MINNEAPOLIS (AP) — The Minnesota Department of Health has improperly retained and distributed for research tens of thousands of blood samples left over from the state's newborn screening program since 1997, without the written consent of parents, the Minnesota Supreme Court ruled Wednesday.
In its decision, the court rejected the state's arguments that the legal authority granted to it under the newborn screening laws gave it an exception to the state's Genetic Privacy Act, which requires written consent to store and distribute genetic information.
"We conclude that the newborn screening statutes provide an express exception to the Genetic Privacy Act only to the extent that the department is authorized to administer newborn screening by testing the samples for heritable and congenital disorders," wrote Justice Helen Meyer for the majority.
Nine families sued the Health Department in 2009, claiming it was illegally storing and distributing the newborn blood samples without parents' permission. The district court dismissed the case and the state Court of Appeals concurred.
On Wednesday, the Supreme Court agreed with the plaintiffs' legal arguments, but said there was no specific evidence that any of the blood samples from the 25 children in the families had been stored or distributed, so the case was sent back to the district court to determine what remedies the families should receive.
Health Commissioner Dr. Ed Ehlinger said in a prepared statement that the department was reviewing the implications of the ruling on the operations of the program, which he said protects Minnesota babies from serious diseases.
A few drops of blood are taken from every child born in a hospital in the state and analyzed for more than 50 disorders because catching the diseases early helps treat them. Since 1997, the Health Department has kept any leftover blood in a depository that now holds more than 800,000 samples.
Meyer wrote that the department has allowed more than 50,000 blood samples to be used in health studies, including for the development of new blood tests and to assure the quality of existing tests. The department has claimed that it was not required to obtain written consent permission from parents to do so.
As part of its argument, the Health Department argued that the blood samples were not specifically identified as genetic information in the Genetic Privacy Act of 2006, the so act didn't apply. The court disagreed.
"We also note that even if the Genetic Privacy Act did not define the blood samples themselves as 'genetic information,' those samples unquestionably contain genetic information," the justices wrote, later concluding, "Unless otherwise expressly provided by law, the department must have written informed consent to collect, use, store, or disseminate those samples."
A statement distributed by the lawyers for the plaintiffs at the Farrish Johnson Law Office in Mankato said that insisting on informed consent for the newborn blood samples "continues to be a paramount concern in this day and age where the medical industry is willing to put profits ahead of privacy."
Scott Kelly, one of the plaintiffs' attorneys, said the families were disputing only how the Health Department handled the blood samples after the newborn screening was finished, not the screening program itself.
Justices Paul Anderson, Christopher Dietzen and David Stras filed documents saying they agreed with parts of the majority's ruling and dissented from others.
Copyright 2011 The Associated Press.