LaPorte v. Gordon

• Decision Date: 24 March 2020
• Docket Number: Case No. 20-10089
• Parties: SHANNON LAPORTE, et al., Plaintiffs, v. ROBERT GORDON, DR. SANDIP SHAH, DR. SARAH LYON-CALLO, MARY KLEYN, AND MARY SEETERLIN, in their official capacities, Defendants.
• Court: U.S. District Court — Eastern District of Michigan

SHANNON LAPORTE, et al., Plaintiffs, v. ROBERT GORDON, DR. SANDIP SHAH, DR. SARAH LYON-CALLO,MARY KLEYN, AND MARY SEETERLIN, in their official capacities, Defendants.

Case No. 20-10089

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN NORTHERN DIVISION

March 24, 2020

Hon. Thomas L. Ludington

Magistrate Patricia T. Morris

OPINION AND ORDER DENYING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION

All 50 states have newborn screening programs for at least 29 health conditions. NIH, How Many Newborns are Screened in the United States?, https://www.nichd.nih.gov/health/topics/newborn/conditioninfo/infants-screened#f3 (last reviewed 9/1/2017). The screening process is begun by withdrawing a few drops of blood from a baby's heel 24 to 36 hours after a child's birth. 50th Anniversary, 1965-2015 Michigan Newborn Screening: A Public Health Success Story, https://www.michigan.gov/documents/mdch/Newborn_Screening_Book_500007_7.pdf. Five or six spots of the blood are maintained on a filter paper card and then sent to the State Newborn Screening Laboratory for testing. Id. The child's primary medical care provider is informed immediately of any adverse health test result. CDC data show that nationally about 12,500 newborns each year are diagnosed with a condition identified through the newborn screening program. How Many Newborns are Screened in the United States? "Approximately 6.9 million Michigan newborns have been screened with more than 7,200 babies identified with disease and treated early for disabling and life threatening conditions." 50th Anniversary.

MCL § 333.5431 was added to the Michigan public health code in 1978 as part of a comprehensive reform to the code. House Legislative Analysis, HB 4070 (March 21, 1977). The House Fiscal Agency analysis explains that "[p]rovisions are included which would govern the classification of diseases and disabilities, reporting and surveillance, and procedures for the investigation and control of diseases and disabilities." Id. Initially, the section required a health professional responsible for assistance in the delivery of the child to test infants for "phenylketonuria and other handicapping conditions" under penalty of a misdemeanor. Public Act 368 of 1978.

Over the years the statute was amended, expanding the number of diseases that would be tested by a health professional to more than 50 disorders, adding reporting requirements, and requiring the department to promulgate rules related to the testing. Public Act 300 of 1986; Public Act 14 of 1987; Senate Fiscal Agency, Senate Analysis Section SB 162 (April 14, 1987); Public Act 264 of 1988; Public Act 81 of 1992; Public Act 88 of 1998; Public Act 138 of 1999; Public Act 691 of 2002. In 2000, the legislature added language requiring the department to "develop a schedule for the retention and disposal of the blood specimens used for the tests after the tests are completed" and allowing the samples to be used for medical research. Public Act 33 of 2000.

MCL § 333.5431 currently provides in part,

(1) A health professional in charge of the care of a newborn infant or, if none, the health professional in charge at the birth of an infant shall administer or cause to be administered to the infant a test for each of the following:

(a) Phenylketonuria.

(b) Galactosemia.

(c) Hypothyroidism.

(d) Maple syrup urine disease.

(e) Biotinidase deficiency.

(f) Sickle cell anemia.

(g) Congenital adrenal hyperplasia.

(h) Medium-chain acyl-coenzyme A dehydrogenase deficiency.

(i) Other treatable but otherwise disabling conditions as designated by the department.

(2) The informed consent requirements of sections 17020 and 17520 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.

The parent or legal representative of a newborn child decides whether all remaining blood samples should be destroyed, only blood samples stored for research should be destroyed, or the blood spots may be stored but not used for research purposes. ECF No. 15-4 at PageID.182.

The opt-in and opt-out processes (depending on an individual's date of birth) are explained on the Michigan Department of Health and Human Services website as well as pamphlets distributed by the department. ECF No. 15-6; 15-8. In short, at birth, a parent or legal guardian decides whether a child's blood spots may be used for research purposes. See the form below.

Image materials not available for display.If the parent wants to amend their response and/or have the blood spot destroyed, the following form is used later.

Image materials not available for display.

