A patient on blood thinners reported bruising and feeling off after a medication change following a Theranos test, the court heard yesterday in the criminal trial of company founder Elizabeth Holmes.
Her doctor had increased the dosing of her blood thinner in response to test results reported by Theranos. “I have not felt ‘right’ since the one increased dose and also experienced various skin bruising on my legs and arms almost immediately after the one dose increase,” she said in an email to Theranos.
That complaint and other issues “raised serious and grave concerns for me about the accuracy of the testing process,” Dr. Adam Rosendorff, Theranos’ former lab director, told jurors in response to questioning by the prosecution.
Other tests the company performed were producing worrisome results, Rosendorff said, and after repeatedly raising the issue with executives, it got to the point where he didn’t feel comfortable staying with the company. “The number and severity of issues had reached a crescendo for me.”
Hiding from inspectors
Warning signs appeared earlier, though. In January 2013, in anticipation of a visit from state inspectors who certify labs for Medicare, Balwani had told employees that no one was to go into or out of the lab that contained the company’s proprietary Edison devices, Rosendorff said. The court also saw an email from Holmes, in which she asked an employee, “Let me know if the path for walking the auditors in and downstairs has been cemented so we avoid areas that cannot be accessed, and what that path is.”
During visits by state inspectors, labs are legally obligated to grant inspectors “access to all areas encompassed under the certificate,” and while it doesn’t appear that Holmes or Balwani barred inspectors from those rooms, keeping the doors shut certainly made it less likely that they would ask to see what’s inside. Typically during inspections, company employees are supposed to “show inspectors what they asked for,” Rosendorff said.
Later, Rosendorff was asked to provide explanations to doctors as to why Theranos tests were producing questionable results. In one instance, Christian Holmes, Elizabeth’s brother, asked Rosendorff to reply to a doctor who wanted a more detailed explanation about cholesterol test results. “I’m going to pass on this one,” Rosendorff replied to Christian. When Holmes’ brother asked him what he meant, he replied, “If you’re asking me to defend these values then the answer is no.”
“Passing,” Christian told him, “is not an option.” In a later email exchange between Christian and Elizabeth, she told her brother, “You handled this excellently.”
Under cross-examination, Holmes’ attorney, Lance Wade, asked Rosendorff, “Did you offer lab tests that you knew at the time were inaccurate or unreliable?” The former lab director replied, “No, I ordered the laboratory to discontinue testing and I raised concerns to management.” Asked if Holmes had ever told him to “report an inaccurate result,” Rosendorff said no, she had not asked him to do so. He also revealed that the patient launch that he pushed to delay was restricted to friends and family.
Wade further pressed Rosendorff on whether his answers to prosecutors’ questions were scripted. “I was always instructed to be truthful and tell the truth,” Rosendorff said.
“Pressured to vouch”
Toward the end of Rosendorff’s tenure at Theranos, his relationship with executives, and Balwani in particular, became increasingly frayed.
In a later email, he outlined a number of issues with the company’s testing protocols, saying, “This is not a question of interpreting results—this is a question of the reliability and accuracy of the result…The most constructive thing at this point is to offer reliable and robust assays, not to spin.”
Ultimately, Rosendorff reached the end of his rope and found another job. He gave notice but stayed on while the company looked for his replacement. In that time, he emailed Holmes about another problematic test result and asked to be taken off the lab’s license. “I am feeling pressured to vouch for results I cannot be confident in,” he wrote to Holmes.
Holmes replied, “How sad and disappointing to see this from you,” claiming that he hadn’t shared his concerns with her earlier—despite being copied on numerous emails, which the jury has seen, where he did exactly that. In a separate reply, Balwani was dismissive of Rosendorff’s complaints and later emailed Holmes, urging her to fire him rather than let him finish his last few days. “We need to respond to him now and cut him Monday.”