IVC Filter Lawsuit – Defective Medical Device Injures Many

A medical device designed to catch blood clots in the body’s largest vein before they can travel to the lungs is now the subject of hundreds of lawsuits claiming the device broke or otherwise malfunctioned, causing serious harm and even death. Baum, Hedlund, Aristei & Goldman, PC, has represented thousands of clients in defective medical device and pharmaceutical cases, and our IVC filter lawsuit team is currently accepting cases from individuals and families who have been injured by, or are facing the threat of serious harm from an IVC filter.

If you would like to speak to an IVC filter lawyer about your case, please contact us today for a free case evaluation.

What Is an IVC Filter?

An IVC filter is a medical device inserted into the inferior vena cava [IVC] , a large vein that carries blood from the lower body back to the heart. (Vena cava is Latin for “hollow vein.”) The IVC is located in back of the abdomen and runs alongside the spine.

Most of us are familiar with the basics of the circulatory system (see diagram below). The heart pumps blood to the lungs, where it picks up oxygen and then returns to the heart. From there, the oxygen-rich blood is pumped through arteries to the cells in the body and used to produce energy from food. The blood, now with much less oxygen, returns to the heart through the veins and is then pumped back to the lungs, where it releases carbon dioxide and picks up new oxygen.

Blood clots in deep veins in the legs, known as deep vein thrombosis (DVT), can interrupt this process. The clots can break loose and may travel up through the inferior vena cava back to the heart and then to the lungs, where they get stuck and block blood flow. This potentially fatal condition is known as a pulmonary embolism (PE). A Pulmonary embolism is a sudden blockage of a major artery in the lung. The IVC filter is designed to catch blood clots before they can travel to the lungs and cause a PE. These filters are primarily used for patients who have repeated DVT despite the use of blood thinners (usually the first treatment given), or in those who cannot take blood thinners for medical reasons.

Retrievable IVC Filter Failure Modes

IVC Filter Complications

There are numerous problems associated with the filters and each IVC filter lawsuit involves a variation on one of several adverse effects. In August of 2010 the U.S. Food and Drug Administration issued a safety communication listing several types of IVC filter complications.

Of the 921 adverse events reported to the FDA there were:

  • 328 cases of device migration.
  • 146 cases involving detachment of device parts, which then moved through the vein to other locations.
  • 70 cases of the IVC perforation (being pierced by the filter).
  • 56 cases involving the fracture of the filter.

Reported IVC Filter Side Effects and Complications

  • Death
  • Heart Attack
  • Stroke
  • Pulmonary embolism
  • Chest pain
  • Compromised respiration (breathing)
  • Perforation/puncture of the inferior vena cava, heart, lungs, blood vessels or other internal organs
  • Hemorrhagic pericardial effusion (excess fluid around the heart)
  • Cardiac tamponade (compression of the heart caused by excess fluid around the heart)
  • IVC filter embolization/movement (migration)
  • Tilting/malposition of the IVC filter
  • Fracture of the IVC filter
  • Splintering of IVC filter
  • Embedded IVC filter requiring surgery
  • Difficulty removing the IVC filter
  • Physician unable to remove/retrieve IVC filter

IVC Filter Migration and Fracture

The filter may detach and move within the IVC. It may also fracture and shards of broken filter may travel (migrate) away from the device. These broken parts may then move through the inferior vena cava and end up lodging in other organs, most notably the heart. The medical term for this is embolization. A recent case study in the journal Case Reports in Cardiology focused on a woman who was found to have a fractured limb of a filter in her right ventricle. The medical literature contains numerous case studies of filters that have migrated to the right ventricle of the heart. This has resulted in abnormal heart beating (arrhythmias), destruction of heart valves, indications of damage to the heart muscle, and the necessity of heart surgery to remove the device.

Several deaths have been caused by IVC filter migration.

In February 2015, filter maker C. R. Bard settled an IVC filter lawsuit brought by a man who alleged that a leg that broke off of his Bard Recovery Filter System, traveled to his heart and punctured it, requiring open heart surgery.

In addition to the IVC filter complications mentioned above, there are instances in which the filter tilts, causing it to function improperly and making it difficult to remove.

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Device Perforation of IVC and Internal Organs

The inferior vena cava runs alongside many internal organs. When the filter perforates (pierces) the wall of the inferior vena cava it may not only damage that particular vessel, but internal organs near it as well.

Medical studies have reported that the piercing of the IVC by filters has damaged areas of the body, such as the:

  • Heart
  • Aorta
  • Lungs
  • Small and large intestine
  • Liver
  • Pancreas
  • Kidney
  • Other veins including the renal vein (which drains the kidney)
  • Spinal column
  • Diaphragm
  • Organs comprising the genital and urinary system

A 2013 study of 591 patients who received an inferior vena cava filter between 2006 and 2009 found that 46% of the filters had penetrated the inferior vena cava and punctured adjacent organs. The plaintiff in a recent IVC filter lawsuit has alleged that his filter pierced the inferior vena cava and abutted his abdominal aorta. The filter can no longer be removed, according to the suit.

