## Facts

- Cary Femrite (Dec. 1989) and Ruth Perkl (Feb. 1990) underwent spinal fusion surgeries at Abbott Northwestern Hospital involving implantation of pedicle screw systems.
- Femrite received a “VSP/Steffee” system; Perkl received a “Cotrel Dubousset” system.
- The operating surgeons were not hospital employees; they were independent physicians with privileges at the hospital.
- At the time of surgery, neither patient was told the procedure was “experimental” or that pedicle implantation was “investigational.”
- Both patients later experienced complications and medical problems and sued the hospital based on the hospital’s alleged role in permitting investigational use without research-subject protections and adequate consent.
- The dispute centered on whether using FDA-cleared orthopedic hardware in spinal pedicles was impermissible investigational research requiring an IDE and IRB-type protections, or instead a permissible “off-label” clinical use.

## Issues

1. Whether implantation of orthopedic screw devices in spinal pedicles constituted legally permissible “off-label” use of FDA-cleared devices.
2. Whether Minn. Stat. § 144.651, subd. 13 (Patients’ Bill of Rights) applies to patients receiving off-label use, or only to persons participating in “experimental research.”
3. Whether a hospital has a duty to ensure informed consent for procedures performed at the hospital by non-employee physicians.

## Decision

- The court affirmed summary judgment for Abbott Northwestern Hospital on all claims.
- The court held the spinal use of the devices was a legally permissible off-label use because the devices were FDA-cleared for other orthopedic uses.
- The court held Minn. Stat. § 144.651, subd. 13 applies only to persons participating in experimental research and did not apply to these surgeries.
- The court held the hospital had no duty to ensure patients gave informed consent for procedures performed by independent, non-employee physicians.

## Legal Principles

- Use of an FDA-cleared medical device for an unapproved anatomical site or indication may be a lawful off-label use within a physician’s professional judgment and does not, by itself, convert treatment into investigational research requiring an IDE.
- Minn. Stat. § 144.651, subd. 13 protects research subjects participating in “experimental research” and does not extend to patients receiving off-label clinical treatment.
- Absent an employment relationship or other special basis for responsibility, a hospital generally has no duty to secure or police informed consent for procedures performed by independent physicians who practice at the hospital.

## Conclusion

The court treated the pedicle screw implantations as off-label clinical care rather than experimental research, rejected reliance on Minnesota’s research-subject provision in the Patients’ Bill of Rights, and held the hospital was not responsible for ensuring informed consent for surgeries performed by non-employee physicians.


Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997)