Looney v. Moore

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT study), conducted at the University of Alabama at Birmingham, was designed to identify the optimal range of oxygen-saturation levels for low-birthweight babies. The study divided babies into two groups. One group was kept at the low end of the standard of care for oxygen saturation, and the other group was kept at the high end of the standard of care for oxygen saturation. DreShan Collins, Christian Lewis, and Jaylen Malone (participants) (plaintiffs) were premature babies who were enrolled in the SUPPORT study after their parents signed informed-consent documents. It was later determined that the informed-consent documents did not meet regulatory standards. Two of the participants developed neurological issues and one developed retinopathy. The participants, through their parents, filed a complaint in federal district court, alleging negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent. The district court granted summary judgment on all claims, finding that there was no proof that the participation in the SUPPORT study injured the participants. On appeal, the United States Court of Appeals for the Eleventh Circuit affirmed the district court’s grant of summary judgment for all claims except for the lack-of-informed-consent claim. The court considered whether a lack-of-informed-consent claim requires a plaintiff to prove an injury arising from participation in a study.