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.