Parents Sue Texas Health Dept. and Texas A&M over Infant Blood Databank

TCRP Press Release

Suit Raises Concerns about Collecting Genetic and DNA Data

Five parents this week filed a federal lawsuit in San Antonio U.S. District Court against the Texas Department of State Health Services (TDSHS), Commissioner David Lakey, M.D., Texas A&M, and Texas A&M Vice Chancellor for Health Affairs Nancy Dickey, M.D., claiming they have unlawfully and deceptively collected blood samples from their children at time of birth and stored those samples indefinitely for undisclosed research purposes, without plaintiffs’ knowledge or consent.

The plaintiffs are Geoffrey Courtney of San Antonio, Andrea Beleno and Maryann Overath of Austin, and Keith Taylor of Houston. Also joining the suit is Nancy Pacheco of Austin, who is expecting a child in August.

Plaintiff Andrea Beleno and her son

The suit alleges that the agencies’ activities constitute unlawful search and seizure and violate fundamental privacy rights, contrary to federal and state law, because at the time newborn children have a blood test to screen them for disease or disorders, TDSHS secretly collects and stores their blood indefinitely for other purposes without telling parents what it is doing or why it is doing it. Law requires newborn screening, but there is no legal authority to “seize” the blood and keep it indefinitely, without consent.

The suit also claims that the agencies violate standard, mandatory medical research protocols of obtaining informed consent from subjects before they are studied, using a method that clearly explains to them all the privacy ramifications.

U.S. Department of Health and Human Services regulations set out protocols with regard to minor children and include providing: (1) a description of the research’s purpose and procedure; (2) disclosure of privacy implications of the research; (3) whom to call if questions arise about the research; (4) parental consent; and, (5) a statement of no reprisals for declining to participate in the research. The state agencies do not abide by a single one of these protocols.

Nor have the agency officials disclosed what financial interests or transactions are involved, such as taxpayer expense or whether the samples are sold.

Since 2002, agency officials have routinely collected blood samples from all babies in Texas at time of birth and stored those samples or “spots” indefinitely at the Texas A&M Health Science Center School of Rural Public Health for purposes of undisclosed research unrelated to the purposes for which the infants’ blood was originally drawn, without the knowledge or consent of the infants’ parents. And they continue to do so. So far, they have collected about 4.2 million samples, and collect about 375,000 each year.

The lawsuit asks the court to destroy all blood samples and spots, which defendants have gathered and stored indefinitely without informed parental consent, or obtain consent, within a period set by the judge.

Plaintiffs also want the judge to order the officials to advise them for what purposes the agencies have used the blood samples and spots of the children and disclose all financial transactions involved with the use of such samples and blood. And they want the agencies to stop collecting blood samples and spots from newborn infants and keeping them indefinitely without informed parental consent.

The Plaintiffs also seek to have the court establish a procedure by which the agencies re-acquire informed consent from those children whose parents give consent, when such child reaches the age of 18 and becomes an adult, or otherwise destroy such blood samples and spots.

The Plaintiffs do 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.

TCRP Director Jim Harrington, who is representing the parents, called the agencies’ actions “an amazingly brazen deception by the state and a stunning overreaching into the private lives of Texans.

“They draw blood for a good reason–newborn screening, but then they secretly collect and keep it indefinitely for their own purposes without telling anyone what they are doing or why they are doing it.

“The government can’t just go around collecting people’s blood with all its confidential genetic information and use it for its own purposes without consent or legal authority. In this case, there is neither. This violates our core, fundamental constitutional principles.

“And for what purposes are these agencies storing blood indefinitely, and why do they need to collect and store blood from every person in Texas? They claim they are doing some kind of ‘research,’ but to do research you don’t need to have the blood and genetic material from everyone in society. This raises the specter of a DNA data bank, which can too easily be matched with other personal information the government collects, such as social security numbers and fingerprints.

“There is something utterly incompetent about this – or utterly sinister – or both. This is ‘Big Brother’ in one of its worst incarnations.”

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State sued over babies’ blood:
Parents say storing samples without consent is illegal

By Mary Ann Roser
AMERICAN-STATESMAN STAFF

Four parents and a pregnant woman sued the state health department Thursday, claiming that its policy of storing infants’ blood indefinitely for possible medical research is unconstitutional.

The nonprofit Texas Civil Rights Project in Austin filed the suit on the parents’ behalf in U.S. District Court in San Antonio. The suit also names Texas A&M University, which stores the blood for the Department of State Health Services.

The suit claims the state is violating constitutional protections against unlawful searches and seizures as well as state privacy laws. It seeks to stop storage of blood samples without parental consent and asks that samples be destroyed unless the state gets parents’ consent.

Since 1965, the state health department has been tasked with screening newborns for birth defects and other disorders under a law that does not require parental consent. In 2002, the health department decided to store the blood samples, so they could be used for possible research and other purposes, such as calibrating lab equipment, department spokesman Doug McBride said.

The state has since amassed 4.2 million samples at the A&M School of Rural Public Health in Bryan.

After the American-Statesman wrote about the practice Feb. 22, some parents said they were angry that their child’s blood was now state property without their consent and wanted it returned or destroyed. They feared the blood spots might be used someday to discriminate against their child.

“The screening (for disorders) is fine,” said James Harrington, director of the Texas Civil Rights Project. “It’s what they’re doing afterwards.”

The state health department has said the samples could one day help scientists find causes or cures for diseases, adding that infant’s identities are not on the paper cards holding the blood spots.

Earlier this month, it said it would consider destroying samples from parents who sent letters, provided it could find a legal way to do so. Harrington called the response inadequate.

“If you want to talk about Big Brother, this is one of its worst incarnations,” Harrington said at a news conference while flanked by three of the plaintiffs.

McBride declined to comment on the suit, and officials at Texas A&M could not be reached for comment — although the school was experiencing power outages Thursday, according to a message on one official’s voice mail.

Andrea Beleno, 33, of Austin said when her son was born Nov. 4 at Seton Medical Center, she had no idea that blood was drawn, much less stored.

“I think the screening program is good. They test for things that can make babies really sick initially,” she said, holding her son.

“And if they’d asked me if I would consent for this blood to be used for specific medical research, … I would have probably said yes.”

But Beleno said she would have said no to storing his blood indefinitely, just as she would refuse to let her own be stored “forever and ever.”