DETROIT (CN) – It’s a sight familiar to many parents of newborns. Their baby son or daughter wails and writhes as a hospital technician pierces their heel with a needle, drawing a few drops of blood.
Four million newborns in the United States undergo the procedure each year, according to the National Institutes of Health. The short, sharp shock allows doctors to screen for congenital defects like sickle cell anemia, cystic fibrosis, and heart and hearing problems as well as more than 50 childhood disorders and diseases.
But on Thursday, four parents in Michigan dived into the ongoing ethical debate over the collection and storage of blood samples by claiming that the state neither asks their permission to draw blood nor protects their children’s privacy once the information is stored, sometimes indefinitely.
In a complaint filed in Detroit federal court by attorney Philip Ellison, Adam and Ashley Kanuszewski, Shannon LaPorte and Lynnette Wiegand call the practice a “noble public policy idea” but say the state should destroy their children’s samples or retroactively obtain their consent. The state has collected 5 million samples since 1987 and the parents are worried that their children’s personal health details could end up in the wrong hands.
They argue the Fourth Amendment protection against unreasonable searches and seizures prohibits the collection of the few blood drops typically drawn by pricking a newborn baby’s heel. The procedure is usually carried out 24 to 48 hours after a baby is born.
This is not the first time the practice has stirred controversy and legal challenges.
Parents in Indiana have also taken legal action. All 50 states and the District of Columbia currently screen newborns for diseases and defects.
Minnesota officials bemoaned a setback to the public’s health in 2009 when 21 families opposed to the practice reached a nearly $1 million settlement, and the state agreed to destroy 1 million newborn blood samples.
In 2010, Texas destroyed 5.3 million blood samples because of a similar legal challenge.
The parents in the Michigan lawsuit are now hoping for the same outcome.
They describe how blood samples are placed on a special card and transferred to the Michigan Neonatal Biobank in Detroit, where samples are stored indefinitely in a temperature and humidity-controlled facility.
According to the lawsuit, the state keeps data about the blood samples that outside agencies could potentially link to a child’s personal information, including their name, gender, weight, gestation time, and other information.
Parents are not given the option to opt out of the procedure before it happens, they say.
Michigan officials claim that blood samples are kept separate from children’s personal data. But the parents allege the Michigan Neonatal Biobank “readily and publicly admits that it is easily possible to request and break the blind causing the private medical and genetic information of the infants to be revealed.”
“This entire process violates the United States Constitution and must be ordered stopped, the samples illegally taken be destroyed (in the absence of retroactive consent), and appropriate reimbursement of losses to be paid by those who stole the blood of millions of newborn children,” the 15-page complaint states.
The state stores 5 million residual newborn blood spot samples at the bank. Michigan has collected blood samples since the 1960s and information at the bank includes newborn blood samples from every birth in the state from at least October 1987, and perhaps as early as 1984, according to the four parents.
“Since the blood spots contain deeply private medical and genetic information, the parents are concerned and fear about the potential for misuse of that information and fear the possibility of discrimination against their infants and perhaps even relatives through the use of such blood samples and research activity thereon,” the lawsuit states, adding that there are no legal protections to stop law enforcement and other officials from accessing their children’s private data.
The parents sued on behalf of their nine children born between 2008 and 2017.
Their attorney, Ellison, said he had discovered that the Michigan Department of Health and Human Services was storing blood samples in Lansing, which was not previously disclosed to parents, after the Michigan Neonatal Biobank sold samples to researchers and state universities. If the data ended up in the hands of a health insurance company, the attorney said, it is possible it could be used to deny coverage based on an identified pre-existing condition.
“Now, do we have examples of this going on right now? We don’t. But the short of it is right now, as the law stands in Michigan, there are no protections or regulations on the use of this blood once it has been taken by the government and stored in these warehouses,” Ellison said in a phone interview.
The named defendants in the lawsuit are the Michigan Department of Health and Human Services, Michigan Neonatal Bank and several health officials. They did not immediately respond to a request for comment Friday.
Natasha Bonhomme, a strategist with health advocacy group Genetic Alliance, said there are protocols and laws in place in Michigan and in other states to prevent law enforcement agencies and insurers from making use of the data. At the federal level, the Genetic Information Nondiscrimination Act of 2008 bars the discriminatory use of genetic information with regards to health insurance and employment.
“I think it’s important that parents have the opportunity to ask those questions, to raise them, and I do think that it is the responsibility of the Department of Health to put information out to address those concerns,” Bonhomme said.
Bonhomme noted, however, that screening of babies has saved thousands of lives. Michigan had worked hard to get the “community’s feedback on both the process around newborn screening, as well as the storage and use of those dried blood spots,” she said.
“I have concerns when the decisions through these lawsuits lead to the destruction of millions of samples…other parents didn’t get a chance to chime in and say what their perspective is and what their wishes are,” Bonhomme added.