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# All Devices Should Be ‘Unavoidably Unsafe’: Attorneys
- URL: https://www.fdaweb.com/all-devices-should-be-unavoidably-unsafe-attorneys/
- Published: 2018-11-15T12:00:00.000Z
- Updated: 2026-09-15T00:45:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142827

Three King & Spalding attorneys say the “unavoidably unsafe” exception in a comment in a section of the Restatement (Second) of Torts should be categorically applied to all medical devices. [Writing](https://www.wlf.org/wp-content/uploads/2018/10/11022018LOL%5FDwyer.pdf?ref=fdaweb.com) in a Washington Legal Foundation (WLF) *Legal Opinion Letter*, the attorneys say the Utah Supreme Court will soon have an opportunity to decide whether the exception should be applied to medical devices.

The court is hearing a strict liability design defect case brought by a married couple who allege that the husband sustained damages from three implanted Wright Medical hip devices that were cleared through the 510(k) pathway. The company moved to dismiss the claims on the ground that the devices were “unavoidably unsafe” and thus barred from strict liability design defect claims under Comment k, which says that “there are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”

The letter notes that in a 1991 case, the Utah Supreme Court applied Comment k to FDA-approved drugs, and Wright has argued that the exception is not limited to prescription drugs but applies to any class of products that are “unavoidably unsafe.”

The plaintiffs argued that the court decision was specifically limited to FDA-approved drugs and said that even if it should be extended to medical devices, it should apply only to devices that are “approved” by FDA through the PMA process and not to those devices that are “cleared” through a 510(k).

The attorneys explain their position that Wright has the stronger argument in saying that the comment should apply to implanted medical devices and in saying that it should apply to both PMA and 510(k) devices.

“The differences between FDA-approved prescription drugs and medical devices — whether subject to FDA’s PMA or 510(k) process — are not sufficient to justify disparate treatment under Comment k’s “unavoidably unsafe” exception,” they conclude. “Differential treatment would be arbitrary and would undoubtedly chill innovation and development in the medical device space, reduce patient access, and increase prices for products that are vital to patients’ health. Accordingly, the Utah Supreme Court should adopt a categorial application of Comment k for all medical devices.”

In an earlier media [statement](https://www.fdaweb.com/grant-implanted-device-exception-wlf/) on the case, WLF says it filed an *amicus* brief to explain why the comment should be extended to medical devices. FDA thoroughly analyzes implanted medical devices’ risks and benefits when clearing the products for public release, it said. And doctors prescribe devices on an individual, case-by-case basis. “If the Utah Supreme Court refuses to consider medical devices as ‘unavoidably unsafe,’” WLF concluded, “juries will step into the shoes of FDA and patients’ physicians.”