A former manager at Regeneron Pharmaceuticals has filed a federal whistleblower lawsuit against the drug giant, claiming he was fired for raising questions about a lack of manufacturing standards.

Stanley Koshy said in a complaint unsealed last week that he was terminated because he expressed concern over the manufacturing practices and lack of quality controls at the plant and at companies contracted to manufacture drugs for Regeneron.

Koshy said his boss became so enraged at him that he went to his office “and stated that he wanted to choke him,” and several days later “stated he wanted to punch Koshy in the nose.”

In one instance, Koshy expressed concern over the testing practices at an Indiana laboratory used by Regeneron, but was ignored. The laboratory, Cook Pharmica, was later cited by the U.S. Food and Drug Administration for inadequate testing.

“Defendant terminated plaintiff because plaintiff reported incidents to Regeneron and objected to and refused to participate in the employer’s unlawful policies and practices,” Koshy’s 11-page complaint said. “Plaintiff has been unable, despite reasonable efforts, to find comparable employment.”

“There is no merit to these claims,” the Greenburgh-based company said in a statement. “Regeneron intends to defend itself vigorously in response to these baseless allegations.”

Koshy was hired in May 2016 to manage the company’s dealings with outside contractors that manufacture pharmaceuticals and provide services for Regeneron.

Cook Pharmacia in Bloomington, IN is begining to do more and more work at their new research lab, open less than a year. Here we photograph workers in labs studying cells and protiens on Tuesday, July 18 2006. (Sam Riche / The Indianapolis Star) (Photo: Sam Riche, Indianapolis Star)

The following month, Koshy raised concerns over a lack of controls after visiting the Cook Pharmica site in Bloomington. He said he feared a possible danger to public health and wrote to his supervisor, but that he received no reply.

Koshy also complained over practices related to rejected pharmaceuticals. He was later put on a grant-funded program to address the Zika virus, but soon began to feel he was being retaliated against, the lawsuit said.

He said he began to be relieved of more and more of his duties, until he was finally fired on Oct. 11, 2016. He filed the lawsuit in October of this year, but it remained sealed until a judge ordered it unsealed this month.

Koshy’s lawsuit, filed in U.S. District Court in White Plains, seeks unspecified damages.

“Our client alleges that he was terminated after expressing concerns regarding safe product production in government-funded projects,” said his attorney, Sarah Burger of the law firm Ianniello Anderson. “He is asking to be made whole for all earnings he would have received but for the retaliation.”

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