Courtice, ONRetrievable inferior vena cava filters (IVC filter) are yet another example of an otherwise promising medical device with a definitive dark side: they can fail while implanted in the body with often disastrous consequences. Designed to be removed after a period of time, most can’t.
It leaves the IVC filter patient dealing with something akin to a ticking time bomb. The emotional toll alone can leave an IVC filter patient in a constant state of worry and emotional distress.
The inferior vena cava filter, on the surface, seemed like a good idea at the time – a hedge against blood clots travelling from the lower extremities, where they have a tendency to form in middle-age and older patients – up the inferior vena cava to the upper part of the body. A blood clot that reaches the lungs can be fatal.
Blood thinners are the most common hedge against blood clots. However, for patients who can’t tolerate them – or for whom blood thinners are not enough on their own – medical science came up with an implantable catcher’s mitt that rests within the inferior vena cava and snares any migrating blood clots before they can do serious damage to the patient.
The problem is when these temporary devices fail. Spider-like with a series of thin, wire struts, IVC filters have been known to migrate away from the insertion point and wind up who-knows-where. The small, thin struts have also been known to break free and pierce organs, or lodge in tissue.
Sometimes they even reach the heart.
The US Food and Drug Administration (FDA) has since released a recommendation that the IVC filter is meant primarily as a temporary measure to ward against disaster when the risk of blood clot is at its highest, and thus should be removed from the body between the 29th and 54th day following implantation.
For most patients, however, this has proven to be impossible. Data shows that the vast majority of ‘retrievable’ IVC filters can’t be retrieved.
The longer they remain in the body, the greater the risk for complication.
In Canada, plaintiff Arie Kuiper has launched a class action lawsuit against the manufacturer of his IVC filter, Cook Medical. At the time his lawsuit was filed, in February of this year, the resident of Courtice, Ontario had undergone two attempts to have the device removed without success. He was scheduled for a third at the time, but was steeling himself for life with the IVC filter forever in his body.
His IVC filter lawsuit, which seeks $500,000 in damages for each class member together with $20 million in punitive damages, notes that Kuiper experiences dizzy spells. He has been told by his health team that it’s possible the Cook Medical IVC filter is becoming clogged, blocking optimum blood flow.
The longer they remain in the body, the greater the risk for complication.
Wendy Kopeck of Red Deer, Alberta is another Canadian client of Cook Medical with an irretrievable IVC filter in her body. When it failed, one of the legs, or struts of the device pierced Kopeck’s internal jugular vein. The remainder of the device migrated into her small intestines, where it remains to this day. Doctors have since determined it is far too dangerous to remove.
“I’m very afraid that someday I may move just the wrong way, or it may just fail on its own, which is what is happening, and the (device’s) leg will break and the filter will travel to my heart and kill me,” Kopeck told CTV News (02/23/16).
While she continues to live with this “ticking time bomb” in her body, a $200 million class action lawsuit she and her husband filed against Cook Medical at the beginning of the year is serving as a welcome distraction.
It was duly noted by CTV News that while every medical device carries some degree of risk, for most people the IVC filter is effective. However, for the minority who experience a problem, the fallout can be devastating. The fact remains as well, that in the majority of cases IVC filters cannot be removed. One specialist, Dr. William Kuo, has created a clinic in California for the sole purpose of removing IVC filters. CTV News notes that Kuo treats patients from around the world, including Canada, and so far his, is the only clinic of its kind specializing in IVC filter removal.
Cook Medical is not the only manufacturer facing litigation. C.R. Bard, manufacturer of the Bard G2 IVC filter, is also facing a spate of lawsuits currently consolidated in multi-district litigation. Bard IVC filter migration bellwether lawsuits are expected to be heard next year.
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