Cook IVC Filters
Pittsburgh residents and others in the surrounding Ohio Valley who were implanted with a Cook IVC filter and then experienced serious side effects may be eligible to recover damages in a personal injury lawsuit.
A number of studies have connected these filters with problematic retrieval, perforation of body organs like the heart and lungs, and other serious injuries. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal cases involving Cook IVC Filters and transferred them to the Southern District of Indiana. Since then, many other patients have filed Cook IVC filter lawsuits, so the total number of cases is now over 100, and is expected to continue to increase.
The IVC filter lawyers at Chaffin Luhana are currently reviewing cases in which the Cook Celect and Cook Gunther Tulip IVC filters did not perform as expected, leaving patients facing additional surgeries and mounting medical costs for medications and other therapies. Families struggling with these issues may be eligible to file a Cook IVC filter lawsuit, which may result in compensation for medical costs, lost wages, pain and suffering.
What Are Cook IVC Filters?
Patients who are at risk for pulmonary embolism (PE)—a life-threatening condition in which a blood clot travels to the lungs) are typically given anticoagulant drugs that help “thin” the blood and reduce risks of blood clots. These medications come with their own risks, however—including excessive bleeding—and are contraindicated in some patients.
Those who can’t use anticoagulant drugs or who find them ineffective at reducing their risk of PE may be implanted with an inferior vena cava (IVC) filter. These are cage-like or spider-like devices that snag blood clots before they can make their way into the lungs. They are implanted in the inferior vena cava, which is the large vein that takes deoxygenated blood from the lower legs back into the heart.
Patients at risk for PE often have deep vein thrombosis (DVT), a condition in which a blood clot can form in the deep veins of the legs. These clots can then break off and travel up into the inferior vena cava and eventually lodge in the lungs.
By placing the IVC filter in the inferior vena cava, doctors hope to reduce the risk of PE for those patients who are particularly vulnerable to the condition. Studies have questioned just how well these filters work, however, and have raised serious concerns regarding the risks of the use of these devices.
Studies Raise Concerns About Cook IVC Filters
In 2012, researchers looked at how Cook Gunther Tulip and Cook Celect IVC filters performed in 50 patients. They found that all of them, without exception, had perforated the inferior vena cava vein within 71 days. They concluded that leaving these filters in patients for longer than a set amount of time would most likely result in perforation. They added that the danger to the patient from these types of perforations could be significant, and recommended retrieving the filters as soon as possible.
The IVC filters were designed to be only temporary. Studies have found that removal rates are inconsistent, however, with many left inside patients for much longer than they should be for safety reasons. A 2013 study, for example, looked at use of these filters in California hospitals between 2006 and 2010, and found a wide variety of reasons for implantation, including bleeding at the time of admission, a major operation for a blood clot after admission, presence of cancer, and extreme severity of illness. Implantation of the filters happened more often than expected in 109 hospitals, and less often than expected in 59 of them.
The researchers added, “Despite uncertainty about the relative benefits vs. risks of VCFs [vena cava filters], the use of VCFs continues to increase rapidly.”
Other studies have raised serious safety concerns about Cook IVC filters. In 2009, researchers found that out of 115 patients implanted with a Cook Celect IVC filter, many were able to have their filters removed without issue, but several presented with complications because the device had become embedded in the inferior vena cava.
A 2012 study found that IVC filters did not reduce mortality rates for stable patients, and a 2013 editorial published in JAMA Internal Medicine questioned their safety, stating that current studies could not validate their supposed benefits. Doctors penning the editorial stated that though the filters should work in theory, they hadn’t proved as effective as hoped in real life.
A more recent 2015 study concluded that the filters were unnecessary in patients who could be treated with blood-thinning drugs, since the data showed no additional benefit in 200 patients who received both the filters and anticoagulant medications.
FDA Warns About IVC Filter Dangers
In 2010, the FDA released a safety communication warning doctors and patients about the potential serious side effects associated with IVC filters. They revealed that between 2005 and 2010, they received 921 reports of adverse events associated with these devices. These included:
• 328 device migrations to other parts of the body
• 146 embolizations (certain parts of the device detached from the device as a whole)
• 70 perforations
• 56 filter fractures
They added that some of these events led to “adverse clinical outcomes in patients,” which means that patients suffered serious injuries.
The FDA recommended at the time that doctors remove the devices as soon as the risk for PE had passed. Since there have been no established standards for when to use or remove these devices, however, the FDA went back to work. In May 2014, they issued an update to their initial 2010 communication, stating that they had developed a “quantitative decision analysis” to determine if there was an ideal time to remove the filters.
Their research showed that if the patient’s risk for PE had passed, the risk/benefit profile favored removal of the IVC filter between 29 and 54 days after implantation. They added that they were requiring manufacturers like Cook Medical to gather additional data to address unanswered safety questions about the devices.
Manufacturers were given two options: 1) participate in the PRESERVE study (PREdicting the Safety and Effectiveness of InferioR Vena Cava Filters), which examines the use of IVC filters to prevent PE; or 2) conduct additional postmarket surveillance to further assess the safety profile of the devices.
Types of Possible Cook IVC Filter Injuries
Types of potential injuries associated with Cook IVC filters include:
• Migration of the device to another part of the body
• Device perforates the inferior vena cava or other body organ, like the heart or lungs
• Components of the device become detached and travel elsewhere to cause injuries
• Device becomes embedded into the inferior vena cava
• Blood clots either where the filter is located or elsewhere
• Hemorrhage or infection
• Difficult or impossible removal
• Filter fracture causing chest pain and shortness of breath
Cook IVC Filter Lawsuits
The Cook Gunther Tulip was released on the market in 2003, and the Cook Celect in 2008. The manufacturers of the Cook IVC Filters, Cook Medical, failed to warn doctors and patients of risks of migration, perforation, and the like. After the FDA’s 2010 update, however, awareness increased, and patients began to realize that if they had problems with their IVC filter, it could be because the device was improperly designed in the first place.
Patients who suffered serious injuries because of Cook IVC filters soon began to file personal injury lawsuits in an attempt to recover damages. Soon a number of cases were pending in various courts across the nation. Patients filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting consolidation in one court, to increase efficiency of pre-trial proceedings.
Cook was against consolidation, stating that the cases involved different questions of fact, depending on the patient and the product used. The panel didn’t agree, however, and transferred 27 cases to the Southern District of Indiana on October 15, 2014. The number of cases pending there has since increased to over100.
Plaintiffs claim that Cook Medical failed to provide adequate warnings about the risks associated with their IVC filters, and designed a defective product that presented too great a risk for serious injury.
A Cook IVC Filter Lawyer Can Help
Pittsburgh residents and those in other areas of the Ohio Valley who were implanted with a Cook IVC filter and then suffered serious injuries like migration, perforation, or difficult retrieval, may be eligible to file a Cook IVC lawsuit. The IVC filter lawyers at Chaffin Luhana have been following developments with Cook IVC filters and stand ready to help victims who have had their lives torn apart because of these devices.
We can help explain your legal options, and examine the facts of your case to determine your chances at compensation. Call today for a free and confidential case evaluation at 1-888-316-2311.