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Significant Legal Cases


The firm represented victorious plaintiffs in each of the following significant federal cases:

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), rehearing den., 172 F.3d 72 (D.C. Cir. 1999) (“Pearson I”)

In the landmark Court of Appeals decision, Pearson I, Emord & Associates filed suit on behalf of Durk Pearson; Sandy Shaw; American Preventative Medical Association; and Citizens for Health against the FDA, challenging the First Amendment validity of FDA regulations that censored four of the plaintiffs’ health claims (folic acid/neural tube defect risk reduction; antioxidant vitamins/cancer risk reduction; omega-3 fatty acids/coronary heart disease risk reduction; and fiber and colorectal cancer risk reduction) despite scientific evidence supporting them. The court held that under the First Amendment FDA may not ban health claims simply because scientific literature is inconclusive, and it stated that when health claims are only potentially misleading, FDA is obliged to rely on succinct and accurate qualifications as a less speech restrictive alternative to an outright ban. The court held that the FDA acted arbitrarily and capriciously by failing to adequately define its standard of review. Read the decision.

Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) (“Pearson II”)

After Pearson I, FDA continued to refuse to authorize the plaintiffs’ folic acid claim. The court held that FDA violated the First Amendment in suppressing the claim rather than proposing a clarifying disclaimer to accompany the claim because the claim was, at worst, only potentially misleading. The court stated, “FDA simply failed to comply with the constitutional guidelines outlined in Pearson [I].” “Indeed, the agency appears to have at best, misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals Opinion.” The court remanded the folic acid claim to FDA with instructions that the agency draft one or more “short, succinct, and accurate alternative disclaimers, which may be chosen by Plaintiffs to accompany their Folic Acid Claim.” Read the decision.

Pearson v. Thompson, 141 F. Supp. 2d 105 (D.D.C. 2001) (“Pearson III”)

In Pearson III, FDA filed a motion for reconsideration of the court’s decision in Pearson II. The court denied FDA’s motion because it failed to show new facts or clear errors of law which compel the court to change its position. In its decision, the court reiterated that “if a health claim is not inherently misleading, the balance tilts in favor of disclaimers rather than suppression.” It also reiterated that FDA must demonstrate with empirical evidence that disclaimers would bewilder consumers and fail to correct for deceptiveness, before it can suppress the folic acid claim. On June 4, 2006, this case was dismissed after an agreement was reached that allowed the labels of dietary supplements containing folic acid to display the health claim with a disclaimer proposed by FDA and chosen by the plaintiffs. Read the decision.

Whitaker v. Thompson, No. 00-0123-PLF, Dkt. No. 28 (D.D.C. April 2, 2001)

On April 2, 2001, Judge Paul L. Friedman of the U.S. District Court for the District of Columbia dismissed the complaint in Whitaker v. Thomspon filed by Emord & Associates that challenged an FDA decision concerning a health claim relating to the intake of B vitamins, folic acid, and a reduction in the risk of vascular disease. The dismissal followed an agreement reached between FDA and the plaintiffs in which FDA abandoned its refusal to allow the claim, stating its intention to exercise enforcement discretion to allow the claim on dietary supplement labels so long as a disclaimer accompanied the claim. Read the decision.

Whitaker v. Thompson, 248 F. Supp. 2d 1 (D.D.C. 2002) (“Whitaker I”)

In Whitaker I, Emord & Associates challenged FDA’s renewed decision prohibiting dietary supplement labels from including the antioxidant vitamin health claim at issue in Pearson I. FDA prohibited the claim because it found a lack of significant scientific agreement in support of the claim, and because it found that the weight of the evidence against the claim was stronger than the evidence in favor of it, and therefore concluded that the claim was inherently misleading and could not be rendered non-misleading with a disclaimer. The court held that as a matter of law the antioxidant vitamin claim was not inherently misleading, and, thus, FDA erred in not considering disclaimers in violation of the constitutional mandate in Pearson I. The court also held that the weight of the scientific evidence was not against the claim. Accordingly, the court instructed FDA to authorize the claim with an appropriate disclaimer. Read the decision.

Nutraceutical Corp. v. Crawford, 364 F. Supp. 2d 1310 (D. Utah 2005), reversed, 459 F.3d 1033 (10th Cir. 2006)

In Nutrceutical Corp., Emord & Associates filed suit on behalf of Nutraceutical Corp. and Solaray, Inc. challenging an FDA regulation banning all ephedrine-alkaloid dietary supplements (“EDS”). The court held that FDA’s use of a risk-benefit analysis to determine whether the risk presented by EDS is unreasonable was inappropriate under DSHEA because it placed a burden on the producers of EDS to demonstrate a benefit as a precondition to sale, contrary to the clear intent of Congress. The court also held that FDA “fail[ed] to prove by a preponderance of the evidence that a dosage of 10 mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury,” and therefore failed to give effect to the dose-specific language of DSHEA. This case reaffirmed that FDA bears the burden of proving dietary supplements adulterated. This decision was reversed on appeal in Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033 (10th Cir. 2006). Read the decision.

Alliance for Natural Health v. Sebelius, 714F. Supp. 2d 48 (D.D.C. May 27, 2010) (“ANH I”)

In Alliance for Natural Health, Emord & Associates filed suit on behalf of Alliance for Natural Health US; Durk Pearson and Sandy Shaw; and Coalition to End FDA and FTC Censorship against the FDA alleging that its censorship of ten selenium-cancer risk reduction claims violated the First Amendment. The court held that FDA violated the constitutional standard in Pearson I by censoring claims and by failing to include reasonable disclaimers on a subset of claims FDA allowed. The court found FDA’s assertion that the claims failed to include pertinent information “not support for banning the claims entirely, but rather reason for remedying any potential misleadingness through “disclosure of additional information.” The Court further held FDA’s lengthy and argumentative disclaimers unconstitutional because they were neither succinct nor accurate but contradicted rather than reasonably qualify the claims. The Court ordered FDA to reconsider all challenged claims and come up with reasonable disclaimers to accompany them with “reasonable speed.” This decision reaffirms that FDA is subject to the strictures of the First Amendment in its evaluation of health claims. Read the decision.

Alliance for Natural Health v. Sebelius, 786 F.Supp. 2d 1 (D.D.C. Apr. 13, 2011) (“ANH II”)

In ANH II, Emord & Associates filed suit on behalf of the Alliance for Natural Health US; Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship against the FDA alleging that its censorship of antioxidant vitamin and cancer risk-reduction claims violated the First Amendment. The Court held that FDA’s rewording of the claims regarding the health effects of vitamin E on bladder cancer and vitamin C on gastric cancer violated the First Amendment. The Court explained that “the FDA’s proposed claim is at odds with the Supreme Court’s mandate that there be a ‘reasonable fit’ between the government’s goal and the restrictions it imposes on commercial speech.” The FDA had “completely eviscerated plaintiffs’ claims, with no explanation as to why a less restrictive approach would not be effective.” Read the decision.

Center for Science in the Public Interest, et al. v. Food and Drug Administration, No. 1:03-cv-01962-RBW (D.D.C. Sep. 17, 2004)

In Center for Science, Emord & Associates represented intervening parties who moved to block the Center for Science (CSPI) from overturning the Pearson decision. Read the decision.

Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.

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