A 28-year-old woman went to the emergency room reporting a pain in her lower back on the right side. After an examination, a CT scan was performed which found a fractured IVC Filter which had been implanted 10 years earlier. The remnants of the device had moved and lodged near her heart and her right ureter. The filter was removed, but it was decided the fragments would be left in place due to the risks of removal.
This patient is not alone. Many who have had this medical device implanted have had similar experiences. It appears that some of the devices implanted over the years were defective. Many of these patients have sued, with more than 12,000 lawsuits filed at the federal level against two manufacturers of this device.
What Are IVC Filters?
Inferior vena cava or IVC Filters are small cage-like devices designed to be placed inside the main vein (the inferior vena cava) returning deoxygenated blood from the lower body to the heart. These devices are used to prevent pulmonary embolism (PE) or blood clots from moving through the heart and lodging in the lungs, which can be life threatening. IVC Filters are intended for those who have difficulty using anticoagulants.
IVC Filters are about one inch long and have small metal legs or struts that spread out to the vein walls when placed to prevent movement of clots beyond the filter while still allowing acceptable blood flow.
There are about 11 companies which manufacture IVC Filters in the U.S., but two have shown a high failure rate. They are C. R. Bard, who manufactures the Recovery and G2 and Denali IVC Filters; and Cook Medical who makes the Celect and the Gunther Tulip IVC Filters.
Potential Complications of IVC Filters
When an IVC filter fractures, the pieces of the filter can move through the body due to blood pressure and lodge in other areas. This includes the heart and lungs, and the fragments can cause other problems. These include:
- Perforation of veins
- Perforation of the heart or lungs
- Hemorrhaging of the heart
- Excess fluid in the heart (causing disruption of heart function)
- Internal bleeding
Regulatory History of IVC Filters
In August 2010, the U.S. Food and Drug Administration (FDA) issued a warning to medical providers of problems with certain types of IVC Filters and recommended removing the devices after the risks of PE had passed.
After receiving hundreds of adverse event reports about IVC Filters in May 2014, the FDA advised doctors that the longer the IVC Filter remained in place, the risk of fracture increases. They advised removal of the devices as soon as possible after implantation.
Many studies have found the IVC Filters manufactured by these two companies had more complications than other products on the market. In August 2015, the Journal of the American Medical Association (JAMA) warned that the risks of using IVC Filters may outweigh any health benefit provided by the device.
Legal Status of IVC Cases
As the volume of cases for these devices mounted at the federal court level, cases were consolidated into Multi-District Litigations (MDL) against the two manufacturers. Currently there are about 6,700 cases against C. R. Bard and about 5,400 cases against Cook Medical. Cases are ongoing.
Nevada IVC Lawsuits
The Richard Harris Personal Injury Law Firm is reviewing defective product cases due to the use of IVC Filters. If you or a loved one was injured or died due to the use of a C. R. Bard or Cook Medical IVC Filter, contact our office today to review your case at (702) 444-4444.