Cite as: 531 U. S. 341 (2001)
Stevens, J., concurring in judgment
however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although Medtronic can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.
In sum, were plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions. On the contrary, the existence of these federal enactments is a critical element in their case. For the reasons stated above, we think this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme.
The judgment of the Court of Appeals is reversed.
It is so ordered.
Justice Stevens, with whom Justice Thomas joins, concurring in the judgment.
As the Court points out, an essential link in the chain of causation that respondent must prove in order to prevail is that, but for petitioner's fraud, the allegedly defective orthopedic bone screws would not have reached the market. The fact that the Food and Drug Administration (FDA) has done nothing to remove the devices from the market, even though it is aware of the basis for the fraud allegations, convinces me that this essential element of the claim cannot be proved. I therefore agree that the case should not proceed.1
1 Though my analysis focuses on the failure of the plaintiffs to establish a necessary element of their claim, that failure is grounded not in the minutiae of state law but in the details of the federal regulatory system for medical devices. Therefore, while this case does not fit neatly into our pre-existing pre-emption jurisprudence, it is accurate, in a sense, to say that federal law "pre-empts" this state-law fraud-on-the-FDA claim because the FDA has not acknowledged such a fraud and taken steps to remove the device from the market.
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