Wills v. Microgenics Corporation

CourtDistrict Court, E.D. New York
DecidedAugust 4, 2025
Docket1:20-cv-04432
StatusUnknown

This text of Wills v. Microgenics Corporation (Wills v. Microgenics Corporation) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Wills v. Microgenics Corporation, (E.D.N.Y. 2025).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK ---------------------------------------------------------- X RUBEN WILLS, : : Plaintiff, : MEMORANDUM DECISION : AND ORDER - against - : : 20-cv-4432 (BMC) MICROGENICS CORPORATION; : SHEILA WOODBERRY; and CAPTAIN : DOE, : : Defendants. : ---------------------------------------------------------- X

COGAN, District Judge.

Plaintiff Ruben Wills, a former New York City Council member, brings claims for negligence and violation of his Fourteenth Amendment right to procedural due process against Microgenics Corporation and Sheila Woodberry, respectively.1 Plaintiff was convicted on corruption charges, although his conviction was later reversed on direct appeal. See People v. Wills, 186 A.D.3d 1416, 130 N.Y.S.3d 93 (2nd Dep’t 2020). While still incarcerated, and shortly before his scheduled parole, officials from the New York State Department of Corrections and Community Supervision (“DOCCS”) selected him for random drug testing. The officials used a urinalysis test and testing protocol that was designed, manufactured, and sold by Microgenics. The test returned what plaintiff claims was a false positive. State officials revoked plaintiff’s eligibility for parole, and plaintiff remained incarcerated for several additional months. He is now out of prison.

1 As a result of prior rulings in the case and plaintiff’s withdrawal of claims against certain defendants, only plaintiff’s claims for negligence against Microgenics and for violation of his procedural due process rights against Woodberry remain. This case is before the Court on Microgenics’ motion to exclude plaintiff’s expert, its motion for summary judgment, and Woodberry’s motion for summary judgment. For the reasons that follow, Microgenics’ motions are denied; Woodberry’s motion is granted. BACKGROUND Microgenics manufactures and sells a drug screening test which consists of an FDA-

approved assay. The test mixes a chemical reagent with urine; and an FDA-approved urinalysis analyzer, a medical device that analyzes the mixture. The assay at issue here, the CEDIA Buprenorphine II Assay (the “Assay”), is used to detect buprenorphine, an opioid that is used to treat opioid use disorder and pain. Microgenics contracted with the New York State Department of Corrections and Community Supervision (“DOCCS”) to provide drug screening tests which included the Assay, training on how to use those tests, and testimony at disciplinary hearings at all of DOCCS’ correctional facilities. The Assay is 98% accurate, but it can produce a false positive result if it reacts with substances in urine other than buprenorphine. This is referred to as “cross-reactivity.” The FDA-approved package insert for the Assay identifies more than 65 potentially cross-reactive

compounds and acknowledges that “[i]t is possible that substances other than those investigated in the specificity study may interfere with the test and cause false results.” The insert also states, under a section entitled “Intended Use,” that “[t]he assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/ tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.” Additionally, “[c]linical and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary results are used.” In a separate section of the insert, entitled “Limitations,” it states that “[t]his is a screening test. All positive results must be confirmed via GC/MS or LC-MS/MS.” The Limitations section also explains that “[i]t is possible that substances other than those investigated in the specificity study may interfere with the test and cause false results.” Despite these statements, approved for the Assay by the FDA, there is no evidence that

Microgenics ever instructed DOCCS during its training on how to use the Assay that a confirmatory test, such as GC/MS or LC-MS/MS, was necessary. Rather, Microgenics approved DOCCS’ policy for handling positive drug test results obtained using the Assay, which was to run a second test using the same Assay. While plaintiff was incarcerated at Lincoln Correctional Facility and participating in a work release program that allowed him to remain in the community six days per week, plaintiff was randomly selected for drug testing. A DOCCS officer used a drug screening test provided by Microgenics, which included the Assay, to drug test plaintiff. The test came back positive for buprenorphine. The DOCCS officer then conducted a second test, also using the Assay, and that test came back positive as well. A Microgenics employee monitored and supervised this drug

testing. Based on these positive drug test results, plaintiff was charged with drug use. DOCCS held a disciplinary hearing on this charge and found plaintiff guilty. The DOCCS official who presided over the hearing sentenced plaintiff to thirty days in “keeplock,” which restricts incarcerated individuals’ ability to leave their cell. This sentence was suspended as long as plaintiff did not commit any further infractions over the next sixty days, and plaintiff was never ultimately placed in keeplock. The DOCCS official also recommended that the Temporary Release Committee (the “TRC”) review plaintiff’s participation in the work release program based on the drug use infraction. The TRC is responsible for making recommendations as to an individual’s participation in work release, which is then either approved or disapproved by the superintendent of the facility at which the individual is being held. A few days after this disciplinary hearing, DOCCS officials found Benadryl in plaintiff’s locker, for which plaintiff did not have a prescription. Plaintiff was charged with unauthorized

possession of medicine and smuggling prohibited items into a DOCCS facility. Woodberry, a DOCCS official, presided over plaintiff’s disciplinary hearing concerning his possession of Benadryl. She found him guilty of unauthorized possession of medicine, but not of smuggling. Woodberry imposed a penalty of 15 days’ loss of recreation. However, she did not recommend that the TRC review plaintiff’s participation in the work release program based on the infraction. Plaintiff appeared before the TRC the day after his hearing before Woodberry for it to reconsider his participation in the work release program. The TRC recommended plaintiff’s removal from the work release program because he denied drug use despite the positive test results and because of his unauthorized Benadryl possession. The superintendent of Lincoln Correctional Facility, Delta Barometre, approved the TRC’s recommendation and plaintiff was

removed from work release. Two days later, the parole board denied plaintiff’s request for presumptive parole, which would have allowed plaintiff to be released without appearing before the parole board, based on both plaintiff’s positive drug test result and his possession of Benadryl. DISCUSSION The Court may only consider admissible evidence in evaluating the parties’ motions for summary judgment. See Raskin v. Wyatt Co., 125 F.3d 55, 66 (2d Cir. 1997). “Accordingly, when a party offers expert testimony in support or opposition to summary judgment and a separate motion has been made to preclude such testimony, a court must decide the motion to preclude first, in order to determine whether such testimony may be considered in connection with the summary judgment motion.” Forte v. Liquidnet Holdings, Inc., No. 14-cv-2185, 2015 WL 5820976, at *4 (S.D.N.Y. Sept. 30, 2015), aff’d, 675 F. App’x 21 (2d Cir. 2017) (citing Raskin, 125 F.3d at 66).

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