FDA Fired Device Whistleblowers

January 30, 2012

The Food and Drug Administration fired six device division reviewers after they complained to Congressional staffers that the agency was approving unsafe or inadequate medical devices. The charge? Leaking confidential business information. The evidence? Personal gmail-account emails viewed on government computers that the agency monitored without employee knowledge, the Washington Post reported this morning.

The six have filed suit for wrongful discharge, as well they should. While there were probably crucial details left out of a short newspaper story and probably unknown to the reporters, there seems little doubt that the actions and comments of the six scientists were driven by differing interpretation of scientific evidence behind the approval of new devices, several of which involved detecting cancer. Firing someone for bringing that to the attention of Capitol Hill staffers after the agency has moved in what they believed was the wrong direction would seem to be a direct violation of the nation’s whistleblower protection laws.

It’s doubly disturbing that the firings occurred in mid-2010 when the debates swirling around the agency involved the inadequacy of the scientific standards being applied to medical devices through its 510(k) process, where new devices can be approved without clinical trials because they are deemed almost the same as the device they are replacing in the marketplace. One has to wonder if these firings were connected to that debate, which remains unresolved.

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One Response to FDA Fired Device Whistleblowers

  1. Joleen Chambers on January 30, 2012 at 1:50 pm

    Yes. I wonder. My brother’s implanted elbow failed after just 4 months. There was no adverse event report generated by the surgeon/designer or hospital. The self report to FDA “could not be located” according to FOI. Joint replacements are the #1 expenditure of Medicare. Orthopedic surgeons are 96% male making an average of $400 annually. The IOM reported that the FDA 510(k) “predicate” system is legislatively flawed and does not assure patients safe and effective devices. FDA device Patient Representatives are not considered full stakeholders and are not allowed to vote. All accountability is on the patient and taxpayer. Congress must act to change federal public policy. The first responsibility of the government is to protect its’ citizens.

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