NEUROLOGIC BIRTH INJURY: PROTECTING THE LEGAL RIGHTS OF THE CHILD
By:
Robert L. Conason
and
Steven E. Pegalis
The authors represent plaintiffs in medical liability cases. The authors are members of the New York State Trial Lawyers Association (NYSTLA) and support NYSTLA’s positions with regard to medical liability issues. Steven E. Pegalis is an Adjunct Professor at New York Law School, while Robert L. Conason is a former Adjunct Professor at New York University School of Law.
TABLE OF CONTENTS
NEUROLOGIC BIRTH INJURY: PROTECTING THE LEGAL
RIGHTS OF THE CHILD
Page
INTRODUCTION………………………………….. 1
THE “NO-FAULT” CONTEXT…………………………. 3
PREAMBLE: MEDICAL ETHICS AND THE CIVIL
JUSTICE SYSTEM………………………………. 7
ANESTHESIOLOGY AS A MODEL FOR PATIENT SAFETY……… 10
LIABILITY CASES AND OBSTETRICS………………….. 12
ACOG’S “ESSENTIAL” CRITERIA AND USE OF STATISTICS
TO MAKE IT APPEAR BAD THINGS OCCUR ONLY “RARELY”
OR “NEVER” ON THEIR WATCH…………………….. 18
THE ELECTRONIC FETAL MONITOR (EFM):
A USELESS GADGET?……………………………. 28
OBSTETRICAL RISK MANAGEMENT/QUALITY ASSURANCE CAN
IMPROVE OUTCOMES AND REDUCE LITIGATION JUST AS
WAS ACCOMPLISHED BY THE ASA…………………… 35
CREATION AND USE OF MEDICAL SCIENCE: COMPLEXITY…… 39
IS THERE A LIGHT AT THE END OF THE TUNNEL?……….. 42
WHAT WOULD SIGNAL THE ARRIVAL
OF AN OBSTETRICAL CULTURE OF SAFETY?…………… 42
CONCLUSION……………………………………. 44
NEUROLOGIC BIRTH INJURY: PROTECTING THE LEGAL
RIGHTS OF THE CHILD
INTRODUCTION
The Journal of Legal Medicine recently published an article written by Mr. Sartwelle, a medical liability defense attorney, entitled “Defending a Neurologic Birth Injury.”1 The American College of Obstetricians and Gynecologists (ACOG) is the national professional organization for obstetricians. The article is related to the defense of a perinatal brain injury case.2 The clear import of the article was that neurologic injury cases never 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 (C.P.) which damage allegedly cannot be prevented.3
ACOG as a national professional organization functions through staff, elected officers, executive and other committees. The obstetrical doctors thus functioning on behalf of ACOG act as “leaders” on behalf of their grassroot obstetrical members with regard to pregnancy issues. Positions taken and advocated by ACOG in committee reports and/or tacitly approved in the ACOG peer review journal represents what the specialty’s leadership has and has not done on behalf of its members.
ACOG can and should take political positions provided that they are in the best interest of its obstetrical patients (mother and fetus). For example, urging better reimbursement for obstetricians and additional funds for a 24/7 in-hospital “laborist” would promote patient safety.
The practice of obstetrics requires 24/7 coverage because labor and obstetrical complications can arise at any time. The private attending obstetrician also has responsibilities for scheduled office patient care (e.g. antepartum prenatal obstetrical care and usually GYN patients) and scheduled in hospital care (e.g. scheduled cesarean deliveries and GYN procedures). This spectrum of responsibility, referred to as multi-tasking, will be an important part of our discussion. If the obstetrician is not with the patient meaningfully focusing and meaningfully acting on relevant patient information during labor, the obstetrician’s absence will adversely impact patient safety.
Plaintiff attorneys and our professional (trial lawyer) organizations have an ethical obligation to our 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 our clients who actually have been the victims of unsafe care. For these reasons, we have in the past and continue to offer to be “allies” with ACOG and any 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 illustrative example of what legal ethical professionalism means – - – acting in the best interest of your clients and society.
The context of the issue that we are thrust into, however, is that it is alleged that plaintiff attorneys knowingly pursue meritless cases, which of course, if true, is something we should not do. Mr. Sartwelle maintains medical experts who testify for a plaintiff use pseudoscience and gibberish to misrepresent in the courtroom and he referred 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 doctors “guilty” of “rogue opinions” not supported by ACOG pronouncements on medical subjects. The censure cited by Mr. Sartwelle is an example of how ACOG has “punished” an expert who they maintain gave a “rogue” opinion. Additionally, they urge handpicking special judges who will use “neutral experts.”5
If attorneys and medical experts have been unethical 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 intentionally pursue meritless cases. If on the other hand, these serious charges have been made without basis as a ruse to intimidate expert witnesses and to limit or frustrate appropriate efforts being made on behalf of injured children who do have meritorious claims, that is another matter.
If plaintiffs are frustrated in efforts to pursue cases that do 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 very 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.
THE “NO-FAULT” CONTEXT
The medical liability issue can be even better understood by noting that when ACOG recently urged its members to support legislation for legal immunity (no fault) they maintained that plaintiff attorneys “. . . have been relentless in their efforts to discredit ACOG and undermine the practice of obstetrics”6 and when ACOG recently (2009) published in its peer review journal a no-fault agenda, the article likened the motivation for expected opposition from plaintiff attorneys to Willie Sutton, the bank robber commenting that he robs banks because that is where the money is.7
The article urging a no-fault law in the State of N.Y. is coauthored by Gary Hankins, M.D. and it maintains that plaintiff attorneys wrongly try to justify their taking of “close to half of the awards” leaving less than ½ of the award for the child and family when court costs are deducted. Please note Dr. Hankins’ name as an influential obstetrical ACOG “leader” will appear repeatedly going back to the creation of the initial ACOG essential criteria (discussed later) and coming forward to the most recent ACOG intrapartum labor guidelines (discussed later). 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 the N.Y. law and has never happened.8
A medical scientific peer review journal when printing an article advocating legal immunity for its member physicians should carefully check its facts about the law and seek to exercise some restraint when enabling an attack on attorneys if they 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 and has not been working as intended, represents a disconnect from an 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 preventible, yet plaintiff attorneys sue in almost all cases of C.P. 9 On the same issue, it was maintained in another recent article coauthored by Dr. Hankins and a Dr. Karin Nelson whose name will also repeatedly appear going back to the aforesaid criteria, that plaintiff attorneys have an advantage of sympathy and “a seemingly reasonable explanation” for the intrapartum cases. Yet they contend that judges, jurors, and family members themselves 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 C.P. is “not currently preventible.” 10
These authors imply 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 an outcome. Then when cerebral palsy (C.P.) later emerges as a disability, the simple fact is that no doctor 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 G leaders) that the use of the gadget really had no purpose because it really could not influence outcome.
We note that the substantive center of gravity of each liability case relates to quality medical care which will be defined in this paper. Sympathy is a good emotion, but under the law must not lead a juror away from rational, logical, common sense, analytical thinking which is the mandatory process for all jurors. 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 they will each take an oath to comply. Aware that the crux issue relates to quality care, jurors are strongly motivated to be open minded and appropriately are very supportive of any physician and hospital that render quality care. It is for this reason, coupled with the fact that our citizens 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 always involves stresses (mechanical and hypoxic) which always create the potential for disabling brain injury which later can produce motor (C.P.) and other deficits. We intend to demonstrate that the gadget (EFM) when properly used can lead to timely and appropriate steps that will avoid disabling brain injury, producing C.P. and/or other disabilities.
The “seemingly reasonable explanation” a plaintiff attorney does offer in a meritorious case, is in fact reasonable because the gadget (EFM) really had and has a purpose that really can be used to influence the outcome. We will demonstrate that prominent obstetricians have in the past and currently concede that substandard care during labor can and does cause disabling brain injury producing C.P. Some of these obstetricians cite as a problem, a lack of training and education in the proper use of the EFM information and a lack of timely response to the EFM information. One apparent and fixable reason for a lack of timely response is due to 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 our clients from “us.” 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 thus constituting another misrepresentation.
Children eligible for ACOG’s proposed no-fault benefits are only full term C.P. children (not prematures or children injured prior to 34 weeks gestation) and not children with C.P. caused by metabolic or genetic reasons and not children without C.P. Quite simply they have 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 “in” or “out” is to be decided by a panel of expert doctors. If a child is “in”, medical expenses (not pain, suffering, loss of enjoyment of life, loss of earnings or career) will be paid if needed and if reasonable and if not covered elsewhere (e.g., medicaid, health insurance). Thus, without benefit of an attorney the family “out” of a lawsuit is now blessed with the navigation of a new bureaucracy.
One currently used meritless defense ploy is to create the appearance that a process of medical deductive reasoning cannot reliably be used to identify cause. Yet the ACOG no-fault proposal is packaged on the premise that medical experts can distinguish intrinsic nonpreventable causes (e.g. genetic/ metabolic) from extrinsic potentially preventable causes such as hypoxic-ischemic brain insults during labor. That is how they would discard from the no-fault Garden of Eden, those children who would not have been plaintiffs anyway.
Although the ACOG medical leaders focusing on liability defense worry about the “seemingly reasonable explanation,” plaintiff attorneys offer for the full term intrapartum cases, they do not have the same milk of human kindness concern for the handicapped child who was premature and/or was damaged antepartum. They perceive prematurity and antepartum “in-utero influences” to be sufficiently “defensible” to give them the upper hand. We intend later to demonstrate why these “defensible” notions also can be part of meritless defenses. We ask all to note the word “defensible” is meaningful. Medical liability defense insurers and attorneys use that word when they feel they can be successful in the liability case. Please note how this word “defensible” is used in a context of a new “unique” patient safety protocol in the obstetrical quality assurance and risk management.
Granting immunity extinguishes the accountability mechanism acting as a force to promote safer care. The same ACOG doctors who claim C.P. is never due to substandard care also assure us in their no fault plan that with immunity they will evaluate cases for substandard care. Thus, they assure us they will police themselves by diligently looking for substandard care which their research already tells them doesn’t exist. We will later discuss how a review of closed perinatal birth injury cases revealed substandard care that triggered changes that led to reduced injury and fewer liability cases.
Attorney Sartwelle in his article praised a study that allegedly proved suboptimal care does not lead to C.P. Indeed according to Mr. Sartwelle’s interpretation of the study, those patients identified in the study to have suboptimal care actually had an increased incidence of C.P. compared to those who had optimum care.11 ACOG in its first codification of litigation criteria discussed hereafter (footnote 47) would thank Dr. Nelson and Dr. Niswander for helping to create the document. The document cites Dr. Niswander’s study (praised by Mr. Sartwelle) which allegedly proves substandard care does not cause C.P. According to Dr. Niswander to prove cause and effect, one must first show that suboptimal care must precede a bad outcome more frequently than a good outcome. With this reasoning, if three of five plane crashes were due to bad weather then pilot error could not have caused the other two crashes.12
Thus, the ACOG mindset to date is that substandard care doesn’t exist with regard to C.P. children, but if we give their doctors immunity, we can rely on their objectivity to look for that which they maintain is not there to be seen. Mr. Sartwelle has reviewed studies and reports of “hindsight and outcome bias” and he arrives at a conclusion that: “… an objective method to determine standard of care does not exist.”13 Absent a standard of care there can be no substandard care. Thus, with or without a no-fault law, legal immunity is the end point result if we adopt interpretations of studies cited and used for litigation settings.
This article is intended as our response to the Sartwelle article. We contend that there are flagrant misrepresentations of the medical science and the law. We argue against a position that, at its core, tramples on the legal rights of the children and profoundly disconnects from the ethical heart of medical professionalism and accountability intrinsic to the civil justice system.
