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Mass Tort Law

IVC Filters

 

Inferior Vena Cava (IVC) Filters

Have you ever had an IVC blood clot filter implanted after 2006? Did you suffer a pulmonary embolism, stroke, or other failure of the IVC filter?  You may be entitled to financial compensation.

The Günther Tulip IVC filter by Cook; image courtesy of Wikimedia Commons.

What Are Inferior Vena Cava (IVC) Filters?

The inferior vena cava is the largest vein in the human body and carries blood from the lower parts of the body to the heart. IVC filters are spider-like wires that are inserted into the inferior vena cava with the purpose of preventing blood clots from reaching the heart, lungs, brain or kidneys. The IVC filters catch blood clots and allow them to break down as time passes.

IVC filters are most commonly used for those patients who have a higher risk of a pulmonary embolism (PE), which is a blockage of one of the arteries in the lung. These patients are also less likely to or unable to take anticoagulant drugs that would help prevent clotting. The IVC filters were designed to help prevent recurrent PE.

Blood clots in these patients can be deadly if the clots reach any of the above-mentioned areas.

However, even in the U.S., the reasons for using IVC filters vary. Currently, there are two conditions or indications for IVC filter use: prophylactic and therapeutic. Therapeutic use is the most common and involves:

  • Deep vein thrombosis (DVT), a dangerous condition in which blood clots form in the deep veins of the legs. They could break loose and travel to the heart, lungs, kidneys or brain and cause death.
  • Massive PE.
  • Situations in which anticoagulation therapy has failed or cannot be used.
  • Severe heart and lung (cardiopulmonary) disease with complications caused by DVT.
Prophylactic use of IVC filters is more controversial and includes:
  • Trauma patients without venous thromboembolism (VTE). VTE is simply the formation of blood clots in the veins.
  • Keeping patients who are undergoing high-risk surgeries like spinal or bariatric procedures from developing PE.

Up until 2002, all IVC filters were permanent implants. In 2002, Bard, Cook and Cordis all raced to be the first company to make retrievable (removable) IVC filters. At last check, IVC filters are manufactured by 11 different companies and almost 250,000 patients in the U.S. alone get one every year. In most cases, the IVC filters present no problems. However, when they do cause problems, the problems are serious and potentially life-threatening.

The risk of problems is so high that experts have recommended that all IVC filters should be removed within 6 - 12 weeks after insertion. Leaving the IVC filters in place for longer than that makes them more difficult to retrieve and increases the risk of dangerous complications.

What is the Problem with IVC Filters?

Many patients have experienced the following issues with their IVC filters:

  • Migration to other parts of the body, including other blood vessels. The latter is called embolization.
  • Fracturing of the IVC filter, allowing sharp metal pieces to spread through the patient’s circulatory system. There is also a risk of vein or organ puncture when the filters fracture.
  • Penetration or perforation of the inferior vena cava itself.
  • Clots forming around the IVC filter (IVC thrombosis).

If the inferior vena cava is punctured and pieces of the IVC filter reach the heart, it may result in perforation of the heart chamber walls. This can cause irregular heartbeat (arrhythmia). Another condition, cardiac tamponade, may develop. In cardiac tamponade, fluids like blood or pus leaks into the lining surrounding the heart (the pericardium). This causes pressure on the heart muscle and can interfere with the patient’s heartbeat.

Other injuries commonly experienced with pieces of the IVC filter reach the lungs or heart includes:

  • Confusion
  • Hypotension (low blood pressure)
  • Chest pain
  • Nausea
  • Lightheadedness
  • Shortness of breath
  • Neck pain
  • Internal bleeding or hemorrhaging

Severe injuries associated with IVC filter fracture when the pieces reach the lungs or heart includes:

  • Pulmonary embolism (a condition the filters are supposed to prevent)
  • Severe bleeding (hemorrhage)
  • Stroke
  • Death

In an article published in the International Journal of Cardiology in 2014, Drs. Mohamad Alkhouli and Riyaz Bashir cited research showing that “late filter-related thrombosis” occurred in 8% - 30% of studied cases. Complications arise, in part, due to late removal of the IVC filters in addition to their design. At the time the authors wrote their article, the highest removal rate reported in the U.S. was 34%, compared to 81% in U.K. They found that some IVC filters aren’t removed for good reasons, such as a tilted filter or a trapped clot.

