The Cook Celect Inferior Vena Cava Filter is designed to prevent pulmonary embolism, a medical emergency that occurs when a blood clot becomes trapped in the lungs. Unfortunately, this device and others like it have been reported to fragment after being implanted, sending metal particles through the bloodstream and causing serious damage to the patient’s internal organs.
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.
Table Of Contents
- Update: California Woman Alleges Heart and Kidney Damage from Cook Celect IVC Filter
- What is the Cook Celect Vena Cava Filter?
- FDA Warning: IVC Filter Complications Include Organ Perforation, Death
- JAMA Study Investigates IVC Filter Risks
- Filter Fracture Warning Signs
- Multidistrict Litigation
- IVC Filter Lawsuit Status
- Cook Celect Linked to 43% Strut Perforation Rate: Study
- Do I Have a Cook Celect IVC Filter Lawsuit?
Update: California Woman Alleges Heart and Kidney Damage from Cook Celect IVC Filter
September 1, 2016 – A woman from California who allegedly suffered severe heart and kidney damage after receiving a Cook IVC filter has filed a product liability lawsuit against the manufacturer. Plaintiff Joan Wiseman suffered the injuries after the fractured strut of the device punctured the right ventricle of her heart, according to the lawsuit. Wiseman holds Cook Medical Inc., Cook Inc., and Cook Group Inc. responsible because they allegedly failed to warn of the risks associated with their IVC filters.
Related Article: Cook IVC Filter Lawsuit California
What is the Cook Celect Vena Cava Filter?
Manufactured by Cook Medical, the Celect IVC Filter is used to prevent pulmonary embolism (PE) in the following situations:
- Pulmonary thromboembolism when the patient is unable to take anticoagulant drugs;
- Failure of anticoagulants in thromboembolic diseases;
- Emergency treatment of massive PE where potential benefits of traditional therapies are reduced;
- Chronic, recurrent pulmonary embolism where anticoagulants have failed or are contraindicated.
FDA Warning: IVC Filter Complications Include Organ Perforation, Death
Unfortunately, despite their purported benefits, vena cava filters like the Cook Celect have been linked to serious health complications. Between the years 2005 and 2010, at least 921 reports were submitted to the U.S. Food & Drug Administration (FDA) regarding injuries linked to IVC filters. Of these:
- 328 cases of filters migrating from the implant site
- 146 cases of embolization after detachment of device components
- 70 cases of filter perforation
- 56 cases of IVC filter fracture
According to the FDA, approximately 4% of these complications resulted in death. The administration has advised doctors to remove retrievable vena cava filters immediately after the threat of pulmonary embolism has subsided. Recent studies have determined that the high failure rates associated with blood clot filters are increased when the devices are left inserted for too long.
Related Article: IVC Filter Lawsuit Update
JAMA Study Investigates IVC Filter Risks
A recent study published in the Archives of Internal Medicine (an archive journal of JAMA) examined the safety of C.R. Bard’s Peripheral Vascular Recovery and G2 vena cava filters. The research team, which was led by Dr. William Nicholson at York Hospital in Pennsylvania, looked at 189 patients who were implanted with these devices between April 2004 and January 2009. Among these:
- 35 patients died
- 10 already had their filter removed
- 1 person was pregnant
Additionally, 80 test subjects underwent fluoroscopy to assess the integrity of their IVC filter. Patients whose devices had fragmented were ordered to undergo echocardiography and cardiac CT scans. Of the 80 patients who underwent fluoroscopy, 52 had received the vena cava filter.
The researchers determined that 16% of the IVC filters fractured after being implanted. In patients with the original recovery filter, 25% fractured such that 1 or more arms of the device broke off. About 70% of the fragmented pieces traveled through the veins of the patient to the heart, resulting in life-threatening symptoms such as rapid heartbeat and fluid buildup, including sudden death.
Despite Bard’s efforts to redesign the original vena cava filter, the study found that 12% of patients implanted with the G2 still experienced problems. The average time the patients in the study had the implants was 50 months with the Recovery filter and 24 months with the G2.
Filter Fracture Warning Signs
Warning signs that a Cook Celect IVC filter has failed may include:
- Severe pain in the heart or chest
- Pulmonary embolus
- Respiratory compromise
- Perforation of organs
Patients who believe their IVC 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.
On October 15, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML)  ruled that all federal lawsuits involving Cook IVC 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.
IVC Filter Lawsuit Status
More than 100 lawsuits have been filed against Cook Medical alleging that its IVC filters have fractured, migrated from the deployed position, and perforated patients’ hearts, lungs, or vena cava. The high rate of Cook filter complications — one study put it at 100% when the devices were implanted for 2-1/2 months or more — has caused damage to patients’ organs and required removal in many cases. Other patients have no symptoms after their IVC filter migrates from the implant site.
The Cook Celect IVC filter has been linked to a 43% increased strut perforation rate compared to the Option IVC filter made by Rex Medical, according to a June 2015 study  published in the Journal of Vascular Interventional Radiology.
“Retrieval rates for the Celect and Option filters were not significantly different,” the researchers said. “However, retrieval of the Options filter required a significantly increased amount of fluoroscopy time compared with the Celect filter, and there was a significantly greater usage of adjunctive retrieval techniques for the Option filter. The Celect filter had a significantly higher rate of strut perforation.”
Other lawsuits against Cook Medical Inc:
- Gianturco-Roehm Bird’s Nest Vena Cava Filter Lawsuit
- CloverSnare Vascular Retrieval Snare Lawyer
- Cook Gunther Tulip Vena Cava Filter Case
See all related medical device lawsuits our attorneys covered so far.
Do I Have a Cook Celect 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 Celect 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.