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In the s, NIH organized consensus-development Task Forces to address recent developments in medical research and practice [ 62 ]. One Task Force on predictors of intrapartum fetal distress was composed of physicians, sociologists, lawyers, and ethicists, among others. With respect to EFM, the Task Force recommended, because there was no evidence of EFM efficacy, that mothers be informed, during the course of prenatal care and again on admission to the labor suite, about EFM limitations and risks [ 62 ].
But informed consent never happened. The EFM informed consent issue did not escape the nursing, midwife, and legal literature [ 65 , 66 , 71 , 72 ], and, in fact, is still discussed today [ 67 , 73 , 74 ]. But these voices have been ignored by obstetricians and ethicists alike.
Kuhn started challenging the scholarly community with his revolutionary science, paradigms, and puzzle-solving in his book, The Structure of Scientific Revolutions [ 36 ]. In the s, for reasons still debated today, there was a sudden, dramatic rise in the frequency and severity of medical malpractice lawsuits and claims, which accelerated rapidly to unprecedented levels, precipitating the first of many medical malpractice-insurance coverage crises early in the s [ 5 , 8 , 9 , 25 ].
But over the past half-century, physicians worldwide have lost the CP-EFM battle to the trial lawyers for a variety of reasons [ 5 , 8 , 9 , 25 ] and are now engulfed in an epidemic explosion of malpractice lawsuits, especially CP-EFM neurologic impairment birth-injury lawsuits [ 5 , 7 — 11 , 15 , 25 ]. The result of the initial trial lawyers versus doctors litigation battle was defensive medicine—prophylactic medicine of little use to the patient, administered primarily for the protection of doctors and hospitals from trial lawyers and lawsuits [ 5 , 7 — 11 , 23 , 25 ].
And while most defensive medicine received considerable criticism from bioethicists, economists, and some clinicians as being medically and ethically questionable, not to mention costly to society [ 75 — 78 ], the EFM criticism, as we have seen, came only from a small number of clinicians and scholars, and even they never addressed the bioethical issue of physicians violating patient autonomy by EFM use without informed consent. Ethicists defaulted in the EFM debate by their overwhelming silence.
The use of a scientifically bankrupt machine solely to protect healthcare providers from trial lawyers and lawsuits when the machine is known to be harming mothers and babies is an egregious conflict of interest and outrageous endorsement of obstetrical defensive medicine—post-modern ethical relativism solely to benefit healthcare providers—and is undeniable proof that evidence-based standard of care and bioethical principles are nothing more than empty rhetoric [ 79 , 80 ].
A part of bioethical morality requires that patients be allowed autonomy and that in the treatment process the physician refrain from harm to the extent practical. But the third principle—beneficence—requires more than avoiding harm. It requires positive steps to benefit the patient, steps that balance benefits, risks, costs, and other patient goals to produce the most optimum results possible [ 33 , 34 ].
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This obligation is fidelity. It results in a fiduciary relationship between patient and physician [ 33 , 34 ]. Conflicts of interest have received enormous attention, primarily due to perceived conflicts in commercial, manufacturing, and financial relationships [ 33 , 34 ]. However, the EFM conflict of interest—using a device that actually causes harm to patients primarily to protect doctors and hospitals from CP lawsuits—is enormously more compromising than gifts, trips, and money, because it has been and is hidden from public view and because the EFM device is fraudulently presented to mothers as a safety device necessary for a healthy baby.
Fidelity could not possibly be more compromised. Law and bioethics are separate, distinct entities. Law concentrates on the criminal and civil penalties to be brought to bear on miscreants who fail to conform [ 33 , 34 ]. Bioethics, on the other hand, are conceived of as moral rules and ideals—how one ought to act toward others—some aspirational and some even unobtainable.
