Eli Lilly moves to settle with whistleblower who flagged alleged manufacturing shortfalls

After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlement talks.

Plaintiff Amrit Mula sued the company last year claiming she was unjustly fired for reporting problems associated with the manufacture of blockbuster diabetes drug Trulicity. Over recent months, the companies have been engaged in discussions to finalize a settlement, according to court filings.

This summer, the parties told they court they reached a tentative agreement, according to documents filed at the end of August. That said, Lilly and Mula needed some “additional time to conclude the agreement," according to last month's filing.

Wednesday was the deadline for the parties to inform the court whether they would resume litigating, Reuters first reported. There have been no docket entries in the case for about a month, indicating that the litigation has likely been put to bed.

Lilly did not immediately reply to Fierce Pharma’s request for comment. 

Lilly fired Mula back in 2019. She had been the top human resources officer at the Branchburg plant for 8 years. In her lawsuit, Mula sought unspecified damages for Lilly’s alleged “unlawful retaliation” and violation of New Jersey’s employee protection law.

Responding to the lawsuit, Lilly last year said it “continues to deny these allegations and looks forward to the opportunity to defend itself in court.”

The former HR officer said she witnessed and reported Lilly employees failing to comply with FDA-mandated standard operating procedures. She also contends employees failed to report contamination, improperly disposed of caustic substances into waterways and falsified quality assurance testing documents.

As she conducted her investigation, Mula was repeatedly told to stop, she alleged in her lawsuit. 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.

Following an earlier Reuters story that detailed Mula’s allegations, the U.S. Department of Justice launched a criminal investigation in 2021 into alleged manufacturing irregularities at the plant.