Tennessee IVC Filter Lawyer
An IVC filter or inferior vena cava filter is a small spider-like metal device that catches and traps a blood clot before it can travel to the heart or lungs. The filter is placed in the inferior vena cava, which is the large vein in the abdomen that circulates blood from the lower body back to the heart.
IVC filters are commonly used in patients at risk for, or with a history of, venous thromboembolism (VTE). VTE is when blood clots form in the veins of the legs, arms or pelvis and then travel to the heart or lungs. The blood clots are termed deep venous thrombosis or DVTs. A DVT can be deadly if it travels to the lungs and prevents normal blood flow to the lungs. C filters are typically prescribed for patients who cannot tolerate blood-thinning medications or for patients who continue to develop clots despite the use of blood-thinning medications.
The use of IVC filters in the United States has sky-rocketed. In 1997, only 2,000 IVC filters were used. By 2007, nearly 167,000 filters were used in the treatment of VTE. By 2012, IVC filters had been placed in over 259,000 patients.
At the David Randolph Smith & Associates, our award-winning team of lawyers are currently accepting cases involving the IVC filter. Call us today at 615-742-1775 to discuss your potential case with you free and without obligation.
Adverse Reports and FDA Lawsuits
Surgeons implant retrievable inferior vena cava filters (IVCs) in the veins of patients who are unable to take anticoagulants (blood thinners) in order to prevent blood clots from moving to the lungs. IVCs catch the clots in the blood stream and, over time, the clots dissipate. But the U.S. Food & Drug Administration (FDA) received hundreds of adverse reports about the retrievable filters. Reported complications included punctured organs, blood vessels and filter migration to different parts of the body.
In 2010, the FDA warned the retrievable filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsided. The FDA updated safety communication in 2014, stating most devices should be removed between the 29th and 54th day after implantation. But the warning signs came too late for some. Plaintiffs began filing lawsuits across the country claiming the filters caused harm and death.
Manufacturers C.R. Bard and Cook Medical are at the center of IVC filter litigation. Five products stand out as a source of problems in lawsuits:
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
Various lawsuits claim negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation on the part the companies and their subsidiaries.
Kinds of IVC Filters
IVC filters can either be permanent or retrievable. Retrievable filters are relatively new and were marketed to patients who do not have a long-term risk of developing clots such as bariatric, orthopedic and trauma patients.
Once the risk of a pulmonary embolism has passed, the filter can and should be removed. The filter should be removed because over time there is a much higher risk that the filter will break, adhere to the wall of the vein, migrate in the vein or perforate the vein or an organ.
In fact, in August of 2010, the FDA published a notice encouraging all medical providers to be mindful of the need to remove the retrievable filters based on the clinical indications for each individual patient. This warning was issued because of the number of adverse events being reported to the FDA.
In May of 2014, the FDA noted in another safety communication that many doctors were not adequately warned about the importance of removing the IVC filter after the risk of EVT had passed. This same communication urged doctors to retrieve the IVC filter if the patient was under no present threat for a clot.
Removal/Placement of IVC Filters
Placement of an IVC filter is performed by an interventional radiologist, vascular surgeon or interventional cardiologist. A catheter is used to position the filter in the vein using x-ray guidance. Removal of the filter again requires the use of x-ray guidance and a catheter with a snare on the end of it. The snare is used to snag the hook at the end of the IVC filter.
While removal of the IVC filter is the preferred course for patients who are no longer at risk of EVT, it is not always possible. Removal of the IVC filter is unlikely if it has adhered to the wall of the vein or if it has fractured, tilted or migrated. If the IVC filter is not removed, the patient is at increased risk for a number of complications including perforation of the venal wall, perforation of the heart or lungs, internal bleeding, perforation of the small intestine, stomach, duodenum, a blood clot at the point of insertion, etc.
Status of Cook IVC Filter Litigation
Plaintiffs filed the first lawsuits against Bard in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated lawsuits against Cook from 11 districts to an MDL in the Southern District of Indiana. The number of lawsuits against cook has increased to more than 100.
