Kanuszewski v. Shah

ADAM KANUSZEWSKI et al., Plaintiffs, v. SANDIP SHAH et al., Defendants.

No. 1:18-cv-10472

United States District Court, E.D. Michigan, Northern Division

September 13, 2022

OPINION AND ORDER (1) GRANTING PLAINTIFFS' MOTION FOR

RECONSIDERATION, (2) DENYING DEFENDANTS' MOTION FOR

RECONSIDERATION, AND (3) VACATING IN PART PRIOR OPINION AND ORDER

THOMAS L. LUDINGTON UNITED STATES DISTRICT JUDGE

The parties have filed cross-motions for reconsideration of this Court's July 2021 Order. As explained hereafter Plaintiffs' Motion for Reconsideration will be granted, Defendants' Motion for Reconsideration will be denied, and the July 2021 Order will be vacated in part. In this way, summary judgment will be granted in Plaintiffs' favor for all but five of their claims for which triable questions of fact remain. Two Fourteenth Amendment claims remain regarding five children, and three Fourth Amendment claims remain regarding all the children.

I.

This case involves a § 1983 action arising from constitutional violations concerning Michigan's Newborn Screening Program (NSP). The following facts have been truncated to address the issues discussed in this Order. For a fuller disquisition, see generally Kanuszewski v. Shah, 551 F.Supp.3d 747, 750-58 (E.D. Mich. 2021).

A.

Under Michigan's NSP, established in the 1960s, the State of Michigan and its agents prick the heel of nearly every newborn to collect five or six drops of blood with a Dried Blood Spot (DBS) collection card.^[1] Kanuszewski v. MDHHS, 927 F.3d 396, 403-04 (6th Cir. 2019). The Michigan Department of Health and Human Services (MDHHS) then tests the blood for 58 disorders. ECF No. 135-11 at PageID.2179. In roughly 60 years, Michigan has diagnosed those disorders in about 0.2-0.25% of its newborns. See ECF No. 147-2 at PageID.4243. The relevant Michigan statute waives informed consent for these tests only.

As the Association of Public Health Laboratories^[2] (APHL) explains as amicus curiae, every state and territory in the United States has an NSP. See ECF No. 146 at PageID.4150. (“More than 98% of all children born in the United States receive [newborn blood screening].”). Although they are not profitable for “state governments,” see Id. at PageID.4152, NSPs allow states to “research” the “biomarkers” of “nearly the entire population,” including their “DNA, RNA, proteins, metabolites, and evidence of exposures to environmental or infectious agents,” id. at PageID.4157, 4159. To that end, the APHL adds, “retention and storage of residual DBS specimens is crucial.” Id. at PageID.4142.

According to the APHL, every state should-but does not-require “an opt-in approach” to obtain parents' informed consent for posttesting use, disposal, and access of their children's blood. See Id. at PageID.4153; accord Sonia M. Suter, Did You Give the Government Your Baby's DNA? Rethinking Consent in Newborn Screening, 15 Minn. J.L. Sci. & Tech. 729, 745 (2014) (“Consent has long been absent in [newborn blood screening] . . . .”); Katherine Drabiak-Syed, Legal Regulation of Banking Newborn Blood Spots for Research: How Bearder and Beleno Resolved the Question of Consent, 11 Hous. J. Health L. & Pol'y 1, 45 (2011) (“Most states do not inform parents that the health department will retain their child's sample or use it for additional research, and few states obtain consent for research using [newborn blood screening]. As such, parents lack the ability to decline their newborn's participation in research.”).

For decades, experts and scholars from medicine to law have criticized state-run NSPs. See, e.g., Albert R. Serrano IV, Pieces of Me: The Immoral and Unjust Appropriation of Genetic Material, 16 Mich. St. U. J. Med. & L. 95, 110-15 (2011) (noting that parents generally “want to be fully informed about the circumstances and at least given the option to decline”); Jaclyn S. D'Arminio, Note, “The Life of the Flesh Is in the Blood”: State Storage and Usage of Baby's Blood Sample, 18 Cardozo J.L. & Gender 753, 760 (2012) (“[I]ssues arise when the state's interest in identifying the disease becomes obsolete, and research becomes the state's primary interest.” (footnote omitted)); see also Alexander Morgan Capron, Which Ills to Bear?: Reevaluating the “Threat” of Modern Genetics, 39 Emory L.J. 665, 684-85 (1990) (discussing “[t]he past lack of attention” to “the ethical and legal issues in genetic screening”).

The preeminent concern about state-run NSPs is the lack of “consensus about or commitment to” obtaining parents' informed consent. See Ellen Wright Clayton, Screening and Treatment of Newborns, 29 Hous. L. Rev. 85, 118 (1992).

