 years. Statutes of repose had been adopted by 38 states, and they were

present for all 14 years in 37 of those states. Among states with statues of repose, the

length ranged from 2 to 10 years, with a mean of 4 years. Throughout the study period,

the same thirteen states had limits on attorneys’ fees in place.

Rates of cesarean and vaginal delivery according to maternal demographic

characteristics and medical history are presented in Table 10. The highest rate of cesarean

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birth was among black women compared to other racial and ethnic groups. Over the 14-

year period, the percentage of cesareans per 100 live singleton births increased with

maternal age. Among mothers aged 45 and older, 37.9% of births were delivered via

cesarean, while among women aged less than 20 years, 18.0% of births were delivered

via cesarean. Nearly 40% of women diagnosed with either chronic or gestational diabetes

and or women with either chronic or pregnancy-associated hypertension underwent

cesarean delivery. Further, 85% of breech or other malpresentations were delivered via

cesarean.

Among gestational age categories (11), the highest rate of cesarean delivery

(38.9%) was among “very premature” infants, those aged 32 weeks or less. The highest

rate of cesarean delivery by birthweight (32.7%) was in the premature category (<36

weeks). Figure 3 shows the trend in cesarean rates among live singleton births from 1991

through 2004. The rates are lower than those typically reported nationally, because

multiple births have been excluded.

Table 7. Live Singleton Births by Delivery Method, United States, 1991-2004

Number Percentage of

Live Singleton Births

Total Annual Mean Live Singleton births 54,224,912 3,873,208 100.0 Delivery Method Vaginal 40,621,058 2,901,504 74.9 VBAC 1,251,784 89,413 2.3 Primary Cesarean 7,188,648 513,475 13.3 Repeat Cesarean 4,631,839 330,846 8.5 All Cesarean 11,820,487 844,321 21.8 Not reported 531,583 37,970 1.0

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Table 8. Cesarean Deliveries (Live Singleton Births) by State,

Ordered by Rate, United States, 1991-2004

State Mean Cesarean Births per Year

Rate Per 100 Live Singleton Births

Louisiana 17,831.0 27.3 Mississippi 10,831.6 26.9 Arizona 8,916.6 25.9 West Virginia 5,383.5 25.1 New Jersey 27,336.5 25.1 Alabama 14,383.5 24.6 Texas 81,979.9 24.1 Florida 46,031.4 23.8 South Carolina 12,043.4 23.7 Tennessee 18,333.1 23.3 Kentucky 11,910.6 23.3 New York 59,761.1 23.2 Delaware 25,18.6 23.0 Virginia 20,647.1 22.5 North Carolina 24,061.2 22.4 California 118,339.5 22.1 Georgia 26,273.6 22.0 Maryland 14,662.2 21.9 Massachusetts 17,414.2 21.8 Missouri 16,302.4 21.7 Maine 2,900.3 21.3 Nevada 5,682.6 21.2 South Dakota 2,230.5 21.2 Nebraska 4,971.7 21.1 Kansas 7,665.8 21.0 Indiana 17,339.2 21.0 Rhode Island 2,671.0 20.9 Michigan 2,7219.5 20.9 Oklahoma 9,543.0 20.7 Ohio 30,608.6 20.4 Illinois 35,810.4 20.3 Iowa 7,262.9 19.7 Connecticut 8,418.4 19.6 New Hampshire 2,728.9 19.6 Montana 2,080.1 19.3 North Dakota 1,738.7 19.0 Washington 14,367.2 18.8 Pennsylvania 30,690.5 18.8 Oregon 8,287.6 18.5 Wyoming 1,095.2 18.5 Arkansas 13,568.7 17.7 Vermont 1,118.2 17.5 Minnesota 11,177.8 17.4

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Hawaii 3,103.6 17.3 New Mexico 4,482.4 16.9 Colorado 9,874.4 16.8 Idaho 3,079.0 16.7 Wisconsin 11,011.9 16.7 Utah 7,046.3 16.2 Alaska 1,602.9 16.0

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Table 9. Number of States with Tort Reforms in Effect by Year, 1991-2004

