A man who suffers complications from a C.R. Bard IVC filter has filed a vein filter lawsuit.

In November 2012, Plaintiff Ivan R. underwent a surgery for the placement of the C.R. Bard inferior vena cava (IVC) filter, specifically, the Meridian model.

When the Meridian filter was removed in August 2013, the filter perforated his right subclavian vein, causing Ivan to develop a large hemothorax.

Blunt or penetrating trauma to the blood vessels can produce a hemothorax, which is a buildup of blood in the pleural chest cavity. It can cause pain and inhibit breathing.

Ivan was in the hospital for a week due to the development of his hemothorax.

The Purpose of IVC Filters

An IVC filter is a medical device designed to stop blood clots from going from the lower extremities to the heart and lungs. They are designed for use among the population who cannot take anticoagulant medications for some reason.

The IVC is the vein in the body that send blood back to the heart from lower portions of the body.

Blood clots can travel from the blood vessels in the legs and pelvis through the vena cava and into the lungs. When these blood clots start in the deep leg veins, the condition is called deep vein thrombosis or DVT.

When blood clots reach the lungs, they are called pulmonary emboli or PE, which can result in death.

Vein Filter Lawsuit Stems from C.R. Bard Issues

According to the lawsuit, C.R. Bard’s IVC filters have been plagued with issues since the beginning.

In a study done in October 2015, the Annals of Surgery journal concluded that IVC filters were not effective in preventing pulmonary emboli, and actually caused pulmonary emboli to occur.

Researchers looked at the results of more than 30,000 trauma patients who had not received IVC filters with those who had received them and found the following results as quoted in the vein filter lawsuit:

• Almost twice the percentage of patients with IVC filters died compared to those who didn’t receive them
• Over five times the relative number of patients with IVC filters developed deep vein thrombosis
• More than four times the relative percentage of patients with filters developed thrombo emboli

Additionally, more than twice the percentage of patients developed a pulmonary embolus – the very condition Bard told the FDA, physicians, and the public that its IVC filters were designed to prevent.

C.R. Bard designed all of its retrievable IVC filters after a permanent IVC filter that had been on the market since 1992. The newly designed retrievable filters bypassed FDA approval because Bard claimed it was substantially similar to the permanent filter on which it was based.

The vein filter lawsuit contends, “Once placed on the market, Bard immediately became aware of numerous confirmed events where its Recovery filter fractured, migrated, or perforated the vena cava, caused thrombus and clotting, and caused serious injury, including death.”

Instead of pulling its IVC filters off the market, Bard continued to focus on marketing to protect its brand and image, the lawsuit contends. Bard also developed subsequent failed IVC filters, including the Meridian, which were all based on the poorly functioning Recovery filter.

The Vein Filter Lawsuit is Case No. 2:16-cv-00509 in the United States District Court for the District of Maine.