Inferior Vena Cava (IVC) filters refer to tiny, cage-like devices implanted into the largest vein in the body to prevent blood clots from getting to the heart and lungs. Since the IVC filters were introduced to mainstream medicine in the 1970s, their use increased dramatically, but there isn’t enough evidence to show the devices’ long-term efficacy and safety. Actually, the devices can themselves be dangerous when they break off, migrate, and puncture organs and veins. Filters manufactured by C.R. Bard, appear to be particularly hazardous as they have been linked to thousands of patient injuries and dozens of deaths.
How IVC Filters Work
An IVC filter is implanted into the Vena Cava, which is the large vein that returns blood from the rest of the body to the heart. The Inferior Vena Cava is the largest vein and serves as the pathway that deoxygenated blood travels from the body to the right side of the heart and then to the lungs where it is re-oxygenated. The oxygenated blood then returns to the left side of the heart where it’s pumped to the rest of the body in order to supply oxygen and nutrients to the tissues. However, individuals diagnosed with certain medical conditions like Deep Vein Thrombosis (DVT) may develop blood clots that can break off and move to the lungs. When a blood clot travels to the lungs, it is referred to as a pulmonary embolism and may cause a near-immediate death.
Most cases of pulmonary embolism occur as a result of blood clots that develop in the legs or other deep veins in the human body. About 900,000 cases of deep vein thrombosis are reported in the U.S. each year. Pulmonary embolism causes about 200,000 United States deaths each year. It’s considered the third most popular cause of hospital-linked death and the most popular preventable cause of hospital death. Because of the link between pulmonary embolism and deep vein thrombosis, physicians refer to these conditions jointly as venous thromboembolism.
The IVC filter is designed to prevent any blood clots that may break away from veins or arteries from traveling through the heart to the lungs and become a fatal pulmonary embolism. Individuals who make good candidates for IVC filters are those taking anti-clotting medications but still experience deep vein thrombosis or other clotting conditions, and/or individuals who cannot put up with blood thinners due to bleeding or adverse reaction. Doctors may as well recommend the IVC filters to patients who undergo surgery or suffer from serious trauma since the risk of blood clots is higher. The IVC filter is a small “cage” or “basket” made of metal and designed to catch blood clots and hold them until they’re broken down by the body’s natural systems.
Example of situations when a doctor may recommend an IVC filter include:
- Spinal cord injury
- Dialysis treatment
- Gunshots or stabbing injuries
- Voluntary or emergency surgeries
- Serious falls
- Post delivery
- Cancer diagnosis or treatment
- Trauma victims
- Patients with pulmonary embolus
- Patients recovering from recent surgery
- Patients diagnosed with DVT
A catheter is used to implant the IVC filter into the inferior vena cava through a small incision in the groin or neck. After the IVC filter placement, a patient will typically need a couple of days to recover from the procedure. Removal of retrievable filters is similar to how they are implanted Before proceeding with the removal; the doctor will first inject x-ray dye or contrast around the device to ensure that it’s safe to remove it. A catheter-like snare is inserted into the vein and works by grabbing the hook located at the end of the filter. The device is covered with a sheath, and the doctor gently pulls the device out of the vein.
The Use of IVC Filters Over the Years
The original IVC filters were permanent devices and were designed to be left in place. Devices such as the Recovery IVC filter were primarily approved for permanent placement. However, current devices were designed to be in place on a temporary basis and are referred to as retrievable IVC devices. These devices must be removed once the danger of the patient developing a blood clot complication has passed. The idea of IVC filters was conceptualized in the 1860s. The use of these devices was pioneered in the 1960s but wasn’t as common until the 1970s. Removable IVC filters were then introduced in the 1990s.
In 1979, the U.S. Food and Drug Administration (FDA) approved the use of IVC filters, and since then, there has been continuous use over the years. Based on a 2016 study in Seminars in Interventional Radiology, approximately 259,000 filters had been implanted in patients by 2012. The FDA reported that 2,000 IVC filters were implanted in 1979, compared to 259, 000 filters in 2012 and 167,000 in 2007.
