IVC Blood Clot Filter Complication Result in Warning for Doctors in Canada

Canadian health officials are calling for more judicious use of inferior vena cava (IVC) filters, indicating that the controversial devices implanted for patients at risk of suffering a pulmonary embolism, should not be used among patients whose blood clot problems can be treated with anticoagulation drugs. 

Last month, Health Canada issued a warning, indicating that the agency has received at least 121 reports of serious complications with IVC blood clot filters. Amid these problems, and similar reports among users worldwide, the agency is now recommending that the devices only be used for certain types of blood clots, when blood thinners do not work.

Inferior vena cava blood clot filters are an alternative treatment for patients at risk for a pulmonary embolism, which contain a number of legs or struts that extend out to “catch” blood clots that may break free in the body and prevent them fro traveling the lungs.

The devices were originally designed for use when an anticoagulant is contraindicated or proven to be ineffective. However, they have become an increasingly popular treatment alternative in recent years.

In August 2010, the FDA first warned about the risk of problems with the devices, indicating that it had received more than 900 adverse event reports involving the filters at that time.

Researchers have identified particularly high failure rates with specific devices, often involving “retrievable” blood clot filters, which are designed to be removed once the risk of a pulmonary embolism has passed. However, the devices are often left in place for long periods of time, increasing the risk that they may puncture the vein, move out of position or fracture, potentially sending small pieces into the heart or lungs.

In May of 2014, the FDA issued an update indicating that IVC blood clot filters should be removed within about one to two months after the risk of a pulmonary embolism has passed.

The Health Canada warning appears to go further, indicating that after a review of clinical evidence it is calling for more restricted use of IVC filters. The agency says they should only be used in patients with acute proximal deep vein thrombosis (DVT) of the leg, and a contraindication to anticoagulation; and patients with acute pulmonary embolism and a contraindication to anticoagulation.

IVC Blood Clot Filter Lawsuits

In the United States, a growing number of IVC blood clot filter lawsuits have been filed in recent years, alleging that manufacturers sold an unreasonably dangerous and defective device, without adequately warning about the risk of problems.

There are currently more than 700 Bard IVC filter lawsuits pending throughout the federal court system, which are currently centralized before one judge for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation.

Another 650 Cook IVC filter lawsuits are centralized as part of a separate MDL, raising similar allegations of problems associated with filters manufactured by Cook Medical.

As IVC filter injury lawyers continue to review and file additional claims over the coming months and years, it is ultimately expected that several thousand cases will be brought on behalf of individuals nationwide.

In each MDL, a small group of “bellwether” cases are being prepared for early trial dates, which are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes of these early trials will not be binding on other plaintiffs, they may influence eventual IVC filter settlements the manufacturers may reach to avoid facing hundreds of individual trials nationwide.