Kanuszewski et al
Filing
200
Opinion and Order Denying Defendants' 143 Daubert Motion. Signed by District Judge Thomas L. Ludington. (KWin)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MICHIGAN
NORTHERN DIVISION
ADAM KANUSZEWSKI, et al.,
Plaintiffs,
Case No. 1:18-cv-10472
v.
Honorable Thomas L. Ludington
United States District Judge
SANDIP SHAH, et al.,
Defendants.
_________________________________________/
OPINION AND ORDER DENYING DEFENDANTS’ DAUBERT MOTION
Defendants filed a motion to exclude the expert testimony of Dr. Elizabeth Eisenhauer and
Professor Sonia Suter. ECF No. 143. As explained hereafter, Defendants’ Motion will be denied.
I.
This case involves a § 1983 action arising from alleged constitutional violations concerning
Michigan’s Newborn Screening Program (NSP). Under the NSP, which Michigan has operated
since the 1960s, the State of Michigan and its agents prick the heel of nearly every newborn to
collect a blood sample with a Dried Blood Spot (DBS) collection card.1 Kanuszewski v. Mich.
Dep’t of Health & Hum. Servs., 927 F.3d 396, 403–04 (6th Cir. 2019). The State of Michigan
purportedly uses the babies’ blood for “medical” and “health” research on its population and to
identify victims and perpetrators of crimes, in addition to selling babies’ blood to private entities
for a substantial, undisclosed profit. See generally id.; see also ECF No. 148 at PageID.4847.
1
In the scientific community, this procedure is called a “neonatal heel prick,” and the cards are
called “Guthrie cards.” Tufik Y. Shayeb, Informed Consent for the Use and Storage of Residual
Dried Blood Samples from State-Mandated Newborn Genetic Screening Programs, 64 BUFF. L.
REV. 1017, 1020 & n.16 (2016).
Currently, Michigan law requires testing of all newborns 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.” MICH. COMP. LAWS § 333.5431(1). According to the Michigan Department of Health
and Human Services (MDHHS), Michigan tests for over 50 disorders and diagnoses about 0.2–
0.25% of Michigan’s newborns with one of the rare disorders. See ECF No. 147-2 at PageID.4243.
On February 8, 2018, Plaintiffs Shannon LaPorte,2 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 (a state epidemiologist), Mary Kleyn (the Manager of the
Newborn Screening Section), Michigan Neonatal Biobank, Inc., and Dr. Antonio Yancey (the
Director of the Michigan Neonatal Biobank). ECF No. 3.
Plaintiffs’ Complaint alleges that 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 that 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.325–29.3
2
On April 4, 2020, the case was consolidated with LaPorte v. Gordon, No. 1:20-CV-10089 (E.D.
Mich. Apr. 29, 2020). See ECF No. 104. However, the LaPorte Plaintiffs have since voluntarily
dismissed their claims from that case. See ECF Nos. 114; 116; 118; 120.
3
See generally Laura Beth Cohen, Informing Consent: Medical Malpractice and the
Criminalization of Pregnancy, 116 MICH. L. REV. 1297, 1304 (2018) (discussing the implications
of informed consent for medical procedures in the context of the Fourth and Fourteenth
Amendment); Margaret A. Berger & Aaron D. Twerski, Uncertainty and Informed Choice:
Unmasking Daubert, 104 MICH. L. REV. 257, 270 (2005) (“The right of a patient to informed
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Defendants filed separate motions to dismiss. ECF Nos. 32, 33, 34. Those motions were
granted, and the complaint was dismissed. See generally Kanuszewski v. Mich. Dep’t of Health &
Hum. Servs., 333 F. Supp. 3d 716 (E.D. Mich. 2018).
On August 8, 2018, Plaintiffs appealed the dismissal to the Sixth Circuit Court of Appeals.
ECF No. 52. Ten months later, the Sixth Circuit affirmed and reversed in part, remanding two
claims for further proceedings: first, 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). Kanuszewski, 927 F.3d 396; ECF No. 78. After
remand, the case proceeded as normal for nearly 21 months. See ECF Nos. 79–142.
On March 24, 2021, Defendants filed a Motion to Exclude Expert Testimony, ECF No.
