On May 5, 2017, plaintiff Ricky P. filed a short form complaint against Cook Medical in U.S. District Court in the Southern District of Indiana, Indianapolis Division. Ricky and other former recipients of IVC filters are raising allegations over inferior vena cava filter dangers.

Some are coming forward to speak of their experience, and others are joining the many multidistrict litigation (MDL) class action lawsuits forming against manufacturers of these devices – manufacturers that allegedly knew of defects in design of their products but pushed them through the Food and Drug Administration’s (FDA) fast track approval program known as section 510(k).

The FDA’s section 510(k) allows medical or pharmaceutical manufacturers to fast track devices or drugs if they can prove that they are roughly equivalent to something already on the market.

They do not have to present the rigorous testing results they would have to present if there were not an ‘equivalent’ product. According to MDL 2570 against Cook Medical and its affiliates, this loophole allows for companies to release products with known defects on the market.

Cook Medical Inferior Vena Cava Filter Dangers 

In Ricky P’s suit against Cook Medical, he specifically is registering an inferior vena cava filter dangers complaint against the Gunther Tulip Inferior vena cava filter. This filter is flower-shaped because of a top hook and four anchoring struts that keep it in place.

The Gunther Tulip inferior vena cava filter dangers that have been documented include numerous failed attempts at retrieval and inferior vena cava perforation.

Inferior vena cava filters are designed to be able to be removed by a surgeon. Perforation of the inferior vena cava wall is an extremely dangerous situation that could lead to internal bleeding, infection and even death.

In addition to several other counts of inferior vena cava filter dangers, the plaintiff is accusing the manufacturer of design defect, failure to warn, breach of express and implied warranty.

What is the Inferior Vena Cava?

The inferior vena cava is the largest vein of the body. It is the avenue by which the body returns blood depleted of its oxygen to the heart and lungs from the lower part of the body.

The aorta, or major artery coming out of the heart and lung region, is more commonly heard of by laypeople and carries fully oxygenated blood to anatomically feed the muscles and organs.

An inferior vena cava filter is a medical device designed to be anchored in place in the inferior vena cava to filter out potential blood clots before they are returned to the heart and lungs.

Some patients are more prone to developing these than others, depending upon genetics and prior medical history.  There are also certain surgeries which make one more prone to their development in the post-operative phase of recovery.

Blood Clots and Human Health

Traveling blood clots are extremely threatening to the human health.  Once they form and move in the body, they can obstruct blood flow in such a manner as to cause heart attack, respiratory arrest or, if they get that far, a stroke.

The treatment of choice for a patient at great risk of developing blood clots has been with blood-thinning medication, but they don’t always work. This is where inferior vena cava filters have, for better or worse, come into play.