Steele-Warrick v. Microgenics Corp.

• Decision Date: 22 March 2021
• Docket Number: 19 Civ. 6558 (VMS)
• Parties: NADEZDA STEELE-WARRICK, individually and on behalf of all others similarly situated, Plaintiff, v. MICROGENICS CORPORATION and THERMO FISHER SCIENTIFIC, INC., Defendants.
• Court: U.S. District Court — Eastern District of New York

NADEZDA STEELE-WARRICK, individuallyand on behalf of all others similarly situated, Plaintiff, v. MICROGENICS CORPORATION andTHERMO FISHER SCIENTIFIC, INC., Defendants.

19 Civ. 6558 (VMS)

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK

March 22, 2021

ORDER

Vera M. Scanlon, United States Magistrate Judge:

Plaintiff Nadezda Steele-Warrick, individually and on behalf of all others similarly situated ("Plaintiff"), brings this action against Defendants Microgenics Corporation ("Microgenics") and Thermo Fisher Scientific, Inc. ("Thermo Fisher," together, "Defendants") alleging a negligence claim under New York law. See First Amended Complaint ("FAC"), ECF No. 31. In summary, Plaintiff alleges that while she was in Department of Corrections and Community Supervision ("DOCCS") custody, Defendants failed to adhere to relevant professional standards in their performance of their contractual obligations in connection with DOCCS's inmate urinalysis drug testing program to provide urinalysis machines, products and related training, support, maintenance and testimony services. See id.

Plaintiff claims that as a result of Defendants' negligence, she and thousands of other inmates suffered undeserved discipline on the basis of false positive drug test reports. See id. Plaintiff brings her negligence claim on her own behalf and on behalf of a similarly situated class of inmates. See id.

Before the Court are Defendants' motions to dismiss for failure to state a claim and to strike Plaintiff's class allegations. See ECF Nos. 47, 47-1, 47-2, 48, 48-1, 48-2. For the reasons that follow, the Court denies Defendants' motions.

I. Facts

The following statement of facts is drawn in the first instance from Plaintiff's operative complaint unless otherwise noted.¹ See FAC, passim.

a. Defendants And IPUA

Defendant Thermo Fisher is a Delaware company that is based in Waltham, Massachusetts. See FAC ¶ 10. Defendant Thermo Fisher manufactures and markets drug-testing machines known as Indiko Plus urinalysis analyzers (hereinafter "IPUA") and assays or reagents used with those machines to test a subject's urine for illicit substances. See FAC ¶¶ 10, 23, 24. As relevant here, after a subject's urine is mixed with reagents, the IPUA interprets the reaction for the presence or absence of illicit substances such as buprenorphine, synthetic cannabinoids, opiates and tetrahydrocannabinol ("THC") according to cutoff detection levels specific to those substances as predetermined by DOCCS and/or the United States Substance Abuse and Mental Health Services Administration ("SAMHSA"). See FAC ¶ 43; Exh. 1 at 80,119²; Exh. 4.³

According to Plaintiff, Defendant Thermo Fisher is responsible for all Federal Drug Administration ("FDA") submissions relating to IPUA machine and assays. See FAC ¶¶ 10, 24. In response, Defendant Thermo Fisher asks the Court to take judicial notice of two FDA records summarizing the agency's review of the IPUA machine and buprenorphine assays—including those pursuant to Clinical and Laboratory Standards Institute ("CLSI") standards and guidelines—pursuant to applications that were made by a Thermo Fisher entity with a slightly different name and by Defendant Microgenics, respectively. See Exh. 5; Exh. 6.⁴

Defendant Thermo Fisher is the parent company to and wholly owns DefendantMicrogenics, which is a Delaware company based in Fremont, California. See FAC ¶¶ 9-10. Defendant Microgenics specializes in the development, manufacture, marketing and sale of products relating to clinical diagnostics. See FAC ¶ 9. Defendant Microgenics is among various medical distributors of Defendant Thermo Fisher's IPUA across the United States. See FAC ¶ 25.

