Eli Lilly settles Whistleblower lawsuit over alleged quality issues

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Settlement talks have been underway between pharmaceutical giant Eli Lilly and a former human resources officer, Amrit Mula, who blew the whistle on alleged manufacturing issues at the company’s extensive Branchburg, New Jersey, production facility.

Mula had filed a lawsuit last year, claiming wrongful termination for raising concerns related to the production of the widely-used diabetes medication, Trulicity. Recent court filings indicate that both parties have been actively working towards finalizing a settlement in recent months.

In August, it was reported that a tentative agreement had been reached between Lilly and Mula, although they needed some additional time to conclude the agreement, as stated in a filing from last month. Wednesday marked the deadline for the parties to inform the court about their intentions to either resume litigation or reach a settlement. Notably, there have been no recent updates in the case, suggesting that the litigation may have been resolved.

Amrit Mula’s employment with Lilly was terminated in 2019. At that time, she had served as the top human resources officer at the Branchburg plant for eight years. In her lawsuit, Mula sought unspecified damages, alleging “unlawful retaliation” by Lilly and violations of New Jersey’s employee protection laws.

Eli Lilly responded to the lawsuit by denying the allegations, expressing readiness to defend itself in court.

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Mula’s claims revolved around her alleged observations and reports of Lilly employees failing to adhere to FDA-mandated standard operating procedures. She further alleged that employees did not report contamination incidents, improperly disposed of harmful substances into waterways, and falsified quality assurance testing records.

During her investigation into these matters, Mula asserted that she was repeatedly instructed to cease her efforts. When she persisted in pressing site leadership to address manufacturing violations, she claimed that Lilly executives responded by sidelining, harassing, and ultimately terminating her position under false pretenses, according to her lawsuit.

The allegations brought forward by Mula garnered attention after Reuters reported on them, leading to a criminal investigation by the US Department of Justice in 2021. This investigation focused on alleged irregularities in manufacturing practices at the Branchburg facility.

As discussions towards a settlement between Eli Lilly and Amrit Mula progress, the pharmaceutical company continues to grapple with the fallout from the whistleblower’s allegations, while striving to maintain its reputation and regulatory compliance in the pharmaceutical industry.

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