Jay Root, The Associated Press
AUSTIN — Texas health authorities will destroy more than 5 million blood samples taken from babies without parental consent and stored indefinitely for scientific research.
The Texas Department of State Health Services announced Tuesday it would destroy the samples after settling a federal lawsuit filed by the Texas Civil Rights Project. The project, acting on behalf of five plaintiffs, had sued the Texas Department of State Health Services and the Texas A&M University System.
The lawsuit alleged that the state’s failure to ask parents for permission to store and possibly use the blood — originally collected to screen for birth defects — violated constitutional protections against unlawful search and seizure. The plaintiffs cited fears their children’s private health data could be misused.
Under the settlement overseen by a San Antonio federal court, the blood samples collected without parental consent must be destroyed by early next year. It also requires the department to publish a list of all research projects that used the blood specimens.
State health services spokeswoman Allison Lowery said an estimated 5.3 million samples would be destroyed. About 4 million to 4.5 million are stored at the Texas A&M School of Rural Public Health, she said.
Andrea Beleno, 33, was one of the parents who sued the state. She said she was stunned to learn that blood samples taken from her son, born in Austin in November 2008, were being stored indefinitely for unspecified research projects.
“You have to give permission for them to give your kid formula in the hospital,” Beleno said. “I don’t understand why you don’t have to give permission for the state to keep your kid’s DNA.”
Texas has been collecting blood samples for decades to screen for at least 27 different birth defects and other disorders. By law the blood could be taken without consent by hospitals, birthing centers and midwives.
The Department of State Health Services established a policy in 2002 in which it began setting aside the blood “spots” after the screenings are done and allowing some of it to be used for research. Before that, the blood was discarded after a certain interval.
This year the Texas Legislature tightened up the procedures, providing opt-out policies for parents, extending privacy guarantees and implementing controls over any scientific research that uses the samples. At issue in the lawsuit settlement are the millions of samples collected and stored before the law took effect in May.
“As a result of this settlement, DSHS will destroy all bloodspot cards received by the department before May 27, 2009,” the health services agency said in a written statement. “We will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”
Under current law, the department can still use the blood samples for quality control and disease research as long as parents don’t object. The department screens about 800,000 newborn blood specimens each year.
State agrees to destroy more than 5 million stored blood samples from newborns
By Mary Ann Roser, AMERICAN-STATESMAN STAFF
To settle a lawsuit, the state has agreed to destroy more than 5 million blood samples from newborns that it had stored indefinitely for possible research without parents’ consent, the two sides said Tuesday.
The Texas Civil Rights Project filed the lawsuit in U.S. District Court in San Antonio in March on behalf of four parents and a pregnant woman who dropped out later. It claimed that the state’s collection and storage of the samples amounted to “an unlawful search and seizure” and violated the privacy rights of the parents and their children. Under the settlement, the state will destroy 5.3 million samples it has collected between 2002, when the Department of State Health Services began storing the blood, and May 27, when a new state law restricting the practice was signed.
Federal Judge Fred Biery approved the settlement agreement Dec. 14 and gave the state 120 days — until April 13 — to finish destroying the samples, which are stored at Texas A&M University’s School of Rural Public Health.
This year, when stories in the American-Statesman brought the practice to light, the state health department and some medical researchers defended it, saying that collecting the blood spots on paper — done when newborns are screened for various health disorders — might one day provide valuable clues about childhood cancer and other diseases. They said that because the samples were coded and did not identify the babies by name, privacy rights were protected.
But the Texas Legislature approved a law in May requiring medical professionals to inform parents or guardians that the blood spots would be collected and stored indefinitely and could be used for research. Parents who objected could send a statement to the state health department, and their child’s samples would have to be destroyed within 60 days. If the parents didn’t do that, the child could upon reaching adulthood.
Between the time the law passed and Nov. 2, about 6,900 Texans have signed forms asking that the state destroy their child’s samples, out of 240,000 children born in that period, department spokeswoman Allison Lowery said. The department is getting 500 to 600 requests a week to destroy samples, she said.
A statement from the state health department said it “believes 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. Newborn screening saves children’s lives, and settling this lawsuit allows us to continue operating this critical program.”
Jim Harrington , director of the nonprofit civil rights group in Austin, said his organization was “very pleased with the way it worked out.”
Harrington said there were only two options to end the lawsuit: destroy the samples or try and go back to 2002 and get consent from all parents. About 400,000 babies a year are born in Texas.
