Neurologic Birth Injury

INTRODUCTION

The Journal of Legal Medicine recently published an article written by Thomas P. Sartwelle, a medical liability defense attorney, entitled Defending a Neurologic Birth Injury. ¹ The article discusses the defense of perinatal brain injury cases. ² The American College of Obstetricians and Gynecologists (ACOG) is the national professional organization for obstetricians. The clear import of the article was that neurologic injury cases rarely have merit. The article reflected the position ACOG has espoused for the past three decades.

The birth injury defense articulated in the Sartwelle article maintains that obstetricians are falsely accused of causing disabling brain damage producing cerebral palsy (CP), and that such damage cannot be prevented. ³ His premise is that “a certain minority” of experts claim timely caesarean sections prevent damage, and plaintiff attorneys use these experts to pursue meritless liability cases. He accuses these experts of providing false testimony that runs “counter” to the “explosion” of worldwide science.

ACOG as a national professional organization functions through staff, elected officers, and its executive and other committees. The obstetrical physicians thus functioning within ACOG act as leaders on behalf of their grassroots obstetrical members with regard to pregnancy issues. Positions advocated by ACOG in committee reports or tacitly approved in the ACOG peer reviewed journal represent what the specialty's leadership has and has not done on behalf of its members.

ACOG should take political positions, provided that they are in the best interests of obstetrical patients (mother and fetus). For example, urging better reimbursement for obstetricians and additional funds for full-time in-hospital “laborists” would promote patient safety.

The practice of obstetrics requires full-time coverage because labor and obstetrical complications can arise at any time. The private attending obstetrician also has responsibilities for scheduled office patient care (for example, antepartum prenatal obstetrical care and usually gynecology patients) and scheduled in-hospital care (such as scheduled caesarean deliveries and gynecological procedures). This spectrum of responsibility, referred to as multi-tasking, is an important part of the discussion below. If the obstetrician is not with the patient, meaningfully focusing and acting on relevant patient information during labor, the obstetrician's absence will adversely impact patient safety.

Plaintiffs' attorneys and their professional (trial lawyer) organizations have an ethical obligation to clients, as well as to the letter and spirit of the law. No one is more invested in the desire to promote patient safety than the clients who have been the victims of unsafe care. For these reasons, the authors and other plaintiffs' attorneys have offered to be allies with ACOG, and any other medical organization, in any political or other endeavor that promotes patient safety. If the promotion of patient safety would produce fewer cases and less income for plaintiff attorneys, that negative financial effect is an example of what legal ethical professionalism means—acting in the best interest of clients and society.

The context of the issue that we are thrust into, however, is the allegation that plaintiffs' attorneys knowingly pursue meritless cases, which, if true, is something we should not do. Sartwelle maintains medical experts who testify for plaintiffs use pseudoscience and gibberish to misrepresent in the courtroom. He refers to one such expert by name, noting that ACOG censured that obstetrician. ⁴ Plaintiff attorneys should not knowingly produce gibberish designed to mislead the judge and jury. ACOG has been using a grievance process to punish physicians guilty of “rogue opinions” not supported by ACOG pronouncements on medical subjects. The censure cited by Sartwelle is an example of how ACOG has punished an expert who ACOG maintains gave a “rogue” opinion. Additionally, ACOG urges handpicking special judges who will use “neutral experts.” ⁵

If attorneys and medical experts have been unethically fooling judges and juries, that is a very serious charge. There are remedies to deal with witnesses who intentionally testify falsely and remedies to discipline attorneys who intentionally suborn perjury and pursue meritless cases. If, on the other hand, these serious charges have been made without basis as a ruse to intimidate expert witnesses and limit or frustrate appropriate efforts being made on behalf of injured children who have meritorious claims, that is another matter.

If plaintiffs are frustrated in efforts to pursue cases that have merit because experts are intimidated by the grievance process, that will have the net effect of creating legal immunity and an absence of accountability for those who have caused serious harm. ACOG seeks as a political solution on behalf of its members a no-fault immunity, or a practical immunity. It does so by attempting to control both the science and the experts on the premise that the civil justice system has not worked for obstetrical care.

I. THE “NO-FAULT” CONTEXT

The medical liability issue can be better understood by noting that when ACOG recently urged its members to support legislation for legal immunity (no fault), it maintained that plaintiff attorneys “have been relentless in their efforts to discredit ACOG and undermine the practice of obstetrics.” ⁶ When ACOG published in 2009 in its peer reviewed journal a no-fault agenda, the article likened the motivation for expected opposition from plaintiff attorneys to Willie Sutton, the bank robber who commented that he robbed banks because that is where the money is kept. ⁷

The article urging a no-fault law in the state of New York was coauthored by Gary Hankins, M.D., and maintains that plaintiff attorneys wrongly try to justify their taking of “close to half of the awards,” leaving less than one-half of the award for the child and family when court costs are deducted. Dr. Hankins is an influential obstetrical leader whose involvement encompasses the creation of the initial ACOG essential criteria (discussed below) as well as the most recent ACOG intrapartum labor guidelines (also discussed below). The statement that plaintiff attorney fees, coupled with court costs, leave the child with less than half of the award is unequivocally false, as that result is not possible under New York law and has never happened. ⁸

A medical peer review journal, when publishing an article advocating legal immunity for its member physicians, should carefully check its facts about the law and seek to exercise restraint when enabling an attack on attorneys who are “guilty” of nothing other than representing their clients diligently and effectively. Likening plaintiff attorneys to bank robbers and accusing these attorneys of being out to undermine obstetrics without ever citing any proof that the civil justice system is not, nor has been, working as intended, represents a disconnect from the objectivity that should be expected from medical professionals.

The medical authors urging no-fault maintain medical science establishes that the “vast majority” of brain injury is not preventable, yet plaintiff attorneys sue in almost all cases of CP. ⁹ On the same issue, it was maintained in another article coauthored by Dr. Hankins that plaintiff attorneys have the advantage of sympathy and “a seemingly reasonable explanation” for the intrapartum cases. Yet, they contend that judges, jurors, and family members cannot appreciate that high-tech gadgets such as the electronic fetal monitor (EFM) cannot reasonably predict or influence an obstetric outcome. They add that, although birth can be a hazardous journey, the EFM “does not help,” as CP is “not currently preventable.” ¹⁰

These authors imply that their knowledge of the legal system establishes the inability of judges and jurors to comprehend simple facts. The simple facts allegedly are that, though a gadget (EFM) is used, the gadget cannot influence the outcome. Then, when CP later emerges as a disability, no physician using the gadget or any other means could have prevented it. Thus, each time, a plaintiff attorney has alleged the gadget (EFM) really did have an important purpose during the labor of what would become a brain injured child, we are assured that the use of the gadget really had no purpose because it could not influence the outcome.

The substantive center of gravity of each liability claim relates to quality medical care (defined below). Sympathy is a good emotion, but under the law must not lead a juror away from rational, logical, common sense, analytical thinking. For that reason, defense attorneys emphasize, especially in the case of a handicapped child, the need for juror mental discipline, and they always make jurors aware that they each will take an oath to comply. Aware that the core issue relates to quality care, jurors are strongly motivated to be open-minded and appropriately very supportive of any physician and hospital that rendered quality care. It is for this reason, coupled with the fact that jurors traditionally take their oath seriously, that the defendants in these cases are not at a legal disadvantage.

This article demonstrates that the labor and birth process is always hazardous because it involves stresses (mechanical and hypoxic) that create the potential for disabling brain injury that can produce motor (for example, CP) and other deficits. We contend that EFM, when properly used, can lead to timely and appropriate steps that will avoid disabling brain injury producing CP or other disabilities.

The “seemingly reasonable explanation” a plaintiff attorney offers in a meritorious case is reasonable because the EFM really has a purpose that can be used to influence the outcome. Prominent obstetricians have conceded, and currently concede, that substandard care during labor can cause disabling brain injury producing CP. Some of these obstetricians cite as a problem a lack of training in the proper use of the EFM information and a lack of timely response to that information. One apparent and fixable reason for a lack of timely response is the fact that obstetricians are multi-tasking and, therefore, not present with their laboring patients.

The packaging and promotion of the ACOG no-fault proposal is striking in that it combines an attack on plaintiff attorneys with a financial rescue of their clients from them. Additionally, a seeming milk of human kindness benevolence for all neurologically handicapped children, regardless of cause, is part of the promotion. The ACOG authors state all children with a neurologic handicap need financial aid. That statement can only be intended to create an appearance that the no-fault program will aid all neurologically impaired children; this constitutes another misrepresentation.

Children eligible for ACOG's proposed no-fault benefits are only full term CP children (not prematures or children injured prior to 34 weeks gestation) and not children with CP caused by metabolic or genetic factors or children without CP. ACOG has “cherry picked” for inclusion only those children who might have cases they do not wish to defend, and all other handicapped children are excluded. The inclusion or exclusion is to be decided by a panel of expert physicians. If a child is deemed eligible, medical expenses (but not pain, suffering, loss of enjoyment of life, or loss of earnings or career) will be paid if needed and reasonable and not covered elsewhere (for example, by Medicaid or private health insurance). Thus, without benefit of an attorney, the family precluded from bringing a lawsuit would be blessed with the navigation of a new bureaucracy.

One currently meritless defense ploy is to create the appearance that a process of medical deductive reasoning cannot reliably be used to identify the cause of an injury. Yet, the ACOG no fault proposal is packaged on the premise that medical experts can distinguish intrinsic, nonpreventable causes (such as genetic or metabolic factors) from extrinsic, potentially preventable causes such as hypoxic-ischemic brain insults during labor. That is how ACOG would discard from the no-fault Garden of Eden those children who would not have been plaintiffs anyway.

Although ACOG leaders focusing on liability defense worry about the “seemingly reasonable explanation” plaintiff attorneys offer for full term intrapartum cases, they do not have the same concern for the handicapped child who was premature or damaged antepartum. They perceive prematurity and antepartum in-utero influences to be sufficiently defensible to give them the upper hand. These supposedly defensible notions also can be part of meritless defenses. The word “defensible” is meaningful. Medical liability defense insurers and attorneys use that word when they feel they can be successful in a liability case. It is notable how the word “defensible” is used in the context of a new, “unique” patient safety protocol in the area of obstetrical quality assurance and risk management.

Granting immunity extinguishes the accountability mechanism acting as a force to promote safer care. The same ACOG that claims CP is never the result of substandard care also maintains in their no fault plan that, despite immunity, physicians will evaluate cases for substandard care. ACOG leaders assure us they will police themselves by diligently looking for substandard care, which their research already tells them does not exist. However, a review of closed perinatal birth injury cases reveals substandard care that triggered changes that led to reduced injury and fewer liability claims.

Attorney Sartwelle praised a study that allegedly proved suboptimal care does not lead to CP. According to Sartwelle's interpretation of the study, the patients identified as having suboptimal care actually had an increased incidence of CP compared to those who had optimum care. ¹¹ ACOG, in its first codification of litigation criteria, ¹² thanks Drs. Nelson and Niswander for helping to create the document. The document cites Niswander's study (praised by Sartwelle), which allegedly proves substandard care does not cause CP. According to Niswander, to prove cause and effect, one must first show that suboptimal care precedes bad outcomes more frequently than good outcomes. With this reasoning, if three of five plane crashes were attributable to bad weather, then pilot error could not have caused the other two crashes. ¹³

Thus, the ACOG mindset is that substandard care does not exist with regard to CP children but, if we give physicians immunity, we can rely on their objectivity to look for that which they maintain is not there to be seen. Sartwelle has reviewed studies of hindsight and outcome bias and arrives at the conclusion that “an objective method to determine standard of care does not exist.” ¹⁴ Absent a standard of care, there can be no substandard care. Thus, with or without a no-fault law, legal immunity is the end result if we apply Sartwelle's interpretations of the studies cited in litigation.

