Kanuszewski v. Shah

636 F.Supp.3d 781

Adam KANUSZEWSKI et al., Plaintiffs, v. Sandip SHAH et al., Defendants.

Case No. 1:18-cv-10472

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

Signed October 20, 2022

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

Aaron W. Levin, Christopher L. Kerr, MI Department of Attorney General, Corporate Oversight Division, Lansing, MI, Joshua Vincent, Hinshaw & Culbertson LLP, Chicago, IL, for Defendants Michigan Department of Health and Human Services, Nick Lyons, Robert Gordon.

Aaron W. Levin, Christopher L. Kerr, Daniel J. Ping, 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, Elizabeth Hertel.

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, for Defendant Michigan Neonatal Biobank, Inc.

Aaron W. Levin, Daniel J. Ping, 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.

OPINION AND ORDER DENYING DEFENDANTS' MOTIONS FOR CERTIFICATE OF APPEALABILITY AND TO STAY CASE, AND VACATING ORDER IN PART

THOMAS L. LUDINGTON, United States District Judge

On September 13, 2022, this Court granted Plaintiffs' motion for reconsideration, denied Defendants' motion for reconsideration, and vacated in part its prior order.

Defendants have since filed a motion for a certificate of appealability on three state-law statutory-interpretation issues and a motion to stay the case pending appeal of those three issues. Plaintiffs contest both motions.

The questions presented are whether those issues involve controlling questions of law, contain substantial grounds for difference of opinion, or would materially advance the case if immediately appealed.

I.

Plaintiffs are four parents of nine Michigan-born children who contend that the State of Michigan, four Michigan officials, and a private biobank and its director have violated the Fourth and Fourteenth Amendments by retaining, transferring, storing, selling, and using the children's blood samples (DBS) for research and other unspecified purposes without informed consent.

After the first round of dispositive motions, the Sixth Circuit reversed and remanded the case with specific instructions: "to apply strict scrutiny to any of Defendants' conduct that lacked informed consent." Kanuszewski v. Shah, No. 1:18-CV-10472, 627 F.Supp.3d 832, 838 (E.D. Mich. Sept. 13, 2022) (citations omitted); see also Kanuszewski v. MDHHS, 927 F.3d 396, 420-21 & 420 n.13 (6th Cir. 2019) (holding that Plaintiffs plausibly alleged Defendants' retention, transfer, storage, and "future use by the state or third parties" was "undertaken without informed parental consent" and "must survive strict scrutiny"). To wit: (1) Did Defendants obtain Plaintiff-parents' informed consent for the retention, transfer, storage, sale, or research of their children's DBS? (2) If not, then does Defendants' conduct survive strict scrutiny?

The reason that all Defendants' conduct required informed consent, the Sixth Circuit held, is that "parents" have "a fundamental right . . . to direct the medical care of their children." Kanuszewski v. MDHHS, 927 F.3d at 418-19. As the Sixth Circuit concluded on the issue, if Defendants "retain the samples, transfer the samples to the Neonatal Biobank, and store the samples indefinitely for further use by the state or third parties . . . . without informed parental consent," then "Defendants' actions constitute a denial of the parents' fundamental right to direct the medical care of their children, and their actions must survive strict scrutiny." Id. at 420. "[E]mphasiz[ing] that a fundamental right is at stake," the Sixth Circuit added that this Court must determine whether the "nature" of "any parental consent that occurred" was "informed" and whether Defendants' conduct fell within the "scope" of the informed consent. Id. at 420 n.13.

On remand, this Court followed the Sixth Circuit's directive. See Kanuszewski v. Shah, 551 F. Supp. 3d 747, 766-68 (E.D. Mich. 2021) (applying strict scrutiny to Defendant's conduct that lacked Plaintiffs' informed consent), vacated in part, No. 1:18-CV-10472, 627 F.Supp.3d 832 (E.D. Mich. Sept. 13, 2022).

Then, addressing the parties' cross-motions for reconsideration, this Court "explain[ed] why the applicable law requires Michigan's informed-consent standard in this case and then appl[ied] that standard to the parties' summary-judgment motions." Kanuszewski, 627 F.Supp.3d at 840. This Court held that all Defendants' conduct lacked informed consent under Michigan's informed-consent statutes.¹ See id. at 845-51.

Defendants have since requested a certificate of appealability for interlocutory appeal, ECF No. 215, and a stay pending appeal, ECF No. 217, both of which Plaintiffs contest, ECF Nos. 216; 218. As explained hereafter, both requests will be denied.

II.

