Lawsuit Against FDA by Whistleblowers is Dismissed

By Jim Dickinson

A Washington, DC, federal judge has dismissed a civil lawsuit by current and former CDRH whistleblowers because they failed to exhaust their administrative remedies. Judge Reggie Walton noted that similar claims are still being reviewed by the government’s Office of Special Counsel.

Filed in 2012, the lawsuit alleged that the whistleblowers’ private e-mails and electronic activities on their computers were illegally monitored by FDA and used against them in internal wrongdoing probes. While at CDRH, the plaintiffs brought to light alleged instances in which supervisors overrode reviewers’ recommendations not to approve unsafe medical devices.

FDA’s two-year covert monitoring of the whistleblowers continued even after the HHS Office of Inspector General (OIG) denied the agency’s request to take any criminal and/or administrative action against the whistleblowers, according to the lawsuit. In its letter of refusal, the OIG told FDA that the whistleblowers’ communications to Congress were protected under law.

The whistleblowers’ claims ultimately led to former CDRH director Dan Shultz leaving the agency and to subsequent management retirements at the center. Shultz was replaced by current director Jeffrey Shuren, who played a significant role in the whistleblowers’ electronic surveillance and subsequent internal probes over alleged disclosure violations, according to the lawsuit. Through the electronic surveillance, Shuren allegedly became aware of a misconduct complaint against him.

Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET]