IVC Filter Lawsuits - Consumer Justice Foundation

IVC Filter Lawsuits

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Patients who use an IVC filter to reduce their risk of blood clots and pulmonary embolism may be at risk for complications like device fracture, injury to nearby organs and migration of the device to other parts of the body.

IVC_FilterUse of IVC filters for preventing blood clots and pulmonary embolism in patients has increased dramatically in recent years, which has raised concerns about the risk-benefit profile of the medical devices, due to a potential risk for serious complications caused by faulty devices. Since 2005, the U.S. Food and Drug Administration (FDA) has received thousands of adverse event reports involving injuries from IVC filters, including migration of the device to other parts of the body, perforation of nearby organs or blood vessels, and pieces of the filters breaking off and embolizing to the heart. If you believe you have been harmed by alleged side effects of IVC filters, contact a reputable product liability lawyer today for legal help. You may have grounds to file an IVC filter lawsuit against the device manufacturing company, in order to pursue financial compensation for your injuries and medical bills.

IVC Filter Alternatives for Preventing Blood Clots

There are two types of IVC filters – temporary (retrievable) and permanent (irretrievable) – and both have been linked to an increased risk of devastating side effects. For patients facing a risk of pulmonary embolism who are unable to take a blood thinner drug, some possible alternative treatment options to an IVC filter for preventing blood clots include the following:

  • Increasing physical activity
  • Maintaining a healthy weight
  • Exercising the legs frequently, especially when sitting for long periods of time
  • Quitting smoking and avoiding second-hand smoke
  • Reducing stress
  • Limiting alcohol consumption to one serving per day (preferably red wine)
  • Consuming foods that are rich in omega-3 fatty acids or vitamin E
  • Consuming other foods and supplements like vitamin C, garlic, ginkgo biloba, nattokinase supplements, curcumin and polyphenol-rich foods

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What is an IVC Filter?

A medical device designed to prevent blood clots from traveling to the heart or lungs that may cause serious side effects in implant recipients.

An IVC filter, also known as an inferior vena cava filter, vena cava filter or blood clot filter, is a small cone-shaped wire cage implanted in the inferior vena cava, the largest vein in the body, just below the kidneys. The medical device is commonly implanted in patients at risk for blood clots, and is designed to capture an embolism (a blood clot that has broken loose from one of the deep veins in the legs), in order to prevent the clot from traveling to the heart or lungs and causing serious complications, like pulmonary embolism. Pulmonary embolism occurs when one or both pulmonary arteries become blocked, preventing deoxygenated blood from being carried to the lungs, and can cause chest pain, difficulty breathing and death. IVC filters are commonly used in patients who are at a high risk for pulmonary embolism, but are unable to take a blood-thinning medication, or anticoagulant. The IVC filter functions by allowing blood flow to continue around the trapped clot, and over time, natural anticoagulants in the blood will help break the clot down. Some of the most common types of IVC filters include the following:

  • C.R. Bard Recovery
  • C.R. Bard G2
  • C.R. Bard G2 Express
  • C.R. Bard Eclipse
  • C.R. Bard Meridian
  • Cook Medical Celect
  • Cook Medical Günther Tulip
  • B Braun Tempofilter
  • Cordis OptEase
  • ALN
  • Rex Medical Option

Potential Side Effects Resulting in an IVC Filter Lawsuits

According to a growing body of research, IVC filters manufactured by C.R. Bard and other manufacturers may cause serious side effects in patients, including:

  • Device migration – The filter may move, migrate or change position, possibly causing damage to internal organs or preventing the device from functioning properly.
  • Perforation of the inferior vena cava – The filter may perforate or erode into the inferior vena cava, possibly causing damage to this vein. It could also protrude from the vein and cause damage to other organs.
  • Device fracture – Parts of the filter may break off, travel through the bloodstream, and cause damage to the heart or lungs.
  • Hemorrhagic pericardial effusion – A potentially dangerous build-up of fluid around the heart
  • Cardiac tamponade – Compression of the heart caused by a build-up of fluid
  • Lower-limb deep vein thrombosis (DVT)
  • Chest pain
  • The filter may become clogged with clots, possibly causing a blockage and preventing blood from flowing into the heart from the lower part of the body.
  • Doctors may be unable to retrieve part or all of the IVC filter

In some cases, patients may have to undergo additional surgical procedures, such as emergency open-heart surgery, to remove the defective filter, and failed removal attempts may result in further injury possibly requiring long-term medical care.

