Adverse Complications from IVC Filters
Across the country, the increased use of inferior vena cava (IVC) filters has prompted an influx of injury and wrongful death claims. The implantation device has been used to prevent recurrent pulmonary embolisms in patients who are at-risk for blood clots, but there is mounting evidence of dangerous complications from IVC filters.
An IVC filter is intended to prevent the migration of deadly blood clots. However, recent evidence has shown these small filters are prone to fracturing or dislodging, which can send pieces of metal throughout the body. There have been many adverse events reported concerning filters that have broken and migrated, damaging blood vessels, the heart, and other organs. As of the time of publication of this article, there have been more than two dozen deaths that are connected to IVC filter complications. If you or a loved one has been injured after having an IVC filter placed, you may have legal standing to pursue a personal injury claim. To arrange a personal consultation, please contact a qualified attorney today.
IVC Filters and Complications
IVC filters are implanted in about 250,000 patients each year as an effective method to prevent catastrophic injuries from dangerous blood clots. Several retrievable filters manufactured by two companies, C.R. Bard and Cook Medical, have been implicated in hundreds of lawsuits citing adverse complications for patients. The devices involved are primarily the Bard Recovery Filter, Bard G2, Bard G2 Express, Cook Gunther Tulip, and Cook Celect. A smaller number of claims have been filed citing the Bard Eclipse and Bard Meridian, as well as filters made by other companies.
There have been many adverse events reported concerning filters that have broken and migrated, damaging blood vessels, the heart, and other organs.
Resembling a small metal cage, these filters are designed to trap blood clots in the IVC, which is a primary vein that carries blood from the lower extremities to the heart. The device is meant to catch dangerous clots and allow them to dissipate before they can cause a more serious condition.
Retrievable IVC filters are meant to be a temporary solution for patients who need an alternative to anticoagulant medications, such as Xarelto®. Studies have shown that the risks of complications from IVC filters increases with the amount of time that the device remains in the body.
In pending court cases, the U.S. Food and Drug Administration (FDA) has issued safety warnings about IVC filters that are part of the discovery timeline. The FDA provided a warning in 2010, noting over 900 adverse incidents related to IVC filters. A 2014 follow-up alert cited evidence that these filters should be removed within 29 to 54 days of placement, after which time the risks outweigh the potential benefits.
However, studies indicate that the device is typically not removed within this timeframe, and retrieval attempts are not always successful. A 2013 report by Dr. Michael Go in Columbus, OH, showed that close to half of 262 IVC filter patients experienced complications, and only 1.6 percent of the devices had been retrieved after several years. Dr. Go also noted that when retrieval attempts were made, the failure rate was 8.5 percent.
Another 2013 study in the Journal of the American Medical Association (JAMA) examined the records of 952 IVC filter patients and found that doctors were unsuccessful in filter retrieval attempts over 20 percent of the time (13 out of 71 cases). In these reports, devices had migrated to an abnormal position, and were embedded or protruding through a blood vessel, preventing retrieval.
Adverse Events Affecting IVC Filter Patients
Complications related to the IVC filter occur primarily because the device moves out of place or breaks, and one or more metal fragments migrate throughout the body. The most common adverse incidents cited in litigation against C.R. Bard or Cook Medical may include:
Organ Damage – There have been many reported incidents of IVC filter components damaging vital organs, such as the heart, lungs, spinal cord, colon, and kidneys. In some cases, metal fragments have been found throughout a patient’s body, and complete removal of the device is virtually impossible. There have been several reports of metal struts piercing patients’ hearts, requiring emergency surgery to save their lives.
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Hemorrhage – The IVC filters in question have been known to tilt within the inferior vena cava, and puncture arterial walls. Severe internal bleeding can occur when the aorta or other major blood vessels are punctured by broken struts.
Cardiac Tamponade – Cardiac tamponade is a potentially deadly condition that occurs when a buildup of fluid creates pressure on the heart. This pressure prevents the heart from functioning properly and can impair blood flow throughout the body. There have been several documented cases of cardiac tamponade caused by IVC filter fractures in which a metal fragment perforates sections of the heart.
Deep Vein Thrombosis (DVT) – DVTs are severe blood clots that develop in the lower extremities. The condition can be life threatening if the clot migrates and obstructs blood flow to the lungs. When the IVC filter moves from its original surgical position, it is no longer an effective treatment for DVT. In the 2013 article reported by JAMA, 7.8 percent of the IVC patients studied suffered a venous thrombotic event.
Pulmonary Embolism – A pulmonary embolism occurs when a DVT migrates towards the lungs and obstructs a blood vessel, causing low oxygen levels. Unless the condition is treated promptly, an embolism can damage the lungs and lead to heart failure. Of the 952 patients studied at Boston Medical Center in 2013, 25 suffered a pulmonary embolism.
Stroke – IVC filters are sometimes placed to prevent strokes, but device failure can actually increase the risk. A stroke occurs when the brain’s blood supply is interrupted or reduced, causing cell death. Risk of stroke connected to a DVT was verified by a major Danish study, which found that the risk is nearly three times greater than normal for the first year after treatment for DVT or embolism.
Death – A September 2015 NBC News report attributed 27 patient deaths to IVC filters. While this number is already unacceptable, the actual number of fatalities from IVC filters cannot be accurately confirmed. Many patients with retrievable devices are unaware of the risks of catastrophic events. As publicity continues to grow from the numerous claims filed, more families will likely come forward seeking answers about the death of loved ones.
IVC Filter Lawsuits
Hundreds of individual plaintiffs and families have filed suit against C.R. Bard and Cook Medical, starting in 2012. These civil lawsuits can provide compensation for those who have suffered from IVC filter complications, including losses for out-of-pocket medical expenses, reduced income, punitive damages, and more.
Experienced personal injury attorneys around the country are assisting IVC filter plaintiffs participate in this important legal action.
Most individual lawsuits have been consolidated into multidistrict litigation (MDL). This allows for combined discovery and investigation processes to resolve common issues more efficiently. Separate cases against Bard and Cook are being overseen by a single judge, but plaintiffs are able to receive individual settlement amounts according to their injuries.
This lawsuit may pertain to you if you or a loved one had a Bard or Cook IVC filter implanted since 2003 and suffered adverse effects. Depending upon your state of residence, the statute of limitations deadline to file your claim may be set to expire soon, so it is important to act quickly.
Seek Legal Help
Experienced personal injury attorneys around the country are assisting IVC filter plaintiffs participate in this important legal action. To obtain a free consultation and find out the status of IVC litigation today, please contact a member of our product liability legal team.