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Bioethics Keyed to Clark, 9th Ed.
Looney v. Moore
Citation:
861 F.3d 1303 (2017)Facts
The SUPPORT study was designed to determine the optimal oxygen saturation range for premature infants within the nationally accepted standard of care (85-95%). The study randomly divided enrolled premature infants into two groups: one maintained at 85-89% oxygen saturation (low end) and the other at 90-95% (high end). Specialized oximeters masked the true oxygen levels but would alarm if levels went outside the 85-95% range. Plaintiffs Lewis and Malone were assigned to the low-oxygen group and later developed neurological issues, while Plaintiff Collins was assigned to the high-oxygen group and developed retinopathy (though without permanent vision loss). The study results showed infants in the high-oxygen group were more likely to develop retinopathy while those in the low-oxygen group had higher mortality rates. After the study’s completion, the Department of Health and Human Services questioned whether the informed consent documents had properly disclosed all risks. Plaintiffs’ expert could not identify any specific alternative care that should have been provided or testify that the study probably caused their medical conditions, only that it “significantly increased the risk” of such ailments.
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