IVC filters are small, cone-shaped devices used to trap blood clots before they reach the heart or lungs. The devices were first used in the 1960s and their use has increased significantly over the decades. Newer, retrievable filters are often used today, but the devices have come under fire for their potential safety risks. Some patients implanted with retrievable IVC filters say the devices fractured inside them, perforated their veins and organs, or traveled to their heart or lungs. The U.S. Food and Drug Administration issued safety communications about the devices and lawsuits are now being filed against their manufacturers.
IVC Filter Lawsuits
Did you develop complications after being implanted with a retrievable IVC filter? Lawsuits are being filed against the manufacturers of multiple IVC filter brands and there may be significant settlements or cash payouts for those affected by the devices.
IVC filters catch blood clots that form in the leg before they travel to the heart or lungs. But these tiny medical devices can cause serious complications of their own. People implanted with the filters say they suffered injuries like vein or organ perforation and movement of the filter to the heart or lungs. Some people implanted with a retrievable IVC filter are not able to have the device removed because it is too dangerous to even try.
IVC filter lawyers and attorneys are working with patients injured by the devices to bring cases against the manufacturers. IVC filter lawsuits accuse device makers of a number of legal claims, including:
- Designing a defective product
- Failing to warn about the potential risks of IVC filters
- Breach of implied and express warranty
Defective IVC Filter Brands
IVC filter lawsuits are being brought against a number of filter manufacturers, but the majority of lawsuits being filed involve the following IVC filter brands:
- Bard Recovery Filter
- Bard G2 Filter
- Bard G2 Express Filter
- Cook Celect Filter
- Cook Gunther Tulip Filter
IVC Filter Multidistrict Litigation
The large number of IVC filter lawsuits filed against C.R. Bard Inc. and Cook Medical led to the consolidation of such claims in 2 U.S. district courts.
What is an MDL?
Multidistrict litigation (MDL) are formed when multiple lawsuits alleging similar claims against a corporation are filed in federal court.
MDLs help the courts save time and money; they cut down on duplicate discovery processes and allow attorneys on both sides to exchange ideas and information about the cases. A few cases are usually chosen out of the pool of lawsuits to be tried first. These bellwether trials allow attorneys to test out legal theories before a jury and can help steer future settlement talks. MDLs are different from class action lawsuits. Cases in an MDL are filed individually, while class action lawsuits are filed by one or more plaintiffs on behalf of others who were affected in a similar way by the same company. Any settlements or verdicts awarded in an MDL are handed down individually, not split equally among plaintiffs like in a class action lawsuit.
Bard IVC Filter MDL
IVC filter lawsuits against C.R. Bard Inc.’s Recovery, G2, and G2 Express filters were consolidated in the District of Arizona in 2015. U.S. District Judge David G. Campbell presides over the litigation, which includes more than 1,500 lawsuits as of March 15, 2017.
Other IVC filters manufactured by Bard, including its Eclipse, Denali, and Meridian filters, are also involved in the lawsuits.
Bellwether trials in this MDL are scheduled to begin in Fall 2017.
Cook IVC Filter MDL
Lawsuits involving Cook Medical’s Celect and Gunther Tulip filters were consolidated before U.S. District Judge Richard L. Young in the Southern District of Indiana. The lawsuits were first consolidated in 2014. At the time, only 27 lawsuits had been filed in federal court against Cook. Now, there are more than 1,500 lawsuits pending in the coordinated proceeding as of March 15, 2017, and more are expected to be filed in the future.
Bellwether trials in this MDL are scheduled to begin in October 2017, but the parties are being encouraged to settle the lawsuits before the trials start.
What is an IVC Filter?
IVC filters are small, cage-like devices used to capture blood clots before they travel to the heart or lungs. IVC filters are placed in the inferior vena cava (IVC), a large vein that carries blood from the lower portion of the body back to the heart.
The filters are designed to catch blood clots that form in a deep vein in the leg, a condition known as deep vein thrombosis (DVT). If that blood clot breaks loose and travels to the lungs, it is called pulmonary embolism (PE). IVC filters are intended to reduce the risk of PE by catching clots before they reach the lungs.
Patients at risk for blood clots, especially those who cannot use traditional blood thinners, are often implanted with an IVC filter to reduce their risk of clot-related injuries, such as PE.
IVC filters have been used for decades. The first of these filters were designed to remain in the body as permanent implants, but newer filters have been introduced that are intended to be retrieved when a person’s risk for blood clots subsides.
The use of IVC filters has grown dramatically since retrievable filters were approved by the U.S. Food and Drug Administration in the early 2000s. Doctors implanted about 167,000 filters in 2007, compared to just 2,000 in 1979, and it was estimated that nearly 260,000 filters would be used in 2012.
Despite their increased use, these retrievable filters have come under fire since a number of patients experienced severe injuries from IVC filter complications. The filters have been known to break apart, migrate to other parts of the body and perforate the vena cava or nearby organs.
Popular IVC Filter Brands
Many brands of IVC filters have been introduced to the U.S. market. Some of these filters are no longer sold because of their risks, while others remain on the market today despite their potential risks.
The most popular brands of IVC filters include:
- Bard G2 filter
- Bard G2 Express filter
- Bard Recovery
- Bard Eclipse
- Boston Scientific Greenfield filter
- Cook Celect
- Cook Gunther Tulip
Side Effects and Complications
IVC filters are designed to save lives from life-threatening injuries, but the filters can cause a number of serious complications on their own.
