The former director of regulatory affairs for Diagnostica Stago Inc., Amarjit Jowandha, has filed suit against the medical device company under New Jersey’s whistleblower law. It was alleged in the suit that Jowandha was fired for reporting noncompliance with state and federal laws to the U.S. Food and Drug Administration (FDA). He served as director of regulatory affairs and quality assurance in Stago’s Parsippany, N.J., office. He alleges in his complaint that he discovered “numerous instances of evasive and purposeful conduct” within several months of his hiring in April 2013 regarding the company’s compliance with federal and state regulations involving the importation and distribution of medical devices, including hemostasis analyzers, reagents and test kits, and others.
The whistleblower says he diligently tried to bring Stago into compliance with various FDA and other regulatory mandates but that the company, including CEO Stephane Zamia, a Defendant in the case, failed to correct the deficiencies and, instead, continued to violate state and federal laws. The whistleblower says he was terminated shortly after he reported the violations to the FDA and informed the company that he planned to report its continued noncompliance in December 2013. The complaint states:
Plaintiff was terminated from Stago for disclosing and/or threatening to disclose wrongdoing on the part of Stago that involved the continued and persistent illegal, unethical, harmful and noncompliant conduct in the regulated industry of medical device distribution, said conduct having a negative impact on the health, safety and welfare of the public.
According to the complaint, the violations involved end-user complaint handling, device tracking, investigation training, mislabeling, recall tracking, investigation techniques and clinical trial oversight and monitoring. For instance, Jowandha says Stago pressured him to sign off on documents relating to clinical trials that he says were not up to par with federal regulations.
In addition to attempting to bring the company into compliance with state and federal regulations, Jowandha also tried to correct the numerous corrective and preventive action notices Stago received from the FDA and other regulatory agencies, he says. When Jowandha made his recommendations to Stago’s upper management, including Zamia, according to the complaint the company asked him to falsify or “cover up” irregularities and regulatory deficiencies.
It’s alleged that after Jowandha reported the deficiencies to the FDA — which he says the company was aware of — the agency conducted an on-site inspection and investigation of Stago and issued additional notices to the company. It’s further alleged that Jowandha was fired on Dec. 18, 2013, shortly after he notified the company that he intended to report Stago’s persistent noncompliance and its unwillingness to achieve regulatory compliance to the FDA.
The complaint alleges Stago violated the Conscientious Employee Protection Act by terminating Jowandha to retaliate for his whistleblowing. It also alleges the company has refused to return Jowandha’s personal property to him. The New Jersey Supreme Court said in a ruling last month that it would consider the rights of watchdog employees when it certified a Johnson & Johnson subsidiary’s appeal of a revived whistleblower suit. That suit involved the retaliatory firing of a former director who raised concerns about the safety and efficacy of the company’s products.
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