Failure-to-warn not preempted by federal law

The Ninth Circuit (en banc) held that a state-law failure-to-warn was not preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act.  The Ninth Circuit explained that the Amendments parallels the state-law claim, and therefore does not preempt, either expressly or impliedly.

What does this mean?  The federal court of appeals made a decision whether a federal court or a state court had jurisdiction over the failure-to-warn claims.  The failure-to-warn state-law claims arise when a medical manufacturer fails to warn the patients or its physicians of known-dangers of the medical device.

The arguments in the lawsuit were rooted on the MDA explicit preemption clause – which provided that federal courts had the power to hear the case exclusively.

So why was that preemption clause irrelevant to this situation?  The Supreme Court had previously ruled, in 3 preemption cases under the MDA, that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.

 

If anything else, this is a very interesting read if you are interested in preemption rationales – express, field, and conflict.

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