PREAMBLE: 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. 14 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 and/or a failure of a planned action to be completed as intended (error of execution) and/or the use of a wrong plan to achieve an aim (an error of planning). Thus an error leading to an injury is caused by medical management rather than the underlying condition of the patient, representing a preventible adverse event that everyone agrees should not happen. Such adverse events are responsible for patient injury and suffering.15
Although the IOM report has urged better systems to provide more lasting and broad-based safety improvement, they have 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. They note that unsafe care is one of the prices paid for not having organized systems of care with clear lines of accountability.16
Medical liability, as part of the civil justice system, exists in a context of a right of the patient to have the benefit of appropriate steps intended to achieve a desired health outcome and the responsibility of the physician to take those appropriate steps and thus avoid a medical error. Each physician must use reasonable care and diligence to accomplish a goal of safety. Liability will arise for failure to take appropriate precautions to safely minimize risk. The obligation to make payment is rooted in the moral concept that a doctor or hospital that is liable should bear full financial responsibility for the bad outcome and additionally the obligation to pay acts as a warning that the law demands the exercise of due care.17
Accountability, arising from individual responsibility recognized by the IOM report as necessary to make care safer, is intrinsic to civil liability. ACOG seeking a no-fault immunity from liability for their 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, the premise must be that the fetal patient no longer requires protection traditionally promoted by such accountability and 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, a child diagnosed with C.P. at one-year-of-age, there is no legal assumption or presumption that the brain injury producing the C.P. did or did not occur during labor or was or was not preventible. All cases require an allegation and supportive proof using expert testimony which can be challenged on cross-exam and contradicted by opposing expert testimony. The rules of evidence apply to every case, the plaintiff (the C.P. 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 doctor or hospital since they have an advantage of medical knowledge and therefore arguably the defendants, [not the child] should have the burden to “prove” they are not liable. We are not aware of any trial lawyer organization ever advocating that position. The child’s traditional legal burden is a fair preponderance of the evidence. Since quality care is intended to “increase the likelihood” of a good outcome, that idea 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 each physician to acknowledge that medical errors that injure patients do occur. When such an injury does occur, the mistake must be reported to the patient as that enables appropriate compensation to the injured party and promotes public trust with the medical profession. Additionally, the reporting and documentation of the mistake forms the basis for appropriate prevention and improvement strategies.18
The same code of professionalism imposes an obligation on all physicians to reduce medical errors and increase patient safety. This ethical professional mandate applies not only to those directly involved, but also applies to all physician activity including their writings, their supervisory and peer review activities, their public speaking, and also when they act as an expert witness.19
Thus, all physicians including the “leaders” communicating through ACOG, have a proactive ethical obligation to make care safer by affirmatively seeking to avoid errors that can lead to preventable injury and death. Proactive efforts importantly include steps to hold individuals including ACOG members, 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, we note again ACOG’s urging of a system to punish 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.20 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 the plaintiff child’s case, violate medical professionalism and arguably constitutes a conspiracy to obstruct justice.
Refocusing on the use of the term “substandard care” to define a legal case with merit, we define a medical error (for instance, a delay in diagnosing fetal jeopardy using the EFM and/or a failure of execution by not doing a timely cesarean delivery) as substandard care creating liability if the EFM information could be used to timely trigger action to prevent the disabling brain injury. Yet, ACOG and Sartwelle maintain the use of the gadget cannot influence obstetrical outcome and nothing an obstetrician does can prevent C.P. 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 professional 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 their patient on their watch. Although it is normal for physicians to wish that a “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 ASA’s response. Specifically, ACOG did not rise up above the kind of wishful thinking that has led to an opportunistic conclusion that nothing bad happens on their doctor’s watch. For more than three decades ACOG has promoted a false response to medical liability cases thus disconnecting obstetricians from the kind of proactive ethically motivated mandates discussed above.
ANESTHESIOLOGY AS A MODEL FOR PATIENT SAFETY
The IOM Report21 and other professional organizations like ACOG have praised the ASA for being a model for patient safety. For example, by adopting and implementing certain minimal mandatory safety standards, the ASA reduced the incidence of anesthesia related death from 1 to 2 per 10,000 anesthetic procedures to 1 for every 200,000 procedures.22
The administration of anesthesia is known to be 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 adopting and implementing mandatory minimal safety standards.
In addition, the cost of their medical malpractice insurance premiums dramatically dropped.23 The malpractice crisis was used by anesthesiologists to galvanize their profession at all levels, including grassroot clinicians 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, patient safety could be studied and interventions planned to achieve better outcomes.24
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 and/or some unknown 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 the anesthesiologist documented that all vital signs were normal when 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 normal vital signs were impossible. Instead of enabling bad care and dishonest record making, objective analysis consistent with the ASA’s ethical mandate produced mandatory additional monitoring and discouraged excuses (lame and otherwise).
ACOG literature has used the twin prongs of rationalization — blaming the underlying condition and/or claiming the cause of the bad outcome is unknown – to in effect evade a mandate understood by ASA members. The ASA understood the crisis was terrible things happening to some of their patients with an additional bad effect of high liability insurance costs. Using the ethical motivation (quality assurance) and the financial motivation (risk management) to promote safer care was a win-win scenario for the ASA and its members.
It is pointful at this juncture to refocus on the need for reliable data and objective analysis to identify quality care vs. substandard care. The objective component requires deductive reasoning which is mandatory for doctors who use the differential diagnosis methodology to arrive at the most likely cause of a problem which methodology is the only proven scientific way to make decisions some of which involve potentially life and death outcomes. As we will develop, ACOG trashes this methodology and the Sartwelle article scoffs at the idea as if deductive reasoning is a ploy created by plaintiff attorneys and plaintiff experts to evade ACOG’s science.25
Unknown is not a cause. There is always a cause for C.P. Only if one organizes the relevant medical data and engages in objective analysis can one determine the most likely cause. The same process of objective deductive reasoning is what enables one to conclude if the quality of care was or was not substandard.
LIABILITY CASES AND OBSTETRICS
At the same time frame that the ASA responded appropriately to their malpractice crisis, ACOG’s most active response to their malpractice crisis was to focus on cases of disabling brain injury related to labor and delivery (intrapartum) of full term infants and to keep the terminology of its obstetrical guidelines “purposefully ambiguous.” This phrase “purposefully ambiguous” comes from a study we will detail in our subsequent discussion of obstetrical risk management. The focused emphasis on the subset of term intrapartum cases was and is explained by the high cost to compensate such a child for a lifetime of disability, coupled with what ACOG doctors understood was their inability to respond to the plaintiff’s “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. They created a false appearance that nothing bad was really happening “on their watch” while they were using the EFM to “watch” their fetal patient and they have promoted the false idea they could do nothing to prevent the bad outcomes (C.P. and other disabilities).
The reader is asked to note the lack of emphasis contained in ACOG communications with regard to the intrapartum fetal death. Liability cases premised on a perinatal death are far less expensive and thus do not attract the same attention from ACOG. Yet as will be shown, the same stresses that can produce fatal complications can also produce in sublethal effect disabling brain damage.
Prominent medical authors have written that for the full term infant “near total safety is obtainable” during labor if one looked for markers of fetal distress early enough to extract the fetus not yet compromised, as long as the decision and execution are fast enough.26 Fetal distress has been defined as a precarious fetal condition which if allowed to persist may lead to permanent damage or death. Prominent 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 tolerate the process without harm, some are not so fortunate. Factors that determine outcomes include preexisting fetal status, the intensity and duration of the stress, and the ability of the labor room team to assess fetal status accurately and react appropriately. They add that it is unreasonable and counterproductive to insist on diagnostic criteria for fetal distress that is so strict as to encourage delay until after damage has occurred. 27
Common sense is inherent in these statements. If labor is stressful to the fetal patient and if these stresses can produce a brain injury or death and if preexisting fetal status and the intensity and duration of the stress will 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 fast enough to safely remove the fetus from harm’s ways by timely safe delivery, before irreversible damage occurs. Common sense consistent with medical ethics also tells us that if the capability to timely prevent disabling brain injury did not exist then going to cesarean would be the method for all deliveries.
A landmark in modern intrapartum care was the development of the electronic fetal monitor (EFM), largely credited to Dr. Edward Hon.28 Since the beginning of the 20th century, intermittent recording of the fetal heart rate (FHR) with a stethoscope was used to detect fetal distress. The intermittent use of FHR (fetal heart rate) auscultation in between contractions was unreliable except in “extreme” cases.29 The labor curve developed by Dr. Friedman in the 1950′s created an ability to better assess the prospects for a safe vaginal delivery and to better identify dystocia (difficult labor) associated with potentially excessive mechanical forces.30 With the development of the EFM tracing in widespread use by the 1970′s, each obstetrician could have continuous information before, during and after each stress producing contraction of what the fetal cardiovascular response was to each stress.
Dr. Hon described each contraction as a repetitive mechanical stress that is applied to the fetal head, the 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 leading to decompensation and the threat of harm such as disabling brain damage.31
According to Dr. Hon, fetal hazards during labor include uterine hyperactivity, trauma (excessive mechanical forces) and hypoxia. In cases of suspected fetal distress, Dr. Hon urged each doctor 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.32
Fetal asphyxia is a result of impaired gas exchange (reduced oxygenation [hypoxia] and increased carbon dioxide) which can occur before and/or during labor. Labor contractions decrease that 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 potentially can be overwhelmed and collapse (decompensation) leading to brain insults [decreased blood flow producing the hypoxic-ischemic event] and potential disabling damage.33
Please note how the current ACOG position previously referenced seeking no-fault immunity conceded labor is hazardous. Some level of mechanical and hypoxic stress undeniably does occur and if excessive can produce death or the sub-lethal effect can be disabling brain injury. Understanding the physiology of these mechanical and hypoxic stresses within the fetus and the need to assess fetal well being in a context of an awareness of a limited ability to adapt and compensate and a potential for decompensation is the reason why the fully trained obstetrician who is properly educated on the subject should be in charge of the labor team.
A 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.34 The problem is not with the gadget if the team has not been properly trained to understand and use the information and/or does not diligently and timely respond. An understanding of the physiology of labor stresses and how for example fetal blood pressure changes due to head or cord compression and/or significant fetal hypoxia can produce FHR decelerations and how a surge in adrenalin can produce a FHR acceleration creates a context for a better informed doctor.
This same prominent obstetrician noted that though in the past attending obstetricians actually sat with their laboring patients evolving practice patterns, requiring clinical multitasking, have made this practice largely unfeasible.35 Often the attending obstetrician is not with the laboring patient and sometimes the obstetrician needs better education to understand the information. Others have noted minimal information in obstetric literature with regard to call responsibilities, an issue related to sleep deprivation and doctors not being in the hospital during labor and thus an issue of “critical importance” since it affects patient safety and liability exposure. In urging an inward look at current obstetric practices to prevent medical errors before asking legislators and others to provide liability and reimbursement relief, 36 a full time [24/7] in hospital slot called a “laborist” would be “win-win” as the cost would be justified by improvement in quality care and increased safety for mother and fetus.37
Why did ACOG not observe three decades ago that multi-tasking was making it less and less “feasible” to be with the laboring fetal patient (and mother) which fetal patient is undergoing a hazardous stressful journey which can be excessive and catastrophic? Why has ACOG not been teaching and promoting the absolute need to understand physiology and the strengths and limitations of the information? Why has ACOG not promoted as mandatory the need for a 24/7 laborist in all hospitals all the time so multi-tasking becomes unnecessary and so excuses for not being there physically and/or mentally are not tolerated? Why hasn’t ACOG promoted the idea of an “inward look” at questionable obstetric practice during the last thirty years before running to the legislature for immunity? We believe these are rhetorical questions as there can be no good answer from ACOG.
