Legal Review & Commentary

Plaintiff alleges negligence led to birth defects

NEWS: A 24-year-old woman presented at a government hospital after receiving a positive pregnancy test. During an ultrasound, health care providers concluded that an early intrauterine pregnancy had occurred. Approximately one week later, the woman returned to the hospital for vaginal bleeding. An ultrasound revealed reassuring developments, including uterine growth. However, no ultrasound report regarding these findings was prepared. Another normal ultrasound was conducted two days later with no documentation regarding the findings. One day after the second ultrasound, an obstetrician concluded that the woman had suffered a miscarriage due to a perceived drop in the pregnancy hormone. A dilation and curettage was performed on the woman approximately 20 days later. Two months later, the woman presented to another government hospital and was found to be 19 weeks pregnant and leaking amniotic fluid. The woman later gave birth to a daughter with serious, permanent brain injury.

BACKGROUND: After confirming her pregnancy with an at-home pregnancy test, a 24-year-old woman presented to her local government hospital. An ultrasound was performed during the visit, and although no intrauterine gestational sac was seen, the health care providers concluded that the woman had an early intrauterine pregnancy. A few days later, the woman returned to the hospital complaining of vaginal bleeding with no pain or cramps. A subsequent ultrasound was performed, and although the ultrasound confirmed the presence of a gestational sac and a yolk sac, as well as uterine growth, no such findings were documented by the radiologist. Rather, the radiologist's report referred back to the first ultrasound's findings. The woman also had blood work performed, which confirmed her pregnancy hormone (hCG) levels were well within normal ranges. The woman was asked to return to the hospital a couple of days later.

During her third visit to the hospital, the woman received a third ultrasound. Again, no documentation was made regarding the findings. The woman's hCG levels had fallen slightly, but were still within normal ranges based on her progression. The next day, the woman's obstetrician concluded, based on the fall in hCG level, that the woman had suffered a "missed abortion." She was prescribed a drug meant to induce a medical abortion and was instructed to return to the hospital for a dilation and curettage two weeks later. The dilation and curettage was performed as scheduled.

Two months later, following a move across country, the woman presented to another federal hospital and was found to be 19 weeks pregnant and leaking amniotic fluid. She was placed on bed rest for 75 days, and her daughter was born via cesarean section shortly thereafter.

The woman, acting on behalf of her daughter, sued the United States alleging negligence in the treatment of her pregnancy. The woman alleged that her daughter suffered serious, permanent brain injury with lifelong sequelae as a result of the hospital's negligence. The health care providers at the hospital should have recognized the viability of the fetus and provided the woman with the proper prenatal care. The plaintiff's expert life-care planner testified that the child will never be able to live independently and will require continued therapy as well as attendant care. The parties settled prior to trial for $4.5 million.

WHAT THIS MEANS TO YOU: The fact that this event occurred in a government hospital is of minor importance. Specifically, the events that occurred in this hospital have the potential to happen in any hospital if the same circumstances or variables are in play.

This patient had three ultrasounds of her uterus and two positive pregnancy tests at the hospital, in addition to the home pregnancy test that was positive. Of the three ultrasound examinations done on different dates, there were no written reports of the findings read by a radiologist for the first and third examinations, although the report of the second examination referred to the observations on the first examination. This failure to read and document the findings in a formal written report is a deviation of the standard of practice. If the obstetrician(s) read the ultrasounds as "wet reads" (unofficial reads) a system should have been in place for the radiologist to review the initial "wet read" findings to compare with the official dictated reading for comparison. In the event the radiologist's official reading does not concur with the "wet reading," a process should be in place to notify the obstetrician, so steps can be taken to change treatment or call back the patient as might be indicated by the official reading. There should be a quality improvement process in place to track the disparate readings by physician and type of misread to analyze for trends and patterns and to provide training if the data show a trend or pattern.

The lack of or failure to officially document the findings by the radiologist is a failure to comply with standard practice and policy. A root cause analysis (RCA) of this issue should be undertaken by risk management to determine whether this is the "tip of the iceberg." Questions to be answered might be whether this is limited to one radiologist, to just OB ultrasounds, or is this an issue with all radiologists and all types of films? When those questions are answered, other questions to answer would be why are official reads not documented on a timely basis for any films? How has patient care been compromised by not having official readings of radiology films dictated and transcribed on a timely basis, if at all? A thorough RCA will give answers to these questions, which then will need to be addressed to correct the problems.

No information is provided regarding findings on physical exam and other signs and symptoms of pregnancy. From what is provided, it appears that medical conclusions were based mainly on the laboratory test results and the ultrasound readings.

However, a D&C was done after the patient took the medication prescribed to induce a medical abortion, based on the findings of the pregnancy test and third ultrasound. No information regarding whether the pathology report indicates products of conception were obtained and if so, how much. If the pathology report indicates no products of conception were obtained at the D&C, that would be a red flag for the physician. At this point, it is possible the patient never returned for a follow-up visit before her move two months later across country. This raises the question whether the physician saw/reviewed the pathology report of the D&C results. This is a process issue that should be addressed regarding validation of review of test results; initiation of contact with the patients as warranted by the test results; and documentation of review and attempts to contact the patient.

Unless this patient was pregnant with twins, it is apparent that the pathology report of the D&C procedure would have reported no products of conception, as she was found to be 19 weeks pregnant upon presenting to the hospital two months later. Whether the leaking amniotic fluid was a result of the D&C is unknown. The duration of the leaking amniotic fluid is also an unknown from the information we are given here.

A root cause analysis (RCA) and a medical peer review should be initiated at the first hospital to determine if the medical care comports with the standard of acceptable obstetrical practice in a situation such as this. The findings of the separate RCA undertaken to address the radiology issues should be addressed with the findings from the obstetrical RCA. Depending on clarification of the pathology report of the D&C tissue, another peer review and RCA may be in order especially to address the handling of the reported information. If no products of conception are reported out, perhaps peer review will undertake to proctor all or some D&C procedures to verify proper procedure.

Another significant variable in this sad untoward outcome is that there is no evidence as to whether the patient saw the same physician on every visit or a different physician. Likewise, it is not clear whether this was a teaching hospital, and whether the patient was seen by residents or obstetricians who had completed their training. Depending on those answers, the risk manager and medical peer review may have additional issues to address and questions to answer.

Reference

United States District Court, W.D. Washington, No. 3:09-cv-5268.