Opinion ID: 4436393
Heading Depth: 1
Heading Rank: 5

Heading: conclusion

Text: ¶40 We first address the fourth certified question to clarify that we do not opine on whether PMA-approved medical devices are unavoidably unsafe as a matter of law because they are already exempt from all state products liability claims under the United States Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). ¶41 We answer the first certified question conditionally. Although the unavoidably unsafe exception might immunize some implanted medical devices from strict products liability, when such a device enters the market through the 510(k) process we cannot say that this will always be the case as a matter of law. ¶42 Regarding the second certified question, the exception does not apply categorically to all 510(k)-cleared devices. It should be raised by the defendant as an affirmative defense and determined by the factfinder on a case-by-case basis. ¶43 As to the third certified question regarding the proper analysis to determine whether the defendant has proven the exception, we conclude that the MUJI instruction properly explains Utah law. However, some additional language must be added explaining that this affirmative defense is unavailable if the plaintiff alleges and proves by a preponderance of the evidence that the product was improperly manufactured or contained inadequate warnings. 16