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Non-economic damages caps

25 23 23 23 25 25 26 25 25 23 23 24 27 27

Cap < $250,000 * 3 3 3 3 4 4 4 3 3 3 2 2 2 8 Cap > $250,000 and < $500,000*

9 8 9 8 9 10 10 12 12 12 13 13 14 15

Cap > $500,000 and < $750,000 *

8 8 7 8 8 8 10 8 8 6 6 6 9 3

Cap > $750,000* 4 4 4 4 3 3 2 2 2 2 2 2 1 1 Collateral Source 30 30 29 29 29 29 29 29 29 29 28 29 30 30 Joint and Several Liability

25 26 26 26 29 30 30 29 29 29 29 31 33 33

Periodic Payments 27 27 27 27 26 27 27 27 27 27 27 29 30 30 Statute of Limitations 50 50 50 50 50 50 50 50 50 50 50 50 50 50 Statute of Repose 37 37 37 37 37 37 37 38 38 38 37 38 38 39 Limit on Attorney Fees 13 13 13 13 13 13 13 13 13 13 13 13 13

*Amounts represent caps in year 2004 dollars, rather than the nominal statutory cap amounts.

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Table 10. Maternal Characteristics by Delivery Method, Live Singleton Births, United States, 1991-2004 Characteristics Cesarean Births

Percent Maternal Race White 21.6 Black 22.7 Native American 18.9 Asian 20.8 Hispanic Ethnicity 21.5 Foreign-born mother 21.4 Maternal Age < 20 18.0 20-24 18.9 25-29 21.6 30-34 24.6 35-39 28.7 40-44 33.0 45+ 37.9 Maternal Education 0-8 years 18.4 9-11 years 18.5 12 years 21.9 13-15 years 23.2 16+ years 24.9 Marital Status: Single 20.0 Primipara 23.5 Smoking 21.3 Diabetes 36.7 Hypertension 37.4 Adequacy of Prenatal Care* Intensive 27.8 Adequate 23.8 Intermediate 20.0 Inadequate 17.2 No care 14,8 Missing/unknown 22.6 Breech or other malpresentation

85.2

*Based on revised graduated index algorithm (R-GINDEX, Alexander, Kotelchuck 1996) (142)

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Table 11. Infant Characteristics by Delivery Method, Live Singleton Births, United States, 1991-2004

Characteristics Cesarean Births

Percent Vaginal Births

Percent Gestational Age < 32 wks 38.9 60.3 32-36 weeks 27.9 71.20 37-41 weeks 21.3 77.8 41+ weeks 21.47 77.6 Birthweight < 2500 g 32.7 66.4 2500- 4,000 20.1 78.9 >4,000 29.4 69.5 1 > 1 and < 499 13.5 85.5 2 >500 and < 1499 51.2 47.9 3 >1500 and < 2499 29.5 69.6 4 >2500< and < 4249 6.7 78.6 5 > 4250 and < 8165 6.8 65.3

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Table 12. Cesarean Deliveries (Live Singleton Births) by State, 1991 and 2004 1991 2004 Percent Increase Alabama 24.4 30.0 18.6 Alaska 15.4 19.6 21.1 Arizona 17.5 22.1 28.5 Arkansas 26.7 29.5 26.8 California 21.5 27.8 21.5 Colorado 15.6 22.5 27.4 Connecticut 20.6 28.4 27.9 Delaware 21.6 28.9 30.8 Florida 23.1 31.8 26.8 Georgia 21.4 27.8 21.8 Hawaii 19.8 22.8 19.6 Idaho 17.2 20.6 24.9 Illinois 21.3 25.9 24.6 Indiana 20.8 25.6 23.6 Iowa 19.8 24.6 25.9 Kansas 22.5 26.9 29.9 Kentucky 24.1 30.9 30.0 Louisiana 27.3 31.0 25.2 Maine 20.6 26.2 27.4 Maryland 22.7 28.4 28.0 Massachusetts 21.3 29.0 25.3 Michigan 20.7 26.3 21.9 Minnesota 16.3 22.9 30.4 Mississippi 25.8 31.4 26.6 Missouri 21.6 27.6 23.2 Montana 19.1 24.2 26.6 Nebraska 18.8 27.6 27.1 Nevada 19.5 28.1 23.4 New Hampshire 20.0 24.4 31.7 New Jersey 23.0 32.7 18.6 New Mexico 17.9 19.6 27.9 New York 22.6 28.9 26.0 North Carolina 21.7 27.0 22.2 North Dakota 18.3 23.2 24.4 Ohio 22.6 25.4 28.9 Oklahoma 19.8 29.9 24.6 Oregon 18.1 25.6 25.3 Pennsylvania 21.4 26.3 26.3 Rhode Island 18.7 27.3 29.0 South Carolina 21.6 30.0 23.7 South Dakota 19.6 24.7 28.1 Tennessee 22.6 29.1 28.9 Texas 26.3 29.9 18.2 Utah 16.9 19.2 21.8 Vermont 18.8 22.8 27.9 Virginia 22.2 28.9 25.1 Washington 18.4 26.1 30.9

