Medical Device Whistleblowers file Lawsuit Against FDA for Surveillance

January 30, 2012 — The Washington Post is reporting that six doctors and scientists who contacted Congress about corruption in the U.S. Food and Drug Administration (FDA) have filed a lawsuit against the agency. After the six contacted Congress, the FDA began secretly surveilling their personal communications on government computers for two years, and ultimately dismissed all six individuals.

The doctors and scientists were concerned about corruption in the agency regarding 12 radiological medical devices that had serious safety problems, and could potentially pose a risk to millions of people. The individuals were concerned about the following products:

• Three medical devices for screening breast cancer could miss signs of cancer
• One device could falsely diagnose osteoporosis, which would lead to unnecessary treatments
• One ultrasound machine could malfunction, potentially causing harm to an unborn baby
• Several colon cancer screening devices could malfunction, sending a very high dose of radiation. This radiation could potentially give cancer to a person who was cancer-free before.
• Another device was under review for screening breast cancer. Doctors, scientists, and their middle-managers recommended against approval. A senior manager ruled against their recommendations, and approved the device in 2008.

The six individuals contacted Congressional staffers regarding the problems within the agency. All six were working in an office that studied radiological devices, mostly involved in cancer screening. Soon after the individuals contacted Congress, the FDA began monitoring all of their communications on government computers, including personal emails. The FDA also began taking snapshots of their screens and saving the documents in a file.

Whenever the individuals logged onto the government computers, they were met with a warning alert that 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.”

Under the Freedom of Information Act, the six individuals were able to obtain information on the government’s surveillance actions against them. In their lawsuit against the FDA, they claim that the government “had no right” to monitor their personal emails because their actions were lawful.

Indeed, the Department of Health and Human Services’ inspector general declined to prosecute the individuals, because they found no evidence of criminal misconduct.

The lawsuit shows just how far the FDA is willing to go to monitor its own employees who have criticized the agency.

The lawsuit comes at a time of heightened Congressional scrutiny of the FDA. In January 2012, House Democrats began calling for a Congressional Hearing on Johnson & Johnson’s transvaginal mesh and Allergan’s Lap Band, FDA-approved devices which have been found to have a high rate of complications and failures. Many in the government and the American public are concerned over the safety of the following medical devices:

• Transvaginal Mesh: This medical device did not go through pre-market or post-market safety testing because of the 501(k) loophole in the FDA approval process that allows for medical devices that are “similar” to existing devices to avoid safety testing. Since Transvaginal Mesh has been available, many people have suffered serious, permanent complications. The FDA is considering re-classifying the devices.
• DePuy Hip implants: These products were sold without pre-market or post-market safety testing because the manufacturer said they were “custom” products. The products were later found to have a high failure rate. The FDA sent the company a warning letter saying that they products were not “custom” and would need to undergo traditional safety testing and approval.
• Allergan’s Lap Band: This weight-loss surgery device has come under scrutiny because of aggressive, misleading marketing by the 1-800-GET-THIN campaign. There is also safety data that suggests a high rate of complications (1/3) and more than 40% of people fail to lose weight after 5 years.
• Brain Stents: These devices were used to open blocked arteries. It was later discovered that a patient had twice the risk of stroke and death compared to patients who had not received the stents. The FDA has not recalled the devices.

Congress will have until October 2012 to discuss whether they will require changes to the FDA before they authorize continued funding to the agency. In a letter from Democrats to Republicans advocating for the meetings, “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. … 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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