In February 2015, C.R. Bard settled the case of Kevin Philips 10 days after the trial began. According to the lawsuit, the Bard Recovery IVC filter broke inside his body and one of the small metal legs traveled to his heart, perforating it. The tear forced him to have open heart surgery and a lengthy recovery.
The U.S. Judicial Panel on MDL consolidated lawsuits against Bard to the U.S. District Court District of Arizona in August 2015. More than 50 lawsuits are pending in the MDL. To see a copy of the order centralizing these lawsuits, click here.
A number of lawsuits are still pending in federal and state courts.
Eventually, the Cook MDL cases will be set for Bellweather trials. Bellweather trials are essentially test cases in which both the plaintiffs and the defendants can get a better idea of how a jury will react to the remaining cases. Both the plaintiffs and defendants get input into which cases will be selected to be bellweather trials and each side will try to pick its strongest cases. The hope with Bellweather trials is that it will allow the parties to assess the strengths and weaknesses of their case so that settlement might be achieved.
For More Information on IVC Filters:
- American Bar Association. (2013). Federal Rule of Civil Procedure 26.
- Bouldry, Huff, Lorenz and Roberts vs. Bard. (2012). 15th Judicial Circuit, Palm Beach County, Florida. Class action complaint for medical monitoring
- Carr v. C. R. Bard. (2014). Case No. 3:13 CV 824. Memorandum opinion and order.
- Cleveland Clinic. (2014). Inferior vene cava (IVC) filter retrieval.
- Davis v. C.R. Bard. (2012). U.S. District Court Eastern District of Michigan Southern Division. Order granting in part and denying in part defendants’ motion for summary judgement.
- Deleon and Gonzalez. (2012). Class complaint for medical monitoring; Demand for trial by jury. Superior Court of the State of California for the County of Los Angeles – Central District.
- Ebert v. C. R. Bard (2014). U.S. District Court for the Eastern District of Pennsylvania. Memorandum.
- Johnson and Johnson v. Cook Medical. (2015). U.S. District Court Eastern District of Michigan Southern Division. Complaint and Demand for Jury Trial.
- Lehmann, J. (2004, December 15). Evaluation of MAUDE reporting rates, sales estimates and comparative bench testing related to vena cava filters.
- Brown and Brown vs. Bard. (2012). Class action complaint for medical monitoring. Court of Common Please Philadelphia County.
- Nicholson, W. et al. (2010, November 8). Prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. JAMA Internal Medicine, 170(20), 1,827-1,831.
- Sandler, T. Naggiar, S., & Gosik, S. (2015, September 3). Did blood-clot filter used on thousands of Americans have fatal flaw? NBC News.
- Sandler, T. Naggiar, S., & Gosik, S. (2015, September 4). Did forged signature clear way for dangerous blood-clot filter?. NBC News.
- Shayna, S., Crowther, M., & Sloan, M. (2013). Indications, complications, and management of inferior vena cava filters: The experience in 952 patients at an academic hospital with a level 1 trauma center. JAMA Internal Medicine, 173(7), 513-517.
- Tillman vs. C. R. Bard. (2013). U.S. District Court Middle District of Florida Jacksonville Division. Complaint for damages.
- U.S. District Court Southern District of Indiana. (2015). MDL Case Information.
- U.S. Food and Drug Administration. (2010, August 9). Removing retrievable inferior vena cava filters: Initial communication.
- U.S. Food and Drug Administration. (2014, May 6). Removing retrievable inferior vena cava filters: FDA safety communication.
- U.S. Judicial Panel on Multidistrict Litigation. (2014, October 15). Transfer Order MDL No. 2570.
- U.S. Judicial Panel on Multidistrict Litigation. (2015, August 17). Transfer Order MDL No. 2641.
- Vlasvich vs. C.R. Bard. (2013). U.S. District Court for the Northern District of Illinois. Complaint.