143, which the parties have fully briefed, ECF Nos. 148; 154.
II.
Relying on the seminal Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
(1993), Defendants seek to exclude the testimony of Plaintiffs’ experts as “not reliable or helpful,”
claiming “both of their testimony is based on insufficient facts or data.” ECF No. 143 at
PageID.3381.
A.
Federal Rule of Evidence 702 governs the admissibility of expert testimony, providing that:
A witness who is qualified as an expert by knowledge, skill, experience, training,
or education may testify in the form of an opinion or otherwise if:
(a) the expert’s scientific, technical, or other specialized knowledge will help
the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
consent has been a staple of U.S. medical malpractice law for [nearly five] decades.”).
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(d) the expert has reliably applied the principles and methods to the facts of the
case.
FED. R. EVID. 702.
Rule 702 assigns the district court “the task of ensuring that an expert’s testimony both
rests on a reliable foundation and is relevant to the task at hand”—a kind of “gatekeeping role.”
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993). In this role, district courts
consider several factors that the Daubert Court identified, including whether the expert’s methods
are testable and subject to peer review. Id. at 593–94; see also United States v. Bonds, 12 F.3d 540,
558 (6th Cir. 1993) (identifying and discussing the so-called “Daubert factors”).
The Daubert factors “do not constitute ‘a definitive checklist or test” and do not apply in
every case. See Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999). “Rather, the law grants
a district court the same broad latitude when it decides how to determine reliability as it enjoys in
respect to its ultimate reliability determination.” Id. at 142; see also Surles ex rel. Johnson v.
Greyhound Lines, Inc., 474 F.3d 288, 295 (6th Cir. 2007) (“The gatekeeping inquiry is contextspecific and ‘must be tied to the facts of a particular case.’”) (quoting Kumho Tire, 526 U.S. at
142).
The qualifications of Dr. Elizabeth R. Eisenhauer will be discussed first, infra Section II.B,
followed by the qualifications of Professor Sonai M. Suter, infra Section II.C, and then the scope
of their testimony, infra Section II.D.
B.
Defendants seek to preclude the testimony of Dr. Elizabeth R. Eisenhauer, Ph.D., R.N.
ECF No. 143-1 at PageID.3393, 3398. As Defendants note, Plaintiffs will offer Dr. Eisenhauer’s
“opinion regarding informed consent and biobanking formed on the basis of one qualitative study.”
ECF No. 143 at PageID.3382.
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Doctor Eisenhauer has the knowledge and education to testify about biobanking and
informed consent. FED. R. EVID. 702. For years, she researched the “ethical, legal, and social
implications of biobanking and genetic testing, specifically related to informed consent.” ECF No.
143-1 at PageID.3393. Moreover, she earned a certificate in Health Informatics before earning a
Ph.D. in Nursing for defending her doctoral dissertation, Informed Choices in Biobanking. Id. at
PageID.3399, 3401. Then she published two peer-reviewed journal articles on biobanking and
informed consent. See id. at PageID.3401. In sum, Dr. Eisenhauer is an expert in biobanking and
informed consent.
Defendant only challenges Dr. Eisenhauer’s testimony as not “based on sufficient facts or
data.” FED. R. EVID. 702(b); see ECF No. 143 at PageID.3385–86. Specifically, Defendant claims
that the published study she relies on is statistically unreliable due to an insufficient sample size.
See ECF No. 143 at PageID.3385–86.
Although qualitative, Dr. Eisenhauer’s study uses a methodology called the
multidimensional measure of informed choice (MMIC), relying on the “knowledge, attitudes, and
participation” of a mother choosing whether “to donate their newborn’s rDBS to the Michigan
BioTrust for Health.” ECF No. 143-1 at PageID.3406, 3412. She directly adopted the MMIC
methodology from the highly published article that created it. See Theresa M. Marteau, Elizabeth
Dormandy & Susan Michie, A Measure of Informed Choice, 4 HEALTH EXPECTATIONS 99 (2001)
(developing “a measure of informed choice”). And at least 234 other articles have cited that article.
See Nat’l Libr. of Med., A Measure of Informed Choice, NAT’L CTR. FOR BIOTECHNOLOGY INFO.
