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Option Elite IVC Filter Problems Resulted in Failed Retrieval, Lawsuit Alleges

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A Florida woman indicates that she may be left with a defective and dangerous blood clot filter in her body for the rest of her life, after the retrieval hook on an Option Elite IVC filter, which was designed to make the device retrievable, got hooked into her inferior vena cava instead. 

In a product liability complaint (PDF) filed in the U.S. District Court for the Southern District of Florida on July 31, Graciela Agama indicates that problems with the Option Elite IVC filter have left her with severe and permanent personal injuries. Argo Medical Devices, Inc. and Rex Medical, L.P. are named as defendants in the lawsuit.

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 Agama’s lawsuit, she was implanted with the Option Elite Retrievable IVC filter in December 2013. However, when a surgeon attempted to retrieve the device in August 2014, he found it to be completely imbedded in her inferior vena cava wall. As of October 2016, the device was found to be extruding through her inferior vena cava, but still cannot be retrieved.

“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 indicates. “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 embedded filter also poses an increased and continual risk of perforation, including perforation of the Plaintiff’s vena cava, perforation of surrounding vital organs, and perforation of the spinal column, all of which can result in severe pain and life-threatening complications.”

The lawsuit also notes there is a risk that the filter could fracture, and that the broken debris could travel to her heart and lungs, which could cause a pulmonary embolism and severe injury or sudden death.

IVC Filter Litigation

Medical device manufacturers face thousands of product liability claims, each raising similar allegations that they failed to adequately warn about the risk that IVC filters may fracture, move out of position or puncture the vena cava, resulting in serious and potentially life-threatening injuries. The vast majority of those claims are filed against C.R. Bard and Cook Medical.

There are currently more than 3,500 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.

In April, a federal jury in Arizona ordered C.R. Bard to pay a woman $3.6 million for injuries suffered after a Bard G2 Vena Cava filter fractured inside of her body, and another bellwether trial is set to begin in September.

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 in the coming months and years.

While the outcomes of these early “bellwether” trials are not binding on other plaintiffs, they are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. If the manufacturers fail to negotiate IVC filter settlements to resolve large numbers of cases in the coming months, they may start facing hundreds of individual trial dates nationwide.

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