Contributing Author: Meghan A. McCaffrey
This past Thursday, the Washington Post reported that the FDA admitted to monitoring personal Gmail communications of a group of its employees, including doctors and scientists who worked for the Office of Device and Evaluation at the FDA. The alleged surveillance occurred over the course of two years as the plaintiffs accessed their personal email accounts from their government computers. The communications that were intercepted include various emails between the FDA employees and congressional staffers regarding concerns over the agency’s approval of cancer-screening and other medical devices as well as draft versions of whistleblower complaints. As reported in Law360, the FDA’s medical device approval and monitoring continues to be a hot topic, as Senators press the White House Office of Management and Budget to release an FDA rule on post-market medical device tracking under review for seven months.
One of the same Senators urging the White House’s Office of Management and Budget to move forward on the FDA medical device rule — Senator Charles E. Grassley (R-Iowa) — is also launching an investigation into the FDA’s monitoring of the purported whistleblowers. Indeed, Grassley’s staffers communicated with the FDA employees about their concerns and are now wanting to know if, in addition to information about the FDA’s surveillance, the agency also procured passwords to the employees’ personal email accounts. The FDA, for its part, claims that the monitoring was only done in response to allegations that its employees had leaked confidential information about pending medical devices to the public.
Admittedly, it may seem a bit strange that we here at the Monitor would in fact be “monitoring” this type of development. However, the FDA’s medical device approval process – and the countless numbers of lawyers paying attention to such approvals and any resulting injury claims — has been the subject of several previous posts (see here, here, and here just for a few examples). As reported by the Washington Post, the agency has also been under scrutiny from the Government Accountability Office, which concluded in 2011 that some allegedly risky medical devices win approval from the FDA through an insufficiently stringent approval process. Indeed, the GAO concluded in 2011 that while the FDA had taken some steps to remediate faulty device processes, the end result was that the agency just hadn’t done enough, which could “increase the risk that unsafe medical devices could remain on the market.”
Regardless of the legality of the FDA’s monitoring of employee email communications, FDA employees expressing concern to congressional members over the FDA medical device approval process — and alleged retaliation from the FDA after doing the same — may prove a relevant issue in potential tort and products cases down the line. We here at the Monitor will continue to cover these issues as they progress.