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An IVC Filter Injury Lawyer Can Help

When an Inferior Vena Cava Filter Placement May Be Necessary

A condition called deep vein thrombosis (DVT) occurs when blood clots develop in the veins of the leg or pelvis. The blood clots can potentially break up resulting in large pieces of the clot traveling to the lungs and heart where they could cause severe complications or even death.

There are many factors that may indicate a person is more likely to be at risk for DVT, ranging from prolonged bed rest, such as during a long hospital stay, or paralysis, to pregnancy, obesity, age,or taking birth control pills or hormone replacement therapy, to having a family history of deep vein thrombosis or pulmonary embolism. All these as well as other factors can increase a person's risk of developing deep vein thrombosis (DVT).

IVC filters were designed to trap large clot fragments and prevent them from traveling through the vena cava vein to the heart and / or lungs.

When anticoagulant therapy cannot be used or is ineffective, IVC filters are frequently placed in patients at risk for DVT, including pulmonary embolism (a blood clot in the lungs). An interventional radiologist or vascular surgeon will preform the minimally invasive procedure of implanting an IVC filter into the inferior vena cava. Although IVC filters were originally designed to be permanent implants, there are also, what are called, optionally retrievable IVC filters available.

 

Although the filters are designed to prevent life-threatening pulmonary embolism (blood clots in the lungs) it turns out that they actually may have life-threatening side effects. If you’ve been implanted with an IVC filter, you may face serious risks with complications that can be life threatening.

There are already numerous lawsuits, both settled and pending that claim in certain IVC filters there are design defects manufacturing defects, breached of implied warranty, negligence, and failure to warn.

FDA Warning Issued

The FDA has warned that recipients of an IVC filter could suffer from a number of serious side effects such as:

- IVC filter migration
- IVC filter fracture
- IVC filter components that puncture internal organs or lodge in blood vessels
- Tilting or moving of the IVC filter from its original position
- Inability or difficulty removing the IVC filter
- Filter particles that break off causing:

  • - Pulmonary embolism,
  • - Compromised respiration
  • - Stroke
  • - Death

 

Exercise Your Legal Rights
Find an IVC Filter Injury Lawyer

When a medical device, such as an IVC filter harms yourself or a loved one, you need to exercise your legal rights. The first step is to speak to an experienced personal injury lawyer who is familiar with the complications arising from IVC filters.

With years of experience in personal injury cases, an attorney at Gordon, Elias & Seely LLP will fight for your right to receive the maximum compensation possible, while holding IVC filter manufacturers accountable for their faulty devices.

We will seek compensation for your:

  • - Pain and suffering
  • - Hospital stays, revision surgeries, and other medically related expenses
  • - Physical rehabilitation as well as any rehabilitative equipment
  • - Lost wages - past and future

 

No Fee Legal Representation

The personal injury attorneys at Gordon, Elias & Seely LLP work on a contingency basis. There is no fee until we win your case. Fill out the injury claim intake form above or call 1-800-773-677 to speak directly with an experienced medical devise injury lawyer.

 

A Bit of ICV Filter History

2004
As early as 2004, Bard, the manufacturer of a number of different ICV filter designs received complaints about their devices. The allegations were regarding the malfunctions of the IVC Filter struts or legs breaking loose and traveling to other parts of the body. A short time later there appeared in various U.S. legal jurisdictions product liability cases alleging that ICV filters  manufactured by Bard, Cook Celect, and Gunther Tulipwere were defective and causing grievous complications and injuries to patients who had received them.

2005
After receiving numerous adverse ICV filters reports, which included filter migration, embolization, IVC perforations, and filter fracture, since 2005, the FDA issued a safety advisory regarding ICV filters in August 2010 and a revised / updated version in 2014. 

 

2010
Recommendations/Actions:
The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.  The FDA developed a quantitative decision analysis to assess what is the time period during which the risk of having an IVC filter in place is expected to outweigh the benefits. The conclusion of the report suggested that if the patient’s transient risk for pulmonary embolism had passed, the risk/benefit profile favors removal of the IVC filter between 29 and 54 days after implantation.

However, even when patients request or the physicians advise the removal of the ICV filter, complications ensue.  In a 2013 study that looked at the indication, complication and management of IVC filters at a Level 1 trauma center, there were 13 unsuccessful removals.  

2012
A study in the medical journal Cardiovascular Interventional Radiology, reports that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall in a little more then 2 months of implantation. The same study also  mentions that 40% of the Cook Celect and Gunther Tulip IVC filters became tilted and out of position.

2013
The JAMA Internal Medicine in March 2013 publishes a report that reveals: less than 10% of IVC filters evaluated in the study were successfully removed from patients. In addition, 8% of recipients of IVC filters suffered a pulmonary embolism anyway, despite the presence of the device.

2014
The FDA releases an updated version safety communication of their 2010 report: Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. The FDA states that most IVC devices should be removed between the 29th and 54th day after implantation.

2015
NEW YORK, July 31, 2015 /PRNewswire/
Federal Drug Administration (FDA) issued a warning letter to C.R. Bard, the manufacturer of Inferior vena cava (IVC) filters, for not taking adequate strides to correct violations the agency found at two of Bard's facilities.

 

Additional Helpful Information

Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication
This safety communication updates FDA’s 2010 Initial Communication. 

Inferior Vena Cava Filter Placement and Removal
An IVC filter traps large clot fragments, preventing them from traveling through the vena cava vein to the heart and lungs, where they potentially could cause severe complications or even death.

Seeger Weiss LLP Reports That The FDA Has Issued A Warning Letter To IVC Filter Manufacturer, C.R. Bard

IVC Filter Lawsuits
A number of lawsuits against Bard and subsidiary companies are still pending in federal and state courts.
Three brands in particular are noted in lawsuits as a source of serious problems:

  • - The Bard Recovery filter
  • - The Bard G2 filter
  • - The Bard G2 Express filter

Cleveland Clinic

What is Venous Thromboembolism (VTE)?
Venous thromboembolism (VTE) is a condition in which blood clots form in the deep veins of the legs, pelvis or arms and then travel to the heart and lungs. These blood clots which form and reside within the deep veins of the upper and lower extremities and pelvis are termed Deep Venous Thromboses or DVTs.
DVTs are not, in themselves, life-threatening. However, the condition can become deadly if the blood clot (PE) travels to the interrupting normal blood flow to the lungs.

Patients for whom IVC filters may be prescribed: 

  • Recurrent VTE, despite treatment with blood-thinning medications
  • Cannot take or tolerate blood-thinning medications due to bleeding, recent surgery or trauma or other adverse reaction to the blood thinners.

Mayo Clinic

Pulmonary embolism
Treatment is aimed at keeping the blood clot from getting bigger and preventing new clots from forming. Prompt treatment is essential to prevent serious complications or death. Learn more about surgical and other procedures.