Lilly whistleblower sues drugmaker, alleging retaliation

A top human resources officer at Eli Lilly and Co.’s factory in New Jersey claims the drugmaker fired her in retaliation for investigating employee complaints about drug manufacturing problems and for refusing to drop the matter.

Amrit Mula, who was terminated in March 2019 as associate director of employee relations, filed suit this month in U.S. District Court in Trenton, New Jersey.

In a statement to IBJ, Lilly denied the allegations and said it is “deeply committed” to the safety and quality of its products.

Mula is bringing her complaint as a whistleblower and is accusing the Indianapolis-based drugmaker of retaliating against her in violation of New Jersey’s Conscientious Employee Protection Act.

That law prohibits employers from taking retaliatory personnel action against an employee who refuses to participate in any activity that the employee believes is in violation of the law.

Mula said that for nearly a year, beginning in August 2018, she witnessed and reported Lilly employees failing to adhere to good manufacturing practices, failing to comply with federally-mandated standard operating procedures, failing to report batch contaminations, improperly disposing of caustic substances into waterways and falsifying quality assurance testing.

The lawsuit says many of the issues were primarily related to the sale of Trulicity, Lilly’s blockbuster medicine for Type 2 diabetes. Trulicity is Lilly’s top-selling product, ringing up sales last year of $6.47 billion, representing about 23% of the company’s revenue of $28.3 billion.

“Throughout the course of her investigations, Lilly officials continually told Ms. Mula to stop her investigations or underplay the severity of the violations she uncovered,” according to the 40-page complaint. “After Ms. Mula repeatedly pressured site leadership to remedy these serious legal and compliance violations, Lilly executives responded by marginalizing, harassing, and eventually terminating her position under false pretenses on or about March 28, 2019.”

In a statement, Lilly said it “has long-standing policies and procedures that enable–and encourage–individuals to come forward with information about any potential issues or concerns without fear of retribution. We take these concerns seriously by conducting thorough investigations and implementing corrective actions, as appropriate.”

The statement continued: “The allegations asserted by Ms. Mula in her recently filed employment retaliation complaint relate to the same baseless claims Ms. Mula made in the press over a year ago.  Lilly continues to deny these allegations and looks forward to the opportunity to defend itself in court.”

Some of the allegations were reported last year by Reuters.

Lilly’s manufacturing plant in Branchburg, New Jersey, is one of the largest of its kind in the biotech industry, stretching 250,000 square feet.

Beginning in 2018, Mula began investigating employee complaints of violation of federal good manufacturing processes. The investigation revealed that at least seven employees falsified records and that the manufacturing department was consistently overdue on employee training, the complaint said. Despite this, Lilly told regulators during this period that its employees were up to date and compliant with training requirements, the lawsuit alleges.

Mula said her superiors told her to designate the incidents as “performance issues” as opposed to recording them as manufacturing violations.

In subsequent months, Mula began investigating an anonymous employee complaint that Lilly had failed to hire a sufficient number of employees to complete the required work, and said she ran into problems with Lilly executives conducting a “whitewash” of the staffing shortfalls and “chronic noncompliance.”

Later that fall, another Lilly employee informed Mula of missing binders of validation protocols discovered during an initial protocol report review.

“During the course of the investigation, hundreds of original pages were found missing, some of the documents were discovered [in] dumpsters,” the complaint said. “Ultimately, all but roughly 52 pages of the original validation protocols for the manufacture of Trulicity were recovered.”

A Lilly executive, Victor Cruz, vice president of biopharmaceutical and operations at the Branchburg site, instructed her to “cease and desist from investigations risking dula,” the complaint said, using Lilly shorthand for dulaglutide, the generic name for Trulicity.

Instead, Mula took her complaint to another Lilly executive, Vice President of Global Quality Leannae Hickman.

Hickman later requested that the Quality Department conduct an investigation into the issue without an accompanying human resources investigation, and requested that Mula abandon her push to initiate a report on the matter, noting that doing so would bring “unwanted attention during regulatory inspections,” Mula’s complaint said.

In 2020, the Food and Drug Administration issued an “official action indicated” notice to Lilly indicating that the problems raised by Mula were significant to pose an imminent health hazard, the complaint said.

Around March 2019, three PhD scientists working in Lilly’s quality control department informed Mula that Lilly was relaying on compromised data in making batch release decisions for Trulicity. The issues were raised on the heels of the resignations of six trained quality control analysts over an eight-month period, the complaint said.

Mula said she began investigating the complaint. But on March 28, 2019, Mula was informed that Lilly had eliminated her position. On the same day, Mula said she noticed that a locked drawer in her desk had been emptied. Among the missing items were the Trulicity investigation file.

Mula began working for ImClone Systems in 2004 and became a Lilly employee when the company acquired ImClone in 2008. During her 15-year employment, she received four promotions and four achievement awards, according to her complaint. Prior to her termination, she never received any disciplinary action, reprimands or unsatisfactory performance evaluations.