Home -> Law Blog Directory -> Personal Injury Law Blogs -> Drug and Device Law

Personal Injury Law

: Drug and Device Law

The Ethics Of Genetic Research

By James M. Beck and Mark Herrmann

This guest post was written by J.C. McElveen, of Jones Day. We thank him for the contribution:

In the late 1980s, members of the Havasupai tribe, an Indian tribe that lives at the bottom of the Grand Canyon, approached an Arizona State University anthropologist with whom the tribe had been working for several decades and asked if he could help shed some light on what the tribe members perceived to be an ?epidemic? of diabetes within the tribe. Suspecting that genetics might be playing a role, the anthropologist got an ASU genetics professor involved, and, pursuant to several agreements and informed consents, the blood of over 200 tribal members was collected, in the early 1990s, to evaluate the genetics of diabetes among the Havasupai. Rather quickly, the researchers found that diabetes was occurring too frequently, and there was too little genetic variability among the tribe members, to conclude that the diabetes was related to genetics, and a paper to that effect was published in 1991.

However, the research did not stop there. From the early 1990s until the early 2000s, research using the blood continued, without the knowledge of the Havasupai. That research included research on schizophrenia and research on theories about population migrations from Asia to North America in ancient times, over the Bering Strait land bridge. The latter research conflicts with the Havasupai belief that, as a people, they originated in southwestern North America.

Once the Havasupai learned of this additional research, they banished ASU teachers and employees from the reservation and, ultimately, the tribe and certain tribal members sued the Regents of the University of Arizona. The most recent decision in this case, Havasupai Tribe of the Havasupai Reservation v. Arizona Board of Regents, 2008 WL 5047641 (Ariz. App. Div. 1) (Nov. 28, 2008), decides only issues having to do with whether certain procedural requirements were satisfied by the tribe and tribal members, before filing suit. However, the allegations in the suit raise very real issues regarding the extent to which genetic material can be used. Basically, the Havasupai claim that they provided blood samples only to ASU researchers, and only for the purpose of studying diabetes among tribal members. Instead, the tribe alleges, the blood was given to people outside ASU, was used for research having nothing to do with diabetes, and was even used (as the decision says) for ?evolutionary genetics? research rather than ?medical genetics? research. The tribe?s and tribal members? causes of action included negligence, fraud, and breach of fiduciary duty, trespass and invasion of privacy. As to this last cause of action, the individual tribal members alleged invasion of personal privacy, and the tribe alleged invasion of cultural and religious privacy.

This case presents many interesting issues, one of which is: ?Is this ?injury? compensable?? The court did address that issue, in the context of ruling on whether the tribe and the tribal members had made claims which ?contain[ed] facts sufficient to permit [the defendant] to understanding the basis upon which liability is claimed and . . . [which set out] a specific amount for which the claim can be settled, and the facts supporting that amount,? as the Arizona statute permitting claims against public entities or public employees requires. A.R.S. 12-821.01(A) (The Arizona Notice of Claim Statute).

The court said that invasion of privacy by testing blood or urine samples beyond the consent given is a well-recognized cause of action (citing Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), and Doe v. High-Tech Institute, Inc., 972 P.2d 1060 (Colo. App. 1998). Similarly, ?dignitary torts,? such as those alleged by the tribe, do not require proof of physical manifestations of injury (citing to Rumbauskas v. Cantor, 266 N.J. Super. 39, 629 A.2d. 1359 (N.J. App. 1993), rev?d on other grounds, 138 N.J. 173, 649 A.2d. 853 (N.J. 1994)), and Snakenberg v. The Hartford Casualty Insurance Co., Inc., 299 S.C. 164, 383 S.E.2d (S.C. App. 1989).

This case is far from over. The majority opinion drew a sharp dissent, and it will either be appealed to the Arizona Supreme Court, or go back to the Maricopa County, Arizona Superior Court for further proceedings (or, of course, it may be settled).

Is this type of case just an ?informed consent? case: i.e., if the ?informed consent? had been broader, there would be no viable claims? Or, does this case have broader implications?

In many way, this case is similar to Moore v. Regents of the University of California, 271 Cal. Rptr. 146, 793 P.2d. 479 (Cal. 1990). In that case, a patient?s leukemia cells were turned into a cell line and patented by his physicians without his knowledge or consent. The patient was allowed to sue for breach of fiduciary duty to disclose facts material to the patient?s consent, or performance of a medical procedure without first having obtained the patient?s consent.

At the very least, the Havasupai case expands this concept to a broader range of scientific research than just medicine. In all likelihood, as individual?s genes become more available, and more commercial opportunities arise as a result of discoveries about them (think about a gene in an individual, or in a group of people, that protects against a type of cancer), the law in this area is going to become much more complex.

Full post as published by Drug and Device Law on January 27, 2009 (boomark / email).