A study of 189 closed perinatal litigation cases will later be discussed in further detail. The obstetrical authors evaluated the information developed from these cases and agreed most of the compensation paid was the result of actual substandard care resulting in preventible injury. Part of the proposal to avoid such injuries included 24-hour in-house obstetric coverage.38 In what we will later refer to as the Clark patient safety study, with the 24-hour in-house coverage as part of their labor protocol, rejecting “purposefully ambiguous” guidelines, “conservative” use of oxytocin and operative vaginal deliveries and “liberal” use of caesarean delivery to avoid a “difficult delivery,” that group did achieve less fetal injury and a 50% reduction in claims.39
In an editorial, a distinguished obstetrician conceded that substandard care related to intrapartum hypoxia can lead to C.P. and praised the Clark patient safety initiatives which focused on “communication” which did make “inroads” on liability caused by substandard care. He 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.” 40
The Physicians Insurers Association of America (PIAA) published in 1998 a malpractice claim study of neurologic impairment in newborns. The publication included a list of risk management recommendations corresponding to what they found as the most prevalent problems in the management of pregnancy, labor and delivery. Among their “suggestions” for improving patient care and minimizing malpractice loss included documenting risk factors, recognizing that communication among all providers is essential, using the EFM in labor which “can be an effective management tool,” and then prompt communication at the “earliest signs of distress” because management of “any intrapartum complication is critical.”
A study was done 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 had sub-optimal care. Specifically identified among the sub-optimal findings were failure to identify during labor, abnormal heart patterns or abnormal progress of labor and poor communication/failure to act appropriately. Thus we see an overlap of identifiable and fixable intrapartum sub-optimal care cited by the PIAA and again cited by an independent study in which substandard care was understood to produce bad outcomes [death and brain injury] for children.41
Part of the uniform protocol that did produce fewer bad outcomes and fewer cesarean deliveries in the Clark study was the inclusion of an “interactive FHR monitoring course.” The need to add the FHR monitoring teaching dovetails with the idea previously expressed that there is a problem with the education of obstetricians and others as to how to use the EFM information. A dramatic decrease in claims associated with fewer adverse outcomes was worthy of the praise given to it in the editorial. Though not explicitly explained in the Clark patient safety article, they report fewer cesarean deliveries in spite of a liberal policy to perform a cesarean delivery. The only rational explanation is that with the in-house 24/7 attending obstetrician being with the patient and intelligently focusing on the information with the benefit of an interactive FHR monitoring course, they were doing those cesarean deliveries that were necessary and meaningful and not doing unnecessary cesarean deliveries. Thus, it is apparent that it is not plaintiff attorneys and not lawsuits and not the use per se of EFM that has caused an increase in the cesarean delivery rate. To whatever extent any increase in the number of cesarean deliveries was due to medically unnecessary procedures, the fault should lie in part with the obstetrician who did the unnecessary cesarean delivery and in part with ACOG which has not been doing what it should have been doing for the past 30+ years.
Though we praise the efforts of the Clark group and the positive editorial statements referred to herein, we must note that the editorial itself remained “politically correct” by continuing to urge tort reform. The Clark study itself was motivated, at least in part, by the liability tort signal and confirmed that an approach that should have been in place more than three decades ago can, for ACOG members, produce the same win-win situation as the ASA accomplished for its members 30 years ago.
So we come full circle back to the medical political correctness of Drs. Hankins, Nelson and others who currently maintain that it has never been safer to have a baby and never more dangerous to be an obstetrician.42 It is our premise that obstetrical care for the patients (maternal and fetal) is not nearly as safe as it could or should be. It is our position that quality obstetrical care must begin as part of a continuum early in pregnancy focusing more forcefully on issues of preterm birth and more forcefully on antepartum surveillance using, for example, the biophysical profile.
Then as part of a 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, the fetal position, uterine contractility and fetal oxygenation is the basis for clinical decision making during labor.43
We urge the reader to retain focus on the idea that 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.
ACOG’S “ESSENTIAL” CRITERIA AND USE OF STATISTICS
TO MAKE IT APPEAR BAD THINGS OCCUR ONLY “RARELY”
OR “NEVER” ON THEIR WATCH
In 1987, ACOG published in its peer review journal an article in which according to the author since “…most litigation is based upon events during the delivery process…” they recommended obtaining a sample of fetal blood only when the baby was depressed so they could use that information to help defend a liability case. On the other hand, if the baby was not depressed they recommended against obtaining a sample of blood because such might be “uncomfortably incriminating.” 44
The ASA undertook in the late 1970′s what they described as a “massive effort” to determine the cause of adverse anesthesia related events and their response was by 1985 a patient safety foundation and mandatory minimal standards. 45 ACOG had the same three decades to deal with the malpractice crises for their members. In 1987 when the ASA had their standards in place, ACOG peer reviewers authorized publication of an article urging the collection of fetal blood to promote the legal defense of the doctor to the legal disadvantage of the patient. Fetal blood belongs to the child. A decision to collect or not collect that blood with the intent that such be used against the legal interests of the child is a flagrant violation of the ethics set forth in the preamble.
It was in this time frame and in this context that what were then referred to as Nelson criteria as determined by Dr. Karin Nelson would be used by the defense to maintain that unless each criterion was explicitly established the plaintiff could not possibly have sustained intrapartum brain damage. 46
ACOG in 1992 (T.B. 163) published a list of essential criteria created by a committee chaired by Gary Hankins, M.D 47 and in 2003 (“encephalopathy”) a new list modifying the old one was issued by an ACOG committee again chaired by Dr. Hankins.48 Dr. Karin Nelson, who was a member of each committee and whose “studies” are cited to support the rigid “all” and “must” essential criteria acknowledged they were “…intended for litigation”. Dr. Nelson added “…juries don’t understand the limits of current technology.” 49
This gives insight into the thinking justifying and energizing the desire to create a criteria list. This insight dovetails with our earlier discussion in which Dr. Hankins and others conclude without any substantiating proof that judges and juries are not capable of comprehending simple medical facts.
In 1990, using Nelson criteria, defense experts swore under oath that it was not possible that perinatal asphyxia produced in a severely handicapped child her damage because all the criteria were not rigidly met. The Nelson criteria and the 1992 ACOG (TB-163) criteria required that a persistently low Apgar and documented evidence of multi-organ damage be proven or the claim must fail.
The Federal Judge who decided in favor of the child noted the Nelson criteria were given to the expert witnesses by defense counsel and one expert conceded Nelson’s writings were in response to litigation making the criteria according to the Judge of questionable value. 50 The ACOG 1992 document (T.B. 163) cites as the sole reference justifying their statement that “all of the following criteria must be present” an article written by Nelson.51
No data support the criteria. The popularity and appeal to obstetricians for such essential criteria is that few cases of disabling brain damage could be due to potentially avoidable intrapartum causes if the criteria were rigidly applied.52 What were essential criteria in 1992 (Apgar scores and multi-organ damage) were demoted in 2003 to a “suggest” list. ACOG unequivocally intended the T.B. 163 (1992) criteria to be viewed as essential yet nothing was ever issued explaining why two criteria in 2003 were no longer essential or how those criteria or any other criteria became essential in the first place.
In Florida, it can be to the legal advantage of an obstetrician that a child’s brain damage did occur during the labor birth process. In this regard, Dr. Hankins, when recently testifying in a Florida proceeding as an expert witness to support an obstetrician’s legal position that a brain injury did occur during the labor and delivery process, swore that the criteria were not essential. Even though Dr. Hankins has acknowledged that the criteria are usually used to support a defendant’s position that causation cannot exist, when the use of the criteria was not to the doctor’s legal advantage, he swore that the criteria were not essential and each case must be evaluated on its own merits.53 Please note that Dr. Hankins, in Florida, used the differential diagnostic method which evaluates each case on the merits which methodology the criteria are intended to bypass.
The essential criteria list in 1992 arbitrarily used four pieces of information potentially obtained at and following birth (acidosis, Apgar score, neonatal neurologic symptoms, multi-organ dysfunction)54 and in 2003 the essential list was modified to three affirmative criteria (acidosis, neonatal encephalopathy, C.P. of the spastic quadriplegic or dyskinetic type).55
Dr. Hankins in his Florida testimony acknowledged that the absence of the acidosis criterion was not essential because prior to delivery a baby can resuscitate in-utero and thus profound acidosis was unnecessary to connect an acute intrapartum hypoxic event to brain injury. Dr. Hankins also stated that the absence of an identifiable moderate or severe neonatal encephalopathy was an unnecessary criterion since documentation of that fact would depend on the expertise of the person examining and the rigor in which the exam was conducted in a context of an awareness that a newborn’s level of alertness and irritability after birth can wax and wane.56
The reasons given by Dr. Hankins in his Florida testimony why “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.57 Further, while a lower pH is more worrisome than a higher pH, just as an accident at 70 m.p.h. is more worrisome than an accident at 40 m.p.h., no one could say the 40 m.p.h. accident couldn’t cause injury and likewise no threshold pH could define damage. Nobody could really believe that a pH of 6.99 made it possible for disabling brain injury but a pH of 7.01 made it impossible, yet that nonsense was and is an essential criterion.
The issue of neonatal encephalopathy is also more involved because the presence or absence of identifiable newborn signs depends in part on what part of the brain is injured and in part whether brain cell death occurs immediately (necrosis) or later (apoptosis). 58 Since there is no single unvarying pathway to disabling brain damage which invariably injures the brain in the same location with the same associated signs and lab data, the issue of causation is not amenable to a list of essential criteria.
Dr. Hankins, in independent testimony, 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 encephalopathy criteria document was not intended to address issues of mechanical stress.59
Since intrapartum mechanical and hypoxic stresses simultaneously impact each individual fetus and since each stress can cause or contribute to cerebral ischemia potentially producing disabling brain damage, it is medically irrational to focus on one stress (hypoxia) and ignore the other stress (mechanical) as if it didn’t exist, especially when the chairman of the committee acknowledges that the stresses can be “additive” to one another in producing disabling brain injury.
As discussed earlier, Dr. Hon and others noted that labor creates repetitive simultaneous mechanical stresses on the same individual fetus who has only limited responsive signals to emit and the 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 forces exerted on the fetal head can itself produce a decrease in cerebral perfusion (ischemia) representing the reason why avoiding abnormal labors and cesarean delivery for dystocia or fetal distress or both must be part of quality care.60
Dr. Hankins acknowledged that the new (2003) cerebral palsy (C.P.) criterion requiring that the brain injury must later produce a specific type of C.P. or it is not possible that the injury to the brain did occur during labor is derived from Dr. Nelson.61 Thus, intrapartum events allegedly cannot produce disabling brain injury unless C.P. (motor defict) is part of the disability and then allegedly only specific kinds of C.P. This Nelson created criterion is as are each of the other criteria derived from a bizarre and scientifically preposterous analysis based on an alleged ability to predict an outcome.
If a study collected and analyzed data from 100,000 auto collisions, it might be pointful to identify those collisions which produced serious injury and correlate the injury with other collected data (independent variables). If the study revealed that in those collisions that produced serious injury, there was a higher statistical incidence of a drunk driver, a failure to have a seatbelt in place, speeds in excess of 70 m.p.h., and a need to tow a vehicle from the scene of the collision in comparison to collisions without serous injury, each of these independent variables might be characterized as “predictive” of serious injury.
The study might then urge stronger laws requiring the use of seatbelts, punishment for DWI, and lower speed limits. The purpose of the study would not be intended to identify the mechanism (or etiology) of the serious injury as it is already known that trauma (excessive mechanical forces) is the cause of such injuries. No one would propose that based on this study, there could not have been a serious injury unless each “predictive” variable (DWI, no seatbelt, speed greater than 70 m.p.h, and towing) existed.
