A settlement was reached with the State of Minnesota and the Minnesota Department of Health over the illegal and improper use of blood samples obtained under the Newborn Screening Program by the Minnesota Department of Health. The settlement is a victory for privacy advocates.
Attorneys Scott Kelly and Dan Bellig of Farrish Johnson Law Office and Robert Bennett and Robert Vaccaro, civil rights lawyers with Gaskins Bennett Birrell & Schupp of Minneapolis, represented 21 families against the Minnesota Department of Health.
The Minnesota Department of Health (MDH) secretly established a bio-bank of blood samples and test results from blood left over after newborn screening. More than 50,000 blood samples and test results were used for research, including research for drug companies and equipment manufacturers like legal steroids uk online. The Minnesota Supreme Court ruled in November 2011 that written, informed consent is required for storage, use, or dissemination of any remaining blood samples or test results after completion of newborn screening. The Minnesota Supreme Court remanded the case for trial. Read the complete Minnesota Supreme Court Decision here.
The Supreme Court decision was a victory for privacy rights, parents and children in Minnesota. The lawsuit forces MDH to destroy over 1,100,000 blood samples and 900,000 test results illegally retained. The settlement lifts a temporary injunction obtained to preserve the evidence (blood samples and test results) pending the litigation. Now that the case has been settled, the blood samples and test results should be destroyed.
The lawsuit also resulted in a change in the law: the legislature specifically mandates written, informed consent before blood samples left over after testing under the newborn screening program can be used for any research, public health study or the development of new screening tests. This is a significant protection for our children now and in the future.
The landmark case pitted genetic privacy advocates against MDH for more than four years.
In 1997 MDH surreptitiously decided to establish a bio-bank of blood samples left over after newborn screening and correlating test results. Since 1997, MDH has collected over 1,100,000 blood samples from children born in Minnesota and more than 900,000 test results. In 2004, MDH began using the blood samples for research projects, including projects for drug companies and equipment manufactures developing testing equipment.
The issue of what was authorized under the statute was brought to the attention of an administrative law judge in 2007. An administrative law judge ruled MDH needed written, informed consent for the storage of blood samples outside of the testing allowed under newborn screening. The Administrative Law Judge noted in her opinion:
“Therefore, after careful consideration, the administrative law judge concludes that the newborn screening statute does not expressly authorize the Department to store genetic information indefinitely or disseminate that information to researchers without written, informed consent provided by parents.”
Read the complete report of the Administrative Law Judge here. Even though the ruling was upheld on appeal, MDH continued its conduct and ignored the law.
In 2008, MDH attempted to pass legislation expressly authorizing MDH to expand the use of blood samples so MDH could continue its independent third party research. Governor Pawlenty vetoed the legislation in May 2008, noting his belief that,
“written, informed consent should be obtained for long term storage or use of blood samples for non-screening research. Government handling and storage of genetic information is a serious matter. Removing the requirement of express authorization from parents regarding the long term storage and potential future uses of genetic samples, especially when such storage and use is not related to newborn screening, is concerning.”
MDH continued to violate the newborn screening statute even after Governor Pawlenty’s veto. Read Governor Pawlenty’s veto letter here.
The issue of the use of blood samples outside of newborn screening testing reached the Commissioner’s desk. In notes of a meeting with researchers, the Commissioner recognized the public’s concern and outrage over the inaction of MDH, noting she was becoming increasingly uncomfortable that no changes were being made to the program.
In October 2008, an employee of MDH prepared an internal memo to the Executive Director of the Newborn Screening Program concerning a request to query and identify potential study participants involving a study outside the scope of the newborn screening program. The employee expressed concern about the possible data practice issues because of the “data mining” and dissemination of data. The employee noted:
“That statute authorizing and governing newborn screening in Minnesota…does not specifically authorize the use of newborn screening data for research purposes.”
As part of the settlement, MDH has now agreed to comply with the newborn screening and genetic privacy laws.
For more information, contact Scott Kelly at 507-625-2525.