Federal appeals court rules Michigan’s newborn blood screening program constitutional

A federal appeals court has reversed a 2022 ruling that found parts of the state’s newborn blood screening program unconstitutional.

The program collects blood samples from newborn babies and screens them for diseases. Three years ago, a district court judge ruled in favor of four parents who raised concerns regarding the leftover dried blood spots, which are kept at the Michigan Neonatal Biobank in Detroit. Scientists can pay a fee to use the spots for research.

On Wednesday, the U.S. Court of Appeals for the Sixth Circuit ruled that those practices do not violate constitutional protections regarding privacy and illegal searches and seizures.

“The Newborn Screening Program saves lives,” Michigan Attorney General Dana Nessel said in a statement. “I want to thank the Court for its decision and the dedicated attorneys in my office who litigated this case for years to ensure Michigan can continue early detection of serious diseases while also advancing medical research through privacy-protected de-identified data.”

Attorney Philip L. Ellison, who represented the parents, did not immediately return a call seeking comment.

The parents who sued argued that the taking and keeping of their babies’ blood for state profit violated the Fourth and Fourteenth amendments.

The 2022 ruling in their favor included an injunction that required the state to mail each plaintiff parent a notice allowing them to request their child’s samples to be returned to them or destroyed.

Both parties agreed to a partial stay of the injunction pending appeal, in which the state agreed to return or destroy all the blood spots but not to destroy the associated data. According to Wednesday’s ruling, the state complied with the injunction.

The state requires parental permission for the leftover spots to be used for outside research. But the plaintiffs argued the program still violated the Constitution. They said the consent form and a related brochure were vague and made no reference to the state collecting fees from scientists for research, the Associated Press reported at the time.

In a press release, Nessel said the Sixth Circuit ruling reaffirmed that the program’s post-screening practices, including analyzing blood spots and making them available to “vetted health researchers,” does not violate constitutional protections.

The ruling also vacated the lower court’s injunction.

“With this ruling, MDHHS can continue to fulfill its commitment to protect the health and well-being of Michigan families, particularly its youngest and most vulnerable residents,” said Elizabeth Hertel, director of Michigan Department of Health and Human Services, which operates the screening program.

“Michigan’s newborn screening program is designed to quickly diagnose babies who may look healthy but have rare and often serious disorders that require early treatment,” Hertel said. “Since 1965, this program has ensured thousands of families were quickly provided information about their baby’s condition, allowing for early interventions and healthier outcomes.”

State officials said newborn screening looks for more than 50 disorders that can affect blood cells, brain development, how the body breaks down nutrients from food, lungs and breathing, hormones and how the body fights infection.

The samples are stored using a randomized numeric code — not the patient or their parent’s name — minimizing any risk to privacy, the state said.

In its ruling, the appeals court wrote that the newborn screening program diagnoses more than 250 Michigan babies each year with a rare disorder. Every U.S. state, as well as Washington, D.C., and Puerto Rico, has a similar program in place, according to MDHHS.

mreinhart@detroitnews.com

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