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Table 12. Cesarean Deliveries (Live Singleton Births) by State, 1991 and 2004 1991 2004 Percent Increase West Virginia 25.2 31.9 20.4 Wisconsin 16.7 21.4 21.6 Wyoming 18.6 22.6 18.6

21.8 21.4 20.9 20.3 19.9 19.7 19.7 20.0 20.8 21.723.2

24.726.1

27.6

0

5

10

15

20

25

30

35

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2001 2003 2004

Perc

ent

Figure 2. Percent of Cesarean Deliveries Among Live Singleton Births, United State, 1991-2004

18.7 (27.3)

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Fixed Effects Analysis

The final models are presented in Table 13, the first model including tort reforms

categorized as direct and indirect, and the second model defining damages caps as a

dichotomous yes/no variable. In alternate specifications, caps were modeled in four

levels, as a continuous variable, as an indicator variable including fractions of a year in

effect, and a version with all tort reform variables coded as dichotomous. Results of these

alternate specifications are presented in Table 14. Parameter estimates differed for each

model, but in all cases the effect of tort reforms on cesarean delivery was minimal.

Coefficients ranged from -.01-0.03 for individual tort reforms. Results varied

somewhat with model specifications defining non-economic damages caps in different

ways, but the difference was small. The effect of direct reforms on cesarean rates,

adjusting for maternal demographic characteristics, maternal medical conditions, and

characteristics of labor and delivery, was greater than was the effect for indirect tort 1

reforms. However, the difference was small, -0.009 compared to -0.004. Non-economic

damages caps were associated with a 0.2% reduction in cesarean deliveries, with a

slightly greater effect shown for collateral source laws (2.0%) and statutes of limitations

(1.7%). Several reforms were associated with slight increases in cesarean delivery, joint

and several liability reform (0.1%), statutes of repose (0.1%), and limits on attorneys’

fees (0.6%).

Table 15 presents the results of the subset analysis by race and Hispanic ethnicity.

There was a small reduction in cesarean deliveries among white and Native American

mothers and a slight increase among black mothers. Collateral source rule modifications,

periodic payments, and statute of limitations changes showed a reduction in cesarean

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deliveries for all groups. Limits on attorneys’ fees showed an increase in cesarean

delivery for all groups, with a greater effect for Native American and Asian than for

white and black mothers. For five of the seven tort reforms, the effect on cesarean

delivery was greater for Native American mothers than for mothers of other racial

groups.

Table 16 presents the results of the subset analysis for maternal educational

attainment and marital status. Damages caps showed a greater reduction in cesarean

deliveries among mothers with 13-15 years of education than other educational

categories. Among unmarried mothers, the effect of non-economic damages caps was a

1.3% increase in cesarean deliveries and for collateral source rule, a 0.3% increase. Each

of the other reforms was associated with a small decrease in cesarean deliveries for

unmarried mothers.

