IVC Filter Claims
Inferior vena cava (IVC) filters are intended to provide a safe alternative for the prevention of pulmonary embolism for patients who cannot take blood thinning medication. IVC filters are placed in the largest vein in the body, where they act like a net that catches embolisms in the blood before they can move into the heart or lungs and cause serious damage.
Unfortunately IVC filters themselves have been the subject of hundreds of complaints to the FDA, with 921 adverse outcomes received by the FDA since 2005 involving IVC filters having caused either injury or death.
IVC filters look almost spider like, and are comprised of a central metal hook with multiple thin, spidery legs coming from it to hold the filter in place in the vein. In practice, the legs can break off or become displaced, allowing part or all of the filter to embed in the vein walls or break loose and travel throughout the body, going on to puncture an organ, such as the heart, or other important areas of the body leading to internal bleeding (hemorrhage). Filters can even move into the heart, entirely or in fragments, causing embolism themselves. In 2010 the FDA issued a statement that IVCs pose a risk of fracture, migration and of perforating organs and need to be removed where possible. Due to migration of the filter or perforation of blood vessels by the filter, removal is often not an option.
IVC filters are mainly manufactured by two companies, C.R Bard and Cook Medical. Bard manufacture the Recovery, G2 and G2 Express IVC filters. Cook manufacture the Gunter Tulip and Celect IVC filters. In 2012 a study on the retrievability of Cook’s two filter types found that of the 50 filters assessed, 43 had at least one filter component perforate the vein wall. All filters that had been installed in the patient for 71 days or more had perforated the vein wall to some extent.
Lawsuits were first brought against the manufacturers of IVC filters in 2012. Since this time hundreds of law suits have been brought against Bard and Cook, with many being consolidated into class actions or multidistrict litigation (MDL). Hundreds of individual lawsuits are also being pursued.
The lawsuits focus on product liability claims including manufacturing defects, design defects and breach of implied warranty. However, IVC filter lawsuits can also include contract law claims such as breach of implied warranty, as well as traditional negligence and wrongful death. It is also alleged that Bard was alerted to the danger posed by its’ IVC filters as early as 2004, when it investigated a number of complaints with the first IVC filter it released, the Recovery. Bard’s failure to disclose these dangers means the company may also be liable for litigation on the basis of a failure to warn and misrepresentation. Often the filters cannot be immediately removed, either due to the displacement or fragmenting of the filters, and in these cases plaintiffs commonly seek expenses for ongoing medical monitoring.
At present over 520 lawsuits against Bard from throughout the US have been transferred into MDL 2641 in the District Court of Arizona. The MDL includes hundreds of individual claims, as well as a class action filed in Arizona on behalf of all recipients of an IVC filter made by Bard (Recovery, G2 and G2 Express). Recipients of one of these filters can join the class action even if they haven’t yet been injured by the filter. The claims primarily revolve around Bard’s negligence and misrepresentation in concealing important testing data that may have revealed the dangers posed by it’s IVC filters.
Lawsuits against Cook, involving the Celect and Gunther Tulit, filed in federal courts throughout the US, have been centralized by the US Judicial Panel on Multidistrict Litigation (JPML) into MDL 2570 in the Southern District of Indiana. The cases all generally argue that Cook is liable for the damage caused to recipients of its’ IVC filters due to the filters having a defective design, due to Cook’s failure to warn patients or doctors about the dangers of the IVC filters it was manufacturing and due to misrepresentation in the marketing of the filters.