In re: Arizona Theranos Incorporated Litigation

CourtDistrict Court, D. Arizona
DecidedMay 4, 2023
Docket2:16-cv-02138
StatusUnknown

This text of In re: Arizona Theranos Incorporated Litigation (In re: Arizona Theranos Incorporated Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Arizona primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re: Arizona Theranos Incorporated Litigation, (D. Ariz. 2023).

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 In re: 9 No. CV-16-02138-PHX-DGC 10 Arizona THERANOS, INC. Litigation, (Consolidated with) 11 No. 2:16-cv-2373-HRH No. 2:16-cv-2660-HRH 12 No. 2:16-cv-2775-DGC 13 -and- No. 2:16-cv-3599-DGC 14 15 ORDER

17 18 Defendants Walgreens Boots Alliance, Inc. and Walgreen Arizona Drug Co. 19 (collectively, “Walgreens”) move for summary judgment on Plaintiffs’ remaining class 20 claims. Doc. 521. Walgreens brings a Celotex motion, arguing that there is “no evidence 21 from which a jury could conclude that Walgreens knew about or recklessly disregarded 22 indications of Theranos’s[] fraud at the time.” Id. at 7. 23 Plaintiffs respond that Walgreens knew, deliberately ignored, or recklessly 24 disregarded that the new Theranos blood testing method lacked reliable results, was not 25 market-ready, and received only minimal regulatory scrutiny. Doc. 538. Plaintiffs cite 26 deposition testimony, emails, and documents. Walgreens argues that Plaintiffs 27 mischaracterize the evidence. Doc. 555. 28 1 The Court must determine whether Plaintiffs have produced sufficient evidence to 2 create triable issues of fact. Celotex Corp. v. Catrett, 477 U.S. 317, 324 (1986). Reviewing 3 the evidence without making credibility determinations, the Court concludes that summary 4 judgment must be denied on Plaintiffs’ remaining counts and granted on Plaintiffs’ request 5 for punitive damages. 6 I. Background. 7 This case arises from Theranos’s claim that it had developed a revolutionary blood 8 testing technique that could evaluate hundreds of blood characteristics from a single finger 9 prick. The claim, promoted by Theranos executives Elizabeth Holmes and Ramesh 10 “Sunny” Balwani (who are Defendants in this case), received worldwide attention and 11 attracted millions of dollars in investments. Walgreens partnered with Theranos to 12 introduce the simple blood tests in Walgreens retail pharmacy stores. Plaintiffs represent 13 class members who received blood tests in Walgreens stores in Arizona and California. 14 Walgreens now acknowledges that the Theranos product was not a legitimate and 15 accurate new blood testing method, but asserts that Walgreens – like many others – was 16 defrauded by Theranos, Holmes, and Balwani. The facts that follow in this section of the 17 order are taken largely from the Walgreens motion for summary judgment. Doc. 521 at 6- 18 15. They provide the basic chronology of the Walgreens-Theranos relationship and 19 illustrate Walgreens’s argument that it was diligent in its investigation of Theranos and is 20 21 not liable for Theranos’s fraud.1 22 Theranos represented to Walgreens that its technology – the Theranos Systems, also 23 known as the “Edison” – had been validated over the course of the previous seven years by 24 10 of the 15 largest pharmaceutical companies, had been validated by the FDA, and had 25 been shown highly accurate by correlation data (comparisons of Theranos test results to 26 results from a commercially available machine). Theranos claimed that its clients included