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Table 13. Parameter Estimates* for the Effect of Direct and Indirect Tort Reforms on Cesarean Delivery

Reforms Categorized as Direct or

Indirect

Individual Reforms

Direct Tort Reforms -0.009 - Non-Economic Damages Cap (Yes/No)

- -0.002

Collateral Source - -0.010

Indirect Tort Reforms -0.004 - Joint and Several Liability - 0.001 Periodic Payments - -0.007 Statute of Limitations - -0.017 Statute of Repose - 0.001 Limit on Attorney Fees - 0.006 Confounders Race -0.002 -0.002 Hispanic ethnicity -0.001 < -0.001 Maternal age 0.032 0.032 Educational attainment 0.003 0.003 Unmarried mother -0.008 -0.007 Foreign birth of mother -0.005 -0.006 Primipara 0.047 0.047 Diabetes (chronic or gestational) -0.038

-0.038

Hypertension 0.026 0.026 Smoking 0.001 -0.002 Inadequate prenatal care -0.031 -0.030 Very preterm birth 0.081 0.081 Preterm birth 0.027 0.026 Postmature birth 0.008 0.008 Low birthweight 0.082 0.082 High birthweight 0.128 0.128 Breech or other malpresentation 0.042

0.043

* All significant at p <.0001 except for Hispanic (significant at .006).

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Table 14. Alternative Model Specifications 1 2 3 4 5 6 Cap Modeled in

Four Levels Cap as

Continuous Variable

Cap Indicator 1 (including

fractions of a year in effect)

Includes Cap Indicator 1 and Continuous Cap Variable

Cap indicator 2 (yes/no), Each Other Reform

as Fraction of a Year

Cap Indicator 2 (yes/no), Each Other Reform

Yes/No

Cap indicator 1 - - -0.005 0.016 - - Cap indicator 2 - - - - -0.002 0.011 Adjusted cap (continuous) - < -0.001 - -0.004 - - Cap < $250,000 0.033 - - - - - Cap > $250,000 and < $500,000 -0.002 - - - - - Cap > $500,000 and < $750,000 -0.020 - - - - - Cap > $750,000 -0.031 - - - - - Collateral Source -0.011 -0.012 -0.011 -0.013 -0.010 -0.009 Joint and Several Liability 0.001 -0.002 < 0.001 -0.001 0.001 0.013 Periodic Payments -0.012 -0.006 -0.006 -0.012 -0.007 ** Statute of Limitations -0.015 -0.019 -0.018 -0.017 -0.017 ** Statute of Repose 0.002 0.003 0.002 0.003 0.001 0.003 Limit on Attorney Fees 0.006 0.007 0.006 0.008 0.006 -0.007 * All significant at p < .0001 except those reported as not uniquely estimable. ** Reported by SAS as not uniquely estimable.

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Table 15. Parameter Estimates,* Effect of Tort Reforms on Cesarean Delivery by Race White Black Native

American Asian Hispanic

Ethnicity Cap (yes/no) -0.004 0.002 -0.009 <0.001 0.012 Collateral Source -0.009 -0.011 -0.007 -0.004 -0.030 Joint and Several Liablity 0.001 0.012 -0.025 0.004 0.052 Periodic Payments -0.007 -0.002 -0.035 -0.008 0.018 Statute of Limitations -0.017 -0.008 -0.016 -0.021 0.013 Statute of Repose 0.002 <.0001 0.003 0.002 -0.002 Limit on Attorney Fees 0.005 0.003 0.029 0.014 **

* Controlling for race (in ethnicity model), Hispanic ethnicity (in race model), maternal age, educational attainment, unmarried mother, foreign birth of mother, primiparas, diabetes (chronic or gestational) hypertension (chronic or gestational), smoking status, inadequate prenatal care, very preterm birth, preterm birth, postmature birth, low birthweight, high birthweight, and breech or other malpresentation.

Table 16. Regression Coefficients, Effect of Tort Reforms on Cesarean Delivery by Maternal Educational Attainment and Marital Status Educational Attainment Marital

Status

< 8 years 9-11 years

12 years

13-15 Years

15+ years

Unmarried

Cap (yes/no) -0.001 ** -0.001 -0.006 -0.012 -0.004 0.128 Collateral Source -0.016 -0.012 -0.011 -0.010 -0.009 0.031 Joint and Several Liablity 0.009 0.005 0.001 -0.004 0.003 -0.007 Periodic Payments -0.003 -0.003 -0.005 -0.005 -0.008 -0.010 Statute of Limitations -0.013 -0.015 -0.017 -0.019 -0.017 -0.024 Statute of Repose 0.002 0.001 0.001 0.002 0.003 -0.037 Limit on Attorney Fees 0.007 0.004 0.005 0.006 0.004 -0.008