Among the parents who sued was Austin lawyer Andrea Beleno, Harrington’s daughter-in-law. Her son Joaquin Harrington was born in November 2008, and Beleno said she had no idea “in the haze after giving birth” that any blood had been drawn and stored.
“To me, this whole thing was about consent,” she said. “If they had asked me … I probably would have consented. The fact that it was a secret program really made me so suspicious of the true motives, there’s no way I would consent now.”
Harrington said he will work with a legislative committee before the next regular session in 2011 to refine the new law.
He wants the state to divulge what research it is using the samples for and whether anyone is making money from it. He also wants to see how well the “opt out” provision is working.
Many other states do what Texas had been doing, and a consumer group in Minnesota has been fighting the practice there for several years.
“The State of Texas has taken first steps to restoring the genetic privacy rights of Texas children. This is a wonderful Christmas present for Texas citizens,” Twila Brase, president of the Citizens’ Council on Health Care in St. Paul/Minneapolis, said in a statement.
State to destroy 4 million newborn blood samples
By PEGGY FIKAC, Austin Bureau
AUSTIN — The state will destroy an estimated 5.3 million blood samples legally collected from newborns but kept without parental consent under a federal lawsuit settlement announced Tuesday.
The number of newborns involved is unclear because multiple samples are received from each by the Texas Department of State Health Services, department spokeswoman Allison Lowery said.
Typically, two samples are taken from each child, but there could be more, she said. The disputed samples cover a period of about seven years starting in 2002. The state conducts newborn screening to detect disorders or illnesses.
“This is about consent,” said lawyer Jim Harrington of the Texas Civil Rights Project. The group, after discovering the agency had been keeping the samples without permission, sued on behalf of parents in federal district court in San Antonio.
The Health Department said in a statement it would destroy the samples — retained as blood spot cards — that it received and stored before legislation took effect last May allowing their retention. The legislation allows parents, guardians or managing conservators to opt out of having the blood retained.
Lowery said the agency is seeking permission from fewer than 400 parents to preserve their babies’ samples because the children tested positive for rare disorders.
Collected before lawsuit
She said samples have been securely stored at the Texas A&M Health Science Center School of Rural Public Health.
That institution said in a statement that all the blood spots at the center were collected before the lawsuit and are subject to a joint resolution between the center and the agency to destroy them.
Andrea Beleno, an Austin mother who was one of the plaintiffs in the lawsuit, said she was pleased with the settlement.
“There’s no financial gain for any of the plaintiffs,” Beleno said. “Basically, what we wanted to do was to make sure that our children’s privacy was being protected and that the state is respecting our rights, because if we don’t stand up and make the government do that, nobody’s going to do it for us.”
Parents from San Antonio and Houston also were part of the lawsuit, which was filed against Commissioner David Lakey of the Department of State Health Services and Dr. Nancy Dickey, president of the Texas A&M Health Science Center and vice chancellor for health affairs of the Texas A&M System.
“The Texas A&M Health Science Center is glad that we have reached agreement in order to settle the lawsuit,” Dickey’s office said in a statement. “We are saddened, however, that a superb database has been lost. This database could have continued to shed light on causes of congenital birth defects and potentially led to preventive measures saving thousands of infants and their families the distress these defects cause.”
The parents’ lawsuit said there was no legal authority to keep the blood indefinitely without consent.
Harrington said his group became aware the blood samples were being stored after being called by a reporter from the Austin American-Statesman. Beleno said she first read about it in the newspaper.
Under the settlement, Harrington said, all blood specimens must be destroyed unless the state gets written permission to retain and use them. The destruction must occur within 120 days of the lawsuit being dismissed with the settlement, which occurred Dec. 14.
The agency also must post information on its newborn screening Web site, including a list of all research projects for which it has provided newborn-screening blood specimens.
In addition, the agency must inform the parents who sued how their children’s blood was used and any financial transactions involving the specimens, Harrington said.
The Texas Department of Health said in its statement that it is complying with the new law and “will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”
“If parents don’t object, the department saves the samples for uses allowed under the new legislation — primarily quality assurance and control purposes to ensure accuracy in lab testing and because the samples could provide an invaluable resource in researching new or more effective ways to prevent, diagnose and treat serious medical conditions that affect Texas children, including leukemia and birth defects,” the agency said in its statement.