Bard G2 Filter Lawsuit Filed Over Perforated Vena Cava

A Texas woman has filed a product liability lawsuit against C.R. Bard over its G2 IVC Filter, alleging that the small, spider-like device, which is designed to prevent blood clots from travelling to the lungs and causing a pulmonary embolism, punctured her vena cava and caused other internal injuries. 

The complaint (PDF) was filed by Judy Kay Alexander of Richardson, Texas, on December 19 in the U.S. District Court for the Northern District of Texas.

According to allegations raised in the Bard IVC filter lawsuit, Alexander was implanted with a G2 filter on February 20, 2009. The device subsequently failed and punctured her inferior vana cava, which is the large vein that carries de-oxygenated blood from the lower half of the body into the right atrium of the heart. She also suffered damage to her right ureter, a tube that carries urine from the kidneys to the bladder.

The Bard G2 Filter is an inferior vena cava (IVC) filter used for individuals who may be at risk for a pulmonary embolism, but for whom an anticoagulant has been ineffective or is contraindicated.

The devices contain a number of legs or struts that extend out to catch blood clots that may break free elsewhere in the body, such as the deep veins of the legs.

Unlike traditional IVC filters, the Bard G2 filter was designed so that it can be removed once the threat of a pulmonary embolism has passed. However, in many cases physicians have allowed the devices to remain in place, which may increase the risk of complications with the IVC filter, where the struts may fracture, perforate the vena cava or allow the device to migrate to other areas of the body, such as the heart or lungs.

In recent years, a number of individuals have filed similar lawsuits over the Bard G2 filter, as well as the Bard Recovery filter, which is an earlier version. The complaints allege that Bard failed to adequately warn about the risk of problems with IVC filters, including the risks associated with leaving the Recovery or G2 filters in place once the threat of a pulmonary embolism has passed.

Problems with Bard G2 and Bard Recovery IVC Filters

The Bard Recovery IVC filter and Bard G2 IVC filter have been associated with a high rate of failures and other problems, which could cause serious and potentially life-threatening injuries.  Pieces of the IVC filters appear to be prone to break or fracture, allowing pieces to flow through the bloodstream travel to the heart, lungs or cause other internal punctures.

According to a study published in the Archives of Internal Medicine in August 2010, the Bard Recovery Filter system failure rate was 25% and the Bard G2 Filter system failure rate was about 12%.  Researchers recommended an immediate halt to the use of the Bard IVC filters to protect patients.

The FDA issued an alert in August 2010, warning about the risk of complications with removable IVC filters that are left in place once the danger of the clot has passed. According the agency, at least 921 adverse event reports were received during 2010, with about 328 involving an IVC filter that broke free and migrated through the body, 146 involving components that broke loose, 70 involving the inferior vena cava being perforated and 56 involving the filter fracturing.

Alexander’s lawsuit charges C.R. Bard with negligence, failure to warn, defective design and manufacturing, breach of warranty, and negligent misrepresentation. The lawsuit claims Alexander suffered significant medical expenses, pain, suffering, loss of enjoyment of life, and disability.