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FORSHAM v. CALIFANO

October 25, 1977

PETER H. FORSHAM, M.D., et al., Plaintiffs,
v.
JOSEPH A. CALIFANO, JR., Defendant.



The opinion of the court was delivered by: HOWARD F. CORCORAN

MEMORANDUM AND ORDER

 I

 Background

 Plaintiffs are seven physicians who specialize in the treatment of diabetes and six diabetic patients taking phenformin hydrochloride (phenformin) prescribed by their physicians as part of their diabetic therapy.

 Phenformin is an orally administered drug designed to control blood sugar levels in patients with adult-onset diabetes who are not dependent on insulin and who cannot or will not reduce their daily caloric intake. Phenformin allows such diabetics to control their condition with fewer dietary restrictions and to delay the time when they must begin taking insulin.

 The defendant is the Secretary of Health, Education and Welfare (the Secretary) who, pursuant to Section 505(e) of the Federal Food, Drug and Cosmetic Act 21 U.S.C. 355(e), (the Act) has suspended new drug applications for phenformin on grounds that the drug poses an "imminent hazard." The pertinent language of 21 U.S.C. § 355(e) states:

 
"That if the Secretary . . . finds that there is an imminent hazard to the public health he may suspend the approval of such [new drug] application immediately and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this proviso to suspend the approval of an application shall not be delegated."

 Plaintiffs seek to enjoin the Secretary from implementing his suspension order. They also seek a declaratory judgment that the suspension order is outside the scope of the Secretary's authority, is arbitrary and capricious, and violates their Fifth Amendment due process rights, the Administrative Procedure Act and the Food and Drug Administration's (FDA's) regulations. *fn1"

 The key events precipitating the issuance of the suspension order and subsequent filing of this suit are as follows:

 
1. On April 22, 1977 the Health Research Group (HRG) a consumer organization petitioned the Secretary to suspend the distribution of phenformin contending that it constituted an "imminent hazard to the public health" under the Act. Underlying the HRG contention were reports that the use of phenformin caused inordinately high instances of lactic acidosis, an often-fatal metabolic disorder in which abnormal amounts of lactic acid accumulate in the blood.
 
2. The Secretary referred the matter to the Food and Drug Administration (FDA) for comment on April 29, 1977. The FDA issued a Notice of Public Hearing) (42 F.R. 21845) to be held May 13, 1977.
 
3. On May 6, 1977 the FDA Bureau of Drugs commenced formal proceedings to withdraw FDA approval of phenformin (42 F.R. 23170). Hearings were scheduled to commence October 5, 1977. *fn2"
 
4. During the May 13th hearing information was presented by the manufacturers of phenformin as well as various professional medical associations and other interested parties including four of the plaintiffs in this case.
 
5. On June 27, 1977 and again on July 18, 1977 the FDA Commissioner forwarded to the Secretary the FDA's analysis of the use and risks of phenformin together with a discussion of options and recommendations.
 
6. On July 25, 1977 the Secretary issued his order suspending new drug applications for phenformin and ordered an end to general marketing within 90 days (October 23, 1977).
 
7. On August 29, 1977 plaintiff filed this action seeking injunctive and declaratory relief with respect to the Secretary's Order.

 II

 Preliminary Injunction

 The standards which guide the decision to grant a preliminary injunction are well established. To prevail, plaintiffs must show a substantial likelihood of success on the merits and that irreparable harm will flow from the denial of an injunction. In addition, the Court must consider the inconvenience that an injunction would cause the opposing party, and must weigh the public interest. See Fund for Animals v. Frizzell, 174 U.S. App. D.C. 130, 530 F.2d 982, 986 (1975); A Quaker Action Group v. Hickel, 137 U.S. App. D.C. 176, 181, 421 F.2d 1111, 1116 (1969); Virginia Petroleum Jobbers Ass'n v. F.P.C., 104 U.S. App. D.C. 106, 110, 259 F.2d 921 925 (1958).

 (A) Likelihood of Success on the Merits

 In considering the likelihood of success on the merits, it should be noted at the outset that the review by this Court of the Secretary's decision to suspend phenformin pursuant to his authority under 21 U.S.C. § 355(e) is limited to a determination of whether that decision was arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law. 5 U.S.C. § 706(2)(A). Thus, in order to satisfy this standard, plaintiffs must demonstrate a substantial likelihood that ultimately they will be able to show the Secretary's decision was arbitrary and capricious. In other words, they must demonstrate the substantial likelihood that the decision was "a clear error of judgment" by the Secretary and that he failed to articulate any rational ...


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