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Bryant v. HCA Health Services of Tennessee3/13/2000
gan Cage. This study was monitored by the defendant hospital's Institutional Review Board. Ms. Bryant, however, concedes that she was "never the subject to a research study that was monitored and reviewed by [the defendant's Institutional Review Board] and a Brantigan I/F Cage was not utilized in her surgery."
Unlike the implantation of the introcular lens in both Friter and Kus, the pedicle screws were not implanted into Ms. Bryant under the MDA exemption for experimental devices. Pedicle screws were approved for off-label uses prior to Ms. Bryant's surgery. See Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535, 541 (Minn. Ct. App. 1997) (noting pedicle screws approved for off-label use in 1986). The plaintiff has not demonstrated that this off-label use was subject to the federal study or mandatory monitoring. The defendant, therefore, was not required by federal regulations to obtain Ms. Bryant's informed consent.
CONCLUSION
We hold that a hospital generally is not required to procure a patient's informed consent to surgical procedures ordered and performed by non-employee doctors. The hospital, however, may assume an independent legal duty to obtain the informed consent of a patient undergoing a procedure that is a part of an investigational study monitored by the FDA. The requisite circumstances necessary to impose this independent legal duty upon the hospital have not been met by the facts presented in this appeal. The trial court's grant of summary judgment for the defendant on this issue of informed consent is affirmed. The case is remanded for further proceedings consistent with this opinion. The costs of this appeal shall be taxed against the plaintiffs for which execution may issue if necessary.
JANICE M. HOLDER, JUSTICE
Concurring: Anderson, C.J. Birch, and Barker, J.J. Drowota, J., Not Participating
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