The wave of lawsuits over defective blood clot filters, implanted in the inferior vena cava — the body’s largest large vein which carries deoxygenated blood from the lower and middle body into the right atrium of the heart, don’t appear to be subsiding.
In March, a federal lawsuit was filed against inferior vena cava (IVC) filter manufacturer B. Braun, and its subsidiary Aesculap Implant Systems, alleging that its “defective implantable blood clot filter” caused the death of patient Keith W., according to The Morning Call.
The lawsuit states that the B. Braun IVC filter dislodged 10 days after being surgically implanted in the plaintiff, resulting in pieces of the device lodging in Keith’s heart and lungs and causing fatal blood clots to form.
IVC filters are designed to prevent blood clots, which are fatal when they migrate to the heart and lungs.
Inferior vena cava filters, known as IVC filters, are surgically implanted in patients at risk of pulmonary embolism — a blockage of an artery in the lungs by a substance that has traveled from somewhere else in the body through the bloodstream — who cannot take a blood-thinner or for whom blood-thinners have not been effective.
In May, a B. Braun IVC filter was the subject of another lawsuit, this one brought by a Valhalla, New York man who claims that the device dislodged and migrated to the right atrium of his heart 10 days after his November 2015 surgery.
The man underwent emergency surgery to remove the B. Braun IVC filter but will require ongoing medical care and monitoring for the rest of his life, according to his complaint.
B. Braun IVC Filter Complications Prompt Lawsuits
IVC filter complications and deaths have spawned thousands of lawsuits filed by U.S. patients.
NBC News reported in 2015 that some 250,000 U.S. patients have blood clot filters implanted each year.
In 2010, the U.S. Food and Drug Administration issued a warning that IVC filters intended for short-term use posed health risks if not removed once a patient’s risk of developing a pulmonary embolism subsided.
The health risks cited by the FDA included lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
The federal agency in 2014 issued an updated safety communication detailing reports of adverse events associated with long-term IVC filter use..
Years earlier, in 2007, B. Braun recalled its IVC filter for compromised sterility during packaging.
On Oct. 30, 2007, the company issued a nationwide Urgent Medical Device Removal Letter recalling its Vena Tech LP Vena Cava Filter System.
The notice stated that a package sealing problem resulted in packaging being partially open on one of the four sealed Tyvek pouch edges.
The medical device removal letter — sent express mail to hospitals that received the recalled lot — was terminated on March 2, 2008.
The FDA terminates a recall once the agency determines that “all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.”
The B. Braun recall was a Class 2, a mid-level recall indicating that using the product may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences with a Class 2 recall is remote, according to the FDA.
If you’ve suffered from IVC filter complications, the attorneys at McDonald Worley can help. Their experienced team of IVC filter attorneys offer a free case evaluation. Call today!