The lawsuit involving the IVC Filter states the manufacturers of the IVC blood clot devices failed to warn patients and physicians of the increased risks of the filters breaking, and metal fragments moving through the blood, potentially damaging an organ. Plaintffs attorneys argue the manufacturer C.R. Bard hid the results of its own research finding the filters dangerous, and even forged an employee's signature on an FDA application in order to get FDA 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 IVC filters causing problems include the Bard Eclipse, Bard Merdian, and Bard Denali.
Why is an IVC Filter Utilized
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 device inserted into this vein in patients who are at high risk of 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 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).
Side Effects and Risks of IVC Filters
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 damaging an internal organ. There are also reports of blood clots occurring at the location where the device was inserted – the same clotting that the device is supposed to prevent.
Below are some of the more frequent injuries experienced when IVC filters break and pieces move to the heart or lungs.
|COMMON INJURIES||SEVERE INJURIES|
|Confusion||Hemorrhage (severe bleeding)|
|Heart Rhythm Problems||Pulmonary Embolism|
|Shortness of Breath|
|Hemorrhaging or Internal Bleeding|
In summary, the IVC filter products are known to break apart (fracture), move, puncture, and result in significant retrieval complications. Perforation (puncturing) of important organs (such as the heart and lungs) is frequent in cases where an IVC filter has broken, fractured, and/or migrated (moved). Retrieval of these filters is often unsuccessful, requiring multiple surgeries.
IVC Filter Lawsuit Videos
IVC Filter Lawsuit Videos
FDA and Scientific Studies Regarding IVC Filter
Removing Retrievable Inferior Vena Cava Filters: Initial CommunicationSince 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided. To read more, click FDA Safety Alert
Removing Retrievable Inferior Vena Cava Filters: FDA Safety CommunicationThe FDA developed a quantitative decision analysis using publicly available data available in the medical literature to assess whether there is a time period during which the risk of having an IVC filter in place is expected to outweigh the benefits. The decision analysis (Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism) was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013. The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation. To read more, click FDA Safety Alert
Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filtersPerforation of at least one filter component through the IVC was observed in 43 of 50 (86%) filters on CT scans obtained between 1 and 880 days after filter placement. All filters imaged after 71 days showed some degree of vena caval perforation, often as a progressive process. Filter tilt was seen in 20 of 50 (40%) filters, and all tilted filters also demonstrated vena caval perforation. Transjugular removal was attempted in 12 of 50 (24%) filters and was successful in 11 of 12 (92%). To read more, click Cardiovasc Intervent Radiology
Bard Recovery filter: evaluation and management of vena cava limb perforation, fracture, and migrationRecovery filter limb perforation of the vena cava increases over time and is associated with a 21% incidence of filter arm fracture and migration. Follow-up imaging is recommended. To read more, click Journal of Vascular and Interventional Radiology
Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and TamponadeThe Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae. To read more, click JAMA Internal Medicine
Frequent Fracture of TrapEase Inferior Vena Cava FiltersThe devices were evaluated at an average of 50.0 months after implantation. Among the 20 patients (20 TrapEase IVCFs), 10 TrapEase IVCFs (50%) were fractured. Remarkably, 9 of the 14 filters (64%) that had been inserted for longer than 4 years revealed fractures. Straight struts were fractured in all cases. Among the 10 fractured IVCFs, 8 had a single fractured strut, while 2 had multiple fractured struts. Radiographic and 3-D CT images revealed the geometrical relationships between the fracture sites and the neighboring structures. Among the fractured filters, the straight struts of the TrapEase IVCF seemed to be fractured by the compression of the vertebral bodies, particularly the vertebral osteophytes (9 cases) and the compression of the tortuous aorta (3 cases). To read more, click JAMA Internal Medicine
IVC Filter Recall Information
As of this time, there has not been a recall of Bard's IVC blood clot filter. However, the FDA has issued two warnings about the device, and recommends that it be used only temporarily if a patient is unable to take anticoagulant (blood clot) medication. The FDA recommends that patients who have received an IVC Filter talk with their physicians as soon as possible to make sure it has not moved or broken apart, and whether the device should now be removed.
IVC Filter Lawsuit NewsWhy 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. To read more, click NBC NewsDid 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. To read more, click NBC News
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. To read more, click NBC News
CR Bard Targeted in NBC News Investig. Over Blood Clot Filter: Purposely Hid Known Dangers
Earlier this month, NBC News completed a year-long investigation of medical device manufacturer CR Bard. It is the company responsible for the Recovery IVC filter, a device inserted into a major vein in order to prevent blood clots from reaching the lungs. Designed to be “retrievable” once the patient is no longer in danger from blood clots, this device has been implicated in 30 fatalities and 300 injuries. NBC News found evidence that Bard executives were fully aware of the dangers to patients who had the device implanted as far back as 2004. To read more, click Ring of Fire
Bard Medical Forges Signature to Get FDA Approval on Dangerous Blood Clot Filter
Bard Medical, also known as C.R. Bard, may have been willing to commit a felony that would merit a long prison term for a natural person in order to preserve its profit margin. As recently reported on several media web sites, someone in the company allegedly forged the signature of an in-house regulatory specialist in order to get FDA approval for a product the company knew to be dangerous. To read more, click Ring of Fire
Big Pharma CR Bard Forged Documents to Get FDA Approval on a Dangerous Blood-Clot Filter Killing Patients
A former regulatory specialist for medical device manufacturer CR Bard alleges that someone at the company forged her signature on an FDA application in order to get approval for a device. Kay Fuller is a regulatory specialist. Her job at CR Bard was to work with the US Food and Drug Administration in order to get approval for medical devices. The device in this particular case is known as the Recovery Blood Clot Filter. Surgeons insert this device into a major artery in order to prevent blood clots from entering the heart or the lungs. According to Ms. Fuller, a clinical trial raised serious questions about the safety of the device. Furthermore, the company itself withheld test results, and did not share them with her. To read more, click Ring of Fire