Femrite v. Abbott Northwestern Hospital
Minnesota Court of Appeals
568 N.W.2d 535 (1997)
- Written by Mary Phelan D'Isa, JD
Facts
Cary Femrite and Ruth Perkl (patients) (plaintiffs) underwent spinal fusion surgeries at Northwestern Hospital (Northwestern) (defendant) during which pedicle screw devices were implanted into their spines. Neither patient was informed that the surgeries were experimental or that the implantation of the devices was investigational. Both patients experienced complication, and both patients sued Northwestern for its alleged violation of federal law by allowing the physicians to engage in such an off-label use and implant the screw devices outside the parameters of an FDA-approved Investigational Device Exemption (IDE). The district court dismissed the patients’ claims, and they appealed. The patients argued that the devices could only be implanted into spinal pedicles as part of an FDA-sanctioned clinical investigation and that it was anomalous to suggest that physicians could consider off-label use to be the standard of care in some cases and at the same time investigational in others. Northwestern argued that because the FDA had already approved the device for use in long and flat bones, the physicians’ spinal use was a permissible off-label use, subject to the physicians’ medical discretion beyond FDA regulation.
Rule of Law
Issue
Holding and Reasoning (Harten, J.)
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