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Shezad Malik MD JD
Shezad Malik MD JD
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Why Do Inferior Vena Cava Filters Fail?

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As the number of Inferior Vena Cava (IVC) filter lawsuits climbs past the 1,500 mark over design defects leading to fractures, migration, tilting and perforation, researchers find that the normal movement and flattening of the vena cava, may be the leading cause of the device failures.

Cook IVC Celect and Gunther Tulip lawsuits

Cook IVC Filter lawsuits moving slowly to trial over claims of migration, perforation and fragment breakup of the devices

According to a study by Baylor Scott & White Health’s Department of Radiology in Dallas, said it may be the “foreshortening and flattening” of the vena cava that causes many of the side effects found with IVC filter fractures.

What are IVC Filters?

IVC filters are umbrella-shaped devices that are implanted in patients at risk of pulmonary embolism or a blood clot to the lung. They are implanted in the IVC to trap blood clots from the leg or deep vein thrombosis, blocking them from traveling to the lungs and causing a pulmonary embolism (PE) which in severe cases can be fatal.

In product liability and personal injury lawsuits filed against C.R. Bard, Cook and Cordis the major manufacturers of retrievable filters, it is claimed that the IVC devices are subject to catastrophic failure, moving out of position, puncturing the vein or fracturing, sending metallic shards into the blood stream.

The top 7 IVC filters that have been most commonly named in lawsuits include:

Cook Celect Filter

Cook Gunther Tulip Filter

Bard Recovery Filter

Bard G2 Filter

Bard G2 Express Filter

Cordis TrapEase

Cordis OptEase

Inferior Vena Cave Punctured in Multiple Places

In the reported case, the patient had a Bard G2 IVC filter in place for six years when a CT scan of her abdomen found that two of the struts had fractured and that the IVC filter was tilted more than 15 degrees out of position. There were multiple punctures of the IVC by the fractured struts.

According to the researchers, “Caval perforation can result in injury to adjacent structures, although most are asymptomatic. Extreme examples include gastrointestinal hemorrhage and aortic dissection. Migration of fracture fragments can cause serious complications, such as life-threatening arrhythmias and myocardial perforation with cardiac tamponade.”

IVC Filters harder to remove with passage of time

Researchers found that filter removal has a high success rate within the first year, the longer the filter is implanted, the harder it may be to remove. Because of constant motion, the IVC filter causes a local tissue reaction and the filters grow into the IVC wall lining.

The researchers noted, “How is it that a filter in good position initially can go on to require complicated retrieval? Electron microscopic analysis of filter fracture has identified foreshortening and flattening in vivo motions transmitted from the IVC to the filter. Transmitted motion can ultimately result in one of two fracture modes: high-cycle metal fatigue secondary to accumulated damage and metal overload sustained from acute stress.”

Many FDA Warnings

The FDA has issued safety warnings regarding these IVC devices due to the number of adverse events associated with them. On August 9, 2010, the FDA issued a Safety Communication warning recommending healthcare providers remove the filter as soon as the protection from PE is no longer needed to minimize chances of an adverse event occurring.

In May 2014, the FDA notified doctors to remove IVC filters within about one to two months after an individual was no longer at risk of suffering a pulmonary embolism, since the risk of problems appeared to be greater the longer the filter was left in place.

These warnings have fallen on deaf ears as the manufacturers sold the devices for years and continue to do so, without informing doctors about the risks associated with leaving them in place.

IVC Filter Litigation

There are more than 700 Bard IVC filter lawsuits filed in the federal court system, centralized for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation in Arizona.

Another 650 Cook IVC filter lawsuits are centralized as part of a separate MDL in Indiana. There over 100 filed claims against Cordis, filed in state court California.