In response to Sartwelle, we point to flagrant misrepresentations of medical science and the law. We argue against a position that, at its core, tramples on the legal rights of children and profoundly diverges from the ethical heart of medical professionalism and accountability intrinsic to the civil justice system.

II. MEDICAL ETHICS AND THE CIVIL JUSTICE SYSTEM

An Institute of Medicine (IOM) panel defined quality medical care as steps taken to increase the likelihood of desired health outcomes, such as avoiding or limiting injury or disability, and noted that quality health care can be precisely defined and measured. ¹⁵ Defining and measuring quality care requires reliable data and objective, rational analysis.

Another IOM report defined a medical error as an error or delay in diagnosis or a failure of a planned action to be completed as intended (error of execution) or the use of a wrong plan to achieve an aim (an error of planning). ¹⁶ Thus, an error leading to an injury is caused by medical management rather than the underlying condition of the patient, representing a preventable adverse event that everyone agrees should not happen. Such adverse events are responsible for patient injury and suffering.

Although the IOM report urged better systems to provide more lasting and broad-based safety improvement, it noted that designing a better system does not mean that individuals can be careless, as people must be vigilant and held responsible for their actions. The report notes that unsafe care is one of the prices paid for not having organized systems of care with clear lines of accountability. ¹⁷

Medical liability, as part of the civil justice system, exists in the context of a patient's right to have the benefit of appropriate steps intended to achieve a desired health outcome, coupled with the physician's responsibility to take those appropriate steps and thus avoid a medical error. Each physician must use reasonable care to accomplish the goal of safety. Liability will arise for failure to take appropriate precautions to minimize risk. The obligation to make payment is rooted in the moral concept that a physician or hospital that is liable should bear full financial responsibility for the bad outcome. Additionally, the obligation to pay acts as a warning that the law demands the exercise of due care. ¹⁸

Accountability, arising from individual responsibility recognized by the IOM report as necessary to make care safer, is intrinsic to civil liability. ACOG, seeking no-fault immunity from liability for its obstetrical members, logically should premise its political advocacy on the idea that obstetricians no longer require accountability related to a legal duty to protect fetal patients during labor. Further, there must be a premise that the fetal patient no longer requires protection traditionally promoted by such accountability and that no moral obligation to be responsible for all damages related to fetal brain injury during labor need exist for the fetal patients who now have neurologic disability.

When there is a bad outcome, for example, in a child diagnosed with CP at one year of age, there is no legal presumption about whether the brain injury producing the CP occurred during labor or was preventable. All cases require an allegation and supportive proof using expert testimony, which can be challenged on cross-examination and contradicted by opposing expert testimony. The rules of evidence apply to every case, the plaintiff (the CP child) has the burden of proof, and due process requires a fair trial.

If plaintiff attorneys argued for tort reform, they might maintain that the burden of proof should be on the physician or hospital because they have the advantage of medical knowledge and therefore, arguably, should have the burden to prove they are not liable. We are not aware of any trial attorney organization ever advocating that position. The plaintiff's traditional legal burden is a fair preponderance of the evidence. The idea that quality care is intended to increase the likelihood of a good outcome is consistent with the legal burden of establishing, on a more likely than not basis, that the child's injury was preventable.

Medical professionalism requires physicians to acknowledge that medical errors that injure patients occur. When such an injury occurs, the mistake must be reported to the patient, as that enables appropriate compensation to the injured party and promotes public trust of the medical profession. Additionally, reporting and documentation of the mistake forms the basis for appropriate prevention and improvement strategies. ¹⁹

The same code of professionalism imposes an obligation on physicians to reduce medical errors and increase patient safety. This ethical mandate applies not only to those directly involved in patient care, but also to other physician activities including writing, supervision, peer review, public speaking, and acting as an expert witness. ²⁰

Thus, all physicians—including ACOG leaders—have a proactive ethical obligation to make care safer by seeking to avoid errors that can lead to preventable injury and death. Important proactive efforts include steps to hold erring physicians liable so that accountability will be a force to minimize unsafe care.

Because it is necessary for a plaintiff to use expert testimony to meet the burden of proof, ACOG's urging of a system that punishes experts guilty of “rogue” opinions is noteworthy. ACOG created false science to help defend cases, exactly the opposite of what physicians are ethically obligated to do. The ACOG hearings to punish “rogue” physicians who do not adhere to the ACOG version of science are also the opposite of what physicians are ethically obligated to do. ²¹ Because physicians have an ethical obligation to be on the side of the patient, efforts to manipulate the civil justice system with false science and intimidation of expert witnesses necessary for a plaintiff child's case violate medical professionalism and—arguably—constitute a conspiracy to obstruct justice.

Refocusing on use of the term “substandard care” to indicate a legal case with merit, we define a medical error (for instance, a delay in diagnosing fetal jeopardy using the EFM or a failure of execution by not doing a timely caesarean delivery) as substandard care creating liability if the EFM information could have been used to trigger timely action to prevent the disabling brain injury. Yet, ACOG and Sartwelle maintain the use of the gadget cannot influence obstetrical outcomes and nothing an obstetrician does can prevent CP. If this ACOG position is false, and substandard obstetrical care can produce disabling brain injury, then ACOG is promoting false testimony. That would further victimize the victim (the disabled child) and, contrary to physicians’ ethical obligations, enable bad practice.

There can be no meaningful quality assurance and risk management action if the starting premise is that no substandard care exists and nothing bad ever happens to patients on the physician's watch. Although it is normal for physicians to wish that bad medical outcomes are unrelated to an error on their part or that of their colleagues, the ethics of the profession mandates that they rise above wishful thinking with honest, objective reasoning.

The American Society of Anesthesiology (ASA) is the national professional organization for anesthesiologists, akin to ACOG for obstetricians. ACOG's response to medical liability claims contrasts with the ASA's response. Specifically, ACOG has not risen above the kind of wishful thinking that has led to the opportunistic conclusion that nothing bad happens on its members’ watch. For more than three decades, ACOG has promoted a false response to medical liability cases, disconnecting obstetricians from the kind of proactive, ethically motivated mandates that are needed.

III. THE ANESTHESIOLOGY MODEL OF PATIENT SAFETY

The IOM ²² and other professional organizations like ACOG have praised the ASA for being a model of patient safety. For example, by adopting and implementing minimum mandatory safety standards, the ASA has reduced the incidence of anesthesia related death from 1 to 2 per 10,000 anesthetic procedures to 1 for every 200,000 procedures. ²³

The administration of anesthesia is an intrinsically hazardous undertaking. Only a narrow margin exists between a safe anesthetic dose and a potentially lethal overdose. The administration of anesthesia has been made safer by mandating careful titrating of doses and timely response to monitoring information. Anesthesiologists used retrospective studies of closed medical malpractice cases to identify avoidable injury and death, and then responded by implementing mandatory safety standards.

In addition, the cost of their medical malpractice insurance premiums dramatically dropped. ²⁴ The malpractice crisis was used by anesthesiologists to galvanize their profession at all levels, including the grassroots, to address serious issues of patient safety. As a result, strong leaders emerged who were willing to admit that patient safety was imperfect and that, like any other medical problem, it could be studied and interventions planned to achieve better outcomes. ²⁵

If an anesthesiologist does not admit fault, that should not lead to a conclusion that death or brain injury must therefore be related to the patient's underlying medical condition or an unknown and unidentifiable cause. An investigation of a claim alleging hypoxia leading to death or brain damage would require objective analysis regarding the manner in which hypoxia influences cardiovascular function. Thus, if an anesthesiologist documented that all vital signs were normal but suddenly the patient's heart stopped beating, an objective evaluation of the facts could result in a conclusion that lack of oxygenation was the only mechanism that fit what happened to that patient and that normal vital signs were impossible. Instead of enabling bad care and dishonest record making, objective analysis consistent with the ASA's ethical mandate produced additional mandatory monitoring and discouraged excuses (weak and otherwise).

ACOG literature has used the twin prongs of rationalization—blaming the underlying condition or claiming the cause of the bad outcome is unknown—to, in effect, evade the mandate understood by ASA members. The ASA understood that there was a crisis of terrible things happening to some of their patients, with an additional bad effect of high liability insurance costs. Using ethical (quality assurance) and financial (risk management) motivations to promote safer care was a win-win scenario for the ASA and its members.

There is a need for reliable data and objective analysis to distinguish quality care from substandard care. The objective component requires deductive reasoning, which is mandatory for physicians who use the differential diagnosis methodology to arrive at the most likely cause of a problem. This methodology is the only proven scientific way to make medical decisions, some of which potentially involve life and death outcomes. ACOG dismisses this methodology and Sartwelle rejects it, as if deductive reasoning is a ploy created by plaintiff attorneys and experts to evade ACOG's science. ²⁶

“Unknown” is not a cause. There is always a cause for CP. Only if one organizes the relevant medical data and engages in objective analysis can one determine the most likely cause. The same process of deductive reasoning is what enables one to conclude whether the quality of care was substandard.

IV. LIABILITY CLAIMS AND OBSTETRICS

At the same time that the ASA responded appropriately to its malpractice crisis, ACOG's response has been to focus on cases of disabling brain injury related to labor and delivery (intrapartum) of full term infants and keep the terminology of its obstetrical guidelines purposefully ambiguous. The focus on the subset of term intrapartum cases is explained by the high cost to compensate such a child for a lifetime of disability, coupled with what ACOG understood was their physicians’ inability to respond to plaintiffs’ seemingly reasonable explanation for the intrapartum cases. Instead of focusing on labor and delivery with the idea of making it safer for the fetal patient, and thus creating a win-win situation, ACOG did the opposite. It created a false appearance that nothing bad was really happening while physicians were using EFM to watch their fetal patients and promoting the false idea they could do nothing to prevent bad outcomes.

ACOG communications did not emphasize intrapartum fetal death. Cases premised on a perinatal death are far less expensive than other injury claims, and thus do not attract the same attention from ACOG. Yet, the same stresses that produce fatal complications can also produce sublethally disabling brain damage.

Prominent medical authors have written that, for the full term infant, “near total safety is obtainable” during labor if one looks for markers of fetal distress early enough to extract the not-yet-compromised fetus. ²⁷ Fetal distress has been defined as a precarious fetal condition that, if allowed to persist, may lead to permanent damage or death. Obstetricians have noted that the labor and delivery process is one of the most physiologically stressful events a human will ever face and, although most patients tolerate the process without harm, some are not so fortunate. Factors that determine outcomes include preexisting fetal status, intensity and duration of the stress, and the ability of the labor room team to assess fetal status accurately and react appropriately. Experts add that it is unreasonable and counterproductive to insist on diagnostic criteria for fetal distress that are so strict as to encourage delay until after damage has occurred. ²⁸

Common sense suggests that if labor is stressful to the fetal patient and these stresses can produce a brain injury or death, and if preexisting fetal status and the intensity and duration of the stress determine the outcome, then the threshold necessary to trigger a timely delivery must not be so strict as to allow delay. Further, the response must be timely enough to safely remove the fetus from harm's way by safe delivery, before irreversible damage occurs. Common sense, consistent with medical ethics, also suggests that if the capability to timely prevent disabling brain injury did not exist, then performing C-sections would be the method for all deliveries.

A landmark event in modern intrapartum care was the development of EFM, largely credited to Dr. Edward Hon. ²⁹ Since the beginning of the twentieth century, intermittent recording of the fetal heart rate (FHR) with a stethoscope was used to detect fetal distress. The intermittent use of FHR auscultation in between contractions was unreliable except in extreme cases. ³⁰ The labor curve developed by Friedman in the 1950s created an ability to better assess the prospects for a safe vaginal delivery and identify dystocia (difficult labor) associated with potentially excessive mechanical forces. ³¹ With EFM tracing in widespread use by the 1970s, each obstetrician could have continuous information before, during, and after each stress-producing contraction of the fetus.