(Jan. 29, 2022), https://pubmed.ncbi.nlm.nih.gov/11359540/ [https://perma.cc/VKL9-MFES].
Moreover, Dr. Eisenhauer’s application of the MMIC is scientifically sound. See ECF No. 148 at
PageID.4842–43.
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Being grounded in reliable methodology, FED. R. EVID. 703, Dr. Eisenhauer’s expert
testimony will corroborate Plaintiffs-parents’ experiences and help the trier of fact contrast their
consent to participate in the NSP to other parents’ informed consent. Indeed, based on her
observational study, Dr. Eisenhauer’s testimony will attempt to illustrate consistency between the
lack of parental informed consent of Plaintiff-parents and other parents. Moreover, Plaintiffs offer
her testimony to contradict Defendants’ claims that Plaintiffs’ consent was constitutionally
adequate. And she will be relying on not only her personal knowledge but also her background
knowledge. Id.
C.
Defendants also seek to preclude the testimony of Plaintiffs’ expert Professor Sonia Mateu
Suter, J.D., M.S. ECF No. 143-1 at PageID.3415. According to Defendants, Professor Mateu Suter
“will provide an opinion regarding ‘informed consent in newborn screening programs’ and
describe an ‘alternative methodology’ to balance ‘the wellbeing of newborns . . . while also
protecting autonomy and privacy as much as possible.’” ECF No. 143 at PageID.3382 (citation
omitted). As Plaintiffs add, she intends to contrast the costs and benefits of an opt-out consent
system to those of an opt-in system. ECF No. 148 at PageID.4846.
Professor Suter has the “knowledge, skill, experience, training, [and] education” to testify
about the alternative methods of obtaining consent in a healthcare setting, specifically regarding
the bioethical implications, law, and policy surrounding consent for genetics research. FED. R.
EVID. 702. Indeed, before obtaining a Master of Science in Human Genetics and then earning the
award for the highest grade in “Law, Medicine, and Bioethics” at the University of Michigan Law
School, she was a Genetic Counselor in obstetrics and pediatrics for two years at Henry Ford
Hospital. ECF No. 143-1 at PageID.3415–16. Later, she completed a two-year fellowship in
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“Bioethics and Health Policy.” Id. at PageID.3415. Now, she teaches “Genetics & Law” and “Law
& Medicine” as the Kahan Family Research Professor of Law at George Washington University
Law School. See id.; ECF Nos. 143 at PageID.3415; 148 at PageID.4845 & n.4. Moreover, among
many other relevant experiences, she served for five years on the expert panel of the NSP at the
American College of Medical Genetics. ECF No. 143-1 at PageID.3422. And through more than
a third of a century, she has completed at least 97 presentations and peer-reviewed journal articles
discussing, among other things, “Baby Markets,” “Ethical Issues in Genetic Testing,” and the
“Duty to Warn” regarding “Legal Challenges in Genetics.” Id. at PageID.3416–23. In other words,
Professor Sonia M. Suter is an expert in the costs and benefits of alternative methods to obtain
consent for genetic research.
Defendants contest Professor Suter’s testimony as not “help[ful to] the trier of fact to
understand the evidence or to determine a fact in issue.”4 FED. R. EVID. 702(a); see ECF No. 143
at PageID.3385–86. Specifically, Defendants contend that “as a law professor,” she “does not
possess scientific, technical, or other specialized knowledge that will assist the Court to understand
evidence or determine a fact in issue.” ECF No. 143 at PageID.3387. As explained, Professor Suter
is much more than a mere law professor; she is a titan in her field. Moreover, district courts often
allow law professors to testify about relevant norms and whether conduct falls within them. See,
e.g., Pinal Creek Grp. v. Newmont Mining Corp., 352 F. Supp. 2d 1037, 1046 (D. Ariz. 2005).
Defendants also argue that Professor Suter’s testimony regarding an alternative method to
obtain consent should be excluded for “focus[ing] more on Plaintiffs’ desired remedy than
Plaintiffs’ alleged injury.” Id. at PageID.3387. But pending before this Court is not only Plaintiffs’
4
Defendants also challenge Professor Suter’s expert testimony as “not ‘[p]ertinent evidence based
on scientifically valid principles.” ECF No. 143 at PageID.3388 (citing Daubert v. Merrell Dow
Pharms., 509 U.S. 579 (1993)). But Defendants offer nothing substantive to this claim. Therefore,
this Court will not consider it.
