Wednesday, May 14, 2008

Video of Today's Preemption Hearing In Congress

We're too busy to watch ourselves (Herrmann's on the road and Bexis is prepping for an appellate argument), but here's a link to what's supposed to be an online video feed of today's congressional hearing on preemption. Drop us a comment if you like once it's over so we'll know what we missed.

According to Pharmalot Congressman Waxman, a long-time plaintiff-side ally and thus preemption opponent has pretty well stacked the deck at this hearing with speakers opposed to preemption. Surprise, surprise. According to Pharmalot, not a single industry representative has been invited to testify.

2 comments:

Anonymous said...

On the issue of panelist make-up, the minority chair complained that there were only two witnesses clearly representing the pro-preemption view. He noted that when he was majority chair, there would have been at least three.

On the issue itself, can you folks clarify the following:

Virtually everyone on the committee and among the panelists (at least through the first half that I could watch) assumed that if a company had committed felony fraud relevant to FDA approval or post-approval requirements, preemption would not apply.

That is not my own understanding. Of course, it would mean that that company would be liable to potential prosecution by the DOJ. But, as far as that opening the door to civil liability, both FDA and DOJ have gone out of their way (as in the Kent amicus) to emphasize that such regulatory or prosecutory actions ought _not_ be any kind of gateway to private litigation.

Can you clarify this point?

Thank you.

Beck/Herrmann said...

Under current law, in Buckman, two justices concurred in order to make precisely that point, that there should be an exception for cases in which the FDA actually found fraud.

The other seven justices recognized preemption without any such exception.

In the briefing concerning Warner-Lambert v. Kent, which we've described in the blog, the industry position generally (there were several defense side briefs) accepted the exception in the Buckman concurrence for FDA-determined fraud.