## Facts

- Two Parkinson’s disease patients enrolled at a medical center site in a multicenter clinical trial sponsored by a pharmaceutical company studying an experimental protein therapy delivered by implanted pump and brain catheters.
- The trial began as a double-blind, placebo-controlled study with a disclosed 50% chance of receiving placebo during the initial phase.
- Participants signed informed-consent documents stating the sponsor could terminate the research and that participation could end.
- After the blinded phase, plaintiffs entered an open-label extension and received the experimental therapy; they reported substantial symptomatic improvement.
- The sponsor terminated the trial nationwide based on safety and efficacy concerns, including antibody formation that might interfere with endogenous protein function, neurotoxic findings in primates, and lack of statistically significant benefit over placebo in humans.
- Plaintiffs requested continued infusions (including on a compassionate-use basis), asserting that termination harmed them by withdrawing a treatment they believed was safe and effective.
- Plaintiffs sued and moved for a preliminary injunction compelling the sponsor to resume providing the experimental therapy.

## Issues

1. Whether plaintiffs satisfied the preliminary-injunction standard by showing irreparable harm and a likelihood of success (or serious questions plus hardship balance) on claims seeking to compel continued provision of an experimental drug.
2. Whether informed-consent and study materials created an enforceable contractual commitment, or a clear promise supporting promissory estoppel, to continue supplying the drug.
3. Whether the sponsor owed research subjects a fiduciary duty requiring continued access to the drug despite termination of the study.

## Decision

- The court denied the motion for a preliminary injunction.
- Plaintiffs failed to show a likelihood of success on the merits of breach of contract, promissory estoppel, or breach of fiduciary duty.
- The informed-consent documents reserved the sponsor’s discretion to terminate and did not promise ongoing access to the experimental therapy.
- The court declined to recognize a fiduciary relationship running from the corporate sponsor to participants based solely on sponsorship of the trial.
- Equitable and public-interest considerations weighed against compelling provision of an unapproved experimental drug outside the terminated trial, given scientific uncertainty and safety concerns.

## Legal Principles

- A preliminary injunction requires irreparable harm and either (a) likelihood of success on the merits or (b) serious questions on the merits and a balance of hardships tipping decidedly toward the movant.
- Informed-consent documents for research participation generally do not create a contract for continued treatment absent clear, enforceable promises; express termination provisions cut against claimed entitlement.
- Promissory estoppel requires a clear and unambiguous promise and reasonable reliance; a participant’s expectations cannot override express reservations of the sponsor’s right to stop the study.
- Fiduciary duties to research participants typically arise, if at all, from the physician-investigator relationship rather than from a sponsor’s role as funder and supplier, absent a recognized legal basis for extending fiduciary status to the sponsor.
- Courts are reluctant to order ongoing access to experimental treatments through injunctive relief where safety, efficacy, and regulatory judgments are disputed and better addressed through research and regulatory processes.

## Conclusion

The court refused to compel the sponsor to continue supplying an experimental Parkinson’s therapy after the sponsor terminated the clinical trial, holding that plaintiffs had not shown probable success on contract, estoppel, or fiduciary-duty theories and that equitable considerations counseled against judicially mandating access to an unproven and potentially unsafe investigational drug.


Suthers v. Amgen, Inc., 372 F. Supp. 2d 416 (S.D.N.Y. 2005)