Pearson v. Thompson

• Decision Date: 09 May 2001
• Docket Number: No. CIV. A. 00-2724(GK).,CIV. A. 00-2724(GK).
• Citation: 141 F.Supp.2d 105
• Parties: Durk PEARSON, et al., Plaintiffs, v. Tommy G. THOMPSON, et al., Defendants.
• Court: U.S. District Court — District of Columbia

141 F.Supp.2d 105

Durk PEARSON, et al., Plaintiffs, v. Tommy G. THOMPSON, et al., Defendants.

No. CIV. A. 00-2724(GK).

United States District Court, District of Columbia.

May 9, 2001.

Jonathan W. Emord, Emord & Associates, P.C., Washington, DC, for Plaintiffs.

Susan Strawn, Drake Cutini, Office of Consumer Litigation, Civil Division, Washington, DC, for Defendants.

MEMORANDUM OPINION

KESSLER, District Judge.

I. Introduction

Plaintiffs are designers, sellers, and manufacturers of dietary supplement formulations containing folic acid.¹ 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.²

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. 34.³

On February 16, 2001, Defendants filed a Motion for Reconsideration of the Court's February 2, 2001 Order.⁴ 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,⁵ 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 that would compel the Court to change its position, this argument will not now be considered when presented for the first time in a motion for reconsideration. See National Ctr. for Mfg. Sciences, 199 F.3d at 511.⁶

Defendants also argue that no federal scientific or professional medical organization which has "considered the issue of periconceptional use of folic acid for reduction in risk of NTDs ... recommends more than 400 mcg folic acid per day." Defs.' Mot. at 6-7. They argue that, given this fact, any statement which states or suggests that 800 mcg⁷ is more effective than 400 mcg is inherently misleading because it cannot be made non-misleading through the use of disclaimers. Id. at 7-8.

Not only have Defendants again failed to state a reason why the extraordinary relief of reconsideration is justified, they also fail to fully and accurately describe the record evidence. Despite Defendants' insistence that the scientific consensus is that 400 mcg, or 0.4 mg, (no more, no less) is the most effective dose at reducing NTD risk, numerous scientific and governmental bodies have indicated, either explicitly or implicitly, that doses of folic acid (i.e., synthetic folic acid and/or food folate) in excess of 400 mcg are beneficial. See Pls.' Mem. in Opp'n to Defs.' Mot. for Recons. ("Pls.' Opp'n") at 7-8. For example, the highly-respected 1998 study conducted by the Institute of Medicine of the National Academy of Sciences ("IOM/NAS Study")⁸ states: "To summarize the data, a reduced risk of NTD has been observed for women who took a folate supplement of 360 to 800 ug/day in addition to dietary folate intake of 200 to 300 ug/day." J.R. at 600 (emphasis added).

Defendants openly acknowledge that "all of the public health organizations recommend 0.4 mg [of folic acid] in addition to" a certain amount of food folate. Defs.' Reply to Pls.' Opp'n to Mot. for Recons. ("Defs.' Reply") at 9 (emphasis in original). However, their argument seems to be that, because "Plaintiffs' customers also eat food, including food containing folate," id., those individuals would obtain the recommended total amount of folic acid (both synthetic folic acid and food folate) by consuming a supplement containing 0.4 mg of folic acid and otherwise eating normally.

Defendants' (new) argument is purely speculative: while many foods are indeed fortified with folic acid (and some contain it naturally), Defendants have never suggested — and certainly have never submitted evidence — that Americans currently obtain a sufficient amount of food folate in their diets.

Accordingly, Defendants' first suggested basis for reconsideration is rejected. The basis is questionable, at best, on the merits, and Defendants certainly fail to make the requisite showing (new facts, intervening change in law or clear error) that would justify reconsideration of the Court's earlier decision.⁹

B. The Court's Application of the Pearson I Standard

Defendants contend that this Court's decision in Pearson II held or implied that "the FDA must authorize a [health] claim whenever any `credible evidence' supports that claim." Defs.' Reply at 13. Defendants seek reconsideration and/or clarification of this statement, which they maintain misstates, or is inconsistent with, the holding of Pearson I.

Notwithstanding Defendant's statement to the contrary, this Court did not hold, or otherwise indicate, that the FDA must approve all health claims supported by some "credible...