IVC Filter Lawsuit

An inferior vena cava (IVC) filter is a medical device used to prevent blood clots that formed from the lower extremities from traveling to more vital organs, specifically the heart and lungs. Since the inferior vena cava has the responsibility of delivering deoxygenated blood from the lower half of the body to the right atrium of the heart, and ultimately to the lungs for oxygenation, blood clots that enter this system pose dangerous health issues including pulmonary embolism (blockage of the pulmonary arteries) and stroke (blockage of blood supply to the brain).

However, tens of thousands of lives are now at risk because of the long-term complications associated with these medical devices.

There are two types of IVC filters: permanent and retrievable. Retrievable filters are intended for short-term use. Permanent IVC filters are designed only for long-term use. Retrievable filters are removed similar to how they were inserted—through catheter insertion. During retrieval, the filter is grabbed via a hook at the end of the device, the filters are covered with a small sheath, and are then pulled out from the incision point.

In 2010, the FDA released a safety advisory to notify medical professionals and patients of the potential risks associated with IVC filters. Between 2005 and 2010, the FDA received 921 adverse event reports involving IVC filters. These reports included 328 counts of device migration, 146 incidents of device component detachment, 70 reports of vein perforation, and 56 involved fracture of the filters.

A study in 2013 from Boston University found out that from a total of 679 retrievable filters placed, only 8.5% were successfully removed. 18.3% of the patients had an unsuccessful retrieval attempt.  During the study, there were also incidents of thrombus formation and pulmonary embolism, all while the IVC filters were in place.

In 2014, the FDA issued a safety update recommending that retrievable IVC filters should be removed 29 to 54 days after implantation (once there’s a lower risk of pulmonary embolism). Physicians and clinicians involved in the ongoing treatment of these patients are also encouraged to issue a referral for removal of the device once the risk/benefit profile of the patient leans towards removal.

In 2015, the FDA decided to issue a warning letter to C.R. Bard addressing several violations found during their inspection of the company’s IVC filter manufacturing facilities in Queensbury, New York, and Tempe, Arizona.

The findings revealed that Bard had been producing and marketing their removal systems without clearance or approval from the FDA. The warning letter also indicated that the company failed to inform the FDA of device malfunctions. In addition, the letter stated that Bard had misfiled or mishandled several customer complaints, including a report of patient death.

Multiple manufacturers are currently facing lawsuits from people who have been implanted with the following specific types of IVC filters: