(CN) – Nipro Medical Corp. tested its Amigo Insulin Pump on its own employees and destroyed or manipulated data that showed the pump is unsafe, says a former engineer for the company. He says the company “is using live patients as the testing population” on a product that is potentially fatal.
The engineer, Vaughn Usher, says he was fired after he told managers they “could all go to jail for what they were doing,” the engineer claims in Broward County Court.
Usher claims he told Nipro managers, including its director of operations, that the pump was defective, to which the operations director allegedly replied “that dealing with the pump’s defects ‘was up to the spin doctors out there.'”
Usher says he has 21 years experience as an engineer, and more than 30 patents for medical devices. He says Nipro and its subsidiary, co-defendant Nipro Diabetes Systems, received a warning letter from the FDA in May 2004, citing it for documentation and audit problems with the pump, which the FDA called “adulterated.”
The Amigo Insulin Pump is a programmable, wearable device that monitors and administers insulin. Usher says Nipro hired him in May 2005. He says he discovered that the pump “had been designed by non-medical people,” that it was “not designed to be capable of the precision needed for the safe and dependable delivery of insulin as required for changing individual needs,” and that he “found no evidence of prior clinical trials or product testing done on the Amigo Insulin Pump demonstrating that it met quality or safety standards as required by FDA rules and regulations.”
Usher says that for all these reasons, he determined that the pumps are “defective for multiple reasons, but the paramount and potentially lethal problem is that insulin leaks backwards out of the syringe resulting in under-dose to the patient.”
He claims that this leak “also may short circuit the electronics in the product with unpredictable results.”
Usher says he told managers of Nipro “that it must stop experimentation on humans, including NDS employees, and that all of them could all go to jail for what they were doing, to which management responded by dismissing plaintiff as a dissident, although they did stop the experimentation on employees, not because it was a risk to human life, but because they feared plaintiff would report the violations to the FDA”.
Usher demands damages for wrongful firing, retaliation and whistleblower violations. He is represented by Karen Coolman Amlong of Fort Lauderdale.