Looney v. Moore

No. 2:13-CV-00733-KOB, 2015 WL 4773747 (N.D. Ala. Aug. 13, 2015)
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The infant Plaintiffs in this case were part of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a clinical research trial aimed at measuring the effects of oxygen saturation levels in premature infants with low birth weights, at the University of Alabama-Birmingham Hospital. For the trial, participants were randomly assigned into groups, and the oxygen saturation levels were varied depending on group assignment. The device that monitored oxygen saturation levels was offset, and as such, nurses and physicians were unaware of the infant’s actual oxygen saturation level unless it dropped above or below a certain percentage.

The Plaintiffs claimed that participation in the study increased their risk of physical and neurological problems.

The Court granted the Defendants’ summary judgment motions as to all of the Plaintiffs’ claims. The Court reasoned that Alabama courts have consistently declined to allow recovery for an increased risk of future harm and require that the Plaintiff suffer an actual injury to state a claim for relief. The Plaintiffs in this case bore the burden of causation, which, in Alabama, required them to prove that the defendant’s acts or omissions “probably caused, rather than only possibly caused, the plaintiff’s injury.”

The Plaintiffs were unable to show causation.  Neither the association between the injury and range of oxygen saturation levels nor the testimony of Dr. Hermansen was enough to establish causation.

“[T]he Plaintiffs’ ‘increased risk of past harm’ theory is unsupported by Alabama law and to allow such claims to move forward would violate Article III standing requirements.” Page 10.

“Given the numerous other possible causes of their injuries, the Plaintiffs must present expert testimony that their participation in the SUPPORT study ‘probably’ caused their injuries.” Page 13.

“Plaintiffs’ claims based on the injuries actually suffered similarly fail because the Plaintiffs are unable to establish that a lack of informed consent, a breach of fiduciary duty, or a defectively designed oximeter probably caused the infant Plaintiffs’ injuries.” Page 15.

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