40 Deaths Later, Medical Device Company Still Says Its IVC Filters Meet ‘All’ Safety Standards

The story is one as old as time itself: Company manufactures a product and the product turns out pose serious risks for complications and injury; but the company ignores said risks and continues to sell the dangerous product for fear of losing profitability.

That’s exactly what’s happened with C.R. Bard and its Inferior Vena Cava (IVC) filters. On the surface, an IVC filter seems like it might be the ultimate problem-solver for men and women who are recovering from accidents or surgeries, or who are otherwise at risk for pulmonary embolism (blood clot in the lungs). The surgical procedure is relatively quick; the spindle-like device is implanted right into one’s inferior vena cava – one of the body’s main veins, which carries blood form the lower body to the heart – and, once inside, the filter catches and traps potential blood clots from reaching one’s lungs, heart, or brain. Then, once a person is no longer at risk for pulmonary embolism, the retrievable device is supposed to be removed.

But for many, the dangerous complications of C.R. Bard’s IVC filters may vastly outweigh the proposed health benefits. Thirty-nine men and women have died due to alleged complications with their Bard-manufactured IVC filters, and the over 900 men and women have reported serious complications to the U.S. Food and Drug Administration (FDA).

Investigation Reveals C.R. Bard’s IVC Filters Got FDA Approval Via Forged Signatures

A recent 3-part NBC News investigation turned up information against the defective IVC filter’s manufacturers, C.R. Bard, a medical device company based out of Murray Hill, New Jersey, and valued at an estimated $14 Billion. Bard first received FDA approval for their “Recovery” IVC filter in 2002, after their applications for FDA approval were twice rejected by the regulatory agency. After the second failed attempt, Bard hired an independent regulatory specialist, Kay Fuller.

Almost immediately, Fuller learned that Bard’s IVC filters were potentially too dangerous to be brought to market. She voiced her concerns to Bard and requested more data on the devices, but Bard denied Fuller access to the data. After some time, Fuller was told she would be fired if she carried on with her investigation into the filter’s safeness.

Fuller told NBC News that she “was shocked” by Bard’s implied threat and, when she refused to sign Bard’s FDA approval application, C.R. Bard allegedly forged her signature. “That is not my signature,” Fuller told NBC News quite plainly. “I will tell you that I did not sign it.”

A History of Health Problems Associated with Bard’s IVC Filters

In the U.S. alone, C.R Bard’s “Recovery” IVC filter has been associated with 27 deaths. The worst part of this is that internal, confidential reports commissioned by Bard executives found that the “Recovery” was over 4 times as likely to create a fatal health problem than all other ICVs combined, and over 13 times more likely than all other retrievable IVC devices to fracture into pieces once inside of the body. In addition to these potential risks, the Bard-manufactured filters also bear risks for:

  • Involuntary device migration
  • Inadvertent “tilting” of the device within the inferior vena cava
  • Broken device fragments being sent toward the heart or lungs
  • Piercing of one’s inferior vena cava
  • Inadvertent embedding of the device inside of a person’s vein – making surgical removal impossible

Still, even with all of the alarming data, Bard opted not to issue a recall and continued to sell the device for 10 more years, during which 27 people died and several hundred others experienced devastating medical injuries and complications.

In 2005, Bard replaced the “Recovery” with their slightly modified G2 series filters. The supposedly new and improved filter also generated hundreds of complaints, mostly regarding device fracturing and tilting while inside of the inferior vena cava. The G2 series device is thought to be associated with an additional 12 deaths.

In response to the public swell of anger and skepticism, Bard has issued a statement claiming that their IVC filters “have protected the lives of thousands of patients who otherwise would have had limited treatment options or may have suffered severe complications or death.” The statement goes on to say: “All of Bard’s vena cava filter devices have been appropriately cleared by the FDA based on required and accurate information.”

IVC Filters Could Be Potentially Deadly

If you or someone you know has had an IVC filter inserted into your inferior vena cava, it’s essential that you speak with a doctor immediately about the dangers and potential complications.

When it comes to IVC filters, one cannot safely assume that the device manufacturer will issue a recall or warn you if a filter is potentially defective. If you suspect that an IVC filter has already caused health problems for you or a loved one, you should contact Sokolove Law for a free consultation.

Author:Sokolove Law Team
Sokolove Law Team

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Last modified: December 28, 2016