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IVC Filter Lawsuit

Have you or a loved one been injured by an IVC filter? If so, you’re not alone and our lawyers can help.

Over 1,000 Reports of Serious Complications: Since 2005, The U.S. Food & Drug Administration (FDA) has received roughly 1,000 adverse event reports related to the use of 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.

Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

Update: Health Canada Issues Warning on Blood Clot Filter Complications

July 26, 2016Health Canada yesterday issued a product safety warning regarding the health risks associated with IVC filters. The agency has received at least 121 reports of adverse health complications associated with the devices since June 6, 2016. Most of the injuries occurred in patients whose filters had been left implanted for more than 30 days, according to Health Canada.

What’s the Problem?

The inferior vena cava is the main vessel that returns blood from the lower half of the body to the heart. IVC filters are implanted in people at risk for developing life-threatening pulmonary embolisms who are unable to take anticoagulant drugs. The devices are umbrella-shaped, and have legs that extend to stop blood clots from migrating from the lower body to the heart and / or lungs. IVC filter candidates are typically people with a history of blood clots, trauma victims, at risk for developing deep vein thrombosis (DVT), or who have had a recent surgery.

Unfortunately, IVC filters have recently been found to have the potential to break off and migrate to the heart, lungs, and other vital organs. When this happens, severe, potentially fatal injuries can ensue. The medical literature has reported a significant statistical rate of IVC filter failure, fracture, and migration.

IVC Filter Complications

  • IVC Filter Fracture
  • Perforation, Puncture or Serious Damage to the Heart, Lungs or Vena Cava
  • Internal Bleeding
  • Cardiac or Pericardial Tamponade
  • Ventricle Tachycardia
  • Lower Limb DVT
  • Hematoma or Nerve Injury at the Puncture Site
  • Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
  • Pulmonary Embolism
  • Infection
  • Death

Fracture / Embolization Warning Signs

Warning signs that an IVC filter has failed may include:

  • Severe pain in the heart or chest
  • Anxiety
  • Pulmonary embolus
  • Respiratory compromise
  • Hemorrhage
  • Perforation of organs, tissues or blood vessels

Patients who believe their IVC filters may have fractured should contact their doctor immediately. A computerized tomography (CT) scan or other test will be used to determine whether the device has failed.

Which IVC Filters are Affected?

Our lawyers are now accepting potential lawsuits on behalf of patients who suffered complications after being implanted with the following brands of inferior vena cava filters:
Bard IVC Filter

Cook IVC Filter

Other IVC Filter Brands

IVC Filter Studies

A research team led by Dr. William Nicholson at York Hospital in Pennsylvania looked at 80 patients who had been implanted with Bard IVC filters between 2004 and 2009. These individuals underwent a fluoroscopy to determine the integrity of the filter and evaluate whether they had broken or if they were still intact. Patients whose devices were fragmented also underwent echocardiography and cardiac computed tomography.

The study’s results indicated that 13 of 80 patients (16%) who received Bard Recovery and Bard G2 filters had at least one fracture. 1st generation Bard Recovery filters had a 25% (7 of 28) fracture rate, with embolizations to the heart occurring in 5 cases. In 2nd generation devices (including the Bard G2 filter), 12% (6 of 52) were also found to have fractured. In 2 cases, the fragment inhibited blood flow, 1 in the vein coming out of the liver and 1 in the lungs. In the other 4 cases, the fragments stayed close to the filter.

“It is essential that patients and their treating physicians be educated about this previously under recognized and potentially life-threatening complication of these devices.” “Armed with this knowledge, educated patients can be alert to the presence of pleuritic chest pain and other symptoms that should prompt immediate evaluation. Such early awareness and evaluation could certainly be life saving. In addition, the propensity for filter fragmentation may be directly related to the duration of implantation. Patients and their physicians should be educated about this fact so that they have the opportunity to consider having the filter removed,” the authors wrote in their report.

Large-Scale Study to Investigate IVC Filter Safety

The first large-scale, multi-specialty research trial to evaluate the safety of IVC filter use, entitled Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE), is set to begin in spring 2015. The goal of the research is to obtain a real-world view of the safety and effectiveness of IVC filters placed in the U.S. Click here to learn more.

