Whistleblower Sues Eli Lilly over Drug Manufacturing Problems

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 a Lilly plant in New Jersey following a Reuters story that detailed some of Mula’s allegations.

A Lilly spokeswoman did not immediately respond to questions about the lawsuit, or on the status of the Justice Department’s investigation.

“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority,” the company said last year.

Reached for comment, Mula said she “made every effort to resolve this controversy and avoid litigation entirely, but unfortunately we were unable to do so.”

The Justice Department did not immediately respond to a request for comment.

An employee at the New Jersey plant starting in 2004, Mula contends in the lawsuit that she repeatedly pressured site leaders starting in 2018 to remedy manufacturing violations involving several biologic drugs, including diabetes medicine Trulicity.

“Lilly executives responded by marginalizing, harassing and eventually terminating her position under false pretenses,” said the lawsuit, filed in a New Jersey federal court.

In November 2019, FDA inspectors arrived at the Branchburg plant for an inspection and found that quality control data had been deleted and not appropriately audited.

Federal documents show the FDA cited the problems in 2020 as “Official Action Indicated,” or OAI, which is its most serious category of violation. The FDA has not taken further public action and did not respond to a request for comment.