Link Between IVC Filters and Side Effects

Research has shown that IVC filters may cause serious side effects in implant recipients, and one study published in the Archives of Internal Medicine in 2010 found that fractures and fragment embolization were common side effects in patients who received retrievable IVC filters manufactured by C.R. Bard. The study was conducted after Dr. William Nicholson of York Hospital in Pennsylvania noticed that one of his patients had suffered chest pain, perforation of the right ventricle, and a build-up of fluid around the heart after receiving a Bard IVC filter. Dr. Nicholson proceeded to ask all 80 of his patients who had been implanted with Bard IVC filters to submit to an exam, and after reviewing the cases, he found that 25% of the older Bard IVC filter devices implanted in patients had fractured and become embolisms, leading to at least one death. Of the patients who received the newer Bard G2 filter, 12% suffered device fracture, and in two cases, the fragments became embolisms.

In another study published in JAMA Internal Medicine in 2013, researchers found that only 8.5% of so-called “retrievable” IVC filters are successfully removed, which means whole filters or broken fragments of the filters may remain in the body, posing a serious risk of future injury. “In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the study authors wrote. “More comprehensive longitudinal data would likely identify additional complications.” Just one year later, the FDA issued an updated IVC filter safety communication, reminding healthcare providers about the importance of removing the filters in a timely manner.

Lawsuits Against IVC Filters for Device Migration, Device Fracture and Perforation of the Inferior Vena Cava

As more information comes to light about the potential risk of IVC filter side effects, consumers across the country are pursuing claims against C.R. Bard and other IVC filter manufacturers, in order to seek compensation for their injuries. More than 6,000 lawsuits pending in federal court allege that migration, fracture and other IVC filter injuries are the result of negligence, design defects and failure to warn. Some of the most recent lawsuits filed over alleged IVC filter side effects include the following:

January 31, 2013 – At least three IVC filter class action lawsuits are pending against C.R. Bard, the maker of the G2 and Recovery IVC filters.

March 2013 – A settlement agreement is reached in an IVC filter lawsuit brought by Lisa Davis, whose G2 filter fractured and migrated to her heart.

June 6, 2013 – A man from Illinois files a product liability lawsuit against C.R. Bard, after his Bard Recovery IVC filter migrated to his heart. He required emergency open-heart surgery, and continues to suffer from complications of the medical device.

November 15, 2013 – A product liability lawsuit is brought on behalf of a woman from Illinois who required emergency open-heart surgery after her Bard G2 IVC filter fractured and pieces of the device migrated to her heart and lungs. She still has pieces of the filter trapped in her lungs because doctors believe they are too dangerous to remove.

October 15, 2014 – All lawsuits involving injuries allegedly caused by Cook Medical IVC filters are centralized for coordinated pretrial proceedings in a federal multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Indiana. At this time, there are 27 lawsuits pending in 11 districts.

February 13, 2015 – Following six days of trial, a settlement for an undisclosed amount is reached between C.R. Bard and a man who required open-heart surgery because of complications allegedly linked to the company’s Recovery IVC filter.

July 6, 2015 – Cook Medical faces nearly 100 federal complaints filed on behalf of patients who allegedly suffered injuries from the company’s IVC filters, like the Günther Tulip and Celect devices.

August 2015 – All federal IVC filter lawsuits against C.R. Bard are consolidated for coordinated pretrial proceedings in the U.S. District of Arizona, as part of a multidistrict litigation. At this time, 22 lawsuits have been filed in 16 different courts.

October 2017 – The first of several IVC filter bellwether cases goes to trial.

November 2017 – The judge in the Bard MDL denies a motion to have all cases brought against the company dismissed.

February 2018 – Cook IVC filters are the subject of more than 3,600 lawsuits pending in the federal court system. Bard IVC filters are the subject of more than 3,500 additional lawsuits.

March 2018 – Cook wins the first bellwether trial. A total of 3,826 Cook IVC filter lawsuits remain pending in the federal MDL. A total of 3,639 lawsuits are pending in the Bard MDL.

April 2018 – A federal jury awards nearly $4 million in damages to the plaintiff in the first Bard IVC filter lawsuit to go to trial in the federal MDL.

