An IVC filter (inferior vena cava filter) is a type of surgical filter and medical device that is implanted by vascular surgeons or interventional radiologists into the large veins that carry blood from the body to the right atrium of the heart. The purpose of the IVC filter is to prevent a deadly condition called a pulmonary embolism (PE), or when a blood clot forms in the body, passes into the lungs, and causes serious injury, coma, or death.
Because of the dangers associated with these types of embolisms, IVC filters quickly made their way to the top as surgical solutions to this problem. They work by catching the blood clots before they reach the lungs and literally filtering them into harmless amounts that can safely pass through the lungs and heart.
However, certain models of this device have been known to fail with these incidents being linked to many reports of serious health complications, including:
Since the early 2000’s, the FDA has been receiving thousands of reports of the device failing with the most common issues being migration (35%), detachment of device components (15%), perforation (7.5%), and fractures (6%). In many of these cases, healthcare providers failed to monitor the device or remove it when it was no longer needed. Inadequate warnings and lack of proper instructions from the manufacturers have also led to the filters remaining in the patient for long periods of time, which increases their risk of potentially deadly complications.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.