The Alabama Supreme Court was asked by the Eleventh Circuit to decide whether claims made by a group of parents who allege a clinical trial caused their premature infants to suffer injuries could proceed on claims of lack of informed consent, Law360 reported.
At issue with the Eleventh Circuit is whether the parents needed to prove the study caused their children’s injuries in order to sue for lack of informed consent over claims that the researchers did not fully disclose the study’s risks.
The lawsuit was filed by the parents in 2013 and names lead researcher Dr. Waldemar Carlo; the University of Alabama Review Board and several of its staffers who approved the study; and a medical device company.
The study aimed to identify the ideal range of oxygen exposure for premature infants. The range is generally considered to be between 85 and 95 percent. The study randomly assigned infants to receive either 85 to 89 percent or 90 to 95 percent oxygen saturation.
Researchers found that study participants who received the upper range of oxygen saturation were more likely to suffer vision damage. Children who received the lower range of oxygen were more likely to die. The parents allege that the study was unethical because it did not allow the infants’ oxygen levels to be adjusted based on their individual medical needs.
During discovery it was never proven that the injuries the infants suffered were due to the study or from complications of prematurity. A summary judgment was granted in August 2015.
The Eleventh Circuit upheld the decision on appeal, tossing most of the claims, but asked the Alabama Supreme Court to clarify whether the ability to prove the study actually resulted in injuries was necessary for the plaintiffs to pursue a claim of lack of informed consent.