Failure to diagnose pregnant woman's fetal defects including missing limbs leads to $4.5 million verdict
By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY
Ericka Saint-Hilaire, JD, RN, MPH
Associate Attorney
Kaufman Borgeest & Ryan
Valhalla, NY
Carol Gulinello, RN, MS, CPHRM
Vice President, Risk Management
Lutheran Medical Center
Brooklyn, NY
News: A 30-year-old pregnant woman's medical team, including ultrasound sonographer and the supervising physician, failed to diagnose her fetus's numerous defects, including missing limbs. A lawsuit was filed against the hospital, ultrasound sonographers, and supervising physician by the child's mother and father on his behalf. Prior to trial, the plaintiffs settled their claims with the hospital for an undisclosed amount. The plaintiffs' claims against the ultrasound sonographer and supervising physician proceeded to trial. Following trial, the jury returned a verdict of $4.5 million.
Background: A 30-year-old female had an ultrasound performed on March 12, 2008, at the hospital and she learned she was approximately 7.8 weeks pregnant. On March 13, 2008, and March 22, 2008, the woman reported to the hospital's emergency department for vaginal bleeding. However, she was reassured each time that the ultrasounds continued to show normal amniotic fluid, fetal motion, and fetal limb movement.
The patient scheduled an anatomical survey ultrasound that was performed on June 4, 2008. A physician prepared the preliminary obstetrical ultrasound report but failed to confirm the presence or absence of legs or arms, normally part of the minimal elements of a standard examination of fetal anatomy. The supervising physician signed the ultrasound report. Genetic counseling and a Level II ultrasound were scheduled because the ultrasound report had diagnosed the fetus's echogenic cardiac focus and unilateral pylectasis.
The patient reported to the hospital for the Level II ultrasound with a sonographer. The sonographer's preliminary report again failed to confirm the presence or absence of legs and arms, and the supervising physician signed each report.
On Oct. 15, 2008, the patient present to the hospital in labor and gave birth to her son via cesarean section. Upon assessment, it was noted that patient's newborn son suffered from aplasia and hypoplasia, with both arms absent below a short humerus, an absent leg with a remnant foot, and three small toes and other anomalies. The mother testified at trial that it was heartbreaking to see her son's condition.
A lawsuit was filed against the hospital, ultrasound sonographers, and supervising physician by the child's mother and father on his behalf. The plaintiffs argued that the hospital negligently breached their duties to provide reasonable care in accordance with prevailing professional standards when they failed to detect the unknown fetal defects. The plaintiffs also argued that the defendants failed to report the minimal elements of a standard fetal anatomy ultrasound, failed to report the minimal elements of a Level II ultrasound, failed to confirm the presence or absence of legs and arms during the ultrasounds, failed to diagnose fetal hypoplasia of the upper extremities and aplasia of the left lower extremity, and failed to inform the plaintiffs of the existing fetal defects. The child's parents also claimed that because of the hospital's negligence, they were unable to make an informed decision about whether to terminate the pregnancy.
Prior to the trial, the plaintiffs' agreed to settle their claims against the hospital. Their remaining claims against the supervising physician and the sonographer proceeded to a jury trial. At trial, the mother testified at trial that had she known about her son's abnormalities, she would have terminated the pregnancy. She also testified about the difficulty her son has playing with toys and how uncomfortable it is for him to wear a prosthetic leg. The plaintiff's also presented expert testimony that detailed the level of care the child will need over the course of his life and the price of various prosthetics and equipment that will be required. In response, the defense argued that ultrasounds are not foolproof tests. They presented the jury with the mother's signed consent forms, which acknowledged that ultrasound results are not a warranty of a normal fetus.
As a result of this lawsuit, the hospital changed its protocols and now identifies each limb of the developing fetus during an ultrasound. This change brings the hospital in line with national standards. After the trial, one juror stated that the jury wanted to send a message that the care received in this case was unacceptable and there was no reason for this to happen.
The jury returned a verdict of $4.5 million for the damages sustained by the patient. The jury determined that the supervising physician was 85% liable and the sonographer was 15% liable. To date, according to court records, an appeal has not been filed.
What this means to you: For informational purposes, the difference between a Level I and Level II ultrasound is the level of detail a practitioner can expect to receive from each study.
A Level I ultrasound is performed before 12-14 weeks of pregnancy and will indicate the fetal anatomy measuring heart, head, limbs, and overall gestational size. If anomalies are detected, there is time for early intervention.
The Level II ultrasound also will focus on the fetal anatomy and is usually performed between the second and third trimester of pregnancy, or 18-22 weeks. It will reveal a greater level of detail such as the size of the fetus (gestational age, fetal growth, and weight), organ formation, presence and absence of extremities, amount of amniotic fluid, any maternal cervical changes that might indicate premature labor, and sometimes the sex. If anomalies are discovered, it is still early enough in the pregnancy for intervention.
Additionally, all ultrasound machines that are designated to perform OB/GYN ultrasound examinations have highly specialized software that includes all the standardized elements recommended by the American College of Obstetricians and Gynecologists (ACOG) or American Institute of Ultrasonic Medicine (AIUM) for Level I and Level II ultrasonography. As part of the routine printed ultrasound report, the presence or absence of limbs, as well as the testing elements listed above, would be standard in the fetal anatomy scan.
According to this case study, this patient underwent 3 Level II ultrasound examinations. At this stage of gestational age, fetal extremities would have been very clearly visualized. It is unclear why there was no mention of the fetal extremities in the formal printed ultrasound reports or in the subsequent physician documentation.
Therefore, from a risk management perspective, the implementation of a standardized checklist would be a prudent corrective action. The checklist should include the required criteria for Level I and Level II sonograms. A checkbox noting that all prior ultrasound exams were reviewed for comparison should be included as well. Both physicians and sonographers must be required to complete the checklist and address each of the criteria listed. A comment section documenting the acknowledgment of the ultrasound results followed by a signature of the physician and sonographer would be required for completion. An audit should be performed by the obstetrics department to ensure compliance with required documentation.
To quote the old adage, 'if it was not documented, it was not done' holds true in this case.
Reference:
15th Judicial Circuit, Palm Beach County, FL. Case No. 50 2010 CA 004745. 2011 WL7070236.
News: A 30-year-old pregnant woman's medical team, including ultrasound sonographer and the supervising physician, failed to diagnose her fetus's numerous defects, including missing limbs.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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