Oxytocin suspect in cases with poor outcomes

Publication
Article
Contemporary OB/GYN JournalVol. 64 No. 07
Volume 64
Issue 7

Oxytocin is one of the most frequently used drugs during labor but it can also become a major issue in a malpractice case filed after a labor and delivery if there is an adverse outcome. PLUS: Carolyn Zelop, MD, provides commentary on a lawsuit involving a patient death during pregnancy due to cardiomyopathy.

A 19-year-old Florida woman brought a malpractice action following the delivery of her child by an obstetrician employed by a federally funded medical clinic. She claimed the obstetrician was negligent for failing to perform an emergency cesarean and continuing use of oxytocin despite ominous signs of fetal compromise. As a result, the child suffered a severe brain injury requiring 24-hour professional care for the rest of his life.

The obstetrician argued that the patient refused cesarean delivery multiple times, against the obstetrician’s medical advice, prior to the vaginal delivery. He noted the refusals in the medical records. He claimed he did not fall below the standard of care in administering oxytocin or using a vacuum for delivery because the patient refused the recommended cesarean delivery.

The verdict: The jury found in favorof the child, the patient, and the husband, including $20,965,144 for the child’s future economic damages and  $7.625 million for his non-economic damages as well as $3.3 million for the patient and $1 million to the father.

ANALYSIS
Oxytocin is one of the most frequently used drugs during labor but it can also become a major issue in a malpractice case filed after a labor and delivery if there is an adverse outcome. If the drug is used during labor, all policies and protocols in effect at the time will be requested during discovery and will be compared to how the patient’s oxytocin dose was managed. Any deviation from the protocol will be pointed out as care falling below the standard, whether or not it had anything to do with the alleged injury. It is imperative that everyone administering oxytocin during labor is aware of what the protocol requires and documents any reason or thought process for deviating from that protocol.

 

Did aggressive use of oxytocin cause uterine rupture?
A Kansas woman presented to a hospital in labor at term. The on-call obstetrician ordered oxytocin augmentation. According to protocol, dosage of the drug was to be increased by 2 MU up to 30 MU or until adequate contraction pattern was observed. Over the next few hours, the nurses increased the infusion several times. When the patient began to push, a bloody discharge from the vagina was noted and the fetal heart rate (FHR) was temporarily lost. When the FHR was found, it was down to 50 beats per minute. After a few attempts to deliver the infant by vacuum and forceps, an emergency cesarean was performed. The patient had a ruptured uterus and the infant suffered permanent brain injury.

The patient sued those involved with the delivery, alleging the health care providers fell below the standard of care by negligently increasing and maintaining the oxytocin at unsafe levels, causing the uterine rupture. The result was a lack of oxygen to the fetus, which caused the subsequent brain injury. The patient’s expert obstetrician testified that the patient’s uterine contractions were adequate when the oxytocin dose reached 14 MU/minute, but the dose continued to be increased.

The verdict: The parties reached a$3.5 million settlement.

 

 

From the author - This will be my final column for Contemporary OB/GYN. I have had the privilege of writing for this magazine for many years and thank the editorial leadership and staff for that opportunity. And thanks to you, the readers, for all your comments and for making the Legally Speaking column a success. – Dawn Collins, JD

Hysterectomy, bowel perforation, multiple complications
A Mississippi woman underwent a hysterectomy in 2011, performed by her gynecologist. Two days later, she returned to the emergency room with complaints of pain. The following day, she was seen by her gynecologist and admitted to the hospital. A general surgery consult was ordered. Exploratory laparotomy performed the next day revealed an abscess and a 1-cm bowel perforation, which was repaired. Despite the repair, the patient endured a rigorous course of recovery. She developed pneumonia, respiratory failure, underwent multiple surgeries, and had recurrent abscesses and fistulas.


The woman sued the gynecologist, alleging he was negligent in perforating her bowel and failing to timely recognize the injury. Her expert opined that such an injury can sometimes be a surgical complication, but it was not in this case as it was alleged the gynecologist was rushed in performing this procedure because he had a patient at another hospital waiting for a cesarean delivery.
The gynecologist denied all liability and argued the perforation happened days after the operation within an abscess. He claimed it would have been obvious to him if it occurred during surgery.

The verdict: The jury deliberated for two and a half hours at the conclusion of an  eight day trial and returned a defense verdict. 

 

Severe hemorrhage, life-threatening complications
In 2013, a 46-year-old North Carolina woman was suffering with a history of increasingly frequent and painful menstrual periods. Her gynecologist was unable to prescribe oral contraceptives due to the patient’s hypertension and recommended a hysteroscopy with resection of a submucosal fibroid, a dilation and curettage, and endometrial ablation. During the procedure, the gynecologist encountered the 2-cm fibroid and attempted to morcellate it from the anterior wall down to a normal-appearing uterine cavity. Although the estimated blood loss was noted to be less than 100 mL the patient began hemorrhaging immediately. The nurses informed the gynecologist multiple times over the course of seven hours that the patient was experiencing severe bleeding. When the gynecologist finally examined the patient, he found that she was in hemorrhagic shock and advised her that a hysterectomy was necessary. During that operation, the woman’s bladder was lacerated twice. After hours of attempting to repair the damage, a urologist was called in to assist. Postoperatively the patient suffered a stroke, respiratory failure, kidney failure, permanent sterility, and significant bladder complications.

