Cales v. Baptist Healthcare Sys., Inc. — Jan. 2017 (Summary)

PRODUCT LIABILITY – OFF-LABEL USE

Cales v. Baptist Healthcare Sys., Inc.
No. 2015-CA-001103-MR (Ky. Ct. App. Jan. 13, 2017)

The Court of Appeals of Kentucky affirmed a lower court’s dismissal of a patient’s product liability claims against a health care system and manufacturer of a medical device, but reversed and remanded her medical negligence claims.

The case arose out of the physician’s off-label use of the Infuse Device.  The FDA approved the Infuse Device, and, as approved, the label provided: “these components must be used as a system.  The Infuse Bone Graft component must not be used without the LT-Cage Lumbar Tapered Fusion Device Component.” As a system, the device consisted of BMP, a BMP/Sponge and an LT-Cage.  During the patient’s surgery, the performing physician utilized a Capstone fusion cage with the BMP/Sponge rather than the LT-Cage.

Consequently, the patient brought two product liability claims, alleging that the health system only purchased a portion of the medical device, which was unreasonably dangerous and defective, the health care system’s hospital breached its duty to act as a reasonably prudent hospital, and, in reselling the medical device, the manufacturer should have known that the device would be used off label.  Furthermore, the patient asserted medical negligence claims alleging that the health care system either knew or should have known of the risks of using the device, and that she would not have consented to the off-label use of the device.

Addressing the product liability claims, the court agreed with the lower court’s dismissal of the claim because the claims were pre-empted by federal law.  Once the FDA has approved a medical device, the Medical Device Amendments of 1976 permit off-label uses and allow a health care provider to use the device in any manner deemed appropriate.  Thus, the FDA approval pre-empts any contention that the BMP/Sponge was defective or unreasonably dangerous.

Turning to the medical negligence claims, the court held that the health care system owed a duty to the patient.  After establishing that the performing physician was an agent of the hospital, the court reasoned that the off-label use of a medical device and the need to inform a patient are questions of fact to be decided by a jury.  Therefore, the court affirmed in regard to the dismissal of the product liability claims, and reversed and remanded to the lower court the medical negligence claims.