Hon described each contraction as a repetitive mechanical stress applied to the fetal head, placenta, and sometimes the umbilical cord. Thus, each contraction creates a simultaneous transient, but recurring, mechanical and hypoxic stress that may encroach on the fetal margin of reserve. The EFM information was developed with an awareness that each fetus has a reserve ability to adapt (compensation) and a limit to the ability to compensate; this limit leads to decompensation and the threat of harm, such as disabling brain damage. ³²

According to Hon, fetal hazards during labor include uterine hyperactivity, trauma (excessive mechanical forces), and hypoxia. In cases of suspected fetal distress, Hon urged each physician to focus on the degree of clinical risk, with an awareness that a fetus already compromised may not be able to tolerate even a few minutes of labor. ³³

Fetal asphyxia is a result of impaired gas exchange (reduced oxygenation or hypoxia and increased carbon dioxide), which can occur before or during labor. Labor contractions decrease gas exchange, and thus labor is an intrinsically asphyxiating process. Adaptive hemodynamic responses (more and better blood flow to the brain) represent the reserve ability of the fetus, which can be overwhelmed and collapse (decompensation)—leading to brain insults (decreased blood flow producing the hypoxic-ischemic event) and disabling damage. ³⁴

The ACOG position advocating no-fault immunity concedes that labor is hazardous. Some level of mechanical and hypoxic stress undeniably occurs and, if excessive, can produce death or disabling brain injury. The need to understand the physiology of these mechanical and hypoxic stresses within the fetus and to assess fetal well being with an awareness of the limited ability to adapt and compensate, as well as the potential for decompensation, is the reason a fully trained obstetrician should be in charge of the labor team.

One prominent obstetrician currently notes that there is a need to better teach intrapartum care because learning to turn on an electronic monitor box is not teaching the principles or physiology of labor, and without diligent staff promptly responding to data, the machines are irrelevant. ³⁵ The problem is not with the gadget if the team has not been properly trained to understand and use the information or does not diligently and timely respond. An understanding of the physiology of labor stresses and, for example, such matters as how fetal blood pressure changes because of head or cord compression or significant fetal hypoxia can produce FHR decelerations and how a surge in adrenaline can produce a FHR acceleration, create a better informed physician.

The same obstetrician author noted that, in the past, attending obstetricians sat with their laboring patients. Modern practice patterns requiring clinical multitasking have made this practice largely unfeasible. ³⁶ Often, the attending obstetrician is not continuously with the laboring patient. Sometimes the obstetrician needs better education to understand the available data to fill the gaps left by the lack of continuous personal observation. Others have noted minimal information in the obstetric literature with regard to call responsibilities; this is an issue related to sleep deprivation and physicians not being in the hospital during labor, and thus is a topic of critical importance affecting patient safety and liability exposure. Taking an inward look at current obstetric practices with an eye toward preventing medical errors, before asking legislators to provide liability and reimbursement relief, ³⁷ plus advocacy of a full-time hospital employee called a “laborist,” would be a win-win proposition. The cost would be justified by improvement in quality care and increased safety for mother and fetus. ³⁸

Why did ACOG not observe three decades ago that multi-tasking was making it less feasible to be with the laboring fetal patient (and mother) while the fetal patient is undergoing a hazardous, stressful journey? Why has ACOG not been teaching and promoting the need to understand physiology and the strengths and limitations of the information available? Why has ACOG not promoted as mandatory the need for a full-time laborist in all hospitals so multi-tasking becomes unnecessary and excuses for not being physically and mentally present are not tolerated? Why has ACOG not promoted an inward look at questionable obstetric practice before lobbying the legislature for immunity? There are no good answers to these questions.

In a study by Clark and others of 189 closed perinatal claims, the obstetrician authors agreed that most of the compensation paid was the result of substandard care resulting in preventable injury. ³⁹ Part of their proposal to avoid such injuries included 24-hour in-house obstetric coverage. In this same patient safety study, a group using full-time in-house coverage as part of their labor protocol, conservative use of oxytocin and operative vaginal deliveries, and liberal use of caesarean delivery to avoid difficult deliveries, achieved less fetal injury and a 50% reduction in claims. ⁴⁰

An editorial by a distinguished obstetrician conceded that substandard care related to intrapartum hypoxia can lead to CP and praised the Clark patient safety initiatives, which focused on communication that made inroads on liability caused by substandard care. The author noted the uniform protocols and an interactive FHR monitoring course led to a dramatic decrease in claims, a decrease in caesarean deliveries, and “fewer adverse outcomes.” ⁴¹

The Physicians Insurers Association of America (PIAA) published in 1998 a malpractice claims study of neurologic impairment in newborns. The publication included a list of risk management recommendations corresponding to the most prevalent problems in the management of pregnancy, labor, and delivery. Among the suggestions for improving patient care and minimizing malpractice loss were: documenting risk factors; recognizing that communication among all providers is essential; using in labor the EFM, which “can be an effective management tool,” and prompt communication at the “earliest signs of distress” because management of “any intrapartum complication is critical.” ⁴²

In 2002, a study was published focusing on term infants who experienced newborn neurologic symptoms (encephalopathy) and death related to intrapartum insults. The study found 86% of the encephalopathy and 85% of the perinatal death cases involved sub-optimal care. Specifically listed among the sub-optimal findings were failure to identify abnormal heart patterns or abnormal progress of labor, poor communication, and failure to act appropriately. ⁴³ Thus, we see an overlap of identifiable and fixable intrapartum sub-optimal care cited by both the PIAA and an independent study wherein substandard care was understood to produce bad outcomes (death and brain injury) for children.

Part of the uniform protocol that produced fewer bad outcomes and caesarean deliveries in the Clark study was the inclusion of an interactive FHR monitoring course. The need to add teaching about FHR monitoring dovetails with the idea that there is a problem with the education of obstetricians and others regarding the use of EFM information. A dramatic decrease in claims associated with fewer adverse outcomes was worthy of the praise given to it. ⁴⁴ Though Clark and colleagues do not explicitly explain it, there were fewer caesarean deliveries in spite of a liberal policy. ⁴⁵ The only rational explanation is that an in-house, full-time attending obstetrician with the patient and intelligently focusing on available information with the benefit of an interactive FHR monitoring course led to doing only caesarean deliveries that were necessary and not doing unnecessary caesarean deliveries.

It is not plaintiff attorneys, lawsuits, nor the use per se of EFM that has caused an increase in the caesarean delivery rate. To whatever extent an increase in the number of caesarean deliveries was medically unnecessary, the fault lies in part with obstetricians who did unnecessary caesarean deliveries and in part with ACOG for its failures over the past 30 years.

Although the Clark study and Freeman's accompanying editorial are praiseworthy, the editorial remained politically correct by urging tort reform. The Clark study was motivated, at least in part, by tort liability accountability and confirmed that an approach that should have been in place more than three decades earlier can, for ACOG members, produce the same benefit as the ASA accomplished for its members.

So, we come full circle to the medical political correctness of those authors who maintain that it has never been safer to have a baby nor more dangerous to be an obstetrician. ⁴⁶ However, obstetrical care for maternal and fetal patients is not nearly as safe as it should be. Quality obstetrical care must begin as part of a continuum early in pregnancy, focusing forcefully on issues of preterm birth and antepartum surveillance using, for example, the biophysical profile. As part of this continuum, an assessment of labor requires a graphic analysis of the relationships among cervical dilation, fetal descent, and elapsed hours in labor. This approach, in conjunction with information about the maternal pelvis, fetal position, uterine contractility, and fetal oxygenation, is the best basis for clinical decision making during labor. ⁴⁷ Put directly, quality obstetrical care requires a continuum of reliable and useable information (antepartum to intrapartum) and an awareness that intrapartum, two simultaneous stresses—mechanical and hypoxic—must be tolerated by the fetus or there will be brain damage or death.

V. ACOG'S “ESSENTIAL” CRITERIA AND USE OF STATISTICS

In 1987, an ACOG journal published an article stating that, because “most litigation is based upon events during the delivery process,” a sample of fetal blood should be obtained only when the baby was depressed, for use of that data to help defend against a liability claim. On the other hand, when the baby was not depressed, the authors recommended against obtaining a sample of blood, because such might be “uncomfortably incriminating.” ⁴⁸

The ASA undertook in the late 1970s a massive effort to determine the cause of adverse anesthesia related events; the response was creation of a patient safety foundation and adoption of mandatory minimum standards. ⁴⁹ ACOG has had the same time to deal with the malpractice crises. In 1987, when the ASA had its standards in place, peer reviewers authorized publication of an article urging the collection of fetal blood to promote the legal defense of physicians being sued by patients. ⁵⁰ Fetal blood belongs to the child. A decision to collect that blood with the intent to use it against the legal interests of the child is a flagrant violation of medical ethics.

It was in that time frame and context that the Nelson criteria were used by the defense bar to maintain that, unless each criterion was explicitly established, the plaintiff could not have sustained intrapartum brain damage. ⁵¹ ACOG published in 1993 a list of essential criteria created by a committee chaired by Dr. Gary Hankins. ⁵² In 2003, a new list modifying the old one was issued, again by an ACOG committee chaired by Dr. Hankins. ⁵³ Dr. Karin Nelson, a member of both committees and author of studies cited to support rigid “all” and “must” language in the ACOG criteria, acknowledged that those criteria were “intended for litigation,” adding: “Juries don't understand the limits of current technology.” ⁵⁴

The Nelson criteria and 1993 ACOG criteria required that a persistently low Apgar score and multi-organ damage be proven or the claim must fail. These criteria were written in response to litigation, making them of questionable value. ⁵⁵ The 1992 ACOG document cites an article by Nelson as the sole reference justifying the statement that “all of the following criteria must be present.” ⁵⁶

No data support the criteria. The popularity and appeal to obstetricians is that few cases of disabling brain damage could be attributed to avoidable intrapartum causes if the criteria were rigidly applied. ⁵⁷ What were essential criteria in 1992 (Apgar scores and multi-organ damage) were demoted in 2003 to suggestions. ACOG unequivocally intended the 1992 criteria to be viewed as essential, yet nothing was ever issued explaining why two elements were no longer essential in 2003, or how those criteria or any others became essential in the first place.

In Florida, it can be to the legal advantage of an obstetrician that a child's brain damage occurred during the labor and birth process. Dr. Hankins, testifying in a Florida proceeding as an expert witness in support of an obstetrician's position that a brain injury occurred during the labor and delivery process, swore that the criteria were not essential and each case must be evaluated on its own merits. He so testified even though he acknowledged that the criteria are usually used to support a defendant's position that causation did not exist. ⁵⁸ The ACOG criteria intended to bypass the deductive reasoning of the differential diagnosis methodology is the method correctly used by Dr. Hankins in his Florida testimony.

The 1992 essential criteria arbitrarily used informational elements obtained at and following birth: acidosis; Apgar score; neonatal neurologic symptoms; and multi-organ dysfunction. ⁵⁹ In 2003, the essential list was modified to contain three criteria: acidosis; neonatal encephalopathy; and CP of the spastic quadriplegic or dyskinetic type. ⁶⁰ Dr. Hankins testified in 2007 that the absence of acidosis was not essential because, prior to delivery, a baby can resuscitate in-utero; thus, profound acidosis was unnecessary to connect an acute intrapartum hypoxic event to brain injury. Dr. Hankins also testified that an identifiable moderate or severe neonatal encephalopathy was unnecessary because its documentation would depend on the expertise of the examining person and the rigor with which the exam was conducted in the context of awareness that a newborn's level of alertness and irritability can wax and wane. ⁶¹

The reason given by Hankins to explain why the missing criteria were not essential is partially correct. Acidosis is a by-product of compensation from systemic hypoxia and is not a measure of brain cell damage. Many infants with acute birth asphyxia are born without acidemia. An infant may produce acid in the tissue without developing circulating acidemia. The presence of acidemia supports a diagnosis of asphyxia, but its absence does not exclude the diagnosis. ⁶² Further, although a lower pH is more worrisome than a higher pH (just as an accident at 70 miles per hour is more worrisome than an accident at 40 miles per hour), the 40 m.p.h. accident can still cause injury; likewise, there is no minimum threshold pH to cause damage. Nobody could reasonably believe that a pH of 6.99 caused disabling brain injury but a pH of 7.01 did not.