Quite often, the complications from IVC filters require patients to undergo emergency procedures to remove the filter. In certain cases, this may mean open heart surgery.

Why do the manufacturers of IVC filters continue to make such dangerous devices? While IVC filters do help many patients, the answer is far less altruistic. The companies wanted to expand their market reach via off-label uses of the filters. Their success was astounding. More IVC filters are used in the U.S. than anywhere else in the world and the market grew from $100 million in 2002 to $300 million in 2012. Profits over patients strikes again.

FDA Actions

The U.S. Food and Drug Administration has taken the following actions in recent years:

  • August 9, 2010 - the Agency issued a safety alert based on the 921 adverse event reports it received since 2005. The FDA determined that the 328 IVC filter migrations, the 146 detachment of device components, the 70 inferior vena cava perforations, and the 56 filter fractures may be related to leaving the IVC filters in place after the risk of PE has passed.
  • May 6, 2014 - The FDA issued an update to the 2010 safety alert. The update recommended IVC filter removal when the risk of PE has passed. It also contained an analysis that showed the risk of IVC filter use outweighed the benefits in patients with transient needs within 29 - 54 days.
  • July 15, 2015 - The Agency issued a warning letter over failure to report and/or misreporting adverse events. The warning also covered failure to create and maintain good procedures for investigating and reporting adverse events, as well as the fact that the manufacturing methods, storage methods and packaging failed to conform to Good Manufacturing Practice (GMP) Guidelines.
  • February, 2016 - The FDA cites manufacturer Bard for safety violations, including not following the company’s own manufacturing procedures and failure to comply with the Agency’s minimum safety regulations pertaining to the post-market trending procedure the company used to identify safety issues with its past IVC filters.

Numerous studies have been published regarding the risks of IVC filters. A short list follows.

In an August 2010 study published in the Archives of Internal Medicine, the failure rate for the Bard Recover Filter system was 25% and that of the Bard G2 Filter system was around 12%. The researchers issued a recommendation that doctors immediately stop using these Bard IVC filters in order to protect their patients from harm.

An April 2012 study published in Cardiovascular Interventional Radiology found that inferior vena cava perforation was common the longer the Günther Tulip and Celect retrievable filters were left in place. Using CT scans taken between 1 and 880 days after insertion of the filter, researchers found that at least one filter component perforated the inferior vena cave in 86% of the patients studied. Some perforation was shown in all filters scanned after 71 days and the perforation often showed as a progressive process. Tilting of the IVC filters was found in 40% of the studied patients with some perforation present in all patients whose IVC filters had tilted. Similar to the FDA and the August 2010 study, these researchers recommended IVC filter removal as soon as possible after the risk of PE had passed. They also advised that doctors should closely examine IVC filters during follow-up imaging scans.

The Journal of Vascular and Interventional Radiology published a March 2015 study by scientists at the University of Colorado and Northwestern University that showed IVC filter perforations happened much more often with the Cook Celect IVC filter than with other IVC filters.

The Journal of the American Medical Association (JAMA) published an April 2015 study that showed IVC filters were not as effective as anticoagulation therapy (drugs) at preventing PE. The data showed that patients with IVC filters were twice as likely as those on anticoagulation therapy to have a blood clot travel to their lungs.

IVC Filter Lawsuits

Based upon such serious injuries, numerous lawsuits have been filed against the various IVC filter manufacturers for failing to warn doctors and patients of the high risks of filter fracture and migration and the possibility of internal organ damage.

Some of the suits filed in state courts have been settled before going to trial. IVC filter makers are not willing to settle the large numbers of cases still pending, though. This has prompted plaintiffs to seek multi-district litigation (MDL) status. MDLs centralize all cases in front of one federal judge and all pre-trial proceedings are done at one time to avoid delays, contradictory decisions and cut expenses.

All Cook IVC filter lawsuits were centralized as an MDL in October 2014 in the U.S. District Court for the Southern District of Indiana. The same happened in August 2015 with all suits against Bard IVC Filter Lawsuit. This MDL is located in Arizona federal court.

The Time to Act is now! Don’t Wait!

The Statute of Limitations (the window during which you may file your case) may be closing. If it does, you will be forever barred from getting the justice you deserve. Contact the experienced attorneys at Justinian and Associates today. We have extensive experience handling dangerous medical device cases, as well as working with MDLs. We’re here for you and we will fight for your rights.

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