Inspections, Compliance, Enforcement, and Criminal Investigations

Court Decisions and Updates 2003

Court Decisions and Updates

Aldridge v. U.S. Dep't of Health & Human Services, et al. (N.D. Tex.). On July 17, 2003, United States District Judge Jerry Buchmeyer granted the government's motion to dismiss the complaint in this case. The pro se plaintiff filed a complaint under the Freedom of Information Act to compel the production of agency records. Judge Buchmeyer found that the complaint was moot because FDA had already provided the requested records. He further found that the court could not consider the claim that the agency's response was insufficient because the plaintiff had not exhausted his administrative remedies. Accordingly, he dismissed the complaint with prejudice.

Appleton v. FDA et al. (D.D.C.). On February 27, 2003, the United States District Court for the District of Columbia granted in part and held in abeyance in part FDA's Motion for an Open America stay. Plaintiff Burton Appleton, a former FDA chemist, brought a pro se action against FDA, seeking to compel FDA to reply fully to his FOIA request for records regarding the drug levothyroxine sodium. FDA submitted a partial answer and a motion for a stay of proceedings pending the completion of its search and production of documents (known as an Open America stay).

FDA asserted that an Open America stay is warranted because FDA has exercised due diligence both in processing the plaintiff's FOIA request and in reducing its backlog of FOIA requests on a first-in, first-out basis. In response, plaintiff vigorously disputed FDA's claims of due diligence and the reduction in FDA's backlog of FOIA requests.

The court concluded that FDA met the requirements for an Open America stay, finding that:

  • FDA has demonstrated good-faith efforts and due diligence in processing the plaintiff's request on a first-in, first-out basis; and
  • FDA has shown "reasonable progress" in reducing its backlog between fiscal year 1998 and fiscal year 2001.

Due to some confusion regarding the scope of plaintiff's request, the court held in abeyance FDA's requested production deadline of March 15, 2004. The court ordered the parties to confer in an effort to clarify and possibly narrow the plaintiff's request, and submit a joint status report. The court denied without prejudice the motions to intervene of Jerome Stevens, Jones Pharma, Abbott, Lloyd, and Vintage Pharmaceuticals, noting that the companies may refile their motions after the submission of the joint status report if necessary.

Nutritional Health Alliance v. FDA (2d Cir.). On January 21, 2003, the United States Court of Appeals for the Second Circuit reversed the district court's previous grant of summary judgment in favor of FDA. Plaintiff Nutritional Health Alliance (NHA), an association whose members include dietary supplement manufacturers, challenged FDA regulations that require unit-dose packaging for certain iron-containing drugs and dietary supplements. Unit-dose packaging consists of separate, nonreusable containers for each tablet or capsule, and the regulations were intended to prevent accidental iron overdosing in children. NHA asserted that FDA lacked the authority to issue these regulations because poison prevention packaging is regulated by the U.S. Consumer Product Safety Commission (CPSC) under the Poison Prevention Packaging Act (PPPA) and because FDA had exceeded its authority under the Federal Food, Drug, and Cosmetic Act (FDCA).

The Second Circuit agreed, finding FDA's reliance on the adulteration provisions of the FDCA misplaced because the risks associated with the unit packaging rule are not directly related to those provisions. The court further held that, even if the statutory provisions were ambiguous, Congress had transferred the authority to regulate poison prevention packaging to the CPSC and FDA's assertions of concurrent jurisdiction were inconsistent with the overall regulatory scheme. The court remanded the case to the district court to implement an appropriate remedy.

Bates v. Rumsfeld, (D.C. Cir.). On December 24, 2002, the Court of Appeals for the District of Columbia Circuit granted appellants-plaintiffs' motion to voluntarily dismiss their appeal; therefore, the district court's earlier dismissal of this matter stands. This case was filed by a former Air Force pilot and Air Force physician who refused to take the anthrax vaccine. The defendants included the Secretary of Defense, the Secretary of Health and Human Services, the Commissioner of Food and Drugs, and Bioport Corporation, the licensed manufacturer of the vaccine. Plaintiffs had sought a declaration that the vaccine is an investigational new drug or a drug unapproved for its applied use under 10 U.S.C. 1107. On May 30, 2003, District Judge Reggie Walton granted the federal defendants' motion to dismiss, finding that the plaintiffs' lacked standing to pursue their claims. Specifically, the plaintiffs had failed to establish that the relief that they sought would redress the alleged injury that they have suffered. Because plaintiffs' withdrew their appeal, the district court's dismissal is the final decision in this case.

