Christian Lewis v. Sheila D. Moore
2017 U.S. App. LEXIS 12096
| 11th Cir. | 2017Background
- SUPPORT was a randomized, double-blind multicenter clinical trial at UAB comparing lower (85–89%) vs higher (90–95%) oxygen saturation targets for extremely premature infants using Masimo oximeters that masked true readings.
- Plaintiffs (through parents) enrolled as infants and later developed injuries: two (Lewis, Malone) in the low-oxygen arm developed neurodevelopmental issues; one (Collins) in the high-oxygen arm developed retinopathy.
- Plaintiffs sued the study designer (Dr. Carlo), IRB physicians, and Masimo for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent; district court granted summary judgment on all claims.
- On appeal, the Eleventh Circuit agreed plaintiffs failed to prove causation for negligence-based claims because experts could not show the study probably caused the injuries rather than prematurity itself.
- The Court certified to the Alabama Supreme Court a controlling unresolved state-law question: whether an informed-consent claim based on enrollment in a clinical study requires proof that the uninformed consent resulted in actual physical injury.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether plaintiffs proved causation for negligence, products-liability, fiduciary claims | SUPPORT increased risk of harm and thus supports recovery | Plaintiffs failed to show the study probably caused harm; prematurity likely caused injuries | Plaintiffs failed to show probable causation; summary judgment affirmed on these claims |
| Whether an informed-consent claim requires proof of actual physical injury | Informed-consent is actionable even absent manifest physical injury (analogous to battery or distinct tort) | Informed-consent is governed by AMLA/common-law malpractice rules and requires physical injury | Eleventh Circuit: unresolved under Alabama law; question certified to Alabama Supreme Court |
| If AMLA governs informed-consent claims, does AMLA’s injury requirement bar recovery without manifested injury | Plaintiffs: AMLA shouldn’t bar consent claims tied to research participation | Defendants: AMLA applies and requires personal injury/wrongful death for malpractice-type claims | Circuit court noted AMLA appears to require injury for malpractice; but whether it controls informed-consent in research context is certifiable question |
| Whether informed-consent in research context is equivalent to battery (no-injury recovery) or negligence (injury required) | Plaintiffs: research consent claims may be non-malpractice and akin to battery (no injury needed) | Defendants: lack-of-informed-consent is negligence-type and thus injury-dependent | Court found Alabama caselaw ambiguous and certified the legal question to state supreme court |
Key Cases Cited
- Cain v. Howorth, 877 So. 2d 566 (Ala. 2003) (plaintiff must show alleged negligence probably caused injury in medical-malpractice actions)
- Rivard v. Univ. of Ala. Health Servs. Found., P.C., 835 So. 2d 987 (Ala. 2002) (causation standard in malpractice cases)
- Lyons v. Walker Regional Med. Ctr., 791 So. 2d 937 (Ala. 2000) (malpractice causation principles)
- Golden v. Stein, 670 So. 2d 904 (Ala. 1995) (malpractice causation rule)
- Hinton ex rel. Hinton v. Monsanto Co., 813 So. 2d 827 (Ala. 2001) (rejection of medical monitoring claims absent manifest injury)
- Houston Cnty. Health Care Auth. v. Williams, 961 So. 2d 795 (Ala. 2006) (AMLA governs claims arising from patient-hospital relationship; mere exposure without manifest injury not actionable)
- S. Bakeries, Inc. v. Knipp, 852 So. 2d 712 (Ala. 2002) (Alabama requires a present, manifest injury for tort recovery)
- Ex parte Vanderwall, 201 So. 3d 525 (Ala. 2015) (AMLA applies to malpractice claims but not to intentional battery outside medical services)
- 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)
- Ex parte Mendel, 942 So. 2d 829 (Ala. 2006) (informed-consent claims analyzed under AMLA discovery rules)
- Harper v. Winston Cnty., 892 So. 2d 346 (Ala. 2004) (assault-and-battery need not show bodily injury)