27 1 Defendant Theranos is now defunct. Defendants Homes and Balwani did not 28 participate in the summary judgment briefing or argument, and the Court’s recitation of evidence in this order is not intended to be a finding of fact against either of them. 1 major pharmaceutical and biopharmaceutical companies, research institutions, and U.S. 2 and foreign health and military organizations. Theranos told Walgreens about notable 3 investors and board members, including Donald Lucas, Larry Ellison, and Bob Shapiro 4 (former CEO of Pfizer). 5 In April 2010, Holmes sent Walgreens three independent due diligence reports on 6 the Theranos technology from GlaxoSmithKline, Pfizer, and Schering-Plough, which she 7 said were based on the pharmaceutical companies’ own technical validations and 8 experiences with Theranos products in the field. Walgreens also engaged a team from 9 Johns Hopkins School of Medicine to review testing data and observe a demonstration of 10 the Theranos technology, leading Johns Hopkins to report that the technology was novel 11 and sound, could accurately run a wide range of routine and special assays, and would be 12 useful in the retail clinic setting. 13 Walgreens engaged Kevin Hunter, the CEO and Managing Partner of Colaborate, a 14 laboratory management consulting firm, to assist in evaluating a potential partnership with 15 Theranos. Hunter expressed excitement about Theranos and concluded that its technology 16 could be a game changer for the lab industry. Walgreens visited Theranos’s headquarters 17 and laboratory, discussed business models, reviewed patents, and discussed regulatory 18 strategy. 19 Walgreens entered into a Master Purchase Agreement with Theranos on July 30, 20 21 2010. The contract was not a commitment to go to market, but secured the opportunity for 22 Walgreens to work exclusively with Theranos on a potential partnership. 23 In June 2011, Walgreens postponed the launch of Theranos testing in its stores until 24 appropriate regulatory approval was in place, even though this meant that Theranos might 25 go to market with a competitor. 26 In June 2012, the parties signed an Amended and Restated Theranos Master 27 Services Agreement. Instead of Theranos testing devices being located inside Walgreens 28 stores, the devices would be located at a stand-alone Theranos laboratory where testing 1 would occur. Walgreens would act as a patient service center. Walgreens or Theranos 2 employees would collect blood samples using Theranos finger-stick technology in 3 “Theranos Wellness Centers” in Walgreens stores, and the blood would be sent to a 4 certified laboratory owned and operated by Theranos. Theranos would be responsible for 5 running tests and sending results to the requesting physician or patient. Walgreens 6 purchased a $40 million convertible note from Theranos and agreed to pay another $100 7 million “Innovation Fee” in installments, based on reaching certain milestones (which 8 Walgreens paid in full by December 2013). 9 The Amended Agreement required all Theranos laboratories to receive a Certificate 10 of Compliance under the Clinical Laboratory Improvement Amendments of 1998 11 (“CLIA”). CLIA regulations are overseen by the Centers for Medicare & Medicaid 12 Services (“CMS”) within the U.S. Department of Health and Human Services, and 13 establish quality standards for laboratory testing to ensure the accuracy, reliability, and 14 timeliness of patient test results. Shortly after signing the 2012 Agreement, Theranos 15 provided Walgreens a copy of its CLIA Certificate of Compliance and associated 16 inspection report. 17 Ken Finnegan, Walgreens’s Vice President of New Product Development and 18 Innovation and a former Quest Diagnostics executive, reviewed Theranos’s proficiency 19 reports and correlation studies and was satisfied with the results. Dr. Jeffrey Kang, 20 21 Walgreens’s Senior Vice President of Pharmacy, Health, and Wellness Services and 22 Solutions, and the former Chief Medical Officer of CMS, visited Theranos and performed 23 his own review of its proficiency data, correlation studies, and inspection reports. 24 Dr. Harry Leider, Walgreens’s Chief Medical Officer, and Dr. Patrick Carroll, Chief 25 Medical Officer of the Healthcare Clinics, also reviewed Theranos’s correlation studies. 26 Walgreens retained another independent third-party consultant, Paul Rust, also a 27 former Quest Diagnostics executive, to further review Theranos’s correlation and 28 1 proficiency test results. Rust visited Theranos in October 2012, reviewed data, and 2 concluded that the results documented excellent performance.

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In re: Arizona Theranos Incorporated Litigation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-arizona-theranos-incorporated-litigation-azd-2023.