What are IVC Filters and why are they used?
Inferior Vena Cava (IVC) Filters are small (approximately 1.5" - 2.0" long) metal devices implanted in the vena cava, which is the vein used to return blood to the heart from the lower body. The filters were first made available in the 1960’s. They are designed to trap large blood clot fragments and prevent them from traveling through the vena cava vein to the heart and lungs, where clots can cause severe complications such as pain, difficulty breathing, shortness of breath or even death.
The filters may be placed in patients who have a history of or are at risk of developing blood clots in the legs and who cannot be successfully treated by other methods, including blood thinning agents. Candidates for IVC Filters include patients with deep vein thrombosis (DVT), pulmonary embolus, or atrial fibrillation (a-fib), as well as trauma victims and those who are immobile or have recently had surgery or delivered a baby.
What types of injuries and side-effects have occurred with IVC Filters?
IVC Filter failures have included:
- device migration (movement from the site where it was originally implanted, such as to the heart or lungs),
- embolizations (detachment of device components),
- perforation of the inferior vena cava vein itself,
- blood clots can become trapped in the filter, making it more difficult for blood to reach the heart, and
- fracture of the device.
Patients with IVC Filter failures may require immediate surgery to remove the broken filter, and are at risk for grave injury or death.
Why are lawsuits being filed against device manufacturers?
Although failures have occurred in other manufacturers' devices, filter manufacturer C.R. Bard, Inc.’s devices have been particularly problematic in comparison to the other ten companies who sell the devices in the U.S. Bard's Recovery, G2, and, G2 Express filters are specifically at issue in many of the current legal cases.
In 2002, Bard brought in a veteran regulatory specialist to help secure a second attempt at FDA approval for their Recovery IVC Filter. The specialist had serious concerns about the device and refused to sign the application unless the issues founding her concerns were resolved. Bard is accused of forging her signature on the application ultimately was approved by the FDA. Although the specialist resigned and reported her concerns to the FDA, the Recovery IVC Filter went on to be associated with 27 deaths between 2002 and 2005.
C.R. Bard’s problems persisted with the G2 series of filters that replaced, but was nearly identical to, the Recovery IVC Filter. An internal company document that included data through 2010 showed their filters continued to have more fractures, migrations, and other reported problems than their competitors, but the company chose not to recall their devices.
Thousands of Bard IVC Filter lawsuits are currently pending in MDL 2641 in the U.S. District Court for the District of Arizona. Claims against Bard allege a total of seven different versions of their filters (the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali) are defective and, compared to other filters, have higher risks of tilting, perforating the IVC, or fracturing and migrating to vital organs. As in many defective product cases, a key issue is Bard’s failure to warn about the known dangers associated with its filters.
How is The Crouch Firm, PLLC involved in the litigation against IVC Filter manufacturers?
The Crouch Firm is currently seeking damages for individuals who have sustained injuries as a result of C.R. Bard IVC Filter failure.