Cook Medical’s Inferior Vena Cava (IVC) filters are known to cause serious injuries when left inside the patient. These injuries have been the cause of action in a growing number of lawsuits against the medical device manufacturer, both in the U.S. and in Canada. Plaintiffs allege that the Indiana-based company was aware of the dangers of the device, as well as the difficulty in removing them, and failed to inform doctors about these risks.
The injuries go beyond the physical. One plaintiff in California will have to live with what has been described as a “ticking time bomb” for the rest of her life. The plaintiff, who has not been named, had a Cook Celect IVC filter implanted in January 2008 after she was diagnosed with a thrombosis, or blood clot. The purpose of the IVC filter was to prevent the clot from reaching her heart and causing an embolism.
It accomplished that goal, but then, the device fractured. Three fragments broke off and traveled to her heart, where they remain lodged to this day. Another part of the device wound up perforating her kidney. The device was never intended to remain inside a patient’s body for such an extended time period. Once the risk of an embolism has passed – a few months at most – the IVC filter is supposed to be removed.
However, this is far easier said than done. Removal in some cases has proven impossible (currently, there is one surgeon in the country who specializes in IVC filter retrieval). When her physicians realized she had fragments of the filter in her heart in October of 2015, they attempted to remove them. They were able to get two of the fragments out, but not the third. After one more attempt a month later, the surgeons realized that it was more dangerous to attempt removal of the remaining fragment than to leave it in place.
The plaintiff will now have to live with that fragment in her heart for the rest of her days. As a result, she will experience ongoing pain and suffering, require extensive (and expensive) medical care. In addition, she will be living under a virtual “Sword of Damocles” hanging over her head, with the constant fear of the day the thread may break.
In 2009 – a year after the plaintiff in this case had the IVC implanted – researchers found that surgeons had attempted to retrieve the device from 130 patients over a two-year period between 2006 and 2008. In 33 of those cases, those efforts failed because the device had fractured or migrated.
This plaintiff’s story is only one of thousands. Another plaintiff from Alberta had a fragment pierce the jugular vein in her neck, while most of the filter wound up in her intestines. Her physicians have deemed that the risk of removal outweighs the risk of leaving it where it is. Another Canadian plaintiff continues to suffer from dizziness, due to his IVC filter having migrated to a location where it is blocking blood flow to the brain. As is the case for the other two victims, doctors have attempted removal without success.
These are just three stories out of thousands. Currently, other manufacturers of similar devices are watching the initial trials closely. Should the plaintiffs prevail in these actions, it may lead other companies to settle their cases before going to trial.