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motion for reconsideration of this Court’s partial denial of summary judgment on their substantivedue-process claim regarding consent, but also Defendants’ motion for reconsideration of this
Court’s finding that the “MDHHS has not shown that it followed the four requirements to ensure
consent was received.” ECF Nos. 172; 174 at PageID.5639. Because both parties still challenge
the substantive aspects of consent as relevant to Plaintiffs’ substantive-due-process claims, issues
of fact remain regarding Plaintiffs’ consent.
D.
Notably, due to timing, it is reasonable to assume that Plaintiffs’ experts developed their
testimony specifically for litigation, giving rise to concerns about reliability. See Daubert v.
Merrell Dow Pharms., 509 U.S. 579, 593–94 (1993); Lust ex rel. Lust v. Merrell Dow Pharms.,
89 F.3d 594, 597 (9th Cir. 1996). But as explained above, their methods were reliable and well
recognized in the scientific community. See discussion supra Sections II.B, II.C. And Defendants
have not offered any scientific evidence to counter the reliability of Plaintiffs’ proposed experts.
See Lust, 89 F.3d at 598. If another expert used the same professional standards but reached a
different conclusion, this Court might reasonably suspect Plaintiffs’ experts did not faithfully apply
the principles and methods. Defendants have not even attempted to prove that case. The testimony
of Plaintiffs’ experts is therefore reliable.
Having established that Plaintiff’s experts have a reliable basis for their testimony,
Defendants’ remaining concerns, including the insufficiency of empirical testing, are relevant to
only the weight of the testimony and should be raised, if at all, on cross-examination. See In re E.
I. Du Pont De Nemours & Co. C-8 Pers. Inj. Litig., 337 F. Supp. 3d 728, 738 (S.D. Ohio 2015)
(noting that the Daubert inquiry is “not intended to supplant the adversary system or the role of
the jury” and that “[a]rguments regarding the weight to be given any testimony or opinions of an
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expert witness are properly left to the jury” (citing In re Scrap Metal Antitrust Litig., 527 F.3d 517,
531–32 (6th Cir. 2008))).
Importantly, however, Plaintiffs’ experts may not spoon-feed the jury conclusions it could
reach on its own. Indeed, “testimony that does no more than ‘tell the jury what result to reach . . .
hardly can be viewed as being helpful to the jury.’” Good v. BioLife Plasma Servs., L.P., No. 1:18CV-11260, 2022 WL 188125, at *6 (E.D. Mich. Jan. 19, 2022) (quoting Jesa Enters. v. Thermoflex
Corp., 268 F. Supp. 3d 968, 973 (E.D. Mich. 2017)).
In the context of the Fourth and Fourteenth Amendments, it is well established that consent
is an issue of fact. United States v. Worley, 193 F.3d 380, 384 (6th Cir. 1999) (collecting cases);
see Schneckloth v. Bustamonte, 412 U.S. 218, 227 (1973) (“[W]hether a consent to a search was
in fact ‘voluntary’ or was the product of duress or coercion, express or implied, is a question of
fact to be determined from the totality of all the circumstances.”); accord United States v. Moon,
513 F.3d 527, 537 (6th Cir. 2008) (quoting Bustamonte, 412 U.S. at 227); see also United States
v. Blomquist, 976 F.3d 755, 758-59 (6th Cir. 2020) (“The government bears the burden of
demonstrating by a preponderance of the evidence, through clear and positive testimony, that the
consent was voluntary, unequivocal, specific, intelligently given, and uncontaminated by duress
or coercion.” (quoting United States v. Alexander, 954 F.3d 910, 918 (6th Cir. 2020))).
