Retrievable IVC Filters
The Problem: IVC Filter injuries can occur when pieces of the device break or fracture, and travel through your blood stream.
The Response: As of April 2016, there is multi-district litigation pending in Indiana (against Cook) and Arizona (against Bard).
What Can We Do to Help: Our experienced attorneys can review your medical records and advise you if filing a case is in your best interest.
The injury attorneys at Gallon, Takacs, Boissoneault & Schaffer are investigating and accepting potential cases for people who suffered serious or life-threatening injuries from a IVC Filter. IVC Filter injuries can occur when pieces of the device break or fracture, and travel through your blood stream.
Did you or someone you know have an IVC Filter and suffered from the device migrating, fracturing or perforating? Find out if you can seek compensation for your injuries by completing our free case evaluation.
Faulty IVC Filters have punctured veins, fractured and migrated to cause other medical issues.
Jonathan Ashton, Partner for GTB&S, recently appeared on NBC 24’s “Better Living” program to discuss the latest developments regarding IVC Filters.
What is an IVC filter?
This animated video illustrates how the IVC Filter is placed and potential problems with its removal.
Doctors implant IVC filters in the inferior vena cava (IVC), the vein that carries deoxygenated blood from the lower body to the heart. An IVC filter is a small, spider-like device designed to capture embolisms (blood clots) that have broken loose from a deep vein in the legs and is on the way to the heart and/or lungs.
Without a filter in place, there is a risk of the embolism causing a blockage in the pulmonary arteries, which carry the deoxygenated blood from the heart to the lungs. Blockage of one or both of these arteries, known as a pulmonary embolism (PE), can cause breathing issues, chest pain, and even death.
IVC filters are for patients who:
- Continue to develop deep vein thrombosis or pulmonary emboli (blood clots in the legs and lungs).
- Are at risk of pulmonary embolisms and cannot tolerate anticoagulation therapy because of other conditions that put them at high risk of bleeding.
- Develop significant bleeding complications from anticoagulation therapy.
- Have large clots in the inferior vena cava or iliac veins.
Initially, researchers developed and designed IVC filters for permanent placement; however, since their creation in the 1980s, there have been many design improvements, leading to the creation of four different categories of filters: permanent, temporary, convertible, and optional.
In 2003, C.R. Bard designed one of the first retrievable (temporary) IVC filters, the Recovery filter, which allows doctors to remove them after the medical condition has improved.
What is the issue with IVC filters?
Since the introduction of the retrievable IVC filter around 2003, the U.S. Food and Drug Administration (FDA) has received an estimated 950 adverse reports as of 2010. Of the these reports, roughly 330 involved device migrations, 150 involved embolizations (detachment of device components), 70 perforated the inferior vena cava, and 60 involved filter fractures.
In August 2010, the FDA sent out a safety alert about the risks of adverse effects after long-term use of IVC filters.
These adverse effects include, but are not limited to:
- Device migration
- Filter fracture
- Embolization (movement of the entire filter or fracture fragments to the heart or lungs)
- Perforation of inferior vena cava
- Difficulty removing device
The FDA recommended that physicians who implant the devices and clinicians responsible for ongoing care of patients with IVC filters should consider removing the filter as soon as protection from PE is no longer necessary (usually between 29 and 54 days).
The FDA also sent Bard, Inc. a warning letter on July 13, 2015, stating that:
- The FDA never approved or cleared the Recovery Cone Removal System.
- The manufacturer’s methods for storing, manufacturing, and packaging did not meet current good manufacturing practices.
- The manufacturer failed to properly establish and maintain procedures for reviewing and evaluating complaints related to the G2, G2X, and Eclipse filters.
- The manufacturer failed to report information that reasonably suggests that its device has malfunctioned and is likely to cause death or serious injury.
Later in 2015, NBC News released a report stating that the manufacturer might have obtained FDA approval for the Recovery filter through fraudulent means after ignoring warnings from Kay Fuller, a regulatory specialist.
Fuller claimed that the manufacturer threatened to take her off the team if she continued to ask questions about her concerns and then forged her signature on the 2002 application for FDA clearance.
The report also claims that Bard knew of the problems with the IVC filters in 2005 and instead of fixing the issues or recalling the filter, simply modified it slightly, and sold it under a different name: the G2.
The FDA has not recalled the IVC filter as of April 2016.
Are there any lawsuits currently pending?
Victims have filed class-action lawsuits against Bard, Inc in California, Florida, and Pennsylvania (the courts have not yet allowed the formation of a class, however). There are no pending class actions against Cook Medical.
As of April 2016, there is multi-district litigation pending in Indiana (against Cook) and Arizona (against Bard).
The types of filters mentioned most often in litigation are:
- Bard Recovery Filter
- Cook Gunther Tulip
- Bard G2 Filter
- Cook Celect
- Bard G2 Express Filter
If you or anyone you know suffered injury because of an IVC filter, you may be entitled to compensation. The IVC filter attorneys at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. are dedicated to holding pharmaceutical companies responsible for the dangerous complications of their devices.
Call our IVC filter attorneys at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. at 1-800-GALLON1 or fill out our contact form for a free case evaluation. Reach out to us today; we want to help you get the compensation you deserve.