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A product liability lawsuit has been over complications with an Option Elite IVC filter, alleging that the small device implanted to “catch” blood clots among individuals at risk of a pulmonary embolism, tilted out of position and became embedded in the vena cava of an Ohio man.
The complaint (PDF) was filed last month by Russell Warnke in the U.S. District Court for the Eastern District of Texas, naming Argon Medical Devices, Inc. and Rex Medical L.P. as defendants.
Inferior vena cava (IVC) filters sold by a number of different manufacturers have been linked to a large number of problems in recent years, commonly involving devices that were designed to be retrievable after the blood clot risk had passed. C.R. Bard, Cook Medical and other manufacturers face hundreds of lawsuits over issues with their products, including allegations that the device moved out of position, punctured the vein or fractured, sending small pieces to the heart or lungs.
The Option Elite IVC filter is a newer device, which was just approved under the FDA’s controversial 510(k) fast-track approval program in 2013, meaning the manufacturer was not required to conduct thorough testing to establish the device was safe and effective, since it was deemed to be “substantially equivalent” to previously approved products.
According to the lawsuit, Warnke an Option Elite Retrievable IVC filter was implanted in January 2014. However, when retrieval was attempted a year and a half later, in June 2015, it was discovered that the IVC filter tilted inside of his body, with its hook imbedded in the wall of Warnke’s inferior vena cava.
“As a direct result, Plaintiff suffered significant injuries, including but not limited to, the embedment of the retrieval hook of the Option Elite Retrievable Inferior Vena Cava which has made the filter un-retrievable,” the lawsuit states. “The embedded filter places the Plaintiff at an increased and continual risk of complications such as the potential for the filter to become occluded with blood clots thereby disrupting the normal flow of blood to the heart and lungs.”
The lawsuit also warns that Warnke faces an increased and ongoing risk of the filter perforating the vena cava and surrounding vital organs, as well as the risk of the device fracturing, sending portions into his heart or lungs, which could be fatal.
IVC Filter Concerns
Concerns about IVC filters emerged nearly 10 years ago, leading the FDA to first warn about problems with IVC filters in August 2010. At that time, the agency indicated that more than 900 adverse event reports had been received involving complications where the device broke free inside the body, migrated out of position, perforated the vena cava or fractured.
In May 2014, the FDA issued another warning, urging doctors to remove IVC filters within about one to two months after an individual was no longer at risk of suffering a pulmonary embolism, since the risk of problems appeared to be greater the longer the filter was left in place. However, many manufacturers sold the devices for years without adequately informing physicians about the risks associated with leaving them in place.
Several studies in recent years have also raised serious questions about the effectiveness of IVC filters, suggesting that they may provide no substantial benefits over other treatment options for blood clots.
As individuals have learned that design problems may be the cause of serious and life-threatening injuries experienced in recent years, a growing number of lawsuits have been filed against manufacturers, alleging that they sold unreasonably dangerous and defective devices, without adequately researching the products or warning about the risk of complications.
There are currently more than 1,800 Bard IVC filter lawsuits pending throughout the federal court system, which are currently centralized before one judge for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation. Another 1,900 Cook IVC filter lawsuits are centralized as part of a separate MDL, raising similar allegations of problems associated with filters manufactured by Cook Medical.
As IVC filter injury lawyers continue to review and file additional claims over the coming months and years, it is ultimately expected that the size of the litigation will continue to grow.