The study might also reveal that identical twins each in a safety seat had different injuries and there were no reports of any ruptured spleen. Though a ruptured spleen might not be considered a “predictive” injury, using deductive reasoning should lead to the undeniable conclusion that a passenger’s ruptured spleen identified following collision was caused by the collision. Though one could not identify why the twin passenger didn’t sustain the exact same injury, deductive reasoning would lead to the undeniable conclusion that there were variables that explain the different outcomes.
Cerebral ischemia (reduced flow of oxygenated blood to and within the brain) produces the hypoxic-ischemic brain insult, which event can and will produce disabling brain injury if it ultimately 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, septic shock, etc. There is no controversy or dispute that the hypoxic-ischemic brain insult can and ultimately will produce disabling brain damage just as excessive forces from an auto collision ultimately can and will produce disabling injury as no human being has an unlimited ability to adapt.
Studies using statistics must always be done in a context using deductive reasoning (common sense). Medical studies must use common sense designed to benefit patients. Doctors analyzing the aforesaid auto collision study would understand that outlawing the towing of vehicles from the scene of the accident would not reduce the incidence of serious injury and would also know that if a vehicle didn’t require a tow that would not mean that the collision didn’t cause a serious injury. What ACOG doctors did with their essential criteria was the equivalent of defending auto collision injury claims by maintaining that if each independent variable was not rigidly present, it is not possible for a collision to cause serious injury. Indeed ACOG added that unless the criteria were met there was no birth asphyxia (equivalent of saying there was no collision).
It is highly predictable that a ball hit over the fence in fair territory (homer) will produce a run and depending on how one defines predictable it may not be statistically predictable that a bunt single will lead to a run. No one would then 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. Yet the ACOG criteria lists were created using notions of predictability dressed up to make it appear as if the list represents science.
Neonatal neuroimaging might show structural brain changes correlating, in time with a recent brain insult and correlating with a disability that will emerge many months (or perhaps years later).62 Such an image might help to time the injury. Whatever the timing, if one can see on an image structural brain damage that fact is predictive of disability but ultimately the proof is in the pudding as disability later will (or will not) emerge and when it does the prior ability to predict becomes moot.
In 1977, Nelson analyzed information from a national collaborative study for the purpose of identifying factors that would have a strong statistical correlation with neurologic impairment. The analysis sought to assess a relationship between prenatal factors existing prior to labor and perinatal factors existing during the labor and delivery process with neurologic impairment. The statistical correlation 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.63
This data could not and should not be used to “prove” that a child with serious handicap must have experienced an intrapartum brain injury. Nelson, however, would use the same data redefining asphyxia as representing certain extremes because according to Nelson “only extremes were considered, because only extremes were associated with substantial increase in risk.”64 Thus, in what is now analogous to bunt singles cannot produce a run or analogous to a claim that only if a car had to be towed from the scene of an accident is it possible that an accident produced a serious injury; the criteria were created.65 Further if there was an auto accident, a ruptured spleen may not be a predictable consequence but yet an undeniable result of the accident. Auto accidents must be avoided because they can produce injury. Whether the injury that emerges was or was not predictable is not relevant to liability or causation.
A study of term children who had neonatal neuroimaging because they had neonatal neurologic symptoms revealed that the events in the immediate perinatal period are most important in neonatal brain injury refuting the idea that the brain injuries occurred earlier when the doctor was “off duty.”66 Excluded from the study were children found to have major congenital malformations and obvious chromosomal disorders as those findings would be the likely cause for the disability of those children. While children with major congenital malformations and obvious chromosomal disorders are not immune from perinatal brain insult, the presence of such an abnormality makes causation proof using the differential diagnosis methodology much more problematic for a plaintiff.
The Cowan study did demonstrate that with neonatal symptoms there was strong evidence the brain injury was perinatally acquired (and therefore potentially preventable) but did not demonstrate that without symptoms and images there was not a perinatal brain injury.
The essential criteria lists were created to bypass a process of deductive reasoning using the differential diagnosis methodology. The differential diagnosis methodology is understood to be scientifically reliable because it was created outside the judicial process; has been subject to peer review and does not frequently result in incorrect conclusions; requires an expert to use a systematic approach using all relevant information 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 or a more valid cause than the cause offered by the proponent. 67
The 2003 encephalopathy criteria list adds as a fourth mandatory criterion the exclusion of other identifiable etiologies such as trauma, coagulation disorders, infectious conditions or genetic disorders. Part of differential diagnosis deductive reasoning is a systematic approach using all relevant data; contrasting all possibilities in an effort to identify the most likely cause and for an expert witness a need to explain why an alterative explanation is not either equal or a more valid cause than that offered by the proponent. Noteworthy is ACOG’s acknowledgment that trauma can cause disabling brain damage leading to C.P. Trauma and hypoxia may both co-exist during labor and are thus “additive.” The child during labor may have an infection and/or may have a coagulation disorder which if either or both existed would make the child more vulnerable to the labor stresses.
If ACOG leaders published a criteria list which 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 the differential diagnosis methodology,” that statement would be to the legal advantage of the patient and therefore consistent with ACOG’s ethical responsibilities.
The ASA, by promoting mandatory minimum standards, in essence aided the potential plaintiff in pursuing the case. As discussed in the preamble, it is the ethical obligation of the negligent doctor and all others to promote what is in the best interests of the patient including the patient’s legal rights.
If a representative population of C.P. children were properly studied using all information and objective deductive reasoning, one could then identify what percentage, on a more likely than not basis, were brain injured from labor stresses (mechanical and/or hypoxic.) 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.
The mechanism of exactly how cigarette smoking actually triggers lung cells to become malignant is less well understood than how a hypoxic-ischemic brain insult triggers disabling brain injury. By using their essential criteria, ACOG has artificially reduced the number of brain injuries arising from labor stresses so that they (and their lawyers) can claim that “bad” intrapartum result is “rare.” Dr. Nelson’s use of statistics further limits what type of C.P. possibly can occur from brain injury during labor thus making the “bad” event even “rarer.”
This “clever” use of statistics set the stage for the next quantum leap which maintains that modern obstetrical practices, in general, and intrapartum care using the EFM, in particular, cannot prevent C.P. because the statistical incidence of C.P. has not been reduced. Thus, the ACOG premise is that EFM information 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 information cannot predict C.P. and because the C.P. incidence is not reduced.68
C.P. rates are significantly influenced by perinatal death rates. For example, the collaborative study (NCCP) collecting data from over 53,000 births between 1959 and 1966 established a perinatal mortality rate (PMR) of 37 per 1000 deliveries (37/1000). All perinatal deaths are caused by a fatal complication and a review of each of the listed associated risk factors and an understanding of the associated lethal mechanisms reveals that the same mechanisms, in sublethal effect, can produce disabling brain injury.69
C.P. statistics are more difficult to compile with precise accuracy because the diagnoses cannot be made until usually at least one year of age and by the time the diagnosis is entered in a registry (if recorded) and accurately connected to a rate per 1000 births, the precise ratio is uncertain. What is not uncertain is that in the NCCP and other world wide data, the C.P. rate in the mid-1960′s, before EFM and other important perinatal advances were all very low compared to the PMR, for example in the 2-3/1000 range. One concern was that if the PMR would be sharply reduced with better care, the population of children “saved” from lethal complications might survive with sublethal consequences such as disabling brain injury producing C.P. Thus if 25 to 30 per 1000 birth children who previously died were now “saved” but 5 to 10 of those children survived with C.P., the C.P. rates could double or triple (or worse). That did not happen as the PMR dramatically declined and yet C.P. rates stayed more or less steady but most importantly did not rise.
In the United States from 1965 onward there was a steady decline in the PMR to the point by 1982 it was 12.6/1000. Thus 25/1000 based on the NCPP rate were “saved”.70 Between 1980 and 2000 approximately half of the decrease in the PMR for the entire 20th century occurred and yet the very preterm birth rate rose between 1981 and 1999.71 A “net gain” was described as a decrease in the PMR less any increase in the C.P. rates. A Swedish study noted that improved care helped to prevent brain injury due to asphyxia, perhaps birth trauma and other causes, and there was therefore a “net gain” in saved non-cerebral palsied children.72 A British study identified a marked fall in intrapartum death associated with asphyxia and trauma by 1970.73
These statistics were misused to try to make it appear as if good care couldn’t prevent C.P. when it is apparent good care can and did prevent lethal and sublethal perinatal injuries. Instead of citing a “net gain” as evidence of what the use of EFM and timely C.D. can accomplish, and instead of urging even better use of those and other advances in the care of obstetrical patients, ACOG leaders (Dr. Hankins again) have promoted the false idea that C.P. cannot be prevented.74
If a diagnosis was 100% accurate (e.g. asphyxia) and an intervention 100% effective then in a sampled population, no relationship between risk and outcome would be demonstrable. Is it conceivable that intelligent physicians would not understand this fact and these same physicians consistent with their ethical obligations would then state the intervention doesn’t influence outcome?
One author responding to the Nelson statistical analysis stated that one is left with the impression that obstetric events are being played down to a minor role (if any). He noted that in light of the recent enormous gains made in obstetrics and modern neonatal intensive care, this conclusion is not warranted. He noted a “very significant decreases in mortality and morbidity among upper birth weight prematures” and increased survival of very low birth weight prematures (well below 1000 grams [Less than 2 lbs.]) and it is within this group that C.P. “may well be on the increase.”75
It is, we believe, pointful at this juncture to refocus on the ACOG grievance process discussed previously in relationship to Footnote No. 20. Dr. Nelson does not believe jurors are capable of understanding the limits of science and Dr. Scott (editor of ACOG’s Journal) believes the system condones “theater,” produces “misleading” testimony and he rails against the “hired guns.” Thus if a “hired gun” stated the criteria were not essential and the EFM can be used to prevent C.P. that would be egregious testimony (except in Florida).
Dr. Hankins’ Florida testimony was given with no fear of an ACOG grievance for testifying against the idea that the criteria are essential since he was for the obstetrician. Doctors following ACOG dogma skip past the deductive reasoning of the differential diagnosis methodology and use the current criteria list as if pure science set it in stone. Skipping past the idea that the whole truth and nothing but the whole truth would require inclusion of the PMR information when using the C.P. statistics to prove an alleged point, the defense experts espousing the ACOG dogma are not “hired guns” according to Dr. Scott.
Let’s next look at the EFM information and how and why it is disparaged.
THE ELECTRONIC FETAL MONITOR (EFM): A USELESS GADGET?
The Sartwelle article’s attack on the differential diagnosis methodology as a plaintiff plot implies that there exists some other way for doctors to arrive at scientifically valid conclusions. Mr. Sartwelle uses “common sense” to support his questioning of the idea that physicians cause C.P. noting the doctor is involved in the pregnancy, labor, and delivery for six to maybe 12 hours total out of a pregnancy’s approximately 7,000 hours. Thus his common sense deductive reasoning is that the injury, based on the number of hours, must have occurred when the doctor was “off duty.” Then he explains that for decades obstetricians themselves told patients that obstetricians are necessary to ensure delivery of a healthy baby, leading people to erroneously believe physicians are in total control of a baby’s brain development. When it turns out the baby is not healthy that according to Mr. Sartwelle triggers a “blame game” leading to C.P. suits. 76
This defense attorney who, as we stated earlier, accused plaintiff experts of testifying to gibberish, gives us a healthy dose of the defense version of common sense backed by his assurance that we have had many decades of an explosion of science proving obstetricians are either “never” or at most “rarely” responsible for a bad outcome like C.P. Let’s continue the discussion with a look at the allegedly useless gadget (the EFM) and what ACOG communicates to their obstetric consumer [the mother] with regard to their member’s role during labor.
