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Update on Roe vs. Rumsfeld

March, 15 2004

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On Monday, Mar 15th, there was a two hour hearing in the Washington, DC federal district court in the case of DOE v. RUMSFELD over the legality of the DoD anthrax vaccine program. ... It is unclear how the outcome of this hearing will impact the final ruling in the case.

Background

1) Judge Sullivan's Dec 22, 2003 order of injunctive relief
2) Judge Sullivan's Jan 7, 2004 order of rescinding injunctive relief for all but the six plaintiffs

Issues

The March 15 hearing focused on arcane, but substantive legal issues regarding:
1) INJUNCTIVE RELIEF
The effect, or lack thereof of, on the judge's final ruling in the case (hinted to be in June) of the six plaintiffs being protected by injunctive relief at the time of the ruling. (Said another way, does the absence of injunctive relief allow the judge broader discretion in ruling without having to consider the ruling's impact on ancillary issues?).
2) SCOPE
Whether the judge's final ruling on the status of the anthrax vaccine will apply only to the six JOHN/JANE DOE plaintiffs -- or to the entire military. Additionally, whether plaintiffs must, as the Government (Defendants) have argued, seek class certification in order to obtain relief for more servicemembers than just the six plaintiffs.

Discussion

The most substantive revelation during the hearing was over the Defendants' (Govt) intentions in the event Judge Sullivan rules in favor of the plaintiffs.
Such a ruling would find the FDA's Final Rule on anthrax vaccine to be flawed, on either procedural or factual grounds, and result in the Final Rule being remanded back to FDA with a Court order to reaccomplish it in compliance with the law. Plaintiffs argue that this would result in a return to the status quo ante prior to the FDA's Dec 30, 2003 Final Rule, wherein the judge found that the absence of a Final Rule rendered the vaccine both "investigational" and "unapproved for its intended use." In either case, the requirements of 10 US Code Sec 1107 would apply, meaning DoD could only mandate the vaccine after obtaining a waiver of informed consent from the President.
When asked by the Judge whether the Government would automatically invoke 10 USC 1107 if the Court remanded the anthrax vaccine Final Rule back to the FDA, the Justice Dept attorney representing the Defendants (DoD and FDA) essentially said no. This mirrors the reluctance of the Asst Secretary of Defense for Health Affairs, Dr. William Winkenwerder, to agree that DoD would obey Judge Sullivan's order of injunctive relief during his Dec 23, 2003 press briefing. See:
http://www.defenselink.mil/transcripts/2003/tr20031223-1062.html

Judge Rulings

(written version will be forthcoming at this URL): http://www.dcd.uscourts.gov/district-court-recent.html
1) The judge had already lifted injunctive relief from receiving the anthrax vaccine for all but the six plaintiffs on Jan 7th, allowing DoD to resume mandatory anthrax vaccinations without informed consent. Today, Mar 15th, he lifted injunctive relief for the six plaintiffs as well, but only after receiving assurances from the Govt that they would not vaccinate the six plaintiffs if those individuals made themselves known to their commander(s) at the time of the order to receive the vaccine.
2) The judge, having solicited briefs on the issue of Scope in January, and having heard those arguments today, decided that he would not rule on the issue at least until the substantive arguments on the merits (i.e. what is the impact of the FDA's Final Rule on whether anthrax vaccine is (is not) an "investigational" drug, or a drug "unapproved for its intended use"?) are submitted to the Court. Judge Sullivan inferred that he may not rule on the Scope issue at all until his final ruling. Given this, he left it up to the plaintiffs' counsel to decide for themselves whether to seek class certification for all those servicemembers who would prefer to receive (or not) the vaccine in voluntary program, with informed consent. (Plaintiffs' counsel have not stated their intentions to do so; however, they informed the Court that doing so could prove embarassing to the DoD if American servicemembers wanted to opt out of the vaccine at the same 50% rate that British servicemembers have).

Commentary

BEST QUOTE Judge Sullivan stating that FDA's Dec 30, 2003 Final Rule on anthrax vaccine (31 years in the making) had appeared "like a jack-in-the-box" [eight days] after he ruled the vaccine to be both "investigational" and "unapproved for its intedned purpose" in December.

Attorney Name:

Attorney Name

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555-555-5555

Email:

Attorney@email.com

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