Blood filters surgically implanted to catch blood clots in the blood stream are breaking apart as a result of defective design. A number of lawsuits have been filed across the United States by patients with these filters who have suffered serious injuries when parts of the filters break off and puncture the vein, heart, or other organs.
Back in 2010, the Food and Drug Administration (FDA) issued a warning to physicians about certain retrievable inferior vena cava (IVC) filters placed inside the vena cava, the largest vein in the body.
IVC filters are devices that are implanted in the vena cava—a large vein that returns deoxygenated blood to the heart—to catch embolisms, or blood clots traveling to the heart. By trapping these clots, blood can continue to flow while anticoagulants work to dissolve the clot. A clot that passes through the heart and to the lungs or brain can be deadly.
Between 2005 and 2010, the agency received more than 900 adverse event reports about IVCs from Bard and Cook that included several problems:
* Device migrating out of the vena cava
* Detaching parts that caused an embolization (the very problem they are supposed to prevent)
* Perforation of body parts by the filter
* Filter breaks
In 2010, the FDA released a stronger warning advising physicians to remove Bard and Cook IVCs within one to two months and after the embolism threat is lower.
In September 2015, NBC reported on a year-long investigation into Bard’s IVC filters. It concluded the manufacturer continued to sell and market the device even after it became aware it caused serious injury and death. NBC uncovered at least 27 deaths and more than 300 injuries associated with Bard’s devices.
In addition, one of Bard’s FDA regulatory specialists, Kay Fuller, quit the company after it refused to address her concerns about Recovery’s safety. Fuller also accused Bard of forging her signature on an application to the FDA for a redesigned IVC filter she refused to endorse.
It’s estimated that about 30,000 patients have been fitted with IVC devices from Bard and Cook Medical over the past 30 years. Reports culled from medical journals indicate:
* 40% of patients with IVC implants have experienced filter fracture after five and a half years
* Almost 10% of patients receiving retrievable IVC implants at Boston Medical Center suffered a blood clot anyway
Patients and their families who believe they suffered injuries from the devices are now fighting back.
A wrongful death lawsuit against Bard was filed in Missouri in September 2015. In addition, a U.S. Judicial Panel approved consolidated federal proceedings in Arizona against Bard and in Indiana against Cook. This allows patients to band together into a single lawsuit and share damages that may be recovered.
If you have had an IVC implant, check with your doctor about the manufacturer. Be sure to also get legal advice to review any unexpected or severe side effects that may be related to the device.
Fill out this form to contact Joe Saunders for a free evaluation, or call 1-800-748-7115.
Saunders & Walker, P.A. Copyright© 2005 - . All rights reserved.