The United States Court of Appeals for the Eleventh Circuit (“Federal Appellate Court”) held in its opinion filed on March 30, 2018 that Alabama law requires that there be an actual injury caused by the treatment in order for a plaintiff who claims that he did not give informed consent to medical treatment provided as part of a clinical study to recover damages. Because the plaintiffs have failed to establish that their lack of informed consent caused any actual injuries, the Federal Appellate Court held that the district court appropriately granted summary judgment to the defendants on these claims.
The Plaintiffs’ Claims
The plaintiffs’ newborns participated in a study created to analyze the effects of differing oxygen saturation levels on premature infants that 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 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.
The results of the study were published in the New England Journal of Medicine, concluding that infants in the high-oxygen group were more likely to be diagnosed with retinopathy of prematurity 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.
In order to enroll in the study, the parents had to execute informed consent documents that were drafted and approved by the defendants. The Department of Health and Human Services subsequently questioned whether these informed consent documents had properly disclosed all of the risks associated with enrollment in the study.
The plaintiffs filed their federal lawsuit, alleging claims for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent. The plaintiffs alleged that they suffered serious injuries as a result of their participation in the study.
The defendants moved for summary judgment, asserting undisputed material facts that the plaintiffs had failed to demonstrate that participation in the study had caused the injuries alleged in the Complaint. The district court determined that the plaintiffs had failed to prove that their injuries were caused by participation in the study, as opposed to being a consequence of their premature births, and granted summary judgment to the defendants. The plaintiffs appealed.
Federal Appellate Court Opinion
The Federal Appellate Court stated that the plaintiffs can show, at most, only an increased risk of harm, not a probability that the alleged negligence actually caused any harm, and that Alabama has long required a manifest, present injury before a plaintiff may recover in tort.
The Federal Appellate Court held that the plaintiffs’ negligence, negligence per se, breach of fiduciary duty, and products liability claims are not viable under Alabama law because the plaintiffs have not provided evidence that the study “probably” caused their injuries.
With regard to the plaintiffs’ informed consent claims, the Federal Appellate Court stated that if an informed consent claim is considered to be a type of medical malpractice claim governed by the Alabama statute addressing such claims, then it is clear that a plaintiff must show the existence of an actual injury resulting from the procedure before he can raise a viable informed consent claim. If an informed consent claim is not classified as a malpractice type of claim (e.g., if an informed consent claim arising out of participation in a medical study administered as part of the medical treatment does not constitute a malpractice claim), then searching Alabama common law is necessary to figure out just what kind of claim it is.
The Federal Appellate Court certified the question to the Alabama Supreme Court, which refused to answer the question. Nonetheless, the Alabama Supreme Court had previously held that the Alabama Medical Liability Act (“AMLA”), Ala. Code § 6-5-480 et seq. and § 6-5-540 et seq. (1975) requires that claims governed by the AMLA require a showing of an actual physical injury.
The Alabama Supreme Court has stated that the elements of a cause of action against a physician for failure to obtain informed consent are: (1) the physician’s failure to inform the plaintiff of all material risks associated with the procedure, and (2) a showing that a reasonably prudent patient, with all the characteristics of the plaintiff and in the position of the plaintiff, would have declined the procedure had the patient been properly informed by the physician. Noticeably missing is any requirement that the undisclosed risk actually materialize or that any injury actually occur.
The Federal Appellate Court held: “we conclude that Alabama law requires an actual injury for informed consent claims in this context. To summarize, we know that the AMLA generally requires an actual injury for medical malpractice actions. And the Alabama Supreme Court has specifically applied the AMLA to informed consent claims in cases like Houston County. Even if the AMLA did not apply to Plaintiffs’ claims, Alabama law suggests that informed consent claims constitute negligence actions. Further, Alabama common law requires an actual injury to maintain a negligence cause of action—and in the specific context of informed consent claims, so do the majority of other courts. Finally, although it is true that in cases discussing informed consent claims, the Alabama Supreme Court did not list actual injury as a required element for those claims, there was no dispute in those cases that an actual injury existed, and the court was focusing on what constitutes informed consent. Thus, we do not consider the omission of ‘injury’ from the list as dispositive.”
The Federal Appellate Court concluded: “because Plaintiffs have offered no evidence to show that the SUPPORT study caused any actual injuries, they cannot state a claim for lack of informed consent. The district court therefore correctly granted summary judgment to Defendants.”
Source Looney v. Moore, No. 15-13979
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