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A nurse practitioner from Arizona testified Tuesday to wildly inconsistent blood test results given to a pregnant patient in her OB-GYN practice by Theranos, the now-defunct company founded by Elizabeth Holmes.
The federal trial of Theranos founder Elizabeth Holmes continued in San Jose on Sept. 21, 2021. Courtesy Bay City News/New Africa.
The test results showed a "significant drop" in pregnancy hormones early in the pregnancy, an event that, if the results were accurate, would be "very concerning."
The patient had already miscarried three times.
The results showed a swing over a two-day period from higher-than-normal values in early pregnancy to a level that "would suggest that the body has already started to eliminate" the pregnancy hormones.
The nurse practitioner, Audra Zachman, told the patient that it was looking like a "nonviable pregnancy" after getting the mystifying Theranos results.
In fact, the story has a happy ending, as the patient, who also testified on Tuesday, successfully carried a baby girl to term.
But the experience left Zachman "very uncertain as to the validity of the results" coming out of the Theranos lab and "uncomfortable as a provider" continuing to use those services.
Holmes is charged with 12 counts of wire fraud and conspiracy to commit wire fraud, based on allegedly false and misleading statements about Theranos' blood-testing technology. If convicted, Holmes faces up to 20 years in prison and $3 million in fines.
Earlier in the day, Holmes' defense team completed their cross-examination of Surekha Gangakhedkar, a scientist who worked for Theranos for eight years and resigned just before the launch of the company's blood-testing technology in Walgreens, out of concern that it was not safe to use on patients.
Defense attorney Lance Wade brought up a series of blood tests, known as assays, that Gangakhedkar and her team successfully developed in the Theranos R&D lab.
Gangakhedkar acknowledged that she was "proud of that work."
The defense is seeking to establish, as it argued in its opening statement two weeks ago, that although Holmes ultimately failed in developing technology once viewed as visionary, "failure is not a crime."
Referring to the many problems she and her team had in running the blood tests on the Theranos Edison machines, Gangakhedkar agreed with defense counsel that "sometimes you have to fail before you can succeed."
But Gangakhedkar pushed back on defense efforts to undermine her testimony that Theranos operated a secretive workplace where information was siloed.
Although emails and calendar invitations showed some sharing of information, Gangakhedkar maintained that the interteam emails had "only high-level information," not details.
She testified that it was "mentioned several times in meetings not to talk about the assays you were working on."
More stories
Prosecution, defense spar over Theranos' finances at Holmes trial
Corporate controller testifies that blood-testing startup had a growing "accumulated deficit."
Former employee says Theranos cherry-picked results from faulty machines
A former lab associate told the jury that the Theranos "Edison" machines "frequently failed" quality control tests.
Theranos employees were 'sleeping in their cars' in effort to address quality control issues
The lengthy recalibration processes for Theranos' blood-testing machines led some employees to work back-to-back shifts to get the devices reset, according to a former lab associate.
Three days before her resignation in September 2013, Gangakhedkar received an email from Ramesh "Sunny" Balwani, Holmes' business partner and former lover, telling Gangakhedkar's team to "put in the hours this month to bring up all assays and work around any challenges that come our way."
Gangakhedkar testified that the idea that her team was somehow not pulling its weight "was a common theme" that was unfair and deeply frustrating.
The court refused to allow defense counsel to ask whether Balwani also pressured Holmes to work harder.
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