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Tuesday, April 18, 2006

Participants in Clinical Drug Trial Sought Continued Treatment Based on Contract Theories

What if an individual who participates in a clinical trial of a drug wants to continue to receive that drug when the study is completed? Does the trial participant have a right to continued treatment based on theories of contractual obligation or promissory estoppel? Seems that the answer depends on whether, in addition to the clinicians, the drug company made any promises.

A group of individuals who suffer from Parkinson’s elected to participate in a clinical study of a drug to treat the disease. The company that developed the drug essentially commissioned the study, which was conducted by researchers at a university.  The drug company entered into a "Clinical Trial Agreement" with the university and researchers, which included a "Protocol" for the trial.  Among other things, the "Protocol" provided that the participants could elect to continue treatment up to 24 months after the study was completed.  The Protocol also allowed the drug company to terminate the study in specified circumstances. 

At some point during the clinical trial, the drug company terminated all clinical use of the drug, citing (1) a study that some trial participants developed neutralizing antibodies that caused irreversible damage to vital organs and (2) a long-term toxicology study of primates using the drug which found that the primates developed lesions on their brains. Some of the trial participants, however, believe that the drug is effective and that their physical, cognitive and emotional faculties have improved. These participants sought an injunction, requiring the drug company to continue to administer the drug to them. They sought the injunction, at least in part, based on breach of contract and promissory estoppel. The court did not issue the injunction and the Sixth Circuit held that the District Court did not abuse its discretion in denying the injunction.

The participants claimed that the drug company was contractually obligated to supply them with the drug. The court held that no contract ever existed between the participants and the drug company that required the company to continue to provide the drug. The participants primarily relied upon an "Informed Consent Document."  The participants had signed the consent form, but this document did not contain a drug company signature. The court held that this document, therefore, did not bind the drug company. The court also held that the Clinical Trial Agreement did not bind the drug company to continue to provide the drug to the participants because the participants were not signatories to that agreement -- rather, it was solely between the drug company, the researchers and the university.  Moreover, the court held that the researchers and university did not make promises to the participants on behalf of the drug company -- because the researchers were independent contractors and did not have apparent authority to bind the drug company.

The participants also claimed that the drug company was required to provide them with the drug based on promissory estoppel – that is, the researchers informed the participants that they would make decisions based upon the patients’ best interests and, if the drug proved to be safe and effective, the participants could continue to receive the drug beyond the trial period. Again, however, the court held that there was no evidence of a promise made by the drug company, and the promises of the university and researchers could not bind the drug company.


[Note: original post updated for clarification].

Abney v. Amgen, Inc., __ F.3d __ ( Mar. 29, 2006 6th Cir. 2006).

[Meredith R. Miller]

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