Bard IVC Filters Lawsuit
Inferior vena cava filters, or IVC filters as they are commonly known, are small devices designed to help prevent blood clots in patients who are at risk of developing deep vein thrombosis, or DVT blood clots. The vena cava is the main artery that runs from the legs upward toward the lungs and chest. IVC filters are designed to prevent blood clots (thrombi) from traveling up the vena cava to the lungs causing a pulmonary embolism (PE). IVC filter use has increased dramatically in the past 30 years, with more than 200,000 devices used in 2012.
The primary manufacturers of IVC filters include:
- R. Bard, Inc.
- Cordis Corporation
- Cook Medical
- Argon Medical Devices
- Volcano Corporation
Even with such a high rate of use, IVC filters are not without risk. These small devices are often left inside the patient, rather than being removed after the risk of blood clots has resolved. Failure to remove IVC filters in a timely manner can result in additional health complication, such as hemorrhages, heart attack, or even death.
Food and Drug Administration (FDA) Approves IVC Filters, Cautions Patients and Medical Professionals with Concerns over Complications
- According to the U.S. Surgeon General, somewhere between 100,000 and 180,000 people die every year from pulmonary embolism, though it is unclear what percentage of those deaths are attributed to IVC filters.
- Since 2005, the FDA has reportedly received hundreds of reports of adverse patient experiences with IVC filters. The FDA has since continued to warn against leaving IVC filters in place longer than is necessary to reduce the risk of blood clots.
- In 2010, the FDA released a report warning patients and healthcare professionals of the dangers of IVC device fractures, migrations, and perforation of nearby organs. Shortly after releasing the report, several lawsuits were filed on behalf of patients who experienced severe health complications.
FDA Demands Trials for Safety of IVC Filters
The FDA has requested that IVC filter manufacturers conduct at least three years of documented trials to assess the safety and effectiveness of IVC filter products. C.R. Bard, Inc., one of the most noted manufacturers, is among those targeted by the FDA.
Currently, litigation surrounding IVC filters includes state and federal courts across the United States. During the early stages of the influx of lawsuits, C.R. Bard, Inc. accidentally released information pertaining to defect and migration rates among older and newer IVC models. Shortly thereafter, it became apparent that the manufacturer was aware of the potential dangers, but failed to report the risks to the FDA. After receiving more than 900 adverse reports from patients across the country in 2012, the FDA released a public safety advisory warning patients of the dangers, and spurring healthcare and legal professionals to take action.
If you or someone you know what been injured or lost their life due to a defective or improperly retrieved IVC filter, do not hesitate to find out your legal rights and learn more.
Frequently Asked Questions Regarding IVC Filters
An IVC filter is a small device made from steel and other materials known as non-ferromagnetic materials, or materials that are safe for MRI and other magnetic testing.
In most instances, IVC filters are used for temporary blood clot prevention, or are used in patients who are unable to be treated with anticoagulation medications, such as Coumadin or Heparin.
The FDA reports that, in 2010 alone, there were 70 instances of perforated organs; 328 migrations; 56 fractures; and 146 instances of embolization, where part of the IVC detached.
Yes. Manufacturers are required to conduct tests and certain that their products are safe and effective. Additionally, manufacturers are required to report any dangers or adverse reports to the FDA and safety officials.
Individuals who have suffered injury, illness, or loss due to a defective medical device may be able to file a lawsuit against the manufacturer. Such lawsuits may claim negligence or strict liability, failure to warn, design defect, or breach of warranty.
In order to determine your legal rights and options, contact an experienced medical device injury attorney.