Theranos test gave false diagnosis of miscarriage, witness says

SAN JOSE, CALIF. — The first patient to testify at the trial of former Theranos CEO Elizabeth Holmes said the company’s blood test incorrectly showed she was having a miscarriage when in fact she was pregnant in good health.

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

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

“She told me your numbers were down, unfortunately, and that I was having a miscarriage,” Gould said, becoming emotional at the stand.

Two Theranos hCG blood tests indicated that Gould was having a miscarriage. However, tests two and four days later at another lab, Quest Diagnostics, confirmed that Gould was still pregnant. She finally had a healthy baby.

“I remember communicating to Brittany that it looked like it was an unviable pregnancy, which would make it her fourth loss,” Zuchman said, later adding “there is no of medical explanation in a pregnancy loss for the value to go from 100 ways in the thousands or to really go up at all. “

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 to continue to have my patients use it,” she recalls.

Gould testified that after giving birth she never used a Theranos product again. “You cannot provide accurate care to patients with inaccurate results,” she said.

Holmes faces a dozen wire fraud and conspiracy to commit wire fraud charges in what prosecutors are calling a multi-million dollar scheme to defraud investors and patients. She pleaded not guilty.

The Silicon Valley prodigy left Stanford at 19 with the idea of ​​revolutionizing healthcare. With Theranos, she promised to do hundreds of tests with a simple blood stick. In 2015, a series of damning reports from former Wall Street Journal reporter John Carreyrou revealed that blood testing technology hadn’t worked.

Among the next government witnesses is Justin Offen, an employee of PricewaterhouseCoopers, who will testify on private text messages between Holmes and Balwani. Prosecutors said they got 12,000 messages between the two, but plan to show a small portion of them to the jury.

Earlier today, during cross-examination of Surekha Gangakhedkar, a longtime senior scientist at Theranos, defense attorneys for Holmes referred to an email from September 2013 that Sunny Balwani, chief operating officer of Theranos, and for a time Holmes’ romantic partner, sent his team and Holmes. .

The email suggested that the Gangakhedkar team was not working hard enough.

“Please note that the software team was there until 3:07 a.m. – and is already there now at 10 am… ”Balwani wrote, adding that the Edison devices were“ all inactive ”.

“In the email, he’s basically bragging about the oppressive hours his team worked like it was a badge of honor or something,” said Lance Wade, an attorney for Holmes. “He’s trying to make you feel guilty that you weren’t working, isn’t he?”

“Yes,” Gangakhedkar replied.

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

“Yes,” she said.

“Did you know Mr. Balwani criticized Ms. Holmes about this since she was the supervisor?” Wade asked.

It was the first time in witness testimony that Holmes’ lawyers had begun to blame Balwani.

Gangakhedkar worked in a laboratory in Theranos for eight years and reported directly to Holmes. She resigned in 2013 due to growing concerns about Edison’s technological capabilities for blood analysis. Gangakhedkar said he repeatedly brought the inaccuracy issues and concerns to Holmes, but the CEO continued with the rollout to Walgreens stores.

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

“Yes,” Gangakhedkar said.