IVC Filter Thrombosis

Thrombosis is the medical term for the clotting of the blood in a blood vessel. Filter devices are designed to catch blood clots, but over time the filter may partially or completely block the inferior vena cava. This is referred to as filter thrombosis. It may be due to the filter doing its job—catching blood clots—or the filter itself may be the primary cause of the blood clot. If the blockage is only partial there may be no symptoms. Complete occlusion of the inferior vena cava is accompanied by swelling, pain and other serious complications.

IVC Filter Lawsuit: FDA Issues Safety Communications

In 2010, the FDA issued its first safety communication regarding IVC filters. Safety communications are the FDA’s primary means of alerting health care professionals to safety risks associated with drugs and medical devices. The FDA warned of serious adverse events associated with the filters and expressed its concern that the filters, which are designed to be retrievable, were being left in place too long. The agency recommended that doctors consider removing the filter as soon as the need for protection from a pulmonary embolism is no longer needed. The problem with that is that the longer a filter is left in place, the more difficult it becomes to remove.

Unfortunately, it appears that the FDA warning had little effect. It was reported that at one large Boston medical center, less than 10% of the filters were being removed, even though they were no longer needed. In 2014, the FDA issued a new safety communication. The FDA’s own analysis had found that if the filters were not removed between 29 and 54 days after implantation, the risks associated with having the filter in place began to exceed all the possible benefits.

… 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.”
FDA Safety Communication, May 6, 2014

Part of the problem is that the filters can be very difficult or impossible to remove. In one study of 978 patients, nearly 20% of the attempts to remove the filters were unsuccessful. In over a seven and a half year period, only 8.5% of the filters were successfully removed.

Major Medical Journal Examines IVC Filter Problems

In 2013, the Journal of the American Medical Association published an editorial questioning the use of IVC filters, with the subtitle, “How Could A Medical Device Be So Well Accepted Without Any Evidence of Efficacy?” The authors review several problems with evidence base.

  • The evidence base for the filter consisted of one study whose results were “nearly uninterpretable.”
  • Only one filter trial (a test involving human subjects) met the highest standards for drug and device testing—the randomized controlled trial. Evidence of effectiveness in that study was “weak,” said the authors. The death rate was the same in those who received the filter and those who did not. Moreover, the occurrence of deep vein thrombosis was higher in those with the filter than in those without it.
  • The devices have received approval for sales in the U.S. not on the basis of controlled clinical trials, but based on the FDA’s 510(k) process, in which manufacturers are only required to establish that their device is similar to an existing device. As the authors point out, the prestigious Institute of Medicine (which became the National Academy of Medicine in 2015) has recommended the 510(k) approval process be discontinued. A committee formed by the institute to investigate the 510(k) process concluded, “510(k) clearance is not a determination that the cleared device is safe or effective”

“IVC filter should capture a blood clot before it reaches the pulmonary circulation
and should improve outcomes. This theory, however, has never been validated by empirical studies.”
Journal of the American Medical Association, April 8, 2013

IVC Filter Lawsuit: A Failure to Warn

Central to each IVC filter lawsuit is the question of whether or not the manufacturers have taken adequate steps to warn consumers of the risks associated with their filters. Considerable evidence shows that manufacturers failed to warn the public about the dangers of IVC filters.

C.R Bard IVC Filters

Problems With the Bard “Recovery” and “G2 Series” IVC Filters

Watch NBC Nightly News: Did Manufacturer of Medical Device Linked to 27 Deaths Ignore Safety Concerns?

IVC Filter Lawsuit

On September 3 and 4, 2015, NBC Nightly News aired a two-part report on an IVC filter (Recovery Filter System) manufactured by C. R. Bard and approved for market in 2003. In part 1, NBC reported that Bard’s Recovery filter had been associated with 27 deaths and 300 other adverse effects. Bard responded to problems with its filter by hiring a public relations firm and conducting a confidential study, which found that the risk of death, filter fracture and filter movement were all significantly higher for the Recovery filter than its competitors. According to the NBC report, even after it became aware of the serious risks associated with its filter, Bard sold 34,000 Recovery filters before replacing it with a new model, the G2, in 2005.

The second part of NBC’s investigation focused on a 510(k) application submitted by Bard to gain FDA clearance to sell its Recovery filter. The FDA had rejected an earlier application and Bard turned to regulatory specialist Kay Fuller for help. Fuller, however, raised concerns about the safety of the device. Bard’s response, she says, was to threaten her with removal from their team. She told her boss she would not sign an application unless her concerns were addressed. Nevertheless, a second application that appeared to bear Fuller’s signature was submitted and approved. Fuller says she never signed the application. An image of the application and Fuller’s actual signature can be seen here. FDA officials and Bard executives both denied requests to be interviewed for the NBC story.

