Should I file an IVC filter lawsuit because the device malfunctioned?
People with IVC filters, especially those made by the Bard company, are filing lawsuits because of problems they experienced. Plaintiffs with the Recovery and G2 IVC filters have been injured and needed follow-up care to correct the damage caused by these filter. According to claims, the devices were poorly designed and Bard failed to warn consumers and the medical community about the risks.
Inferior vena cava (IVC) filters are medical devices that block blood clots from traveling to the lungs, which can be fatal. IVC filters are implanted in the body’s largest vein (the vena cava) when a person has an increased risk for blood clots. These metal filters catch the clot and hold it in place until it disintegrates naturally, so it cannot cause any damage.
Temporary IVC filters, like those made by Bard, are supposed to be removed as soon as the danger for clotting has passed. However, many people who were implanted with temporary filters still have them in place, despite the danger.
FDA Receives Adverse Event Reports
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.
By 2010, the FDA had received nearly 1000 adverse event reports related to IVC filters. These reports include:
- Device embolism: detachment of parts traveled throughout the body
- Device migration: entire device moved from original site
- Filter perforation or fracture: device broke and/or punctured tissue in the body
In response to the numerous reports, the FDA issued an advisory warning to doctors. The warning alerted doctors to the fact these retrievable devices should be removed and if left in place too long, would cause serious complications.
Medical studies confirmed the danger and showed a high failure rate for Bard’s Recovery and G2 filters. Data showed complications that included:
- Venous wall puncture
- Venous thrombosis
- Pulmonary embolism
- Device removal failure
According to one of the studies, only nine percent of the retrievable devices had been removed – leaving 91 percent of IVC filter recipients at risk.
FDA Updates Warning
In 2014, the FDA issued an updated warning about IVC filter. The warning called for doctors to remove retrievable IVC devices within 29 to 54 days of implantation.
Patients who are left with devices beyond the encouraged removal date are at risk for:
- Severe pain
- Blood clots
- Hemorrhaging due to perforation
- Pulmonary embolism
- Heart failure
IVC Filter Lawsuits
As a result of the problems with IVC filters many users have filed lawsuits against Bard. The first case to go to trial settled in 2015 after just 10 days of litigation. The plaintiff in the case was forced to undergo open heart surgery following device embolism that perforated his heart.
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.
As a result of Bard’s negligence and their experience with a faulty medical device, IVC filter recipients might be eligible for compensation. In addition to money for pain and suffering, medical treatments, and lost wages, some might receive punitive damages because the company hid issues with its product.
If you or a loved one has been injured because of problems with an IVC filter, you should speak to an attorney as soon as you can.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.