In Looney v. Moore, 2018 WL 1547260 (11th Circuit Mar. 30, 2018), the Eleventh Circuit confirmed Alabama law’s rejection of an “increased risk of harm causation standard and established that lack of informed consent plaintiffs must have a physical injury.

Looney is a clinical trial case. Parents of several infants who were born prematurely claimed that the infants suffered injuries as a result of their participation in a clinical trial aimed at analyzing the effects of differing oxygen saturation levels on premature infants. Plaintiffs made negligence, negligence per se, product liability, breach of fiduciary duty and lack of informed consent claims, and they sued the doctors involved in the study, as well as the independent review board and the company that made the medical equipment for the study. Defendants won at the summary judgment stage, and the Eleventh Circuit affirmed.

The simplest issue was causation. The Eleventh Circuit applied Alabama’s strict requirement that a plaintiff making a negligence claim must show that the negligence more than likely caused plaintiff’s injury. An “increase risk of harm” is insufficient:

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. . . . . An alleged “increased risk of harm” is not sufficient to survive summary judgment under Alabama law, which requires proof that the alleged negligence probably caused the injury.

Id. at *3.

Confirming this standard turned out to be the end of plaintiffs’ negligence claims. That’s because no expert, whether it be for plaintiffs or defendants, was willing to say that the defendants’ negligence during the clinical trial probably caused any of the infants’ injuries. At their depositions, defendants’ experts said that the infants’ premature births probably caused their injuries, not participation in the study. Id. Plaintiffs’ own expert could only manage to say that the clinical trial “increased the risk of harm” to the infants, not that it more likely than not injured them. Id. This testimony gave a jury no basis to find for plaintiffs, and the Eleventh Circuit affirmed defendants’ summary judgment victory. Id. at *4.

Plaintiffs’ informed consent claim was a bit trickier. Plaintiffs argued that they did not need a physical injury to make this claim, something that Alabama law had not directly addressed. Id. The Eleventh Circuit sought help on this, certifying a question to the Alabama Supreme Court. But the Alabama Supreme Court declined to answer. Id. This left the Eleventh Circuit in the position of having to predict how Alabama law would decide the issue. Id.

To do this, the Eleventh Circuit first considered the Alabama Medical Liability Act. It required an injury. The Eleventh Circuit also considered Alabama Supreme Court informed consent decisions. In each instance, the court laid out the elements of any informed consent claim, but they did not explicitly include injury. The Eleventh Circuit was not troubled by this because, in each case, the plaintiff not only suffered an injury, but a serious one. Id. at *5.

Left looking for any support for their theory of a claim without physical injury, plaintiffs pointed to battery claims, in particular medical battery claims, which in Alabama do not require physical injury. Id. at *7. The Eleventh Circuit distinguished these claims. Battery claims are not based in negligence, but instead on a lack of any consent at all. Id. On the other hand, plaintiffs in lack of informed consent claims actually give consent to the procedure. They just claim that their consent was ill informed. Id. at *8. In other words, their claims are based on the negligence of the medical providers. And that brings us back to the strict requirement under Alabama law that a plaintiff making a negligence claim must establish that the negligence probably caused an injury. With that, the Eleventh Circuit upheld summary judgment against plaintiffs’ informed consent claims. Id. at *9.