A whistleblower who was fired by Eli Lilly three years ago has filed suit against the pharma giant, alleging that her dismissal came in response to her reporting manufacturing problems at the company’s massive plant in Branchburg, New Jersey.
Amrit Mula, the top human resources officer at the plant for eight years, seeks unspecified damages for Lilly’s alleged “unlawful retaliation” and violation of New Jersey’s employee protection law. She filed her lawsuit in New Jersey federal court on Monday.
Mula told Reuters that she “made every effort to resolve this controversy and avoid litigation entirely, but unfortunately we were unable to do so.” The Branchburg plant has been in the headlines for nearly two years thanks to manufacturing shortfalls there. The DOJ has even subpoenaed the drugmaker for documents related to the site.
Mula's complaint surrounds her unsuccessful attempts to force Lilly address problems associated with the manufacture of blockbuster diabetes drug Trulicity, which generated sales of $6.5 billion last year.
"The allegations asserted by Ms. Mula in her recently filed employment retaliation complaint relate to the same baseless claims Ms. Mula made in the press over a year ago. Lilly continues to deny these allegations and looks forward to the opportunity to defend itself in court," Lilly said in a statement.
The former HR officer says she witnessed and reported Lilly employees failing to comply with FDA-mandated standard operating procedures, failing to report contaminations, improperly disposing caustic substances into waterways and falsifying quality assurance testing documents.
As she conducted her investigation, Mula was repeatedly told to stop, she alleges. After pressuring site leadership to remedy the manufacturing violations, Lilly “executives responded by marginalizing, harassing and eventually terminating her position under false pretenses,” the suit says.
She was dismissed roughly five weeks after sending an internal letter to management urging action. After her termination, which was “disguised as a job elimination,” according to the complaint, Mula has suffered “loss of pay, benefits, emotional distress and serious damage to her career.”
Shortly after taking over as Lilly CEO in 2017, David Ricks installed cost-cutting measures which reduced Lilly’s workforce by 8%, or roughly 3,500 employees. Around this time, Mula began hearing complaints from employees of violations including falsification of records.
In November of 2019, FDA inspectors found auditing errors at the plant, including quality control documents had been deleted.
Following the Reuters story last year that detailed Mula’s allegations, the U.S. Department of Justice launched a criminal investigation in 2021 into alleged manufacturing irregularities at the plant.
"Lilly is deeply committed to manufacturing high-quality medicines, and the safety and quality of our products is our highest priority," the company said in its statement on Tuesday. "Lilly has long-standing policies and procedures that enable – and encourage – individuals to come forward with information about any potential issues or concerns without fear of retribution. We take these concerns seriously by conducting thorough investigations and implementing corrective actions, as appropriate."