No. C3-97-51.Minnesota Court of Appeals.
Filed September 23, 1997.
This opinion will be unpublished and may not be cited except as provided by Minn. Stat. § 480A.08, subd. 3 (1996).
Appeal from the District Court, Hennepin County, File No. MP 95-014941.
Ronald S. Goldser, Keelyn M. Friesen, Zimmerman Reed, (for Appellants).
Rebecca Egge Moos, Gregory W. Deckert, Bassford, Lockhart, Truesdell Briggs, (for Respondent).
Considered and decided by Norton, Presiding Judge, Peterson, Judge, and Schultz, Judge.[*]
UNPUBLISHED OPINION
NORTON, Judge.
Appellants challenge summary judgment on various tort claims arising from injuries they incurred as a result of spinal fusion surgery. The district court properly granted summary judgment in favor of respondent on all claims. We affirm.
FACTS
Appellants Jay Wyttenhove, Lynda Dahl, Gail Christian, and Dana Frank underwent spinal fusion surgery in which their doctors implanted orthopedic screw devices into the pedicles of their spines to secure the vertebrae and allow the bones to fuse properly. Appellants’ surgeries occurred between 1990 and 1992 at respondent Fairview-Riverside Hospital. After each patient experienced complications from the surgical implants, they commenced this action against Fairview alleging negligence, corporate negligence, negligence per se, fraudulent concealment, and strict liability in administrative services.
Fairview moved for summary judgment. After a hearing, the district court determined that appellants’ claims were viable under the six-year statute of limitations. Minn. Stat. § 541.05 (1996). The court, however, granted summary judgment for Fairview on all claims. The district court dismissed the negligence claims on the basis that use of the screw device in spinal fusion surgery did not violate the Food, Drug, and Cosmetic Act (FDCA). The court declined to adopt the doctrines of corporate negligence and strict liability in administrative services. The court determined that the FDCA does not provide a private cause of action. The court also determined that appellants’ fraudulent concealment claim failed because the physician, not the hospital, has the duty to obtain a patient’s informed consent and the record contained no evidence that Fairview actively concealed anything from appellants.
Appellants contend the district court erroneously granted summary judgment for Fairview on all of these claims. Fairview, in a notice of review, contends that two other bases existed for summary judgment: an expired statute of limitations and appellants’ failure to provide an affidavit of expert review, as required under Minn. Stat. § 145.682
(1996).
On appeal, this case was stayed pending the decision in Femrite, etal. v. Abbott Northwestern Hosp. ___ N.W.2d ___ (Minn.App. September 9, 1997).
DECISION
After an exhaustive and intensive examination of the record and the law relating to the issues in this case, we have determined that the issues raised here are essentially the same as those raised in Femrite,
___ N.W.2d at ___. Both Fairview and Abbott-Northwestern Hospital allowed doctors to implant the screw devices without informing patients of the investigational nature of the device, even though both hospitals were simultaneously conducting clinical studies in which they were evaluating the safety and effectiveness of the screw devices in patients who gave informed consent to receive investigational medical devices.
Although this case raises serious questions regarding the safety of the uncontrolled off-label use of medical devices that the FDA may simultaneously label “investigative” in nature, we recognize that these questions are not for this court, but rather for the FDA and the medical community to address.
The FDA documents, of which the court took judicial notice in Femrite,
establish unequivocally that the FDA was aware that implant of the screw device in spinal pedicles was a permitted off-label use and not a violation of the FDCA. Consequently, pursuant to this court’s decision inFemrite on all issues, we affirm the district court’s grant of summary judgment in favor of Fairview.
Affirmed.