Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Looney v. Moore

United States Court of Appeals, Eleventh Circuit

March 30, 2018

BILLY RYAN LOONEY, etc., et al., Plaintiffs,
v.
SHEILA D. MOORE, Director of the Office of the University of Alabama Institutional Review Board, FERDINAND URTHALER, M.D., Chairman of the University of Alabama Institutional Review Board, WALDEMAR A. CARLO, M.D., In his individual capacity, MASIMO CORPORATION, DR. JOHN CARPENTER, in his individual capacity, et al, Defendants - Appellees, CHRISTIAN LEWIS, By and through his parents, Bernita Lewis and Earnest Thomas, DRESHAN COLLINS, By and through his mother, Sharrissa Cook, JAYLEN MALONE, By and through his mother, Nikida Sellers, Plaintiffs - Appellants, INDIVIDUAL MEMBERS OF THE UNIVERSITY OF ALABAMA INSTITUTIONAL REVIEW BOARD, THE, etc., et al., Defendants.

          Appeal from the United States District Court for the Northern District of Alabama D.C. Docket No. 2:13-cv-00733-KOB

          Before WILSON, and JULIE CARNES, Circuit Judges, and HALL, [*] District Judge.

          JULIE CARNES, CIRCUIT JUDGE.

         Through their parents, Plaintiffs DreShan Collins, Christian Lewis, and Jaylen Malone brought claims against Defendants for harms allegedly visited on Plaintiffs when the latter were enrolled in a clinical study while being treated for health issues accompanying their premature births. Defendants fall into three groups: (1) Dr. Carlo, the physician who designed and ran the study; (2) Internal Review Board (IRB) physicians who approved the study and the informed consent materials; and (3) Masimo Corporation, which manufactured medical equipment used in the study.

         Plaintiffs brought claims against the various Defendants for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent. The district court granted summary judgment on all claims. Like the district court, we conclude that Plaintiffs have failed to establish that participation in the clinical study caused any injuries, which means that, under Alabama law, the negligence, negligence per se, breach of fiduciary duty, and products liability claims were properly dismissed.

         Alabama law has not directly addressed the viability of the claim alleging lack of informed consent. At issue is whether a plaintiff who claims that he did not give informed consent to medical treatment provided as part of a clinical study must show that he was injured as a result of that treatment. Based on our review of analogous Alabama caselaw, we conclude that Alabama law requires that there be an actual injury caused by the treatment. Accordingly, because Plaintiffs have failed to establish that their lack of informed consent caused any actual injuries, the district court appropriately granted summary judgment to Defendants on these claims as well.

         I. BACKGROUND

         A. Factual Background

          The University of Alabama at Birmingham was the lead study site for a national clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial ("SUPPORT"). Designed by Dr. Carlo and approved by the IBR Defendants, the SUPPORT 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%. This standard notwithstanding, it was also known that a prolonged period of high oxygen saturation can result in oxygen toxicity, which leads to an increased risk of "retinopathy of prematurity."[1] On the other hand, a prolonged period of low oxygen saturation can result in neuro-developmental impairment and death. Given the difficulties of calibrating the optimal oxygen range, the SUPPORT 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.

         The SUPPORT study randomly divided eligible and enrolled premature infants into two groups. 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. Further, to ensure double-blind data collection, the study would employ specialized oximeters (manufactured by Masimo) that 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%.

         Publishing the results of the study in the New England Journal of Medicine, the study authors 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, Plaintiffs' guardians had to execute informed consent documents that were drafted and approved by Defendants. After the study's completion, however, 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 SUPPORT study.

         B. Procedural History

         Plaintiffs filed the operative Fifth Amended Complaint in the United States District Court for the Northern District of Alabama asserting claims against Defendants for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent. Plaintiffs allege that they suffered serious injuries as a result of their participation in the study. Specifically, 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 fortunately he did not suffer permanent vision loss.

         Following discovery, Defendants moved for summary judgment asserting that, based on the undisputed material facts, Plaintiffs had failed to demonstrate that participation in the SUPPORT study had caused the injuries alleged in the Complaint. The district court agreed that Plaintiffs had failed to prove that their injuries were caused by participation in the SUPPORT study, as opposed to being a consequence of their premature births, and the court granted summary judgment to Defendants.

         II. STANDARD OF REVIEW

         "We review de novo the district court's grant of summary judgment." Greenberg v. BellSouth Telecomms., Inc., 498 F.3d 1258, 1263 (11th Cir. 2007). Summary judgment is appropriate "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56. Viewing the evidence in the light most favorable to the nonmoving party, "[t]here is a genuine issue of material fact if the nonmoving party has produced evidence such that a reasonable factfinder could return a verdict in its favor." Greenberg, 498 F.3d at 1263 (quoting Waddell v. Valley Forge Dental Assocs., Inc., 276 F.3d 1275, 1279 (11th Cir. 2001)).

         III. ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.