After a fertility clinic used Theranos for a patient’s pregnancy test, the result came back negative so her doctor adjusted her medications accordingly. But, according to an email introduced as potential evidence in Theranos founder Elizabeth Holmes’ criminal fraud trial, a subsequent test a few weeks later showed a different result.
“We brought her in and I scanned her, and there was in fact a baby, and a heartbeat,” a representative from the Phoenix clinic wrote in the email to Theranos, the defunct Palo Alto blood-testing startup launched by Stanford University dropout Holmes in 2003.
The email was passed to Theranos president Sunny Balwani, according to a federal court filing by prosecutors this week. Balwani sent it to Holmes, who responded, “How did that happen?” Balwani replied, “finding out.”
Holmes and Balwani are each facing a dozen felony fraud counts over claims that Theranos’s machines could conduct a full range of medical tests using a few drops of blood. Federal prosecutors have accused the two of misleading investors and business partners, and defrauding doctors and “many hundreds” of patients. Holmes and Balwani have denied the allegations, with lawyers for Holmes arguing in a December court filing that the government’s case was “unconstitutionally vague” and lacked specific claims of misrepresentation.
The fertility clinic’s 2014 email was introduced by federal prosecutors in a filing of potential evidence to be introduced at Holmes’ trial, scheduled to start this fall in U.S. District Court in San Jose, pandemic permitting. Also included in the filing was a 2019 memo from a U.S. Food and Drug Administration criminal investigator about an interview with a nurse practitioner at an Arizona women’s medical clinic, who recalled the pitch from a Theranos sales rep. “The technology was presented as being ‘new age,’” the investigator reported. “It was presented as being cheaper and as being something that patients could pay cash for if they didn’t have insurance.”
The nurse practitioner remembered “seeing Elizabeth Holmes on the front of a magazine in the airport and feeling proud that (the clinic) was partnered with Theranos,” the memo said.
A clinic patient with a history of miscarriages who had already received a positive result from a urine-based pregnancy test had her blood tested by Theranos in 2014, producing results indicating a miscarriage, the practitioner told the investigator, according to the memo. After a “difficult” conversation with the patient, the practitioner ordered further testing, by a different company, to confirm the miscarriage, but those results showed “a sure signal of pregnancy,” the memo said.
Had the practitioner relied on the Theranos result, she very likely “would have terminated a viable pregnancy,” according to the memo. The woman ended up giving birth, according to another document filed by prosecutors.
After the practitioner complained to Theranos, she received a “vague” response blaming the problem on “a simple laboratory error” that “would be addressed,” the FDA memo said.
Another memo, from an FBI investigator, concerned a woman whose blood was tested in connection with an annual medical check-up, with an HIV/AIDS screening done by Theranos. The result came back positive for HIV infection, the document said. When the woman learned the results, she “thought she was dying,” the memo said. Since she was without insurance, it was some time before she could be re-tested, the memo said. The re-test results were negative.
According to the memo, Theranos later reimbursed the woman for the cost of the test, sending a check and some documents, and the woman “remembered the documents saying something about not admitting wrongdoing.”
