Eli Lilly sued by whistleblower over drug manufacturing issues
An employee at a pharma manufacturing plant that has drawn the ire of the FDA and the DOJ, is bringing a suit against her former employer.
Pharma company Eli Lilly is being brought to court in New Jersey by a former employee who is seeking damages after acting as a whistleblower.
The case centers around the plaintiff Amrit Mula, a former associate director of employee relations at Lilly’s plant in Branchburg, New Jersey.
Beginning in August 2018, and continuing until her termination, Mula began to investigate employee complaints of serious violations to the FDA concerning regulations in the manufacturing of Lilly pharmaceutical drugs. Mula is also to have allegedly witnessed and reported employees failing to adhere to current GMPs.
Mula also notified the FDA that the plant failed to comply with FDA-mandated standard operating procedures, along with failing to report batch contaminations, improperly disposing of caustic substances into waterways as well as falsifying quality assurance testing.
In particular, the failures of production Mula observed and reported were primarily related to the sale of the diabetes drug Trulicity.
The case alleges that throughout Mula’s investigations, Lilly officials continually told Mula to stop investigating or to underplay the severity of the violations, and after Mula repeatedly pressured site leadership to remedy the situation, Lilly executives allegedly responded by marginalizing, harassing and eventually terminating her position around March 28, 2019.
The case documents said that Mula conducted a data integrity investigation, which revealed that at least seven employees falsified records and that the manufacturing department was consistently overdue on cGMP training. She also uncovered that several Branchburg site employees repeatedly recorded that SOPs were performed while knowing that a required step had been intentionally omitted and then misrepresented data was being recorded in cGMP documents. She also found that several employees had failed to complete mandatory cGMP training, among other infractions.
Mula is seeking reinstatement and other injunctive relief as well as compensatory damages.
Lilly’s Branchburg plant has been in the government’s crosshairs for a while. In 2021, the FDA was investigating the location, which produces Covid-19 antibody bamlanivimab, for inadequate quality and laboratory controls.
The DOJ also hit Lilly with a subpoena requesting additional documentation on its work at a Branchburg.
This is not the end of Lilly’s legal woes as in May, Lilly, along with two other companies, is also facing a lawsuit brought on by the Arkansas Attorney General alleging that the pharma companies colluded with benefits managers (PBMs) to artificially drive up insulin prices.