## Facts

- Extremely premature infants were enrolled, through parental permission, in a multicenter clinical trial studying oxygen-saturation targets, with the University of Alabama at Birmingham as the lead site.
- The trial randomized infants into two narrower oxygen-saturation target ranges, each within the then-accepted standard-of-care range (one lower, one higher).
- Oxygen saturation was monitored using pulse oximetry equipment manufactured by a device company.
- Parents signed Institutional Review Board–approved informed-consent forms; later regulatory review concluded the forms inadequately disclosed certain reasonably foreseeable risks and alternatives.
- The plaintiffs alleged serious long-term injuries (neurological issues for two children and retinopathy for one) and claimed they would not have consented with adequate disclosure.
- Plaintiffs sued the principal investigator, IRB officials/members, and the device manufacturer under Alabama law for negligence, negligence per se, breach of fiduciary duty, products liability, and lack of informed consent.
- The district court granted summary judgment to all defendants on all claims, primarily for failure to produce evidence that study participation caused the alleged injuries.

## Issues

1. Whether plaintiffs produced sufficient evidence of proximate causation between participation in the clinical trial and the infants’ alleged injuries to sustain negligence-based and products-liability claims under Alabama law.
2. Whether, under Alabama law, a lack-of-informed-consent claim can proceed without proof of an actual injury proximately caused by the treatment/research protocol.

## Decision

- The Eleventh Circuit affirmed summary judgment for all defendants on all claims.
- For negligence, negligence per se, breach of fiduciary duty, and products liability, the court held plaintiffs failed to present evidence that the clinical trial caused the alleged injuries, defeating required causation.
- For lack of informed consent, the court held Alabama law requires proof of an actual injury caused by the treatment; absent evidence tying the injuries to the study, the informed-consent claims also failed.

## Legal Principles

- Under Alabama tort law, negligence-based and products-liability claims require proof that the defendant’s conduct proximately caused the plaintiff’s injury.
- Under Alabama law, lack of informed consent is treated as a medical-malpractice theory requiring proof of an actual injury caused by the treatment/procedure at issue.
- A plaintiff cannot recover on an informed-consent theory based solely on deficient disclosure; the nondisclosure must be linked to a treatment decision that resulted in compensable injury.

## Conclusion

The court held that, without evidence that the trial protocol caused the infants’ injuries, all Alabama tort claims failed, and that Alabama informed-consent liability likewise requires proof of an actual injury proximately caused by the treatment or research protocol.


Looney v. Moore, 861 F.3d 1303 (11th Cir. 2017)