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In this website, IVC filter lawyer Brandon Bogle provides the details of the IVC filter lawsuit, including the side effects of filter perforations, filter migrations, filter fractures, embolisms, and death. This page is designed to provide you the current legal and medical facts regarding this litigation, including a potential recall and settlement.
The IVC Filter lawsuit 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. Additionally, the lawsuit states that 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 lawsuits: The Bard Recovery filter; The Bard G2 filter; The Bard G2 Express filter; The Cook Gunther Tulip filter; and the Cook Celect filter.
IVC (Inferior Vena Cava) 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).
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. To date, the Recovery IVC Filter has been implicated in at least 30 deaths and 300 injuries.
If pieces of the IVC filter break and move to the heart or lungs, symptoms may include:
In severe cases, injuries can lead to:
In conclusion, 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.
As of this time, there has not been a recall of Bard’s IVC blood clot filter. However, the investigation into this device, from a legal standpoint, is still in its early stages. It often takes many years; tens of thousands of hours of attorney time; and the expense of many millions of dollars before all the facts come out that will lead to a recall. 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.
Our law firm has been in existence since 1955, and is considered a national leader in this type of litigation. We are the founder of Mass Torts Made Perfect, which is a national seminar attended by approximately 700 lawyers twice per year where we help teach the successful discovery and trial techniques in national litigation against drug companies. In litigation like this, federal judges often select a few attorneys to lead the investigation for all those injured who have filed a federal lawsuit. To date, federal judges have selected our attorneys more than 35 times to serve in this capacity.
For a detailed discussion of our history, credentials, accomplishments and results, please visit our About Us section.
Our IVC Filter lawyers provide absolutely free confidential consultation, and if we are fortunate enough for you to hire us, we never will charge you any fees or costs unless you first recover.
The fee we charge ranges from 20% to 40% depending upon the amount we recover for you. This fee should be similar to, if not exactly the same, as to what other lawyers are charging. This is true whether your lawyer has never handled a medical device case or whether it has been the focus of their practice for more than 60 years, as with our law firm.
Every state has maximum time limitations on when a IVC Filter claim must be filed. These time restrictions are known as statutes of limitations. If a claim is not filed against the manufacturer, marketers, sellers and healthcare providers before the statute of limitation ends, the injured persons are forever prevented from bringing a claim against the companies and persons who may have caused their injuries.
If you have been potentially injured by the use of an IVC Filter, your statute of limitations may already have ended, or may end in the very near future. Unfortunately, there is no way for us to tell you without us first reviewing the individual facts of your case. The one thing we can absolutely state is that every day you wait to hire an attorney may be the last day you can bring a claim.
As of this time, there have been no large group settlements involving Bard’s IVC filters. However, the IVC filter lawsuits are still in the early stages of litigation. Lawsuits likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, large groups of settlements do not occur until a few cases are tried before a jury, and the manufacturer is able to understand its financial risk. This in no way means you can wait to hire an attorney and file a lawsuit. Just the opposite. If you wait, you could permanently lose all of your rights, even if a settlement occurs in the future. This is because every state has time restrictions in which you can file a lawsuit for any injuries that you have sustained or could sustain.
The IVC Filter litigation will not likely be handled as a “class action”. The term “class action” means a type of lawsuit where a small group of individuals represent the interest of a very large group of individuals. The small group handles the litigation on behalf of the large group, and the results obtained by the small group are binding on the large group. This is not the type of litigation we are pursuing for those injured by IVC blood clot filters.
Instead, we will bring individual lawsuits for each of our clients. Most likely, the majority of our lawsuits will be combined before one judge in what is called multi-district litigation (MDL). The cases in a MDL are joined together for purposes of discovery and investigation, and hopefully settlement. However, as part of a MDL, each individual case is separate, and no one client is forced to settle his/her case as part of a class action group, and no one is bound by the jury trials of others. Each client gets to make his/her own decision whether to go to trial or not.
To contact us for a free confidential consult, you can call us at (800) 277-1193 (toll free). You also can request a private and confidential consultation by clicking Free & Confidential Consult, which form will be immediately reviewed by one of our attorneys handling this litigation.
Removing Retrievable Inferior Vena Cava Filters: Initial Communication: Since 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 Communication: The 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 filters: Perforation 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 migration: Recovery 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 Tamponade: The 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 Filters: The 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
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. To read more, click NBC News
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. 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
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