ACOG has published clear and unambiguous educational information to the maternal consumer stating that during labor the monitor can alert “your doctor” to warning signs that will enable your doctor “to take steps to help your baby.” Mothers are told that if the heart rate monitor pattern is abnormal “your doctor” might take steps to help by giving you oxygen and IV fluids and steps to weaken your contractions (in-utero resuscitation). However, if the information “suggests” your baby has a problem your doctor may decide to deliver right away and it is most likely that your doctor will opt for caesarean birth.77
Each mother so educated is thus led to believe that her obstetrical doctor does use the EFM because if the EFM information “suggests” a problem, action most likely a caesarean delivery, will be done right away to help her baby.
Currently, a New York State obstetric safety initiative program sponsored in part by ACOG urges “vital training” on how to interpret, communicate, and effectively respond to FHR tracings to help improve perinatal outcomes. 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.”78
By implication, there must be an appropriate use of the EFM information and common sense is that the only appropriate use is to see the warning signs and act before there is an injury such as brain damage.
ACOG has used its influence to discontinue the use of the term “fetal distress” because allegedly using those words may result in inappropriate action by an obstetrician such as an unnecessarily urgent C-section delivery. 79 ACOG notes that in the past those who used the term fetal distress sometimes delivered a “vigorous child.” Hence, by using the term “non-reassuring fetal status” these new words will not be interpreted to mean that the child was really “ill.” ACOG maintains that its new term “nonreassuring fetal status” is an acknowledgment of the “imprecision inherent in the interpretation of the data.”
Obstetricians, like all other doctors, are required to understand the strengths and limitations of the information available to them in a specific clinical setting. ACOG should, of course, urge that the obstetrician not overreact by doing an unnecessary emergency C-section provided ACOG also urges [which it does not] that it is mandatory not to under react. ACOG should also emphasize that delivery of a vigorous child is not a bad thing but a good thing 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, but does not, state that the obstetrician must be present, and must 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 logical reason to change the words “fetal distress” which term ACOG could define to the words “non-reassuring,” which term ACOG does not define, other than an intention to promote a liability defense. It is not possible that anyone could believe the use of the words “fetal distress” would trigger an unnecessary emergency cesarean delivery or that obstetricians could not understand that whatever words are used, the issue is whether the fetus is or is not in a precarious condition that can if it continues lead to harm.
Instead of requiring better education to make certain each obstetrician can use the information to distinguish precarious (unsafe) from safe and instead of using the tort system to promote an incentive to be present, vigilant and effective, ACOG’s focus is on liability defense. The ACOG approach reflects a disconnect from what the civil justice system and medical ethics strive for. “Fetal distress” is a term focused on the fetus. “Non-reassuring” is a term focused on the doctor. Promoting the idea that labor is not really dangerous for each fetus and all the doctor need do after the fact is say “I was reassured” is unsafe for the fetus.
In TB-163 ACOG cited a study promoting the idea that the EFM does not prevent brain damage.80 The actual study was designed to assess the difference, if any, between continuous electronic monitoring and the periodic use of a stethoscope (auscultation) 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 cerebral palsy 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 electronic fetal monitor as compared with 60 minutes with periodic auscultation.
Increased duration of an abnormal fetal heart rate (representing increased duration of stresses threatening hypoxic-ischemic damage) did increase the incidence and therefore risk of cerebral palsy. Hence, ACOG, seemingly preoccupied with the idea of “proving” that electronic fetal monitor information does not help prevent brain damage, cited a study which did prove that any abnormal fetal monitor information is crucially important because a timely response is crucial, since the longer the baby is stressed the more likely it is that irreversible brain damage will occur.
ACOG has in the past and currently in its most recent intrapartum FHR monitoring Practice Bulletin81 stated because available data does not show a clear benefit for the use of EFM over intermittent auscultation, either option is acceptable in a patient without complications. However labor with high risk conditions (e.g., suspected fetal growth restriction, preeclampsia, and Type 1 diabetes) should be monitored with continuous FHR monitoring.
Since auscultation gives intermittent rather than continuous information; since the information from auscultation is far less specific (e.g. one cannot determine baseline variability or FHR accelerations); since the information that is obtained may be inaccurate (e.g. FHR late decelerations seen on a tracing are often missed on auscultation82); and since auscultation is not practical based on nursing staff ratios there must be a reason why ACOG persists in leaving open the auscultation option. The only reason that fits is that this option seemingly promotes the idea that EFM information is not very good information.
A recent task force formed to choose the words to communicate about the EFM information resulted in a three-tiered label for EFM information including a normal and abnormal label and thus led to the current (2009) Practice Bulletin. The third tier label is now “indeterminent.”83 The task force included Dr. Hankins. A task force member who also wrote the editorial stated that members of the committee had significant concerns with the wording “….fearing its potential legal implication.”84
A terminology change urged by the task force did away with the word hyperstimulation to characterize a contraction pattern and replaced it with the word tachysystole. The change in semantics can only be intended to eliminate the word “hyper” from the courtroom. Contractions are an independent variable and can occur too frequently or too strongly or last too long and if any or all of these events occur there can be too much stress for the fetus. With or without a hyper contraction pattern (or if you must use a different word – a tachy contraction pattern) focusing on the contractions promotes informed interpretation into the FHR cardiovascular response. Urging the team to pay attention to what is creating the stresses and to note hyper (or tachy) information is worrisome is part of what is not said.
One group published a five tiered FHR tracing protocol. Whatever the pluses and minuses of that five tiered protocol are, we note that the paper at least incorporates the idea of correlating the EFM information with a concept of fetal compensation leading to decompensation.85
Each doctor who is responsible for the well-being of a patient requires information so the doctor can communicate with the patient (or in the case of a fetus the patient’s mother). With an awareness that during labor each fetus is experiencing a series of repetitive stresses the obstetrician requires information as to how that fetal patient is doing.
In labor it is reasonable for the obstetrician to in effect want to ask the fetus “Are you doing o.k. and can you safely continue” and the obstetrician must have an answer to the question. If normal means reliable information from the fetus that “I’m sure I’m o.k. and I’m sure I can safely continue to tolerate this potentially dangerous journey” that is a useful answer.
If “abnormal” information reliably means “I’m sure I’m in trouble and decompensating and require immediate rescue,” that is an answer requiring immediate action, usually cesarean delivery. The newest guidelines do not even mention cesarean delivery as an option for “abnormal”.
No legal, moral, or ethical obligation exists on the part of the fetus to sustain a burden of proof when EFM information is not as unequivocal as the aforesaid “normal” or “abnormal.” On the contrary, it is the proactive professional obligation of the obstetrician to seek an answer and if the answer is “I’m not sure if I’m o.k. and I’m not sure I can tolerate more” the obstetrician must pay attention and must do something rational to protect the fetal patient.
The obstetrician might like to know what the fetal pH is but the bottom line issue relates to a decompensation that can occur within the brain contributed to by head compression (leading to ischemic damage) and/or globally contributed to by 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’m not yet acidotic.” The reason why dystocia appropriately produces most caesarean deliveries is because excessive mechanical forces (head compression) can produce ischemic brain damage.
Dr. Hankins, in independent testimony has acknowledged 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.86 He has also acknowledged, in independent testimony, that if there is an abnormality of the EFM tracing reflecting a fetal stress, one can use that information to assess if the fetus is still compensating rather than decompensating. Dr. Hankins also testified that when a baby is still able to compensate and thus still has reserve, and because the longer a baby experiences a hypoxic-ischemic insult, the more likely there will be damage, and since he often cannot count on a pattern of such stress to resolve, he would therefore want to mobilize and get the baby out as soon as possible (which he says can be done from initiation of anesthesia to delivery in 2-3 minutes). Therefore, his approach is “better safe than sorry.”87
Why is this kind of medical common sense not made part of mandatory ACOG protocols similar to the ASA? If obstetricians are told they must use the EFM properly; they must timely act while the fetus still can compensate; and they must adopt a credo of “better safe than sorry” the message will ring true.
Preoccupied with the idea of creating words and phrases that will not be used against the obstetrician in the liability case and preoccupied with the idea of creating “purposefully ambiguous” guidelines so that the obstetrician will have a legal defense, and preoccupied with the idea that it is best for the legal defense that bad things rarely occur for the fetus during labor and delivery, we have had for more than three decades “politically correct” writings that have lost track of the medical mission.
If radiologists re-reviewed mammograms previously reported to be negative and concluded that only in retrospect, now aware the patient has cancer do they see the mass, the “study” would need to explain why the abnormality was not seen. Because the only important reason for the image was to find a mass that might be malignant, the initial mindset should have presumed a mass is there until proven otherwise. If this hypothetical study did not make clear why the mass seen in retrospect was not seen de novo, the “study” would reek with contrivance.
ACOG emphasizes “studies” which allegedly prove that if it is known there is a bad neonatal outcome a reviewer may then change the EFM interpretation and then more likely find evidence of fetal hypoxia. Thus, ACOG in its prior bulletin (#70-2005) said reinterpretation “is not reliable” and currently states reinterpretation “may not be reliable.” Missing is any effort to explain why was not seen initially and strategies to make certain such misreadings never occur again.
If a lack of oxygen type trouble can be seen on EFM in retrospect knowing a bad outcome, the very same lack of oxygen type trouble is there to be seen before the trouble is allowed to harm the child. If the current and past ACOG bulletins promoted the need for an educated understanding of the EFM information and emphasized that the doctor must presume the baby is in a precarious condition until the doctor can establish the baby is safe and uncertainty must be resolved in favor of protecting the child, that focus should lead to seeing what is there to be seen de novo.
Physicians do have a natural bias when reviewing the quality of care of another physician which bias is to “protect their own, sometimes at the expense of patients” and for that reason have been “inept and ineffectual” with regard to self policing.88 Any physician who reviews EFM tracings or any other records after the fact must know that the fault of a fellow physician is at issue. As discussed earlier, (Footnote #13) Mr. Sartwelle claims “hindsight and outcome bias” means there is no ability to objectively determine standard of care.
When looking at closed cases and/or any other rereview, doctors must rise above their natural bias which is to support their colleagues. Mr. Sartwelle’s opportunistic use of alleged outcome and hindsight bias is equivalent to excusing a driver from striking a pedestrian if the driver simply explains he or she did not see the pedestrian when in fact the pedestrian was there to be seen if the driver looked carefully.
ACOG has sent clear unequivocal signals in the form of patient education to the obstetrical mother. The State of New York cosponsored by ACOG promotes the idea that the appropriate use of the monitor can prevent brain injury. Yet at the same time, ACOG promotes inconsistent signals that the EFM gadget is useless. The explanation for doing away with words like “fetal distress” and “hyperstimulation” are preposterous. If ACOG has information that some of their obstetricians were using the word “fetal distress” and then jumping into unnecessary emergency C-sections, they should condemn that practice. If information is imprecise, their obstetrical members must be with the patient and must make decisions that resolve issues of uncertainty in favor of protecting the child. Instead of promoting legal defenses ACOG must promote the idea that it is not the moral or ethical burden of the fetus to prove that he or she really is in trouble but the job of the doctor is to establish the opposite.
What can be accomplished if an obstetric team with clear mandates applies itself appropriately? That leads us to the next subject.
OBSTETRICAL RISK MANAGEMENT/QUALITY ASSURANCE CAN
IMPROVE OUTCOMES AND REDUCE LITIGATION JUST AS WAS
ACCOMPLISHED BY THE ASA
In what was described as a comprehensive redesign of the patient safety process begun in 2000, an article published in 2008 reported that as a result of their “unique” approach in a population of 220,000 deliveries each year they lowered maternal and fetal injury, produced a 50% reduction in medical liability claims and a fivefold reduction in the cost of claims.89 Part of what we will refer to as the Clark patient safety “unique” approach was a liberal use of caesarean deliveries (C.D.s) yet they reported fewer C.D.s. Thus, without legal immunity, they used the malpractice crisis to the advantage of their patients reporting “improvements in patient outcomes” and also a “dramatic decline in litigation claims.”
