Blood clot filters have been implanted in thousands of people who are at risk for pulmonary embolisms, also referred to as blood clots. However, new reports indicate that certain types of blood clot filters may be defective, contributing to patient injury and death. There have been about 27 deaths associated with C.R. Bard’s Recovery blood clot filter, as well as 300 other non-fatal incidents according to an NBC News report.
The problems include allegations that pieces of the filter break off, requiring the patient to get emergency open-heart surgery with a great risk of serious complications or death. These types of devices have been implanted in patients since the 1960s, and the manufacturer, C.R. Bard, gained FDA clearance to market inferior vena cava (IVC) filters over a decade ago.
In 2010, The FDA issued a safety warning about IVC filters that had a risk of adverse events with long-term use. With 921 reported device-related adverse events over a five-year period, there are many patients who have already suffered serious or deadly consequences, and others who may be currently at risk.
The main problem that has been identified is the detachment of device components which migrate, leading to lower limb deep vein thrombosis, or the potential for broken pieces of the filter to perforate the heart or lungs, with potentially tragic results.
The NBC News article reports that although death and injury reports continued to climb, the company chose to continue selling the device. Over 34,000 were sold over a three year period, before the company replaced the device with a newer version called G2.
About 250,000 blood clot filters of all brands are implanted in patients every year, and 11 different companies manufacture various versions.
How Blood Filters Can Injure Patients
These devices are most commonly implanted in patients who cannot tolerate anticoagulant (blood-thinning) medication. The filter is supposed to stop the clots from travelling to major organs.
Questions have arisen about whether the manufacturer was aware that the device had problems, according to an NBC News report. Although cleared by the FDA, the report notes that the process did not go smoothly. There are even allegations of a forged signature on the application submitted to the FDA, according to NBC.
FDA Warning Letter
In August 2015, the FDA issued a Warning Letter to C.R. Bard, the blood clot filter manufacturer, about several violations, including:
- Adulteration/misbranding of product.
- Marketing a device without FDA approval that has not acquired the legally required premarket approval.
- Quality system regulation violations.
- Failure to establish and maintain procedures in inspection testing or otherwise verify that incoming products are conforming to specified requirements.
- Failure to establish and maintain systems to ensure suppliers meet the required specifications.
- Failure to submit information to the FDA regarding reports that a device has malfunctioned and may contribute to a patient suffering death or serious injury.
Legal Help for Victims of Blood Filter Injuries in South Carolina
If you have suffered a serious injury or a loved one has died after having a blood filter implanted during surgery that later failed, it is imperative that you seek legal help you can trust. You could have the right to seek compensation for your damages, including medical expenses, pain and suffering and other losses.
Our dedicated South Carolina personal injury lawyers at Joye Law Firm are compassionate, professional and committed to pursuing justice in these cases. You can count on our blood clot filter attorneys to give you a fair and honest evaluation of your claim.
Just Call Joye now or fill out our online contact form for a free case evaluation.
- NBC News: Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?
- FDA: Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
- NBC News New York: Fatal Flaws? Questions Raised About Blood-Clot Filter
- NBC News: Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?
- FDA: Warning Letter to C.R. Bard, Inc. 7/13/15