STORY FROM: Drugs & Medical Devices

Application of ‘Avoidably Unsafe’ Doctrine Should be Decided on Case-By-Case Basis, Utah High Court Rules

SALT LAKE CITY – The question of whether the "unavoidably unsafe" doctrine in comment k to Section 402A of the Restatement (Second) of Torts applies to implanted medical devices should be decided on a case-by-case basis, the Utah Supreme Court has ruled.

In a Sept. 5 opinion, the high court answered certified questions posed by the U.S. District Court for the District of Utah. The high court concluded that “when an implanted medical device enters the market through the 510(k) process, and a manufacturer raises the affirmative defense that the product is unavoidably unsafe in response to a design defect ...

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Duane Morris
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