IVC filters are primarily manufactured by 3 companies: C.R. Bard, Boston Scientific, and Cook Medical.
The most popular brands include:
- The Bard G2 filter
- The Cook Celect filter
- The Bard G2 Express filter
- The Cook Gunther Tulip filter
- The Bard Recovery filter
- The Boston Greenfield filter
IVC Filter Safety Concerns
According to a 2016 analysis by the American College of Cardiology, IVC filters were likely being overused, the rates of retrieval were low, and their surveillance data was missing. Despite a lack of long-term studies showing the safety and efficacy of IVC filters and research showing that individuals who received IVC filters still suffer from a pulmonary embolism, thousands of these devices are implanted in U.S. patients each year.
The concept behind the use of these devices has been called into question by research as well as a high volume of reported device complications. Between 2005 and 2010, The FDA received over 1,000 adverse event reports related to IVC filter. Some of the complaints were:
- Device migration (328 reports)
- Device components detaching (146 reports)
- Organ or vein perforation (70 reports)
- Filter fracture (56 reports)
While many of the newer versions of IVC filters are intended to be removed immediately the patient is medically cleared, the removal of the device may come with complications. A study by the Journal of the American Medical Association (JAMA) found that 2 percent of the device retrievals failed, for reasons such as:
- Abnormal filter position
- Filter was embedded in the inferior vena cava
- Blood clot inside the filter
- Filter protruding through a blood vessel
Over a 10-year period, the FDA received almost 1,000 adverse event reports for problems like migration and device breakage. IVC filter injuries have attracted numerous lawsuits against the device manufacturer, with the victims claiming that the device is defective and the company failed to warn them of the impending health risks properly.
The FDA issued safety warnings concerning IVC filter complications in 2010 and 2014. The complications cited were filter fracture, device migration, blood vessel perforation, embolization, lower limb deep vein thrombosis, inferior vena cava occlusion, and difficulty removing the device. Doctors are advised to consider removing retrievable filters once the pulmonary embolism passes and normally within a 29-54-day window. Once this time period elapses, the likely benefit may be outweighed by the potential harm, as indicated in a 2013 FDA analysis. Additionally, in a 2014 safety communication, the agency said that it was concerned that the retrievable IVC filters are not always removed once the risk of pulmonary embolism subsidies.
COOK, BARD IVC Filters May Be Particularly Dangerous
Studies suggest that IVC filters made by Cook Medical and C.R. Bard may be riskier than others because they are prone to complications.
A JAMA study on the Bard G2 and the Bard Recovery filters concluded that they both had high incidences of fracture. The study revealed that:
- 16% of the Bard G2 and the Bard Recovery devices had strut fractures
- 12% of the Bard G2 filters fractured. 33 percent of these cases involved patients who had fragments in their organs.
- 25% of the Bard Recovery filters embolized and fractured. 71 percent of these had broken pieces that traveled to the heart. Three patients experienced life-threatening problems, and one died.
A different study concluded that the Bard G2 and the Bard Recovery filters have a general fracture rate of 12%. According to NBC News, at least 27 deaths are linked to Recovery filters, while at least 12 deaths and hundreds of non-fatal complications are linked to the Bard G2 filters. An investigation by the NBC concludes that C.R. Bard was aware of the deadly device defects for years, but engaged in an elaborated cover-up scheme to keep the filters on the market. The company continued selling the faulty filters, putting thousands of patients at risk of potentially life-threatening injuries.
In July 2015, the FDA sent a warning letter to C.R. Bard stating that the manufacturer had failed to alert the federal agency of serious device defects, had misfiled consumer complaints, and was producing the Recovery Cone Removal System without approval or clearance from the FDA.
