Jun 6, 2022. A former human resources officer at Eli Lilly and Co sued the drugmaker on Monday, alleging she was terminated after pointing out poor manufacturing practices and data falsification involving one of its blockbuster diabetes drugs.
The plaintiff, Amrit Mula, alleges violations of an employee protection law and seeks unspecified damages. The U.S. Department of Justice last year launched a criminal investigation into alleged manufacturing irregularities at an Eli Lilly plant in New Jersey following a Reuters story that detailed some of Mula’s allegations. (Reuters)
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.
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.”
(fiercepharma.com)
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