Cook IVC Filter Lawsuit

People who experience deep vein thrombosis—a condition in which blood clots form in the deep veins of the legs, then travel back to the lungs through the inferior vena cava—are most commonly prescribed anticoagulant medications (blood thinners) to keep the blood from clotting. However, some patients are medically unable to take these drugs.

Patients who cannot take blood thinners may be implanted with an IVC filter as a means to temporarily prevent a pulmonary embolism. The Gunther Tulip and Celect IVC filters both were designed to be retrievable. Unfortunately, for some, these devices aren’t removed in time and can cause a number of serious adverse effects stemming from migration, perforation, embolization (detachment of IVC filter components) and/or fracture.

Gunther Tulip IVC Filter

The U.S. Food and Drug Administration approved the Cook Medical Gunther Tulip IVC Filter for permanent use in October of 2000. Three years later, the FDA approved the Gunther Tulip for temporary use.

The Gunther Tulip IVC Filter was marketed as a safe and effective treatment for prevention or recurrent pulmonary embolism. However, the Cook IVC Filter lawsuits allege that the Gunther Tulip is prone to fracturing, even after the risk of blood clots and pulmonary embolism has passed. In the event that the Gunther Tulip fractures and/or migrates, the device becomes extremely difficult to retrieve.

Celect IVC Filter

Cook Medical’s Celect IVC filter was approved in 2008 through the FDA’s controversial 510(k) application. The FDA’s 510(k) program allows companies to obtain a fast-track approval process for devices share similarities to other devices that are already on the market. The controversy with this application is that the approval process requires only minimal testing because the newer products are believed to be as safe as the existing devices.

Much like the Gunther Tulip, the Celect IVC filter has the potential for fracture and migration, according to the Cook IVC Filter lawsuits. Studies have also found that the filter can embed itself in the vena cava, which makes them extremely difficult to remove.

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Cook IVC Filter Problems

In 2010, the FDA released a safety communication warning consumers and the medical community about adverse health risks associated with IVC filters. According to the alert, the FDA received 921 adverse event reports involving IVC filters between 2005 and 2010, of which four percent involved fatalities. The other adverse events cited in the FDA communication:

• 328 involved migration of the device or a part of the device to another part of the body.
• 146 involved embolization.
• 70 involved perforation.
• 56 involved filter fracture.

The FDA safety communication noted that patients could be experiencing these problems because the IVC filters they received remained implanted beyond the safe use of the device. In some cases, patients still had IVC filters in place long after the risk for pulmonary embolism (PE) had subsided.

According to the FDA, the long-term risks associated with IVC filters “include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.” The alert further advised doctors to remove IVC filters from patients as soon as possible once the risk of PE had passed.

In 2014, the FDA released another communication pertaining to IVC filters, which stated that the agency examined all publicly available data from the medical literature in order to “assess whether there is a time during which the risk of having an IVC filter in place is expected to outweigh the benefits.”

The communication suggested that IVC filters should be removed between 29 and 54 days after they have been implanted. The agency further stated that all IVC manufacturers, including Cook Medical, would be required to collect additional clinical data to address some unanswered questions about the safety of IVC filters.

Reported Cook IVC Filter Complications

• Damage to the heart, lungs or vena cava
• Internal bleeding
• Death
• Filter fracture
• Perforation
• Ventricle tachycardia (lower chambers of the heart beat very quickly)
• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Infection
• Nerve Injury
• Hematoma
• Cardiac tamponade (compression of the heart caused by fluid collected in the sac surrounding the heart)

Cook Medical IVC Filter Studies

Journal of Vascular and Interventional Radiology (2015)– Researchers compared the Cook Celect IVC Filter with the Rex Medical Option IVC Filter. A total of 99 Celect IVC Filters and 86 Rex Medical Option IVC Filters were implanted in patients who were observed over a 33-month span.

Celect IVC Filters were found to be far more likely to cause perforation (43 percent perforation rate) when compared to the Rex Medical Option IVC Filter.

Journal of Vascular and Interventional Radiology (2009)– Researchers reviewed charts of 115 patients who received a Cook Medical Celect IVC Filter between 2005 and 2007. The study found that doctors had trouble retrieving the filters, because they occasionally became embedded in the vena cava wall.

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