Here, too-without obtaining informed consent-Michigan indefinitely stores babies' blood to conduct “medical” and “health” research, to identify victims and suspects of crimes, and to make a substantial profit by selling it to private entities. See ECF Nos. 135-12 at PageID.2180- 85; 148 at PageID.4847. See generally Kanuszewski v. MDHHS, 927 F.3d 396 (6th Cir. 2019).

Considering the 6,000-ish newborns that would not have otherwise been diagnosed with rare blood disorders, it is well understood that enjoining Michigan's unconstitutional conduct would have significant consequences. That said, this case is limited to the claims of only nine Michiganders. See Sharpe v. Cureton, 319 F.3d 259, 273 (6th Cir. 2003) (“[I]njunctive relief should be no more burdensome to the defendant than necessary to provide complete relief to the plaintiffs.” (citations omitted)).

B.

On February 8, 2018, Plaintiffs Shannon LaPorte,^[3] Adam and Ashley Kanuszewski, and Lynette Wiegand, individually and as parent-guardians of their minor children, sued the MDHHS, Nick Lyon (the then-Director of the MDHHS), Dr. Sandip Shah (the Director of the Bureau of Laboratories), Dr. Sarah Lyon-Callo (an MDHHS epidemiologist), Mary Kleyn (the Manager of the Newborn Screening Section), the Michigan Neonatal Biobank, and Dr. Antonio Yancey (the Director of the Biobank). ECF No. 3.

Plaintiffs' Complaint alleges Defendants violated Plaintiffs' Fourteenth Amendment (substantive due process) rights by extracting blood from their babies then storing and using the blood spots without their constitutionally adequate consent (Counts I and II). ECF No. 26 at PageID.322-25. Plaintiffs also allege Defendants violated their Fourth Amendment rights (against unreasonable searches and seizures) by extracting the blood (Count III) and by indefinitely storing the blood spots (Count IV). See Id. at PageID.325-29.^[4] Defendants filed separate motions to dismiss. ECF Nos. 32, 33, 34. Those motions were granted, and the complaint was dismissed. See generally Kanuszewski v. MDHHS, 333 F.Supp.3d 716 (E.D. Mich. 2018).

C.

On appeal, the Sixth Circuit affirmed and reversed in part, remanding Count II and Count IV for discovery and further proceedings. See generally Kanuszewski v. MDHHS, 927 F.3d 396 (6th Cir. 2019). As to the Fourth Amendment (Count IV), the Sixth Circuit held that “the ongoing retention, storage, or use of the [DBS] constitutes a separate, independent violation.” Id. at 424. This distinction exists, Judge Clay added, despite the possible constitutionality of the initial “drawing and screening.” Id. To that end, he remanded the question of “whether Plaintiffs consented to any aspect of Defendants' retention, storage, or future use of the blood samples.” Id. at 425.

Addressing the Fourteenth Amendment (Count II), the Sixth Circuit held that Plaintiff-parents “have a fundamental right to direct the medical care of their children,” subject to strict scrutiny. Id. at 421. To that end, Judge Clay reasoned that parents' rights (1) “to direct the education and upbringing of [their] children” and (2) “to make decisions concerning the care, custody, and control of [their] children,” would both (3) “seem to naturally include the right to direct their children's medical care,” because (4) “a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment,” and (5) “[c]hildren are assumed to be subject to the control of their parents.” Id. at 418-19 (citations and internal quotation marks omitted).

The Sixth Circuit went on to conclude that Plaintiff-parents plausibly alleged Fourteenth Amendment violations based on the lack of informed consent for the “subsequent retention, transfer, [] storage,” “research,” and “selling” of their children's DBS. Id. at 420-21. On remand, this Court was directed to answer (1) “whether the evidence demonstrates that Defendants' actions interfered with the parents' right to direct their children's medical care” and (2) “whether those [interfering] actions survive strict scrutiny.” Id.

But the Sixth Circuit did not address the Nation's history or tradition of parents' right to direct their children's medical care or how that right is implicit in the concept of ordered liberty. Id. at 418 (holding that the Constitution “would seem to naturally include [parents'] right to direct their children's medical care”); see also Dobbs v. Jackson Women's Health Org., 142 S.Ct. 2228, 2242 (2022) (holding that any Fourteenth Amendment right “not mentioned in the Constitution[] . . . must be ‘deeply rooted in this Nation's history and tradition' and ‘implicit in the concept of ordered liberty'” (quoting Washington v. Glucksberg, 521 U.S. 702, 721 (1997))). The same is true even though earlier in the same opinion the Sixth Circuit held not only that “parents' substantive due process right to direct the upbringing and education of children . . . . does not address the issue of parents' right to control their children's medical care,” but also that “parents' right to control their children's medical care” is not clearly established. I...