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Eli Lilly & Co, a pharmaceutical giant, has reached a settlement in a lawsuit brought forth by a former employee who alleged wrongful termination after exposing manufacturing irregularities and data manipulation tied to a popular diabetes medication. Court documents reveal this resolution.
Former Employee’s Claims
Amrit Mula, previously a human resources officer at a New Jersey facility, maintained in her lawsuit that she repeatedly alerted the facility’s leadership to address issues concerning various biologic drugs, including the widely-used Type 2 diabetes medication, Trulicity.
Lilly’s Response
Eli Lilly countered Mula’s allegations, describing her as a non-scientist and asserting that her claims were baseless. Court records reflect their stance.
Both parties tentatively agreed to a settlement earlier this year, with ongoing efforts to finalize the terms, as confirmed in an August court filing.
Deadline Looms
A deadline was set by the presiding judge, with both sides required to inform the court by Wednesday whether they intended to resume litigation. Failure to do so would result in the case’s dismissal. No further court filings have been made by either party.
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No Admissions of Wrongdoing
A spokesperson for Eli Lilly emphasized that the settlement does not constitute an admission of wrongdoing on their part. However, they refrained from disclosing specific details of the agreement. An attorney representing Amrit Mula did not provide comments when approached for inquiries.
The New Jersey facility in question has faced scrutiny from the U.S. Food and Drug Administration since 2019 when inspectors discovered instances of data deletion without proper audit trails. This facility also produces cancer medications and a COVID-19 therapy.
Ongoing FDA Concerns
Subsequent inspections identified additional issues, including the discarding of drug batches due to manufacturing errors and inadequate investigations into quality control problems. Eli Lilly has stated its commitment to collaborating with the FDA to address these concerns.
In a separate development, the U.S. Department of Justice initiated a criminal investigation in 2021 following a Reuters report that highlighted some of Amrit Mula’s allegations. As of now, no charges have been filed, and the Department of Justice has not commented on the status of this investigation.
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