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Background about the Newborn Screening Program

UPDATE [07/31/2023]: The post-testing retention of blood spots (and private medical data from those blood spots) declared unconstitutional. More details to be posted soon.

Since at least the 1980s, the State of Michigan has operated a program which has seized blood samples from its youngest citizens as newborn Michiganders less than 48 hours old to "test" for various diseases. Known as the Michigan Newborn Screening program, Michigan law requires that newborns be tested for various dieases including phenylketonuria, galactosemia, hypothyroidism, 'maple syrup' urine disease, biotinidase deficiency, sickle cell anemia, congenital adrenal hyperplasia, and more than two dozen more health concerns.

Early testing for newborns is undoubtedly a great public policy idea but the method by which Michigan has opted to implement the program violates the United States Constitution.

MDHHS and its officials, together with individuals from public universities, have purposely failed to obtain express consent from the newborn or his/her legal guardian, or to secure a required search warrant before taking the blood into the custody of the state government. But even more problematic, the state government keeps the excess blood samples without obtaining the consent or permission of parents or legal guardians.

The State, and its self-created non-profit entity, the Michigan Neonatal Biobank, keeps and stores millions of residual newborn screening dried blood spot specimens representing nearly every Michigan birth since July 1984. While the program and its goals are good policy, the process by which the blood samples were taken and then indefinitely kept is not.

Many parents, including the parents in this legal action, lacked a complete understanding or full knowledge that the blood or blood spots being drawn from their newborn child were being turned over the government while their precious new additions to their families were in the care of hospital staff.

In February 2018, Outside Legal Counsel filed a federal lawsuit against the Michigan Department of Health and Human Services, its officials, the Michigan Neonatal Biobank, and its official, regarding the illegal search, seizure, and retention of blood sample spots taken from newborns in Michigan.

The Legal Problem

Under federal constitutional protections, each and every citizen is entitled "to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures." The Founders were concerned about the government simply going too far into being able to search into and take away the privacy rights belonging to the citizenry. Through various Supreme Court cases, it has been held that drawing a person's blood for analysis constitutes a search within the meaning of the Fourth Amendment. Because it is a search, any governmental official who desires to do the same must either secure a judicial warrant (by explaining and proving to a judge there is a valid purpose for the blood draw) or fit within one of the narrow exceptions.

In the 1960s, public health advocates started a program to test Michigan's newborns for a handful of diseases. The purpose was laudable. Once the testing was done, the leftover blood was simply destroyed or discarded.

However, starting in the 1980s, Michigan's government made a radical decision; it secretly decided to simply start keeping the leftover amounts of blood from taken samples. They never informed parents they were doing so until fairly recently but even today the explanation is vague, at best.

Since at least 1987, the Michigan Department of Health and Human Services has been quietly keeping the extra blood spots which were not needed once the primary disease-based testing was complete. It is unclear why they decided to do this. The Michigan Legislature has never expressly authorized this action.

Formal Policy Statement of MDHHS

Fast-forward a few more years, and now the State contracted with an entity it helped create known as the Michigan Neonatal Biobank, a not-for-profit entity which is funded by government-imposed fees collected by hospitals for the blood tests. This entity, on behalf of the MDHHS, keeps and stores millions of blood samples in a warehouse in Detroit. A second warehouse of blood samples has also been revealed by this case.

In addition to the blood spot samples, the State also require hospitals to submit private and personal medical data information about the newborn and the mother including the infants' names, genders, weight, gestation time, and whether transfused with red blood cells and whether part of a single or multiple-newborn birth (i.e. twins, triplets). The data is kept by the State in a large database.

MDHHS Dried Blood Card

It is believed that the Biobank was created to avoid transparency and scrutiny because it is, techically, a privately-created entity. The Biobank has a Board of Directors who are made up of the very same group of researchers who want and utilize access to blood samples not otherwise available without consent of patients. Unlike many other quasi-public entities, members of this Board are not elected or held accountable by the citizens.

In short, the State has set up a complicated maze of people and entities to hide the existence and ongoing collection of newborns' blood, perhaps seized originally for a greater purpose but has since been utilized for other non-disclosed purposes in violation of federal constitutional protections.

Are You Against Children's Health and Safety?

One question that keeps coming up is whether we want to end all testing. The answer is no. Testing, broadly-speaking, is a great idea, but hospitals should do it. It is our position that should the State conduct these tests, parents need to have and give informed consent. The problem is not the testing; the problem is the backhanded process by which the State is violating the privacy of citizens by illegally and unconstitutionally seizing the blood of newborns for one purpose and then secretly keeping and using it for another.

The Lawsuit

On February 8, 2018, the parents of nine Michigan children filed a federal lawsuit against the Michigan Department of Health and Human Services, the Michigan Neonatal Biobank, and other individual officials who been involved with the creation and operation of a blood extraction and retention program. The lawsuit alleges that the process undertaken violates the Fourth and Fourteenth Amendments to the United States Constitution. The lawsuit seeks to have a federal judge order the halt of method being utilized by the State and its officials in illegally seizing and retaining blood samples from Michigan citizens. The lawsuit also seeks reimbursement of attorney fees.
The lawsuit has been pending for over five years, with one appeal already taken to the US Court of Appeals for the Sixth Circuit.

The Rulings

The case has had three major rulings so far. After initially dismissing the case, the United States Court of Appeals for the Sixth Circuit reinstated the lawsuit finding that while the initial extraction of the blood samples could not be challenged, the post-extraction testing and storage could be. Upon remand, discovery was undertaken, including the interview depositions of the state officials in charge of the Newborn Screening Program. Thereafter on July 29, 2021, the federal district court ruled that the acts of taking the blood spots and storing the same before May 2010 was partially unconstitutional. On September 13, 2022, the federal court reconsidered its decision and issued a revised opinion more widely holding that "informed" consent, and not just "general" consent, is legally required. Viewed through that proper legal lens, the Newborn Screening Program has operated unconstitutionally.

Additionally, the State and Plaintiffs reached a partial resolution of the case with the return and destruction of what MDHHS self-labelled the "parent spot." According to the State's attorneys, one retained dried blood spot — the Parent Spot — was supposedly allocated for the exclusive use of the newborn (after reaching the age of majority) or their parents (before the child has reached the age of majority) in the event that they are needed for uses unrelated to newborn screening. From Plaintiffs' perspective, this was view doubtfully because effectively no Michigan parent had any knowledge of the existence of the spot. With the guiding assistance of a magistrate judge, the State agreed to "destroy and fully dispose of all Parent Spots regardless of when designated and regardless of where stored." The State has since confirmed destruction of the same.

A trial on the few remaining issues was held in February 2023. A ruling will be issued soon. The State has indicated it will appeal to the Sixth Circuit.

Official Website of the Michigan Newborn Blood Seizure & Retention Lawsuit