The “unique” approach was based on the following five principles:
1. Uniform processes and procedure result in an improved quality, including medical care. As a corollary, process variation generally leads to poor quality.
2. 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.
3. In the current environment, caesarean delivery is best viewed as a process alternative, not an outcome or quality end point.
4. 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.
5. 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, the Clark article states 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.” Adding that the achievement of large-scale quality improvement measures requires effective peer review, the paper notes that in practice this is difficult to carry out particularly when most reviewers find themselves either the partners or economic competitors of the individual being reviewed.
In discussing “the problems” confronting the specialty of obstetrics, the Clark paper describes “…unsatisfactory perinatal outcomes and an ongoing malpractice crisis despite increased costs and more caesarean deliveries.”
They note that the mark of a good obstetrician and safe, highly reliable care, is the ability to send home a healthy mother and baby and 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” and while wishing to avoid unnecessary caesarean deliveries they urge and encourage the use of caesarean “liberally for individual cases of labor arrest and abnormal fetal heart rate tracings.”
They repeat the statement that the best way to avoid litigation is to avoid adverse outcomes “rather than attempt to defend various interpretations of the word ‘immediately’.” They cite the use of oxytocin as a high risk medication and strongly encourage and support the establishment of a 24-hour in-hospital obstetric coverage program.
They cite a paper in which two of the authors reviewed 189 closed malpractice cases and these authors found that 40% of adverse outcomes related to intrapartum fetal hypoxia and their associated malpractice claims may have been avoided if they had the in-hospital 24-hour coverage.90
The study by the Clark group 91 of 189 closed “perinatal claims” revealed to these obstetrical authors that most money currently paid was the result of substandard care resulting in preventable injury. The information from closed liability claim files is developed in a unique way in that each closed liability case had a legal advocate for the patient supported by expert opinion and pretrial discovery and a legal advocate and expert for the defense. The Clark group evaluation was not due process, per se, as they could conclude injury was or was not preventable and/or due to substandard care and yet either plaintiff or defendant might still disagree regardless of how the case resolved.
As discussed earlier the ASA did look at closed cases and did devise standards consistent with a common sense intention to use the unique information so they could plan interventions to achieve better outcomes. The Clark group looked at closed cases, they did form a new plan, they did implement interventions intended to achieve better outcomes and they report they did get better outcomes.
The Clark patient safety article 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 approach to litigation avoidance” taken by others and therefore specificity and not ambiguity is the answer “to both patient safety and litigation.”
The presence of a 24-hour in-hospital obstetric coverage program [The “Laborist”] in which uniform processes and procedures were in place, in which every member of the obstetric team [nurse, resident obstetrician, et. al.] was empowered and required to halt any process that was deemed to be dangerous, in which the liberal use of caesarean delivery was encouraged in individual cases of labor arrest and abnormal fetal heart rate tracings, and in which they were unwilling to “tough out” a difficult delivery, represents medical common sense consistent with the principles contained in the preamble. We thus have a measurable microcosm of how obstetrics can create the win (better outcomes) – win (less cost) result achieved by the ASA 30 years ago. Pointfully there is no denial that there are bad perinatal outcomes described as “unsatisfactory.”
Obstetric leaders have known for the past three plus decades that malpractice loss is best avoided by reduction in adverse outcomes; that unambiguous guidelines rather than attempting to make outcomes more “defensible” is the solution to all the relevant issues; that the performance of a caesarean delivery and caesarean delivery rates are not in and of themselves quality end point outcomes; that toughing out a difficult delivery is bad obstetrics and that a liberal use of caesarean delivery for individual cases of labor arrest and abnormal fetal heart rate tracings are examples of good obstetrics; and that having quality in-house coverage 24/7 is essential with each member of the team required to intervene since each member of the team (attending, in-house “laborist,” resident, and nurse) should be not only empowered but also required to intervene and halt any process that is dangerous.
The Clark patient safety paper notes that protocols are not the sole answers to current litigation issues as physician compliance with protocols is “far from ideal.” Indeed, they concede that “…poor practice is also a significant contributor to the current malpractice crisis in our speciality.”
CREATION AND USE OF MEDICAL SCIENCE: COMPLEXITY
The preface of the 2003 “encephalopathy” document92 written by Dr. Hankins, describes the mechanisms of cerebral palsy as complex and incompletely understood thereby making prevention “elusive.” He adds that because the positive and negative predictive values are influenced by disease prevalence, cerebral palsy is a rare event. Therefore, he urges caution in ascribing intervention to prevent its occurrence without a cost-benefit analysis.
The risk of an injury from an auto collision is perhaps 0.01%, yet seatbelts are required. For the individual injured in an auto accident and for the child brain injured during labor or antepartum from a preventable stress who later develops cerebral palsy, the statistic is 100%. Hypoxic and/or mechanical stresses will if sufficiently excessive ultimately cross a threshold and produce disabling brain injury or death 100% of the time, 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 100% predictive that excessive stresses can and ultimately will injure fetal patients and auto passengers. Therefore, due care is mandatory to avoid such foreseeable injuries. Dr. Hankins in his preface to the “encephalopathy” document engages in what amounts to medical double-talk. There is nothing complex about the obstetrical ethical duty to protect the fetal patient. Better safe than sorry is what Dr. Hankins and other ACOG leaders should preach. Efforts to make this simple issue appear “elusive” is not consistent with what ACOG leaders should ethically preach.
The medical liability issue relates to acquired brain insults that actually cross a threshold of reversibility to irreversibility in a child who had and did initiate adaptive mechanisms that ultimately failed. It is the ability of a fetal child to make the adaption that creates a window of opportunity to act and an understanding of cardiovascular and other physiological responses that should create for the focused diligent doctor a need to act and thus take advantage of the opportunity. Genetics may make some children more vulnerable than other children; stresses may co-exist [e.g. hypoxia, infection, trauma et. al]; stresses may begin antepartum and persist with superimposed intrapartum stresses; stresses may be longer lasting (chronic) and less intensive giving a fetus a much greater ability to adapt or may be shorter acting (acute) and more intense giving the fetus less time and opportunity to adapt; and brain cell death may be immediate or delayed.
The complexity related to what actually occurs at the brain cell level relates to an issue of neuroprotection intervention after the brain insult.93 The obstetrician’s job is to anticipate and avoid brain insults, if at all reasonably possible, and if not to limit the insult as much as possible. This idea is simple and no more complex in concept than the idea that the driver of a car must use due care to avoid a collision because such can cause grievous harm. One may not be able to figure out why twin passengers in a car collision did not sustain the exact same injury but one would understand there must have been variables and the mechanism of injury was trauma. The complexity related to what actually occurs at the brain cell level is not relevant to the simple idea that the obstetrician has an ethical duty to use the EFM and other information to avoid or limit the brain insult in the first place.
A risk or risk factor is information that a complication is occurring and/or likely will occur. Using an awareness of the pathway and sequence of events, by which a complication can produce harm, an awareness of the mechanism producing the actual injury and an understanding of the consequences of the injury, should lead to the most rational steps to prevent or limit the injury. Thus, risk factors are used for the benefit of patients to protect them from injury. Using risk factors to make it appear as if C.P. is “multi-factoral and thus complex, is disingenuous and not in the child’s best interest. What is in the child’s best interest is objective deductive reasoning for each individual case which process can and should be used to determine the most likely cause.
The biophysical profile (BPP) scoring system was created using risk factors such as decreased fetal movement, growth restriction, preeclampsia, et. al., to identify a high-risk population of fetuses who might develop chronic fetal stress that in turn could produce death or disabling brain damage. Understanding that a fetus could make protective adaptions and “reset” himself or herself to the new hostile environment was part of the process to create the system of care. Understanding that the fetus making those adaptions would become more vulnerable to further ongoing stresses or any superimposed stress was another part of the process. Understanding that the fetus itself may express mixed signals (e.g., the normal strong fetal signals to move and exercise and the adaptive fetal signals in the face of a stress not to move and thereby conserve energy are thus “mixed”) was the context for creating a scoring system. The idea was to create and use a scoring system using a combination of tests to get a clearer idea as to where in the pathway to irreversible damage the fetus was.94
The medical common sense implied that as each of the 5 different tests became abnormal, it was more likely that the fetus was moving closer and closer to irreversible harm. The studies used both short-term and long-term measuring rods which did confirm that hypothesis. For example, one short term measuring rod revealed an incremental increase in the development of fetal distress requiring caesarean delivery with a corresponding decrease in the biophysical profile scoring system. Thus, if the current biophysical profile score was 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, if the most recent biophysical score was 0 out of 10, there was almost a 97% incidence of a subsequent labor requiring operative delivery for fetal distress.95
The long term measuring rods established that using the BPP scoring system for the high risk patient population there was actually a lower C.P. rate in comparison to the overall population (1.33/per thousand vs 4.74 per thousand) and when comparing children with a BPP score of 0/10 vs 10/10 there was a 300% increase in C.P.96
Armed with that information, aware that the fetus is being stressed and has a 300-fold increased likelihood of disabling brain damage and cerebral palsy and an almost 97% likelihood of fetal distress, common sense would dictate removing the child from harm’s way rather than for example inducing with the idea of later engaging in a rescue.
The 2003 “encephalopathy” document is conspicuous for what it does and does not say about the B.P.P. It notes that the antepartum use of B.P.P. reported a 1.33/1000 incidence of C.P. compared to a 4.74/1000 among patients not monitored with B.P.P.97
The document adds that abnormal test results are found more frequently in patients with abnormal neurologic outcome. However, according to this ACOG document, the predictive value of antenatal testing remains poor because of the high frequency of abnormal test results in patients with normal outcomes.
Thus we have another example of medical double talk. If tests such as B.P.P. are used and do reveal abnormalities and the patient turns out normal that implies a proper use of the testing information. Injecting into the discussion that the predictive value of the test is poor can only mean that Dr. Hankins and his committee were intending to deemphasize how B.P.P. testing can and has been used to reduce the incidence of C.P.
Bear in mind the “encephalopathy” (2003) document was created by an ACOG committee chaired by Dr. Hankins. Then ACOG using its medical political influence obtained endorsement from the pediatric specialty group and others.
This ACOG 2003 “encephalopathy” document created for litigation, is packaged for courtroom use with lots of glitter. The essential criteria with or without the glitter are not and never were essential. C.P. is a serious disability that can with proper focus in individual cases be prevented antepartum and intrapartum with good quality care.
A review of each ACOG Practice Bulletin related to preterm birth, shoulder dystocia, and vacuum and forceps deliveries each reveal “purposefully ambiguous” discussions with the emphasis on what can’t be done instead of the emphasis on what can and must be done.
IS THERE A LIGHT AT THE END OF THE TUNNEL?
The IOM report referred to in our preamble urges a culture of safety. ACOG’s medical political influence is such that only when its leadership demonstrates a culture of safety consistent with what the IOM has urged and what the ASA did more than three decades ago will this specialty connect with its mission.
WHAT WOULD SIGNAL THE ARRIVAL
OF AN OBSTETRICAL CULTURE OF SAFETY?
If the current intrapartum practice bulletin said the following we would know a culture of safety arrived:
1. Essential criteria are withdrawn as only an objective analysis of each individual case can determine likely cause.
2. Labor must be viewed as a potentially hazardous event for every fetus.
3. The labor assessment must begin antepartum to identify each fetus who is or might be compromised and thus unable to safely tolerate labor’s hazards.
