Newborn Blood Spot Litigation: 70 Days to Destroy 5+ Million Samples

Burned holeSometime in the next few months, Texas will destroy more than 5 million blood samples collected from newborn babies across the state over the past seven years. The lawsuit that led to this result—agreed to as part of a settlement reached between the state and a civil rights group representing a group of parents—illustrates a number of interesting points about the law and litigation of genetics issues.

As we discussed in A Closer Look at Biobanking of Newborn Blood Spots, states collect blood samples from most infants born in the United States each year, with the goal of detecting and treating a variety of potentially serious conditions. The Texas Department of State Health Services (DSHS) has been collecting newborn blood samples from babies born within the state since the 1960s. Texas currently tests for conditions including cystic fibrosis, endocrine disorders, fatty acid disorders, and others—28 disorders in all (pdf). At least some of the samples are apparently subjected to genetic testing for hemoglobinopathy, phenylketonuria, and galactosemia.

According to the complaint (pdf) filed in federal court in March 2009 by the Texas Civil Rights Project, the state began to retain the samples for research use in 2002. The five plaintiffs in the lawsuit were parents of children born in Texas, including one woman who was pregnant when the suit was filed. The defendants in the suit were the DSHS and its commissioner, along with Texas A&M University and several university administrators.

In response to the suit, the Texas legislature quickly enacted a law governing the collection of newborn blood samples. The new law, which went into effect in May 2009, provides that the DSHS “may retain for use by the department or laboratory genetic material used to conduct the newborn screening tests.” Parents are given the opportunity to opt out—they can ensure that the samples taken from their child are destroyed by filling out a “Destruction Directive” form (pdf). The new law also provides for de-identification of samples provided to researchers and oversight by an institutional review board.

The defendants claimed that these changes to Texas law made the suit moot—that the case no longer presented a valid legal dispute. In its order (pdf), the court rejected this argument because the new law did not address the blood spots already collected by the DSHS, including those allegedly collected from the plaintiffs’ children.

Having rejected the argument that the changes in the law meant that the suit should be dismissed, the court turned to the interesting question of whether the parents had the right to sue. To sue in federal court, a plaintiff must show “standing”—that he or she is the right person to argue the dispute before the court. Courts analyzing this issue focus on the question of injury—has the defendant caused an injury to the plaintiff that the court has the power to remedy? The question of injury often comes up in public interest cases, and especially in civil rights and environmental litigation. Here, the state claimed that the parents did not meet the injury requirement because the injury they claimed was “only conjectural and hypothetical,” relating only to the “potential for misuse of the blood specimens or ‘medical and genetic’ information contained in them.”

If the court had accepted this argument, it could have set a precedent1 that would limit future litigation—it would be very difficult for a plaintiff in this sort of case to conclusively show that he or she was directly injured by a misused sample. The court rejected this argument, however, stating that there is “reasonable fear of the potential for misuse because of the continued storage of the samples.” If other courts adopt this standard, a plaintiff suing a laboratory or researcher would not necessarily have to show that his own sample was misused, only that his sample was part of the group of samples subject to misuse. With newborn blood spots—where state policy often requires sample collection from all infants born in the state—this requirement will be easy to meet.

Next, the court addressed the Fourth Amendment of the U.S. Constitution, the first of two federal constitutional theories argued by the plaintiffs. In general terms, the Fourth Amendment protects against “unreasonable searches and seizures” by the government. In their response to the defendant’s motion to dismiss (pdf), the plaintiffs argued that they did not “object to the state’s mandated newborn screening program so long as safeguards are in place to destroy an infant’s samples within a reasonable period of time.” What they objected to, they said, was “the secret seizure of the initial [newborn blood spot] collection as a continuing deprivation of rights” because the state did not have “consent to draw infants’ blood for indefinite storage and undisclosed research, and did so deceptively.”2 Although the court did not fully resolve this issue, it did refuse to grant the defendants’ motion to dismiss the lawsuit, a decision that likely precipitated the settlement.

