## Facts

- Eighteen chronic fatigue syndrome patients, including Kristina Anne Dahl, participated in a double-blind clinical trial of Ampligen, an FDA-classified investigational new drug manufactured by HEM Pharmaceuticals Corporation and HEM Research, Inc. (HEM).
- Participants signed informed-consent forms describing Ampligen as experimental and disclosing potential risks and side effects; some patients received Ampligen and others received placebo, without patients or physicians knowing which.
- Trial participation required substantial burdens, including frequent injections and testing, travel or relocation to study sites, and foregoing other treatments.
- After the double-blind phase ended, HEM stopped providing Ampligen.
- Patients sued seeking injunctive and related relief, alleging HEM promised that if they completed the protocol and statistical analysis showed Ampligen effective compared to placebo, HEM would provide post-trial Ampligen for at least one additional year.
- The district court entered a preliminary injunction ordering HEM to provide Ampligen for twelve months and later held HEM in civil contempt for initial noncompliance.
- HEM appealed the preliminary injunction and contempt order; one plaintiff cross-appealed, arguing the injunction should extend beyond twelve months.

## Issues

1. Whether the district court abused its discretion by granting a preliminary injunction compelling HEM to supply Ampligen for twelve months based on a likely unilateral contract formed by trial participation.
2. Whether the injunction improperly conflicted with the FDA’s regulatory authority over investigational drugs or required deference under primary jurisdiction principles.
3. Whether limiting relief to twelve months (rather than a longer or indefinite period) was error.
4. Whether the civil contempt order was proper given HEM’s initial failure to comply with the injunction.

## Decision

- Affirmed the preliminary injunction requiring HEM to provide Ampligen for twelve months.
- Held the record supported a sufficient likelihood of success on a unilateral-contract theory, along with irreparable harm and a balance of hardships favoring the patients.
- Rejected the argument that the injunction usurped FDA authority, reasoning the order operated within existing FDA mechanisms for controlled investigational use and did not compel FDA approval.
- Affirmed the twelve-month limit, finding insufficient evidence of a longer or indefinite promise.
- Affirmed the civil contempt finding based on violation of a clear and definite court order and failure to take all reasonable steps to comply.

## Legal Principles

- A sponsor’s conditional promise of post-trial access to an investigational drug may constitute an offer for a unilateral contract, accepted by participants’ completion of a demanding trial protocol that supplies consideration.
- Preliminary injunctive relief may be appropriate where plaintiffs show a sufficient likelihood of success, irreparable harm from withdrawal of medically beneficial treatment, and equities favoring continued access.
- Enforcing private obligations to provide an investigational drug does not necessarily conflict with FDA authority when the relief can be implemented within existing FDA-permitted investigational pathways and does not countermand an agency determination.
- A court may confine preliminary relief to the promise supported by credible evidence; broader claims of indefinite supply require stronger proof.
- Civil contempt may be imposed for noncompliance with a specific and definite court order when the party fails to take all reasonable steps within its power to comply.

## Conclusion

The Ninth Circuit upheld a preliminary injunction requiring continued provision of an investigational drug based on a likely unilateral contract formed through burdensome trial participation, concluded the order did not interfere with FDA regulatory authority when implemented within permissible investigational use, sustained the twelve-month limit for lack of proof of a longer promise, and affirmed civil contempt for initial noncompliance.


Dahl v. HEM Pharms. Corp., 7 F.3d 1399 (9th Cir. 1993)