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# ‘Roundabout’ Causation in Failure-to-Report Claims: Attorney
- URL: https://www.fdaweb.com/roundabout-causation-in-failure-to-report-claims-attorney/
- Published: 2016-09-20T12:00:00.000Z
- Updated: 2026-09-14T21:33:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136860

Attorney **James Beck** (Reed Smith) says that causation in failure-to-report claims is necessarily roundabout because, as the 9th Circuit Court of Appeals held in 2013, “any attempt to predicate the claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=eb402403-06d5-4bfe-9d79-446fa8cafe54&ref=fdaweb.com), Beck says that the causal chain requires first that FDA would do something differently (such as make adverse events public), and second, that the hypothetical action by FDA would have caused the prescriber, in turn, to change his or her prescribing decision in some way that would have prevented the claimed injuries.

He notes that he believes the 9th Circuit erred in its 2013 *Stengel v. Medtronic* decision when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a government agency such as FDA. But since the Supreme Court declined to hear an appeal of the decision, the ruling stands.

Beck’s lengthy post reviews a number of cases, often decided on the pleadings, that explore the role of causation when a federal agency with preemptive power is involved in state-law litigation.