The issue of neonatal encephalopathy also is more involved. The presence or absence of identifiable newborn signs depends in part on what section of the brain is injured and in part on whether brain cell death occurs immediately (necrosis) or later (apoptosis). ⁶³ Because there is no single pathway to disabling damage that invariably injures the brain in the same location with the same associated signs and lab results, proof of causation is not amenable to a list of essential criteria.

In a different case, Hankins acknowledged that excessive mechanical forces (trauma) during labor and delivery can cause brain damage, and that independent intrapartum stresses such as hypoxia and trauma can have an additive effect in producing a brain injury. Yet, he stated that the 2003 ACOG encephalopathy criteria were not intended to address issues of mechanical stress. ⁶⁴ Because intrapartum mechanical and hypoxic stresses simultaneously impact each fetus and each stress can contribute to cerebral ischemia, potentially producing disabling brain damage, it is medically irrational to focus on hypoxia and ignore mechanical stress. This is especially true when the stresses can be “additive” to one another in producing disabling brain injury.

Labor creates repetitive simultaneous mechanical stresses on the fetus, which has only limited responsive signals to emit. Consequences of the ischemic damage representing the final common pathway to harm are the same to the child regardless of which stress was most culpable. Excessive mechanical force exerted on the fetal head can produce a decrease in cerebral perfusion (ischemia), representing the reason that avoiding abnormal labors and caesarean delivery for dystocia or fetal distress must be a part of quality care. ⁶⁵

Dr. Hankins acknowledged in his testimony that the 2003 ACOG criterion requiring that, unless the brain injury later produces a specific type of CP, it is not possible that the brain injury occurred during labor was derived from Dr. Nelson. ⁶⁶ Intrapartum events allegedly cannot produce disabling brain injury unless motor deficit is part of the disability, and then only specific kinds of CP. This Nelson criterion is (as are each of the other criteria) derived from a scientifically preposterous analysis based on an alleged ability to predict an outcome.

If a study analyzed data from 100,000 auto collisions, it might be able to identify those collisions that produced serious injuries and correlate the injuries with other collected data (independent variables). If the study revealed that, in those collisions producing serious injury, there was a higher incidence of drunk drivers, a failure to have a seatbelt in place, excessive speeds, and a need to tow a vehicle from the scene of the collision than there was in the situation of collisions without serious injury, then each of these independent variables might be characterized as predictive of serious injury. The investigators might urge stronger laws requiring the use of seatbelts, punishment for driving while intoxicated, and lower speed limits. The purpose of the study would not be to identify the mechanism or etiology of the serious injury, as it is already known that trauma or excessive mechanical force is the cause of such injuries. No one would propose, based on this study, that there could not have been a serious injury unless each predictive variable existed.

The study might also reveal that identical twins, each in a safety seat, had different injuries and there was only one report of a ruptured spleen. Although a ruptured spleen might not be considered a predictable injury, deductive reasoning should lead to the conclusion that the passenger's ruptured spleen identified following collision was caused by the collision and that there were variables that explain why the twin passenger did not suffer the same outcome.

Cerebral ischemia (reduced flow of oxygenated blood to and within the brain) produces the hypoxic-ischemic brain insult that can produce disabling brain injury if it crosses a threshold of irreversibility. The hypoxic-ischemic brain insult is the most frequent cause of acquired disabling brain injury and can be the final common pathway to injury from a number of triggering mechanisms (individually or in combination), such as systemic hypoxia, head trauma, and septic shock. There is no dispute that the hypoxic-ischemic brain insult can produce disabling brain damage, just as excessive force from an auto collision can produce disabling injury, given that no human being has an unlimited ability to adapt.

Studies must be done using deductive reasoning or common sense designed to benefit patients. Investigators analyzing the hypothetical auto collisions would understand that outlawing towing vehicles from the scene of the accident would not reduce the incidence of serious injury. They would also know that the fact that a vehicle did not require a tow does not mean that the collision did not cause a serious injury. What ACOG did with its essential criteria was the equivalent of defending auto collision injury claims by maintaining that, because each independent variable was not rigidly present, it was not possible for a collision to cause serious injury. ACOG added that, unless the criteria were met, there was no birth asphyxia—the equivalent of saying there was no collision.

It is highly predictable that a baseball hit over the fence in fair territory (a homer) will produce a run; depending on how one defines “predictable,” it may not be statistically predictable that a bunt single will lead to a run. No reasonable person would conclude that a bunt single cannot contribute to a run, nor would anyone claim that without a homer it is impossible for a run to score. Depending on how one does the math, the risk of an injury from an auto collision is less than .01% for each occupant of a vehicle; yet, this lack of predictability does not mean that seatbelts should be optional for adults or children and drivers need not use due care. Nonetheless, the ACOG criteria were created using notions of predictability that made it appear as if the list represented science.

Neonatal neuroimaging might show structural brain changes correlating in time with a recent brain insult and with a disability that will emerge many months (or perhaps years) later. ⁶⁷ An image might help to time the injury. Whatever the timing, seeing structural brain damage on an image may be predictive of disability; ultimately, however, disability either will or will not emerge later and, if it does, prior ability to predict it becomes moot.

In 1977, Nelson and Broman analyzed data from a national collaborative study for the purpose of identifying factors with a strong statistical correlation with neurologic impairment. ⁶⁸ The study sought to assess the existence of a relationship between prenatal and perinatal factors, on one hand, and neurologic impairment, on the other. The statistical analysis revealed that perinatal complications, particularly those thought to be associated with asphyxia, were considerably more common in children who eventually showed severe motor and mental disabilities than children who did not later suffer those handicaps. None of the identified prenatal factors statistically correlated with neurologic handicap.

This study does not prove that a child with a serious handicap must have experienced an intrapartum brain injury. Nelson, however, in redefining asphyxia, states that “only extremes were considered, because only extremes were associated with substantial increase in risk.” ⁶⁹ Thus, in reasoning analogous to claiming that bunt singles cannot produce a run or that an accident produced a serious injury only if a car had to be towed from the scene, the ACOG criteria were created. ⁷⁰ Further, in an auto accident, a ruptured spleen may not be a predictable consequence, yet it still could be an undeniable result of the accident. Auto accidents must be avoided because they can produce injury. Whether the injury that emerges from the accident was predictable is not relevant to liability or causation.

A study of term children who had neonatal neuroimaging because of their symptoms revealed that events in the immediate perinatal period are most important in neonatal brain injury, refuting the idea that the brain injuries occurred earlier when the physician was “off duty.” ⁷¹ Excluded from the study were children found to have major congenital malformations and obvious chromosomal disorders, as those factors likely would be the cause of disability in those children. Although children with major congenital malformations and obvious chromosomal disorders are not immune from perinatal brain insult, the presence of those factors makes proving causation much more problematic for a plaintiff. The Cowan study demonstrated that neonatal symptoms provide strong evidence the brain injury was perinatally acquired (and therefore potentially preventable), but did not establish that the absence of symptoms and images means there was not a perinatal brain injury.

The ACOG criteria were created to bypass a process of deductive reasoning using differential diagnosis methodology. The differential diagnosis methodology is scientifically reliable because it: was created outside the judicial process; has been subjected to peer review and does not frequently result in incorrect conclusions; requires an expert to take a systematic approach using all relevant information and contrasting all the possibilities in an effort to identify the most likely cause; and encompasses a need to explain why a proposed alternative explanation is not either equal to or more valid than the causation theory offered by the proponent. ⁷²

The 2003 encephalopathy document added as a fourth mandatory criterion the exclusion of other identifiable etiologies such as trauma, coagulation disorders, infectious conditions, or genetic disorders. Differential diagnosis deductive reasoning is a systematic approach using all relevant data and comparing possibilities in an effort to identify the most likely cause of an injury; an expert witness would need to explain why an alterative explanation is not either equal to or more valid than the causation theory offered by the theory's proponent. ACOG acknowledged that trauma can cause disabling brain damage leading to CP. Trauma and hypoxia may co-exist during labor, and thus are additive. During labor, the child may have an infection or a coagulation disorder; either or both would make the child more vulnerable to the stresses of labor. ⁷³

A causation criteria list that stated: “If all of the following criteria are met, then it should be presumed that a child's disabling brain damage occurred intrapartum, but if all of the criteria are not met, then each case should be evaluated on its individual merits using the deductive reasoning of differential diagnosis,” would be to the legal advantage of the patient and, therefore, consistent with ACOG's ethical responsibilities. The ASA, by promoting mandatory minimum standards of care, in essence aided potential plaintiffs in pursuing claims. It is the ethical obligation of the negligent physician and others to promote the best interests of the patient, including the patient's legal rights.

If a representative population sample of CP children were properly studied using all information and objective, deductive reasoning, one could identify what percentage of CP children more likely than not were brain injured from mechanical or hypoxic labor stresses. Epidemiology was used to prove cigarette smoking causes lung cancer and other adverse effects, after many years of denial by cigarette manufacturers. Discontinuing smoking would not eliminate lung cancer, but would prevent lung cancer caused by smoking.

How cigarette smoking triggers lung cells to become malignant is less well understood than how a hypoxic-ischemic brain insult triggers disabling brain injury. Under its criteria, ACOG has artificially reduced the number of brain injuries arising from labor stresses so that obstetricians can claim that a bad intrapartum result is rare.

This clever use of statistics sets the stage for the quantum leap that maintains that modern obstetrical practices in general, and intrapartum care using the EFM in particular, cannot prevent CP because the statistical incidence of CP has not been reduced. Thus, the ACOG premise is that EFM data representing a continuous record of fetal response to stresses (and therefore usually an important part of the plaintiff's evidence) is to be disparaged because the EFM data cannot predict CP and the incidence of CP has not been reduced. ⁷⁴

CP rates are influenced significantly by perinatal death rates. For example, the National Collaborative Perinatal Project (NCPP), collecting data from over 53,000 births between 1959 and 1966 established a perinatal mortality rate (PMR) of 37 per 1000 deliveries. All perinatal deaths are caused by a fatal complication; a review of each of the listed risk factors and an understanding of the associated lethal mechanisms reveals that the same mechanisms—in sublethal effect—can produce disabling brain injury. ⁷⁵

CP statistics are difficult to compile with accuracy because the diagnosis usually cannot be made until at least one year of age, and by the time it is entered in a registry (if recorded at all), the precise ratio is uncertain. What is not uncertain is that in the NCCP and other global databases, the CP rate in the mid-1960s—before EFM and other important perinatal advances—was very low compared to the PMR. One concern was that, were the PMR sharply reduced with better care, the population of children “saved” from lethal complications might survive with sublethal consequences such as disabling brain injury producing CP. Thus, if 25 to 30 per 1000 children who previously died were now saved, but 5 to 10 of those children survived with CP, the CP rates could double or triple (or worse). That did not happen, as the PMR dramatically declined; yet, CP rates stayed more or less steady but—most importantly—did not rise.

