By Tim Welch
Another state’s newborn screening program has come under fire recently, highlighting growing concerns about the protection and proper use of human tissue and genetic information.
On March 12, 2009, five parents filed a lawsuit in the United States District Court for the Western District of Texas in San Antonio against the Texas Department of State Health Services (TDSHS), Texas A&M University, and various Texas A&M University officials (Beleno v. Texas Dept. of State Health Serv.). The plaintiffs claim that TDSHS violated federal and state law when, as part of the legally-mandated Texas newborn screening program, TDSHS collected blood samples from the plaintiffs’ newborn babies, stored the samples indefinitely, and allegedly used the samples for unidentified research purposes, all without the plaintiffs’ knowledge or consent.
The Beleno plaintiffs allege that TDSHS has violated their right to be free from unlawful search and seizure, as guaranteed by the Fourth Amendment to the U.S. Constitution and Article I, Section 9 of the Texas Constitution. The plaintiffs also claim that TDSHS has deprived them of their liberty and privacy interests, as guaranteed by the Fourteenth Amendment to the U.S. Constitution, the Texas Constitution, and Texas common law.
Back in March, I blogged about a factually similar case (Bearder v. Minnesota) filed that month in a Minnesota state court. A group of families sued the Minnesota Department of Health (MDH) for collecting blood samples from newborns for a newborn screening program without parental knowledge or consent, retaining the samples indefinitely, and sharing the samples with private research institutions and hospitals. While the factual scenarios in Bearder and Beleno are similar, the causes of action are based in very different legal theories.
In Bearder, the MN plaintiffs allege that MDH violated a state genetic privacy statute when it collected, stored, and disseminated the newborns’ blood samples without parental consent. Minnesota is one of 11 U.S. states that require written consent for genetic testing. A Minnesota statute explicitly prohibits “collection, storage, use, and dissemination of genetic information” without “written informed consent” (Minn. Stat. §13.386). The plaintiffs contest that, although another Minnesota statute mandates the state’s newborn screening program [Read more here], MDH is bound by the state’s informed consent statute to ask the parents permission to collect, store and use their babies’ DNA.
In Beleno, the TX plaintiffs are invoking their rights under federal and state constitutions. The Texas parents claim that the U.S. Constitution and the Texas Constitution prevent TDSHS from unlawfully “seizing” their minor children’s property–i.e. their minor children’s blood–without parental consent. The plaintiffs also claim that the U.S. and Texas Constitutions and Texas common law guarantee a fundamental right to privacy that is violated by the actions of TDSHS. The plaintiffs clarify in their complaint that they do not object to the Texas newborn screening program as long as proper measures are in place to obtain parental consent.
These cases highlight the growing concern about proper collection, use, and storage of human tissue and genetic information. There are over 282 million archived and identifiable pathological specimens from more than 176 million individuals stored in United States biological repositories. It used to be accepted that if a name and identity were removed from a human tissue sample, there would be no risk of later identification and thus no need to obtain informed consent for later use of the tissue. However, modern genetic technology has rendered this reasoning archaic and obsolete. Employers with access to genetic information could decide not to hire a potential employee who has a genetic predisposition to a costly disease. Police with access to biological repositories for forensic purposes could catch a criminal with DNA information originally collected for a state newborn screening program. Do babies have the right not to self-incriminate themselves?
Some state legislatures–such as Minnesota’s–have responded to concerns about genetic privacy by passing laws that prohibit the collection and use of human tissue and genetic information without informed consent. In Bearder, the plaintiffs want the court to recognize that a Minnesota state law gives them the right to choose what happens to their babies’ blood. The Beleno plaintiffs are taking the issue to the next level. They want a federal court to declare they have a fundamental right that is protected by the U.S. Constitution to decide what does and does not happen to their babies’ DNA. It will be interesting to see how the court decides, as this is an issue that certainly will not be going anywhere any time soon.