U.S. Court of Appeals for the Ninth Circuit upheld damages awarded to a patient who suffered heart damage from C.R. Bard’s clot-stopping vein filter. The court ruled that the U.S. Food and Drug Administration’s edicts did not pre-empt Georgia’s state law underscoring a duty to warn.
In 2007, patient Sherr-Una Booker underwent a surgical procedure to place a Bard’s G2 model inferior vena cava (IVC) filter near her heart. When fragments of the filter became detached, Booker was forced to under heart revision surgery.
After two years of clinical trials, a new type of IVC filter was recently implanted in a number of patients under “real world” conditions in an Arizona hospital. The product is called the “Sentry” and is produced by BTG Interventional Medicine, a company based in the UK.
Introduced this month at Vascular Interventional Advances Conference in Las Vegas, the new IVC filter has what the manufacturer describes as a “unique bioconversion feature”, making retrieval of the device unnecessary.
Cook Medical, already facing more than 3,000 lawsuits over defective IVC filters, was targeted in several more complaints filed this month by injured parties from California to New York. The lawsuits name two different models: the Günther Tulip® and the Celect®. At the same time, Rex Medical L.P. and Argon Medical Devices Inc. have been targeted by plaintiffs in Michigan and New Jersey over their OptionTM ELITE IVC Filter. In both of the latter cases, the device tilted, puncturing the artery wall, and surgeons were unable to remove them.
It was the best of filters – so the manufacturer claimed. It turned out to be the worst of filters. An early study involving the Cook Celect Vena Cava Filter indicated the device was incredible. Another study, published three years later, demonstrated otherwise.
Ongoing litigation over inferior vena cava (IVC) filters have had mixed results so far this year. In March, the first bellwether trial ended in a verdict for the plaintiff. A jury in Phoenix Arizona ordered medical device manufacturer C.R. Bard to pay a total of $3.6 million to a woman whose IVC fractured and migrated to her heart.
IVC Filter: a Stationary Object in a Continually Moving Body – Could Designers Not Have Foreseen this Problem?
One fact about the bodies of virtually all animals – including those of homo sapiens – is that Nature designed them to be in continual motion, even when appearing dormant. Even when sleeping or at rest, bodies stir, twitch and roll over.
During most of its waking hours, the human body is walking, running, manipulating objects using arms and hands, bending over, standing, sitting, and more (at least it should be). Given this, why would the designers of the inferior vena cava (IVC) filter create a device intended to remain in one place?
After several years of growing popularity, use of IVC filters started falling in 2010 – shortly after the FDA issued a safety alert about the long-term use of these devices. According to two studies presented at a recent meeting of the Society of Interventional Radiology, this decrease can be attributed to the FDA warning.
Water filters, oil filters on a motor vehicle, furnace filters, dust filters – all must be removed and replaced at some point in order for the machinery to continue to function properly. Logically, this should apply to IVC filters as well. However, removal of the IVC filter from a patient has proven to be extremely problematic. Once implanted, they have a tendency to fall out of place, migrate to other parts of the body and break apart. The shards can cause severe injury to arteries and organs.
At first, IVC (inferior vena cava) filters seemed to be a great idea. Anticoagulant medications can be tricky, causing an elevated risk of serious hemorrhaging, and some patients cannot handle them at all. Placing a small metal cage into the primary artery leading to the heart and lungs in order to trap clots and prevent them from reaching it appeared to be the ideal solution. So, why is it that this particular cure has proven to be worse than the disease?
Recent efforts to reach a settlement agreement in the Cook IVC Filter Litigation were unsuccessful, meaning a select number of cases for early “bellwether” trials could get underway next year, if additional settlement attempts don’t result in an agreement.