In the United States since 1965, there has been a steady decline in the PMR; by 1982, it was 12.6 per 1000. Thus, 25 per 1000—based on the NCPP rate—were saved. ⁷⁶ Approximately half of the decrease in the PMR for the entire twentieth century occurred between 1980 and 2000, yet the very preterm birth rate rose between 1981 and 1999. ⁷⁷ A net gain was described as a decrease in the PMR, less any increase in CP rates. A Swedish study noted that improved care helped to prevent brain injury resulting from asphyxia, birth trauma, and other causes, and there was therefore a net gain in saved non-cerebral palsied children. ⁷⁸ A British study identified a marked fall in intrapartum death associated with asphyxia and trauma by 1970. ⁷⁹

These statistics have been misused to try to make it appear as though good care could not prevent CP, when it is apparent good care can and did prevent lethal and sublethal perinatal injuries. Instead of citing a purported net gain as evidence of what the use of EFM and timely C-section delivery can accomplish and urging better use of those and other advances in the care of obstetrical patients, ACOG has promoted the false idea that CP cannot be prevented. ⁸⁰

If a diagnosis (for instance, asphyxia) were totally accurate and an intervention totally effective in a sampled population, no relationship between risk and outcome would be demonstrable. Intelligent physicians should understand this fact and—consistent with their ethical obligations—should not maintain that the intervention does not influence outcome. One author noted that, in light of enormous gains made in obstetrics and modern neonatal intensive care, minimization of obstetrical events is not warranted; he observed that “very significant decreases in mortality and morbidity [have taken place] among upper birth weight prematures,” but that an increased survival of very low birth weight prematures (well below 1000 grams) accounts for the group within which CP “may well be on the increase.” ⁸¹

Recall the ACOG grievance process discussed previously. ⁸² ACOG does not believe jurors are capable of understanding the limits of science and that the system condones “theater,” produces “misleading” testimony, and uses “hired guns.” Thus, if a “hired gun” stated the ACOG criteria were not essential and that EFM can be used to prevent CP, that would be egregious testimony (except in Florida). The Hankins’ Florida testimony discussed earlier ⁸³ was given with no fear of an ACOG grievance for repudiating the idea that the ACOG criteria are essential, because Hankins was testifying for the obstetrician. Physicians following ACOG dogma skip past deductive reasoning and use the ACOG criteria as if pure science set it in stone. The defense experts espousing the ACOG position are spared the designation of “hired guns.”

VI. THE ELECTRONIC FETAL MONITOR: A USELESS GADGET?

Sartwelle's attack on the differential diagnosis methodology as a plaintiff plot implies that there exists some other way for physicians to arrive at scientifically valid conclusions. ⁸⁴ Sartwelle uses “common sense” to support his questioning of the idea that physicians cause CP, noting the physician is involved in the pregnancy, labor, and delivery for maybe 6 to 12 hours out of a pregnancy's approximately 7,000 hours. Thus, his reasoning is that, based on the number of hours of physician involvement, the injury must have occurred when the physician was “off duty.” He explains that, for decades, obstetricians told patients that they are necessary to ensure delivery of a healthy baby—leading people to believe erroneously physicians are in total control of a baby's brain development. When the baby is not healthy, according to Sartwelle, that triggers a “blame game” leading to CP suits. ⁸⁵ We examine Sartwelle's contention with a look at the allegedly useless gadget (the EFM) and what ACOG communicates to its obstetric consumers (mothers) regarding its members’ role during labor.

ACOG has published clear and unambiguous educational information to the maternal consumer stating that, during labor, the EFM can alert “your doctor” to warning signs that will enable the physician “to take steps to help your baby.” ⁸⁶ Mothers are told that, if the heart rate monitor pattern is abnormal, “your doctor” might take steps to help by giving oxygen and intravenous fluids and taking steps to weaken contractions (in-utero resuscitation). ⁸⁷ However, if the EFM “suggests” the baby has a problem, the physician may decide to deliver right away and it is most likely that the physician will opt for caesarean delivery. ⁸⁸ Mothers so educated are led to believe that the obstetrician does use the EFM.

A New York obstetrical safety initiative sponsored in part by ACOG urges “vital training” on how to interpret, communicate, and effectively respond to FHR tracings to help improve perinatal outcomes. ⁸⁹ Noting that the EFM is the most widely implemented method of intrapartum surveillance, the message is that, “when the information is appropriately” used, it can warn the obstetrical team of fetal complications that “lead to injury”—including “brain damage.” ⁹⁰ By implication, there must be an appropriate use for EFM data—to see the warning signs and act before there is an injury such as brain damage.

ACOG has used its influence to discontinue use of the term “fetal distress,” based on concern that those words may result in inappropriate action by an obstetrician, such as an unnecessary caesarean delivery. ⁹¹ ACOG maintains that its new term, “nonreassuring fetal status,” is an acknowledgment of the “imprecision inherent in the interpretation of the data” and should not be interpreted to mean that the child was really ill. ⁹²

Obstetricians, like other physicians, are required to understand the strengths and limitations of the information available to them in a specific clinical setting. ACOG should urge obstetricians not to overreact by doing unnecessary emergency caesarean sections, but also not to underreact either. ACOG should also emphasize that delivery of a vigorous child is good because it is more likely that a child vigorous at birth is further from a threshold of irreversible harm than a depressed child. ACOG should take the position that the obstetrician must be present and confirm that no fetal distress exists—meaning that the fetus is not in a precarious condition that can lead to brain injury.

There is no reason to change the words “fetal distress” (a term ACOG could define) to “non-reassuring” (a term ACOG does not define), other than an intention to promote a liability defense. It is not possible that anyone could believe use of the words “fetal distress” would trigger an unnecessary emergency caesarean delivery or that obstetricians cannot understand that—whatever words are used—the issue is whether the fetus is in a precarious condition that can lead to harm.

Instead of requiring better education to make certain each obstetrician uses EFM data to distinguish precarious from safe situations, and instead of using the tort system to promote an incentive for the obstetrician to be present, vigilant, and effective, ACOG's focus is on liability defense. The ACOG approach reflects a disconnect between the civil justice system and the goals of medical ethics. “Fetal distress” is a term focused on the fetus. “Non-reassuring” is a term focused on the physician. Promoting the idea that labor is not dangerous for each fetus and that all the physician needs to do after the fact is say, “I was reassured,” is unsafe for the fetus.

ACOG Technical Bulletin 163 cites a study promoting the idea that EFM does not prevent brain damage. ⁹³ The cited study was designed to assess the difference, if any, between continuous electronic monitoring and the periodic use of a stethoscope in a population of preterm fetal patients known to be at high risk for brain injury and death during labor. The structured program of periodic auscultation resulted in much faster reactions to abnormal fetal heart rate patterns. The study found that the risk of CP increased with the duration of the abnormal fetal heart rate patterns. The median time to delivery after diagnosis of the abnormal fetal heart rate patterns was 104 minutes with the EFM as compared to 60 minutes with periodic auscultation. ⁹⁴

Increased duration of an abnormal fetal heart rate (representing increased duration of stresses threatening hypoxic-ischemic damage) increased the incidence (that is, the risk) of CP. Hence, ACOG, seemingly preoccupied with the desire to establish that EFM data does not help prevent brain damage, cited a study that proved that any abnormal EFM data necessitates a timely response because the longer the baby is stressed, the more likely is irreversible brain damage.

ACOG has, in the past and in its most recent intrapartum EFM monitoring Practice Bulletin, stated that because available data do not show a clear benefit for the use of EFM over intermittent auscultation, either option is acceptable in a patient without complications. ⁹⁵ However, labor with high risk conditions (for example, suspected fetal growth restriction, preeclampsia, and Type 1 diabetes) should be monitored with continuous EFM monitoring.

However, auscultation gives intermittent rather than continuous information. The information from auscultation is far less specific; for example, one cannot determine baseline variability or heart rate accelerations. The information obtained may be inaccurate; for instance, FHR late decelerations seen on a tracing are often missed on auscultation. ⁹⁶ Moreover, auscultation is not practical based on nursing staff ratios. Hence, the only reason ACOG persists in leaving open the auscultation option is that this option seemingly promotes the position that EFM does not provide very good information.

An ACOG task force formed to choose the words to communicate about EFM data resulted in three tiers, including normal and abnormal labels as contained in the 2009 Practice Bulletin. ⁹⁷ The third tier label is “indeterminate.” ⁹⁸ One task force member stated that members of the committee had significant concerns with the wording, “fearing its potential legal implication.” ⁹⁹

A terminology change urged by the task force did away with the word “hyperstimulation” to characterize a contraction pattern, replacing it with “tachysystole.” The change in semantics can only be intended to eliminate the term “hyper” from the courtroom. Contractions are an independent variable and, if occurring too frequently or strongly or lasting too long, can present too much stress for the fetus. With or without a hyper or tachy contraction pattern, focusing on the contractions promotes informed interpretation of the fetal cardiovascular response. ACOG fails to urge the medical team to pay attention to what is creating the stresses and to note that hyper or tachy data is worrisome.

One group published a five-tiered cardiovascular tracing protocol. ¹⁰⁰ Whatever the pluses and minuses of that protocol, it at least incorporates the idea of correlating the EFM data with the concept of fetal compensation leading to decompensation.

Each physician responsible for the well-being of a patient requires information so the physician can communicate with the patient (or, in the case of a fetus, the patient's mother). Because during labor each fetus experiences a series of repetitive stresses, the obstetrician requires information about how that fetal patient is doing.

In labor, it is reasonable for the obstetrician to want to ask the fetus, “Are you doing all right and can you safely continue?” The obstetrician must have an answer to the question. If normal data mean a reliable response from the fetus, “I am sure I am all right and can safely continue to tolerate this potentially dangerous journey,” that is a useful answer. If abnormal data reliably mean, “I am sure I am in trouble and decompensating and require immediate rescue,” that answer requires immediate action, usually caesarean delivery. ACOG guidelines do not even mention caesarean-section delivery as an option for abnormal data.

The obstetrician might like to know the fetal pH, but the ultimate issue relates to a decompensation that can occur within the brain contributed to by head compression (leading to ischemic damage) or hypoxia (also leading to ischemic brain damage). With a failure to progress and a contraction pattern previously labeled hyperstimulation (now called tachysystole), a meaningful answer from the fetus would not be, “I am not yet acidotic.” The reason that dystocia appropriately produces most caesarean deliveries is that excessive mechanical forces (head compression) can produce ischemic brain damage.

Dr. Hankins has testified that: good studies show that EFM properly acted on can, in some circumstances, prevent injury; his personal bias is that EFM is superior to auscultation to detect ischemia or hypoxia; and the overwhelming value of the EFM is that it is able to demonstrate when the fetus is tolerating the labor process. ¹⁰¹ He has also acknowledged that, when there is an abnormality of the EFM tracing reflecting a fetal stress, one can use the data to assess whether the fetus is still compensating rather than decompensating. ¹⁰² Hankins also testified that, when a baby is still able to compensate and thus still has reserve, the longer a baby experiences a hypoxic-ischemic insult, the more likely there will be damage, and he often cannot count on a pattern of such stress to resolve. Therefore, he would want to deliver the baby as quickly as possible (which he says can be done in two to three minutes from initiation of anesthesia to delivery). ¹⁰³ Therefore, his approach is better safe than sorry. ¹⁰⁴

This approach should be made part of mandatory ACOG protocols, similar to those of the ASA. If obstetricians were told they must use the EFM properly, timely act while the fetus still can compensate, and adopt a credo of better safe than sorry, the message would be reinforced. Instead, some obstetricians have been preoccupied with creating phrases that will not be used against them in litigation and with creating purposefully ambiguous guidelines for legal defense, and with the idea that it is best for one's legal defense that bad things rarely occur for the fetus during labor and delivery. In so doing, those obstetricians have lost track of the medical mission.