* Controlling for race, Hispanic ethnicity, maternal age, educational attainment (in marital status model), unmarried mother (in educational attainment model), foreign birth of mother, primiparas, diabetes (chronic or gestational) hypertension (chronic or gestational), smoking status, inadequate pren atal care, very preterm birth, preterm birth, postmature birth, low birthweight, high birthweight, and breech or other malpresentation. **p> .05

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CHAPTER 5

CONCLUSIONS

Based on this analysis, the effect of tort reforms on cesarean delivery and on

defensive medicine appears to be minimal. This finding does add support to other

literature reporting little or no effect of tort reforms on defensive medicine which has

important implications for both tort reform and maternal and child health.

The testable hypothesis for this analysis was “Other things equal, in states that have

adopted certain tort reform measures, the probability of having a cesarean delivery is

lower following implementation of the reforms,” or, framed as a null hypothesis, “Other

things equal, in states that that have adopted certain tort reform measures, implementation

of the reforms had no effect on cesarean delivery rates.” Given the extremely small effect

found in this analysis, it is not reasonable to reject the null hypothesis of no effect.

Two research questions, one with four hypotheses and one with a single hypothesis,

were to be evaluated by this study (page 45), each proposing that tort reforms would

decrease the probability of cesarean delivery.The five hypotheses are not supported by

the results of the analyses. The hypotheses that tort reforms, particularly non-economic

damages caps, would reduce cesarean delivery rates were based on the findings of other

researchers, as discussed in Chapter 2. (102, 105, 107), (111),

The findings of the present study could mean that defensive medicine does not

exist, that defensive medicine is not a large component of the increase in cesarean rates,

or that physicians do not respond to tort reforms by modifying clinical practice. There are

also several other possible explanations for the findings.

95

Although the dataset included 54 million live singleton births, small numbers may

have been a problem due to the small number of changes in tort laws during the study

period. Particularly when dividing non-economic damages caps into levels, numbers for

each year were very small. For example, caps of $250,000 or less, the level hypothesized

to have the greatest effect on cesarean delivery, were in effect for a mean number of 3.4

states per year. It may be that the number of data points was simply insufficient to show

the anticipated effect.

It is also possible that there are unobserved time varying factors exerting a greater

influence than the effect of state-level tort reform on the decision to perform a cesarean

delivery. Examples of factors that might have an effect of this type within a particular

state are changes in physician practice patterns over time, changing political factors, and

insurance-related changes affecting either malpractice insurance or patient procedure use.

A change sufficient to obscure a relationship between tort reforms and cesarean is likely

on a broader scale than one or two states. Further, the data were examined for extreme

outliers to explore whether perhaps a few states with both very high caps and high

cesarean rates could be driving parameter estimates, but no such outliers were found.

This study addresses non-economic damages but not economic damages. Caps on

non-economic damages would not reduce liability if economic damages are high, and

legal cases involving catastrophic birth injuries, for example, are of very high value.

Economic damages, which may include lifetime wage loss and custodial care, may be

valued in the millions of dollars. Additionally, it has been reported that the presence of

non-economic damages caps may increase economic damages awards. (164)

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Strengths

The two databases used in the study are among its strengths. The birth certificate

data includes all recorded births in the United States 1991-2004. Some variables on the

birth certificate are more reliable than others; however, for the outcome variable,

cesarean delivery, sensitivity is reportedly greater than 98%. Data for the maternal

characteristics and birth characteristics most likely to confound an association between

tort reform and cesarean delivery were adequately captured by the data, and it was

possible to control for them. The tort reform database used for the study was

meticulously researched and validated, (111) whereas some prior studies have relied upon

compilations containing omissions and miscoding (109)

Use of fixed effects methodology is a strength of the study, as it controlled for

potential unobserved confounding factors within states that were fixed over the 14-year

study period and factors that varied among states.

Limitations

This study overcomes limitations of some earlier studies, which include use of

data from only one or a few states or a few years, aggregation of birth data to the state or

county level, rather than use of individual level data for birth certificate variables, and use

of incomplete tort reform information. This study does, however, have several

limitations.

Among the study’s limitations are those inherent in analysis of secondary data.

