Opinion ID: 1060640
Heading Depth: 1
Heading Rank: 4

Heading: independent legal duty

Text: The plaintiff argues that the defendant assumed an independent duty to procure her informed consent by participating in a monitored investigational study involving implantation of pedicle screws. We disagree. A hospital may assume an independent duty which it would not ordinarily bear with regard to informed consent by participating in a clinical study monitored by the Federal Drug Administration (FDA). Watkins v. Hospital of the University of Penn., 737 A.2d 263, 268 (Pa.Super.Ct.1999). In Friter v. Iolab Corp., 414 Pa.Super. 622, 607 A.2d 1111 (1992), the hospital was participating in an investigational clinical study monitored by the FDA. As a participant in the study, the hospital was required by federal regulations to obtain informed consent from any patient undergoing the experimental treatment. The court in Friter found an exception to the general rule that there is no independent duty for a non-physician to obtain a patient's informed consent. Watkins, 737 A.2d at 268. Similarly, in Kus v. Sherman Hosp., 268 Ill.App.3d 771, 206 Ill.Dec. 161, 644 N.E.2d 1214 (1995), the hospital was involved in a monitored clinical study for the implantation of intraocular lens. The implantation of intraocular lens into human subjects was permitted only under the Medical Device Amendments (MDA) of 1976 exemption for experimental devices. See generally 21 U.S.C. § 301, et seq. (1988). Pursuant to federal regulations, the internal review board of the defendant hospital was charged with the responsibility of assuring that legally effective informed consent [was] obtained. Kus, 206 Ill.Dec. 161, 644 N.E.2d at 1216. Moreover, the federal regulations mandated that certain disclosures be provided to patients involved in the study. In Kus , the court held that the hospital had an independent duty to obtain the informed consent of patients receiving implantation of intraocular lens permitted under the federal investigational exemption. Id. at 1219-1222. In the case now before us, Dr. McCord was involved in a clinical study involving the use of pedicle screws in conjunction with an I/F Brantigan Cage. This study was monitored by the defendant hospital's Institutional Review Board. Ms. Bryant, however, concedes that she was never the subject to [ sic ] 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.