Earlier this year a Plaintiff from South Dakota filed a personal injury and defective product liability lawsuit against C.R. Bard. She has claimed in her lawsuit that she was the recipient of an Eclipse IVC filter manufactured by C.R. Bard. It was implanted into her body in order to protect her from blood clots which could migrate toward her heart and lungs. The woman was at risk of suffering pulmonary embolism or other major health problems.
According to the plaintiff she received a Bard Eclipse IVC filter in October 2012. She then discovered that the medical device had migrated out of position and became lodged in her organs. Plaintiff proclaim that her filter has broken into pieces and those pieces have migrated in her body. In January 2014 surgeons tried to remove them but they were unsuccessful and now she is living in fear that a sudden and potentially fatal event could happen at any moment due to the broken filter. She states that this filter places her at risk for increased health complications which could potentially be life-threatening.
The Bard Recovery Filter is a medical device created by C.R. Bard, Inc. and approved by FDA in 2002 to prevent blood clots from traveling through the body and causing a pulmonary embolism. The device is implanted in individuals at risk for a pulmonary embolism, who are unable to take an anticoagulant or if such medications have failed. The Bard Recovery is designed so that the IVC filter can be removed or retrieved from the body after the threat of a pulmonary embolism has passed.
The U.S. Food and Drug Administration issued a warning to the physician stating them that there was number of complications patients suffering from after implanting a IVC filter such as puncturing of the vena cava, device migration, filter perforation, filter fracture, and detached device components (called device embolization). The FDA implied that the IVC filters should be removed as soon as the patient was no longer in danger of having a pulmonary embolism. This FDA warning about Bard IVC Filters was issued in August 2010. Since that time, the FDA has received at least 900 complaints about potentially defective Bard IVC filters.
A number of medical studies have indicated that the Bard Recovery failure rate is between 21% and 31.7%:
- A study published in the Archives of Internal Medicine in 2010 found that the rate of complications with Bard Recovery IVC filters was 25%, with researchers finding that pieces of the Bard Recovery Filter migrated to the heart in more than 70% of those who experienced a fracture.
- Another study published in 2013 in Journal of the American Medical Association (JAMA) Internal Medicine noted that there were no standards in place concerning when to implant IVC filters, with hospitals varying widely on their recommendations.
- Last year a study was published in JAMA compared patients with pulmonary embolism who received a filter and blood-thinning therapy, and those who received blood-thinning therapy alone. Researchers followed all patients for at least six months. Results showed that among hospitalized patients with severe acute pulmonary embolism, the use of an IVC didn’t reduce the risk of recurrent PE at three months. In other words, the filter seemed unnecessary in patients who could use blood-thinning drugs.
According to the NBC News investigation in September of 2015, executives at C.R. Bard were very much aware of the dangers of their original Recovery IVC filter, but the company did not communicate the adverse effect of the device to the FDA or the public. However, the company eventually replaced the filter with an updated version called the G2. Despite hundreds of complaints to the FDA indicating that the G2 failed to correct the problems of the earlier model, Bard not only failed to correct the issues associated with the Recovery filter, but refused to recall the product as a result thousands of lawsuits filed in the court alleging the life threatening risk of the device.