Infant Injured In Clinical Studies: Is It A Recoverable Injury?


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.

The philosophy supporting the utilization of clinical studies is sound, as such studies allow researchers in the medical community to review the effects of novel techniques or medications while often compensating the subjects of the study for their time and increased risk of harm. However, as the above case demonstrates, where the effects of the study mirror or are similar to the effects of the ailment suffered by the subjects, the legal burden of showing that the breach of the appropriate standard of care probably caused the injury will be difficult for a plaintiff to overcome. In most jurisdictions, a showing that the negligence possibly or potentially caused the injury is insufficient, which stacks the cards against the injured plaintiff from the outset. Moreover, even an increased risk of harm is insufficient to satisfy the burden of showing a probability that the alleged negligence actually caused any harm.

Alternatively, the Court of Appeals’ decision suggests that similar plaintiffs might have a higher likelihood of prevailing if the pleadings set forth a claim for lack of consent under the tort claim for intentional battery, rather than lack of informed consent under a negligence theory. Under the former, an actual injury is not a necessary element, while the latter requires the existence of a physical injury and thus a showing that the defendant’s actions caused that physical injury. In the above case, the inclusion of the word “informed” shifted imposed the additional burden of the existence of an actual injury arising from the alleged breached duty.

While the ultimate question of whether an actual injury is required to prevail on a claim for lack of informed consent, an individual suffering from an illness contemplating participating in a clinical study should consider whether the type of adverse effects that could be caused by the treatment are so similar to that of the illness that the similarity would make it highly unlikely that the adverse effects could be contributed to the treatment.

Please note that the Law Offices of Kevin C. Ford is currently accepting serious infant  and adult clinical study injury cases throughout the State of  Georgia. If you or a loved one has been injured as the result of the tortious conduct of a health care provider, then please contact me immediately, as time if of the essence and crucial information and evidence needs to be secured as soon as possible.  We have the necessary experience to help you!

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