IVC Filters – A Litigation Guide

A significant number of recent product-liability suits involve the implantation of dangerous medical devices that result in a patient’s injury, for which they are entitled to seek relief. The medical field is constantly evolving as it continues to utilize new technologies and introduce new techniques to administer treatments. One such procedure that has often resulted in litigation is the implantation of IVC (inferior vena cava) filters in patients at risk for pulmonary embolisms. We researched the various complications resulting from use of these devices that could result in a products-liability suit to provide an overview of the types of experts used in such instances. Use this litigation guide to get an idea of what experts you may need in an IVC filter case.

Background

IVC filters are small medical devices inserted into the main blood vessel in the abdomen, through minimally invasive surgery, that returns blood from the lower half of the body to the heart. The spider-like device is designed to catch the blood clots that develop deep in the lower veins thereby preventing them from reaching the lungs, resulting in a condition known as a “pulmonary embolism” (PE). It is estimated that over 50,000 people die year each from PEs, which occur when a blood clot dislodges from a deep vein in the lower extremities, travels through the body, and causes a blockage on its way to the lung. The most common disease associated with PEs is a condition called “deep vein thrombosis” or DVT. Anti-coagulants, or blood thinners, are the preferred treatment for this disorder, but for many people these types of medications cannot be used due to an adverse medical history. Of the patients who do receive IVC filters, most are given retrievable IVC filters intended for short term implantation. These filters are designed to be removed once a PE is no longer a threat.

Over the years, thousands of patients in the United States have increasingly been implanted with this device, and fatal complications have made IVC’s the star of much litigation. Studies have shown that the filters are prone to fracture, and can migrate through the body and cause bleeding, severe pain, and even death. Nationwide, patients are bringing personal injury and product liability suits against manufacturers of models like the Cook IVC filter, the Bard Recovery IVC filter, and the Bard G2 IVC filter. Twenty-two cases involving the Bard IVC Filter are being heard in Federal Court, and there are at least 16 additional cases pending in United States District Courts.

Complications

One of the largest issues at the center of litigation involving IVC filters concerns the different complications associated with the product that can result in severe injury to the patient, especially due to the product’s design. An IVC filter is extremely small, measuring about 25-mm in length. Given its tiny size and placement in the body, the device can pose a large threat to a patient. The minuscule size and fragile construction of the device make migration of broken components through the body fairly common. For example, one of the prongs of the filter can shift out of place and puncture the wall of the vein, causing internal bleeding, pain, and a slew of other issues.

Indications

What can sometimes be a litigious issue involving IVC filters concerns what medical professionals call the “indication”- in other words, the specific medical condition or circumstances that led to the determination that an IVC filter was needed. When a treating physician makes a medical prognosis determining that an IVC filter was necessary, that physician makes a judgment call, based on certain factors or “indications.” Based on these indications, one of which includes the “contraindication” against anti-coagulants, doctors make an affirmative recommendation for the use of an IVC filter. In the litigation context, improper assessment of an indication or lack of care in thoroughly screening the patient for any pre-existing conditions could be the reason for an “indication” IVC filter suit.

 

Author: Mehjabeen Rahman