Washington, DCWhen it comes to assessing where a manufacturer is with pending litigation, there’s no better source than with the manufacturer itself. To that end, C.R. Bard released details concerning the current state of affairs over IVC filter lawsuits as part of its Form 10-K report that provides a snapshot of the company at the end of its fiscal year, December 31, 2016.
The report was filed with the US Securities and Exchange Commission (SEC) in February, and reveals no fewer than 1,425 inferior vena cava filter lawsuits filed against C.R. Bard in various federal and state courts.
The report also details and summarizes various putative class actions filed north of the border, in Canada. Specifically, a putative class action was filed against the manufacturer in a Quebec court in March of last year, with additional class actions filed in the provinces of Ontario and British Columbia in April, and May of 2016 respectively. Finally, in November a putative Canadian class action Bard IVC filter lawsuit was filed in the province of Saskatchewan.
Bard noted in its report to the SEC that it was aware of 25 additional claims and complaints against the manufacturer but those claims had yet, by the end of the fiscal year, to be filed in Canada.
C.R. Bard is one of the leading manufacturers of the inferior vena cava filter, a device implanted in the inferior vena cava to entrap meandering blood clots that form in the lower extremities and threaten to lodge in the heart or lungs. The inferior vena cava is the primary artery delivering deoxygenated blood from the legs and lower extremities up to the heart and lungs. IVC filters are, for the most part, viewed as a temporary preventer of strokes for those individuals who have trouble tolerating blood thinners.
There are two types of IVC filters: permanent filters, and removable filters that have been reported as having a less robust design given the expectation they would be removed as soon as the imminent danger of blood clots have passed. In recent years, most IVC filters implanted have been the removable variety.
However, the IVC filter has been plagued with problems. C.R. Bard is the manufacturer of an earlier version of the Bard IVC filter that was found to have serious issues. Instead of triggering an IVC filter recall however, Bard was accused of leaving the troubled IVC filter on the market for about three years while it quietly developed a successor, the Bard G2 filter. When launched, observers and plaintiffs have alleged the G2 is no better than the IVC filter it was meant to replace.
The issues surrounding IVC filters are two-fold: they have been known to fail, with struts breaking away and migrating to the heart and lungs (sometimes, the entire filter dislodges and migrates through the inferior vena cava). There has also been a growing problem with the filters having been left in place for too long, or not removed at all. In some cases, due to various issues, the filters could not be successfully retrieved following an attempt to remove the device. A removable filter that is left in too long – or indefinitely – only exacerbates the risk for harm were the filter to fail.
In theory, the IVC is an effective alternative – or addendum – to blood thinners as a way to deal with the threat of a blood clot and mitigate the risk of stroke. The IVC filter is a spider-like device deployed in the inferior vena cava to entrap blood clots akin to a catcher’s mitt at a baseball game. Thin, spider-like struts grab the inner walls of the inferior vena cava, holding the IVC filter in place and allowing blood to pass through, while entrapping blood clots before they can move up the inferior vena cava to do potential damage.
However, IVC filters that are left in too long can become so intertwined with the inferior vena cava wall that removal poses a risk to the inferior vena cava itself. Struts – the long, thin ‘legs’ of the spider-like device – have been known to fracture, break free and migrate to the heart and lungs.
The US Food and Drug Administration (FDA) has since imposed guidance, suggesting that retrievable IVC filters – including, but not limited to the Bard G2 IVC filter – should be removed as soon as the danger of blood clot has passed, but at the outside should be left in place no longer than a couple of months.
Plaintiffs allege they have been left with grievous injuries and health issues following the failure of an inferior vena cava filter, and seek compensation in an IVC filter lawsuit.
In its Form 10-K report, Bard suggests trials with regard to IVC product liability are expected to take place over the next 12 months.
In August 2015, the Judicial Panel for Multi-District Litigation ordered the creation of a Multi-District Litigation for all federal filter product claims in the District of Arizona.
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