Greenberg v. Miami Children's Hospital Research Institute, Inc.
121 A.L.R. 5th 687, 264 F.Supp.2d 1064, 2003 U.S. Dist. LEXIS 8959 (2003)
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Rule of Law:
Individuals who donate biological materials for medical research do not retain a property interest in those materials or the subsequent commercial products. While researchers generally have no duty to disclose their economic interests under theories of informed consent or fiduciary duty, donors may have a claim for unjust enrichment if researchers profit from the donations in a manner that is inequitable given the nature of the collaboration.
Facts:
- Beginning in 1987, parents of children with Canavan disease and non-profit organizations (Plaintiffs) approached Dr. Reuben Matalón to research the fatal genetic disorder.
- Plaintiffs provided Dr. Matalón with financial support, tissue samples (blood, urine), and access to a confidential 'Canavan registry' containing medical and family information.
- Plaintiffs alleged they provided these resources with the understanding that the research would remain in the public domain and any resulting tests would be affordable and accessible.
- In 1990, Dr. Matalón moved his research to Miami Children's Hospital (MCH) and continued to accept support and materials from the Plaintiffs.
- In 1993, using the resources provided by the Plaintiffs, Dr. Matalón and his research team successfully isolated the gene responsible for Canavan disease.
- Unbeknownst to the Plaintiffs, Matalón and MCH filed a patent application for the gene sequence in September 1994, which was granted in October 1997.
- In November 1998, MCH began enforcing its patent rights by restricting access to Canavan disease testing and charging royalty fees, actions the Plaintiffs were not aware of beforehand.
Procedural Posture:
- Plaintiffs filed a six-count complaint against Defendants in the U.S. District Court for the Northern District of Illinois.
- The case was transferred to the U.S. District Court for the Southern District of Florida.
- Defendants filed motions to dismiss the entire complaint for failure to state a claim upon which relief may be granted, pursuant to Federal Rule of Civil Procedure 12(b)(6).
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Issue:
Do individuals and organizations who voluntarily donate biological tissue, confidential data, and funds for medical research have a legal claim against researchers who, without disclosure, later patent and commercialize the results of that research for their own economic benefit?
Opinions:
Majority - Moreno, J.
No, as to the claims for lack of informed consent, breach of fiduciary duty, conversion, fraudulent concealment, and misappropriation of trade secrets, but Yes, as to the claim for unjust enrichment. The court declined to extend the duty of informed consent to cover a researcher's undisclosed economic interests, distinguishing this case from the therapeutic doctor-patient relationship in Moore v. Regents. The court reasoned that imposing such a duty would be unworkable and would chill medical research. Similarly, the court found no fiduciary relationship existed, as the plaintiffs failed to allege that the defendants accepted the trust reposed in them. Following Moore, the court held that the plaintiffs had no cognizable property interest in their donated tissue under a theory of conversion, as any property rights were extinguished upon voluntary donation. The fraudulent concealment and trade secret claims failed due to insufficient pleading. However, the court found that the plaintiffs sufficiently alleged a claim for unjust enrichment. The facts suggested a collaborative research effort, not a simple donation, making it potentially inequitable for the defendants to retain all the commercial benefits derived from the plaintiffs' significant contributions of time, resources, and biological material.
Analysis:
This decision reinforces the principle from Moore v. Regents that individuals do not retain property rights in their voluntarily donated biological materials, limiting claims like conversion. It shows judicial reluctance to expand the doctrine of informed consent to require disclosure of researchers' financial interests, fearing it would cripple research. The case's primary significance lies in its preservation of unjust enrichment as a viable cause of action in this context. This provides a potential equitable remedy for research participants or donors who contribute significantly to profitable discoveries, especially when there was a collaborative relationship and an expectation that the research was for public benefit rather than commercial exploitation.
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