IVC Filter Lawsuits
The inferior cava filter (IVC) is a small, metal medical device designed to stop dangerous blood clots from migrating toward the lungs of patients. Often characterized as a tiny cage that is surgically placed into a vein, these mechanisms have been the subject of increased controversy and significant litigation.
In a typical case where blood clots present a serious risk, anticoagulant drugs are prescribed to safeguard the patient, but for some, these medications cannot be medically tolerated. In such instances, IVC filters have been viewed by many physicians as a sound option to achieve the same goal. First arriving on the market in 1979, the devices have been in consistent use for decades as a means of treating thousands of individuals.
At The Sanders Firm, we are alarmed by the growing number of reports of serious injury and death resulting from IVC filters and want you to know that if you or a loved one are among the victims, we stand prepared to help.
IVC filters and deep venous thrombosis
A condition in which potentially deadly blood clots develop in the extremities, deep vein thrombosis (“DVT”) can be deadly if the clots migrate to the lungs and cause a pulmonary embolism (“PE”). With embolisms of this type known to cause approximately 300,000 deaths each year, it is no surprise that physicians have turned to IVC filters as a method of prevention.
The problem is that not every IVC filter provides an identical degree of usefulness, as recent studies have shown. There are some devices currently available which display a propensity for traveling from their initial implantation site to other parts of the body. This is a very dangerous effect which can puncture veins and cause uncontrollable bleeding events.
Intended functioning of IVC filters
The inferior vena cava is the largest vein within the human body and it works to move oxygenated blood to the lungs, heart and throughout our entire bodies. An IVC filter is designed to halt the migration of blood clots to the lungs, which can prove deadly. These metal devices are placed with the help of a catheter used by a surgeon, cardiologist or radiologist.
IVC filters are comprised of metal wires meant to catch blood clots and prevent travel to the lungs, and two broad categories of the devices are used with regularity. A permanent filter remains in the body for the life of the patient, while a retrievable filter is designed to be removed once the patient is no longer facing the threat of blood clots. It is this latter category of filter which has been the target of increasing numbers of adverse event reports and lawsuits stemming from mechanism migration, organ perforation and device disintegration incidents.
IVC filter adverse event reports mount
Those who have had IVC filters implanted are at ongoing risk of damage to their veins and also of the development of dangerous blood clots that travel to the lungs. These devices have seen a troubling rise in the number of complications being reported by patients. In 2010, the U.S. Food and Drug Administration (“FDA”) issued a safety alert which described the growth in adverse event reports concerning IVC filters. Among the most frequently cited issues have been:
- Puncture of the vena cava
- Perforation of the aorta
- Cardiac tamponade
- Device migration
- Filter fractures
- Embolization, or breakage of device components
More than 35 percent of reported problems relate to device migration beyond the original site of implantation. Embolization was the second most frequent problem connected to retrievable filters. Though these devices are intended to be removed as soon as the risk of blood clot has passed, the FDA has signaled that an unacceptable number of these filters are allowed to remain in patients’ bodies for unnecessarily extended periods, subjecting them to very real risks.
Making matters worse is the fact that, according to the FDA, though IVC filters are meant only for use in patients who cannot take blood thinners and who have an existing risk of pulmonary embolism, far too many physicians are using them to treat patients with neither of those indicators. This practice represents needless risk of serious harm and even death, according to the agency.
Research highlights suspected IVC filter risks
Recent research has underscored the concern about retrievable IVC filters. The Journal of the American Medical Association included in a recent issue a study exploring complications experienced by IVC filter patients at a large trauma facility. In a surprisingly large number of cases, IVC filters were simply not removed from patients after their clot risk had passed. Of 679 implant cases, only 58 patients had their retrievable devices removed. As a result, some patients experienced dangerous embolisms or other complications.
A report in the Archives of Internal Medicine highlighted major issues with two specific varieties of IVC filters, namely the Bard Recovery and Bard G2 products. The alleged failure rates of these filters are alarming, with nearly 25 percent of the Recovery devices suffering disintegration and/or fractures. With a failure rate of approximately 12 percent, the G2 filter also posed a serious level of risk. Bard is not alone in receiving significant criticism and scrutiny for its IVC filters, as Cook and Gunther are also among the manufacturers now facing complaints, investigation and growing numbers of lawsuits.
IVC filter MDLs
As lawsuits have continued to mount concerning retrievable IVC filters from a range of manufacturers, calls for consolidation have been answered by the U.S. Judicial Panel on Multidistrict Litigation (JPML). Federal cases related to Cook Celect and Gunther Tulip filters have been centralized within the U.S. District Court for the Southern District of Indiana. On August 17, all federal matters pertaining to IVC filters manufactured by C.R. Bard were transferred for consolidated proceedings before Judge David Campbell in the District of Arizona.
The similarity of fact patterns involved and commonality of legal arguments and evidence made these cases ripe for centralization. It is hoped that the MDLs will result in judicial economies, better coordination of discovery processes and consistent pretrial rulings. If large-scale settlements do not result from the federal MDLs, individual cases can be returned to their original courts for further hearing. It is unclear whether the February 2015 settlement between Bard and a perforation plaintiff is a telling sign of things to come.
Seeking justice for IVC filter victims
Suspicion is growing that IVC filter manufacturers failed to warn physicians and the general public about known dangers presented by their devices and placed on the market products that were unreasonably risky. At The Sanders Firm, we are committed to helping victims fight not only for fair financial recovery, but also for justice and accountability in the face of what appears to be unacceptable negligence on the part of device makers.
If you or a loved one has been harmed by an IVC filter and you wish to align yourself with aggressive advocates who are dedicated to asserting the rights afforded to you by the legal process, The Sanders Firm is prepared to assist. For a free initial evaluation of your case, contact us today as 1-800-FAIR-PLAY.
- United States Judicial Panel on Mutidistrict Litigation, IN RE: Bard IVC Filters Products Liability Litigation – Transfer Order, http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2641-Initial_Transfer-07-15.pdf
- United States District Court Southern District of Indiana, MDL Case Information – MDL No. 2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation, http://www.insd.uscourts.gov/mdl-case-information
- Jama Internal Medicine, Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, http://archinte.jamanetwork.com/article.aspx?articleid=226212
- U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: Initial Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm
- Cleveland Clinic, Inferior Vena Cava (IVC) Filter Removal, http://my.clevelandclinic.org/services/heart/services/vascular_surgery/ivc-filter-retrieval
- NBC News, Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?, http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536
- U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm