The estimates are enormous- as many as 7,000 Americans may be walking around with a fractured IVC filter in their body that has the potential to embolize or break off into smaller pieces, migrate from the implant site, and pierce the heart or other vital organs.
That is not the way these medical devices were designed to function.
What is an IVC Filter?
An IVC filter is a small medical device resembling a daddy long legs spider. The cap or top is like a hat and designed to be placed in the inferior vena cava (IVC), the large vein carrying blood from the lower half of the body to the lungs. The long legs are fragile and made of the metal alloy, nitinol. They are designed to anchor the filter firmly in the inferior vena cava as they fixate in the walls of the IVC.
But the Food and Drug Administration (FDA) has noted 27 deaths reported with the Recovery IVC filter made by C.R. Bard and 12 deaths with the G2 Bard IVC filter device. These are the most serious outcomes but not the only ones.
Injuries Related to IVC Filter Use
There have been more than 900 adverse events reported to the FDA involving IVC filters. Included in those complication reports are 328 cases of device migration, 70 instances of the filter perforating an artery or organ, 56 filter fractures and more than 100 instances of a filter pieces breaking and traveling within the body.
Obviously this is not the way these devices were designed to work. Anyone involved in research and development for C.R. Bard will tell you that there is something wrong with these devices. They are not fulfilling the function they were designed for and are instead injuring patients. They are therefore defective.
There is a risk with any surgery. There is a risk of infection anytime you enter a hospital. But besides these risks, what are these specific problems telling us?
The Problem with IVC Filters
IVC filters are a fragile and delicate medical device and because of their lightness they have been seen to move and migrate to another part of the body. The IVC filter legs or struts, as they are called, are as thin as a needle. Because of that, they have been observed fragmenting in the body, known as an emboli, and travelling in the bloodstream to lodge in a blood vessel or organ, causing a blockage or embolism.
IVC filters can become so filled with clotting material that they block blood flow, negating the purpose they were implanted for in the first place.
And the design defect appears to occur more frequently the longer the IVC filter remains in the body.
One study from a Pennsylvania hospital of 80 patients found the fragmentation and embolization occurred in one-quarter of patients who had been outfitted with a Bard Recovery IVC filter. In 12 percent of those implanted with the Bard G2, the device fragmented and cause an embolism.
This is obvious dangerous especially when the emboli lands in the right ventricle, as it did in five out of the seven patients with the Recovery.
FDA Communication about IVC Filters
That design defect led to the initial communication from the FDA on August 9, 2010 which suggested implanting physicians consider removing the IVC filter after the danger of a pulmonary embolism has passed, anywhere from 29 to 54 days after implantation. Still, about 70 percent of retrievable IVC filters are never removed and remain behind in the patient.
A product liability lawsuit attempts to bring to light a design defect, a defective manufacturing process or defective instructions to the end user, that is, the doctor. The discovery process reveals what the company knew when it launched and continued to sell its defective product. Often, it becomes crystal clear that the company put profits before the patients it was supposed to help. Additionally, patients were not told there was a potential for metal fragments to move through their blood, so there is a problem with providing the patient with a true informed consent.
Does the IVC Filter’s Manufacturer Know it Is Dangerous?
It’s been revealed through product liability litigation and the discovery process that at least one manufacturer, C.R. Bard, based in Murray Hill, NJ, knew that it had a problem with one of its filters, the Recovery, but hid that research from the public and doctors. When the company hired a woman who was supposed to help get the device on the market, she asked to see the documentation of safety. Bard executives refused to show it to her and she was fired.
Later, NBC News asked the woman, Kay Fuller, why she signed off on the Bard Recovery filter in the application to the FDA. “I didn’t,” she said. That wasn’t her signature.
The FDA Problem
Part of the problem is the FDA itself. Most Americans are unaware the agency doesn’t approve medical devices based on safety. That bears repeating. The U.S. Food and Drug Administration allows an exchange of paperwork to suffice for a manufacturer to enter the marketplace to sell a device. What about safety and efficacy? Not needed with most medical devices, says the FDA. Clinical trials are not required.
Instead, a company is told to fill out paperwork, called a 510(k) application, named for the FDA code it is based on. As long as there is a device that that is the “substantial equivalent,” which must be named, already being sold and on the market, you can claim your device is enough alike and it will be essentially grandfathered into commerce.
The agency relies on the integrity of the manufacturer, which in many cases, has not proven itself deserving of that confidence. The corporations are truly in charge of the process.
Even with all of these problems, the FDA has not issued a recall for IVC filters, but there are now hundreds of lawsuits consolidated in two federal courts in multidistrict litigation – in Arizona for Bard and in Indiana for Cook Medical. An MDL consolidates cases that are similar so they can be prepared for trial in a more streamlined fashion.
Lawsuits Against IVC Filter Manufacturers
The lawsuits will attempt to prove before a jury that the IVC filter which has caused substantial harm to a plaintiff is a defective device. Unfortunately, it is often years after a device is on the market that these trials take place and the public becomes aware of any device’s dangers.
The FDA tries to serve two masters- balancing safety with innovation. It is difficult to protect patients when manufacturers, through Congress, do not fund the agency adequately enough to fulfill its role. At the same time, manufacturers push Congress to lighten regulations even further so they can get more medical devices on the market calling it “innovation”.
Most Americans do not understand that is how it works and that is how the Bard Recovery filter, Bard G2, Cook Gunther Tulip filter and the Cook Celect filter, all made it to the market.
As Americans we want to trust our U.S.-based companies. We want to trust they will stand behind the products they sell and warranty them with pride. What litigation shows us is that too often profits trump patient safety and we were fooled into believing in our companies, our FDA and our doctors.
Contact an IVC Filter Design Issue Lawyer at Farah & Farah Today
Farah & Farah is currently investigating injuries relating to IVC filter use nationwide. Let us help you hold large drug manufacturers responsible for injuries they’ve caused. Our IVC filter lawyers can be reached anytime at (800) 533-3555.