I first stepped into a maternity unit to work as a junior doctor in 1991. Through my professional life I have often heard something along the lines of “you have to use CTG monitoring because the lawyers say so”. Other versions of this argument are more specifically related to today’s post – such as “when that baby is diagnosed with cerebral palsy in 3 years time, a CTG recording will provide your best legal defence if you were to be sued”. Anyone who works in maternity care will tell you that one of the drivers for CTG use is concern about legal and / or regulatory consequences for individual practitioners and/or for the organisation employing them. This has been confirmed in research (Chuey, et al., 2020).
Sartwelle, an American lawyer, and his co-authors have repeatedly argued that CTG monitoring should be dismissed from medical litigation cases about cerebral palsy on the basis it is “junk science” (Sartwelle et al., 2017; 2018; 2019; 2020). But for this to happen there must first be a significant paradigm shift. They have argued:
The electronic fetal monitoring manufacturers make billions, trial lawyers have created a lucrative cerebral palsy litigation cottage industry, and hospitals and physicians make more money using electronic fetal monitoring and performing C-sections. Electronic fetal monitoring use will continue because the people who should change the paradigm do not want the paradigm changed.
Sartwelle, et al., 2019, p. 6
But something has happened, and it looks like we might be on the cusp of that paradigm change after all.
What is the Daubert doctrine?
What has come to be known in legal circles as the Daubert doctrine, arose from the case of Daubert vs Merril-Dow, the pharmaceutical company manufacturing Bendectin. The Daubert family claimed their child developed congenital abnormalities because their mother used Bendectin (a mix of three drugs used to treat nausea and vomiting in pregnancy). Faced with expert witnesses who were very creative with their “evidence”, the US supreme court established the following rules for courts to consider (Coscia, 2020):
- Whether the theory or technique can be and has been tested
- Whether the theory or technique been subject to peer review and publication
- Whether there is a known or potential rate of error and whether standards exist for controlling the technique’s operation
- Whether the theory or technique has been generally accepted within the relevant scientific community
While it had its origins in medical litigation, the Daubert doctrine has rarely been applied in medicolegal arguments since then (Coscia, 2020). Instead, the standard has been to ask what is accepted clinical practice. As we know, when it comes to CTG use in labour, accepted clinical practice flies in the face of evidence.
What has changed?
Politi and colleagues (2023) recently reported that the Italian Supreme Court of Cassation made use of the Daubert doctrine in 2019 to uphold the acquittal of medical staff on criminal charges. While the case was not about intrapartum CTG use, it represents the use of the doctrine for medicolegal purposes AND in a country other than the USA. It is potentially a sign that it will soon no longer be acceptable for medicolegal experts to rely on the argument that “everyone is doing it so it must be the right thing to do”, and this shift will occur in many high-income countries.
Why is this a big deal?
As Politi and colleagues argue, intrapartum CTG traces do not satisfy the Daubert doctrine as a source of evidence in cases relating to cerebral palsy. If the Daubert doctrine becomes standard in medicolegal circles, then it seems likely it will no longer be legally acceptable to present a CTG trace in a court of law to use as proof for or against a claim. This is a significant paradigm shift. As the authors say:
Taking cue from this verdict, we may assume that obstetricians and midwives should not be convicted solely on the basis of deceitful CTG trace reinterpretation because … CTG ex-post reinterpretation should meet Daubert criteria in order to ban “junk science” from the courtrooms. … around the world there’s a plethora of CTG courtroom experts specialised in “courtroom deliveries of neurologically perfect neonates”: these experts, through the unreliable ex-post reanalysis of CTG traces, claim to identify the exact moment when the negligent defendant should have delivered what the experts said was a neurologically perfect infant. Instead, the child is allegedly neurologically damaged by the negligent defendant unable to manage evident CTG abnormalities. This statement is repeatedly proven to be biased and unscientific at best, or fraudulent at worst.
Politi, et al., 2023, p 3-4.
