IVC FILTER LAWSUIT
The Inferior Vena Cava Filter, or “IVC Filter,” is a medical device that’s surgically implanted in patients who are at risk for developing pulmonary embolism. In other words, the device is used to prevent blood clots. There are various types of filters; however, these devices can be divided into two main categories: “permanent,” and “retrievable.” As the name suggests, permanent IVC filters cannot be removed once surgically implanted in a patient. On the other hand, retrievable filters are designed with a “retrieval hook” which allow surgeons to extract the implanted device.
In the United States, an estimated two million patients received Inferior Vena Cava Filters over the past decade. Unfortunately, many patients remain unaware of potential serious issues posed by these devices. To put this in perspective, IVC Filters may pose a risk of serious injury, or death at any given moment. The Food and Drug Administration (FDA) actually published several advisories regarding IVC Filters. As a result, anyone with an implanted device may be entitled to file an IVC Filter lawsuit.
This page shares information on different types of IVC devices. Specifically, why some filters are permanent, why some are retrievable, and most importantly, the potentially fatal dangers/complications associated with this device that have led to mass lawsuits against certain manufacturers.
Manufacturers and Devices
Many people implanted with an IVC Filter are currently at risk for several adverse consequences. One of these risks involves the filter migrating into their heart. This migration could lead to permanent serious injury or death. In fact, the FDA encourages an immediate follow up and removal of the device when possible.
Below this paragraph is a list of the primary manufacturers involved in lawsuits along with their individual devices. If you, or a loved one received one of the devices listed below, you should contact our legal team immediately as there may be a Statute of Limitations on your case. It’s important to note, our lawyers can pursue these cases anywhere in the United States. You can visit the links below for more information on each individual manufacturer.
Cook IVC Filters – Cook devices include: Gunther Tulip, Celect, Celect Platinum, and Bird’s Nest.
Bard IVC Filters – Bard devices include: Simon Nitinol, Recovery, G2, G2 Express, Eclipse, Meridian, and Denali.
Cordis IVC Filters – Cordis devices include: OptEase, and TrapEase.
Others – If the device you’re inquiring about is not listed above, you should still contact us as numerous other devices may be subject to an IVC Filter Lawsuit.
IVC Filter Complications
Many people implanted with one of these instruments are currently at risk for several adverse, and potentially fatal consequences In fact, the FDA encourages an immediate follow up and removal of the device when possible. Possible complications include, but are not limited to the following:
Migration – IVC Filter migration is one of the most serious complications. In simple terms, this occurs when the device becomes “dislodged” inside a patient and moves away from the original area of placement. This is serious because it can migrate toward a patient’s vital organs such as the heart and cause death. If a filter migrates by 2 cm or greater, it’s considered significant migration, and is potentially dangerous/fatal.
IVC Filter Tilt – This is one of the more common issues associated with these instruments. When a filter tilts inside a patient’s vena cava, it exposes the patient to risks such as organ damage and pulmonary embolism. Additionally, tilting may cause the device to become embedded in the patient making the removal of the filter difficult, if not, impossible. A tilt of this device is defined as greater than 15 degrees.
Thrombosis – While IVC devices intended to decrease the risk of pulmonary embolism, it also increases the risk of a condition called Deep Venous Thrombosis (DVT). This occurs when blood clots develop in a deep vein of the body. Signs of DVT include: pain/swelling of the legs, heavy aches, and reddening of the skin around affected areas.
Fracture – As it sounds, fracture occurs when there’s a structural flaw in the inferior vena cava filter and parts break off into a patient’s body. Needless to say, this causes serious potential health concerns including organ perforation from projectiles of the device.
Retrieval failure – Filter removal can be a highly risky procedure. In fact, despite the FDA encouraging removal when possible, there are instances where the filter cannot be removed without seriously injuring or killing the patient (see next section for more information).
IVC Filter Removal
Originally, many devices were designed as a permanent solution because manufacturers did not believe there was a high enough risk for complications/failure to justify the addition of a retrieval mechanism. After studies began to surface that vena cava filters significantly increased the risk of serious long term health complications, they started designing filters that were retrievable.
In 2010, the U.S Food and Drug Administration issued a warning regarding the dangerous of IVC Filters and recommended guidelines on removal. The following is an official statement by the FDA,
“FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.” (U.S Food and Drug Administration, Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use 2010)
Several years after the initial warning in 2010, the FDA reinforced their position and issued a stronger advisory. In fact, the FDA encouraged doctors and patients to remove retrievable filters as soon as the risk of pulmonary embolism subsides.
Unfortunately, the removal of inferior vena cava filters carry a significant risk of injury in patients. Additionally, when the device tilts, fractures, or migrates, it may severely complicate the retrieval procedure and expose the patient to grave danger.
IVC Filter Lawsuit Settlements
The two main device manufacturers, Cook Medical, and Bard, currently face over over 7,000 lawsuits. As a result, the two companies are facing separate Multidistrict Litigation cases (MDLs). So far, Bard settled some cases for undisclosed amounts, while results of Cook settlements remain private.
Compensation for IVC Filter Injury includes but is not limited to:
- Physical trauma
- Medical expenses
- Emotional suffering
- Psychological trauma
- Loss of wages or potential earnings
- Wrongful death
What Can You Do?
Di Pietro Partners has an experienced staff of product liability and medical malpractice attorneys. Furthermore, we work with top quality, board certified, medical professionals. If you or someone you know has an IVC Filter, you should seek legal and medical advice immediately. Contact the experienced attorneys at Di Pietro Partners for a free case evaluation. 1.800.712.8462