Cook Medical IVC Filter Lawsuit Lawyers Serving Indiana and the Entire US
Cook Medical is a manufacturer of inferior vena cava (IVC) filters. The Celect IVC and Gunther Tulip IVC are two Cook medical devices that are used to help prevent pulmonary embolism, or blood clots in the lungs, in patients with a high risk for clotting. The filters are inserted into the patient’s blood vessels (vena cava) to catch blood clots and keep them from traveling to the lungs where the clots could block blood flow and cause serious injuries. IVC filters are often used when anticoagulant medication cannot effectively be used.
Problems with Cook Celect IVC filters and Gunther Tulip IVC filters
Patients have reported adverse events in which the metal filter leads of these IVC devices have fractured and traveled to other parts of the body perforating blood vessels and organs causing severe pain and internal bleeding. Other reports involve the filters becoming tilted out of position requiring corrective surgery or removal.
Injuries from these IVC filters can include:
- Internal Bleeding
- Organ Perforation
- Pulmonary Embolism
- Deep Vein Thrombosis (DVT)
IVC Perforation Injury
One report filed with the FDA in 2009 describes a patient who experienced groin pain 2 weeks after having the Cook Celect IVC filter inserted. A CT scan showed struts protruding out of the vena cava and penetrating the aorta. Patient had to undergo a corrective surgery to have filter repositioned.
FDA Warning for Cook IVC Filters
The FDA has received 921 adverse event reports involving IVC filters since 2005. A breakdown of this information shows 328 patients experienced a migration of the filter, 146 patients had pieces of the device came apart inside their bodies, 70 patients had their blood vessel perforated by the filter, and 56 patients experienced a fracture in the filter. Based on this information, the FDA issued a safety warning in 2010 related to the use of IVC filters and highlighted the increased risk for deep vein thrombosis, filter fracture, filter migration, filter breakage, and blood vessel perforation involving the extended use of these devices.
In May 2014, the FDA revised its safety warning for IVC filter devices after review of data available in medical literature. A report was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders indicating an ideal removal timeframe for IVC devices of 29 to 54 days after implantation to avoid and increased risk of patient safety. The report highlighted a list of adverse events included in the FDAs safety warning issued in 2010. Events including migration of filters, blood vessel perforation, and filter breakage were indicated to be at a higher risk level after the ideal removal timeframe.
Cook IVC Filter Lawsuits
Lawsuits have been filed against Cook Medical for failing to warn doctors and patients of the increased risk of serious personal injury related to the use of the Celect IVC and Gunther Tulip IVC filters. Our firm is investigating claims on behalf of people who have been implanted with these medical devices and suffered serious personal injury including organ perforation, internal bleeding and severe pain. Our product liability attorneys have experience litigating claims against large corporations and pharmaceutical manufacturers and can provide you with a Free Case Evaluation. Contact us now.