Here’s a Bad Idea: Injecting People with Damaged Stem Cells

A California man is suing a stem cell research company, saying they fired
him when he complained that the company was cranking out damaged stem
cells — and planning to inject them into patients. In a
retaliation lawsuit filed in Alameda County in California, whistleblower Rob Williams says
he sent emails to the higher-ups at StemCells, Inc., warning them about
the problem and how dangerous it was. Not only did the company ignore
his warning, he says, but they fired him for his troubles. Williams is
suing under the California False Claims Act, alleging that the company
retaliated against him because they didn’t like it when he told
them the truth.

A report in Courthouse News, entitled
Whistle-Blower Alarmed at Stem Cell Work, lays out Williams’ allegations. He says he has email to back up
his claims. If so, it’s like that radio ad says — some things
are good ideas and some are just bad ideas. Here’s my personal vote:

Using bad manufacturing practices to make stem cells?

I’m going to have to vote: Bad Idea.

StemCells Inc. apparently rakes in millions of dollars in grants from the
California Institute for Regenerative Medicine and other government agencies.
As part of its application for funding, Williams says that the company
claims that the stem cells it is manufacturing are “safe for human
stem cell transplantation.” StemCells also has to follow FDA manufacturing
standards, called “Good Manufacturing Practices,” when it
manufactures the stem cells.

Williams says that StemCells is making false claims, however. He says that
sterilization during the manufacturing process is poor, and there are
large manufacturing deviations during cryopreservation.

The result? Dangerously high numbers of damaged cells in many of the company’s
stem cell lots, according to Williams.

Deciding to release the stem cells so they could be injected into patients?

My vote: Really, really bad Idea.

Williams says “the high level of damaged cells and the possibility
of contaminating microorganisms could cause serious harm to patients.”
Using the cells could “skew patient test results, effectively jeopardizing
data behind years of clinical trials and research.” Yikes.

Ignoring the employee who warns you about what is happening and how dangerous it is?

Again, I’m voting: Bad Idea.

Sometimes you might think an idea sounds pretty good when someone first
floats it. “Hey, I know! We’ve got these bad stem cells. Why
don’t we inject them into people?!” OK, probably not here.
But when an employee warns you about the problems, it’s obvious
that not everyone thinks the idea is a good one and you need to reevaluate.

Firing the employee who gave you the warning?

My vote: Yet another bad Idea.

StemCells hired Williams in December 2013 as its senior manager of manufacturing,
but the job didn’t last long. Williams says he was suspended and
then fired within just a few weeks of taking the post.

Like many states, California has a False Claims Act that protects whistleblowers
from retaliation.
Cal. Gov. Code § 12653. The Act says that an employee, contractor or agent cannot be “discharged,
demoted, suspended, threatened, harassed, or in any other manner discriminated
against in the terms and conditions of his or her employment because of
lawful acts” he does to try to stop someone from cheating the Government.
The whistleblower is entitled to “two times his back pay, interest
on the back pay, and compensation for any special damages sustained as
a result of the discrimination.” Williams also is requesting punitive
damages, which are allowed under the California FCA. If StemCells loses,
it will have to pay Williams’ litigation costs and attorneys’ fees.

California’s False Claims Act, like most, also allows a whistleblower
to get a percentage of what the government recovers as a result of the suit.