The woman sued the gynecologist alleging all the complications she suffered were the result of the gynecologist’s actions.
 
The verdict: The case settled for a confidential amount at mediation. 

Alleged catheter tip found in bladder years after hysterectomy
An Alabama woman underwent a hysterectomy in 2009. As part of the procedure, a Foley catheter was inserted in the bladder and the balloon was inflated. The catheter was removed a week later when the patient when to see the gynecologist. At that time, she complained of pain and the gynecologist was called back in to speak with her. Subsequently, she suffered persistent pain and infections related to her bladder. Three months later, the woman’s primary care physician referred her to a urologist, who ordered a computed tomography scan of the bladder. The report noted a “linear band of hyper dense material . . . which could represent some minimal areas of hemorrhage or debris” but no further investigation was done. Over two years later, the patient continued to experience bladder problems that no healthcare providers could treat definitively. In 2012, a surgeon performed bladder surgery and removed an object which he believed to be a catheter tip. The subsequent pathology report on the object identified it as a calcified catheter tip.
The patient sued her healthcare providers, including the gynecologist, urologist, primary care physician, radiologist, and hospital. She criticized the gynecologist for not having removed the catheter tip, and the others for not having discovered its continuing presence in a timelier fashion. According to the gynecologist, he tested the balloon and examined the tip of the catheter after it was removed. Both were intact. The patient later questioned whether he actually checked the integrity of the catheter. The notes in the medical records did not indicate that he had performed this check when the catheter was removed.
The defendants responded with a denial of any breach of the standard of care. The gynecologist could not remember who inserted the catheter or who took it out and further expressed uncertainty that any catheter had been removed from the patient in his office. Finally, the gynecologist and the urologist questioned whether the item removed from the patient’s bladder was a catheter tip, although the pathology report stated the contrary.

The verdict: The first trial began in July of 2017 but ended in a mistrial after the jury heard inadmissible evidence about the defendants’ liability insurance. The second trial lasted eight days and the jury found in favor of all the defendants.

" target="_blank">Death due to cardiomyopathy during pregnancy
A 30-year-old California woman experienced shortness of breath and chest discomfort during her pregnancy while lying down. To alleviate the shortness of breath, she propped herself up with pillows. The woman informed her obstetrician of her symptoms and was told they were common in pregnancy. That conversation was not recorded in the patient’s medical record and no further investigation was done. A month later, the woman’s husband found her unresponsive at 24 weeks’ gestation and called an ambulance. She was taken to the hospital and immediately delivered but pronounced dead after delivery. The infant died three days later due to extreme prematurity. The woman’s autopsy showed she died due to an undiagnosed cardiomyopathy and suffered a sudden cardiac arrhythmia.

A lawsuit was filed against the obstetrician, alleging that she should have investigated the patient’s symptoms further and that her dismissal of the patient’s complaints deprived her of a proper diagnosis and treatment that could have saved her life. The lawsuit claimed an echocardiogram would have revealed the patient’s condition and she could have been treated.

The obstetrician asserted that her evaluation and determination based on the patient’s symptoms were reasonable and within the standard of care. She also maintained that because the symptoms were determined to be a result of the pregnancy, it was not necessary to note that in the chart. She also argued that it would have taken close to a month to determine the diagnosis and any treatment would have only minimized the probability of a cardiac arrhythmia, not prevented it.

The verdict: The jury deliberated for almost two and a half hours at the conclusion of an 11-day trial and returned a defense verdict.

Medical analysis from Carolyn Zelop, MD
This tragic case presentation underscores the need to educate all clinicians about the increasing prevalence of cardiac complications during pregnancy. Cardiac disease including cardiomyopathy is the leading etiology of maternal death as detailed in our opening January editorial - http://bit.ly/CVmorbidity. While the physiologic changes of pregnancy can lead to maternal complaints of breathlessness and fatigue, pregnancy can unmask congenital or acquired cardiac disease. Cardiac conditions that may precede pregnancy or be pregnancy-associated can be life-threatening including: cardiomyopathy, valvular disease or arrhythmias.  Attributing these symptoms to “just pregnancy” is a diagnosis of exclusion. Any patient with persistent signs and symptoms of dyspnea requires thorough evaluation with EKG and echocardiogram. 

Dr. Zelop is Director of Ultrasound, Fetal Echocardiography and Perinatal Research at Valley Hospital in Ridgewood, New Jersey, and Clinical Professor of Obstetrics and Gynecology at NYU School of Medicine, New York. She works actively with ACOG and the American Heart Association (AHA) on issues of maternal cardiac arrest and mortality. Dr. Zelop is the Series Editor of the Contemporary OB/GYN series on maternal mortality.

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