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# Grant Implanted Device Exception: WLF
- URL: https://www.fdaweb.com/grant-implanted-device-exception-wlf/
- Published: 2018-10-04T12:00:00.000Z
- Updated: 2026-09-15T00:36:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142512

Washington Legal Foundation (WLF) is asking the Utah Supreme Court to adopt the exception to strict product liability for implanted medical devices that has long applied to prescription drugs. In its *amicus* [brief](https://www.wlf.org/wp-content/uploads/2018/10/1032018%5FWLF-Amicus-Brief-Burningham.pdf?ref=fdaweb.com) in a case certified to the state court by the Utah federal court, WLF says that strict product liability litigation alleging defective design could force manufacturers to stop production or alternatively increase prices and pass the costs on to consumers.

The Utah Supreme Court is being asked to answer the federal court’s question of whether implanted medical devices (such as Wright Medical implanted hips, in this case) fall under the “unavoidably unsafe” exception to strict product liability in design defect claims,

In a media [statement](https://www.wlf.org/2018/10/03/communicating/wlf-urges-utah-supreme-court-to-exempt-implanted-medical-devices-from-strict-products-liability/?ref=fdaweb.com), WLF says the state court applied that exception to prescription drugs in a 1991 case, reasoning that prescription drugs merit such legal protection because of their unique characteristics. “Each patient can react to prescription drugs differently,” WLF says, “making it impossible to develop a product that is completely without risk. But there is a great public interest in the availability and affordability of these potentially life-saving products. Implanted medical devices pose similar risks even when used as intended, but like prescription drugs, the benefits they provide outweigh those risks.”

FDA thoroughly analyzes implanted medical devices’ risks and benefits when clearing the products for public release, WLF says. And doctors prescribe devices on an individual, case-by-case basis. “If the Utah Supreme Court refuses to consider medical devices as ‘unavoidably unsafe,’” it concludes, “juries will step into the shoes of FDA and patients’ physicians.”