Use of secondary data limits the variables available for analysis to those included in the

dataset, rather than those that might be ideal for addressing a particular research question.

97

(51) Use of data collected, coded, and re-coded by others is challenging, and the

investigator must develop an understanding of variable definitions, variable coding, and

the reliability of individual data elements in order to analyze and interpret the data. (51)

Limitations specific to use of birth certificate data include variation in reliability

and validity of data elements. Many of the birth certificate variables, particularly labor

and delivery characteristics, are significantly underreported in the birth certificate data,

some with sensitivity rates of less than 20%. This low level of sensitivity may represent

differential reporting by maternal demographic characteristics or according the birth

characteristics, with more complete reporting for adverse outcomes, as the complications

are checked off on the certificate after the outcome is already known. This makes many

variables, many of which have been included in the analyses of other researchers,

inappropriate for inclusion in the models. The final list of confounders for inclusion in

the models in this study was comprised of only those considered most important and most

reliably captured in the data: maternal age, race, Hispanic ethnicity, foreign birth,

education, marital status, parity, diabetes, hypertension, tobacco use, pre-natal care

utilization and the fetal characteristics of gestational age, birthweight, and non-vertex

presentation. Additional analyses characterized seven tort reforms by state and year.

There is a possibility of residual confounding as a result of factors that varied over

time and were either unobserved or could not be adequately measured. Several important

confounders for which no data were available are maternal insurance status, maternal

socioeconomic status, prevalence of maternal obesity, and insurance carrier policies on

VBAC. Failure to adjust for these confounders may have somewhat attenuated an effect

of tort reforms on cesarean delivery but are unlikely to have been solely responsible for

98

the lack of effect. Two important potential confounders were too unreliably reported in

the birth certificate data for inclusion in the models, dysfunctional labor and fetal distress.

According to obstetric texts, (12) the majority of cesarean deliveries are performed for

one of these two indications, yet in the descriptive analysis, among live singleton births

delivered via cesarean, just 8.75% of the birth certificates reported dysfunctional labor as

a complication and 9.97% reported fetal distress.

Endogeneity was of concern in this analysis, because tort reforms in some states

may have been enacted in response to a perceived malpractice crisis, characterized by

increases in malpractice insurance premiums, malpractice lawsuits, and and/or damage

awards. In some states, tort reform has been limited to medical malpractice cases in

response to a perceived crisis specifically in medical malpractice cases. Obstetrics is the

most common specialty involved in malpractice suits, and negligent failure to perform a

cesarean is a common cause of action in those lawsuits. Cesarean rates may therefore in

some cases have an influence on enactment of some tort reforms. Endogeneity could

result in an underestimate of the effect of tort reforms if reforms were adopted in

response to increasing cesarean delivery rates. If both adoption of tort reforms and

increasing cesarean rates are associated with an omitted variable, an overestimate of the

effect could result.

Fixed effects specifications will not control for time-varying state-level

characteristics. If provider density, legal climate, political climate, obstetric practice

patterns, or any of a variety of and social and economic factors changed within states

over the study period, it is possible that these factors affected the results.

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Although limiting the study to live singleton births prevents over-counting of

cesarean deliveries, it limits generalizability to all births. Multiple gestation pregnancies

are at high risk for low birthweight and preterm birth. (51) Although multiple births

represent just 1.7% of all births, 65.5% of multiple gestation pregnancies are delivered

via cesarean, (165) and rates of multiple birth have increased over time. (20)

Implications

There has been great concern since cesarean rates resumed their rise in the late

1990’s, following a brief decline, that the rates are too high, and the pattern of increase

has continued each year. How high is too high? There is no clear standard, and likely

different standards should apply to different groups of pregnant women. Rates of both

maternal and infant mortality have decreased dramatically since cesarean delivery

became readily available early in the last century. Nevertheless, it appears that in many

cases, cesarean is performed based on some small risk of an adverse outcome or perhaps

related to some element of personal choice on the part of the mother or physician. This

exposes mother and fetus to surgical risk and deprives them of benefits associated with

natural vaginal birth. The role defensive medicine may play in the decision to perform

surgery is not fully understood.

