In lawsuit against FDA, public health and corporate interests collide

How does an agency like the U.S. Food and Drug Administration balance its mandate to safeguard public health and protect confidential business information simultaneously?

That delicate balance has come under the spotlight in a whistle-blower lawsuitagainst the agency brought by six current and former employees who charge that the FDA was secretly monitoring their personal email accounts.

The group of doctors and scientists, all part of the Office of Device Evaluation, were communicating to Congress their concerns that risky medical devices were being approved by the agency at great peril to consumers. Two of the six were later fired by the FDA after the emails were collected, two were passed over for promotions and two others suffered harassment, the Washington Post reported.

FDA employees know from a warning posted on their computers that there they can have “no reasonable expectation of privacy’ and that data gathered from them can be used for lawful purposes. However, the lawsuit alleges that the agency violated their Constitutionally-protected right to privacy by peering into personal email accounts even though the monitoring may have been lawful.

While the scientists feel that they lost their jobs while trying to protect the public, the FDA seems to feel that the employees had disclosed confidential business information.

However, on two separate occasions — even after Jeffrey Shuren, director for the Center for Devices and Radiological Health, wrote to theDepartment of Health and Human Services’ inspector general — HHS did not pursue an action against the plaintiffs.

The devices that the scientists and doctors charge were unsafe but were approved are:

• three cancer-screening devices that allegedly missed signs of cancer
• a diagnosis device that misdiagnosed osteoporosis prompting unnecessary treatment
• an ultrasound device that could malfunction when testing a pregnant woman
• several devices that screened for colon cancer that had very high levels of radiation
• a breast-cancer screening imaging device that scientists agreed should not be approved

The Washington Post article notes that one device maker — icad Inc., which makes a breast-cancer imaging device that the scientists suggested be rejected — wrote to FDA in 2009 alleging that employees had improperly disclosed confidential business information to Congress within days after a newspaper article brought to light the internal battle between scientists and FDA management.

While the lawsuit filed in Washington, D.C. last week will likely decide whether the FDA breached privacy rights of its employees when they monitored their personal email accounts, the larger question of how it balances public health concerns with protecting corporate business information may be a tug of war that no one litigation can properly answer.