In a civil case, a district judge may certify a nonfinal order for interlocutory appeal if "[1] the order involves a controlling question of law to which there is [2] substantial ground for difference of opinion and . . . [3] an immediate appeal may materially advance the termination of the litigation." In re Trump, 874 F.3d 948, 951 (6th Cir. 2017) (cleaned up) (quoting 28 U.S.C. § 1292(b)). These findings, "along with other prudential factors," guide the Sixth Circuit's discretion to permit an appeal of a district-court order. Id.

Defendants raise two questions:

(1) whether Michigan's informed-consent statutes apply to Michigan's newborn screening program, and

(2) whether Michigan's informed-consent statutes apply to Michigan's BioTrust program.

ECF No. 215 at PageID.5858-66.² To that end, as the parties note, there are three possible sources of informed consent: (1) Michigan Compiled Laws §§ 333.17020 and 333.17520, (2) 45 C.F.R. § 46.116(d) as referenced in Michigan Compiled Laws § 333.5431(7)(b), and (3) the constitutional "voluntary and knowing" requirements for waiver of fundamental rights.

A.

Interpreting a statute is a question of law. See Smith v. Comm'r of Soc. Sec., 482 F.3d 873, 876 (6th Cir. 2007). Defendants' questions both involve interpretations of Michigan Compiled Laws §§ 333.17020 and 333.17520, so they both involve questions of law.

Although Defendants invoke two "question[s] of law," the questions are not "controlling." A question of law is controlling if it could materially affect the outcome of the case. In re City of Memphis, 293 F.3d 345, 351 (6th Cir. 2002). Neither question could do so here.

1.

Defendants first assert their nonresearch posttesting use of the DBS did not require the Plaintiff-parents' informed consent under § 333.17020, § 333.17520 or § 46.116(d). See ECF No. 215 at PageID.5858-63.

Defendants are incorrect. The Sixth Circuit mandated that this Court search for "informed consent to Defendants' actions" and, if absent, then apply strict scrutiny. Kanuszewski v. MDHHS, 927 F.3d 396, 420-21 (6th Cir. 2019); see also supra discussion Part I. And this Court already found that Defendants' nonresearch posttesting use of the DBS lacked informed consent under Michigan law and § 46.116. Kanuszewski v. Shah, 551 F. Supp. 3d 747, 763-65 (E.D. Mich. 2021) (holding that Defendants did not obtain informed consent under 45 C.F.R. § 46.116); Kanuszewski v. Shah, No. 1:18-CV-10472, 627 F.Supp.3d 832, 845-51 (E.D. Mich. Sept. 13, 2022) (same under Michigan Compiled Laws §§ 333.17020 and 333.17520).

As Defendants concede, if "there is no codified guidance, e.g., for use of DBS post-screening, given the law of this case, [then] strict scrutiny would apply." ECF No. 218 at PageID.5932-33. Thus, if informed consent is not required under Michigan law or § 46.116, then the only remaining issue here is whether Defendant's nonresearch posttesting conduct would survive strict scrutiny.

This Court has already found that Defendant's nonresearch posttesting use of the DBS fails the strict-scrutiny analysis. See Kanuszewski, 551 F. Supp. 3d at 766-68 (holding that Defendants' conduct failed strict scrutiny); Kanuszewski, 627 F.Supp.3d at 850-52 (same). Thus—regardless of whether the requirements of informed consent are grounded in Michigan law, § 46.116, or the Constitution—the outcome would be the same: Defendants did not obtain Plaintiffs' informed consent for any nonresearch posttesting use of the DBS.

For these reasons, Defendant's questions would have no material impact on the outcome of this case and are not controlling.

2.

The next issue is "whether the parents of RFK, CKK, LRW, CJW, and HJW gave their informed consent to research." Kanuszewski v. Shah, No. 1:18-CV-10472, 627 F.Supp.3d 832, 850 (E.D. Mich. Sept. 13, 2022) (emphasis added).

Defendants add that the informed-consent provisions of 45 C.F.R. § 46.116 apply to the Biobank's research. Id. at PageID.5864 ("Mich. Comp. Laws § 333.5431(7)(i) incorporates 45 C.F.R. § 46.116 by reference.").

But, even if that is true, the Sixth Circuit mandated informed consent for Defendants' posttesting research, too, as a matter of constitutional law. Kanuszewski v. MDHHS, 927 F.3d at 420-21. Thus, even if § 46.116 applies to Defendants' research, the more rigorous constitutional requirements for informed consent must also apply.

This Court has already explained how Defendants' research fails the IRB waiver provisions of § 46.116(d)—a much lower standard than informed consent. Kanuszewski v. Shah, 551 F. Supp. 3d at 763-65. And this Court has explained how the research-consent claims of RFK, CKK, LRW, CJW, and...