The question of whether tort reforms have the potential to curtail increases in

cesarean rates has not been answered. One explanation for the results observed in this

study is that there is truly no effect of tort reform on cesarean delivery. If this is true,

other approaches to addressing the desired reduction in cesarean rates should be pursued.

Increasing the number of women offered a trial of labor, with a consequent increase in

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VBAC rates, which will likely occur as a result of ACOG’s August 2010 revised VBAC

recommendations, (166) is one such approach. The incidence of maternal choice cesarean

has not been well-established. Some reports assert that women seek cesarean delivery for

reasons of convenience, (167, 168) while others counter that elective cesareans without

clear medical indication are more likely performed because of physician convenience.

(168) Elective induction of labor for reasons of convenience has also been reportedly

increasing. (169) Induction of labor has been found to be associated with cesarean

delivery, particularly for a first birth, (170) as the induction agent may fail to induce

contractions sufficient for a vaginal birth. Induction of labor in post-dates pregnancies

has become routine. (171) Reducing cesarean deliveries in each of the foregoing

circumstances, in the absence of clear medical indications, would contribute to curbing

the cesarean rate. Lowering the rate of cesarean delivery in the absence of clear medical

indications would, in turn reduce morbidity due to iatrogenic prematurity. Late pre-term

delivery (37-38 weeks gestation) has been increasing and is associated with significant

morbidity. (172)

This study has several implications for maternal and child health. Firstly, it should

be noted that the small percentage by which cesarean deliveries were reduced represents

large numbers of births. Among approximately 4 million live births in the United States

in 2009, 32.9% were cesarean deliveries. (2) Secondly, if tort reforms do not contribute to

reduction in cesarean rates, attention must be focused on other means of achieving

reduction goals specified by Healthy People 2020. (26) These other means include

avoiding cesarean delivery in the absence of clear medical indications, reducing induction

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and stimulation of labor, which can lead to cesarean delivery, and increasing trials of

labor leading to VBAC.

There are several implications for tort reform. Adoption of some reforms (non-

economic damages caps, collateral source rule modifications, and shorter statutes of

limitations) may result in a small reduction in defensive medicine but are not

alone are likely insufficient to significantly reduce defensive medicine. Damages caps

and modifications to the collateral source rule have also been shown to be associated with

other measures of malpractice pressure (i.e., malpractice insurance premiums), and the

findings of this study support their adoption as part of a strategy for reducing defensive

medicine. This study supports findings of other studies that other reforms are less likely

to reduce defensive medicine.

In this study, cesarean delivery is used as a marker for defensive medicine. This

study found only a small effect of tort reforms on cesarean delivery. A stronger finding

would have provided greater empirical support for the existence of defensive medicine.

There is, nonetheless, strong anecdotal evidence that defensive medicine is widely

practiced, which is supported by a number of physician surveys. Lack of effect of tort

reform on cesarean delivery could mean that defensive medicine does not exist but more

likely means that physicians do not respond to tort reform by modifying clinical practice.

Carrier et al. conducted a survey of a nationwide sample of physicians, reporting that

physicians indicated a level of concern over the possibility of being sued that is

disproportionate to their actual risk and that concern appears relatively insensitive to tort

reform. (81) The idea that damages caps would reduce defensive medicine assumes that

the greatest motivation for defensive medicine is fear of large jury verdicts. It may be that

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physicians’ real concern in avoiding lawsuits is more focused on non-economic aspects

of a lawsuit, such as reputational harm and the unpleasantness associated with lawsuits.

Empirical evidence demonstrating the existence of defensive medicine and whether it is

reduced by tort reform is still very much needed and calls for further research.

As stated in one of the introductory paragraphs of this document, “defensive

medicine is a complex phenomenon”. The findings of this study do not show that the

practice of defensive medicine does not exist but rather confirmed that it is difficult to

measure. Whether tort reforms can curtail defensive medicine or increasing cesarean rates

has not been resolved, but this study lends support to other reports that the likely effect is

small. Other factors, alone or in combination with defensive medicine practices, are yet to

be identified or fully explored to stem the rise and reduce the overall rate of cesarean

section births in the U.S.

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APPENDIX A

INSTITUTIONAL REVIEW BOARD APPROVAL FORM

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