In December 2015, NBC News published a follow-up report on the Bard’s G2 IVC filter (approved via 510[k] process after the Recovery filter). According to the story, Bard was aware of problems with the G2 shortly after its release, but continued to sell the device and a similar filter, the G2 Express. (The Express was released in 2008.) By 2010 Bard had sold over 160,000 G2 and G2 Express IVC filters. Dr. William T. Kuo is an interventional radiologist and the director of Stanford University’s IVC Filter Clinic. He told NBC News, “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.” Kuo believes that a Bard IVC filter recall should have been issued.

In September 2015, a New York woman filed a Bard IVC filter lawsuit after imaging tests revealed that the filter had punctured her inferior vena cava. Struts (or legs) of the device were protruding toward her lumbar spine, but doctors have advised her that surgery to remove the device would be too risky.

Here are several other Bard IVC filters are the subject of at least one IVC filter lawsuit:

  • Eclipse IVC Filter
  • Meridian IVC Filter
  • Denali IVC Filter

Cook Medical, Inc. IVC Filters

High Perforation Rates with Cook Günther Tulip and Celect IVC Filters

The other filter manufacturer playing a major role in the IVC filter litigation is Cook Medical, Inc. Nearly 200 IVC filter lawsuit cases were recently consolidated in the U.S. District Court for the Southern District of Indiana (see below). Cook makes two filters, the Günther Tulip, which received FDA approval in 2003, and the Cook Celect, which was approved by the FDA in 2008, under the 510(k) process.

Doctors at the University of California, San Francisco investigated the Celect and Günther Tulip filters and published their results in 2012 in the medical journal Cardiovascular Interventional Radiology. They found that 86% of the Günther Tulip and Celect filters had perforated through the IVC. After 71 days all of the filters showed “some degree of vena caval perforation, often as a progressive process.” Surprisingly, the newer Celect filter actually had higher perforation rates than the Günther Tulip and the most severe penetrations—those in which the filter passed through the inferior vena cava and contacted or perforated an outside structure—were more frequent in the newer Celect filter.

The progressive nature of the perforation was confirmed in an April 2013 study published in the Journal of Vascular and Interventional Radiology (JVIR). In that study researchers compared patients with the Günther Tulip filter (GTF) to patients with another similar device, the Option IVC filter. They found that “only GTFs showed time-dependent penetration, with penetration becoming more likely after prolonged indwelling times.” A June 2015 study comparing the same two filters, also published in the JVIR, found, “The incidence of strut perforation was 43% for Celect filters versus 0% for Option filters.”

The Cook filters appear to be uniquely prone to perforation problems. Did Cook properly warn patients and physicians of the defects associated with its filters? The plaintiffs in each Cook IVC filter lawsuit will argue they did not.

Latest IVC Filter News

IVC Filter Lawsuit: Multidistrict Litigation

In many cases, those who have filed an IVC filter lawsuit will be grouped together with other similar cases in what is known as multidistrict litigation (MDL). Instead of trying each IVC filter lawsuit separately, multidistrict litigation brings all the cases before one judge to avoid having conflicting pretrial rulings and to conserve resources of both plaintiffs and defendants in the discovery process. The MDL process gives both sides a chance to see how courts and juries view the evidence.

In August of 2015, 16 cases against Bard were transferred to the U.S. District Court for the District of Arizona. By the end of January 2016, the Bard IVC filter lawsuit count in Arizona was up to 90.

More than 200 cases against Cook Medical have been consolidated in the United States District Court for the Southern District of Indiana (MDL No. 2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation), and the pace of the IVC filter lawsuit filings against Cook increased significantly in the latter half of 2015.

Types of IVC Filters:

  • Bard Recovery IVC Filter
  • Bard G2 IVC Filter
  • Bard G2 Express / G2x Filter
  • Bard Eclipse
  • Bard Meridian
  • Bard Denali IVC Filter
  • Cook Günther Tulip
  • Cook Celect IVC Filter
  • B Braun Tempofilter IVC Filter
  • Cordis OptEase IVC Filter

Do I Have an IVC Filter Lawsuit?

If you or someone you know has been injured, by an IVC filter, the IVC filter lawsuit team at Baum, Hedlund, Aristei & Goldman would like to hear from you. Even if you are simply facing the threat of adverse effects resulting from the implantation of a filter, you have been unquestionably harmed.

Our firm has successfully represented thousands of clients against many of the largest drug and medical device manufacturers in the world. For over several decades, we have developed unique and very effective techniques to uncover evidence that device makers would prefer remains hidden from consumers and even physicians. If you are considering filing an IVC filter lawsuit, please contact our firm for a free case evaluation. You may fill out the form on this page or simply call us at 310-207-3233.

If you are considering filing an IVC filter lawsuit, please contact our firm for a free case evaluation.

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