However, this is hardly a new problem.
The US Food and Drug Administration (FDA) warned doctors and health care professionals as to the risks associated with long-term use of devices designed to ward against blood clots by way of placement in the inferior vena cava, a primary artery carrying deoxygenated blood from the lower extremities up to the heart and lungs. Blood clots migrating up from the legs pose a serious health risk if they reach the lungs. A pulmonary embolism is a serious consequence and in severe cases can result in death. For patients who do not tolerate blood thinners readily, the IVC filter was designed to ‘catch’ a migrating blood clot at the inferior vena cava until such times as the clot could be broken up or removed altogether (along with the filter), in concert with the imminent risk and danger of blood clot having passed.
The IVC filter was originally designed for long-term use, with approval based on a risk assessment that the benefits outweighed any risk. While there were individual problems stemming from long-term use of the permanent IVC filter, it was the advent of the retrievable filter that began to foster an increase in adverse events. This prompted the FDA, in the summer of 2010, to issue an advisory to doctors and healthcare professionals against leaving the retrievable IVC filter in place for too long.
“The FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient,” the agency advised. “If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.”
While the FDA continues to maintain that the benefits outweigh the risks, the number of lawsuits against IVC filter manufacturers has spiked exponentially, with some 1,400 lawsuits against C.R. Bard involving the Bard G2 IVC filter centralized as part of the Bard MDL in Arizona. Similarly there are roughly 1,300 lawsuits against Cook Medical centralized in Indiana. Plaintiffs allege that IVC filters can fracture and / or move out of position, posing a risk of serious IVC filter side effects to the patient through the puncture of the arterial wall, or IVC filter migration to the heart or lungs of the entire device, or shards of metal stemming from the fracture of a strut.
The FDA, in May of 2014 further updated its cautionary stance on retrievable IVC filters, denoting a window of a month or two where placement of the IVC filter was deemed acceptable. Certainly, the FDA maintains, the inferior vena cava filter should be removed once the danger of a blood clot or deep vein thrombosis has passed, and in any event a filter left in place longer than two months risks a rising wave of complications, including an increased difficulty for retrieve and remove. Filters have been known to grow into the inferior vena cava wall, to the point where any attempt at removal could pose a serious threat to the patient.
Various studies have suggested that most retrievable IVC filters are not removed, and thus left in place for an incalculable period of time. Some attempts at removal have ended in failure.
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Bellwether trials involving products from Cook Medical and C.R. Bard are expected this year. Meanwhile the two most recent inferior vena cava filter lawsuits name Cook Medical as the defendant:
Rainer Abrams v. Cook Medical Inc. et al., Case Number: 1:17-cv-00700, and
Pamela Brown v. Cook Medical Inc. et al., Case Number: 1:17-cv-00699,
both in the US district Court for the Southern District of Indiana.