The circumstances behind a wrongful death based on medical malpractice range from misdiagnosis to medication errors. One related area of injury law is based on claims that defective drugs or medical devices caused a person’s death, prolonged an illness or resulted in other harm.
A recent opinion from the Supreme Court of South Carolina reveals some of the complexities that can occur when a patient or family members pursue a product liability claim against a medical device manufacturer. In Graves v. CAS Medical Systems, parents who lost their six-month-old premature daughter claimed that a design defect in a baby monitor led to the baby girl's death.
The girl was one of a set of prematurely born triplets who spent their first six weeks in the hospital. Upon their release, the family’s doctor recommended that the parents employ a CAS monitor to track heart rates and breathing to signal attacks of apnea, bradycardia or tachycardia.
When the mother went in to check on the triplets around 4 a.m. one morning, one of the girls was unresponsive. Though the mother immediately began performing CPR, the baby was dead before an ambulance arrived, and the official cause of death was ultimately identified as Sudden Infant Death Syndrome (SIDS).
The parents reported that the alarm on the CAS baby monitor never sounded. However, the device recorded a slow heartbeat and multiple apneic and bradycardia events after 2 a.m. and indicated that the baby had passed the point of resuscitation at 2:52 a.m. The device also recorded that the alarm had sounded for each of the more than two dozen adverse health events that it detected.
Based in part on the testimony of software experts, the parents pursued a strict liability design defect lawsuit against CAS. The trial court granted summary judgment to the defendant, finding that the expert testimony was unreliable and that circumstantial evidence of the alarm’s failure to sound could not substantiate a product liability claim.
Complex Medical Device Litigation Means Complex Issues of Proof
The heart of the deficiency in the plaintiffs’ experts’ opinions regarding the baby monitor was their failure to thoroughly test for a software error that failed to sound the alarm but allowed the device to indicate that it had. All three experts had concluded that a software error occurred based on a “reasoning to the best inference” analysis of causation due to the unlikelihood that the parents (and another family member staying in the house) could have slept through the high volume alarm.
Reviewing the case, the Supreme Court agreed that the expert testimony was insufficient to support the claim and upheld the trial court’s rejection of the claim. Rule 702 of the South Carolina Rules of Evidence governs the use of scientific, technical, or other specialized knowledge to help a judge or jury understand the evidence. Expert testimony is only admissible if it explains something beyond the ordinary knowledge of juries, the expert has the requisite knowledge to provide that explanation, and the substance of the testimony is reliable.
In this case, reliability was brought into question by the experts’ failure to consider the possibility that the parents failed to hear the alarm. While the simultaneous rejection of the conclusions of three separate experts seems particularly severe, the opinion points out the importance of experience and diligent legal preparation to ensure that a client harmed by a complex technical device gets his or her day in court.