## Facts

- Parents of children with Canavan disease and nonprofit organizations helped recruit affected families, collect biological samples, and provide funding and data to support research to identify the Canavan gene and develop testing.
- Plaintiffs assembled and maintained a confidential registry containing medical, epidemiological, and pedigree information and shared it with the research effort.
- A physician-researcher affiliated first with an Illinois university and later with a Miami hospital and its research institute continued the Canavan research using the donated samples and information.
- The researcher and affiliated hospital entities identified the Canavan gene and obtained a patent covering the gene sequence and related diagnostic methods.
- Plaintiffs alleged they participated based on an understanding that resulting research and testing would remain publicly available at affordable cost and that defendants did not disclose any plan to seek exclusive proprietary control.
- After patenting, defendants allegedly granted exclusive licensing, charged licensing and royalty fees, and threatened or pursued enforcement actions that restricted others from offering Canavan testing.
- Plaintiffs sued in diversity seeking damages and equitable relief; the case was transferred to the Southern District of Florida, and defendants moved to dismiss for failure to state a claim.

## Issues

1. Whether research participants and supporting organizations retained a legally cognizable ownership or property interest in voluntarily donated tissue, genetic material, or shared registry data sufficient to support conversion or trade secret theories.
2. Whether defendants owed plaintiffs duties (informed consent or fiduciary) requiring disclosure of intended patenting and commercialization of research results.
3. Whether plaintiffs pleaded fraudulent concealment with required particularity and a predicate duty to disclose.
4. Whether plaintiffs plausibly stated an unjust enrichment claim based on defendants’ receipt and use of plaintiffs’ samples, data, and funding to obtain patent-based licensing revenue.

## Decision

- The court granted the motions to dismiss as to lack of informed consent, breach of fiduciary duty, fraudulent concealment, conversion, and misappropriation of trade secrets.
- The court denied the motions to dismiss as to unjust enrichment, allowing that claim to proceed.

## Legal Principles

- Voluntary donation of human tissue and genetic material for research, absent an express reservation, does not leave the donor with a continuing property interest sufficient to support conversion based on later research uses or patenting.
- Informed consent doctrine generally concerns disclosure of medical or research procedures and associated physical risks and benefits, not disclosure of possible future commercial value, patenting, or downstream licensing plans.
- A research participant–researcher relationship does not, without additional facts, create a fiduciary duty that requires placing participants’ interests above the researcher’s or institution’s interests in commercialization decisions.
- Fraudulent concealment must satisfy heightened pleading requirements and generally requires a duty to disclose; where no such duty is plausibly alleged, nondisclosure of commercialization intentions will not support the claim.
- Unjust enrichment may be stated without proving continued ownership of transferred materials; it focuses on whether defendants knowingly retained substantial benefits conferred by plaintiffs under circumstances that may make retention without compensation inequitable.

## Conclusion

The court rejected tort and property-based theories premised on ongoing ownership of donated genetic materials or a duty to disclose intended patenting, but permitted an equitable unjust enrichment claim to proceed based on allegations that defendants obtained and monetized patent rights using plaintiffs’ non-gratuitous contributions.


Greenberg v. Miami Child.'s Hosp. Rsch. Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003)