September 25, 2014

Complaint Against FDA for Whistleblower Retaliation Rejected

By Jason Enzler

A complaint alleging the FDA engaged in whistleblower retaliation was dismissed by a federal court this week, but the case may be far from over.  The lawsuit, filed by six current and former FDA scientists and doctors, alleged that the agency retaliated against the whistleblowers after they raised concerns over the safety and approval process of medical devices.  The D.C. District Court tossed the complaint not on the merits, but because the whistleblowers failed to “exhaust the administrative remedies.”  Which means the whistleblowers may seek relief at the agency level and, if left unsatisfied, return to federal court for redress.

The case, captioned Hardy v. Hamburg, CV No. 11-1739, was brought by whistleblowers working on the FDA’s review and approval of medical devices for cancer screening.  According to the court’s opinion (which is quoting the complaint), around November 2008, they began “raising significant health and safety concerns regarding the FDA’s regulatory review and clearance/approval of [allegedly] unsafe and ineffective medical devices,” and that “FDA doctors and scientists had been ‘intimidated and coerced’ into ‘modifying their scientific reviews, conclusions, and recommendations.’”  The whistleblowers raised their concerns internally at the FDA, as well as with Congress, President Obama, and the news media.

After the whistleblowers went outside the agency with their concerns, the FDA allegedly began a retaliation campaign that included surveillance of the whistleblowers’ computer activities, termination of employment, negative performance reviews, and threats of disciplinary action.  The court noted these allegations were “troubling,” but went on to rule that the Civil Service laws under which the whistleblowers claimed protection required them to first lodge a complaint with the Office of Special Counsel and then, if unsatisfied with that decision, appeal to the Merit Systems Protection Board.  Only after that process is completed would the court have jurisdiction to hear the complaint.

While the court dismissed the complaint, it would seem as though the whistleblowers have a relatively clear path ahead outlined, should they choose to pursue it.  In a case that spurred both the White House and the Department of Health and Human Services to issue guidelines and warnings prohibiting certain types of surveillance of employees, the stakes seem high enough to anticipate that the whistleblowers will persevere.

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