If radiologists reviewed mammograms previously reported to be negative and concluded in retrospect—now aware the patient has cancer—they see the mass, the study would need to explain why the abnormality was not previously seen. Because the only important reason for the imaging was to find a mass that might be malignant, the radiologist's initial mindset should have presumed a mass present until proven otherwise. If the hypothetical study did not make clear the reason the mass seen in retrospect was not seen initially, the study would reek with contrivance.

ACOG emphasizes studies that allegedly prove that, when a bad neonatal outcome is revealed retrospectively, reviewers may change their earlier EFM interpretations and more likely then find evidence of fetal hypoxia. Thus, ACOG asserts that reinterpretation may not be reliable. Missing is any effort to explain why the abnormality was not seen initially and strategies to make certain such misreadings never occur again.

If a lack of oxygen can be seen on EFM in retrospect, once the physician knows about a bad outcome, the same information is there to be seen before the problem is allowed to harm the child. ACOG should promote the need for an educated understanding of EFM data and emphasize that the physician must presume the baby is in a precarious condition until the physician can establish the baby is safe. Uncertainty must be resolved in favor of protecting the child. ¹⁰⁵

Physicians have a natural bias when reviewing the quality of care of another physician: to “protect their own, sometimes at the expense of patients”; for that reason, physicians have been “inept and ineffectual” in self-policing. ¹⁰⁶ Any physician who reviews EFM tracings or other records after the fact must know that the potential fault of a fellow physician is at issue. As discussed earlier, Sartwelle claims that “hindsight and outcome bias” means there is no ability to objectively determine the standard of care. ¹⁰⁷ Physicians must rise above any natural bias to support their colleagues. Sartwelle's opportunistic use of alleged outcome and hindsight bias is equivalent to excusing a driver who strikes a pedestrian if the driver simply explains he or she did not see the pedestrian even though the pedestrian was there to be seen if the driver looked carefully.

ACOG has sent unequivocal signals in the form of patient education to the mother, and a New York project cosponsored by ACOG sends signals that promote the position that the appropriate use of the EFM can prevent brain injury. Yet, ACOG inconsistently signals that the EFM is useless. The explanations for doing away with terms like “fetal distress” and “hyperstimulation” are unconvincing. If ACOG has information that some obstetricians are using fetal distress to jump into unnecessary emergency caesarean sections, it should condemn that practice. If data are imprecise, obstetricians must be with the patient and resolve imprecisions by making decisions that protect the child. Instead of promoting legal defenses, ACOG must reject the idea that it is the moral burden of the fetus to prove that he or she is in trouble and instead recognize an obligation by the physician to establish the opposite.

VII. OBSTETRICAL RISK MANAGEMENT AND QUALITY ASSURANCE

In describing a supposed comprehensive redesign of the patient safety process begun in 2000, a 2008 article reported that, as a result of a “unique” approach in a population of 220,000 deliveries each year, the authors lowered maternal and fetal injury and produced a 50% reduction in medical liability claims and a five-fold reduction in the cost of claims. ¹⁰⁸ Part of the Clark patient safety approach was a liberal use of caesarean deliveries even though the authors reported fewer of them. Thus, without legal immunity, the authors used the malpractice crisis to the advantage of their patients.

The Clark approach was based on the following five principles: uniform processes and procedures result in improved quality in medical care, with the corollary that process variation generally leads to poor quality; every member of the obstetric team should be not only empowered, but also required, to intervene and halt any process that is deemed to be dangerous; caesarean delivery is best viewed as a process alternative, not an outcome or quality end point; malpractice loss is best avoided by reduction in adverse outcomes and the development of unambiguous practice guidelines, rather than by attempting to make unusual care more defensible through the use of nonspecific guidelines; and effective peer review is essential to quality medical practice, yet may be impossible to achieve at a local level in some departments.

With regard to the last principle, Clark and colleagues state that, after an obstetrician has become board certified, “few standard processes exist that will ever again adequately scrutinize the quality of the physician's clinical care outside the local hospital peer review committee process.” ¹⁰⁹ Adding that the achievement of large-scale quality improvement requires effective peer review, the authors note that in practice this is difficult to carry out—particularly when most reviewers find themselves either the partners or economic competitors of an individual being reviewed.

In discussing the problems confronting the specialty of obstetrics, Clark and colleagues describe “unsatisfactory perinatal outcomes and an ongoing malpractice crisis despite increased costs and more caesarean deliveries.” ¹¹⁰ They note that the mark of a good obstetrician and safe care is the ability to send home a healthy mother and baby, not the ability to “tough out” a difficult delivery. Thus, they are “unwilling to tolerate any avoidable adverse outcomes in the pursuit of an arbitrary caesarean delivery rate” ¹¹¹ and, although wishing to avoid unnecessary caesarean deliveries, they encourage their use “liberally for individual cases of labor arrest and abnormal fetal heart rate tracings.” ¹¹² They argue that the best way to avoid litigation is to avoid adverse outcomes, “rather than attempt to defend various interpretations of the word ‘immediately.’” ¹¹³ They also cite the use of oxytocin as a high risk medication, ¹¹⁴ and encourage establishment of a 24-hour in-hospital obstetric coverage program. ¹¹⁵

Clark and colleagues cite a study in which two of them had reviewed 189 closed malpractice cases and found that 40% of adverse outcomes related to intrapartum fetal hypoxia and that associated malpractice claims might have been avoided by in-hospital 24-hour coverage. ¹¹⁶ The study revealed that most damages paid were the result of substandard care causing preventable injury. In each closed liability claim filed, there was a legal advocate for the patient supported by expert opinion and pretrial discovery, as well as a legal advocate and expert for the defense. Either the plaintiff or defendant might disagree with the evaluations of the study investigators.

As discussed earlier, the ASA looked at closed claims and devised standards consistent with interventions to achieve better outcomes. Clark looked at closed claims and implemented interventions intended to achieve, and were successful at achieving, better outcomes. Clark noted that guidelines that give a general sense of clinical direction are purposely ambiguous and that such ambiguity may assist in the defense of cases. They conclude that guidelines “with substantial ambiguity are not the [best] approach to litigation avoidance” and that specificity is the answer “to both patient safety and litigation.” ¹¹⁷

Good practice involves: the presence of a 24-hour in-hospital obstetric coverage (“laborist”) program, in which uniform processes and procedures are in place; every member of the obstetric team being empowered and required to halt any process deemed dangerous; and the liberal use of caesarean delivery in cases of labor arrest and abnormal fetal heart rate tracings. This is how obstetrics can create the better outcomes with less cost result achieved by the ASA 30 years ago.

Obstetric leaders have long known the following: malpractice loss is best avoided by reduction in adverse outcomes; unambiguous guidelines, rather than attempting to make outcomes more “defensible,” is best; caesarean delivery rates are not quality outcomes; “toughing out” a difficult delivery is bad obstetrics; liberal use of caesarean delivery in cases of labor arrest and abnormal fetal heart rate tracings is good obstetrics; and having quality in-house, full-time coverage, with each member of the team required to intervene and halt any process that is dangerous, is essential.

VIII. CREATION AND USE OF MEDICAL SCIENCE: COMPLEXITY

The preface of ACOG's 2003 encephalopathy document describes the mechanisms of CP as complex and incompletely understood, thereby making prevention elusive. ¹¹⁸ It adds that, because the positive and negative predictive values are influenced by disease prevalence, CP is a rare event. Therefore, it urges caution in ascribing intervention to prevent its occurrence without a cost-benefit analysis. ¹¹⁹

The risk of an injury from an auto collision is small, yet seatbelts are required. For the individual injured in an auto accident, as for the child whose brain is injured during labor or antepartum from a preventable stress who later develops CP, the statistic is 100%. Hypoxic or mechanical stresses, if excessive, produce disabling brain injury or death, as no fetal patient has an unlimited ability to adapt. No passenger in an automobile is immune from an auto collision injury if the forces become too great. Thus, it is completely predictable that excessive stresses can injure fetal patients and auto passengers. Therefore, due care is mandatory to avoid such foreseeable injuries. There is nothing complex about the obstetrical ethical duty to protect the fetal patient. Efforts to make this simple issue appear elusive is not consistent with medical ethics.

Medical liability relates to acquired brain insults that cross a threshold of reversibility in a child whose adaptive mechanisms failed. It is the ability of a fetus to make the adaption that creates a window of opportunity for the focused, diligent physician to act. Genetics may make some children more vulnerable than others. Stresses such as hypoxia, infection, or trauma may co-exist. Stresses may begin antepartum and persist with superimposed intrapartum stresses. They may be chronic and less intensive (giving a fetus a much greater ability to adapt) or acute and intense (giving the fetus less opportunity to adapt). Brain cell death may be immediate or delayed.

The complexity related to what occurs at the brain cell level relates to neuroprotection intervention after the brain insult. ¹²⁰ The obstetrician's job is to anticipate and avoid brain insults, if reasonably possible and, if not, to limit the insult as much as possible. This is no more complex a concept than the idea that the driver of a car must use due care to avoid a collision because a collision can cause grievous harm. Even if we are not able to figure out why twin passengers in a car collision did not sustain the exact same injuries, we can understand the mechanism of injury was trauma. What occurs at the brain cell level is not relevant to the obstetrician's ethical duty to use EFM and other information to avoid or limit the brain insult.

An awareness of risk factors and an understanding of the consequences of injury should lead to the most rational steps to prevent or limit the injury. Citing risk factors to make it appear as though CP is multi-factoral is disingenuous and not in the child's best interest.

The biophysical profile (BPP) scoring system was created using risk factors such as decreased fetal movement, growth restriction, and preeclampsia to identify a high-risk population of fetuses who might develop chronic fetal stress that, in turn, could produce death or disabling brain damage. ¹²¹ Understanding that a fetus could make protective adaptations to a hostile environment was part of the process used to create the BPP. Understanding that the fetus making those adaptations would become more vulnerable to ongoing or superimposed stresses was another part of the process, as was understanding that the fetus may express mixed signals (for example, normal strong fetal signals to move and exercise and adaptative fetal signals not to move to conserve energy). The idea was to create a scoring system using a combination of tests to get a clearer idea about the pathway to irreversible fetal damage.

Common sense dictates that, as each of the different factors became abnormal, it was more likely that the fetus was moving closer to irreversible harm. Studies using both short- and long-term measures confirmed that hypothesis. ¹²² For example, one short-term measure revealed an incremental increase in the development of fetal distress requiring caesarean delivery, with a corresponding decrease in the BPP. ¹²³ Thus, if the BPP were 10 out of 10 with all other things being equal, an induction of labor likely would not produce fetal distress requiring operative delivery. On the other hand, a BPP of zero presented almost a 97% incidence of subsequent labor requiring operative delivery for fetal distress. ¹²⁴

Using the BPP scoring system for the high risk patient population lowered the CP rate in comparison to the overall population (1.33 per thousand versus 4.74 per thousand). Children with a BPP of zero showed a 300% increase in CP as compared to those with a BPP of 10. ¹²⁵ Armed with that data, an obstetrician should know that removing a stressed fetus from harm's way (rather than, for example, inducing with the idea of later engaging in a rescue) is the best course of action.

The 2003 ACOG document conspicuously noted that the antepartum use of BPP was associated with a 1.33 per 1000 incidence of CP, compared to a 4.74 per 1000 incidence rate among patients not monitored with BPP. ¹²⁶ The document adds that abnormal test results are found more frequently in patients with abnormal neurologic outcomes. ¹²⁷ However. according to this document, the predictive value of antenatal testing remains poor because of the high frequency of abnormal test results in patients with normal outcomes. ¹²⁸

That position is erroneous. If tests such as BPP are used and reveal abnormalities, but the patient turns out to be normal, that implies a proper use of the testing information. Suggesting that the predictive value of the test is poor can only mean that ACOG intended to deemphasize how BPP has been used to reduce the incidence of CP. The ACOG document was created solely for litigation purposes.

