Malpractice

MALPRACTICE
Risk management in obstetrics and gynecology

Fetal oxygen saturation and informed consent

A 19-year-old Utah woman went to the hospital at 40 weeks' gestation with a spontaneous rupture of the membranes. Oxytocin was started about 6 hours later and late decelerations were noted on the fetal heart rate tracing several hours later. Late and variable decelerations persisted over the next several hours and the oxytocin was turned off and on, an amnioinfusion was started, terbutaline was given, and oxygen was used intermittently. Approximately 23 hours after the woman's admission, a request was made to allow the placement of a fetal oxygen saturation monitor. Consent was given and vaginal delivery occurred 9 to 10 hours later. The newborn's Apgar scores were 3, 7, and 8, with an arterial cord pH of 7.18. The newborn developed seizure activity at 12 hours of age and subsequent magnetic resonance imaging and computed tomography scans revealed a diffuse brain injury consistent with hypoxic ischemic encephalopathy. The baby died at 9 days of age.

The parents sued the hospital and the residents involved with the delivery. They claimed that although consent for the fetal oxygen saturation monitor was given, they understood this was only for data gathering. The hospital maintained that the parents were told that the device was placed so FHR tracings, which were nonreassuring, could be weighed against readings from the fetal oxygen saturation monitor; as long as the monitor showed adequate fetal oxygen saturation, labor would continue. The parents contended the form and the manner with which the consent was obtained were insufficient, and thus informed consent was not given. They argued that the residents and nurses inappropriately relied on the monitor. The parents also put forth the claim that the resident responsible for managing labor had been working 18 to 20 hours when a cesarean section was indicated and he was too fatigued to recognize the danger signs or too overconfident to call for help from a more-qualified physician. A confidential settlement was reached just prior to trial.

Legal perspective

The patient in the case described here was part of the fetal oxygen saturation device study. The device itself functioned properly on this patient and all parameters were met. The manufacturer was not named in the lawsuit. Reliance on the device seemed to have been appropriate since the newborn did not have significant acidosis at birth. Whatever happened to this newborn may or may not have been related to an intrapartum event, but the issue in the lawsuit became the informed consent for using the device.

This case illustrates the importance of obtaining informed consent, not just in a study situation but at any time. This can be critical when using a new device, procedure, or test. Patients must understand exactly what data will be obtained and how it will impact their management, both of which should be documented. The defense experts would have testified that the newborn's condition at birth was not consistent with significant metabolic acidosis, thus intrapartum asphyxia was not the cause of the anoxic insult. This case, however, was settled before getting to trial because of a question regarding the information given to the patient for the consent.

Perforated colon

A laparoscopy and left salpingo-oophorectomy was performed on a 54-year-old woman in 1996. A preoperative sonogram showed a left ovarian cyst with adhesion to the left fallopian tube and sigmoid colon. The procedure started as a laparoscopy for removal of the adnexal mass, but was converted to a laparotomy. The adhesions were lysed to facilitate the removal of the left ovary and fallopian tube. The sigmoid colon was perforated, causing a colocutaneous fistula that subsequently ruptured. A third surgery was necessary to repair the fistula, and a subsequent laparotomy to resect the sigmoid colon via side-by-side anastomosis. The patient was left with an unsightly abdominal scar.

The New York woman sued the surgeons and the medical center involved in the first operation. She claimed that while taking down the adhesions the physicians weakened the wall of the colon, and negligently perforated the sigmoid colon, and that they failed to prevent the perforation by not oversewing the colon prior to closure.

The physicians denied that the surgery resulted in a perforation. They contended that even if the surgery had resulted in such an injury, perforations were a known risk of the procedure, especially in a patient with extensive adhesions. This action was settled prior to jury selection for $352,000.

Negligence alleged in labor and delivery

In 1994, a 35-year-old Florida woman was admitted to the hospital due to placenta previa. A C/S was performed at term and the infant was delivered without a problem. The woman began to hemorrhage shortly after delivery and placenta accreta was diagnosed. A hysterectomy was performed, but she suffered profound blood loss and died approximately 1 month later.

A lawsuit was filed on the patient's behalf, alleging that the physicians were negligent and deviated from the standard of care in providing medical services to the woman by failing to closely monitor her blood volume and inappropriately treating the bleeding, resulting in her death. The jury in this case returned a defense verdict.

Failure to diagnose placental abruption

A pregnant woman with sickle cell anemia presented to an emergency room at a hospital in the District of Columbia. The emergency room physicians treated her with IV fluids and sent her home. When she returned the following day complaining of abdominal discomfort, a second-year resident administered IV fluids and sent her home again without assessing fetal well-being. Several hours later, the woman presented to another hospital, where she was admitted and diagnosed with placental abruption and a fetal demise at 27 weeks' gestation.

The woman sued the first emergency room physicians, the second-year resident and that hospital. She alleged negligence in failure to diagnose the abruption and in failure to intervene in a timely manner. The emergency room physicians from the first visit contended that she did not exhibit signs and symptoms of abruption that would have indicated any need for admission or treatment. The physician she saw during the second visit contended that the patient had no true signs of placental abruption and that the abruption occurred after her discharge. The jury found the second-year resident and the hospital negligent and awarded the woman $356,000. They returned a defense verdict for the first emergency room physicians.

Ureter stapled during hysterectomy

An Ohio woman in her 50s underwent a hysterectomy and, during the procedure, the physician inadvertently placed a staple on the woman's ureter. Many years later, her kidney function began to decline, ultimately resulting in the loss of the organ. The woman sued the surgeon and the hospital and alleged that the physician was negligent in misplacing the staple, resulting in the loss of her kidney. During the course of litigation, the woman died of unrelated causes.

The physician admitted liability, but contended that the woman's overall health was not impaired by the loss of one kidney. An $18,000 settlement was reached with her estate.

Department editor Dawn Collins, JD, is an attorney specializing in medical malpractice in Long Beach, Calif. She welcomes feedback on this column via e-mail to DawnCF@aol.com.

Many times, the factual information available about the cases presented here is incomplete. Thus it may not always be possible to discuss all of the elements of negligence or nuances involved in a given situation. The outcomes described also may not reflect the current standard of care or the best practice in obstetrics and gynecology. What these cases do represent are the types of clinical situations in the specialty that typically result in litigation and the variation in jury verdicts and awards across the nation. Some of the cases described have merit but many do not.

Dawn Collins, JD

Dawn Collins. Malpractice.

Contemporary Ob/Gyn

2000;11:140, 143.