$15 million awarded for fetal monitoring that was negligent and resulted in cerebral palsy
News: The parents of a 9-year-old brought suit against a hospital and an obstetrician for medical negligence after the obstetrician failed to adequately monitor their child, a 7.5-month-old fetus at the time, while conducting a scheduled fetal blood sample. Just an hour before the procedure, the fetus’s heart rate was recorded in the 120s, a normal value; however, 30 minutes into the procedure, the fetal heart rate had fallen to a mere 65 beats per minute. The plaintiffs alleged that as a result of the doctor’s failure to properly monitor the fetus, the child suffered perinatal asphyxia and severe spastic quadriplegic cerebral palsy. Experts on both sides of the case agreed that absent the doctor’s failure to provide a reasonable standard of care, the baby would have been born perfectly healthy. After a two-week jury trial, the plaintiffs were awarded $15 million in damages.
Background: In 2002, the plaintiff was diagnosed as having antibodies against the HPA-1a platelet while her husband was homozygous with HPA-1a antigen. This situation essentially rendered subsequent pregnancies between the two spouses susceptible to an extremely high risk of being affected with alloimmune thrombocytopenia, a common blood condition during pregnancy that results in a low platelet count for the mother and fetus. Despite this diagnosis, there was hope for the couple, as they were eligible to participate in a clinical research trial studying the prenatal treatment during pregnancies.
By signing the clinical trial’s informed consent form, the plaintiff agreed to receive randomized treatment with a combination of intravenous immunoglobulins (IVIG) and prednisone between 20-30 weeks of gestation. During the study, a fetal blood sample taken from the umbilical vein would be used to determine the effectiveness of the treatment.
Tragically, the events that unfolded on the date of the procedure were not as planned. As per the study’s protocol, the anesthesiologist began to administer anesthesia to the plaintiff. However, shortly after administration, the plaintiff’s blood pressure (as measured by systolic and diastolic values) fell from 130 over 72 to 75 over 34. Notwithstanding the fetus’s critically low blood pressure, the fetal blood sampling procedure began by insertion through the plaintiff’s abdomen, uterus, and umbilical cord. At this point, the doctors failed to monitor the current state of the fetus during the procedure. Twenty minutes into the procedure, the doctors first took note of the fetal heart rate, which had slowed to an alarming 65 beats per minute, well below the acceptable range of 120-150. At that point, the treating obstetrician decided to perform an emergency c-section.
While the c-section was successful, the child remained in the neonatal intensive care unit for treatment of prematurity, perinatal anoxia, and severe respiratory distress syndrome. Ultimately the child was discharged but was diagnosed at age 10 months with cerebral palsy as a result of the failure to monitor the fetus and mother adequately during the fetal blood sampling procedure.
Consequently, the father and mother of the child brought suit as individuals and on behalf of their child against the anesthesiologist, the obstetrician, and the hospital. The plaintiffs asserted that the doctor overseeing the study (the obstetrician) and the anesthesiologist failed to properly monitor the condition of the mother and child during blood sampling procedure. Additionally, the plaintiffs contended that both doctors’ conduct fell below the required standard of care when they failed to immediately stop the procedure to prevent fetal anoxia and resulting cerebral palsy. Additionally, the mother of the child asserted claims for medical expenses, pain and suffering, emotional distress, lost wages, and various other expenses suffered as a result of doctors’ conduct.
After a two-week trial, the jury awarded $10 million to the child and $5 million to the parents against the medical center and the obstetrician and held both jointly and severally liable for the damages. The jury did find for the anesthesiologist. However, this case does not end here. Raising similar issues to those in the first case, the issue remains whether the judgment will be upheld based on the statutory caps on judgments in the state of Indiana.
In 1975, Indiana was one of the first states to adopt medical caps on medical liability and the first state to set a cap for both economic damages (such as lost wages) and non-economic damages (such as pain and suffering). While most states do impose caps on non-economic damages, Indiana imposes a combined statutory cap of $1.25 million for economic and non-economic damages in medical liability suits. Because of the Indiana law, the obstetrician and the hospital cannot be held responsible for more than $250,000 in damages. The remaining $1 million will be paid from the physicians’ pooled insurance plan. In light of the statutory damages cap, the judge likely will enter an amended verdict for the statutory cap of $1.25 million. At this point, the plaintiffs’ only recourse will be to appeal the amended judgment.
Should the amended judgment be upheld on appeal, a very interesting responsibility might befall the citizens of Indiana. As presented during the trial, the life care plan for the child is expected to cost between $8 million and $10 million for a life expectancy between 50 and 60 years. Since the parents do not have adequate funds to cover current and future medical expenses, the child’s care will likely be paid for through Medicaid, funded in part by taxpayers in Indiana.
What this means to you: Although healthcare treatment in the United States is considered by most to be "state-of-the-art," mistakes happen all too frequently even with the best medical staff available. Unfortunately, each year 95,000 U.S. patients do not survive injuries sustained as a result of medical error, according to a recent study conducted by Harvard University.
Medical professionals and hospitals need to consider how clinical trials are managed in their organizations. All research studies, including clinical trials, must be overseen by institutional review boards (IRBs). IRBs approve research studies according to federal guidelines to protect the rights of human subjects, especially those in high risk categories such as pregnant women. The IRB will review the study protocol to assure that it meets the definition of research and shows a benefit to society that outweighs potential risks. The IRB also reviews the consent process for each study to ensure that all of the potential risks are elaborated upon in language that the subject can understand.
In this particular study protocol, there should have been detailed information on how the fetus would be monitored during the procedure.Without that information, it is doubtful that the study would have passed IRB review. If there was deviation from the protocol and the fetus was not monitored as required, the principal investigator and the study sponsor would hold various degrees of liability, depending on their contractual agreement. In addition, an adverse event report would have to be timely filed with the Food and Drug Administration.
Each organization that conducts its own research or allows investigators to use their facilities has an accountable executive for research. Seek out that individual and ask what research is being conducted at your hospital. You might be surprised to find out that studies are being done by physicians and other professionals without the knowledge of the accountable executive or the hospital’s or community’s IRB. If this is the case, you are likely at risk of additional liability including federal penalties.
Additionally, it is essential for doctors and other medical providers to create an ongoing dialogue with their legal counsel to understand how medical malpractice caps apply in their state. While many jurisdictions throughout the country have placed limits on medical malpractice recovery for plaintiffs, the types of limitations vary depending on the kind of damages sought. In medical malpractice suits, a plaintiff may request economic and non-economic damages.
Many states throughout the country have passed legislation to place limits on the amount of non-economic damages a plaintiff may recover. In this particular case, Indiana has placed a limit for recovery for all damages, including economic and non-economic damages, at $1.25 million dollars. It is critical to ask your in-house or outside counsel to explain if and how state caps apply to you. Doing so will ensure that you are adequately apprised of the financial risks and protections afforded to you by the state in which you practice.
- Case No. 82C01-0508-CT-667 (Vanderburgh Circuit Court, Vanderburgh County, IN). Aug. 23, 2013. F