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Parents win key ruling in blood dispute

By ED WHITE

Associated Press

DETROIT — A judge has found key parts of Michigan’s newborn blood-testing program unconstitutional in a challenge by four parents who raised concerns about how leftover samples are used long after screening for rare diseases.

The lawsuit is not a class action. But the decision this week is likely to have an impact on how the state maintains millions of dried blood spots and makes them available for outside research.

Research with newborn blood spots occurs in other states, too.

“Michigan undoubtedly has some level of interest in detecting rare blood diseases in its infant population,” U.S. District Judge Thomas Ludington said. “But … defendants’ post-testing conduct is not necessary to effectuate that interest because ‘the health of the child is no longer at stake.'”

At the state’s direction, Michigan hospitals routinely prick the heels of newborns to draw blood to check for more than 50 diseases, a longstanding practice across the U.S.

Leftover blood spots are sent to the Michigan Neonatal Biobank in Detroit for safekeeping. Scientists can pay a fee to use them for various research projects.

Since 2010, Michigan must have permission from parents to use spots for outside research.

But attorney Phil Ellison argued that the program still violates constitutional protections against searches and seizures and might not be fully understood by parents who are given a form soon after the rigors of childbirth.

Ellison said the consent form and a related brochure are vague, making no reference, for example, to the state collecting fees from scientists for research.

“Indeed, the forms state explicitly that the DBS will be ‘used by the state lab.’ In other words, there is no evidence of plaintiff-parents’ informed consent to sell the DBS,” the judge said in a 32-page opinion, using an acronym for dried blood spots.

Ludington ruled in favor of the four parents on more than a dozen issues, including long-term storage and use of blood spots by private parties. He set some points aside for a future trial.

The judge didn’t come up with a remedy.

But he suggested the state could avoid future conflicts by simply creating a detailed form with a series of checkboxes for parents to consider.xxxxxxxxxxxxxxxxxxxxxxxxxxxxx

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