The Michigan BioTrust for Health and Michigan Neonatal Biobank oversee the storage and use of blood spots for research. MDHHS, Michigan BioTrust for Health, https://www.michigan.gov/mdhhs/0,5885,7-339-73971_4911_4916_53246---,00.html (last visited 3/18/2020); Wayne State University, Michigan Neonatal Biobank, https://mnb.wayne.edu (last visited 3/18/2020). "The Michigan Biotrust for Health was established by MDHHS to promote the research use of residual newborn screening dried blood spots while more optimally preserving the specimens, improving parental decision-making opportunities and increasing awareness in the general public. The Michigan Neonatal Biobank ('Biobank') is a storage and management facility for the archive of dried blood spot cards." Michigan Neonatal Biobank. Any unused blood spots from the initial testing of the baby are managed by the BioTrust and stored for up to 100 years. MDHHS, Michigan BioTrust for Health.

I.

On January 14, 2020, Plaintiff, Shannon LaPorte on behalf of herself and as parent-guardian of her unborn child, B.O., filed a complaint against officials from the Michigan Department of Health and Human Services ("MDHHS") in their official capacities. ECF No. 1. Plaintiffs do not clearly differentiate the difference between the alleged violations of B.O.'s parent's rights and B.O.'s rights. The complaint alleges four counts - Count I alleges that MCL § 333.5431(2) violates the Fourth Amendment, Count III alleges MCL § 333.5431(2) violates the Fourteenth Amendment, Count II alleges the extraction and testing of blood spots of newborns through an MDHHS program violates the Fourth Amendment, and Count IV alleges that medical testing of the blood spots without informed consent violates the Fourteenth Amendment. Id. Plaintiffs seek injunctive and declaratory relief, as well as attorney fees. ECF No. 1 at PageID.19.

Plaintiffs also filed a motion for preliminary injunction on the same day. ECF No. 3. Plaintiffs explain their circumstance as follows,

B.O. is set to be born in late April or early May 2020. The wrongs being challenged are set to occur 24-48 hours after the birth of B.O. absent pre-judgment injunctive relief by this Court. The harm will have been done. And there are no monetary damages available to cure the suffered harm due to state sovereign immunity. As such, a preliminary injunction is hereby sought to prevent Defendants and all those other persons who are in active concert or participation with Defendants (i.e. the conscripted healthcare professionals at local hospitals and all employees and technicians under the direction of Defendants) from extracting, seizing, and testing B.O.'s blood shortly after the birth of B.O. at the hospital for the purpose of exacting and cataloging highly personal and deeply private genetic/medical data. A preliminary injunction is warranted until such time as a merits decision on this case can be rendered.

ECF No. 3 at PageID.41 (emphasis added).

The briefing on the motion for preliminary injunction only addresses Counts II and IV of the complaint. Accordingly, Counts I and III will not be addressed.

II.

A related case needs to be addressed: Kanuszewski v. Michigan Department of Health and Human Services, 18-10472. When LaPorte v. Gordon was filed, Plaintiffs flagged Kanuszewski v. Michigan Department of Health and Human Services as a possible companion case. ECF No. 1. Judge Roberts agreed and reassigned LaPorte to this Court as a companion case. ECF No. 4. Plaintiff LaPorte is a plaintiff in both the current case and in Kanuszewski.

A.

On February 8, 2018, Plaintiff LaPorte, along with Adam and Ashley Kanuszewski, and Lynnette Wiegand, individually and as parent-guardians of their minor children, filed suit against the Michigan Department of Health and Human Services, Nick Lyon (the then-Director of MDHHS), the Dr. Sandip Shah (Director of the Bureau of Laboratories), Dr. Sarah Lyon-Callo (state epidemiologist), Mary Kleyn (Manager of the Newborn Screening Section), MichiganNeonatal Biobank, Inc., and Dr. Antonio Yancey (Director of the Michigan Neonatal Biobank). ECF No. 3 in 18-10472.

The complaint alleged Defendants violated Plaintiffs' Fourteenth Amendment rights (substantive due process) by extracting and storing blood spots without sufficient consent (Counts I and II), violated Plaintiffs' Fourth Amendment rights by extracting and testing the blood spots (Count III), and violated Plaintiffs' Fourth Amendment rights by indefinitely storing blood spots (Count IV). ECF No. 26 in 18-10472.

Defendants filed motions to dismiss. ECF Nos. 32, 33, 34 in 18-10472. This Court granted the motions to dismiss on the merits, finding the minor children failed to state a claim as to their substantive due process rights because as minors they are not competent to make medical decisions, but their parents are presumed to be competent (Counts I and II), the parents failed to state a claim as to substantive due process rights because their fundamental right to the care of their children was not violated by the extraction and testing of their children's blood (Counts I and II), the children failed to state a claim that their Fourth Amendment right to be free from an unreasonable...