Former Theranos patient testifies blood test gave her false miscarriage diagnosis

Wealth

Elizabeth Holmes, founder of Theranos Inc., exits federal court in San Jose, California, on Tuesday, Aug. 31, 2021.
David Paul Morris | Bloomberg | Getty Images

SAN JOSE, CALIF. — The first patient to take the stand in trial of former Theranos CEO Elizabeth Holmes said that the company’s blood test inaccurately showed she was suffering a miscarriage when in fact she had a healthy pregnancy.

Brittany Gould, who had already miscarried three times testified on Tuesday that in September 2014 she took a Theranos blood-test at a Walgreens store in Arizona after learning that she was pregnant.

After reviewing the results of the Theranos hCG test, which measured a pregnancy hormone, Gould’s nurse practitioner, Audra Zuchman, delivered some alarming news.

“She told me your numbers are falling, unfortunately, and that I was miscarrying,” Gould said, getting emotional on the stand.

Two Theranos hCG blood-tests indicated Gould was miscarrying. However, tests taken two and four days later through a different lab, Quest Diagnostics, confirmed that Gould was still pregnant. She eventually had a healthy baby.

“I remember communicating to Brittany that it was looking as though this was a non-viable pregnancy which would make it her fourth loss,” Zuchman testified, later adding “there isn’t a medical explanation in a pregnancy loss for the value to go from 100 way back into the thousands or to go up at all really.”

After filing a complaint with Theranos, Zuchman said she stopped sending patients there. “I felt very uncertain of the validity of the results and felt uncomfortable as a provider continuing to have my patients use it,” she recalled.

Gould testified that after giving birth, she never used a Theranos product again. “You can’t provide accurate patient care with inaccurate results,” she said.

Holmes is facing a dozen charges of wire fraud and conspiracy to commit wire fraud in connection with what prosecutors call a multi-million dollar scheme to defraud investors and patients. She has pleaded not guilty.

The one-time wunderkind of Silicon Valley dropped out of Stanford at 19 years old with the idea of revolutionizing healthcare. With Theranos, she promised to run hundreds of tests with just a finger-prick of blood. In 2015 a series of damning reports by former Wall Street Journal reporter John Carreyrou exposed the blood-testing technology fell short.

Among the government’s next witnesses is Justin Offen, an employee from PricewaterhouseCoopers, who will testify about private text messages between Holmes and Balwani. Prosecutors said they have obtained 12,000 messages between the two but plan to show a small portion to the jury.

Cross examination of former scientist

Earlier in the day, during cross examination of Surekha Gangakhedkar, a longtime senior scientist at Theranos, Holmes’ defense attorneys brought up a September 2013 email that Sunny Balwani, Theranos COO and for a time Holmes’ romantic partner, sent to her team and Holmes.

The email suggested Gangakhedkar’s team wasn’t working hard enough.

“Please note that the software team was here till 3:07am – and is already here now at 10am…” Balwani wrote, adding that the Edison devices were “all sitting idle.”

“In the email he essentially boasts about the oppressive hours his team was working as though that was a badge of honor or something,” said Lance Wade, an attorney for Holmes. “He’s trying to make you feel guilty about the fact that you weren’t working, wasn’t he?”

“Yes,” replied Gangakhedkar.

“And he was trying to make your whole team feel guilty,” said Wade.

“Yes” she testified.

“Were you aware that Mr. Balwani criticized Ms. Holmes about that since she was the supervisor?” asked Wade.

It was the first time during witness testimony that Holmes’ attorneys began shifting blame to Balwani.

Gangakhedkar worked in a Theranos lab for eight years and reported directly to Holmes. She quit in 2013 over increasing concerns about the Edison blood-testing technology capabilities. Gangakhedkar testified that she repeatedly flagged the inaccuracy issues and her concerns to Holmes yet the CEO pushed ahead with the rollout in Walgreens stores.

“In research and development sometimes you have to fail before you can succeed, right?” Wade asked.

“Yes,” Gangakhedkar said.

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