Christian Lewis v. Sheila D. Moore
886 F.3d 1058
11th Cir.2018Background
- SUPPORT was a randomized, double-blind clinical trial at UAB comparing lower (85–89%) vs. higher (90–95%) oxygen saturation targets for extremely premature infants; Masimo oximeters were used to mask true readings.
- Standard of care at the time accepted 85–95% saturation; known tradeoffs: higher oxygen increases retinopathy risk, lower oxygen increases risk of death and neurodevelopmental injury.
- Plaintiffs (through parents) alleged injuries: one infant developed retinopathy (high-oxygen arm); two infants developed neurological problems (low-oxygen arm). Plaintiffs claim negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent based on study design and consent forms.
- Defendants moved for summary judgment arguing plaintiffs failed to show the study probably caused the alleged injuries rather than those injuries being attributable to extreme prematurity; defendants’ experts attributed the harms to prematurity; plaintiffs’ expert only testified to an increased risk, not probable causation.
- District court granted summary judgment for defendants; Eleventh Circuit affirmed, holding plaintiffs did not prove causation and that Alabama law requires an actual injury for informed consent claims arising in this context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether SUPPORT participation probably caused plaintiffs’ injuries | Study increased risk and therefore caused injuries | Injuries are consistent with extreme prematurity; plaintiffs lack proof of probable causation | Plaintiffs failed to show probable causation; summary judgment affirmed |
| Whether an increased risk (without proof risk manifested) suffices under Alabama law | Increased risk is actionable (past or future) | Alabama requires proof the negligent act probably caused actual injury | Increased risk alone is insufficient; Alabama requires probable causation |
| Whether informed-consent claims require proof of an actual injury under Alabama law | Informed-consent is distinct from malpractice/battery; does not require physical injury | Informed-consent claims are governed by AMLA/treated as negligence and require actual injury | Court predicts Alabama would require an actual injury for informed-consent claims in this context; claim fails |
| Whether informed-consent claims arising from research should be treated as battery (no-injury) or negligence/malpractice (injury required) | Analogize to battery: consent absent or defective, injury not required | Distinguish battery (intentional nonconsensual touching) from lack of informed consent (negligence); AMLA governs informed consent | Court rejects battery analogy; treats informed consent as within malpractice/negligence framework requiring injury |
Key Cases Cited
- Cain v. Howorth, 877 So.2d 566 (Ala. 2003) (medical-malpractice causation requires proof negligence probably caused injury)
- Houston County Health Care Auth. v. Williams, 961 So.2d 795 (Ala. 2006) (AMLA governs medical-injury claims, exposure without manifest physical injury is not actionable)
- Giles v. Brookwood Health Servs., Inc., 5 So.3d 533 (Ala. 2008) (elements of informed-consent claim: failure to disclose material risks and that a reasonable patient would have declined)
- Phelps v. Dempsey, 656 So.2d 377 (Ala. 1995) (articulating informed-consent elements in context of actual injury)
- Ex parte Vanderwall, 201 So.3d 525 (Ala. 2015) (AMLA’s scope; distinguishes battery from injuries arising from medical services)
- Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972) (majority rule: undisclosed risk must materialize into actual injury for informed-consent liability)