Design Defects with IVC Filters

An IVC filter is a cage-like or basket-like device that is inserted surgically into the inferior vena cava, the IVC, for the purpose of catching embolisms or blood clots, trapping them, and preventing them from traveling to the heart or lungs while allowing blood flow through the filter.

A design defect is just what it sounds like. It is a problem that was inherent in the very design of a product that inevitably or at least foreseeably would lead to failure and injury that might justify bringing a lawsuit. In the classic case, people may think of Ford Pintos with the exploding gas tank. That was a defect in the design of the car. Under normal use of the product, for example if you get into a rear-end accident, which is foreseeable—when you are a car manufacturer, you know your cars will be involved in a rear-end accidents—you do not expect the car to explode. That was a design defect in those vehicles that brought about a great deal of harm and suffering.

Alleged Design Defects 

There are a host of alleged design defects with IVC filters and there is discovery ongoing. The litigation documents are confidential, but the simple version of it is, the filters are not acting in the way that a filter is expected to act. In other words, when you have one of these filters implanted in your body—to help save your life by ostensibly preventing pulmonary embolisms—you do not believe and should not be expected to believe that the trade-off is that you may have a piece of a filter embolized through your heart or your lungs.

It can be contended that should someone experience said injuries from an IVC filter, they are a result of design defects. There are a host of contingents in that regard, from the overall design, to the materials that were used, to the engineering of the product, all of which were foreseeable.

Failure to Test

There was also failure to test. These retrievable filters were under a 510(k) process with the FDA, which essentially allows manufacturer to get a product approved without substantial testing, because it is similar to other already approved products. As a result of that, these filters did not receive the same pre-market scrutiny that they would have received had they gone through the full process.

510(k) devices are much more likely to have defects or have design defects slip through the cracks because they are not subject to the same scrutiny as they would be if they had gone through the normal process.

Manufacturer Knowledge of IVC Filter Design Defects

The manufacturers of products have a duty to know of design defects. They cannot claim ignorance as a defense. If they should have known it was defective, or had the defect been discoverable or predictable, if they had done what they were supposed to do on the front end and taken all necessary care in designing and testing the filters, then they can still be held liable whether they knew about the defect or not.

Going all the way back to 2001, certainly by 2004, Cook’s Gunther Tulip had only been on the market for a year. Bard’s recovery filter went on the market that year. There were already scientific studies showing problems that should have alerted them that these IVC filters had issues, whether those be manufacturing defects, design defects, or some other problem with the filter.