Blood clots in the circulatory system can pose a lethal risk to patients following surgery, or in persons who are unable to tolerate anticoagulant drugs like Warfarin or Heparin. To resolve this problem, medical device manufacturers like Cook Medical, C.R. Bard and others have developed a small filter device (IVC Filter) that can be inserted into a large vein near the neck or groin area to capture blood clots that pass from the lower legs to organs like the heart, lungs or brain. If a blood clot lodges in these organs, the result could require more surgery to remove the blockage, but it could also result in death of the patient.
Cook inferior vena cava (IVC) filters are an extremely small, cage-like shape, and they are made of light-weight metals. In most cases, they are removable and are only meant to remain in place for a short period of time for best results. IVC Filters often are combined with use of anticoagulant medicines, if the patient is able to take such drugs without allergic reactions. These filters are recommended as an option for fighting pulmonary embolism (PE) in persons who are allergic to anticoagulants; it could be their only alternative.
IVC Filters were first used in 1969, with use of the Mobin-Uddin system. Prior to this, a remedy from the 1930s was surgical open femoral vein ligation and later, in the 1940s, inferior vena cava clipping. The FDA first approved these new retrievable IVC Filters in 2003 and 2004. Today, around 50,000 IVC Filters are placed annually in the United States. The filters save lives, but in too many cases, they have created new problems for IVC Filter recipients. Some patients needed additional surgery to fix problems created when IVC Filters failed or malfunctioned. Others died from bleeding when parts of the device fragmented and pierced veins, their heart, lungs or other organs.
A major problem with IVC Filters is that there has been only one randomized controlled trial to determine and evaluate the thrombosis rate reduction in patients. In recent times, more studies have been conducted, and the results are not very positive. That original study showed effectiveness for reduction of pulmonary embolism (PE) was significant at 12 days after insertion of the device and when combined with use of anticoagulants, but those patients ran a higher risk of developing deep vein thrombosis (DVT) at the 2-year mark. The conclusion was to use an IVC Filter with caution only in high-risk patients, because the filters worked well in the very beginning, but long-term results were not favorable.
Types of IVC Filters by Cook
Cook Medical was founded in 1963 in Bloomington, Indiana. Their original product line included wire guides, needles and catheters. They primarily produce minimally invasive medical devices, including IVC Filters. Today Cook employs 2,467 people and their product line includes over 16,000 items, shipped to 135 countries.
As problems began to develop in patients who had IVC Filters implanted, the FDA issued warnings about their use and potential defects that could occur, including fracturing of the thin metal parts, migration of shards to other organs and misplacement of the devices when rotation occurred.
Cook IVC Filters are among many brands cited in class-action lawsuits across the U.S. Recalls were issued for many brands of IVC Filters, including several made by Cook Medical. IVC Filters produced by Cook Medical that have been recently recalled include:
- Gunther Tulip Vena Cava Filter
- Celect Platinum Vena Cava Filter
- Cook Gianturco-Roehm Bird’s Nest Vena Cava Filter
IVC Filter Lawsuits
Many patients who had a medical procedure to help reduce blood clots are filing lawsuits against Cook Medical, the maker of their inferior vena cava (IVC) filter, after the devices failed to perform as expected. Problems with these filters were first publicized after the FDA issued warnings in 2010 and 2014. In 2014, lawsuits against Cook in Indiana were consolidated into a Multi-District Litigation (MDL) in the Southern District court. There are still more than 100 lawsuits against Cook in Indiana, and 27 or more additional Cook Celect or Cook Gunther Tulip IVC Filter lawsuits filed in various U.S. District Courts in other states.
An Indiana lawsuit filed by Larry and Brenda Johnson accused Cook of reckless design, testing and manufacture of the Cook Celect Filter. Mr. Johnson’s doctor implanted that model IVC Filter following Johnson’s knee surgery. Within four years, the unit had fractured and migrated to his heart. Johnson suffered a loss of consciousness while driving and needed three additional surgeries due to these complications.
Claims made in Cook IVC Filter lawsuits include:
- Negligence and misrepresentation
- Medical expenses & care
- Lost wages/income
- Non-economic claims – pain & suffering, loss of companionship, loss of normal lifestyle
In 2012, one study found that 100% of patients who received the Cook Celect and Gunther Tulip IVC Filters suffered from perforated vena cava walls in less than 71 days following implantation. In 40% of those cases, the filters also tilted out of the desired position for effectiveness.
Cook Lawsuit Attorney
If you have had a Cook IVC Filter implanted and then suffered from conditions related to product failure, you may be able to file a Personal Injury lawsuit or join an existing class-action lawsuit to recover monetary compensation for your damage claims against Cook Medical. You deserve to be compensated when negligent behavior or defective products hurt you physically, emotionally, financially and disrupt your life. This also is true if a loved one died following use of a Cook IVC Filter.
By working with an experienced Personal Injury Attorney who also has handled similar cases, you increase your opportunity to obtain the best possible results, including highest compensation awards. If you are eligible to participate in a class-action lawsuit, you may join others sharing rewards in the millions of dollars for the group.
Bring your concerns about Cook IVC Filters to our Personal Injury Attorney. We have the knowledge, skill and experience to offer top-quality legal advice and representation for you in your pursuit of justice. Call today to arrange for a free and confidential consultation with our IVC Filter Lawyer.