Imagine…
If CTGs were no longer considered to be a reliable source of legal information – what impact would that have on your clinical practice? If maternity professionals and their employers were no longer concerned about the possibility of expensive cerebral palsy litigation, I suspect we would see:
- A change in hospital policy to support widespread use of intermittent auscultation, and a requirement for rigorous explanation of the dangers of CTG use and appropriate documentation when a women chooses to use it
- Mandatory CTG training days would disappear
- The cost of insurance for maternity professionals would fall and it would be easier for professionals to purchase insurance
- The caesarean section and instrumental birth rate would fall and the associated maternal and neonatal harms related to these would follow
Paradigm shifts in healthcare do happen. It seems like nothing will ever change for a very long time, then suddenly everything changes. Are we about to see that for intrapartum CTGs?
References
Chuey, M., De Vries, R., Dal Cin, S., & Low, L. K. (2020, Jan/Mar). Maternity providers’ perspectives on barriers to utilization of intermittent fetal monitoring: A qualitative study. Journal of Perinatal and Neonatal Nursing, 34(1), 46-55. https://doi.org/10.1097/JPN.0000000000000453
Coscia, M. (2020). “Trust me, I’m a doctor”: Medical malpractice as a Duabert-free zone. Georgetown Law Journal, 108, 1761 – 1814. https://www.law.georgetown.edu/georgetown-law-journal/wp-content/uploads/sites/26/2020/06/Coscia_“Trust-Me-I’m-a-Doctor”-Medical-Malpractice-as-a-Daubert-Free-Zone.pdf
Politi, S., Mastroroberto, L., & Ghi, T. (2023, Mar 4). The time has come for a paradigm shift in obstetrics’ medico-legal litigations. European Journal of Obstetrics & Gynecology and Reproductive Biology, 284, 1-4. https://doi.org/10.1016/j.ejogrb.2023.02.018
Sartwelle, T. P. (2017, Jul 13). Electronic fetal monitoring: A defense lawyer’s view. Reviews in Obstetrics and Gynecology, 5(3/4), e121-e125. https://doi.org/10.3909/riog0191
Sartwelle, T. P., & Johnston, J. C. (2018, Feb 09). Continuous electronic fetal monitoring during labor: A critique and a reply to contemporary proponents. The Surgery Journal, 04(01), e23-e28. https://doi.org/10.1055/s-0038-1632404
Sartwelle, T. P., Johnston, J. C., Arda, B., & Zebenigus, M. (2019, May 24). Cerebral palsy, cesarean sections, and electronic fetal monitoring: All the light we cannot see. Clinical Ethics, 45, 1-8. https://doi.org/10.1177/1477750919851055
Sartwelle, T. P., Johnston, J. C., Arda, B., & Zebenigus, M. (2020, Oct-Dec). Cerebral palsy litigation after fifty years: A hoax on you. Indian Journal of Medical Ethics, V(4), 1-15. https://doi.org/10.20529/ijme.2020.093
Categories: CTG, EFM, Obstetrics, Perinatal brain injury
Tags: Daubert, medicolegal, Paradigm shift
Birth Small Talk 
see also: Spector-Bagdady K, De Vries R, Harris LH, Low LK. Stemming the Standard-of-Care Sprawl: Clinician Self-Interest and the Case of Electronic Fetal Monitoring. Hastings Cent Rep. 2017 Nov;47(6):16-24. doi: 10.1002/hast.781.
“Care that serves the patient’s best interests and care that is recognized as good medical practice do not always coincide. The best-interests standard is based on evidence about outcomes, but the legal standard of care is often based on evidence about typical physician practice and can be influenced by other factors. Aligning the standards requires identifying the many sources of the legal standard.”
If you are interested in a copy email me at rdevries@umich.edu
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Thanks Raymond, I read it when it was first published. It’s a great paper. Wouldn’t it be wonderful if we could narrow the gap between “what is best” and “what gets done”?
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Hi Kirsten
This would be the best paradigm shift ever. It would benefit women and babies, benefit midwives and benefit the future for generations to come. Keep up the good work.
Warmly Valerie
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Thanks Valerie – I’ll keep plugging away at it.
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