Greenfield IVC Filter Perforates Patient With All 6 Legs: Study

A study published in the European Heart Journal on June 15, 2015, described a 52-year-old male patient implanted with an abnormally deployed Greenfield IVC filter that had shattered and perforated his inferior vena cava. “Two legs were located in the prevertebral space, one abutted the anterior aortic wall, one leg was deeply invading the right psoas muscle, and two legs arose very close to the duodenum ending up in close proximity to the small bowel loops.” Click here to learn more.

FDA Warning: Filters Intended for Short-Term Use Only

In August 2010, the U.S. Food & Drug Administration (FDA) issued a warning against leaving inferior vena cava filters implanted in patients for extended periods due to their potential to cause cause adverse health complications. FDA warned that IVC filters are for short-term use in patients at risk for pulmonary embolism, and implanting doctors are to remove the devices once the risk subsides. The administration was concerned about doctors not retrieving IVC filters intended for short-term placement, exposing patients to problems caused by fractured implants.

The FDA warning came after the study conducted by Dr. Nicholson noted above found a high prevalence of fracture and fragment embolizations with retrievable inferior vena cava filters. Nicholson’s study was used to challenge the FDA’s medical device approval process. The agency considers IVC filters as Class II devices, or low risk, clearing them without clinical safety or effectiveness data via their controversial 510(k) approval loophole.

How Many People Have Been Injured by IVC Filter Complications?

Since 2005, FDA has been made aware of at least 921 adverse event reports involving IVC filters, which included:

  • 328 cases of device migration
  • 146 reports of detachment of device component and embolization
  • 70 cases of perforation of the inferior vena cava
  • 56 IVC filter breaks

NBC News Investigation Reveals ‘Fatal Flaw’ with Bard IVC Filters

A year-long investigation by NBC Nightly News has raised serious questions about why C.R. Bard continued to sell its IVC filters even after it became aware that the devices were failing and causing death and other adverse health complications at rates significantly higher than competing brands. Click on the link below to watch the video:

IVC Filter Recall

In December 2005, the FDA issued a nationwide Class I Recall for the Boston Scientific Stainless Steel Greenfield Vena Cava Filter. Devices affected by the recall were made before March 10, 2004, and can be identified by the product code M001505010. The filters were recalled due to multiple reports of detachment at the bond between the carrier capsule and the outer sheath of the filter’s delivery system during implantation, putting patients at risk of adverse cardiac outcomes. A total of 8 complaints were received, 2 of which involved severe injuries requiring intervention, and 1 was reported as a death. There were approximately 18,000 Boston Scientific IVC filters affected by the recall.

Bard IVC Filter Litigation

In September 2012, a class action lawsuit filed against C.R. Bard over its Recovery and G2 IVC filters was removed from Florida state court to the federal court system. Attorneys for Bard filed a petition to have the case transferred to the U.S. District Court for the Southern District of Florida, which means that the company believes that the class action will eventually likely include more than 100 plaintiffs, that the total claims could top $5 million, and that members of the plaintiff class will be diverse from at least one defendant.

In addition to the Florida case, a number of other Bard IVC filter lawsuits have been filed in Pennsylvania and California courts, each involving similar allegations that Bard knew – or should have known – about its products’ potential to cause serious side effects, but that it failed to warn about these risks. The claims seek compensation to pay for the medical monitoring patients will require to ensure that the IVC filters have not fractured or embolized in their bodies as long as they remain implanted. To date, approximately 100,000 Bard IVC filters have been implanted in patients around the country.

Cook IVC Filter Multidistrict Litigation

On October 15, 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ruled that all federal lawsuits involving Cook IVC filters will be centralized in the Southern District of Indiana before District Judge Richard L. Young. All of the complaints involve similar allegations that manufacturing defects with Cook vena cava filters make the devices likely to fracture, migrate and puncture internal organs. Click here to learn more.

Do I Have an IVC Filter Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new IVC filter complications cases in all 50 states.

Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

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