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Pearson v. Thompson

May 9, 2001


The opinion of the court was delivered by: Gladys Kessler United States District Judge


I. Introduction

Plaintiffs are designers, sellers, and manufacturers of dietary supplement formulations containing folic acid. *fn1 They bring this action against Defendants Tommy G. Thompson, Secretary, United States Department of Health and Human Services ("HHS"), in his official capacity; HHS; Bernard A. Schwetz, Acting Principal Deputy Commissioner, Food and Drug Administration ("FDA"), in his official capacity; the FDA; and the United States of America. *fn2

Plaintiffs previously filed a motion for a preliminary injunction, seeking to enjoin the implementation of an FDA decision which prohibited them from including on their dietary supplements' labels the following health claim: ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form" ("Folic Acid Claim").

On February 2, 2001, this Court granted Plaintiffs' motion, finding that Defendants had violated the First Amendment in refusing to approve Plaintiffs' Folic Acid Claim, with or without disclaimers, and ordering that the case be immediately remanded to the FDA "for the purpose of drafting one or more short, succinct, and accurate alternative disclaimers, which may be chosen by Plaintiffs to accompany their Folic Acid Claim." See Pearson v. Shalala, 130 F. Supp. 2d 105, 121 (D.D.C. 2001) ("Pearson II"). The Court suggested that the FDA consider two disclaimers in particular, and anticipated that the agency would "complete its task within 60 days." Id. at 120 & n.34. *fn3

On February 16, 2001, Defendants filed a Motion for Reconsideration of the Court's February 2, 2001 Order. *fn4 This Motion is now before the Court. Upon consideration of the Motion, Opposition, Reply, and the entire record herein, for the reasons stated below, Defendants' Motion for Reconsideration [#29] is denied.

II. Legal Standard

Defendants bring their motion for reconsideration pursuant to Fed. R. Civ. P. 59(e). Such motions should be granted only if the Court "finds that there is an intervening change of controlling law, the availability of new evidence, or the need to correct a clear error or prevent manifest injustice." Firestone v. Firestone, 76 F.3d 1205, 1208 (D.C. Cir. 1996) (internal citations and quotations omitted). In other words, Defendants must show "new facts or clear errors of law which compel the court to change its prior position." National Ctr. for Mfg. Sciences v. Department of Defense, 199 F.3d 507, 511 (D.C. Cir. 2000) (internal citation omitted). A motion for reconsideration will not be granted if a party is simply attempting to renew factual or legal arguments that it asserted in its original briefs and that were already rejected by the Court. See State of New York v. United States, 880 F. Supp. 37, 38 (D.D.C. 1995); Assassination Archives and Research Ctr. v. United States Dep't of Justice, 828 F. Supp. 100, 101-102 (D.D.C. 1993).

III. Analysis

Defendants concede that there has not been an intervening change in relevant law nor has new evidence been discovered in this case. Rather, they argue that reconsideration is warranted because the Court has committed "clear error" in two ways: first, by "assign[ing] undue weight" to a particular clinical study and failing to consider the relevant scientific evidence in totality; and second, by creating a legal standard which is inconsistent with the Court of Appeals decision in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) ("Pearson I"). Defendants also request clarification as to how they should apply this legal standard. The Court finds that neither of Defendants' alleged bases for reconsideration establishes that the Court committed clear error or otherwise makes the requisite showing necessary to warrant reconsideration of the Court's February 2, 2001 Opinion. Indeed, the arguments contained in the motion for reconsideration further demonstrate Defendants' reluctance to fully comply with Pearson I, as will be explained in Section III.B below.

A. Conclusions Relating to the Cziezel Study

Defendants' first suggested basis for reconsideration is that the Court should "reconsider the [administrative] record evidence relevant" to its conclusion that the FDA failed to adequately consider the Cziezel Study, a 1992 human clinical intervention trial conducted on Hungarian women, *fn5 in evaluating the accuracy of Plaintiffs' Folic Acid Claim. Defs.' Mem. in Supp. of Mot. for Recons. ("Defs.' Mot.") at 3-4. Defendants make essentially two arguments in support of their first basis for reconsideration.

Defendants first argue that, "[c]ontrary to the Court's conclusion, the record does suggest that other vitamins in a multivitamin supplement [like the one given to pregnant women in the Cziezel Study] might have provided some of the protective effect ascribed by the Court" (i.e., a further reduction in the occurrence of neural tube defects "NTDs"). Id. at 4. In other words, Defendants question the validity of the Cziezel Study because it failed to isolate the effects of the various vitamins and minerals contained in the dietary supplements studied, and because it failed to prove that the reduction in NTD incidence was due exclusively to folic acid rather than other substances.

Defendants had ample opportunity to make this argument at the appropriate time, namely, in their opposition to Plaintiff's motion for a preliminary injunction. They did not. As the Court pointed out in its February 2, 2001 decision, "the FDA does not suggest [in its legal briefs] any other nutrients or vitamins in the multivitamin/multimineral supplements [used in the Cziezel Study] which could be responsible for decreased NTD risk besides folic acid." Pearson II, 130 F. Supp. 2d at 116. Defendants do not contest the accuracy of this statement in their motion for reconsideration briefs. Instead, they make a new argument, without any justification for having failed to raise it before, after the Court has thoroughly considered and decided Plaintiffs' motion for a preliminary injunction. Since Defendants do not present a new fact or clear error of law ...

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