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Looney v. Moore

United States Court of Appeals, Eleventh Circuit

July 6, 2017

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.

          CERTIFICATION FROM THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT TO THE SUPREME COURT OF ALABAMA PURSUANT TO ALABAMA RULE OF APPELLATE PROCEDURE 18.

          JULIE CARNES, Circuit Judge

         TO THE SUPREME COURT OF ALABAMA AND ITS HONORABLE JUSTICES:

         This appeal concerns an unsettled question of Alabama law that, in the interests of comity and consistency, we believe the Alabama Supreme Court to be the appropriate court to answer. 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 the negligence, negligence per se, breach of fiduciary duty, and products liability claims were properly dismissed.

         The viability of the claim alleging lack of informed consent, however, is less clear. 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. Alabama law has not addressed this particular question. Because its resolution will determine whether Plaintiffs' claim may proceed and because there are "no clear controlling precedents" from the Alabama Supreme Court, we respectfully certify this question to the Alabama Supreme Court pursuant to Alabama Rule of Appellate Procedure 18.

         I. 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.

         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.

          II. ANALYSIS

         We agree that under applicable Alabama law and taking all inferences in the light most favorable to Plaintiffs, Plaintiffs have failed to show that enrollment in the SUPPORT study caused their injuries. What is not clear is whether the absence of an actual physical injury caused by the SUPPORT study dooms Plaintiffs' argument that Defendants are nonetheless liable because they failed to obtain Plaintiffs' informed consent to participate in that study. We first discuss the causation issue before turning to the question that we certify concerning the informed consent claim.[2]

         A. Plaintiffs Have Presented Insufficient Evidence that the SUPPORT Study Caused Plaintiff's Alleged Injuries

         The Alabama Supreme Court has made clear that, "to present a jury question, the plaintiff in a medical-malpractice action must adduce some evidence indicating that the alleged negligence (the breach of the appropriate standard of care) probably caused the injury. A mere possibility is insufficient."[3]Cain v.Howorth, 877 So.2d 566, 576 (Ala. 2003) (quoting Rivard v. Univ. of AlabamaHealth Servs. Found., P.C., 835 So.2d 987, 988 (Ala. 2002)) (alterations omitted; emphasis in original); see also Lyons v. Walker Reg'l Med. Ctr., 791 So.2d 937, 942 (Ala. 2000); Golden v. Stein, 670 So.2d 904, 907 (Ala. 1995). The district court concluded that Plaintiffs had failed to show that it was their participation in the SUPPORT study, as opposed to their premature births and consequent low birth-weight, that caused Plaintiffs' injuries. Defendants' three experts each recognized that the injuries suffered by Plaintiffs are consistent with those that extremely low birth-weight infants experience. In other words extreme prematurity, by itself, carries increased risks of the kinds of ...


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