Conversely, research published in the Journal of Vascular and International Radiology found that cook filters had a 43 percent rate of perforation when compared to Rex Medical filters, which had a 0% rate. Also, a 2012 study published in the CardioVascular Interventional Radiology journal showed that the Cook Celect and Gunther Tulip, manufactured by Cook Medical, had a high rate of puncturing the Vena Cava wall within 71 days of placement. The study also showed a 40% rate of migration.
While retrievable IVC filter devices should be removed once the risk of pulmonary embolism has been eliminated, a study conducted in 2013 showed that less 9% of these devices were actually removed. The study also found other problems, including:
- 8% venous thrombosis events. Of these, 25% were pulmonary embolisms, the condition that the device should prevent
- 18% failure rate in device removal attempts
Potential Complications Associated with IVC Filters
IVC filters are likely to migrate away from their original location, making them ineffective. In some cases, the device itself punctures a vein, which can, in turn, cause internal bleeding and other complications. Pieces that break from the devices can travel through the blood and lodge in organs. Retrievable filters are linked to potential risks like failing to stop blood clots from dodging the device and damaging veins. Common injuries experienced when pieces of an IVC filters reach the heart or lungs include:
- Hemorrhage (severe bleeding)
- Pulmonary embolism
- Shortness of breath
- Chest pain
- Neck pain
- Heart rhythm problems
IVC filter complications can be put into three groups: procedural, delayed, and retrieval.
Procedural complications typically occur when the device is being implanted and include:
- Defective filter deployment
- Access site bruising and/or bleeding
- Incorrect placement of the device
- Blood vessel puncture
Delayed complications are those that occur when the device is still in the body. These include:
- Perforated organs
- Deep vein thrombosis
- Device infection
- Migration to another part of the vena cava or other organs
- A blockage that causes swelling in the legs
- Filter breakage or fracture
Retrieval complications may occur during the device’s removal. These include:
- Difficulty retrieving the device, causing extended surgery periods
- Perforation of blood vessels
- Scars in the vein that inhibit device removal
Patients who stay with the device past the recommended removal date are at risk for heart failure, blood clots, severe pain, pulmonary embolism, hemorrhaging as a result of perforation, or death
The FDA Actions
As already mentioned, the FDA received about 1,000 reports of adverse events linked to IVC filters between 2005 and 2010. A majority of the reports involved embolization and filter migration. The FDA concluded that the complications could have been associated with retrieval filters remaining inside the body long after the risk for pulmonary embolism had passed. For this reason, the agency recommended that the devices be retrieved within 54 days after implantation if the risk has subsided.
Also, the agency required manufacturers to take part in studies that will offer additional information concerning the safety of both retrievable and permanent filters. All manufacturers were given the option being part of specific research, referred to as the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) or various post marketing surveillance studies. This PRESERVE study was scheduled for completion in May 2019. These studies focused on determining the safety and efficacy of IVC filters in the prevention of pulmonary embolism. According to a 2016 study in Seminars in Interventional Radiology, the information collected from these studies will help manufacturers, the FDA, and health care professionals assess the use and safety profile IVC filters. The studies will also help them understand the evolving patterns of clinical use of the devices in order to help improve their usage and patient care.
IVC Filter Recalls
Between 2005 and 2015, over 81,000 units were affected by six major IVC filter recalls. According to the manufacturers, most of the recalls were instigated by packaging and labeling problems.
The major IVC filter recalls include:
- Greenfield (August 2005): 2 lots recalled for possible blood vessel damage
- Greenfield (December 2005): 18,000 units recalled for device defect that could lead to pulmonary embolism
- VenaTech (October 2007): 60 units recalled for packaging error
- OptEase (March 2013): 33,000 units recalled for incorrect labeling that could cause backward insertion
- Denali (March 2015): 1,183 units recalled for a missing label warning
While no major recalls have been issued since 2015, thousands of IVC filter recipients have reported complications with the devices. Moreover, some of the devices that are particularly prone to failure have not been recalled. A 2015 investigation by NBC News linked Bard G2 and Recovery filters to 39 deaths. None of these devices were recalled, but instead, the manufacturer swapped the filters with similar models. At the time of this investigation, about 20,000 people were living with Bard IVC filters implanted in their bodies. Since Bard took its Recovery IVC filter off the market and replaced it with the G2 filter, the FDA said it cannot issue a mandatory recall.