CONCLUSION

The following developments would signal that a culture of safety had arrived: each obstetrical case is analyzed individually by the involved obstetrical team; labor is viewed as a potentially hazardous event for every fetus; the labor assessment begins antepartum to identify each fetus who might be compromised and thus unable to safely tolerate labor's hazards; multi-tasking is not a valid excuse for not having a qualified attending obstetrician present during labor, and instead there is a fully trained obstetrician present and in charge of the team at all times; each labor team member is empowered and required to stop anything that is dangerous; and each team member has EFM monitoring education, including an understanding of the physiology of labor and fetal cardiovascular responses to labor stresses.

Other indicators would be: a conservative use of oxytocin and instrumental vaginal delivery in the context of a clear protocol reflecting an awareness of how each of these adds to the fetal risks; liberal use of caesarean delivery for failure of labor to progress or any EFM information reflecting that the fetus is in a precarious condition; caesarean delivery considered a process alternative, not a quality end point; the practice of “toughing out” a difficult vaginal delivery for any reason being discouraged; informed use of EFM information in the best interest of each unique fetus; the presence of reassuring (normal) information (baseline rate, variability, and reactivity) and the absence of a sustained fall in the heart rate—findings reflecting that the fetus is tolerating the stresses of labor—leading to advising the mother that the prospects are good for a safe vaginal delivery and all other EFM patterns being viewed with caution, and EFM patterns reflecting decompensation mandating expeditious delivery, usually by caesarean.

Additional indicators would include auscultation not considered an acceptable alternative when EFM is available; the intrapartum focus for each fetus being whether the physiological stresses of labor are creating a precarious fetal condition that—if it persists—may lead to permanent brain injury or death; the entire labor team focusing on factors that determine intrapartum outcome, including preexisting fetal status and the intensity and duration of the stress; action to protect the fetus not being delayed by adherence to strict criteria, a lack of vigilance, or inability to respond timely and appropriately; recognition that medical liability is prevented by avoiding bad outcomes and not by defensive tactics; and expert witnesses not being subjected to a grievance process.

We are critical of ACOG's involvement in the CP liability setting. The legal and medical professions are each noble professions and should not be in competition with each other. The professions must coexist, aware that the goal of the civil justice system is justice.

It is impossible to know how many meritorious liability claims were not pursued or, if pursued, were unsuccessful because contrived defenses were used. It is also impossible to know how many preventable brain injuries occurred over the past three decades that would not have occurred if a patient safety approach consistent with that of the ASA had been adopted. Both attorneys and physicians have an ethical responsibility to successfully resolve the problems discussed in this article.

Notes

Thomas P. Sartwelle, Defending a Neurologic Birth Injury: Asphyxia Neonatorum Redux, 30 J. Legal Med. 181 (2009).

The medical liability cases referred to are sometimes called cerebral palsy (CP) cases or neonatal or perinatal brain injury cases, or birth asphyxia or birth injury cases. The case Sartwelle targets for defense, consistent with an ACOG focus, is a brain injury alleged to arise during labor (intrapartum) in a full term infant. The variable labels for “the case” may create confusion, as each label does not necessarily mean the same thing. Whatever label is applied, an allegation that a foreseeable complication was a substantial contributing cause of disabling brain injury forms the basis of a meritorious case if a fair preponderance of the credible evidence establishes that such injury was reasonably avoidable by due care.

Sartwelle, supra note 1, at 184 (citing many references and maintaining asphyxia (lack of oxygen) causes only a tiny fraction of CP cases and, more importantly, CP because of asphyxia is not preventable). According to the author, despite research to the contrary, a certain minority of physicians continue to testify that timely caesarean sections (C-sections) prevent neonatal oxygen deprivation damage. This testimony, according to Sartwelle, is false because it allegedly runs counter to worldwide medical information that physicians can rarely prevent “neurologic birth injury.” Sartwelle thus states CP from asphyxia is not preventable and birth injury is rarely preventable.Is it rare or never? Is he talking about the same thing? Neonatal oxygen deprivation is an event occurring after birth. What does he mean by birth injury? Lack of oxygen and asphyxia are related, but not exactly the same thing. As developed below, a lack of oxygen (hypoxia) ultimately can lead to an adaptive decompensation that produces an ischemic brain insult that can cause disabling brain damage.

Sartwelle, supra note 1, at 214.

Alastair MacLennan et al., Who Will Deliver Our Grandchildren? Implications of Cerebral Palsy Litigation, 294 J.A.M.A. 1689 (2005); see also infra note 20 (detailing ACOG's grievance process).

E-mail from the American College of Obstetricians and Gynecologists [hereinafter ACOG] to its members (Oct. 31, 2007) (on file with author).

Richard L. Berkowitz et al., A Proposed Model for Managing Cases of Neurologically Impaired Infants, 113 Ob. & Gyn. 683 (2009).

N.Y. Judiciary Law § 474-a (McKinney 2009) contains a sliding scale fee and allows counsel, subject to court scrutiny, to justify a fee of up to—but no more than—one-third of the recovery. There is not a single instance in which the child and child's family has not received at least two-thirds of the recovery, and almost always a greater percentage.

Berkowitz et al., supra note 7.

MacLennan et al., supra note 5, at 1689.

Sartwelle, supra note 1, at 240-42.

See infra note 52.

See Kenneth R. Niswander, Adverse Outcomes of Pregnancy and the Quality of OB Care, 2 Lancet 827 (1984); Kenneth R. Niswander, Does Substandard Obstetrical Care Cause C.P.?, Contemp. Ob. & Gyn., Oct. 1987, at 42-60.

Sartwelle, supra note 1, at 243.

Mark R. Chassin et al., The Urgent Need to Improve Health Care Quality: Institute of Medicine National Roundtable on Healthcare Quality, 280 J.A.M.A. 1000, 1001 (1998), available at http://jama.ama-assn.org/cgi/reprint/280/11/1000.pdf (citing Medicare: A Strategy for Quality Assurance (Kathleen N. Lohr ed., 1990)).

Institute of Medicine, To Err Is Human: Building a Safer Health System IX-X & 8, 36 (Linda Kohn et al. eds., 2000).

Id. at 3-5.

See, e.g., Pike v. Honsinger, 155 N.Y. 201 (1898); Toth v. Cmty. Hosp. of Glen Cove, 22 N.Y.2d 255, 263 (1968); Bing v. Thunig, 2 N.Y.2d 656, 666 (1957).

Linda Blank et al., Medical Professionalism in the New Millenium: A Physicians’ Charter, 136 Annals Intern. Med. 243 (2002).

Id.

ACOG's grievance process is triggered when one ACOG Fellow reports that another Fellow has given inappropriate, “egregious” testimony. A plaintiff who is not an ACOG member may not file a grievance against a defense expert. The process involves ACOG designated physicians deciding—without rules of evidence or any legal authority—whether the testimony was “egregious.” Because the process can never benefit a patient's legal rights but only work against the patient, it is intrinsically unethical and a transparent effort to influence the civil justice system to the patient's disadvantage. Charles B. Hammond & Peter A. Schwartz, Ethical Issues Related to Medical Expert Testimony, 106 Ob. & Gyn. 1055 (2005).One ACOG leader maintains that during civil liability trials, “theater often takes precedence over science as a way to impress the jury” and, because “only answers to questions attorneys ask are allowed, the story as depicted is often misleading.” Critical of the “hired guns” who give “biased, outdated or simply wrong” testimony, this author singles out CP testimony as a “particular problem.” James R. Scott, Expert Witness: Perpetuating a Flawed System, 106 Ob. & Gyn. 902 (2005) (citing MacLennan et al., supra note 5).Dr. Scott maintains the civil justice system functions as a “free-for-all.” If this were true, no verdict against an obstetrician would stand, as a “free-for-all” means there was no due process. No one can document a verdict against an obstetrician based on a “free-for-all” or on misleading, outdated, biased, or wrong testimony, because those circumstances would require reversal. Scott maintains that he wants only objective, scientific sources of evidence, such as ACOG Practice Guidelines. Thus, what he wants is experts to endorse what ACOG leaders create. That would allegedly ensure that the medical justice system is reliable and fair. “Reliable and fair” is thus a euphemism to mean no liability in CP cases, because ACOG insists that CP cannot be prevented.

Insitute of Medicine, supra note 16, at 32 & 144-45.

Paul A. Gluck, Patient Safety: A New Imperative, 6 ACOG Clin. Rev. 1 (2001).

John H. Eichhorn et al., Standards for Patient Monitoring During Anesthesia at Harvard Medical School, 256 J.A.M.A. 1017 (1986); American Society of Anesthesiologists, Standards for Basic Anesthetic Monitoring, available at http://www.asahq.org/publicationsAndServices/standards/02.pdf (last visited Oct. 14, 2009).

David M. Gaba, Anesthesiology as a Model for Patient Safety in Health Care, 320 Brit. Med. J. 785 (2000); see generally Jeffrey B. Cooper & David Gaba, No Myth: Anesthesia Is a Model for Addressing Patient Safety, 97 Anesthesiology 1335 (2002).

Sartwelle, supra note 1, at 237-40.

Fred Kubil, Perinatal Events and Brain Damage in Surviving Children 185 (1988).

Richard J. Martin et al., Neonatal-Perinatal Medicine: Diseases of the Fetus and Infant 109 (1997).

Lawrence D. DeVoe, The Future of Intrapartum Care: Navigating the Perfect Storm—An Obstetrician's Odyssey, 201 Am. J. Ob. & Gyn. 100 (2009).

Ralph C. Benson et al., Fetal Heart Rate as Predictor of Fetal Distress: A Report from the Collaborative Project, 32 Ob. & Gyn. 259 (1968).

Emanuel A. Friedman, Labor: Clinical Evaluation and Management (1978).

Edward H. Hon & Kee S. Koh, Management of Labor and Delivery, in Gordon B. Avery, Neonatology: Pathophysiology and Management of the Newborn 120-31 (1982).

Id. at 120-31.

Adré du Plessis, Perinatal Asphyxia and Hypoxic-Ischemic Brain Injury in the Full-Term Infant, in Intensive Care of the Fetus and Neonate 775 (Alan R. Spitzer ed., 2d ed. 2005).

DeVoe, supra note 29, at 3.

Id. at 4.

Louis Weinstein & Thomas J. Garite, On Call for Obstetrics—Time for a Change, 196 Am. J. Ob. & Gyn. 3 (2007).

Louis Weinstein, The Laborist: A New Focus of Practice for the Obstetrician, 188 Am. J. Ob. & Gyn. 310 (2003).

Steven L. Clark et al., Reducing Obstetric Litigation Through Alterations in Practice Patterns, 112 Ob. & Gyn. 1279 (2008).

Steven L. Clark et al., Improved Outcomes, Fewer Caesarean Deliveries and Reduced Litigation: Results of a New Paradigm in Patient Safety, 199 Am. J. Ob. & Gyn. 105 (2008).

Roger K. Freeman, Medical and Legal Implications for Necessary Requirements to Diagnose Damaging Hypoxic-Ischemic Encephalopathy Leading to Later Cerebral Palsy, 199 Am. J. Ob. & Gyn. 585 (2008).

Physician Insurers Association of America, Neurologic Impairment in Newborns: A Malpractice Claim Study 43 (1998).

Elizabeth S. Draper et al., A Confidential Enquiry into Cases of Neonatal Encephalopathy, 87 Arch. Dis. Child, Fetal, Neonatal F176 (2002).

Freeman, supra note 41, at 586.

Clark, supra note 40, at 105.

MacLennan et al., supra note 5, at 1689.

