This mass tort alleges that some IVC blood clot filters are migrating or fracturing within the body, causing damage or even death. (NBC News carried on a yearlong investigation of this problem.)
A blood clot that develops inside the arms, legs, or pelvis is known as a DVT or deep vein thrombosis. It is usually not life-threatening, unless it travels to the heart or to the lungs, where it is known as a PE or pulmonary embolism. Pulmonary embolisms can cut off the flow of blood to the lungs, and they are the third most common cause of death in hospitals. While blood clots are most easily treated with blood thinners, some patients are unable to take them because of other conditions. In those cases, an IVC blood clot filter may be used.
IVC blood clot filters are small devices made of wire- or rod-like metal in the shape of cages or cones that are implanted in the interior vena cava, the large blood vessel running from the lower half of the body to the heart and then to the lungs. The filter is intended to catch clots as they travel through the blood and prevent them from reaching the heart or the lungs. Blood clots caught in the filters are eventually dissolved by the anticoagulants in the blood.
Some filters are permanently implanted, but others are put in temporarily, for use when a patient runs a particularly high risk of blood clots, such as after an accident. These retrievable filters are the subject of this mass tort lawsuit, since they are alleged to have caused problems in patients.
The FDA has received more than 900 complaints about IVC blood clot filters since 2005. The most common problem is migration, where the filter travels within the body instead of staying where it was placed. Other problems include fracture (where the filter breaks), puncture (where the filter or a part of it punctures the blood vessel, nearby blood vessels, or even the lungs or the heart), and detached device components (where broken pieces of the device may travel in the body or create embolisms).
The FDA believes that these problems might be related to the IVC blood clot filters remaining in the body for longer than they need to. It suggests that retrievable filters be removed from patients as soon as risks of clot have subsided.
However, in one study, researchers discovered that only 58 out of 679 retrievable IVC filters were removed after use. Unfortunately, even when attempt were made to remove the device, sometimes they failed; and in some cases, broken parts had moved farther into the body and could not be retrieved.
The filters under investigation in this mass tort include the Recovery, G2, G2 X, Eclipse, Meridian, and Denali (all by Bard) and the Gunther Tulip and Celect (both by Cook).
Who is affected? Patients who have had problems such as migration and puncturing with one of the models of retrievable IVC blood clot filters above.
What is the status of the mass tort? The lawsuits are now in the investigation stage and will be handled as a mass tort. In a mass tort, multiple cases are combined into a single “group” lawsuit. Unlike class action suits, they are not tried together in a single trial represented by a single plaintiff or group of plaintiffs; each is tried individually, but will still benefit from lower expenses and reduced legal procedures.