4. Multi-tasking is not a valid excuse for not having a qualified attending obstetrician present during labor. Whatever combination of adjusting on call schedules and/or requiring a qualified 24/7 laborist is used, there must be a fully trained obstetrician present and in charge of the team.
5. Each labor team member (nurse, resident, OB attending, et. al.) must be empowered to and required to stop anything that is dangerous. Each team member must have EFM monitoring education requiring an understanding of the physiology of labor and fetal cardiovascular responses to labor stresses so that each can understand what is or is not dangerous.
6. There must be a conservative use of oxytocin and instrument vaginal delivery in the context of a clear unambiguous protocol reflecting an awareness of how each adds to the fetal risks.
7. There must be a liberal use of cesarean delivery for failure of labor to progress and/or any FHR information reflecting that the fetus is in a precarious condition.
8. Cesarean delivery is a process alternative, not a quality end point and any practice of “toughing out” a difficult vaginal delivery for any reason is to be discouraged.
9. An informed use of EFM information requires an awareness of the strengths and limitations of the information used in the best interest of each fetus in each unique clinical setting.
10. The presence of reassuring information (normal baseline rate, variability and reactivity) and the absence of periodic FHR decelerations or a sustained fall in the heart rate reflects that the fetus is tolerating the stresses of labor. If all other information support a rational conclusion that the prospects are good for a safe vaginal delivery, the mother should be so advised.
11. All other EFM patterns are to be viewed with caution.
12. Certain EFM patterns reflect decompensation mandating expeditious delivery usually by cesarean.
13. Auscultation is never an acceptable alternative when EFM is available.
14. The specific intrapartum issue for each fetus is whether the physiological stresses of the labor are creating a precarious fetal condition which if it persists may lead to permanent brain injury or death.
15. Factors that determine intrapartum outcome include preexisting fetal status and the intensity and duration of the stress. Therefore the entire labor team must focus on these issues.
16. Accurate assessment of the EFM information requires an awareness that the pathway to fetal decompensation and grievous harm is never capable of a precise time table and therefore action to protect the fetus must not be delayed by strict criteria and/or a lack of vigilance and/or inability to respond timely and appropriately.
17. Medical liability cases are to be avoided by avoiding bad outcomes and not by trying to make it appear care is “defensible.”
18. The grievance process for expert witnesses is discontinued.
CONCLUSION
We have discussed the ACOG grievance process, how and why ACOG created their essential criteria and how and why they create purposefully ambiguous guidelines. We maintain these activities do and have constituted an obstruction of justice. The legal and medical professions are each noble professions. Neither is more important than the other as they are not in competition with one another. The professions must coexist with members of each profession aware that the end point of the civil justice system is justice.
It is impossible to know how many meritorious liability cases were not pursued or if pursued were unsuccessful because contrived defenses were “used.” It is also impossible to know how many preventible brain injuries occurred over the past three decades which would not have occurred if an approach consistent with the ASA had been adopted.
We accept on behalf of our clients the legal burden of
proof, the need to comply with the rules of evidence and the
spirit of due process. The intrapartum protocol we urge is consistent with medical ethics. Our dispute with ACOG is not, in our view, a difference of opinion. Rather the dispute relates to issues of right and wrong.
ENDNOTES
1. T.P. Sartwelle, Defending a Neurologic Birth Injury: Asphyxia Neonatorum Redux. JOURNAL OF LEGAL MEDICINE 30: 181-247 (2009)
2. The medical liability cases referred to are sometimes called C.P. or cerebral palsy cases and/or neonatal or perinatal brain injury cases, and/or birth asphyxia or birth injury cases. The case Mr. 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.
3. Id., No.1., p. 184 . . Mr. Sartwelle cites many references and he maintains asphyxia (lack of oxygen) causes only a tiny fraction of C.P. cases and more importantly C.P. because of asphyxia is not preventible. According to the author despite research to the contrary, a certain minority of physicians continue to testify that timely C-sections prevent neonatal oxygen deprivation damage. This testimony according to the article is false since it allegedly runs counter to worldwide medical information that physicians can rarely prevent “neurologic birth injury.” Mr. Sartwelle thus states C.P. 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 will be developed, a lack of oxygen (hypoxia) ultimately can lead to an adaptive decompensation that produces an ischemic brain insult which can cause disabling brain damage. Mr. Sartwelle refers on p. 192 of his article to a “world-wide research explosion” establishing that physician acts and omissions “rarely” cause C.P. and “never” cause mental retardation absent C.P.
5. A. MacLennan, K.B. Nelson, G. Hankins, et. al., Who Will Deliver our Grandchildren? Implications of Cerebral Palsy Litigation. JAMA, Oct 5, 2005 – Vol. 294, No. 13, at p. 1689. See also footnote no. 20 detailing ACOG’s grievance process.
6. ACOG E-mail to its members dated October 31, 2007.
7. R.L. Berkowitz, G. Hankins, et. al.: A Proposed Model for Managing Cases of Neurologically Impaired Infants. OB-GYN, Vol. 113, No. 3, March 2009, p. 683-686.
8. N.Y. Judiciary Law, No.474-A 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. No one will be able to show a single instance in which the child and child’s family has not received at least 2/3 of the recovery and almost always a greater percentage.
10. A. MacLennan, K.B. Nelson, G. Hankins, et. al., Who Will Deliver our Grandchildren? Implications of Cerebral Palsy Litigation. JAMA, Oct 5, 2005 – Vol. 294, No. 13, at p. 1688-1690.
12. See later Discussion of ACOG criteria and T.B.-163. See: K.R. Niswander. Adverse Outcomes of Pregnancy and the Quality of OB Care, Lancet, 10/13/74, p. 827; K. R. Niswander, Does Substandard Obstetrical Care Cause C.P.? CONTEMPORARY OB/GYN. Oct. 1987, pp. 42-60.
14. Mark R. Chassin, et. al, The Urgent Need to Improve Health Care Quality: Institute of Medicine National Roundtable on Healthcare Quality, 280 JAMA 1000, 1001 (1998), available at http://jama.ama-assn.org/cgi/ reprint/280/11/1000.pdf (citing MEDICARE: A STRATEGY FOR QUALITY ASSURANCE (K.N. Lohr ed., 1990)
15. See generally INST. OF MED., To Err is Human: Building a Safer Health System (Linda Kohn et. al. eds., 2000) at 1X-X, and 8, 36.
16. See Id. @ generally INST. OF MED., To Err is Human: Building a Safer Health System (Linda Kohn et. al. eds., 2000) at 3-5.
17. See Pike v. Honsinger, 155 N.Y. 201 (1898), Toth v. Cmty. Hosp. of Glen Cove, 22 N.Y.2d 255, 263 (1968) and Bing v. Thunig, 2 N.Y.2d 656, 666 (1957).
18. Medical Professionalism in the New Millenium: A Physicians’ Charter: Ann. Int. Med. 136:243-246 (2002).
20. ACOG’s grievance process is triggered when one ACOG member (Fellow) reports that another Fellow has given inappropriate “egregious” testimony. A plaintiff who is not an ACOG member could not file a grievance against a defense expert. The process involves ACOG chosen doctors deciding without rules of evidence and without any legal authority creating the process if the testimony was “egregious”. Since the entire 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. C.B. Hammond and P.A. Schwartz, Ethical Issues Related to Medical Expert Testimony. 2005; Vol. 106. OB-GYN 1055-58.
Dr. Scott, an influential 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, Dr. Scott singles out C.P. testimony as a “particular problem.” He supports his view about C.P. cases by citing the article co-authored by Dr. Hankins, Dr. Nelson (footnote no. 5). See: J.R. Scott, Expert Witness: Perpetuating a Flawed System. 2005. Vol. 106, OB-GYN 902-903.
Dr. Scott maintains the Civil Justice System functions as a “free-for-all.” If any case actually constituted a “free-for-all”, a verdict against an obstetrician would not 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 based on misleading, outdated, biased or wrong testimony as those circumstances would require reversal. Dr. Scott maintains that he wants only objective and scientific sources of evidence such as for example, ACOG Practice Guidelines. Thus, what he wants is experts to parrot only what he and other ACOG “leaders” create. In that way, it allegedly will ensure that the “medical justice system” will be reliable and fair. Reliable and fair is thus a euphemism to mean no liability in C.P. cases as ACOG leaders have already said C.P. cannot be prevented.
21. INST. OF MED., supra note 14, at 32, 144-45.
22. ACOG, Clinical Review, Patient Safety, A New Imperative, Vol. 6, issue 4, July/August 2001.
23. John H. Eichhorn et. al., Standards for Patient Monitoring During Anesthesia at Harvard Medical School, 256 JAMA 1017, 1017-20 (1986) and Cf.id.; AM. SOC. OF ANESTHESIOLOGISTS STANDARDS, GUIDELINES & STATEMENTS, STANDARDS FOR BASIC ANESTHETIC MONITORING (2006), available at http://www.asahq. org/publications And Services/standards/02.pdf.
24. David M. Gaba, Anesthesiology as a Model for Patient Safety in Health Care, 320 Brit. Med. J. 785, 785 (2000). See generally Jeffrey B. Cooper & David Gaba, No Myth: Anesthesia is a Model for Addressing Patient Safety, 97 Anesthesiology 1335, 1335-37 (2002).
25. Id. No. 1, pp. 237-240.
26. C. Amel-Tison, Neurologic Morbidity of Term Infants as an Indicator of Safe Obstetrical Practice: Perinatal Events and Brain Damage in Surviving Children, SPRINGER-VERLAG, 1988, p. 185.
27. J.F. Huddleston. & R.K. Freeman, p. 109 in NEONATAL/PERINATAL MEDICINE 6THED., 1997 Ed, Fanaroff/Martin.
28. L.D. DeVoe: The Future of Intrapartum Care: Navigating the Perfect Storm-An Obstetrician’s Odyssey: AM. J. OB/GYN, pp. 1-5 (2009).
29. R.C. Benson, et. al.: Fetal Heart Rate as Predictor of Fetal Distress: A Report from the collaborative project. Vol. 32, No. 2, OB/GYN, pp. 259-266 (1968).
30. E.A. Friedman. LABOR: CLINICAL EVALUATION AND MANAGEMENT, 2ND ED. New York: Appleton-Century-Crofts, 1978.
31. E.H. Hon, E.H., and A.K. Koh: Management of Labor and Delivery, Chap. 7, pp. 120-131 in NEONATOLOGY: PATHOPHYSIOLOGY AND MANAGEMENT OF THE NEWBORN/Ed. by G.B. Avery, Second Edition: Lippincott, 1982.
33. duPlessis, Adres. PERINATAL ASPHYXIA AND HYPOXIC-ISCHEMIC BRAIN INJURY IN THE FULL-TERM INFANT, P. 775 IN INTENSIVE CARE OF THE FETUS AND NEONATE, 2nd Ed, Edited by Spitzer, A.R. (2005).
36. L. Weinstein, T.S. Garite, On Call for Obstetrics – Time for A Change. AM. J. OB/GYN (Jan. 2007), p. 3.
37. L. Weinstein, The Laborist: A New Focus of Practice For the Obstetrician. AM. J. OB/GYN (Feb. 2003) pp. 310-312.
38. S.L. Clark, et. al., Reducing Obstetric Litigation Through Alterations in Practice Patterns. OB/GYN 2008; 112:1279-83.
39. S.L. Clark, et. al. Improved Outcomes, Fewer Caesarean Deliveries and Reduced Litigation: Results of a New Paradigm in Patient Safety. AM. J. OB/GYN 2008; 199: 105e1-105e7.
40. R.K. Freeman, Dec. 2004. AM. J. OB-GYN – 585-586.
41. E. S. Draper, et. al. A Confidential Enquiry into Cases of Neonatal Encephalopathy. ARCH. DIS. CHILD, FETAL, NEONATAL, ed. 2002; 87:F176-F180.
