Many personal injury lawsuits have been filed by patients across the nation who state that they have been harmed or are still being harmed by their IVC filter devices. The U.S. Food and Drug Administration (FDA) has reported that between the years of 2005 and 2010, they had received a total of 921 adverse event reports discussing complications suffered by patients with IVC filters.
The adverse event reports complied by the FDA show that 328 of the incidents involved “device migration,” where an IVC filter detaches from its implantation spot and moves through the body. Another 146 reports involved “embolizations,” which occur when an IVC filter or pieces of it migrate to vessels which provide the lungs and heart with blood. Lastly, 70 of the reports involved perforation of a blood vessel or organ and 56 reports involved the breaking apart of the IVC filters within the body.
IVC filters are generally used for patients who are at risk of developing blood clots, but are unable to take blood-thinning drugs. The devices are designed to trap blood clots in the blood stream and hold them until they dissipate. The devices are intended to be used temporarily and be removed when the risk subsides.
The filters have become the topic of several FDA safety communications. On August 9th of 2010, the FDA released an initial communication titled “Removing Retrievable Inferior Vena Cava Filters” that directed surgeons to remove the filters as soon as a patients’ pulmonary embolism risks have subsided. An investigation by the agency had found that in many cases, the filters were not being removed when medically appropriate. On May 6th of 2015, the FDA issued an updated safety communication regarding the filters saying that they should be removed from patients within 29-54 days following implantation, unless the patient is still at risk of pulmonary embolism.
In one of the latest lawsuits filed regarding the IVF filters, a South Dakota woman filed a lawsuit regarding a Bard IVC filter in the U.S. District Court for the Southern District of South Dakota. The plaintiff alleges that she suffered severe injuries after being implanted with a Bard Eclipse IVC filter on October 12, 2012 at the Sanford University of South Dakota Medical Center. She is seeking more than $75,000 in compensation for damages.
In that case, around one and a half years after her implantation, doctors at the same medical center discovered that the filter had traveled from its insertion location. The device had lodged in her internal organs and was unable to be retrieved due to the riskiness of its new location. The device reportedly remains inside of the patient to this day, where it could cause additional and possibly life-threatening harm. This lawsuit is expected to be transferred to the District of Arizona shortly, where all federally-filed Bard IVC filter lawsuits have now been consolidated.