Drug Maker Eli Lilly Settles Whistleblower Lawsuit Over Manufacturing Problems
Pharmaceutical giant Eli Lilly and a former human resource officer, Amrit Mula, have reached a settlement in a whistleblower lawsuit filed last year. The lawsuit sparked several probes from the Department of Justice (DOJ) and the Food and Drug Administration (FDA).
Lilly and Mula had been actively working on finalizing a settlement agreement, and it was reported that a tentative agreement had been reached in August. However, additional time was needed to finalize the details. Recent court documents show that the deadline for both parties to notify the court about a settlement deal or additional time to resume litigation had passed, with neither party filing a motion, indicating that litigation had concluded.
Mula filed the lawsuit claiming she was wrongfully terminated after raising concerns about the production of diabetes drug Trulicity. In 2019 Mula was terminated from her role as top human resource officer in the Branchburg, New Jersey, production facility after voicing her concerns.
Under the Department of Labor's whistleblower protection laws, it is illegal for an employer to retaliate against an employee who sheds light on a company's fraudulent behavior or illegal misconduct. Many federal agencies enforce whistleblower and anti-retaliation laws including the Occupational Safety and Health Administration (OSHA), the Mine Safety and Health Administration (MSHA), the Office of Federal Contract Compliance Programs (OFCCP), the Wage and Hour Division (WHD), and the Veterans Employment and Training Services (VETS). In a “qui tam” whistleblower lawsuit, the plaintiff files on behalf of the government, which can pursue the case itself or allow the plaintiff to take the lead. In either case the whistleblower can share in a percentage of the reward the government receives.
Mula’s claims included that observation and reports of employees at the plant did not adhere to FDA-mandated standard operating procedures. Additionally, Mula said that employees falsified quality assurance testing records, did not report contamination incidents, and that they improperly disposed of harmful material into waterways.
When Mula investigated these issues and voiced her concerns, she was allegedly told on numerous occasions to stop. Despite this, she brought her concerns to site leadership officials but was instead met with executives deciding to terminate her from her role with the company.
The allegations Mula brought up are especially notable because they prompted a criminal investigation by the U.S. Department of Justice in 2021. The DOJ’s investigation focused on irregularities regarding manufacturing practices at the New Jersey facility.
An investigation by the U.S. Food and Drug Administration found that since at least 2019, quality control data had been deleted or not appropriately audited and that there were batches of drugs that were discarded because of manufacturing mistakes and quality control issues. The FDA also determined Lilly’s internal investigation into the manufacturing mistake was not conducted properly which prevented reoccurrence.
Despite the investigations and the probe by the DOJ in 2021, no charges have been filed against the drug maker.
Lilly maintains that it is continuing to work collaboratively with the FDA but defends in this recent settlement that the company "in no way admits any wrongdoing." Details of the settlement have not been disclosed.