Filters manufactured by Cook Medical were also linked to injuries and deaths. Hundreds of adverse events report of Gunther Tulip and Cook Celect have been submitted to the FDA, but the manufacturer never recalled the two devices.
IVC Filter Lawsuits
Because of the problems with IVC filters, many of those who have been harmed by these devices have filed lawsuits against the manufacturers. The first case that went to trial settled for an undisclosed amount in 2015, ten days after the trial began. In this case, the device had perforated the plaintiff’s heart, forcing him to undergo open-heart surgery. In general, the mass torts claim that:
- The device carries the unreasonable risk of fracture and migration in the body, but the manufacturers did not warn patients and doctors of this problem
- Device migration caused vena cava puncture and perforation of the patient’s organs
- Device migration triggered cardiac tamponade
- The exterior surface of the IVC filter was inadequately prepared, which increased the risk of weakening and failure
- The device had insufficient structural integrity or strength to withstand normal placement within the body
- The device was not designed to tolerate the stressors of the respiratory and cardiac cycles of the body
- Impossible device removal
According to the complaints, device manufacturers started receiving complaints as early as 2005 and were aware of the issues with the IVC filters, but opted not to disclose the reports to the FDA, the patients, and the medical community.
IVC Filter Mass Torts and Settlements
As of July 2019, more than 11,000 IVC filter lawsuits and mass torts have been file against device manufacturers, including Cook, Bard, and Boston Scientific. Most of the mass torts involve the retrievable models. The first cases against Bard were consolidated into MDL in Indiana on October 2014. The U.S. Judicial Panel on Multidistrict Litigation consolidated other cases against Bard in Arizona. Boston Scientific IVC filter cases are consolidated in Ohio.
In the first case to go to trial, a jury found that Bard was not negligent and did not sell a defective product. Courts record show that Brad has settled at least 3 cases involving between 2013 and 2015. In Florida, C.R. Bard won a partial summary judgment due to undisputed evidence that perforation is a risk in the IVC filter design. The judge instructed plaintiffs not to sue the manufacturer over negligent misrepresentation or failure to properly warn. However, plaintiffs are still entitled to sue for design as well as punitive damages for injuries sustained.
In March 2013, Bard reached a confidential settlement with a plaintiff who claimed the G2 filter broke and traveled to her heart. In 2014, Bard agreed to an undisclosed settlement with another plaintiff who claimed the Bard Recovery IVC filter device broke and perforated his heart. In March 2018, Bard was ordered to pay $1.2 million to a firefighter who experienced blood vessel and organ perforations. The jury found that the manufacturer should have properly wanted the plaintiff’s surgeon of the potential risks of its Cook Celect IVC filter.
The first great verdict against Cook was in April 2018 when the jury awarded $3.6 million to a plaintiff in the first bellwether trial. A jury found that the G2 IVC filter was susceptible to fracture due to Bard’s negligence. The amount comprised of $1.6 million in compensation and $2 million in punitive damages to punish Bard for their conduct. The punitive damages increase the settlement value of all other cases. In February 2019, an Indianapolis jury awarded $3 million to a plaintiff who suffered a cardiac injury caused by a defective Cook IVC filter.
No IVC filter mass torts have made it all the way through trial, but attorneys are still very high on the cases. The next bellwether trial was to begin on May 2019, but Judge Campbell said a sixth test trial will not be held and all the cases will be remanded back to the states for trial if a settlement is not reached.
Find an IVC Filter Mass Tort Near Me
If you or someone you know has suffered serious side effects and deaths due to a defective IVC filter, the mass tort experts at Consumer Alert Now are prepared to help you. Call us at 800-511-0747 or complete our contact form for a free, no-obligation case review. We operate nationwide and connect individuals with experienced mass attorneys who can take on huge manufacturers.