Monday, February 25, 2008

Warner-Lambert v. Kent - Transcript Of Oral Argument

The court reporters were a little late today, but the oral argument transcript for Warner-Lambert v. Kent is now available. Compare your impressions to those of our intrepid correspondent.
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1 comment:

Henry Greenspan, Ph.D. said...

Small point - However the USC decides Kent, Michigan's so-called "fraud exception" was meaningless. As worded, it requires both (a) a finding of intentional (e.g., felony) misrepresentation and (b) drug withdrawal directly linked with that finding.

There has not been a single case in the past twenty-five years that meets both criteria. As FDA's own amicus emphasizes in Kent, FDA favors a wide range of responses when fraud is suspected or fully uncovered - settling with company through a monetary fine and without pursuing prosecution, a label change, or some sort of warning/remedial program. None of these circumstances satisfy either condition. Nor (obviously) do they satisfy both.

As is well known, there is also a "would have been withdrawn" phrasing in Michigan's law had the intentional suppressed or mispresented facts been known. This bit is definitively impossible to litigate since no agency knows, or has a body which could decide, what it "would have done" under X, Y, Z circumstances. Thus, the writers of the Michigan law - whatever else one may say - were not the brightest bulbs in the state. FDA's inability to determine what it "might have done" - as well as its disinclination to be a "gatekeeper" to civil action - is also much emphasized in its amicus.

Thus, this decision is much more likely to impact fraud findings in states in which state court findings of fraud are a condition for punitive damages - famously, New Jersey - than Michigan.

4:59 PM

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