Retrievable Inferior Vena Cava (IVC) filters are small, “spider-like” devices that are placed inside the inferior vena (a major vessel returning blood from the lower half of the body to the heart) to trap blood clots and stop them from continuing to travel to the lungs and causing a pulmonary embolism (a blood clot in the lungs), which can be fatal. IVC filters are implanted in patients who are at risk of a pulmonary embolism who cannot take blood thinners or have previously taken blood thinners that did not work for them.
The FDA reports that IVC filters have been on the U.S. market for over 30 years and the use of IVC filters is expected to increase. However, the FDA has received 921 adverse events reports about IVC filters since 2005. The agency says 328 reports involved the filters migrating, 146 involved the components detaching, 70 involved perforation, and 56 involved filter fracture.[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm, August 9, 2010] [fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm, May 6, 2014]
Bard Recovery IVC Filters and G2 retrievable IVC Filters Study
The C.R. Bard Recovery filter was brought to market by C.R. Bard in 2003. Just two years later, it was replaced with the G2 filter, a slightly modified version. When it introduced the G2 IVC filter, Bard promised that it offered “enhanced fracture resistance”, “improved centering” and “increased migration resistance.” However, IVC filter lawsuits allege that both the Recovery and G2 devices are associated with particularly high rates of fracture, migration and other problems that could cause serious and potentially fatal injuries. In 2010, a study published in the Archives of Internal Medicine suggested that the Bard Recovery filter failure rate was 25%, while the Bard G2 filter failure rate was around 12%.
Bard Recovery IVC Filters and G2 retrievable Filters Lawsuits
In August 2015, it was determined that the litigation involving Bard IVC filters was large enough to warrant the creation of a multidistrict litigation. All federal IVC filter lawsuits alleging injury as a result of either the Recovery or G2 device have been transferred to the U.S. District Court, District of Arizona, to be presided over by a single judge. By October 2015, more than 50 claims were pending in the proceeding. But legal experts believe that hundreds of IVC filter lawsuit could soon be added to the litigation. Plaintiffs who have filed Bard IVC filter lawsuits, either Bard Recovery IVC Filter lawsuits or G2 retrievable IVC Filter lawsuits claim that doctors were not provided with adequate warnings regarding the need to retrieve the Recovery and G2 devices.
Cook Medical IVC Studies
Studies allegedly indicate that Cook Medical’s IVC filters are prone to perforate and tilt. For instance, a study was conducted over a 33-month period that examined 99 Celect and 86 Option filters that found that Cook Medical’s Celect IVC filter had a 43 percent rate of vena cava perforation than Rex Medical’s Option IVC filter, which had a 0 percent perforation rate. The study was published in the Journal of Vascular Interventional Radiology in June 2015 [ncbi.nlm.nih.gov/pubmed/25791334, Journal of Vascular Interventional Radiology, June 2015] A study published in April 2012 also showed Cook’s Celect and Günther Tulip IVC filters were prone to perforate after researchers reviewed medical records of patients who underwent IVC filter implants between July 2007 and May 2009. The 50 IVC filters examined showed some degree of vena caval perforation within 71 days after the patients received the implant, according to the study published in Cardiovascular Interventional Radiology. Additionally, 40 percent of the Cook’s filters tilted and all tilted filters had perforated the patients’ vena caval wall.[ncbi.nlm.nih.gov/pubmed/21448771, April 2012]
Cook Celect and Günther Tulip IVC Filters Lawsuits
A multidistrict litigation (MDL) was established in October 2014 for Cook’s Celect and Günther Tulip IVC filter lawsuits in the U.S. District Court, Southern District of Indiana. Court records show that more than 130 IVC filter complaints are pending that allege Cook Medical’s IVC filters have defects in the design and cause injuries to patients due to the devices fracturing, migrating, tilting or perforating the inferior vena cava.
(In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation – MDL 2570)
The injuries associated with the filters include:
- Perforation of the vena cava
- Pulmonary embolism
- Filter fracturing
- Migration of the filter to the heart or lungs
- Tilting of the filter
Wright & Schulte LLC is investigating IVC Filter lawsuits due to failure. If you or a loved one have sustained injuries that could be linked to an IVC filters, it is important for you to retain a knowledgeable IVC attorney. You may be eligible to file a IVC Filter Lawsuit if you have been injured by the device. To learn more about the legal options available to you or to file a IVC Filter Lawsuit, contact Wright & Schulte by filling out our online form or calling 1-800-399-0795.