An Ohio man has joined thousands of others with a lawsuit against C.R. Bard over its allegedly defective retrievable IVC filter. Marton F. was implanted with the G2 inferior vena cava (IVC) filter on Feb. 7, 2011. Doctors thought the device would be effective in preventing pulmonary embolism, but a lawsuit filed by the patient alleges the device failed, injuring Marton.
IVC filters are shaped like an inverted umbrella, made of simple tines that are designed to catch blood clots before they enter the heart or lungs. The makers of IVC filters, however, have been faced with thousands of lawsuits due to the device migrating, tilting, breaking apart and perforating the vein and/or organs.
Marton alleges that the failed device injured him in such a way that he is now facing a lifetime of health problems, according to The Daily Hornet.
The G2, like many retrievable filters of its kind, is made to be implanted temporarily. Retrievable IVC filters were approved by the FDA using the 510(k) process, which allows a company to fast-track a product onto the market without adequately testing the product for safety and efficacy as long as the device meets one criteria – that it is similar to a previously tested and sold product. Then it can be legally marketed and sold for use in humans.
The problem with the fast-track approval process is that the G2 is based on the Recovery filter, which has been linked to hundreds of non-fatal injuries and at least 27 deaths. The G2 has also been linked to at least 12 deaths and hundreds of injuries. The Recovery was withdrawn from the market the very same year the G2 was approved by the FDA.
More than 2,000 lawsuits across the U.S. are now pending against Bard alone for its allegedly defective IVC filters.