A Pennsylvania woman is suing C.R. Bard, the maker of her retrievable inferior vena cava (IVC) filter, for injuries she alleges she sustained when the device failed.
Violet C. received a G2 IVC filter at a hospital in Pennsylvania in 2009. The filter was placed to prevent pulmonary embolism from blood clots she had developed. It later fractured, with fragments migrating to the pulmonary arteries, the right ventricle, pericardium, iliac vein, and kidney. Four of the fractured filter limbs were located not far from the filter, but three of the limbs were never found.
Only a year after Violet received her IVC filter, the FDA released reports of nearly 1,000 adverse incidents since 2005 that resulted from the device tilting, fracturing, migrating, or perforating. The FDA at the time strongly suggested that doctors remove retrievable IVC filters as soon as the risk of blood clots had passed. The administration now suggests the removal occur within 29-54 days.
That same year, Bard pulled the G2 filter off the market without a recall. Throughout its availability on the market from 2005 to 2010, an estimated 160,000 G2 filters had been sold.
In 2014, a study was conducted of 892 patients who had received the G2 filter. The results concluded that an estimated 38 percent would fracture within five years, strikingly similar to Bard’s Recovery filter, which has a 40 percent failure rate in 5.5 years.
The lawsuit accuses Bard of negligence, selling a knowingly defective device it claimed to be safe, as well as downplaying the dangerous risks.
According to NBC News, in December 2015 the G2 filter alone has been linked to at least 12 deaths and hundreds of other non-fatal injuries.