Bard Knew IVC Filters Were Deadly

 
Category: 
Defective Medical Devices

By Sandra Dalton, Staff Writer

On December 31, 2015, NBC News released yet another report about device maker C. R. Bard and its defective IVC filters. According to the new report, Bard chose to continue selling G2 series IVC filters for five years after it knew that the devices were failing, and when it had another filter that seemed to be much safer. G2 series filters have been linked to hundreds of injuries and at least 12 deaths.

IVC Filters

A retrievable inferior vena cava (IVC) filter is medical device use to prevent pulmonary embolism (PE). It is a tiny metal cage that is placed in an artery, and it is supposed to catch the clot and stop it from moving into the heart or lungs. It is used in people who are at risk, but who cannot use anti-clotting drugs. IVC filters are used when there is an elevated risk of PE, such as after surgery or during pregnancy. According to a safety alert from the U.S. Food and Drug Administration (FDA), it should be removed once the danger has passed.

The Problem with IVC Filters

A defective IVC filter can kill you. Malfunctions can include:

  • Device fracture
  • Pieces of the device breaking off and moving into the heart or lungs
  • Tilting of the device
  • Perforation of the artery in which it was placed
  • Perforation of internal organs
  • Migration of the entire device

Sometimes, the blood clot that the filter is supposed to stop will actually push the filter into the heart or lungs.

To make matters worse, surgery to remove a defective IVC filter is complicated and very risky. Even in the hands of the most highly trained and experienced experts, pieces of the device can break off and travel to the heart during surgery. Many surgeons refuse to attempt the dangerous procedure.

Evidence that Bard Knew About the Defects

Bard’s Recovery filter killed at least 27 people, and there were at least 300 reports of non-fatal problems with the device. The company hired a doctor to conduct a secret study of the device and he found that the Recovery had a higher risk of death and complications than any of its competitors. But Bard chose not to recall the deadly device.

In 2005, Bard replaced the Recovery filter with the G2. NBC News was able to obtain bard records showing that the company was aware of problems with the G2 as soon as four months after it received approval from the (FDA).

NBC obtained an internal memo from December 2005, in which a Bard vice president expressed concerns about complaints of complications with the G2. He also said that the company had another IVC filter with “virtually no complaints” and asked, “"Why shouldn't doctors be using that one rather than the G2?"

But Bard did not recall the defective device. It continued to sell the G2 and G2 Express until 2010. Over 160,000 were sold. So far, at least 12 deaths and hundreds of injuries have been associated with G2 filters.

If you were injured by an IVC filter or if you have lost someone as a result of IVC filter complications, you can learn more about your rights and how you can recover damages for your losses by searching our directory to find a lawyer near you.

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