In the weeks before state health officials destroyed more than 5 million newborn blood samples they had stored without consent, privacy advocates, parents and lawmakers reached a last-ditch accord to save them — but couldn’t convince the Department of State Health Services to sign on.
The agency agreed in December to destroy the blood spots, after a civil rights attorney and several Texas parents sued the state for storing them for research purposes without permission. But after the court settlement was signed, privacy advocates lobbied the agency for an alternate solution: a research database that would keep the blood spots intact while seeking electronic consent from parents. They got the go-ahead from some key lawmakers and from the lawsuit’s plaintiffs, who pledged to void the settlement, but not from DSHS.
When The Texas Tribune discovered last month that state health officials had turned hundreds of baby blood spots over to a federal Armed Forces lab between 2003 and 2007 to build a mitochondrial DNA database — and that the agency hadn’t been upfront about it with lawmakers or the public — any chance for saving the blood spots fizzled out. All 5 million blood spots were sent to a Houston-area incinerator last week.
“If there was any way the blood spots were going to be saved, the whole thing fell apart at that point,” said state Sen. Bob Deuell, R-Greenville, who asked the agency for a full briefing on the newborn blood screening program last year but was never told about the federal study. “When this came out about these specimens going to the military, I said, ‘We’ve lost this one.’”
Texas has screened infants for birth defects for decades, pricking their heels and collecting drops of blood on paper cards. Starting in 2002, the state health department began storing the blood spots for “research into selected diseases” but never notified parents of the change. When a group of parents learned last year that their babies’ blood was being stored without their consent, they sued DSHS. The agency quickly settled the lawsuit, agreeing to destroy all existing blood spot cards. Meanwhile, the Legislature passed a law allowing all future de-identified blood spots to be stored for research while installing a far more rigorous parental consent process.
State health officials say Austin-based national patient privacy advocate Deborah Peel and Deuell, a physician, approached DSHS Commissioner David Lakey early this year about using electronic consents to save the 5 million existing blood spots from destruction. The agency reviewed the idea but never pursued it. “The lawsuit was settled. We had an agreement. We had no plans to back out of that agreement,” said agency spokeswoman Carrie Williams. “We settled the lawsuit because a negative result would have put the newborn screening program at risk.”
Critics say that’s not the only reason. They say DSHS conveniently settled the lawsuit before the trial went to the discovery phase, meaning the documents on the federal DNA study were never disclosed to the plaintiffs. (The Tribune obtained the documents on the federal project — designed to build a forensics tool to help identify missing persons and crack cold cases — through Texas open-records laws.) “Unfortunately, that of course confirmed the plaintiffs' worst fears,” said Peel, founder of the nonprofit advocacy group Patient Privacy Rights.
Peel said the state’s decision not to seek a non-destructive solution is a shame. She said there was national interest in “saving this treasure trove” of baby blood spots, and that she was working with researchers and lawmakers in Texas and Washington, D.C., to seek funding for a state-of-the-art research database that would allow parents to give consent electronically.
“We were going to … reach out to those 5 million families and let them know they had an alternative to having their blood spots destroyed,” Peel said.
While Jim Harrington, the civil rights attorney who filed the blood spot lawsuit, and the parents he represented were willing to delay the destruction of the spots to reach an agreement, Peel said, “it was really clear [state health officials] had been through so much legal trauma that they weren’t interested in trying to go backward.”
Deuell said the impression he got from state health officials was that they feared they would be subject to litigation from other parents if they negotiated with the plaintiffs not to destroy the blood spots. “Lakey said, ‘I can’t go against a court order,’” Deuell said. “They didn’t want to take a chance. They said, ‘The plaintiffs are just three people out of 5 million. Who’s to say somebody else wouldn’t come back and file a new suit?’”
Harrington said that worry is “utter nonsense.” He said both sides could have gone back to the judge to have a new settlement drafted — one that would’ve protected the agency. “What’s the harm in that?” Harrington asked. “We would have supplemented or amended the settlement. It would have been totally possible.”
But once news broke that some of the blood spots had been turned over to the federal lab — and that the state had no intention of destroying those samples — the plaintiffs’ offer was off the table. Instead, they have demanded that the state get the blood spots back from the federal government, or they’ll file another lawsuit.
“There was a lot of distrust on both sides,” Peel said, “without enough time to work through it.”