IVC Filters

Maine IVC Filter Lawyer

Recent safety communications from the FDA warn that retrievable Inferior Vena Cava (“IVC”) filters are prone to serious health risks, including life-threatening injuries.

Evidence is also mounting that IVC filter manufacturers have known about the high failure rates associated with their devices for years but done little to warn patients and physicians about the potential dangers.

What Are IVC Filters?

An IVC filter is a vascular device with what is often described as an umbrella or cage-like appearance. IVC filters have arms and legs called struts which function to trap blood clots developing in the lower extremities from migrating to the heart or lungs. Once trapped by the filter, the clots may eventually be broken down by the body.

IVC filters are placed endovascularly by a surgeon via the femoral vein (groin) or the internal jugular vein (neck). To implant the filter, a catheter is guided into the vena cava using fluoroscopic guidance. The IVC filter is then pushed through the catheter and deployed within the vena cava just below the renal branches.

Permanent vs. Retrievable IVC Filters

Early IVC filters were designed and intended to be permanently left in the body and were implanted surgically.

By the early 2000’s, manufacturers began to develop smaller, less invasive filters, many of which were designed to only be temporarily placed in the body. With this introduction of retrievability, IVC filters gained in popularity and have been used with increasing frequency ever since.

IVC Filters Under Investigation

The following companies and models of IVC filters are currently under scrutiny:

ALN: Optional
Argon: Option, Option Elite
B. Braun Medical: Tempofilter, VenaTech
Cook Medical: Celect, Gunther Tulip
Cordis: OpTease, TrapEase
C.R. Bard Recovery, G2, G2 Express, Eclipse, Meridian, Denali
Rex Medical: Option, Option Elite

IVC Filter Injuries

In August 2010 and again in May 2014, the FDA issued Safety Notifications warning that IVC filters are prone to serious complications including:

Fracture: arms or legs breaking off and lodging in the heart, lungs or other vital organs
Perforation: arms or legs puncturing through the vena cava or into organs
Tilt: the device turning perpendicular to the directional flow of the vena cava
Migration: moving of the filter within the vascular system
IVC filter thrombosis: blood clots developing and/or aggregating within the IVC filter
Inability to retrieve the filter
Recurrent blood clots
Death

Increasing Studies Confirm the Serious Risks Associated with IVC Filters

A growing body of research demonstrates the serious safety concerns and lack of efficacy associated with retrievable IVC filters, including:

Journal of Vascular and Interventional Radiology (2011): The study found that 40% of C.R. Bard’s Recovery IVC filters fractured after 5 ½ years.
Archives of Internal Medicine (2010): The study examined certain patients who received a Bard Recovery or Bard G2 IVC filter from 2004-2009 and found that 16% of the Recovery filters and 12% of the G2 filters had fractured within the five-year window.
Cardiovascular Interventional Radiology (2012): The study found that 100% of Cook Medical’s Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall after 71 days in the body and that 40% of the filters became tilted and out of position.
JAMA Internal Medicine (2013): The study found incredibly low retrieval rates with only 8.5% of the 679 IVC filters studied being successfully removed.
Journal of the American Medical Association (2015): The study found that among hospitalized patients with a pulmonary embolism, the use of an IVC filter did not reduce the risk of recurrent pulmonary embolism suggesting that the IVC filters were unnecessary in patients who could tolerate blood-thinning drugs.

IVC Filter Litigation

A growing number of IVC filter lawsuits are being filed against various manufacturers in courts around the United States. In August 2015, federal lawsuits involving C.R. Bard’s IVC filter cases were centralized in a multi-district litigation (“MDL”) before U.S. District Court Judge David Campbell in the United States District Court for the District of Arizona.

Similarly, in October 2015, all Cook Medical IVC filter cases were consolidated in a MDL before U.S. District Court Judge Richard Young in the United States District Court for the Southern District of Indiana.

Plaintiffs in IVC filter cases allege that manufacturers either knew about the potential for serious complications or should have known about the risks. Plaintiffs also claim that the manufacturers failed to provide adequate warnings about the risks associated with their devices, and failed to thoroughly study the devices before releasing them on the market. Plaintiffs also allege that some companies stopped manufacturing or redesigned certain devices due to high failure rates but chose to not notify patients or physicians about the problems or the true reasons for discontinuing the sale of devices.

Maine IVC Filter Lawsuit

If you or someone you love has suffered complications from an IVC filter, you may be entitled to significant compensation for your injuries, including pain and suffering, past and future medical treatment, lost wages, loss of earning capacity, loss of enjoyment or quality of life, emotional distress, loss of consortium, and wrongful death.

To speak with an experienced, Maine IVC filter lawyer, contact a medical device attorney at Fitzgerald Law Group at (844) FITZ-LAW or (844) 348-9529, or complete the contact form on this website for a free, confidential, case assessment.

Our Maine IVC filter attorneys will evaluate your individual claim and discuss with you the steps we will take to obtain you recovery in a Maine IVC filter lawsuit.