conduct a confidential interview with one of the lab associates who
worked in Normandy and had direct experience with the Edisons. She
was made to wait in a windowless room for a long time until a young
woman finally appeared. As soon as she sat down, the woman asked
for an attorney. She looked coached and afraid.
—
ERIKA CHEUNG AND I had remained in sporadic contact after her
parking lot scare in late June, but I didn’t know she’d gathered the
courage to reach out to a federal regulator. When I first heard about
the CMS inspection, I had no idea it had been triggered by her.
Throughout the fall of 2015 and into the winter of 2016, I tried to
find out what the inspection had uncovered. After Yamamoto and
Bennett completed their second visit in November, there were
rumblings from former Theranos employees in contact with current
ones that it hadn’t gone well, but details were hard to come by. In late
January, we were finally able to publish a story reporting that the CMS
inspectors had found “serious” deficiencies at the Newark lab, citing
sources familiar with the matter. How serious became clear a few days
later when the agency released a letter it had sent the company saying
they posed “immediate jeopardy to patient health and safety.” The
letter gave the company ten days to come up with a credible correction
plan and warned that failing to come back into compliance quickly
could cause the lab to lose its federal certification.
This was major. The overseer of clinical laboratories in the United
States had not only confirmed that there were significant problems
with Theranos’s blood tests, it had deemed the problems grave enough
to put patients in immediate danger. Suddenly, Heather King’s written
retraction demands, which had been arriving like clockwork after each
story we published, stopped.
However, Theranos continued to minimize the seriousness of the
situation. In a statement, it claimed to have already addressed many of
the deficiencies and that the inspection findings didn’t reflect the
current state of the Newark lab. It also claimed that the problems were