Saturday, March 01, 2008

AVA a-okay

Here's a link to yesterday's United States District Court for the District of Columbia opinion rejecting eight servicemembers' legal challenge to the anthrax vaccine. Rempfer v. Von Eschenbach, Civil Action No. 06-2131 (RMC) (D.D.C. Feb. 29, 2008). The servicemembers' counsel, Mark Zaid, has said he will appeal the ruling.

Here's a link to a WaPo article discussing the opinion.
Posted by Dwight Sullivan at 1:22 PM

7 comments:

John O'Connor said...

I think you could dump a case like this on military deference without ever reaching, as No Man would call it, girlie-man agency deference.

Sat Mar 01, 05:28:00 PM EST
Anonymous said...

I'm the other counsel with Mark on this case. We have tried to avoid the military deference issue up to this point, and haven't really had to deal with it, because the focus is the FDA's role in approving the vaccine. If we can show, as we did in the first round, that FDA failed to properly approve AVA, then the AVIP falls apart under 10 USC 1107 and 1107a becasue of the drug's status. Only if DoD were to invoke the extraordinary provisions of 1107 would we reach the miltiary deference issue. That would be an even tougher case to win. The statute clearly envisions bypassing normal FDA requirements, although it's hard to imagine the FDA being more cavalier about AVA approval than it has been so far.
John Michels

Sat Mar 01, 06:09:00 PM EST
Dwight Sullivan said...

I don't think military deference was an available theory in this case. Counts I-III of the suit were about the FDA approval process. I certainly hope that military deference is not so broad as to further limit an APA challenge to a non-military agency's decision simply because the plaintiff happens to be a servicemember.

Count IV did concern a military decision and Secretary Gates was a named defendant. But Count IV alleged that servicemembers were being subjected to a drug unapproved for its intended use without informed consent. Application of the military deference doctrine in that scenario would seem to be inconsistent with 10 U.S.C. § 1107, in which Congress provides protections to servicemembers in response to past incidents where servicemembers were treated as human guinea pigs. Judge Collyer kicked that count on standing grounds, ruling that none of the plaintiffs were being subjected to the alleged unapproved use, so she didn't have an opportunity to decide whether to apply the military deference doctrine. But this count could return in a another suit with a different plaintiff who did have standing, so that issue might be addressed in a future case.

Sat Mar 01, 06:09:00 PM EST
Anonymous said...

You are correct, CAAFlog, although we think the judge was a bit nearsighted in her view of the standing issue. We asserted that all these folks were eligible to be depolyed and in some cases were already in the AOR, thus giving them standing to attack the off label use issue. We'll see what happens on the reconsideration / appeal.

Sat Mar 01, 06:13:00 PM EST
Anonymous said...

And sorry, it's me again on the above comment.

John Michels

Sat Mar 01, 06:14:00 PM EST
John O'Connor said...

I guess I'd have to read the statute. I'm pretty well on record that the military deference doctrine applies only when military need or government interest is part of the relevant constitutional/statutory analysis. Obviously, if Congress passes a statute that says no drugs administered to soldiers without satisfying Conditions A and B, then no amount of deference would undermine that statutory requirement.

Sat Mar 01, 10:30:00 PM EST
Mike "No Man" Navarre said...

This case is all about girlie man agency defenrence and that uber-brand of agency deference, inerpretation of the agency's own regulations.

Tue Mar 04, 08:52:00 PM EST

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