While Senator Chuck Grassley (R-Iowa) has demanded information about the individuals who approved the use of software that could monitor the electronic communications of Food and Drug Administration (FDA) scientists who expressed concerns to Congress about the safety of medical devices, a court has ordered the agency to produce documents in related litigation brought by the whistleblowing scientists against the agency. Additional information about FDA’s surveillance action and the inadvertent posting of the scientists’ personal emails on the Internet appears in “The Final Word” section of the July 19, 2012, issue of Shook, Hardy & Bacon’s Product Liability Litigation Report.
Noting that the scientists do not seek expedited processing of the 80,000 pages of documents that were published on the Internet, a federal court in the District of Columbia has ordered FDA to produce responsive documents not among those already made public by specific dates in August and September 2012. Nat’l Whistleblower Ctr. v. Dep’t of Health & Human Servs., No. 10-2120 (U.S. Dist. Ct., D.D.C., order entered July 23, 2012). The court has also scheduled a status conference for September 27.
Meanwhile, The National Law Journal has reported that other government agencies, including the Drug Enforcement Administration and U.S. Department of Veterans Affairs also purportedly purchased the software that FDA used to monitor its scientists’ computers after they wrote to Congress, lawyers, journalists, and President Barack Obama (D) contending that the agency approved medical imaging devices that allegedly exposed mammogram and colonoscopy patients to unsafe radiation levels. FDA has reportedly claimed that it used the software to ensure that the scientists were not leaking confidential material that contained trade secrets. A spokesperson from Grassley’s office has apparently indicated that the senator may widen the scope of his investigation to other agencies. See The National Law Journal, July 30, 2012.