A woman has filed a vena cava filter injury lawsuit after she suffered serious injury.

Plaintiff Pamela B. received a Cook Medical Gunther Tulip Vena Cava Filter implanted on March 7, 2006.

Vena cava filters are tiny metal, cage-like medical devices designed to fit in the vena cava vein with the intent of blocking blood clots before they travel to the heart or lungs. The vena cava artery is the largest vein in the body and returns blood to the heart.

Patients unable to tolerate oral blood thinners are often candidates for vena cava filters. Unfortunately, an increasing number of these devices have failed, leading in some cases to serious injury.

Vena Cava Filter Injury Lawsuit Alleges Device is Dangerous

Pamela’s vena cava filter injury lawsuit alleges that she was injured by the device, which has been prone to breakage.

According to Pamela, Cook Medical either knew or should have known that the Gunther Tulip Vena Cava Filter’s design lends itself to serious and possibly life-threatening situations. The company continued to market the medical device as a safe and effective alternative to anticoagulant (blood thinner) medication.

The FDA reports hundreds of adverse event reports have been logged regarding the failures of IVC filters over the last decade.

IVC filter complications include migration to other parts of the body, where they can lodge in organs. Sometimes one or more of the tiny “legs” on the device can break free, puncturing the blood vessel wall or traveling to parts of the body, wreaking havoc in other veins or organs.

In at least one documented case, an IVC filter had trapped a large blood clot, but the blood clot pushed the IVC filter up through the vein and punctured a woman’s heart, killing her.

FDA Alerts Regarding IVC Filters

The FDA approved inferior vena cava filters in 1979. By 2012, nearly 259,000 patients had received the implants.

Between 2005 and 2010, the FDA counted 921 adverse event reports relating to retrievable IVC filters. IVC filters allegedly migrated to other parts of the body or perforated the vein wall.

In some cases, the filter itself fractured and detached parts traveled within the body. In fact, 35 percent of the adverse event reports related to device migration.

Because retrievable IVC filters are meant to be in place for only a short period of time, the FDA believed at least some of the adverse events occurred because the devices were left in even after the risk of blood clots had subsided.

In 2014, the FDA declared that when possible, retrievable IVC filters should be removed 29 to 54 days after implantation.

According to Cook Medical’s website regarding the Gunther Tulip Vena Cava Filter, doctors and patients can “[l]eave it or retrieve it, but use the filter you can trust.”

The website also advertises that the filter now “includes tactile bump indicating filter is fully advanced.”

This indicates recognition that earlier devices possibly did not deploy properly, due to either incorrect placement or unfulfilled deployment.

Pamela’s vena cava filter injury lawsuit is just one of thousands of claims that allege serious injury or even death from these medical devices.

If you or someone you know has received an IVC filter and suffered adverse effects, you could qualify to file an IVC filter lawsuit to compensate for expenses incurred by the resulting medical bills and lost wages.

The Vena Cava Filter Injury Lawsuit is Case No. 1:17-cv-00699-RLY-TAB, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.