Inferior Vena Cava Filter Lawsuits
Inferior Vena Cava Filter Lawsuits
Physicians first began using inferior vena cava (IVC) filters in the late 1970’s as an alternative preventative treatment for patients who could not take blood thinners. The devices are implanted into the inferior vena cava vein of patients with deep vein thrombosis and are intended to be used temporarily to block dangerous blood clots—known as pulmonary embolisms—from reaching a patient’s lungs. However, the filters are now the subject of hundreds of FDA adverse effect warnings and multiple lawsuits after patients have experienced harmful and, at times, fatal complications.
What is an IVC Filter?
The inferior vena cava is a large vein that moves blood from the legs, and into the lungs and heart. Patients who suffer from deep vein thrombosis—a condition in which blood clots form in the lower extremities—are often at risk for those clots to travel through the IVC vein causing a potentially fatal blockage, or pulmonary embolism. Inferior vena cava filters are small metal devices that are implanted into the vein to prevent pulmonary embolisms from occurring.
The devices are intended to provide temporary filtration of blood through the vein by catching clots before they can reach a patient’s lungs. When a patient is no longer considered to be “at risk,” the device is supposed to be removed.
Complications related to IVC Filters
Studies have revealed that IVC filters can cause complications related to migration within the body, organ and blood vessel perforation, and failing to prevent pulmonary embolism from occurring.
Reports have also shown that a significant number of filters have been left in patients past the recommend timeframe. Complications due to temporary IVC filters have been implicated in hundreds of FDA adverse effect reports. Serious complications include:
- Damage to veins from perforation
- Damage to organs from punctures
- Failing to prevent blood clots from reaching the lungs
- Filter migration
- Filter fracturing
- Internal bleeding
- Chest Pain
- Respiratory issues
- Inability to remove filter
One of the most common complications that patients have experienced is fracturing and migration of the filter. The FDA issued an announcement in 2010 specifying that of the 921 reports received between 2005 and 2010, 328 concerned filter migration and 56 reports concerned filter fractures. Further, the FDA reported that these complications were believed to be a result of long-term implantation, for which the IVC filters were not intended. The Administration released further guidance in 2014, recommending that the IVC filter be removed between the 29th and 54th day following implantation.
In 2015, NBC News published information from an internal investigation which revealed that at least 27 people had died from IVC filter related complications. Other instances of severe complications included one in which the device migrated and fatally punctured a patient’s heart.
View the NBC report below:
Lawsuits against IVC Filter Manufacturers
Patients who had received temporary IVC filters have filed claims against device manufacturers C.R. Bard and Cook Medical. The specific devices listed in the legal filings are:
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
Patients and their attorneys are alleging that the manufacturers failed to warn patients and physicians of the risks related to the device, and that the device was designed irresponsibly and caused avoidable complications. The lawsuits also claim that the manufacturers were negligent in the representation of the device.
Specific claims of failure to warn and negligence stem from information that C.R. Bard received complaints of device fractures and defects a year after the introduction of the Recovery filter. The manufacturer then failed to disclose this information to the public and the FDA, disclosing the reports only to employees with the intention of keeping the information secret.
In addition to these charges, a former regulatory specialist—who was hired by C.R. Bard to assist the company in gaining FDA clearance for the devices—has claimed that upon refusing to support the company’s request for clearance, her signature was forged on the FDA application. C.R. Bard has been cited by the FDA for eight violations of federal law related to the devices’ safety.
If you or a loved one has suffered as a result of a temporary IVC filter implant, contact the experienced medical device liability attorneys at Peter Angelos, P.C. to schedule a review of your claims.