Kanuszewski v. Shah

551 F.Supp.3d 747

Adam KANUSZEWSKI, et al., Plaintiffs,

v.Sandip SHAH, et al., Defendants.

Case No. 18-cv-10472

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

Signed July 29, 2021

Philip L. Ellison, Outside Legal Counsel PLC, Hemlock, MI, for Plaintiffs.

Aaron W. Levin, Christopher L. Kerr, Santiago Rios, Thomas S. Marks, MI Department of Attorney General, Corporate Oversight Division, Lansing, MI, Joshua Vincent, Hinshaw & Culbertson LLP, Chicago, IL, for Defendants Sandip Shah, Sarah Lyon-Callo, Mary Kleyn.

Aaron W. Levin, MI Department of Attorney General, Corporate Oversight Division, Lansing, MI, Jeremy C. Kennedy, Jerold Lax, Pear sperling Eggan & Daniels, P.C., Ann Arbor, MI, Joshua Vincent, Hinshaw & Culbertson LLP, Chicago, IL, Thomas F. Cavalier, Wayne State University Office of the General Counsel, Detroit, MI, for Defendant Antonio Yancey.

Aaron W. Levin, Christopher L. Kerr, MI Department of Attorney General, Corporate Oversight Division, Lansing, MI, Joshua Vincent, Hinshaw & Culbertson LLP, Chicago, IL, for Defendant Elizabeth Hertel.

OPINION AND ORDER GRANTING IN PART AND DENYING IN PART PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT, GRANTING IN PART AND DENYING IN PART STATE DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT, GRANTING IN PART AND DENYING IN PART DEFENDANT YANCEY'S MOTION FOR SUMMARY JUDGMENT, DENYING PLAINTIFFS’ MOTION FOR LEAVE TO FILE EXHIBIT IN THE TRADITIONAL MANNER, AND DIRECTING PLAINTIFFS TO FILE SUPPLEMENTAL BRIEFING

THOMAS L. LUDINGTON, United States District Judge

On February 8, 2018, Plaintiff LaPorte, along with Adam and Ashley Kanuszewski, and Lynette Wiegand, individually and as parent-guardians of their minor children, filed suit against the Michigan Department of Health and Human Services ("the Department" or "MDHHS"), Nick Lyon¹ (the then-Director of MDHHS), Dr. Sandip Shah (Director of the Bureau of Laboratories), Dr. Sarah Lyon-Callo (state epidemiologist), Mary Kleyn (Manager of the Newborn Screening Section), Michigan Neonatal Biobank, Inc., and Dr. Antonio Yancey (Director of the Michigan Neonatal Biobank). ECF No. 3. The Complaint alleged that Defendants violated Plaintiffs’ Fourteenth Amendment (substantive due process) rights by extracting blood from infants and then storing those "blood spots" without adequate parental consent (Counts I and II). Plaintiffs further alleged that Defendants violated their Fourth Amendment rights by extracting and then testing the blood spots (Count III) and by indefinitely storing the blood spots (Count IV). ECF No. 26.

Defendants filed separate motions to dismiss. ECF Nos. 32, 33, 34. Those motions were eventually granted, and the Complaint was dismissed. ECF Nos. 50, 51.

On August 8, 2018, Plaintiffs appealed this Court's decision to the United States Court of Appeals for the Sixth Circuit. ECF No. 52. The Sixth Circuit affirmed in part and reversed in part, remanding two claims for further proceedings: first, the Plaintiff-parents’ substantive due process claim for the storage of the blood samples seeking injunctive and declaratory relief (Count II); and second, the Plaintiff-children's Fourth Amendment claim for the storage of the blood samples seeking injunctive and declaratory relief (Count IV).

On April 4, 2020, the case was consolidated with LaPorte v. Gordon , case no. 20-10089 (E.D. Mich. 2020). ECF No. 104. However, the LaPorte Plaintiffs have since voluntarily dismissed their claims from case no. 20-10089. ECF Nos. 114, 116, 118, 120.

I.

A.

The State of Michigan created a newborn screening program in 1965. 1965 PA 119. The program initially only required health professionals to test newborn infants for phenylketonuria which "can cause intellectual disability, seizure, behavioral problems, and other mental disorders." ECF No. 147 at PageID.4196–97. The majority of the more than 50 disorders tested for today are identified through a blood test, although the program also includes a hearing and critical congenital heart defect screening that is not challenged in this lawsuit. ECF No. 147-24 at PageID.4365 (Lyon-Callo Dep.). MDHHS Defendants concisely explain the history of the screening law,

[B]y 1978 the statute was amended to allow additional diseases to be tested and to provide that a person who violates the statute's newborn screening requirements is guilty of a misdemeanor.

To ensure the quality, consistency, and efficiency of newborn screening through centralized screening, the statute was amended in 1987 to permit the Michigan Department of Health and Human Services (‘MDHHS’) to require that newborn screening be performed at the MDHHS Laboratory. In 2000, the statute was again amended to, among other things, expressly exempt newborn screening testing from informed consent requirements and require MDHHS to: (1) develop a schedule for the retention and disposal of residual dried blood spots (‘DBS’) after newborn screening is completed; (2) make the DBS available for medical research during the established retention period; and (3) publish a pamphlet explaining the newborn screening program and statutory requirements, including the retention and disposal period for DBS and that they may be used for medical research.

