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In the early 1980’s while an assistant general counsel at Brigham and Women’s Hospital, an oft discussed issue was the necessity for informed consent in relation to obstetrical or gynecological procedures.  The age of patient autonomy was rapidly progressing with books such as “The Unkindest Cut” which posited that too many deliveries were being performed by cesarean delivery rather than vaginally to the detriment of both the mother and the fetus.  At the very least, the rule of informed consent seemed to dictate that the decision be less of a unilateral decree by the obstetrician and more of a shared decision with the mother.  Over the next twenty years, the pendulum clearly swung in this direction and, in fact, went a bit further with vaginal deliveries being the prefered route unless there were medical indications for surgical delivery.  Being the father of four, with the first by c section in the early 80’s and the next three vaginally by 1989, I was personally involved in these discussions with my wife, her physicians and the other health care professionals attending the deliveries and the pre natal work ups.  VBAC was the anacronym- vaginal birth after caesarian- and the attendant potential consequences was an oft repeated topic of discussion during the initial eight months and then, more intensely, in the days, weeks and hours leading up to the time of delivery.   There was no question that if our choice was to pursue VBAC, our knowing consent would be an important part of the process and, absent other medical considerations, pretty much my wife’s decision.   The night before the second delivery, the ob was literally with us all night and there was a significant amount of concern being expressed  by all of those attending to the last hours of the labor.  But all went well and I am quite certain that the right decision was made.  On the other hand, a health care professional we knew told us that, by choice, she had delivered her three daughters by c section really as a matter of convenience, finding the recovery from abdominal surgery well worth the trade off.  Two families-both well informed about the choices-making different decisions-decisions that fit their lives.  


At the same time, there was an explosion in medical malpractice cases alleging that children suffering from the diagnosis of cerebral palsy were often caused to suffer from that debilitating illness due to the failure of the attending obstetrician to perform a necessary c section.  This argument would be posited by an expert witness who would focus on some real or fictitious finding on a fetal monitor strip or in a nurse’s note which allegedly was an indication of fetal distress in utero.   That showing of stress in utero, according to very questionable medical opinion testimony, had deprived the fetus’ brain of oxygen to such a degree that the fetus was neurologically seriously injured resulting in the developmental diagnosis of cerebral palsy.  While most of this analysis was later disproved by clinical studies (the incidence of cerebral palsy was similar with or without c-section delivery) , millions of dollars in damages were awarded by sympathetic jurors and thousands of  concerned obstetricians fretted over their delivery practices.

 

Then in 2006, the issue came almost full cycle when the National Institute of Health considered the issue of Caesarean Delivery on Maternal Request.   At that time, the recognition of patient autonomy was a driving factor in both the consideration of the issue as well as the conclusions reached.  During the seventies and eighties, there was a great push by hospitals and boards of health to tract and decrease the number of c sections being performed.  However, as the NIH report concluded: “The incidence of CD without medical/obstetrical indications is rising in the United States, and a component of this is due to CDMR.”   The Committee further concluded that “There is insufficient evidence to evaluate fully the benefits and risks of CDMR as compared to PVD, and more research is needed.”  Now, a new study has concluded that there is greater morbidity associated with CDMR than with PVD.  A study reported in the March, 2007 Journal of Obstetrics and Gynecology concluded  that there was a greater risk of rehospitalization in the first 30 days after giving birth by planned caesarean section when compared with planned vaginal births due most commonly to wound complications and infection.    There was also a finding that the cost of a vaginal delivery was $2487 compared to the cost of a planned c-section which was $4372.  While this economic finding would seem of less significance in a society where most deliveries are covered by private or governmental insurance programs, the rapidly escalating practice of co-pay requirements could increase the importance of economic considerations in the decision process. 

Regardless, the underlying legal principle would be the same in application over the last thirty years.  The NIH committee concluded:  “The foundation of the ethical relationship between a woman and her health care providers is based on a respectful partnership that requires the exchange of accurate information and effective communication.”  This is precisely the premise upon which the law of informed consent was founded.  As medical knowledge changes, the information that need be shared with a patient also must change, to allow for an informed and reasoned decision.  However,  the guidelines by which the law will evaluate the adequacy of the patient’s involvement in the informed consent process have not really varied but have been further refined.  In general terms, a physician must inform a patient of material facts that a reasonable person would find important in making an informed treatment decision.  As always, this standard is not nearly as definitive as some practitioners would prefer.  The best way to approach this issue is for the health care facility to provide written guidance to the professional staff about what information should be provided and, perhaps, written documents that set forth the benefits and risks in a form that can be signed by the patient considering CDMR.  This form would then be included with the medical chart as are other such forms.  Finally, any health care professional providing information and guidance to a patient considering this decision should carefully note in the record the occurrence of such a discussion as well as details of what was discussed.


Healthcare Law, Litigation & Public Policy   Medical Licensure & Discipline ♦ Employment Board of Registration

Informed Consent and C-Section and Delivery on Maternal Request

by Attorney Frank E. Reardon

July 2007

REARDON LAW OFFICE