In re Arizona Theranos, Inc., Litigation

256 F. Supp. 3d 1009, 2017 WL 2556763, 2017 U.S. Dist. LEXIS 90965
CourtDistrict Court, D. Arizona
DecidedJune 13, 2017
DocketNo. 2:16-cv-2138-HRH (Consolidated with No. 2:16-cv-2373-HRH, No. 2:16-cv-2660-HRH, No. 2:16-cv-2775-HRH and No. 2:16-cv-3599-HRH)
StatusPublished
Cited by10 cases

This text of 256 F. Supp. 3d 1009 (In re Arizona Theranos, Inc., 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, Inc., Litigation, 256 F. Supp. 3d 1009, 2017 WL 2556763, 2017 U.S. Dist. LEXIS 90965 (D. Ariz. 2017).

Opinion

[1019]*1019ORDER

H. Russel Holland, United States District Judge

Motions to Dismiss

Defendants move to dismiss plaintiffs’ first amended consolidated class action complaint.1 The motions to dismiss are opposed.2 Oral argument was not requested and is not deemed necessary.

Background

Plaintiffs are A.R.; B.B.; B.P.; D.L.; L.M.; M.P.; R.C.; R.G.; S.J.; and S.L. A.R. is alleged to be a resident of Califor[1020]*1020nia.3 The other plaintiffs are alleged to be residents of Arizona.4 Defendants are Theranos, Inc. (“Theranos”); Elizabeth Holmes; Ramesh Balwani; Walgreens Boots Alliance, Inc.; and Walgreen Arizona Drug Company.5

In 2003, Theranos was founded by defendant Holmes.6 Balwani was the President and Chief Operating Officer of Thera-nos until he resigned in 2016.7

“Theranos initially focused on development of a hand-held device that would use a tiny needle to obtain a small drop of blood for analysis.”8 “By 2008, the project had grown into what is now known as the ‘Edison’ device.”9 “The Edison device ... was supposedly able to take a few drops of blood from a patient’s finger placed into a nanotainer capsule, and reliably conduct hundreds of blood tests, all outside a lab.”10 However, the project did not apparently get that far because the blood drawn from clients such as plaintiffs was actually tested at Theranos laboratories.

Plaintiffs allege that defendants knew that the Theranos blood tests “were unreliable, not ready-for-market, and failed to meet even basic industry standards,”11 but that in 2012, “Theranos entered into a partnership agreement with Walgreens, under which Walgreens invested $140 million in Theranos ... and agreed to operate clinics, which it called Wellness Centers,’ at Walgreen Pharmacies in Arizona and California.”12 Through the Wellness Centers, “Theranos, along with Walgreens, sold blood [tests] to individuals.”13 Plaintiffs allege that Walgreens entered into this agreement with Theranos even though “Walgreens was aware of numerous serious red flags about the tests that put it on notice about the unreliability of the tests[J”14

Plaintiffs allege that “[defendants intentionally concealed vital information from consumers, their doctors, and the public at large, about the tests’ unreliability and about the deficient nature of the [Thera-nos] testing facilities and equipment.”15 Plaintiffs allege that

[d]efendants also made pervasive misrepresentations — including in their marketing, in the stores where tests were sold, and in a steady stream of press releases and other media statements— falsely stating and asserting that Thera-nos tests met the highest standards of [1021]*1021reliability, were industry-leading in quality, and had been developed under and validated under, and were compliant with, federal guidelines.!16]

Plaintiffs allege that “[defendants aggressively promoted Theranos tests as being ready-for-market, and encouraged consumers and their doctors to use and rely on them in making important health and treatment decisions, including, but not limited to, ... such ... matters as cancer, HIV, diabetes, kidney disease, and heart disease.”17

But, plaintiffs allege that “[i]n reality, [defendants knew ... Theranos tests were dangerously unreliable, had not been validated as advertised, and did not meet federal guidelines as advertised.”18 Plaintiffs allege that “in a hurry to get the tests to market and thereby assist [defendants in developing their still-in-development products and services, ... [defendants prematurely marketed and sold the [blood] tests to consumers who were, in essence, subject to beta testing and product development research without their knowledge and consent....”19 Plaintiffs allege that they “were misinformed about the essential purpose of [the blood tests] and thus they did not provide, and could not have provided, consent for such procedure[s] and intrusion.”20 Plaintiffs allege that “[o]ffering blood tests to the general public enabled [defendants to collect blood samples from human subjects without sacrificing the time and money necessary to recruit volunteers for formal clinical trials.”21 Plaintiffs further allege that this helped defendants “evade regulatory scrutiny. ...”22

Plaintiffs allege that in 2016, “[a]fter the Center for Medicare and Medicaid Services cited Theranos’s Newark, California lab for numerous deficiencies,” Theranos voided the test results' “from its proprietary Edison blood testing devices, which consisted of tens of thousands of test results.” 23 Plaintiffs further allege that “[n]umerous additional test results ... have now been voided or belatedly ‘corrected’ by Theranos[.]”24 Plaintiffs allege that “[a]s a result of revelations regarding problems with Theranos’s technology and laboratory standards, Theranos test results have lost all credibility within the medical community.”25 Holmes and Bal-wani have been banned “from owning or operating a blood-testing business for at least two years” and Theranos’s license to operate a blood lab in California has been revoked.26 Theranos is now working on developing a “miniLab” which is apparently a device that could run diagnostic tests [1022]*1022on small amounts of blood.27

In their first amended complaint, plaintiffs assert seventeen causes of action and seek damages and injunctive relief. Pursuant to Federal Rules of Civil Procedure 9(b), 12(b)(1), and 12(b)(6), defendants now move to dismiss all of plaintiffs’ causes of action.

Discussion

“A suit brought by. a plaintiff without Article III standing is not a ‘case or controversy,’ and an Article III federal court therefore lacks subject matter jurisdiction over the suit.” Cetacean Community v. Bush, 386 F,3d 1169, 1174 (9th Cir. 2004). “In that event, the suit should be dismissed'under Rule 12(b)(1).” Id.

“ ‘To survive a [Rule 12(b)(6) ] motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Zixiang Li v. Kerry, 710 F.3d 995, 999 (9th Cir. 2013) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009)). “A claim is facially plausible Vhen the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.’ ” Id. (quoting Iqbal, 556 U.S. at 678, 129 S.Ct. 1937).

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256 F. Supp. 3d 1009, 2017 WL 2556763, 2017 U.S. Dist. LEXIS 90965, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-arizona-theranos-inc-litigation-azd-2017.