What Is an IVC Filter?
An inferior vena cava filter (IVC filter) is a tiny medical device that is implanted into the large vein which returns blood from the body to the heart. This vein is also known as the vena cava. The IVC filter is intended to “catch” any blood clots that may break away from arteries or veins before they travel through the heart to the lungs and become a deadly pulmonary embolism. The IVC filter is used in patients at risk of a pulmonary embolism due to deep vein thrombosis (DVT) or other clotting disorders.
The inferior vena cava is the largest vein in the human body. It is the pathway that “used” blood travels from the body to the right side of the heart where it is pumped to the lungs to be re-oxygenated. From the lungs, the blood returns to the left side of the heart where it is pumped again to provide oxygen and nutrients to body tissues.
People with certain medical conditions, such as deep vein thrombosis (DVT) and other clotting disorders, may develop blood clots that can break off and travel to the lungs. A blood clot that travels to the lungs is known as a pulmonary embolism and may result in near-immediate death.
Most patients with DVT and related clotting disorders will be given anticoagulant medication, but not all patients may tolerate this medicine. IVC filters were designed to be implanted into the inferior vena cava in these patients, to catch any blood clots which may have formed and are loose in the blood.
The IVC filter is a very small “basket” or “cage” made of metal that catches any blood clot and retains it until the body’s natural systems break it down. The first IVC filters were “permanent” devices and were intended to be left in place. When devices such as the Recovery IVC filter were approved, they were initially approved for permanent placement and later approved as “retrievable”, intended for removal after the danger of DVT or clot has passed.
Unfortunately, though currently marketed IVC filters are intended to be removed, retrieval may be difficult, and many are left in place. The devices may shift in place, perforate venous tissue, break apart, or detach from the original placement.
There are many companies that manufacture IVC filters. All IVC filters have the potential to cause serious complications, and several manufacturers are facing lawsuits. One of those companies, Bard, is facing hundreds of lawsuits by plaintiffs who claim that its Recovery IVC filter and G2-IVC filter caused a medical injury. This is not Bard’s first experience with lawsuits as they have faced thousands of legal claims regarding harm caused by transvaginal mesh and other medical devices.
Who Is Bard?
Bard, formerly called C.R. Bard, is a New Jersey-based medical device manufacturer with an estimated annual revenue of about $3 billion. Bard manufactures a number of medical devices including urological, surgical, and gynecological products, and is one of the largest manufacturers of IVC filters. Two of Bard’s most popular products include the Recovery and G2 IVC filters.
The Bard Recovery filter and Bard G2 filter have been named as two of the retrievable IVC filters that are prone to failure. The Recovery filter was the first-generation filter and was introduced in 2003. The second generation, or G2, was introduced in 2005. The G2 was intended to replace the Recovery device.
Bard’s initial application for FDA approval of its IVC filters was denied in 2002. Its devices ultimately gained FDA approval in 2003 and 2004. The IVC filters were labeled as Class II, which is the same safety classification as mercury thermometers. The approval of these devices was without any clinical data on safety and effectiveness. Many of the IVC filters on the market were approved via the FDA’s shortcut approval process known as 501(k). This allows medical products similar to those already on the market to be approved for sale without the usual tests required for new products.
Between 2005 and 2010, the FDA received 921 reports of serious adverse events involving IVC filters including reports of:
- Device migration or movement to another area
- Detached device components which travel to other organs (called device embolization)
- Filter perforation
- Filter fracture
Device migration was the most common adverse event and was responsible for 36 percent of adverse event reports. Device embolization was the second most frequently reported adverse event.
The FDA issued a warning in 2010 stating that complications could be caused by retrievable filters which remained in place for too long. The FDA recommended that implants be removed as soon as the danger of blood clots had passed. Although the FDA issued this warning, most retrievable IVC filters are never retrieved.
A 2010 study published in the Journal of the American Medical Association (JAMA) Internal Medicine showed that about one-fourth of Bard G2 filters failed with device fractures or breakages. The study reported the death of one patient though the cause of death was not specified.
A 2012 research study published in the CardioVascular Interventional Radiology journal indicated retrievable IVC filters manufactured by other companies also failed. Two devices, the Gunther Tulip and Cook Select were shown to have a high rate of vena cava wall puncture within 71 days of placement and showed a 40 percent migration rate.
Even though the retrievable IVC filter devices should be removed after the risk of pulmonary embolism has passed, a 2013 study showed that less than 9 percent of devices were actually removed.
The same study identified other issues including:
- 18.3 percent failure rate in device removal attempts
- 7.8 percent venous thrombosis event, 25 percent of which were pulmonary embolism, the exact medical condition the devices were intended to prevent.
Because of these complications, in May 2014, the FDA advised that retrievable IVC filters should be removed within 29 to 54 days after implantation.
Patients who are left with devices beyond the encouraged removal date are at risk for:
- Blood clots
- Severe pain
- Hemorrhaging due to perforation
- Pulmonary embolism
- Heart failure
Because of the risk of device migration, fracture, and detachment, IVC filters may also cause serious side effects including:
- Perforation of blood vessels, tissues, and other organs
- Internal bleeding or hemorrhage
- Additional blood clots
- Cardiac Tamponade
Medical device manufacturer, Bard, is facing several hundred lawsuits regarding injury caused by the Recovery and G2 IVC filter devices. Bard has tried unsuccessfully to have several of the lawsuits dismissed.
Manufacturers of IVC filters may be sued on several grounds. These include:
- Defective design of the product
- Defect in manufacturing
- Failure to warn
- False labeling
Plaintiffs allege that the company knew the devices were prone to fracture and migration but failed to warn the public and the medical community.
Injuries cited in IVC Filter lawsuits include blood clots, pulmonary embolism, heart failure, hemorrhage, and death that occurred after receiving a Bard Recovery of B2 IVC filter.
Additional lawsuits included claims of:
- Device fracture and migration to the renal vein
- Device embolism in the heart
- Devices migration to the pulmonary artery
- Device migration that triggered cardiac tamponade
- Vena cava puncture from device migration
According to information listed in the complaints, Bard began receiving complaints in 2014 and knew there were issues with the IVC filters but chose not to disclose the reports to the FDA or the medical community.
The first case to go to trial was settled in 2015 after just 10 days of litigation. The plaintiff in the case was forced to undergo open heart surgery following a device embolism that perforated his heart.
In cases such as these, plaintiffs may be entitled to receive monetary compensation if the manufacturer is found to have breached some duty or violated some right. The goal with these damages is to try and make the injured party whole.
Damages recovered in IVC filter lawsuits include:
- Past medical costs
- Present medical costs
- Future medical costs
- Lost wages
- Future earnings
- Pain and suffering
- Emotional distress
- Punitive damages
- Wrongful death – if the product caused the death
Bard has been ordered to pay out millions of dollars in settlements to various patients who were injured by the Recovery and G2 IVC filters.
- In 2020, Bard was ordered to pay $3.6 million as the result of a product liability lawsuit.
- Bard was ordered to pay another plaintiff over $2.1 million in damages and over $300,000 for future medical expenses. This plaintiff experienced blood clots in her lungs due to the IVC filter breaking which caused pieces of the filter to go to her heart and lungs.
- In 2021, Bard was ordered to pay $3.3 million to a plaintiff whose IVC filter was lodged in her vein.
- In 2022, Bard was ordered to pay almost $400,000 to a plaintiff who experienced a fractured IVC filter.
Bard is not the only IVC filter manufacturer defending lawsuits due to injuries and complications. Many other manufacturers have settled lawsuits out of court, and the details of those settlements are not public.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.