Plaintiffs’ second constitutional argument was based on their right to privacy and liberty under the Fourteenth Amendment. The court found that the plaintiffs stated a claim under the Fourteenth Amendment, assuming that the facts they claimed were true. Specifically, the court noted that the plaintiffs claimed that the blood spots “contain deeply private medical and genetic information, and were expropriated without knowledge or consent,” a claim that the court viewed as involving “bodily integrity.”3 The court also referred to plaintiffs’ claims that the protocols used by the Texas researchers were not consistent with federal protections for human research subjects under the Common Rule, including its requirements for informed consent. Like the Fourth Amendment decision, the court’s recognition that samples of genetic material involves privacy and liberty interests protected by the Fourteenth Amendment could be significant in future cases, possibly providing a form of constitutional protection in situations where the Common Rule may not apply.

Finally, the case is interesting for what it reveals about the interests at stake in civil rights litigation over genetic issues. Here, the plaintiffs and their civil rights lawyer sought to vindicate privacy interests related to their genetic information. They viewed the retention of the samples as government overreaching, as indicated by references to “Big Brother” and “the specter of a DNA data bank” in the Texas Civil Rights Project’s press release announcing the suit. By contrast, the state’s primary interest was continuing its work of screening newborn infants for treatable conditions. As the DSHS stated in its press release announcing the settlement, “settling this lawsuit is in the best interest of this program’s core mission to screen all newborn babies in Texas for life-threatening disorders.” Much to the regret of many researchers, neither party in the case had the primary goal of protecting the millions of samples scheduled for destruction for use in ongoing and future research.4

In July 2009, the American College of Medical Genetics released its Position Statement on Importance of Residual Newborn Screening Dried Blood Spots (pdf). In the statement, the ACMG describes opponents of research using retained newborn blood spots as “a very small but very vocal minority” with “arguments based on unsubstantiated and highly exaggerated privacy concerns.” As noted above, federal courts require parties to litigation to demonstrate an “injury”—a real stake in the outcome of a case. In future cases involving newborn blood spots, it will be interesting to see whether individual researchers or groups like the ACMG become more directly involved in such litigation. The result in this case—the destruction of millions of samples pursuant to a settlement agreement between two parties, neither of which was primarily interested in research goals—could well help support such involvement.

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1Because this case was before a federal district court, it would not bind other federal courts in the same way that a decision in the U.S. Supreme Court or the Circuit Courts can. Nevertheless, district court decisions can be highly influential on other courts, especially when they deal with relatively unexplored legal issues, as this one did.

2The state also argued that all samples were de-identified of any connection to the donor before being used for research purposes. Although this point could impact the legal analysis, including requiring a court to opine on the effectiveness of de-identification as a technique for ensuring privacy, the proceedings never got far enough for it to be relevant.

3The right to bodily integrity, grounded in the Fourteenth Amendment, was a key part of the holding in the 1942 Supreme Court decision in Skinner v. Oklahoma. In Skinner, the Supreme Court held unconstitutional an Oklahoma law that permitted the involuntary sterilization of certain “habitual criminals.” (In the process, it also overturned the result in the infamous case of Buck v. Bell, which we previously discussed on the GLR.) In rejecting the Oklahoma law, the Court held that the power to sterilize can have “subtle, far-reaching and devastating effects,” especially in “evil or reckless hands,” where it could cause “races or types which are inimical to the dominant group to wither and disappear.” Accordingly, the court noted, a person sterilized by the state is a person “forever deprived of a basic liberty.” With this language, Skinner was the first step in the line of cases that eventually led to Roe v. Wade.

4Press reports do indicate, however, that the 10,000 to 12,000 bloodspots already released to some 35 different research projects can continue to be used under the terms of the settlement. The court’s docket does not contain a copy of the settlement agreement.

Filed under: Biobanking, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, Pending Litigation, Pending Regulation, Privacy
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