How seriously these moral rules must be taken is still in dispute among the ethical legalists and ethical antinomianists [ 33 , 34 ], but neither extreme in that debate contradicts the fact that ethical rules are essentially unenforceable save for the mild, occasional organizational enforcement and perhaps occasional licensing rebuke. After all, at the dawn of bioethics there was no enforceability other than words and public exposure of medical procedures that most agreed were morally wrong and dismissive of individual autonomy.
Bioethics changed the entirety of medicine and the Hippocratic tradition that had ruled for centuries. Words were the only weapons needed. So the question arises, can words still be used to change the EFM bioethics? Said another way, can bioethics shed light in the darkness of 50 years of EFM paternalism?
It would be a far better thing to voluntarily come to the light of EFM autonomy-informed consent now, rather than being forced into the light tomorrow by the trial lawyers. The authors received no financial support for the research, authorship or publication of this article. All authors contributed to the research, drafting, reviewing and editing of this paper.
All authors read and approved the final manuscript. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Thomas P. Sartwelle, Email: moc. James C. Johnston, Email: moc. Berna Arda, Email: rt.
National Center for Biotechnology Information , U. Matern Health Neonatol Perinatol. Published online Nov Sartwelle , 1 James C. Johnston , 2, 3 and Berna Arda 4. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Jun 4; Accepted Sep 8. This article has been cited by other articles in PMC.
Associated Data Data Availability Statement The data and materials supporting this article are publicly available and included in the endnotes. Abstract Bioethics abolished the prevailing Hippocratic tenet instructing physicians to make treatment decisions, replacing it with autonomy through informed consent. Keywords: Medical ethics, Cerebral palsy, Electronic fetal monitoring, Medical malpractice. Deus ex machina Thus, in , when EFM was introduced into clinical practice [ 2 ], obstetricians were comfortable operating in the Hippocratic sphere in which they made all medical decisions without input from patients.
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The revolution Science is always progressing. Is EFM really experimental? Vincible ignorance It is no longer a secret why BRPOs, medical societies, and individual physicians and hospitals ignored the year EFM volcano erupting with undeniable, unrefuted evidence that EFM is junk science and causes harm to mothers and babies. In plain sight Although it is impossible to determine the moment that paternalism died and autonomy was born, we can isolate one period in early EFM history when autonomy was recognized as dominant over paternalistic EFM use.
Acknowledgements Not applicable. Funding The authors received no financial support for the research, authorship or publication of this article. Availability of data and materials The data and materials supporting this article are publicly available and included in the endnotes. Notes Ethics approval and consent to participate Not applicable. Consent for publication All authors have approved the manuscript for submission. Competing interests The authors declare that they have no competing interests.
Contributor Information Thomas P. References 1. Fetal monitoring: is it worth it? Obstet Gynecol. Fetal heat rate monitoring. Parer JT. Personalities, politics, and territorial tiffs: a half century of fetal heart rate monitoring. Am J Obstet Gynecol. Jenkins HML. Thirty years of electronic intrapartum fetal heart rate monitoring: discussion paper.
J Royal Soc Med. Sartwelle TP. Electronic fetal monitoring: a bridge too far. J Legal Med. Greene MF. Obstetricians still await a deus ex machina. New Engl. Cerebral palsy — causes, pathways, and the role of genetic variants. Neonatal encephalopathy opportunity lost and words unspoken.
Cerebral palsy litigation: change course or abandon ship. J Child Neurol. Medico-legal implications of hypoxic-ischemic birth injury.
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Semin Fetal Neonatal Med. Badawi N, Keogh JM.
Causal pathways in cerebral palsy. J Pediatrics and Child Health. Semin Perinatol. Electronic fetal monitoring as a public health screening program: the arithmetic of failure.
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Fetal heart rate monitoring—is it a waste of time? Only an expert witness can prevent cerebral palsy. Who will deliver our grandchildren? Clark S, Hankins G. Temporal and demographic trends in cerebral palsy—facts and fiction.
Chapter 23 Optimal policies for natural monopolies - ScienceDirect
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