Boston Scientific is yet another manufacturer facing litigation. This past May, plaintiff Katherine Milan filed her inferior vena cava filter lawsuit against Boston Scientific. According to court records, she experienced pain in her thigh and lower abdomen soon after receiving a Greenfield IVC filter from Boston Scientific. Milan also claims to have suffered from extensive clots. A CAT scan later showed that the IVC filter had become occluded, her complaint says, requiring Milan to be on blood thinners for the rest of her life.
Inferior vena cava filters are commonly used as a defense against blood clots when a patient is at high risk, and for whom pharmaceutical intervention through the use of blood thinners is neither appropriate, nor effective. The IVC filter, a small device that resembles a spider or a fishing lure, is designed to languish in the inferior vena cava – a primary artery – and capture migrating blood clots moving up from the lower extremities, before they have the opportunity to reach the lungs – where they can often be fatal.
The issue with IVC filters – and the foundation of IVC filter lawsuits – is when IVC filters break free from their primary insertion point and migrate themselves towards the heart. Such IVC filter migration often impacts the heart or tissue in the inferior vena cava with devastating results. The fine, metallic struts of the IVC filter have also been found to break off and travel elsewhere, often becoming lodged in arterial tissue or vital internal organs.
Most IVC filters are designed as a temporary measure, and are to be retrieved once the imminent danger of blood clot migration has passed. The US Food and Drug Administration has since determined – and released a recommendation to that end – that removal of IVC filters should be undertaken no later than three months following initial implantation.
Various studies, however, have determined that the vast majority of temporary IVC filters are never successfully retrieved – only adding to the long-term risk of IVC filter side effects.
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The angiogram discovered much more: the Cook Celect IVC filter had effectively tilted out of position, fostering deep vein thrombosis in her left lower extremity. A subsequent IVC filter placed above the failed Cook IVC filter was followed by insertion of right and left vein catheter placements.
Both Milan and Homes will be on blood thinners long term.
“Defendants negligently, recklessly, wantonly, and carelessly failed to properly design and manufacture the [IVC filters],” the IVC filter lawsuits claim.
The cases are Katherine Milan et al. v. Boston Scientific Corp., Case No. 5:16-cv-00065, and Olenda Homes et al. v. Cook Medical Inc. et al., Case No. 5:16-cv-00066, both in the US District Court for the Western District of Kentucky.