Inferior vena cava filters like Cook Gunther Tulip System have been linked to more than 1,000 adverse event reports submitted to the U.S. Food & Drug Administration (FDA) since 2005. This is serious because IVC filter complications may be life-threatening and include filter migration, perforation of organs, bacterial infection, internal bleeding, and death.
Free Confidential IVC Filter Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
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Update: Tennessee Man Files Cook Günther Tulip IVC Filter Lawsuit
June 20, 2016 – The lawsuit was filed by Plaintiff Robert Douglas Debord, a man from Tennessee who received the Günther Tulip blood clot filter in November 2006. Debord’s case has been entered into the multidistrict litigation (MDL No. 2570)  in Indiana under case number 1:16-cv-01518-SEB-MJD .
Hundreds of Vena Cava Injuries Reported to FDA
From 2005 to 2010, the Food & Drug Administration received at least 921 reports of adverse events associated with IVC filters like the Cook Gunther Tulip System, including:
- 328 cases involving device migration to the heart or pulmonary artery causing fluid accumulation, heart arrhythmia, or death
- 146 cases involving embolization (blockage in the artery) after detachment of IVC filter components
- 70 cases involving filter perforation (damage to artery walls and/or organs)
- 56 cases involving filter fracture
- 4% of cases involving death
FDA recommends that retrievable IVC filters like the Gunther Tulip be removed immediately after the threat of pulmonary embolism has subsided. A number of credible medical studies have detailed the high failure rates linked to blood clot filters and the significant risks to patients when the devices are used or left implanted for too long.
Related Article: IVC Filter Lawsuit Update
- Fracture of the IVC Filter
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest, or Elsewhere in the Body
- Pulmonary Embolism
Fracture / Embolization Warning Signs
Warning signs that a Cook Gunther IVC Filter has failed may include:
- Severe pain in the heart or chest
- Pulmonary embolus
- Respiratory compromise
- Perforation of organs, tissues, or blood vessels
Patients who believe their vena cava filters may have fractured should contact their doctor immediately. A computerized tomography (CT) scan or other test will be used to determine whether the device has failed.
Cook Gunther Tulip FDA 510(k) Approval Process
In 2003, FDA approved the Cook Gunther Tulip IVC filter for permanent and temporary placement, which was marketed as a revolutionary solution for patients in need of close management and control over thromboembolic disease. Then in 2008, Cook introduced the Celect vena cava filter, with FDA 510(k) clearance following trials in other countries. The Celect was designed to capture and prevent clots from reaching the lungs following trauma or surgery. It was intended to be a design improvement on the Gunther Tulip, but both devices have been the subject of many adverse event reports submitted to the FDA.
On October 15, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML)  ruled that all federal lawsuits involving vena cava filters will be centralized in the Southern District of Indiana before District Judge Richard L. Young. All of the complaints involve similar allegations that manufacturing defects with Cook vena cava filters make the devices likely to fracture, migrate and puncture internal organs.
Other lawsuits against Cook Medical Inc:
- Cook Celect IVC Filter Claim
- Gianturco-Roehm Bird’s Nest Vena Cava Filter Suit
- CloverSnare Vascular Retrieval Snare Claim
See all related medical device lawsuits our lawyers covered so far.
Do I Have a Cook Gunther Tulip IVC Filter Lawsuit?
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cook Gunther Tulip IVC Filter Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.