Defective Inferior Vena Cava (IVC) filters were in the national news recently after the airing of a 2-part NBC special. The series highlighted a yearlong investigation into the potential dangers of the Recovery blood clot filter developed by medical-technology manufacturing company C.R. Bard. The device has been associated with 27 deaths and hundreds of other serious medical problems. Sadly, the Recovery is not the only IVC filter that has been associated with adverse health effects, and the U.S. Food and Drug Administration (FDA) has issued warnings about the devices in the past.
What Are IVC Filters? And Why Can They Be So Dangerous?
IVC filters are devices implanted in the inferior vena cava, which is the main vessel that returns blood from the lower half of the body to the heart. These devices may be considered necessary when patients at risk for pulmonary embolism (blood clot in the lungs) are unable to undergo anticoagulant therapy. The IVC filters look like small, spider-shaped cages and many are designed to be permanent implants.
The NBC special may have re-invigorated public interest in IVC filters, but these dangerous medical devices are not new to the FDA or the U.S. Courts. The FDA has received over 1,600 adverse event reports associated with IVC filters and litigation involving these devices has been going on for years. IVC filter complications may include:
- Device migration (involuntary movement or shifting of the device internally)
- Filter fracture
- Tilting within the inferior vena cava
- Fracture fragments to the heart or lungs
- Perforation of the inferior vena cava
- Embedding in the vein, making the device difficult or impossible to remove
These defects can result in internal bleeding, severe pain, infection, serious injury, or even death.
NBC IVC Filter Special Raises Questions About Deception
The NBC News investigation into the Recovery filter made by C.R. Bard uncovered and shared 2 main points: 1) That IVC filters can be deadly, and 2) That C. R. Bard may have tried everything — including allegedly forging signatures — to get FDA clearance and put their products on the market.
Part 1 touched on the hundreds of medical problems and 27 deaths caused by this brand of filter — including that of a 55-year-old mother who died after a clot pushed the Recovery filter into her heart and punctured it.
C.R. Bard hired an outside doctor to conduct a confidential study, which NBC News was able to obtain. In this confidential study, the doctor urgently encouraged further investigation and “found the Recovery filter had higher rates of relative risk for death, filter fracture, and movement than all its competitors,” said NBC.
C.R. Bard seemingly chose to ignore this information and continued to sell about 34,000 more Recovery filters over 3 years, until they were replaced with a modified version – which may cause similar problems according to lawsuits pending in federal court. The Recovery was sold until 2005, and as of 2006, Bard’s confidential records estimated that more than 20,000 people still have the Recovery device implanted.
Serious Accusations of Forgery Emerge
In Part 2 of the special, NBC spoke with Kay Fuller, a veteran regulatory specialist who was hired by C.R. Bard to help them secure FDA clearance for the Recovery filter. Fuller told NBC that she had serious concerns about the IVC filter and shared them with the company, but they responded by telling her that if she kept asking questions, she would be asked to leave the team.
Fuller told her boss that she was not comfortable signing the FDA application until certain issues were resolved. After that, it appears that her name was signed on the application without her knowledge. Fuller resigned from Bard and reported her safety concerns to the FDA.
Injured by an IVC Filter? Contact Sokolove Law Today
If you or a loved one have an IVC filter implanted, be sure to speak with your doctor about any concerns you may have and whether or not it would be best to remove the device. Alternatively, if you had an IVC filter implanted and developed health problems, or if a loved one died due to complications from this device, you may have a case and could be entitled to compensation. Contact Sokolove Law today for a free consultation.