 |
| Photo Credit: AP. |
DETROIT (AP) — 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.
“This case
isn’t about stopping the newborn screening program,” Ellison told The
Associated Press. “It’s to put the scope of participation in the hands of moms
and dads as opposed to the government or a government bureaucrat. ... Moms and
dads have to be fully informed and make intelligent decisions. The current
practice doesn’t meet that.”
Despite the
judge’s ruling, the state health department said Friday that it’s confident the
program complies with state and federal laws.
Earlier this
year, at a separate stage of the case, the health department agreed to destroy
more than 3 million blood spots stored in Lansing, but millions more remain
under state control.
The
department has defended the program. It emphasizes that no spots are stored for
research unless parents give permission. Spots also can be destroyed upon
request, though the number of people who have taken that step is small.
A code — not
someone’s name — is attached to blood 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 they 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.
Follow Ed
White at http://twitter.com/edwritez