Michigan Newborn Blood Seizure and Retention Lawsuit

Kanuszewski, et al v Michigan Dept of Health and Human Services, et al




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 approximate four million (but some estimates are even higher) of residual newborn screening dried blood spot specimens representing nearly every Michigan birth since October 1987. 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.

What's the 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 Child's Health and Safety?

One question that keeps coming up is whether we want to end all testing. The answer is no. Testing 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 cetain damages and reimbursement of attorney fees. Copies of the documents will be posted on this website.

Documents and Evidence

Below are links to documents obtained from the Michigan Department of Health and Human Services' website or provided in response to a Freedom of Information Act request.

MEDIA INQUIRIES:

All media interviews related to this case are being exclusively coordinated through Outside Legal Counsel.

Philip L. Ellison
(989) 642-0055

STATE WEBSITES

Michigan Newborn Screening Program

Michigan BioTrust for Health

Michigan Neonatal Biobank

Michigan DHHS


COURT DOCUMENTS

 Federal Court Complaint
    Exhibit A
    Exhibit B
    Exhibit C
    Exhibit D
    Exhibit E
    Exhibit F
    Exhibit G
    Exhibit H