Plaintiff alleges that, pursuant to Defendants' own standards as the manufacturers of IPUA machines and products, the accuracy of any positive drug test results obtained through IPUA urinalysis is to be verified by a confirmatory test using gas chromatography or some other method. See FAC ¶¶ 28-41; id. ¶¶ 7, 34, 43-44, 77. This standard is in place in order to eliminate a urinalysis test risk of false positives due to reagents' cross-reactivity potential, which refers to when reagent reactions are triggered by lawful medications or other non-illicit substances in urine. See FAC ¶¶ 28-41; id. ¶¶ 7, 34, 43-44, 77; ECF No. 48-1 at 4 (citing to Lahey v. Kelly, 71 N.Y. 2d 135, 139 (N.Y. 1987) (discussing, among other things, challenges to the false positive immunoassay scans on the basis of cross-reactivity with medications)); id. (citing Peranzo v. Coughlin, 608 F. Supp. 1504, 1514 (S.D.N.Y. 1985) (same)); id. at 21 n.8 (noting the defendants' understanding of the plaintiff's allegations to be about IPUA urinalysis test scans providing false positive as a result of reagents' cross-reactivity issues with the non-illicit substances it was meant to detect). Stated differently by way of example, the problem of "cross-reactivity" in drug screens occurs where "innocent items like poppy seeds will be confused with illicit substances." Coleman v. Town of Hempstead, 30 F. Supp. 2d 356, 365 (E.D.N.Y. 1999) (citation omitted); see Santiago v. Greyhound Lines, Inc., 956 F. Supp. 144, 150 (N.D.N.Y. 1997) ("Drug screens are plagued by the problems of 'cross-reactivity'—namely, the familiar concern that metabolites of benign consumables, like poppy seed muffins, will beconfused with metabolites of illicit substances[.]"); Frantz v. Venettozzi, 146 A.D.3d 1254, 1255 (3d Dep't 2017) (noting that urinalysis testing equipment manual contained at least one page pertaining to cross-reactivity issues).

b. DOCCS's Inmate Urinalysis Program

Consistent with Plaintiff's allegation that Defendants' manufacturer standards require that confirmatory testing verify any positive result obtained by their IPUA urinalysis, see FAC ¶ 34, Defendants state that DOCCS has known for nearly 40 years that immunoassay manufacturers recommend that positive urinalysis drug-screen results be confirmed by an alternative scientific method, such as gas chromatography-mass spectrometry, see ECF No. 48-1 at 4 (citing Peranzo, 608 F. Supp. at 1514). As relevant here, assuming that a urinalysis screen is generally reliable, the confirmatory-test recommendation is meant to minimize any false-positive margin of error, however small, inherent in relying on urinalysis testing alone. See Peranzo, 608 F. Supp. at 1514. Even still, DOCCS's inmate urinalysis testing has at all relevant times employed reagent test urinalysis scans (also known as the "immunoassay" method) alone without confirmatory testing "to verify whether or not an inmate has used drugs." N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.1; see Exh. 1 at 80; Exh. 4 at 189-92. Evidence that DOCCS's has intentionally elected not to make confirmatory testing a part of its inmate urinalysis program is the fact that DOCCS has made a different choice as to other drug testing programs, such as DOCCS's parolee and employee drug testing programs. Compare Exhs. 2-3 (DOCCS directives governing parolee and employee drug testing) with Exh. 4 (DOCCS directive governing inmate urinalysis program).

With respect to DOCCS's inmate urinalysis testing program, New York regulation and DOCCS Directive 4937 outline "the procedures to be followed by each [DOCCS] facility in theadministration of inmate urinalysis testing." N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.2; see Exh. 4. For example, at the time an inmate's urine is collected, all DOCCS personnel handling the specimen must be identified on a DOCCS chain of custody form and inquiry must be made as to whether the inmate "has been taking any medication in the past month," N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.4(d)(2); see Exh. 4. "If the facility has [a] urinalysis testing apparatus . . . [t]he individual performing the urinalysis testing shall have been appropriately trained in the use of the testing apparatus and shall precisely follow procedures recommended by the manufacturer for the operation of the testing apparatus." N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.4(f)(1)(iii); see Exh. 4. DOCCS facilities are required to enroll in the Urine Toxicology Testing Service of the American Association of Bioanalysts ("AAB"). See N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.7 ("The facility shall enroll in the Urine Toxicology Proficiency Testing Service of the American Association of Bioanalysts, 205 West Levee, Brownsville, TX 78520."); see N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.4(f)(1)(iii); Exh. 4. This requirement may suggest that the DOCCS standard for an "appropriately trained" individual's urinalysis testing proficiency is determined with reference to that that institution's standards. New York requires that

[i]f a positive result is obtained on the first test [of the urine specimen provided by the inmate], the procedure followed and the results obtained shall be noted by the operator on the [relevant DOCCS] urinalysis procedure form. A second test shall be performed on the same sample. The results of the second test shall be noted on a second [DOCCS] urinalysis procedure form. If a positive result is obtained from the second test, the individual performing the urinalysis testing shall cause a misbehavior report to be issued. The inmate's copy of the misbehavior report shall be accompanied by the request for urinalysis test form, the urinalysis procedure form, the inmate's printed results produced by the urinalysis testing apparatus for the positive tests and a statement of the scientific principles [hereinafter "Statement of Scientific Principles"] and validity of the testing apparatus [hereinafter "Statement of Testing Apparatus Validity"].

N.Y. Comp. Codes R. & Regs. tit. 7 § 1020.4(f)(1)(iv); Exh. 4 at 187 § IV.G.d (DOCCSDirective 4937). As to any inmate who receives a positive urine drug screen and who also reported taking medication at the time the sample was obtained, DOCCS must conduct an "inquiry . . . to medical personnel as to what...