Plaintiffs Allege IVC Filters Are Dangerous, Cannot Be Retrieved as Designed

Sioux Falls, SDFor many, 2016 began not with a resolution, but with resolute determination to seek justice and compensation from manufacturers of inferior vena cava (IVC) filters following failures of the implantable device.

Some of those IVC filter failures have been catastrophic in nature, leaving many patients not only having to deal with pain and suffering, but also the nagging realization that the other shoe could drop at any time when an inferior vena cava filter - designed to be retrieved - cannot be.

And that goes for the majority. According to expert sources, fewer than 10 percent of retrievable filters that are inserted and designed to be deployed only for a period of time wind up becoming a permanent fixture, and a constant worry going forward, for the patient.

Amber Nordin is one such patient and plaintiff. A resident of South Dakota, Nordin received an Eclipse IVC filter manufactured by C.R. Bard due to a risk for blood clots migrating to the lung, which are known medically as pulmonary embolisms. Like other filters with similar designs, the Eclipse filter is inserted into the inferior vena cava. Thin, spider-like appendages are designed to hold the filter in place, along with the capacity for “catching” a wayward blood clot before it can make its way to the lung.

Nordin’s device was designed to be retrieved once the danger of a pulmonary embolism had passed. And had the device remained at the point of insertion and successfully retrieved, we therefore would not be having this conversation about Amber Nordin from South Dakota.

But we are. And the reason for that - akin to problems other plaintiffs have reported - is alleged to be the migration of the Eclipse IVC filter away from its original insertion point, subsequently becoming lodged in her internal organs.

Nordin alleges in her IVC filter lawsuit that subsequent surgery to remove the device as designed was unsuccessful. The Bard IVC filter remains imbedded in the plaintiff’s internal organs, as doctors could not free the device without damaging sensitive tissue.

She initially received the device in 2012; with the unsuccessful attempt to have it removed coming two years later. Nordin has now lived with the device embedded in her internal organs since the unsuccessful surgery in January 2014. She faces further complications - which could be life-threatening - together with ongoing medical care to help minimize the risk of further injury from the device lodged inside her body.

Nordin, like other IVC filter lawsuit plaintiffs, faces a life with the possibility of a catastrophic failure or medical emergency hanging over her head.

Nordin launched a lawsuit over her failed Bard IVC filter. And there are others…

In late 2015, plaintiff Bradley Ricker filed an IVC filter lawsuit against C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (Case No. 1:15-cv-02453-JEJ in US District Court, Middle District of Pennsylvania). A week prior, plaintiff Florence Bures filed a lawsuit against those same defendants and in the same court (Case No. 3:15-cv-02420-RDM), with a third lawsuit titled Rouse v. C.R. Bard Incorporated, et al (Case No. 5:15-cv-04569) transferred out of US District Court for the Northern District of California, into the US District Court for the District of Arizona, Phoenix Division (Case No. 2:150cv-02227-DGC).

For its part, the US Food and Drug Administration (FDA) revealed in 2010 that no fewer than 900 adverse events reports had been brought to the attention of the regulator. Those events included migration, fracture and embolization, and perforation of the inferior vena cava, which is part of the cardiovascular system.

Four years later, the FDA released renewed guidance for doctors and the medical community, reflecting the need for retrievable IVC filters to be removed within 29 to 54 days following implantation of the device.

That advisory was issued the same year Nordin had her unsuccessful surgery to remove the Bard IVC filter. Two years later, Nordin still has the wayward IVC filter embedded within her body.

A study in JAMA: Internal Medicine released in April 2013 revealed that fewer than 10 percent of patients fitted with the retrievable IVC filter were successfully freed from the devices.

Plaintiffs accuse C.R. Bard and other manufacturers of knowing about the risks of migration and internal injury, but failing to share such risk with consumers or their medical practitioners. Plaintiffs also allege that when C.R. Bard became aware of issues surrounding its original Recovery IVC filter, the manufacturer failed to undertake an IVC filter recall and instead issued the Bard G2 IVC filter, with slight modifications.

Plaintiffs allege the Bard G2 filter held little to no improvement over the first...