## Facts

- Phenformin hydrochloride was an orally administered antidiabetic drug used by some adult-onset diabetics to help control blood sugar, relax dietary limits, and delay the need for insulin.
- Reports associated phenformin with lactic acidosis, an often-fatal condition involving abnormal accumulation of lactic acid in the blood.
- A consumer group (Health Research Group) petitioned the Secretary of Health, Education, and Welfare (HEW) to suspend phenformin as an “imminent hazard to the public health” under 21 U.S.C. § 355(e).
- In evaluating whether phenformin posed an imminent hazard, the Secretary considered, among other things:
  - Actions by foreign regulators banning or sharply restricting phenformin,
  - Information that certain diabetes clinics had stopped using the drug,
  - FDA staff recommendations that approval be withdrawn,
  - Data suggesting phenformin use could be linked to multiple deaths per month.
- Acting personally (as required by the statute’s non-delegation proviso for “imminent hazard” suspensions), the Secretary ordered immediate suspension of phenformin’s new drug applications (NDAs), with an expedited post-suspension hearing for the applicant contemplated by § 355(e).
- Peter H. Forsham, M.D., other physicians, and several diabetic patients sued the Secretary, seeking to enjoin implementation of the suspension order and to obtain declaratory relief.
- Plaintiffs alleged the suspension exceeded statutory authority and was arbitrary and capricious under the Administrative Procedure Act (APA), and that suspending approval before a hearing violated due process.

## Issues

1. Whether plaintiffs showed a substantial likelihood of success in challenging the Secretary’s immediate suspension of phenformin NDAs as an “imminent hazard” under 21 U.S.C. § 355(e) (including APA and statutory-authority objections).
2. Whether plaintiffs showed a substantial likelihood of success on their claim that suspending approval before an evidentiary hearing violated Fifth Amendment due process.
3. Whether plaintiffs met the requirements for a preliminary injunction, including irreparable harm and a balance of harms consistent with the public interest in drug safety.

## Decision

- The court denied plaintiffs’ motion for a preliminary injunction.
- The court found plaintiffs had not shown a substantial likelihood of success on the merits of their statutory/APA claims because the Secretary’s imminent-hazard determination had a rational basis in the record considered.
- The court rejected, at this stage, plaintiffs’ due process arguments, noting that § 355(e) authorizes immediate suspension with a prompt, expedited post-suspension hearing.
- Plaintiffs did not establish irreparable harm that outweighed the public-health risk reflected in the Secretary’s findings.
- The balance of harms and the public interest favored leaving the suspension in place pending further proceedings.

## Legal Principles

- Under 21 U.S.C. § 355(e), if the Secretary finds an “imminent hazard to the public health,” the Secretary may suspend approval of a new drug application immediately and then provide the applicant prompt notice and an opportunity for an expedited hearing.
- On preliminary-injunction review of agency action, a court asks whether the plaintiffs have shown a strong likelihood of success, including whether the agency’s action appears arbitrary or capricious; where the record shows a rational connection between the evidence and the agency’s finding, preliminary relief is generally not warranted.
- Due process may permit “suspend now, hear later” procedures when the government’s interest in preventing serious harm is weighty and the statutory scheme provides prompt post-deprivation process for the regulated party.
- A preliminary injunction is extraordinary relief; even where plaintiffs allege disruption to medical treatment, courts weigh that harm against potential injury to the public from continued exposure to a drug associated with severe adverse outcomes.

## Conclusion

In *Forsham v. Califano*, the district court refused to preliminarily enjoin HEW’s immediate suspension of phenformin NDAs under § 355(e), concluding that the Secretary’s imminent-hazard determination was supported by a rational basis in the information considered, that the statute’s post-suspension hearing process defeated plaintiffs’ due process showing at the preliminary stage, and that plaintiffs failed to demonstrate irreparable harm outweighing the public interest in preventing potentially fatal drug-related risks.


Forsham v. Califano, 442 F. Supp. 203 (1977)