42. A. MacLennan, K.B. Nelson, G. Hankins, M. Speer, Who Will Deliver Our Grandchildren? Implications of Cerebral Palsy Litigation. JAMA, (Oct. 2005), Vol. 294, No. 13, p. 1688.
43. W. R. Cohen, Normal and Abnormal Labor, P. 455 IN HANDBOOK OF CLINICAL OBSTETRICS: THE FETUS AND MOTHER, 3rd Ed. Reece, Hobbins (2007) Blackwell Publishing Ltd.
44. Perkins, Perspective on Perinatal Brain Damage, OB/GYN 69:807 (1987)
46. See, e.g., First of America Bank v. U.S., 752 F.Supp 764, (U.S. District Court, E.D. Michigan, Southern Div. 1990).
47. ACOG, TECHNICAL BULLETIN 163-Jan, 1992, Fetal and Neonatal Neurologic Injury.
48. ACOG, NEONATAL ENCEPHALOPATHY AND CEREBRAL PALSY: DEFINING THE PATHOGENESIS AND PATHOPHYSIOLOGY, Jan. 2003.
49. M. McCullough, PHILADELPHIA INQUIRER, Feb 10, 2003, A Dispute on Doctor Cerebral Palsy Role.
51. Id., 47. Footnote 15.
52. R.C. Goodlin, Do Concepts of Causes and Prevention of Cerebral Palsy Require Revision? AM. J. OB-GYN – 1995: 172; 1830-6.
53. Bennett v. Florida Birth-Related Neurological Compensation Association; Case No. 06-2422N. Testimony 6/13/07 and 7/9/07.
57. M.C. Hermansen, The Acidosis Paradox: Asphyxial Brain Injury Without Coincident Acidemia. DEV. MED. AND CHILD NEUROLOGIC. 2003, 45:335-356.
58. Volpe, NEUROLOGY OF THE NEWBORN, 4th Ed., Phil. W.B. Saunders (2001) pp. 232, 217, noting that a brain injury typically after a longer less intense insult produces apoptotic cell death at a later point in time without an associated inflammatory response while a more intense, more acute insult will more likely produce necrosis with an inflammatory response. Also the text at pp. 297-298, 302-304, 310-312, 315, 317 notes that one neuropathology consequence of the ischemic insult is selective neuronal necrosis due to repeated reversible transient ischemic events, which individually are not sufficient to produce the brain injury.
59. Gould v. Baptist Health, District Court Garfield County, Oklahoma, Case No. C.J.-03-138-01, p. 139, 169, 197.
60. C. Amiel-Tison, C. Syreau, S.M. Shnider. Cerebral Handicap in Full Term Neonates Related to the Mechanical Forces of Labor. Bailliere’s Clinical OB-GYN – Vol. 2, No. 1, (1988). See also: J.M. Freeman, K.B. Nelson, Intrapartum Asphyxia and Cerebral Palsy: Pediatrics, 1988; 82:240-49. Maintaining that as C.P. due to birth trauma from prolonged, difficult labor and forcep deliveries became a less frequent cause of C.P. as obstetrical practice changed and improved that hypoxic/ischemic injury was then more commonly “blamed” for neurologic deficit. This article co-authored by Dr. Nelson was intended to dispose of birth trauma as a nonexistent event of the past. Thus only intrapartum asphyxia potentially exists to produce an intrapartum hypoxic-ischemic brain injury. Dr. Nelson and others then used the essential criteria and C.P. statistics to make intrapartum asphyxia as a cause of C.P. rare and not preventable.
61. K.B. Nelson, J. K. Grether. Potentially Asphyxiating Conditions and Spastic Cerebral Palsy in Infants of Normal Birth Weight. AM. J.OB-GYN 1998; 179:507-13. Hankins Testimony Id., 59, p. 149.
62. F. Cowan, et. al., Origin and Timing of Brain Lesions in Term Infants With Neonatal Encephalopathy. THE LANCET (2003), 361:236-42.
63. K.B. Nelson, S.H. Broman, Perinatal Risk Factors in Children with Serious Motor and Mental Handicaps, ANN. OF NEUROL. 2:371-377 (1977).
64. K.B. Nelson, Ellenberg. Antecedents of Cerebral Palsy. NEW ENG. J. OF MEDICINE (1986); 315:81-6.
65. See: D. Shier and J. L. Tilson, The Temporal Stage Fallacy: A Novel Statistical Fallacy in Medical Literature. MEDICINE, HEALTH CARE AND PHILOSOPHY (2006) 9:243-247 in which the authors demonstrated how the Nelson engineering of a new consensus in the medical community that lack of oxygen at birth rarely causes C.P. relies on straightforwardly fallacious statistical reasoning.
66. Cowan – Id. – No. 62.
67. See: Westberry v. Gislaved, 178 F3d 257 (U.S. Circuit Ct. Of Appeals, 4th Circuit, 1999) and Handyman v. North Fork and Western Railroad Co., 243 F3d 255 (U.S. Court of Appeals, 6th Circuit, 2001).
69. Naeye, Causes of Perinatal Mortality in the Ultrasound Collaborative Perinatal Project, JAMA, 238:228 (1977).
70. E. Fried, Maternal Mortality and Perinatal Mortality: Definitions, Data and Epidemiology. OBSTETRICS AND EPIDEMIOLOGY. Psg. Publishing Co., Littleton, Mass. (1985)
71. L.L. Wright, et. al. PERINATAL-NEONATAL EPIDEMIOLOGY, CHAPTER 1, IN AVERY’S DISEASES OF THE NEWBORN, 8th Ed. (2005) Tacusch/Ballard/Clarkson.
72. B. Hagberg, et. al. Gains and Hazards of Intensive Neonatal Care: An analysis of the Swedish C.P. Epidemiology. DEV. MED. AND CHILD NEUROLOGY, 1982; 24:13-19; Hagberg The changing panorama of Cerebral Palsy in Sweden: Epidemiological Trends 1959-78. ACTA PEDIATRICA SCANDINAVIA 73:433, (1984). K. Himmelmann, etc. The Changing Panorama of Cerebral Palsy in Sweden. Prevalence and Origin in the Birth-Year Period 1995-1998, ACTA PEDIATRICA, 2005; 94:287-294 (noting a decreasing trend in C.P. rates)
73. Chamberlien. British Births, 1970. In the first week of life, London: HEINEMANN MEDICAL BOOKS, LTD. (1975)
74. S.L. Clark, G.D.V. Hankins, Temporal and Demographic Trends in Cerebral Palsy, Am.J. OB-GYN 2003; 188:628-33. Pointfully, this paper noted that the EFM use coupled with an increase in the C.D. rate, has eliminated sudden unexpected intrapartum fetal death. It is the same intrapartum fetal stresses that can in sublethal effect produce disabling brain injury, that also can produce an intrapartum fetal death. The intelligent doctors who wrote this article (and other similar articles) which are clearly intended to support legal defenses, must understand that a proper use of the statistics, motivated to protect their fetal patients, actually “prove” that a proper use of EFM and timely C.D. can prevent both intrapartum fetal death and brain injury.
75. A.L. Scherzer, Past President American Academy of Cerebral Palsy and Developmental Medicine: The Changing Face of Cerebral Palsies? DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY, 29: 550 (1987))
76. Id., No, 1, pp. 185, 232-235. No case has ever been successful against an obstetrician premised on an allegation that if a child is disabled the brain injury must have occurred during labor and premised on the notion that the obstetrician was liable because he or she had total control of brain development. These straw man fallacies connected to the idea that civil trials are a “free-for-all” are ideas that promote a scam.
77. ACOG Patient Education: Fetal Heart Rate Monitoring During Labor (2001). A mid-wife can manage a normal pregnancy and a normal labor and delivery. A general surgeon could easily learn how to do a safe cesarean delivery. ACOG educates patient women by leading them to believe that obstetricians (as opposed to a G.P.) really are necessary to ensure delivery of a healthy baby.
78. N.Y. State’s Obstetric Safety Initiative: Providing Excellence in Electronic Fetal Monitoring (2009).
79. ACOG Committee Opinion No. 303, Oct. 2004, Inappropriate Use of the Term Fetal Distress and Birth Asphyxia.
80. K. Shy, et. al., Effects of Electronic Fetal Heart Rate Monitoring as Compared with Period Auscultation, on the Neurologic Development of Premature Infants. NEW ENGLAND JOURNAL OF MEDICINE (1990) Vol. 322, pp. 588-593.
81. ACOG PRACTICE BULLETIN: Clinical Management Guidelines for Obstetrician-Gynecologists No. 106, July 2009.
82. F. C. Miller, et. al. FHR Pattern Recognition by the Method of Auscultation: OB-GYN 64: 332, 1984 – noting that auscultation led to a failure to recognize significant FHR patterns by as much as one-third of the time making it unacceptable in modern obstetrics.
83. The 2008 National Institute of Child Health and Human Development Workshop Report on Electronic Monitoring: G.A. Macones, G. Hankins, C.Y. Spong, et. al. OB-GYN 2008; 112:601-6.
84. C.Y. Spong, Electronic Fetal Heart Rate Monitoring, Another Look. OB-GYN – 2008; 112:506-507.
85. J. T. Parer, et. al. A Framework for Standardized Management of Intrapartum Fetal Heart Rate Patterns. AM. J. OB-GYN 2007: 197:26e1-26e6.
86. Id., 59 at pp. 23, 24, 127-129.
87. Lemons v. San Jacinto Methodist, p. 117, Nalder v. West Park Hospital, p. 126-128, Wisehart v. Calen of Kentucky, pp. 16, 17, 29, Winston v. USA, pp. 19, 34. See also: K.B. Nelson, etc. Uncertain value of electronic fetal monitoring in predicting cerebral palsy, N. Eng. J. 1996; 334:613-8. This article coauthored again by Dr. Nelson and frequently cited to support the idea that EFM is not useful “in predicting” C.P. used EFM information “noted in the birth records”. Nobody reviewed any EFM strips to correlate EFM findings with bad outcomes.
88. Robert M. Wachter & Kaveh G. Shojania, Internal Bleeding: The Truth Behind America’s Terrifying Epidemic of Medical Mistakes (2005) at 322-323.
89. S.L. Clark, N.A. Belfort, N.A., et. al., Improved Outcomes, Fewer Caesarean Deliveries, and Reduced Litigation: Results of a New Paradigm in Patient Safety, AM. J. OB/GYN, 2008; 199:105.e1-105.e7.
90. Id., p. 105.e5 ref S.L. Clark, N.A. Belfort, et. al., Reducing Obstetric Litigation Through Alterations in Practice Patterns – Experience with 189 Closed Claims. OB/GYN 2008; 112:1279-83.
93. S. Shankaran, et. al. Whole-Body Hypothermia for Neonates with Hypoxic-Ischemic Encephalopathy. N. ENG.J.MED. 353; 15. (October 13, 2005); J.J. Volpe Perinatal Brain Injury: From Pathogenesis to Neuroprotection. Mental Retardation and Developmental Disabilities. Research Reviews 2001; 7; 56-64.
94. C. R. Harman, et. al. FETAL BIOPHYSICAL VARIABLES AND FETAL STATUS: ASPHYXIA AND FETAL BRAIN DAMAGE, ed. Maulik, 1998, pp. 279-283.
95. C.R. Harman, Assessment of Fetal Health, Chapter 21 in Maternal-Fetal Medicine, 5th Ed. By R.K. Creasy and R. Resnick (2004).
96. F.A. Manning, et. al. Fetal Assessment Based on Fetal Biophysical Profile Scoring; the incidence of cerebral palsy in tested and untested perinates. AM. J. OB-GYN 1998, 178:696-706.
