DETROIT – The state of Michigan must return or destroy dried blood samples from nine newborns or get approval from parents to keep them, according to the latest scathing opinion from a federal judge who found parts of a routine testing program unconstitutional.
U.S. District Judge Thomas Ludington is not interfering with the practice of pricking the heels of babies to draw blood to screen for more than 50 diseases, a longstanding procedure in hospitals across the United States.
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Rather, he is overseeing a lawsuit that challenges how the Michigan health department handles leftover blood spots — and whether parents truly understand what they're doing when, following childbirth, they check a box allowing the state to use spots for research.
The form, for example, doesn't disclose that health researchers pay to use leftover blood spots and that police can get access to them in some circumstances. Ludington noted that newborn genetic markers are effectively stored indefinitely.
“The Fourth Amendment shelters citizens against governmental intrusions,” the judge said in a lengthy opinion on July 31.
The state's “attempts to sidestep constitutional scrutiny fall flat in the face of the imperatives of the Fourth Amendment,” Ludington wrote. “Even within the confines of medical and law-enforcement purposes, the retention and usage of blood samples bear implications that tread on personal privacy rights.”
He said the state was relying on “sanctimonious rationales” for its conduct.
Ludington said the state must contact the parents of nine children in the lawsuit and explain several options, including the return of dried blood spots, destruction of the spots and any related data, or approval to continue storing them. The spots must be destroyed if no consent is given within a year.
The order is a follow-up to a 2022 decision in which Ludington said parts of the program were unconstitutional.
The lawsuit is limited to children of four parents and is not a class action lawsuit. That means the judge's order is not a sweeping remedy that applies to every blood spot stored at the Michigan Neonatal Biobank in Detroit.
But Phil Ellison, an attorney who won the case, said Ludington set a valuable precedent.
“He's set a template for millions of others whose blood samples are in the Detroit biobank unknowingly,” Ellison told The Associated Press. “I think it's going to force the state to change the entire program — and change it for the better.”
He said the vague form, and the timing of when parents are asked for consent, doesn't allow them to make a thorough decision about the use of a baby's blood spots.
“The judge did a really unique thing. He changed the balance here,” Ellison said. “It's going to highly incentivize the state to change the process so moms and dads have all the information and can make an informed choice.”
The current version of the consent form has been in use since 2017.
The health department is "reviewing this decision and determining next steps. At this time, no changes are planned,” spokesperson Lynn Sutfin said in an email.
In 2022, at a separate stage of the case, the health department agreed to destroy more than 3 million blood spots stored in Lansing, Michigan, but millions more remain under state control.
The department has defended the program. It notes that no blood spots are kept for research unless parents give permission, though the spots still will be stored for up to a hundred years even if permission is not granted.
Spots also can be destroyed upon request, but the number of people who have taken that step is small.
A code — not someone’s name — is attached to spots that are stored in Detroit, making threats to privacy during research "very low,” according to the state.
Research with blood spots occurs in other states, including California, New York and Minnesota, where samples can be kept for decades.
In 2009, Texas agreed to destroy millions of newborn blood spots that were stored without consent. Spots obtained since 2012 now are destroyed after two years unless Texas parents agree to have them maintained longer for research.
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Follow Ed White at http://twitter.com/edwritez