Nature of the Case
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Facts
The University of Alabama was the lead study site for a national clinical research trial. The study was created to analyze the effects of differing oxygen saturation levels on premature infants. At the time of the study, it was nationally accepted (and neither party contests) that the recognized standard of care was to keep the oxygen saturation levels of low-birth-weight infants at between 85% and 95%. A prolonged period of high oxygen saturation can result in oxygen toxicity, which leads to an increased risk of 'retinopathy of prematurity.' A prolonged period of low oxygen saturation can result in neuro-developmental impairment and death. The study sought to determine whether, within the accepted standard of care, there was a more precise range of oxygen saturation that would better reduce the risk of exposing an infant to either too much or too little oxygen. One group was to be kept at an oxygen saturation level between 85-89%, which is the low end of the standard-of-care range, while the other would be kept at an oxygen saturation level between 90-95%, which is the high end of that range. Specialized oximeters would 'mask' to an onlooker the true oxygen saturation levels of the infants. The oximeters would, however, signal an alarm whenever an infant's oxygen level strayed below 85% or above 95%. The study concluded that infants in the high-oxygen group were more likely to be diagnosed with retinopathy while infants in the low-oxygen group were more likely to die. There was no statistically significant difference in the incidence of neuro-developmental impairments between the high and low groups. To enroll in the study, Ps had to execute informed consent documents that were drafted and approved by Ds. After the study's completion, the Department of Health and Human Services authored a letter questioning whether these informed consent documents had properly disclosed all of the risks associated with enrollment in the study. Ps sued Ds for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent. Plaintiffs Lewis and Malone were assigned to the low-oxygen group, with prolonged periods of low oxygen saturation being associated with neuro-developmental impairment and death. Fortunately, neither infant died, but they did develop neurological issues. Plaintiff Collins was assigned to the high-oxygen group, with prolonged high oxygen saturation being associated with retinopathy, which can lead to blindness. Plaintiff Collins did develop retinopathy but did not suffer permanent vision loss. The district court concluded that Ps had failed to show that it was their participation in the study, as opposed to their premature births and consequent low birth weight, that caused Ps' injuries. Ds' three experts each recognized that the injuries suffered by Ps are consistent with those that extremely low birth-weight infants experience. The district court granted summary judgment to Ds. Ps appealed.
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