When medical devices fail, the consequences can be devastating and even deadly. Lately, there have been growing concerns and lawsuits filed over the safety of an implantable medical device called an inferior vena cava (IVC) filter. Several different IVC filters are currently the basis for nearly 900 lawsuits against their manufacturers, including allegations that they failed to inform patients about potentially lethal side effects. Do you have all the facts about your IVC filter?
What Is an IVC Filter?
An IVC filter is an implantable medical device that fits in the inferior vena cava, the large vein that supplies your heart and lungs with blood from your lower body. The device itself looks like a small, spider-like cage of metal wire. It is typically inserted into a vein near the neck or groin, threaded into the IVC, and then allowed to expand, fixing itself in place. IVC filters are designed to allow blood to flow freely past the device, while catching any blood clots before they can enter the heart and be pumped into the lungs.
Deep Vein Thrombosis and Why IVC Filters Are Used
IVC filters are sometimes used whenever there is a major risk factor for blood clotting that cannot otherwise be controlled by medication. They may particularly be used after major orthopedic surgeries, such as knee and hip replacements or hip repair, in which there is an increased risk for a condition called deep vein thrombosis (DVT).
DVT is the formation of a blood clot in a vein buried deep inside the body. With DVT, the biggest concern is that a clot can break free and be pulled through the heart and into the lungs, where it can cause a pulmonary embolism. This is a life-threatening emergency that, when untreated, can result in either instantaneous death or death within 30 days in up to 30% of cases.
Risk Factors for DVT
There are a number of risk factors that can make a DVT, and thereby a pulmonary embolism, more likely. Some of these risk factors include:
- Certain cancer therapies and treatments
- Obesity or excess weight
- A history of heart attack or stroke
- Pregnancy and childbirth
- Varicose veins
- Long periods of inactivity, particularly air travel or recovery after surgery
- Surgery that causes reduced blood flow to a limb or other part of the body, such as joint or hip replacement
Usually, blood clotting issues are managed via the use of anti-coagulant medication that thins the blood and reduces clotting. Sometimes, though, this is not possible. For example, a patient may be taking medication that conflicts with blood thinners, or there is another underlying issue that prevents anti-coagulants from being used. An IVC filter is one of the medical alternatives to help prevent a dangerous embolism in cases like these.
Increased Use of Filters and Lawsuits
Though IVC filters have been around since at least the 1960s, use didn’t truly begin to skyrocket until the late 1990s. As use has soared from an estimated 2,000 filters in 1979 to over 150,000 in 2007, the Food and Drug Administration began receiving reports of adverse events occurring with filter patients. By 2010, the FDA had produced a safety alert about the risk. The FDA’s report makes note of 921 adverse events, including:
- 328 cases in which the filter migrated to other parts of the body
- 146 cases in which the device itself detached and caused an embolism
- 70 cases in which the inferior vena cava itself was perforated (torn)
- 56 cases in which the filter itself fractured
As reports of dangerous adverse events have piled in, it has become increasingly clear that there are major issues with devices from two major manufacturers. Cook Medical, the makers of the Cook Celect and Cook Gunther Tulip filters, has had over 400 filter-related lawsuits. Many of these suits have been joined together into multi-district litigation (MDL) to speed up the litigation process, and several bellwether trials against the company are set to begin in 2017. These bellwether trials are important, as they will determine how the remainder of cases will be handled by the court.
Get Legal Help Now
If you or your loved one have suffered harm an IVC filter failure, legal help is available right now. Please contact the offices of Wayne Wright at 800-237-3334 today for a free consultation, or use our online contact form so that our legal team can reach out to you right away.