They do so, Condor conjectures, because this bit alone will sustain a conviction of Holmes on all the fraud-related counts. [In it, an impartial government agency charged with evaluating patient safety in novel device trials (CMS)… makes clear that Holmes and Balwani, and Theranos, were trying to mislead it, and about matters that implicate patient safety, specifically. So, game over, on this evidence. And it has already been shown to the jury.]
Team Holmes’ effort will fail — and she will be convicted — see this cogent eleven pager, from the able AUSAs (Judge Davila already ruled against the Holmes team, on almost all these arguments):
…The findings within the January 2016 CMS Report are relevant to the inability of Theranos to provide accurate and reliable tests during 2014 and 2015, as well as Defendant’s knowledge of this inability. The Third Superseding Indictment (“TSI”) alleges that Defendant devised a scheme to defraud patients between approximately 2013 and 2016—when Theranos elected to shutter its lab following interactions with CMS. ECF No. 469 ¶¶ 14–18.
Specifically, the TSI alleges that from 2013 to 2016, the entire time Theranos was providing testing services to patients, Theranos represented to doctors and patients that Theranos could provide accurate, fast, reliable, and cheap blood tests and test results when Defendant knew that Theranos was not, in fact, capable of consistently producing accurate and reliable results. Id. Trial Exhibits 4621A and 4621B — which relate to patient testing that Theranos conducted in 2014 and 2015 — are directly relevant to allegations in the TSI. CMS, or a state agency on its behalf, inspects laboratories once every two years. 09/29/2021 Hearing Transcript (“9/29 Tr.”) at 2114:10–2118:3; 11/29/2021 Hearing Transcript (“11/29 Tr.”) at 7794:1–16, 7809:3–20, 7811:10–22; 12/07/2021 Hearing Transcript (“12/7 Tr.”) at 8438:15–24. When California’s state agency inspected Theranos’ California lab in 2013, Defendant admitted it was largely using unmodified, FDA-approved commercially available third-party analyzers, and had only three or four lab-developed tests running on Theranos technology. 12/7 Tr. at 8438:15–8440:21. By the time of its next inspection in 2015, CMS had received complaints, including from Erika Cheung, about Theranos’ blood testing practices in its CLIA lab. 09/15/2021 Hearing Transcript (“9/15 Tr.”) at 985:8–986:5; 12/7 Tr. at 8493:3–6. Ms. Cheung and others at Theranos had escalated these issues to Defendant and co-Defendant Balwani to no avail in early 2014. See 9/15 Tr. at 973:1–981:18; 11/30/2021 Hearing Transcript (“11/30 Tr.”) at 7972:13–7977:8, 7979:1–7993:3 (Defendant acknowledging that she now knows Ms. Cheung and Tyler Shultz were right but at the time in 2014 she minimized the seriousness of the issues they were raising).
In fall 2015, CMS analyzed paperwork and Theranos’ lab practices from 2014 and 2015 — essentially since the last state-run inspection — and found widespread issues. See generally 11/9 Tr. at 5818:8–5835:14, 5854:11–17, 5855:22–5857:7. Defendant hired Dr. Das to internally analyze CMS’s findings and respond to the CMS report Theranos received in January 2016. Id. at 5784:11 21, 5794:23–5795:16. In doing so, Dr. Das did his own independent analysis, reviewed a broader universe of data than had been provided to CMS, and concluded that the deficiencies identified in the CMS report were only a “representative” sample of the actual deficiencies within Theranos’ Newark laboratory….
So it goes. I will cross-post this to the Shkreli site tonight, as his team is at this moment (on a Sunday) withdrawing the expert testimony the able Judge Cote had already largely stricken — and in turn, the FTC is withdrawing its answering expert testimony in reply to that bit.
So a similar, in tandem dance — in both trials, now.
Out, grinning.