Pharmaceutical

FDA monitored emails of staff who questioned medical device safety

A group of former and current Food and Drug Administration (FDA) officials have filed a lawsuit against the agency alleging the FDA secretly monitored their private email after they questioned the approval of certain medical devices which they felt put the public’s health and safety at risk.

The group of nine doctors and scientists told members of Congress and the incoming Obama administration in 2008 that they were shocked to find medical devices they had researched had been approved by the FDA. In 2009, after Obama was elected but before he took office, the plaintiffs sent Obama’s transition team a letter complaining of corruption with the FDA’s device review process.

Over the next two years, the plaintiffs say emails sent from their personal Gmail and Yahoo accounts, including emails to congressional staff regarding their concerns, was monitored by the agency. Rather than having their concerns addressed, the doctors and scientists say they received warnings from or lost their contracts with the FDA.

The FDA’s review process for medical devices has been a growing cause for concern following recalls on some products and numerous complaints on others. In August 2010, Johnson & Johnson subsidiary DePuy Orthopaedics recalled its metal-on-metal ASR XL hip replacement and resurfacing systems after an unusually high number of failures.

While similar to traditional implants made with ceramic and plastic parts, the DePuy ASR is made with metal parts, which appears to be a design nightmare. The metal may leech into the bloodstream, and is suspected as a cause for the devices to fail and patients to suffer from blood poisoning.

The FDA said it monitored emails from its in-house whistleblowers in order to launch a criminal investigation. However, the agency found no criminal conduct and noted that disclosures relating to public safety to Congress were protected whistle-blower activity.

Source: The Boston Globe