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Henry Kissinger and Riegel

By James M. Beck and Mark Herrmann

We didn't really think there was any connection between President Reagan and Riegel v. Medtronic.

But then we saw how the case brought out the best in one plaintiff's lawyer. So that got us to thinking.

Back in the 1950s and '60s, Tom Lehrer wrote an awful lot of riotously funny songs. (For example: "The Lord's our shepherd, says the Psalm; but just in case, we'd better get a bomb.") According to the urban legend, Lehrer gave up his calling when Henry Kissinger received the Nobel Peace Prize. Lehrer insisted that awarding the Nobel Peace Prize to Henry Kissinger made political satire obsolete.

What are we ranting about here?

We've decided that the Supreme Court's decision in Riegel similarly made our "Device Preemption Scorecard" (over in the right-hand column of this blog) obsolete. We now know the answers to the two big questions: There's typically no preemption for devices approved through the 510(k) process, and there typically is preemption for devices approved through premarket approval. We suspect it'll be a mighty long time before the Court takes a case involving "investigational device" or "product development protocol" preemption, so we now know all we're likely to hear on this subject.

We're going to leave the "Device Preemption Scorecard" in existence for a while (largely for reference purposes; it may help, for example, if someone needs more ammunition than we've already provided to win a case involving a premarket approval supplement). But we won't be updating the Scorecard any more.

Depending on how the case law starts to break, we just may start an "Alleged FDA Noncompliance Scorecard." Given the holding in Riegel, we have the creeping suspicion that the plaintiffs' bar is going to decide that no device manufacturer has ever complied with the FDA regulations, which plaintiffs will insist is the allegation they need to keep their cases alive.
We sure hope law enforcement officials are watching. If those allegations are right, the plaintiffs' bar is about to begin exposing an epidemic of lawlessness that has previously gone unnoticed and unpunished.

Or maybe our analysis is right, and it will be a little tougher to pursue noncompliance claims than the plaintiffs are hoping.

Anyway, the Device Preemption Scorecard is dead; long live whatever succeeds it.

Full post as published by Drug and Device Law on February 26, 2008 (boomark / email).