ECF No. 147 at PageID.4197–98.

Currently, Michigan law requires all newborn infants to be tested for phenylketonuria, galactosemia, hypothyroidism, maple syrup urine disease, biotinidase deficiency, sickle cell anemia, congenital adrenal hyperplasia, medium-chain acyl-coenzyme A dehydrogenase deficiency, and "[o]ther treatable but otherwise disabling conditions as designated by the department." MCL § 333.5431(1). According to MDHHS, the State tests for over 50 disorders, and more than 250 babies born each year in Michigan are diagnosed with one of the rare disorders. ECF No. 147-2 at PageID.4243 (Michigan Newborn Screening Questions and Answers , MDHHS). The tested disorders "may affect blood cells, brain development, how the body breaks down nutrients from food, lungs and breathing, hormones, and how the body fights infection." ECF No. 147-3.

"Between 24 and 36 hours of life, a few drops of blood are drawn from a baby's heel to fill five or six spots on a filter paper card." ECF No. 135-4 at PageID.2071 (1965-2015 Michigan Newborn Screening: A Public Health Success Story , MDHHS); ECF No. 147-2 at PageID.4244 (Michigan Newborn Screening Questions and Answers , MDHHS). Michigan law provides that the newborn screening test is exempt from the State's informed consent requirements. MCL § 333.5431(2) ("The informed consent requirements [for genetic testing] do not apply to the tests required under subsection (1). The tests required under subsection (1) shall be administered and reported within a time and under conditions prescribed by the department. The department may require that the tests be performed by the department."). Simply stated, parental consent is not needed for the screening. However, the Department is required to inform parents if the results of a test are positive. Id. § 333.5431(3). An individual who violates either the statute or rules promulgated by MDHHS for the screening program is guilty of a misdemeanor. Id. § 333.5431(5). After the infant's blood is tested, the remaining dried blood spots ("DBS") are sent to MDHHS.

The two remaining questions in this case concern MDHHS’ storage and subsequent use of the DBS for research.

B.

There are multiple entities involved in the newborn screening program and later storage of the excess DBS² : MDHHS, the Michigan BioTrust, and the Michigan Neonatal BioBank ("MNB" or "BioBank"). The Michigan BioTrust is a state program operated by MDHHS "that addresses the residual dried blood spots." ECF No. 147-24 at PageID.4336 (Lyon-Callo Dep.). The BioTrust oversees the storage and research of the DBS. Id. at PageID.4343–49 (Lyon-Callo Dep.); Newborn Screening Blood Spots , MDHHS, https://www.michigan.gov/documents/mdch/Dried_Blood_Spot_Research_Table_Public_Report_347898_7.pdf [https://perma.cc/6NNN-38AR]³ . However, the State does not have the capacity to store all the excess DBS, so it contracts with the BioBank to store most of the excess DBS. ECF No. 147-24 at PageID.4344–46 (Lyon-Callo Dep.). Accordingly, the BioBank is the "depository" whose sole job is to "store the blood spots." ECF No. 147-31 at PageID.4680 (Yancey Dep.); ECF No. 135-35 at PageID.2372. Director Yancey also promotes the BioBank to researchers, including sharing pamphlets and other promotional material, including at Wayne State's new faculty orientations. ECF No. 147-24 at PageID.4388 (Lyon-Callo Dep.); ECF No. 147-31 at PageID.4742–43 (Yancey Dep.).

Plaintiff-parents are the parents of the nine Plaintiff-children. Adam and Ashley Kanuszewski are parents of DWL⁴ (born Jan. 17, 2018), RFK (born April 22, 2013), and CKK (born Feb. 10, 2016). Shannon LaPorte is mother to MTL (born October 19, 2008) and EMO (born Feb. 6, 2017). Lynette Wiegand is mother to LRW (born Nov. 21, 2011), CJW (born July 17, 2013), HJW (born December 24, 2014), and MLW (born Jan. 30, 2017). See ECF No. 26.

Defendants are employees of MDHHS or of the Michigan Neonatal BioBank. Defendant Mary Seeterlin is the Section Manager of the Newborn Screening Section at the MDHHS Laboratory. ECF No. 147-22 at PageID.4322. Mary Kleyn is the Manager of the Newborn Screening Follow-up Section at MDHHS. ECF No. 147-23 at PageID.4329. Elizabeth Hertel is the current Director of the Michigan Department of Health and Human Services. Doctor Sarah Lyon-Callo is director of the Bureau of Epidemiology and Population Health at MDHHS. ECF No. 147-24 at PageID.4340 (Lyon-Callo Dep.). Doctor Sandip Shah is the state public health laboratory director for MDHHS. ECF No. 135-42 at PageID.2428. He "oversee[s] all the public health-related testing in [the MDHHS] laboratory, state laboratory as well as county laboratories as a regional laboratory system." Id. at PageID.2438 (Shah Dep.). Drs. Shah and Lyon-Callo "are responsible for the dried blood spots...