Wayne R. Cohen, Normal and Abnormal Labor, in Handbook of Clinical Obstetrics: The Fetus and Mother 455 (E. Albert Reece et al. eds., 3d ed. 2007).

Richard P. Perkins, Perspectives on Perinatal Brain Damage, 69 Ob. & Gyn. 807 (1987).

American Society of Anesthesiology, at http://www.asahq.org/safety.htm (last visited Oct. 14, 2009).

Perkins, supra note 48.

See, e.g., First of America Bank v. United States, 752 F. Supp. 764 (E.D. Mich. 1990).

ACOG, Practice Bulletin No. 163: Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Policies, 41 J. Ob. & Gyn. 97 (1993).

Gary D. V. Hankins & Michael Spear, Neonatal Encephalopathy and Cerebral Palsy: Defining the Pathogenesis and Pathophysiology, 103 Ob. & Gyn. 628 (2003).

Marie McCullough, A Dispute on Doctor Cerebral Palsy Role, Phila. Inquirer, Feb. 10, 2003, at D01.

See First of America Bank, 752 F. Supp. at 764.

ACOG, supra note 52, at 97.

Robert C. Goodlin, Do Concepts of Causes and Prevention of Cerebral Palsy Require Revision?, 172 Am. J. Ob. & Gyn. 1830 (1995).

Testimony of Gary Hankins, June 6, 2007 & July 9, 2007, Bennett v. Florida Birth-Related Neurological Compensation Ass'n, No. 06-2422N (Fla. Cir. Ct. 2007).

ACOG, supra note 52, at 97.

Hankins & Spear, supra note 53, at 628.

Testimony of Gary Hankins, supra note 58.

Marcus C. Hermansen, The Acidosis Paradox: Asphyxial Brain Injury Without Coincident Acidemia, 45 Dev. Med. & Child Neurol. 353 (2003).

Joseph J. Volpe, Neurology of the Newborn 217, 232 (2001) (noting that typically a brain injury after a longer, less intense insult produces apoptotic cell death at a later time without an associated inflammatory response, while a more intense, acute insult will likely produce necrosis with an inflammatory response). See also id. at 297-98, 302-04, 310-12, 315 & 317 (noting that one neuropathology consequence of the ischemic insult is selective neuronal necrosis because of repeated reversible transient ischemic events, which individually are not sufficient to produce the brain injury).

Testimony of Gary Hankins at 139-97, Apr. 5, 2007, Gould v. Integris Bass Baptist Health Center, No. CJ-2003-138 (D. Garfield Co., Okla. 2007).

Claudine Amiel-Tison et al., Cerebral Handicap in Full Term Neonates Related to the Mechanical Forces of Labor, 2 Baillière's Clinical Ob. & Gyn. 145 (1988); see also John M. Freeman & Karin B. Nelson, Intrapartum Asphyxia and Cerebral Palsy, 82 Pediatrics 240 (1988) (maintaining that, as CP because of birth trauma from prolonged, difficult labor and forcep deliveries became a less frequent cause of CP as obstetrical practice improved, that hypoxic or ischemic injury became blamed more commonly for neurologic deficit). This article was intended to dispose of birth trauma as a nonexistent event of the past. Thus, only intrapartum asphyxia exists to produce an intrapartum hypoxic-ischemic brain injury. Some then used the essential criteria and CP statistics to suggest that intrapartum asphyxia was rare and not preventable as a cause of CP.

Testimony of Gary Hankins, supra note 64, at 149.

Frances Cowan et al., Origin and Timing of Brain Lesions in Term Infants with Neonatal Encephalopathy, 361 Lancet 736 (2003).

Karin B. Nelson & Sarah H. Broman, Perinatal Risk Factors in Children with Serious Motor and Mental Handicaps, 2 Annals Neurol. 371 (1977).

Karin B. Nelson & Jonas H. Ellenberg, Antecedents of Cerebral Palsy: Multivariate Analysis of Risk, 315 New Eng. J. Med. 81 (1986).

See David Shier & J. Lee Tilson, The Temporal Stage Fallacy: A Novel Statistical Fallacy in Medical Literature, 9 Med. Health Care & Phil. 243 (2006) (demonstrating how the new consensus in the medical community that lack of oxygen at birth rarely causes CP relies on fallacious reasoning).

Cowan et al., supra note 67.

See Westberry v. Gislaved, 178 F.3d 257 (4th Cir. 1999); Handyman v. N. Fork & W. R.R. Co., 243 F.3d 255 (6th Cir. 2001).

See, e.g., Michael J. Noetzel, Perinatal Trauma and Cerebral Palsy, 33 Clinics in Perinatology 355 (2006).

Sartwelle, supra note 1, at 184; MacLennan et al., supra note 5; Berkowitz, supra note 7.

Richard Naeye, Causes of Perinatal Mortality in the US Collaborative Perinatal Project, 238 J.A.M.A. 228 (1977).

Alan Fried & Roger Rochat, Maternal Mortality and Perinatal Mortality: Definitions, Data and Epidemiology, in Obstetrics Epidemiology 35 (B. Sachs ed. 1985).

Linda L. Wright et al., Perinatal-Neonatal Epidemiology, in Avery's Diseases of the Newborn 1 (Roberta A. Ballard et al. eds., 8th ed. 2005).

Bengt Hagberg et al., Gains and Hazards of Intensive Neonatal Care: An Analysis of the Swedish Cerebral Palsy Epidemiology, 24 Dev. Med. & Child Neurology 13 (1982); Bengt Hagberg et al., The Changing Panorama of Cerebral Palsy in Sweden: Epidemiological Trends 1959-1978, 73 Acta Pediatrica Scandinavica 433 (1984); Kate Himmelmann et al., The Changing Panorama of Cerebral Palsy in Sweden: Prevalence and Origin in the Birth-Year Period 1995-1998, 94 Acta Pediatrica 287 (2005) (noting a decreasing trend in CP rates).

Richard Chamberlain et al., 1970 British Births Cohort Study: A Survey Under the Joint Auspices of the National Birthday Trust Fund and the Royal College of Obstetricians and Gynaecologists 278 (1975).

Steven L. Clark & Gary D.V. Hankins, Temporal and Demographic Trends in Cerebral Palsy, 188 Am. J. Ob. & Gyn. 628 (2003) (noting that the EFM use coupled with an increase in the C-section delivery rate, has eliminated sudden unexpected intrapartum fetal death). The same intrapartum fetal stresses that can in sublethal effect produce disabling brain injury also can produce an intrapartum fetal death. The physicians who wrote this (and similar) articles, which are clearly intended to support legal defenses, must understand that a proper use of statistics actually proves that proper use of EFM and timely C-section delivery can prevent both intrapartum fetal death and brain injury.

Alfred L. Scherzer, The Changing Face of Cerebral Palsy?, 29 Dev. Med. & Child Neurology 550 (1987).

Scott, supra note 21.

Testimony of Gary Hankins, supra note 58.

Sartwelle, supra note 1.

Id. at 185 & 232-35. No case has ever been successful against an obstetrician premised on an allegation that a disabled child's brain injury must have occurred during labor and that the obstetrician was liable because he or she had total control of brain development. These are strawman fallacies connected to the assertion that civil trials are a “free-for-all.”

ACOG, Educational Pamphlet AP015: Fetal Heart Rate Monitoring During Labor (2001). A midwife can manage a normal pregnancy, labor, and delivery. A general surgeon could easily learn how to do a safe caesarean delivery. Nonetheless, ACOG leads women to believe that obstetricians are necessary to ensure delivery of a healthy baby.

Id.

Id.

Acog.org, New York State's Obstetric Safety Initiative: Providing Excellence in Electronic Fetal Monitoring, available at http://www.acog.org/acog_districts/dist_notice.cfm?recno=1&bulletin=2916 (last visited Oct. 14, 2009).

Id.

ACOG Committee Opinion, Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia, 104 J. Ob. & Gyn. 903 (2004).

Id.

ACOG, supra note 52 (citing Kirkwood Shy et al., Effects of Electronic Fetal Heart Rate Monitoring as Compared with Periodic Auscultation on the Neurologic Development of Premature Infants, 322 New Eng. J. Med. 588 (1990)).

Shy, supra note 93.

ACOG, Practice Bulletin No. 106: Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Policies, 114 J. Ob. & Gyn. 192 (2009).

Frank C. Miller et al., FHR Pattern Recognition by the Method of Auscultation, 64 Am. J. Ob. & Gyn. 332 (1984) (noting that auscultation led to a failure to recognize significant FHR patterns as much as one-third of the time, making it unacceptable in modern obstetrics).

ACOG, supra note 95, at 192.

George A. Macones et al., The 2008 National Institute of Child Health and Human Development Workshop Report on Electronic Monitoring, 112 Am. J. Ob. & Gyn. 601 (2008).

Catherine Y. Spong, Electronic Fetal Heart Rate Monitoring, Another Look, 112 Am. J. Ob. & Gyn. 506 (2008).

Julian T. Parer et al., A Framework for Standardized Management of Intrapartum Fetal Heart Rate Patterns, 197 Am J. Ob. & Gyn. 26.e1 (2007).

Testimony of Gary Hankins, supra note 64, at 23-24 & 127-29.

Id.

Id.

Nalder v. West Park Hosp., 254 F.3d 1168 (10th Cir. 2001); see also Karin B. Nelson, et al., Uncertain Value of Electronic Fetal Monitoring in Predicting Cerebral Palsy, 334 New Eng. J. Med. 613 (1996). This article, frequently cited to support the idea that EFM is not useful in predicting CP, used EFM information noted in the birth records. Nobody reviewed any EFM strips to correlate EFM findings with bad outcomes.

See, e.g., Tim Draycott et al., Does Training in Obstetric Emergencies Improve Neonatal Outcome?, 113 Brit. J. Obstet. Gyn. 177 (2006) (finding a six-month course on EFM training for all clinical staff produced a significant reduction in newborns with neurologic symptoms); see also Robert D.F. Keith et al., A Multicentre Comparative Study of 17 Experts and an Intelligent Computer System for Managing Labor Using the Cardiogram, 102 Brit. J. Obstet. Gyn. 688 (1995) (finding consistently good agreement among experts using EFM data concerning the timing of caesarean section recommendations). ACOG guidelines fail to cite these reports to promote a proactive commitment to patient safety.

Robert M. Wachter & Kaveh G. Shojania, Internal Bleeding: The Truth Behind America's Terrifying Epidemic of Medical Mistakes 322-23 (2005).

Sartwelle, supra note 1, at 243.

Clark et al., supra note 40.

Id. at 105.e2.

Id.

Id. at 105.e3.

Id. at 105.e4.

Id. at 105.e5.

Id.

Id.

Clark et al., supra note 39.

Clark et al., supra note 40, at 105.e4.

ACOG, supra note 53, at 628-36.

Id.

Seetha Shankaran et al., Whole-Body Hypothermia for Neonates with Hypoxic-Ischemic Encephalopathy, 353 New Eng. J. Med. 1574 (2005); Joseph Volpe, Perinatal Brain Injury: From Pathogenesis to Neuroprotection, 7 Mental Retardation & Devel. Disabilities Res. Rev. 56 (2001).

Christopher R. Harman, Fetal Biophysical Variables and Fetal Status, in Asphyxia and Fetal Brain Damage 279-83 (Dev Maulik ed., 1998).

Christopher R. Harman, Assessment of Fetal Health, in Maternal-Fetal Medicine: Principles and Practice 357-402 (Robert K. Creasy et al. eds., 2003).

Id. at 357-403.

Id.

Frank A. Manning et al., Fetal Assessment Based on Fetal Biophysical Profile Scoring: The Incidence of Cerebral Palsy in Tested and Untested Perinates, 178 Am. J. Ob. & Gyn. 696 (1998).

ACOG, supra note 53, at 628.

Id.

Id.