Legal Challenges to Dried Blood Spot Use in Michigan Highlight the Role of Informed Consent in Valuable Public Health Activities
November 30, 2023
Overview
In the U.S., every state health department operates a newborn screening (NBS) program. NBS programs result in the early diagnosis of serious conditions in over 13,000 babies annually, making it a powerful public health intervention. As NBS requires the collection of personal information, it raises important considerations regarding individual privacy, autonomy, and ethical uses of data.
In the U.S., every state health department operates a newborn screening (NBS) program requiring that newborns be screened for certain genetic, endocrine, and metabolic disorders that threaten long-term health and survival. Because many newborns with these conditions do not have noticeable symptoms, early detection can be challenging. Fortunately, the availability of NBS allows healthcare providers to detect and diagnose conditions soon after birth and to respond with early treatment, which can often prevent serious disability or death.
According to the CDC, NBS leads to the early diagnosis of serious conditions in over 13,000 babies each year, making it a powerful public health intervention. However, NBS does not guarantee that newborns diagnosed with these conditions receive adequate follow-up care, and treatment inequities exist, particularly when lack of health insurance poses barriers to care.
As NBS requires the collection of personal information, it raises important considerations regarding individual privacy, autonomy, and ethical uses of data. Below is an outline of the role of these considerations in litigation involving the storage and use of information collected through the Michigan NBS program.
Blood Spot Screening and Post-Screening Practices
The NBS process is relatively straightforward. Blood spot screening, a key component of NBS, involves a healthcare provider pricking a newborn’s heel, collecting drops of blood on a filter paper card, and sending the sample to a laboratory for screening. While each state screens dried blood samples for a different set of health conditions, most states screen for some or all of those listed on the Recommended Uniform Screening Panel, which includes cystic fibrosis, sickle cell disease, and phenylketonuria, among other serious conditions. When a newborn tests positive for one or more conditions, the NBS program and healthcare provider can use this information to treat the newborn and provide support to their family.
After this screening process, most states retain leftover dried blood samples for various purposes, such as evaluation and improvement of NBS tests, research, and further diagnostic testing at parents’ request. In Michigan, leftover dried blood samples and related data (demographic details, disease diagnoses, and genetic markers) are primarily retained for improvement of NBS tests and for research seeking to understand and address a wide range of public health issues. Under Michigan Department of Health and Human Services (MDHHS) policy, third parties may request to use dried blood samples for approved research, which must be deidentified unless the researchers obtain study-specific consent from study participants. According to MDHHS, it also provides individuals’ samples to law enforcement if it receives consent from the individual, a parent, or another authorized representative.
Litigation in Michigan
This post-screening conduct is the subject of recent litigation in Michigan centering on the role of informed consent in MDHHS’s retention and use of dried blood samples and related data. In 2018, nine Michigan-born children and their parents filed a civil rights action, Kanuszewski v. MDHHS, against MDHHS and several other defendants claiming that MDHHS’s collection, retention, and use of the plaintiff children’s dried blood samples violated the U.S. Constitution’s Fourth Amendment and Fourteenth Amendment Due Process Clause. The plaintiffs alleged that MDHHS collected and used the children’s blood samples without their parents’ consent or knowledge. According to the plaintiffs, this practice violated their Fourth Amendment right to be free from unreasonable search and seizure, along with their Fourteenth Amendment substantive due process right to direct the children’s medical care.
The United States District Court for the Eastern District of Michigan dismissed the plaintiffs’ complaint, and, on appeal, the Sixth Circuit Court of Appeals affirmed dismissal of the claims arising out of the initial collection and screening of blood samples. However, the Sixth Circuit held that the plaintiffs’ claims relating to the storage and use of leftover samples and related data could proceed. Importantly, the Sixth Circuit concluded that the plaintiffs’ claims implicated a parent’s fundamental right to direct the medical care of their child. Therefore, if MDHHS acted without informed consent, its conduct would be subject to strict scrutiny—the most exacting level of review applied to alleged constitutional violations.
In a subsequent decision, the district court determined that MDHHS did not obtain the plaintiff parents’ informed consent. According to the court’s opinion, while the parents had signed informed consent forms, the record did not demonstrate that MDHHS had confirmed that they understood all conduct to which they consented. In light of this finding, the court concluded that MDHHS’s post-screening storage and use of the samples and data violated the parents’ Fourteenth Amendment right to direct the medical care of their children.
Most recently, in a July 2023 decision, the court found that, given the absence of informed consent, MDHHS’s storage, transfer, and use of the samples and data violated the Fourth Amendment. In reaching its decision, the court emphasized the sensitive nature of genetic information; the non-medical purposes for which samples are used, including disclosures to law enforcement per parental consent or court order; and the indefinite retention period of samples and data. The court directed MDHHS to destroy the plaintiffs’ samples and data if informed consent is not received within one year. MDHHS and the other defendants have filed a notice of appeal in the Sixth Circuit, indicating their intent to challenge the outcome reached by the district court.
Considerations for NBS Programs
The Kanuszewski case is not a class action and therefore only determined the rights of the nine children and their parents. Nonetheless, it raises important considerations for NBS programs in Michigan and other states, such as the adequacy of methods for obtaining informed consent and the effects of permitting samples to be used for non-public health purposes. Kanuszewski thus reflects a common tension between the need to protect privacy and the use of data to promote public health.
Here, despite MDHHS’s efforts to obtain informed consent and protect individual privacy, the district court concluded that these interests were given insufficient weight in furthering public health interventions. But Kanuszewski highlights an overarching value that can help to bridge this tension—building community trust by providing individuals with knowledge and choice. Particularly when others’ health is not immediately implicated, health departments may do well to err on the side of prioritizing autonomy, as doing so both respects constitutional safeguards and builds the trust integral to the protection of public health.
This post was written by Emma Kaeser, Staff Attorney, Network for Public Health Law—Mid-States Region. The Network for Public Health Law provides information and technical assistance on issues related to public health.
The legal information and assistance provided in this document do not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state. Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not represent the views of (and should not be attributed to) RWJF.