FDA, IVC Filters and Medical Complications

In August 2010, the FDA issued a drug safety communication to consumers and the medical community, after receiving reports of more than 900 adverse events associated with IVC filters. At the time of the FDA’s IVC filter warning, the agency had received 921 adverse event reports from patients who received an IVC filter to prevent pulmonary embolism. Of the 921 reports, 328 involved migration of the device to other parts of the body, 146 involved broken pieces of the IVC filter traveling in the bloodstream, 70 involved the filter perforating the inferior vena cava, and 56 involved fractures of the IVC filter. In 2014, the FDA issued another drug safety communication recommending that IVC filters be retrieved within 29-54 days, as long as the patient’s risk of pulmonary embolism has subsided at that time. According to a media report in 2015, C.R. Bard continued to market and sell its IVC filters despite knowing that the devices were failing and causing serious injuries and even death.

IVC Filter Side Effect Studies

In light of the potential for IVC filters to cause devastating side effects in patients, a growing number of studies are being conducted in order to examine the alleged safety risks of IVC filters for implant recipients. The following are some recent IVC filter side effect studies published by credible medical journals:

November 8, 2010 – The Archives of Internal Medicine publishes research indicating that the Bard Recovery and Bard G2 IVC filters are associated with high rates of fracture and embolization, with potentially life-threatening complications.

August 28, 2012 – A study published in the American Journal of Medicine indicates that IVC filters don’t actually reduce mortality rates for stable patients experiencing pulmonary embolism. In fact, the researchers concluded that only a small percentage of pulmonary embolism patients actually benefited from the IVC filter, and the rest were exposed to an unnecessary risk of possible side effects.

March 21, 2013 – The Journal of the American Medical Association publishes an editorial and two studies questioning the safety and efficacy of IVC filters. One study details the various ways in which IVC filters are used, and the other advises against using IVC filters, due to the high risk of blood clots and low retrieval rates.

April 2013 – JAMA Internal Medicine publishes a study indicating that only roughly 8.5% of retrievable IVC filters are successfully removed.

March 2, 2014 – A study published in the Journal of the American College of Cardiology establishes a potential connection between the use of IVC filters and a lower risk of pulmonary embolism, but ties the medical device to a higher risk of recurrent venous thromboembolism (VTE).

April 30, 2015 – According to research published in the Journal of the American Medical Association, IVC filters may not benefit patients who can use blood thinner medications instead, to reduce their risk of blood clots.

June 2017 – JAMA Internal Medicine publishes a study indicating that FDA warnings, reports of complications and lawsuits over injuries from IVC filters led to a significant decline in the use of the medical devices.

Why We Think the Makers of IVC Filters Should Be Held Liable for Complications

Estimates suggest that, in the last 30 years, approximately 30,000 IVC filters have been implanted. Patients who receive an IVC filter expect the medical device to capture blood clots before they enter the lungs, in order to reduce their risk of suffering pulmonary embolism. However, allegedly defective IVC filters have punctured veins, fractured, and migrated to other parts of the body in some patients, causing serious medical issues, and critics of the medical devices believe C.R. Bard and other IVC filter manufacturing companies should be held liable for side effects allegedly caused by their devices. Lawsuits filed against the makers of IVC filters allege the following:

  • C.R. Bard and other IVC filter manufacturers designed and sold defective devices.
  • The companies knew or should have known about the risk of device migration and other potential side effects from IVC filters, and failed to provide consumers and doctors with adequate warnings about this risk.
  • Bard began receiving complaints of IVC filter malfunctions as early as 2004, but withheld information about these complaints from the public.
  • Bard and other manufacturers were aware that their IVC filters were prone to fracturing and traveling to other parts of the body, possibly causing serious injury.
  • Bard employees received a document known as the “Lehmann report” in early 2004, which included information about Bard’s vena cava filters and anticipated and ongoing lawsuits over consumer injuries.

What should you do? If you believe you have been harmed by side effects allegedly caused by an IVC filter, you should contact a lawyer as soon as possible to discuss filing a lawsuit against the device manufacturing company.

Since the FDA issued its first IVC filter warning in 2010, consumers nationwide have come forward with claims of injuries allegedly caused by the medical devices, including filter fracture, organ perforation and device migration. Many of these implant recipients have suffered complications like chronic chest or abdominal pain, pulmonary embolism, or constant worry over the fact that their IVC filter may fracture and cause severe injury to their internal organs. If you or a loved one received an IVC filter to prevent blood clots in the past, and you have since suffered one or more devastating side effects, consult a knowledgeable IVC filter attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, which you can pursue by filing an IVC filter complaint against the device manufacturing company.

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