The FDA + Shoddy Medical Devices + Surveillance of Employees’ Gmail = Lawsuit

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After a group of Food and Drug Administration (FDA) scientists and doctors informed Congress that they felt certain medical devices being approved by the agency posed unacceptable risks to the people who would utilize them, the agency then monitored the personal email accounts of those scientists and doctors. The devices were intended for use in cancer screening, as well as other purposes.

After learning of the agency's surveillance, which occurred over a two year period, a half dozen of the group of scientists and doctors filed suit against the FDA in Washington, just last week. The agency accessed the groups' Gmail accounts from government computers.

As a result of the email surveillance, all six of the FDA employees were both harassed and eventually fired, per the suit.

Commencing in January of 2009, the FDA began reviewing communications with congressional staffers, as well as drafted versions of whistleblower complaints. In addition the FDA took electronic snapshots of the desktops of the FDA employees' computers. As well, they looked at documents they'd saved on the hard drives of the computers belonging to the agency.

When users log on to an FDA computers, they're given a warning that they should have “no reasonable expectation of privacy” as regards any information stored in its system. As well, they're informed that the government may look at any information whenever they want, as long as it is for a lawful government purpose.

However, the group of scientists and doctors believe their constitutional privacy rights were violated by the FDA when they looked at their personal e-mail accounts.

The FDA tried twice, unsuccessfully, to launch an investigation via the Department of Health and Human Services' inspector general's office, which oversees the operations of the FDA, against the group of employees in 2010.

The situation begs the question – among others – has technology made the line between work and home gray?

Sen. Charles E. Grassley (R-Iowa) was quoted as having said in a statement recently regarding the matter: “The FDA has a huge responsibility to protect public health and safety. It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress.”

However, Michael Sussmann, currently a partner at the Perkins Coie law firm, and who served formerly federal prosecutor, is of the mind the FDA was within its rights in looking at email accounts. He was quoted as having said in the January 29th article, “FDA staffers sue agency over surveillance of personal e-mail”: “Anything on this agency's network is fair game by use of this banner, as long as they're lawfully targeting their employee.”

The scientists and doctors were employed by the FDA's Office of Device Evaluation, and had initially expressed their concerns in 2007 about devices that had been approved, or were in the final stages of approval, that were either ineffective, or that could potentially cause harm to millions. In addition, the group expressed their concerns to Congress, the White House and the HHS inspector general.

Per the article, the group of FDA employees contends that several devices would not pick up on signs of breast cancer. One more posed the risk of diagnosing osteoporosis, when in fact that was not the case, which would then lead to medical treatments that were not needed. An ultrasound device, they contend, posed the risk of working improperly while monitoring a pregnant woman while she was in labor, and that posed a risk to the baby. Still other devices for screening colon cancer, they believed, utilized large doses of radiation that could potentially cause cancer in healthy individuals.

However, because of the time frame of approval of said devices — many in just the last two years — doubt has been cast upon the fears the FDA scientists and doctors expressed.

But, per the article, the Institute of Medicine, following a major study last year, the process the FDA uses for approving medical devices needed changed and that it needed to be based on “sound science”.

So the question becomes, is Big Brother watching, or isn't he? And is that good or bad? It's hard to decide what's more disturbing, rather, chilling about the entire situation – the Gestapo like fashion in which the United States government is pursuing and policing its own people, or the alleged ‘approval' process of apparently both shoddy and harmful medical devices – and that their use would most likely increase business tenfold for doctors and pharmaceutical companies alike. Hmmm. Legalities aside, an extra prayer for good health today couldn't hurt.

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