IVC Filters and the FDA

Many patients who have IVC filters placed have ended up having some type of adverse event or injury. The most common type of incidents involves an IVC filter which punctures a vein, fractures, and then migrates to other organs. The end result is often serious injury and death.

There have been hundreds of injury lawsuits filed against different manufacturers of IVC filters, asserting that they knew of the serious risks their products posed to patients but failed to warn—or concealed these risks from—doctors and patients. These companies claimed their products were not only effective for treatment, but also safe for the patient.

Experienced attorneys involved in these lawsuits often argue that manufacturers concealed the design flaws the IVC filters have, such as their tendency to tilt out of position in a manner that causes it to puncture through the vein, fracture, and migrate to other parts of the body. Attorneys also argue that manufacturers knew that these design defects could result in serious damage to a patient’s heart or lungs, as well as severe internal bleeding injuries. The three companies named in these lawsuits are C.R. Bard, Cook Medical, and Boston Scientific.

FDA Complaints

In the past dozen years, the Food and Drug Administration (FDA) has heard from hundreds of victims and doctors about injuries caused by IVC filters. However, recently uncovered evidence gives reason to believe the manufacturers knew what type of serious complications the IVC filters could pose even before the products were ever put on the market.

The FDA began receiving complaints of adverse events with the IVC filters in 2005. Between 2005 and 2010, more than 900 adverse events were reported. They concluded that the adverse events were likely attributed to a retrievable, or temporary, filter being left inside a patient after their risk for pulmonary embolism had passed. The agency issued a recommendation that retrievable devices should not be left inside a patient longer than 54 days, as long as the risk of pulmonary embolism had subsided.

Injuries Suffered

It has since been found that these devices eventually wear down, a process which can ultimately result in a filter fracture occurring. This is why it is critical that IVC filters be removed when the blood clot danger has passed.

While retrievable IVC filters can be removed, permanent ones cannot. Even worse, permanent IVC filters also have migration issues—twice as often as retrievable ones, in fact. Unfortunately, the injuries that a patient can suffer when a filter migrates through the body often required emergency intervention, such as open-heart surgery, but often have tragic results.

Charles E. Boyk Law Offices, LLC