Keeping with the unexpected and odd circumstances surrounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial.
That hearing stemmed from the government’s star witness in Holmes’ 2021 trial—a pathologist—visiting her home in August to speak with the disgraced former Theranos CEO.
As of press time, Judge Edward Davila at U.S. District Court for the Northern District of California had not ruled on the motion for a new trial.
While this latest twist was dramatic, of greater interest to lab managers and pathologists is how the latest court filings shed even more light on the testimony of the witness, former Theranos Lab Director and pathologist Adam Rosendorff, MD.
The Dark Report checked with attorney Matthew Murer, chair of the national healthcare practice at law firm Polsinelli in Chicago, about the new court documents. Murer concluded that the filings reiterated the responsibilities of lab directors under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Liability from Flawed Testing
Murer further noted that Rosendorff recognized liabilities in how Theranos conducted flawed diagnostic blood testing with its Edison machine.
“Theranos failed to properly conduct proficiency testing because they couldn’t get accurate results on their standard testing,” Murer recalled. “So, here’s the CLIA laboratory director telling the jury that he knew Theranos wasn’t following the proper protocol for proficiency testing, and it really was a way of cheating.”
Holmes was convicted in January on four counts of defrauding Theranos investors and conspiracy to commit wire fraud. (See TDR, “Jury Finds Elizabeth Holmes Guilty in Four of 11 Criminal Counts,” Jan. 10, 2022.) Her sentencing was delayed until Nov. 18 due to her motion for a new trial.
Visit to Holmes’ Residence
According to a court document filed by Holmes’ attorneys, on Aug. 8, Rosendorff visited the residence of Holmes and her partner, Williams Evans, in Woodside, Calif. Rosendorff asked to speak to Holmes, a request that Evans declined.
“Dr. Rosendorff explained that he wanted to speak to Ms. Holmes because it would be ‘healing for both himself and Elizabeth to talk,’” the filing stated, which was referencing Evans’ recollection of the conversation.
Evans alleged that Rosendorff stated he tried to answer questions honestly in his testimony during Holmes’ 2021 trial, but that “the government made things sound worse than they were,” and that employees at Theranos were “working so hard to do something good and meaningful,” according to the court document.
Further, Evans alleged that Rosendorff “stated that ‘he fe[lt] guilty’ and that he ‘felt like he had done something wrong,’ apparently in connection with his testimony in Ms. Holmes’ case,” the filing said. “He stated that these issues were ‘weighing on him’ and that ‘he was having trouble sleeping.’”
Based on Rosendorff’s alleged statements to Evans, Holmes’ attorney sought a new trial or at least an evidentiary hear ing. The motion for a new trial argued that Rosendorff’s words raised questions about how prosecutors presented evidence during the trial and cast doubt on Holmes’ guilty verdict.
However, on Sept. 15, Rosendorff signed an affidavit confirming that his testimony was accurate in both Holmes’ trial and that of former Theranos Chief Operating Officer Ramesh “Sunny” Balwani.
Asked by Judge Davila during the Oct. 17 evidentiary hearing whether he testified truthfully, Rosendorff confirmed he had. But he also expressed remorse over how Holmes and Evans’ one-year-old child would be without a mother if Holmes receives prison time for her convictions, The Wall Street Journal reported, noting that Holmes “appeared at court visibly pregnant” during the hearing.
Murer also suspected the discrepancy between what Rosendorff said at Holmes’ residence and what he stated in his affidavit comes down to how Theranos was portrayed during the trial.
“The phrase that comes up in a lot of the filings is, ‘We were all working very hard at trying to make this technology work,’” Murer noted. “What the government said is, ‘That may have been everyone’s intent at Theranos, but Holmes knew that the technology didn’t work and then lied to the investors to get them to invest.’”
Subpoena to Obtain Emails
Before the hearing, Holmes’ legal team attempted to subpoena Rosendorff’s emails about his past testimony. Rosendorff’s attorneys filed a motion in court to quash the subpoena, which Davila agreed to do after finding the subpoena to be excessive, the San Jose Mercury News reported.
Murer also wanted to inform other CLIA lab directors about insightful information in Rosendorff’s testimony that has not been publicly discussed. In its opposition to Holmes’ motion for a new trial, the government brought up further noteworthy details about what Rosendorff witnessed at Theranos.
“Once Theranos started offering tests to patients, Dr. Rosendorff continued to observe accuracy problems with one Theranos assay after another,” the government stated, paraphrasing trial testimony.
“In mid-2014, Theranos’ HCG assay—used to monitor pregnancy status—was performing so poorly in patient testing that Dr. Rosendorff ordered it moved to standard commercial analyzers, forbidding the lab from running it on the Edison device.” Doing so illustrates the steps laboratory directors must take under CLIA to ensure proper testing.
‘Not Getting Good Results’
“That’s a good example of how proactive CLIA lab directors need to be,” Murer said. “Rosendorff knew that these Edison machines weren’t getting good results, so he ordered all the testing to go over to commercial analyzers to make sure the tests were getting accurate results. That’s a smart move for a lab director.”
A surprising revelation in court documents concerned when Rosendorff quit Theranos in 2014. “Around the time of his departure, Dr. Rosendorff was exploring the possibility of bringing a federal whistleblower lawsuit against Theranos, in order to ‘right the wrongs, basically, to alert the public of what was going on at Theranos,’” the government stated.
Despite the hoopla of the Holmes trial, Rosendorff’s actions while at Theranos were consistent with CLIA requirements—something CLIA lab directors elsewhere should note, Murer explained.
“Dr. Rosendorff decided to leave Theranos due to things he witnessed there,” Murer concluded. “He testified that he felt it was a question of his integrity as a physician to remain at Theranos and to continue endorsing results that he didn’t have faith in. He was uncomfortable with what was happening in the company, and he felt pressured to vouch for results in which he was not confident.”
Contact Matthew Murer at email@example.com or 312-873-3603