IVC Filter Lawsuit
If you sustained injuries or suffered a medical complication from a defective IVC filter, contact FrancoLaw today. You might be entitled to compensation.
Certain IVC filter devices have been linked to a number of adverse health risks that the manufacturers failed to adequately test for and warn consumers about. IVC filters are used in patients who are at risk of developing blood clots, but who are not candidates for blood thinner medication. To date, the FDA has received thousands of adverse event reports and many patients are reporting serious IVC filter complications and injuries including perforation or other damage to organs when the device migrates or fractures.
Medical device companies are required to perform safety tests, meet all quality standards, and provide adequate warnings of all potential risks before placing their products on the market. If a patient or doctor does not know the possible adverse effects associated with a medical device, they don’t have the ability to make an informed decision regarding treatment options or choosing a different device to protect oneself from injury or illness. Companies should be held liable for failing to adequately warn patients about the harmful effects of using their medical devices.
At FrancoLaw, we have the experience and resources to stand up against device manufacturers and hold them accountable for the harm they have caused. We will be your advocate and fight by your side for the justice and compensation you deserve. For a free consultation to discuss the circumstances of your injury and determine the available legal options, call FrancoLaw today at (888) 213-0761.
What is an IVC Filter?
IVC filters are small, cage-like devices that are surgically implanted into the inferior vena cava (IVC) to capture blood clots and prevent them from reaching the heart and lungs. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective. Reports estimate that more than 250,000 devices are implanted each year, but only a small percentage of the filters are removed.
Unless there is a very good reason to keep the IVC filter in place, the FDA now recommends the removal of retrievable IVC filters. According to a safety communication posted by the FDA in August of 2010, IVC filters are intended for short-term placement and have caused risks when left in long-term including lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
Common Complications Associated with IVC Filters
Since the introduction of IVC filters in 2005, the FDA has received thousands of adverse reports involving these filters. Specifically, it was reported that IVC filters fragment and embolize inside the body. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. A defective IVC filter can cause a range of dangerous side effects, such as:
- Tissue damage
- Perforated veins, arteries, and blood vessels
- Respiratory distress
- Cardiac tamponade (fluid buildup)
- Pulmonary embolism
- Internal bleeding
- Deep vein thrombosis (DVT)
If you suffered a serious side effect or injury due to a defective IVC filter, call FrancoLaw to discuss your legal options. We can review the circumstances of your case and determine if you qualify for a IVC Filter lawsuit.
FDA Warnings on IVC Filters
The FDA first released a public safety communication in 2010, warning of possible adverse health events associated with long-term IVC filter use.
- August 2010: The FDA reported that it had received more than 900 reports of people suffering adverse events following the implantation of a filter. These events included device embolization, fractures, perforation of organs, and device migration. The agency recommended that doctors remove filters as soon as they were no longer needed.
- May 2014: The FDA updated its 2010 warning to recommend that doctors take out IVC filters within 29-54 days of implantation. It is requiring IVC Filter manufacturers to conduct studies of the device’s safety.
- July 2015: The FDA issued a warning letter to C.R. Bard after an FDA investigation found that the manufacturer was producing a certain IVC filter device removal system without marketing clearance or approval. The letter also informed Bard that it was (1) not following good manufacturing practices in the manufacture, storage, and packaging of IVC filters; (2) did not properly establish and maintain procedures in regard to reviewing and evaluating complaints relating to certain models; and (3) did not report information that reasonably suggested its devices had malfunctioned, and those malfunctions could lead to either a severe injury or death.
IVC Filter Complication News
- Why did firm keep selling problem blood-clot filters? – NBC news
- Did blood-clot filter used on thousands of Americans have fatal flaw? – nbcnews.com
Contact Us Today
If you sustained injuries or suffered a medical complication from a defective IVC filter, you may be eligible to file a IVC Filter lawsuit. You can discuss your case with us during a free consultation and receive the legal advice you need to make an informed decision about what to do next. Let us fight for you to hold the manufacturer accountable for your injuries and recover the compensation you deserve. Our firm is experienced in handling defective medical device cases and we welcome any questions you may have. Call us now at (888) 213-0761 for a free consultation.