Eli Lilly Settles Whistleblower Lawsuit over Manufacturing Problems

Eli Lilly and Co LLY.N and a former employee agreed to settle a lawsuit in which the worker claimed she was terminated after pointing out poor manufacturing practices and data falsification involving one of its blockbuster diabetes drugs, according to court filings.

The former human resources officer, Amrit Mula, contended in the lawsuit that she repeatedly urged leaders at a New Jersey plant to remedy problems involving several biologic drugs, including Type 2 diabetes medicine Trulicity.

Lilly called Mula a non-scientist whose allegations were “simply wrong,” according to court filings.

Both sides reached a tentative agreement this year and were working to finalize the settlement, according to an August court filing.

A judge set a Wednesday deadline to inform the court whether they would resume litigating, and said that if they did not, the case would be dismissed. Neither side made additional court filings.

A Lilly spokesperson said the resolution “in no way admits any wrongdoing,” and did not comment on details of the settlement. An attorney for Mula did not respond to an inquiry.

The New Jersey facility has been under scrutiny by the U.S. Food and Drug Administration since 2019 when inspectors found quality control data had been deleted and not appropriately audited, Reuters has reported. The plant has also produced several cancer medications and a COVID-19 therapy.

Inspectors later returned and found more problems, including that batches of drugs had been discarded because of manufacturing mistakes and quality control problems were not being properly investigated by the company to prevent recurrence.

Lilly has said it was working collaboratively with the FDA to address the agency’s concerns.

Separately, the U.S. Department of Justice in 2021 launched a criminal investigation following a Reuters story that detailed some of Mula’s allegations.

No charges have been filed. A DOJ spokesperson did not respond to a request for comment on the status of the investigation.