Genentech faces a whistleblower lawsuit filed by a former employee who claims that the biotech company allegedly put participants in a cancer drug trial at risk by not following federal clinical trial rules and then fired her after she questioned the company’s rush to meet an approval deadline.
Plaintiff Juliet Kniley was a former senior clinical program manager at Genentech who worked with the Pi3 Kinase program team. In her suit, she alleges that she was “harassed, demoted, and eventually let go after questioning the company’s failure to follow federal guidelines over clinical trials,” according to The San Mateo Daily Journal.
The whistleblower lawsuit filed in San Mateo County Superior Court alleges that the failure to follow the rules put the participants of the clinical trials “at unnecessary risk of death and injury.”
Genentech denies the allegations contained in the suit, according to FierceBiotech.
Kniley alleges that, in July and August 2009, she was told to let the clinical trial proceed without necessary approvals but when she refused, she was demoted and then removed from the program, according to The San Mateo Daily Journal. Her suit claims that she was twice told that Genentech’s parent company, Roche, would take the drug away from the Pi3 Kinase team if it saw her recommended approval timelines.
Kniley sued Genentech under a whistleblower provision in the False Claims Act, which allows citizens to act as whistleblowers to file lawsuits against companies that have directly or indirectly defrauded the government.
If you or someone you know has information about a company defrauding the government, contact Sokolove Law for a free legal consultation. For legal help, call (800) 581-6358.