Whitaker v. Thompson, 239 F. Supp. 2d 43 (D.D.C. 2003). On January 3, 2003, a District Judge granted the government's motion to dismiss and upheld FDA's denial of a health claim petition for the following claim: "Consumption of 320 mg. daily of Saw Palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild benign prostatic hyperplasia (BPH)." FDA maintained that the claim related to an effect on an existing disease and, as a result, was not within the statute's definition of a health claim.

If this claim were made in the product's labeling, the product would be subject to regulation as a drug and would require an approved New Drug Application prior to marketing. The plaintiffs in this case, individuals and companies that sell dietary supplements containing saw palmetto, had argued that FDA's decision violated the Federal Food, Drug, and Cosmetic Act (FDCA), the Administrative Procedure Act (APA), and the First Amendment. The district court rejected plaintiffs' arguments.

In upholding FDA's interpretation, the court noted that courts have long upheld the agency's decisions to classify products based on their intended use. In addition, the court agreed with FDA that the FDCA's definitions of dietary supplement and drug are not mutually exclusive. Because the claim addressed BPH symptom treatment, FDA's concerns that authorizing such a claim as a health claim would not provide an adequate level of protection to vulnerable consumers were valid. Based on its review, the court found FDA's decision to limit health claims to those involving disease risk reduction to be permissible and reasonable.

The court further found that FDA's decision provided an adequate rationale for the agency's determination, was neither arbitrary nor capricious, and did not violate the APA. Finally, the court found that FDA's decision did not violate the First Amendment. The court explained that, because FDA had concluded that claims about effects on existing disease do not fall within the scope of the FDCA's health claim provisions, the saw palmetto claim was an unlawful drug claim. Because there is "no doubt that unlawful speech can be banned," the court concluded that FDA's denial of plaintiffs' health claim petition does not violate the First Amendment. The plaintiffs appealed.

UPDATE: Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004). On January 9, 2004, the U.S. Court of Appeals affirmed the District Court's January 3, 2003, decision upholding FDA's denial of appellants' petition seeking authorization for a health claim about saw palmetto and symptoms of benign prostatic hyperplasia (BPH). In addressing appellants' argument that FDA's decision to regulate the saw palmetto claim as a drug claim rather than a health claim violated the FDCA, the court found that the statutory language of the relevant provisions of the FDCA and its legislative history do not demonstrate clear intent with respect to the scope of permissible health claims. The court further found that Congress provided little guidance as to how FDA should regulate claims that arguably fit both the drug and health claim definitions and that FDA's interpretation of the statutory language was reasonable.

In affirming FDA's interpretation, the court found that the legislative history of the health claims provision indicated that the purpose of authorizing health claims was to promote the role of diet in reducing disease risk, not treating existing diseases. The court further found that the health claims provision of the FDCA was enacted against a longstanding backdrop of application of drug regulation to foods and dietary supplements that make claims to treat disease. Therefore, the court concluded that FDA's interpretation was entitled to deference.

The court also held that FDA's decision did not violate the First Amendment because it is constitutionally permissible for FDA to use speech, in the form of labeling, to establish intended use for the purposes of determining that the saw palmetto claim was a drug claim and that the sale of the product with a drug claim would constitute the sale of an unapproved new drug.

Dowhal v. SmithKline Beecham et al. (Cal. Sup. Ct.). On October 23, 2002, the California Supreme Court granted the defendants' petition for review of this case. FDA supported the defendants through an amicus filing. Defendants were charged with violating Proposition 65, a state law, by knowingly and intentionally causing pregnant women and their unborn fetuses to be exposed to nicotine through the use of defendants' nicotine replacement therapy products without providing particular warnings. Plaintiff asked the court to order the defendants to use language warning pregnant women that nicotine "can harm your baby." Defendants objected because, they argued, federal law preempts any state law requirement for labeling that is inconsistent with, or in violation of, the Federal Food, Drug, and Cosmetic Act. In its filing, FDA argued that the warning sought by plaintiff is preempted because it would cause the product to be misbranded under federal law. The verdict is under appeal.

Page Last Updated: 05/02/2016
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