By Robert B. Barnett Jr., J.D.
Individuals involved in a clinical research trial as premature infants could not sue the operators of that trial because they failed to establish that the clinical trial caused the medical conditions that they later suffered as adults, the U.S. Court of Appeals for the Eleventh Circuit ruled in upholding a lower court’s grant of summary judgment for the operators. The individuals’ own medical expert could testify only that the clinical trial "significantly increased the risk" of injuries, which was insufficient to establish actual damages under Alabama law. State law requires at least that the alleged negligence probably caused the injury. Furthermore, the Eleventh Circuit ruled for the first time that a claim for informed consent in Alabama requires an actual injury (Looney v. Moore, March 30, 2018, Carnes, J.).
A national clinical trial led by the University of Alabama at Birmingham sought to determine the optimum levels of oxygen saturation for premature infants. Under the then-current medical understanding, too high oxygen saturation could result in oxygen poisoning, often resulting in blindness. Too little oxygen saturation, on the other hand, could lead to brain damage or death. Three individuals involved in the trials brought suit in Alabama federal district court against the physician who ran the study, a board of physicians who approved the study, and Masimo Corporation, which manufactured the medical equipment used in the study. They alleged claims for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent. The district court granted summary judgment to the three groups of defendants, and the three individuals appealed to the Eleventh Circuit.
Damages. In Alabama, in what is essentially a medical malpractice action, the plaintiff must produce evidence that the alleged negligence at least probably caused the injury. A mere possibility is insufficient. The challenge for the three individuals was to prove that the conditions that they currently suffered were caused by their participation in the study, as opposed to being a consequence of their premature births and low birth weights. Three medical experts for the study operators testified that the injuries currently suffered by the clinical trial participants were consistent with injuries typically suffered by premature infants. In their opinion, the injuries were more likely caused by their prematurity than by their participation in the clinical trial.
The medical expert for the three individuals, however, could not say that the clinical trial participation probably caused their injuries. The best he could do was to say that their participation "significantly increased the risk" that they would suffer the injuries. Under Alabama law, an alleged increased risk of harm is insufficient to survive summary judgment in a negligence action. It did not matter for liability purposes, the court said, whether the increased risk of harm occurred in the past or the future—Alabama law requires a present injury. As a result, the court affirmed the lower court’s grant of summary judgment for the negligence, negligence per se, breach of fiduciary duty, and products liability claims.
Informed consent. The Eleventh Circuit concluded that Alabama law had not yet addressed whether proof of a medical injury was required to recover in a claim for informed consent. Clearly, if the claim were to be characterized as negligence or medical malpractice, actual injury would be required, just as it would be for any similar claim. To that end, the Eleventh Circuit certified the question to the Alabama Supreme Court, which refused to answer it. The Eleventh Circuit, therefore, was left to guess how the Alabama Supreme Court would rule. On the one hand, the Alabama Supreme Court, when listing the elements for an informed consent claim in other cases, never listed an injury as one of the elements (see, for example, Phelps. v. Dempsey, 656 S. 2d 377, 377 (Ala. 1995)).
Ultimately, however, the Eleventh Circuit concluded that Alabama law requires an actual injury for informed consent because (1) the malpractice law requires an actual injury, (2) the Alabama Supreme Court ruled that the state malpractice law applied to informed consent claims, (3) actual injuries are required generally in Alabama common law negligence actions, (4) the majority of other states require actual injury for informed consent claims, and (5) the Alabama Supreme Court’s failure to address actual injury in the previous cases can be explained away because actual injuries were obviously present in those cases. As a result, the Eleventh Circuit upheld the lower court’s grant of summary judgment for lack of actual injury for the informed consent claim.
The Eleventh Circuit, therefore, affirmed in full the lower court’s grant of summary judgment to the clinical trial operators.
The case is No. 15-13979.
Attorneys: Reginald D. McDaniel (Reginald McDaniel, Attorney, LLC) for Billy Ryan Looney. Jay M. Ezelle (Starnes Davis Florie LLP) for Sheila D. Moore.
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