The 11th Circuit Court of Appeals, whose opinions are binding on Federal and State Courts in Alabama, Florida, and Georgia, recently affirmed the holding of the United States District Court for the Northern District of Alabama to the extent that plaintiffs failed to establish that participation in a clinical study caused any injuries due to the negligence of the defendants (the physician who designed and conducted the study, Internal Review Board who approved the study, and Masimo Corporation, who manufactured the equipment used in the study). Thus, the Court of Appeals found the plaintiff’s claims for negligence, negligence per se, breach of duty, and products liability claims were properly dismissed. However, although the Federal District Court also dismissed the plaintiff’s claim alleging lack of informed consent, the Appellate Court certified to the Alabama Supreme Court to determine whether a plaintiff who claims that he did not give informed consent to medical treatment provided as part of a clinical study must first show that he was injured as a result of that treatment.
The guardians of the plaintiff infants were required to execute informed consent documents to enroll the premature infants in a study designed to analyze the effects of differing oxygen saturation levels on premature infants. During the study, the infants were randomly divided into two groups whom would be subjected to varying levels of oxygen saturation. The group subjected to higher levels of oxygen saturation faced an increased risk of developing retinopathy, which can lead to blindness, while the group subjected to lower levels of oxygen saturation faced an increased risk of neuro-developmental impairment or other neurological issues. Both test groups subsequently suffered from the ailments; however, because both retinopathy and neuro-developmental impairment are consistent with injuries associated with extremely low birth-weight infants, the plaintiffs were unable to show that it was their participation in the study, and not their premature births and low birth-weight, that caused their injuries.
Because the above case turns upon a material state law question, the 11th Circuit Court of Appeals certified the following question for determination of Alabama law to the Alabama Supreme Court: “Must a patient whose particular medical treatment is dictated by the parameters of a clinical study, and who has not received adequate warnings of the risks of that particular protocol, prove that an injury actually resulted from the medical treatment in order to succeed on a claim that his consent to the procedure was not informed?” Importantly, by refusing to rule on the issue and certifying the question to the Alabama Supreme Court, whatever conclusion drawn in Alabama will not be binding on Georgia or Florida, leaving the question unresolved for Florida and Georgia.