The same is true regarding the scope of consent. See United States v. Garrido-Santana,
360 F.3d 565, 570 (6th Cir. 2004).
As a guidepost, the Sixth Circuit has addressed the admissibility of expert testimony in the
context of medical consent. In Hanson v. Parkside Surgery Center, a patient who was blinded in
one eye during a radial keratotomy5 brought a medical malpractice action against the performing
5
A radial keratotomy is a medical procedure to correct nearsightedness. Schachar v. Am. Acad. of
Ophthalmology, Inc., 870 F.2d 397, 397 (7th Cir. 1989); see also Mark A. Hall & Carl E.
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doctor. 872 F.2d 745 (6th Cir. 1989). The plaintiff-patient sought to admit expert testimony “on
the issue of informed consent.” Id. at 750. Specifically, the expert sought to testify whether a
videotape that patients view as part of the informed-consent process improperly minimizes the
procedure’s risks. Id. Bifurcating the testimony, the district court permitted the expert to testify
about what information was missing from the videotape, but it precluded him from testifying about
“his belief that the tape presented the risks involved in the procedure in a ‘persuasive’ manner.”
Id. The district court bifurcated the testimony because the expert’s expertise did not include
“communications.” Id.
This case is practically similar to Hanson. Although the grounds for the claim are different,
the issue of consent is sufficiently analogous: When attempting to obtain consent, did the medical
facility provide enough information about the procedure to render consent voluntary, or was the
process impermissibly coercive?
The critical difference between Hanson and this case is that both Dr. Eisenhauer and
Professor Suter have expertise in such “communications.”
For more than six years, Doctor Eisenhauer has studied consent in the medical context,
including the extent to which patients’ ideological backgrounds affect such decisions. See, e.g.,
Elizabeth R. Eisenhauer, Rsch. Assistant, Univ. of Mich. Sch. of Nursing, Poster Presentation of
Analysis of Content Coverage for Informed Consent Concepts at the American Medical
Informatics Association Annual Symposium (Nov. 16, 2014) (transcript available from the
AMIA). Moreover, she conducted a qualitative study during which she observed Michigan’s
consent process. See Elizabeth R. Eisenhauer et al., Mothers’ Decisions About Donating
Newborns’ Blood Spots for Research, 33 CONTINUING EDUC. 361 (2019). This study, and other
Schneider, Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106
MICH. L. REV. 643, 659 n.75 (2008).
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aspects of her background, will help the jury understand the early stages of Michigan’s biobanking
system, including what could happen and has happened in an examination room. And though she
did not observe Plaintiffs’ consent, her testimony will aid the jury in contrasting Plaintiffs’
experiences with those of other parents, providing a better understanding of the context of
Plaintiffs’ consent.
Similarly, Professor Suter has been studying consent in the context of medical decisions
for nearly a decade. See Sonia M. Suter, The Politics of Information, Informed Consent in Abortion
and End-of-Life Decision Making, 39 AM. J.L. MED. 7 (2013). And her focus on bioethics only
makes her testimony even more unique and therefore valuable to the jury. Indeed, Professor Suter
could succinctly translate the complex background and history of biobanking systems and survey
the costs and benefits of biobanking, which will undoubtedly assist the jury.
For these reasons, Dr. Eisenhauer will be permitted to testify about biobanking and
informed consent, and Professor Suter will be permitted to testify about informed consent and
alternative methodologies that hospitals might use to obtain consent for genetic research. Neither
expert may testify about whether Plaintiffs gave constitutionally or legally adequate consent, but
they may “state opinions that suggest the answer to the ultimate issue or that give the jury all the
information from which it can draw inferences as to the ultimate issue.” United States v. Maya,
966 F.3d 493, 506 (6th Cir. 2020) (cleaned up) (quoting United States v. Volkman, 797 F.3d 377,
382 (6th Cir. 2015)); see also Hygh v. Jacobs, 961 F.2d 359, 363 (2d Cir. 1992) (collecting cases).
Consequently, Defendant’s Daubert Motion will be denied, and Dr. Eisenhauer and
Professor Suter will be permitted to testify consistent with this Opinion and subject to further order
of this Court.
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III.
Accordingly, it is ORDERED that Defendants’ Motion to Exclude Expert Testimony,
ECF No. 143, is DENIED.
Dated: February 3, 2022
s/Thomas L. Ludington
THOMAS L. LUDINGTON
United States District Judge
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