Minn. Stat. §480A.08, subd. 3 (1996).
STATE OF MINNESOTA
IN COURT OF APPEALS
Jay Wyttenhove, et al., on behalf of
themselves and all others similarly situated,
Fairview Hospital and Healthcare Services,
Filed September 23, 1997
Hennepin County District Court
File No. MP 95-014941
Ronald S. Goldser, Keelyn M. Friesen, Zimmerman Reed, 5200 Norwest Center, 90 South Seventh Street, Minneapolis, MN 55402 (for Appellants)
Rebecca Egge Moos, Gregory W. Deckert, Bassford, Lockhart, Truesdell & Briggs, 3550 Multifoods Tower, 33 South Sixth Street, Minneapolis, MN 55402 (for Respondent)
Considered and decided by Norton, Presiding Judge, Peterson, Judge, and Schultz, 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.
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, et al. v. Abbott Northwestern Hosp. ___ N.W.2d ___ (Minn. App. September 9, 1997).
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 in Femrite on all issues, we affirm the district court's grant of summary judgment in favor of Fairview.
[*] Retired judge of the district court, serving as judge of the Minnesota Court of Appeals by appointment pursuant to Minn. Const. art. VI, § 10.