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The very first IVC filters to hit the market were designed to be permanent, but the numerous risks and complications since discovered have prompted the design and approval of similar devices that are meant only to be used until patients are no longer at risk of a pulmonary embolism or stroke. Mounting legal pressure in both the United States and Canada have prompted severe legal action and three manufacturers may soon be forced to pull their defective IVC filters from the market. Two class action lawsuits were filed in Canada when plaintiffs claimed that they were never warned of risks associated with the devices and doctors were unable to remove them.
Pulmonary Embolism a Growing Concern in the United States
Studies have shown that as many as 600,000 people in the United States suffer from blood clots and these clots can travel from the legs to the lungs, heart or brain. A pulmonary embolism occurs when a clot moves to the lungs and contributes to the deaths of 180,000 people in the nation every year. The IVC filter received market approval in 1979 and the permanent filters were in use for over 35 years. It was in 2012 that removable filters were introduced to the market and these products are the cause of the current slew of lawsuits being levied against C.R Bard, Cook Medical and Cordis.
It is estimated that over 75% of the IVC filters on the market today have been designed and manufactured by one of these three companies.
One Canadian plaintiff claimed that she had an IVC implanted in August of 2013 and doctors believed that it was too risky to remove the device when it was scheduled to be taken out. A later diagnostic scan revealed that the device had fractured and a fragment moved to her jugular vein while other pieces migrated into her intestines. She sought over $200 million in damages while another class action lawsuit sought over $500,000 per plaintiff named.
Removable Filters Did Not Receive Proper Approval Prior to Entering Market
In the United States, complaints are being filed alleging that removable IVC filters did not receive proper FDA approval and were sent to market through a loophole that required no clinical trials or approval because they were considered substantially similar to permanent IVC filters that posed fewer complications. This process is known as the 510(k) and more and more medications and medical devices are being sent to market through this loophole than ever before.
An article on Drugwatch.com revealed that over 259,000 removable IVC filters were implanted in patients inside the United States by the year 2012. Now that litigation has commenced in Canada, a mounting mass tort in the US is following. The primary complaints that plaintiffs have are that the devices have fractured, migrated to different areas of the body, failed to break up blood clots as intended and caused extensive damage to blood vessels and internal organs. Many patients have also suffered from complications such as infections, severe pain and sudden hemorrhaging.
The injuries victims have suffered have resulted in physical and emotional trauma, the inability to work and a permanent reduction in quality of life.
While it stands to reason that the removal of IVC filters after the risk of blood clots may be beneficial, in practice, it has been a massive failure. The devices which are meant to be distracted may become irremovable and jeopardize patients’ lives. Anyone who is considering a procedure that requires the implantation of one of these devices should be presented with all of the facts prior to being asked to make a choice concerning his or her medical treatment.