The IVC filter lawsuits claim these devices have been defectively designed and that they are failing at a high rate.
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What Do We Know About the IVC Filter Lawsuits
The lawsuits involving the IVC Filter state the manufacturers of the device failed to warn patients and physicians of the increased risks of the filter breaking, and metal fragments moving through the blood, potentially damaging an organ.
Attorneys argue that C.R. Bard (the manufacturer) hid the results of its own research which found the filter dangerous, and even forged an employee's signature on an FDA application in order to get approval.
Five products are most often involved in the IVC filter litigation: The Bard Recovery filter; The Bard G2 filter; The Bard G2 Express filter; The Cook Gunther Tulip filter; and the Cook Celect filter. Other filters causing problems include the Bard Eclipse, Bard Merdian, and Bard Denali.
IVC Filter Injuries & Side Effects
There have been reports of the IVC blood clot filter falling out of place or breaking apart. The metal device, or pieces from it, can then move through the blood, working their way through a vein wall and puncturing an internal organ.
There are also reports of blood clots occurring at the location where the device was inserted – the same clotting the device is supposed to prevent.
Below are some of the more frequent injuries experienced when parts from an IVC filter reach the heart or lungs. If you believe your IVC filter might have failed, you should notify your primary physician and seek medical care.
|COMMON INJURIES||SEVERE INJURIES|
|Confusion||Hemorrhage (severe bleeding)|
|Heart Rhythm Problems||Pulmonary Embolism|
|Shortness of Breath|
|Hemorrhaging or Internal Bleeding|
What has happened in many cases is that an IVC filter fractures and sends small, sharp metal shards through the patient's circulatory system, or falls out of position altogether. Either way, this can cause severe, painful and life-threatening injuries.
When the artery is punctured, it can cause secondary injuries to other organs. The metal shards can even reach the heart itself, causing arrhythmia (irregular heartbeat), perforating the walls of the heart chamber.
It can also result in a condition known as cardiac tamponade, in which fluid such as pus or blood leaks into the pericardium (the tissue lining surrounding the heart muscle), causing pressure and interfering with heartbeat.
IVC Filter Lawsuit Settlement Amounts
In March 2013, Bard settled an IVC filter case brought by plaintiff Lisa Davis, who received a G2 filter in 2006. The device fractured in 2008, migrating to her heart, resulting in ongoing health problems and making it necessary for her to take anticoagulant medications for the remainder of her life. Davis filed her complaint in 2011 in the U.S. District Court for the Eastern District of Michigan.
In January 2015, Bard settled a lawsuit brought by Kelly Vlasvich, alleging her IVC filter had fragmented. One of the twelve struts of the device lodged in her heart and two in her lungs. As a result, Mrs. Vlasvich suffered “permanent and extensive disfigurement.”
In February 2015, Bard reached a settlement with plaintiff Kevin Phillips for an undisclosed amount. Phillips filed the case in June 2012, alleging that the device, which had been implanted in 2005, fractured after five years. As a result, a fragment of the filter pierced and injured his heart. The case was tried in the U.S. District Court for the District of Nevada. Bard reached the settlement ten days after the opening of the trial.
IVC Filter Recall Information
In August 2010, the U.S. Food and Drug Administration issued a warning on “known long-term risks associated with IVC filters,” including “lower limb deep vein thrombosis [DVT], filter fracture, filter migration, filter embolization, and IVC perforation.” This warning came after the agency had received over 900 adverse event reports involving device migration, fracturing, and injuries resulting from organ perforation. The FDA made a recommendation that filters be removed from the patient as soon as the risk of pulmonary embolism was passed.
In March 2015, Bard issued a Class 2 Device Recall for its Denali IVC Filter. The recall notice cited missing label information in the product's instructions for use concerning “patients with uncontrolled sepsis and patients with known hypersensitivity to nickel-titanium alloys.” The recall affected 1,183 units.
In July 2015, the FDA issued a warning letter to Bard regarding the Recovery Cone Removal System, Model RC-15. This device was designed to facilitate the removal of the company's IVC filters from patients' bodies. According to the letter, the company was manufacturing the device “without marketing clearance or approval.” The device had been approved for the removal of some IVC filter models, but not others.
In August 2016, Health Canada issued a general safety warning regarding IVC filters after receiving over 120 “incident reports” of device fracture, organ and vein perforation, and patient deaths. The warning included twelve different models from six manufacturers, including Bard Peripheral Vascular and Cook Medical. The notice reported that most injuries and complications occurred after 30 days following implantation. Published in Health Canada - IVC Filter Risks
What is the Purpose of an IVC Filter?
The inferior vena cava (IVC) is a major vein that carries blood from the lower body into the heart. An IVC filter is a spider-like wire inserted into this vein in patients who are at high risk of a pulmonary embolism (a blockage in one of the arteries in the lungs).
The IVC filter's purpose is to prevent blood clots from entering the heart, lungs, kidneys or brain by catching the clots in the bloodstream and allowing them to break down over time. The filters often are used with patients who are not able to take anticoagulant medication (drugs that help prevent blood clots).
It's recommended that the filter be removed from the patient within six to twelve weeks of being inserted. The longer the filter remains in the patient the more difficult it is to remove, and the greater chance of injury.
A study conducted at Boston University School of Medicine found that IVC filters provide no significant benefit in survivability rate among trauma patients.
A separate clinical trial found that treating an acute pulmonary embolism patient with an IVC filter and an anticoagulation drug provided no additional benefit compared to treating the patient with just an anticoagulation drug.
After extensive clinical research, physicians from the Albert Einstein College of Medicine in New York City concluded that traumatic spinal cord injury (SCI) patients treated with an IVC filter were at higher risk for experiencing a deep vein thromboembolism than SCI patients who were simply provided anticoagulant medication.
IVC Filter Lawsuit News
No new trial for Bard in $4m vena cava filter loss
Becton Dickinson & Co. subsidiary C.R. Bard failed to win a new trial after a jury awarded nearly $4 million to the plaintiff in a bellwether product liability lawsuit brought over Bard’s inferior vena cava filter. Published in Mass Device - New Trial Denied
Why Did Firm Keep Selling Problem Blood-Clot Filters?
A company that made a blood-clot filter associated with 27 deaths and hundreds of problems replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market. Confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company's Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration. But instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them. At least 12 deaths and hundreds of problems are now linked to the G2 series filters, according to Bard and FDA records. Published in NBC News - IVC Filter Blood-Clots
Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?
In 2002, medical giant C.R. Bard recruited Kay Fuller, a veteran regulatory specialist, to help secure FDA clearance for its Recovery blood clot filter, after the agency had turned down a previous application. The Recovery, a one-and-a-half-inch metal trap, was designed to sit inside a major vein, the vena cava, and block blood clots from traveling to the heart or lungs, where they could be deadly. Published in NBC News - IVC Filter Forged Signature
Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?
Serious questions are being raised about a medical device implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws. At least 27 deaths have been associated with the Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade, an NBC News investigation has found. Published in NBC News - IVC Filter Fatal Flaw