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Medical Device Whistleblowers file Lawsuit Against FDA for Surveillance

Medical Device Whistleblowers file Lawsuit Against FDA for Surveillance

January 30, 2012 — The Washington Post reports that the U.S. Food and Drug Administration (FDA) secretly monitored the personal emails of at least six employees after they warned Congress of corruption within the FDA. They warned that the FDA was approving medical devices that posed an unacceptable risk to patients, above the opinions of doctors and scientists within the organization. The six employees were using government computers, and the surveillance ultimately led to the harassment or dismissal of all six employees.

The doctors originally voiced their concerns in 2007 over 12 radiological devices whose effectiveness was not proven and could pose health risks to millions of people.

  • Three devices risked missing signs of breast cancer
  • One device risked missing signs of osteoporosis, leading to unnecessary treatments
  • One ultrasound machine could malfunction and harm an unborn baby
  • Several devices for colon cancer screening could accidentally use a much higher dose of radiation, giving cancer to otherwise health patients
  • One device that searched for signs of breast cancer. Although doctors, scientists, and their middle-managers recommended against approval, a senior manager approved the device in 2008.

The six doctors and scientists have filed a lawsuit against the FDA in U.S. District Court, based on information they collected under the Freedom of Information Act.

The doctors and scientists worked together in an office and were responsible for reviewing medical devices used for cancer screening and more. Their lawsuit against the FDA accuses the administration of monitoring their personal emails for two years. In January 2009, the FDA intercepted emails between Congressional staffers and the men, including draft versions of a whistle-blower lawsuit.

They were using government computers for personal communications. When they logged on to the government computers, they were met with a prominent warning alert box that clearly said “you have no reasonable expectation of privacy regarding any communications,” and “for any lawful government purpose, the government may monitor, intercept, and search and seize any communication or data.”

The doctors and scientists who filed the lawsuit contend that their actions were lawful. Indeed, they have a legal right to voice their concerns to Congress or journalists.

The Department of Health and Human Services’ inspector general, which oversees the FDA operations, found no evidence of criminal misconduct and is not pursuing an investigation against the doctors and scientists.

The lawsuit brings to light just how far this federal agency is willing to go to monitor and surveil its employees. The agency took snapshots of the employees’ computer screens, showing documents and emails, and stored the information.

The news of this lawsuit comes at a time when the FDA is under intense Congressional scrutiny regarding the safety of medical devices. In January 2012, House Democrats began calling for a Congressional Hearing on Johnson & Johnson’s transvaginal mesh and Allergan’s Lap Band. The FDA is under scrutiny regarding several medical products:

  • Transvaginal mesh: The companies selling the medical products did not conduct pre-market or post-market safety studies, a lawful exception under the FDA’s 501(k) program. After the products were sold, many people experienced serious complications. The FDA is considering re-classifying the devices.
  • DePuy Hip implants: Sold as “custom” devices to avoid safety testing. After people received the implants, they were found to have a high rate of failure.
  • Lap-Band: Studies found that 1/3 of patients experience a serious complication, and 40% fail to lose weight with the device.
  • Brain Stents: Used to open blocked arteries during cardiac surgery. Patients with the device were found to have twice the rate of strokes and death compared to patients without the stents.

The U.S. Congress has until October 2012 to decide whether they will authorize funding to the FDA review of medical products.

“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Democrats said in a letter to the Republicans. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”

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