Side effects and complications associated with IVC filters include:
- Migration of the device
- Filter fracture
- Movement of the entire filter or filter fragments to the heart or lungs (embolization)
- Perforation of the inferior vena cava
- Difficulty removing the device
Longterm risks of IVC filters include deep vein thrombosis and blockage of the IVC, called occlusion.
IVC Filter Recalls
Some IVC filters have been removed from the market because of the risks they pose to patients. CR. Bard Inc. has stopped selling a number of its IVC filters, though it did not issue a formal recall of the devices. The company simply stopped selling its problem filters in the U.S.
The following IVC filters are no longer available:
- Bard G2 filter
- Bard G2 Express filter
- Bard Recovery filter
- Bard Eclipse filter
- Bard Meridian filter
How do IVC Filters Work?
IVC filters are placed in the inferior vena cava to prevent blood clots from reaching the heart or lungs. The IVC is the main vein that carries deoxygenated blood from the lower half of the body back to the heart. The spider-like legs of the filter help trap the clots and hold them in place, keeping them from reaching vital organs.
Doctors insert IVC filters through the large vein in the neck or groin. They use x-rays and contrast dye to show where the filter can be safely placed and deploy the filter using a special catheter. The procedure usually takes about an hour and is typically performed in an out-patient setting.
IVC filters are intended to reduce a person’s risk of pulmonary embolism and other clot-related injuries. Retrievable filters should be removed once a person’s risk for these complications has subsided. The longer a filters stays in, the harder it is to remove. Research suggests about 80% of IVC filter patients will be able to have their filter removed.
Doctors remove IVC filters similarly to how they put them in, using contrast dye and x-rays to locate the filter, a snare to capture the device and a catheter to remove it.
In some cases, the filter cannot be removed because of complications, like device migration or fracture.
Types of IVC Filters
There are 2 types of IVC filters: retrievable (also called optional) and non-retrievable.
Retrievable IVC Filters
Retrievable filters were first introduced in the early 2000s and are meant to provide short-term protection from pulmonary embolism.
In general, good candidates for these new types of filters are patients who need protection from PE for only a short period of time, such as trauma patients. (Although, there is new research that suggests IVC filters do not reduce the risk of clot-related injuries in trauma patients.)
The FDA cautions that retrievable filters should be removed as soon as a patient’s risk for PE has subsided. Leaving an IVC filter in too long can increase the person’s risk for filter-related complications.
Non-retrievable IVC Filters
The first IVC filters to hit the market were considered non-retrievable. These filters were designed to remain inside a person’s body for the rest of their life.
The first IVC filter, called the Mobin-Uddin umbrella filter, was approved by the FDA in the late 1960s. The device caused complications in a number of patients and was superseded by the Kimray-Greenfield filter in the 1970s. The Greenfield filter, manufactured by Boston Scientific, has been on the market the longest and still available today.
Non-retrievable IVC filters are associated with complications like blood clots at the insertion site, IVC blockage and recurrent DVT.
Who Might Get an IVC Filter?
IVC filters are traditionally used to prevent PE in patients who cannot use traditional blood thinners. However, IVC filter use has expanded since the introduction of retrievable filters. People who may be at a short-term risk for blood clots, such as those who suffered severe trauma or are undergoing surgery, may have a retrievable filter implanted to temporarily reduce their risk.
Doctors may choose to use an IVC filter in the following patients:
- Patients who can’t use traditional blood thinners
- Trauma patients
- Patients at risk for recurrent PE
- Patients undergoing knee or hip replacement surgery
- Obese patients undergoing bariatric surgery
IVC Filters and Anticoagulation
Anticoagulants, also called blood thinners, are commonly prescribed to patents who are at risk for blood clots. These medications are the first line of defense when treating or preventing a blood clot, but not all patients may respond well to the drugs.
IVC filters can be used as a secondary treatment to prevent pulmonary embolism when anticoagulation is not enough. They can also be used in patients who are unable to take traditional blood thinners, such as patients who are at high risk for a bleeding episode or who are about to undergo surgery. Doctors may choose to implant an IVC filter in these patients until their risk for blood clots subsides or they’re able to begin taking anticoagulation medication again.
FDA Warnings & Actions
The FDA has issued several warnings about IVC filters over the years in an attempt to inform the public about their potential risks.
August 2010 Safety Communication
The FDA first took action against IVC filters in August 2010 when it issued a safety communication to physicians and the public. The FDA said it had received a number of adverse event reports regarding IVC filters and worried the retrievable filters were being left in the body too long.
From 2005 to 2010, the FDA received 921 adverse event reports relating to different IVC filter brands. The reports indicated the filters could cause serious complications in patients including:
- Device migration (328 reports)
- Embolization (146)
- Perforation of the inferior vena cava (70)
- Filter fracture (56)
Some of these complications led to other serious injuries in patients.
The FDA advised physicians to remove retrievable filters as soon as a person’s risk for pulmonary embolism had subsided because the longer a filter remained in place, the harder it would be to remove it.
May 2014 Updated Safety Communication
In May 2014, the FDA issued an updated safety communication, advising doctors of the ideal window for safe filter retrieval. Based on its own analysis, the FDA said filters should typically be removed between 29 and 54 days after the device had been implanted, as long a patient’s risk for PE had subsided.
Studies Show Risk of IVC Filter Complications
Although IVC filters are used routinely, their benefit-risk profile is not well-established. Recent studies have attempted to shine a light on the safety and effectiveness of IVC filters in certain patients.
IVC Filters Raise Risk of PE, 2015
A study published in the Journal of the American Medical Association in April 2015 looked at the safety and effectiveness of IVC filters used simultaneously with blood thinners versus blood thinners alone.
Researchers found that patients treated with an IVC filter and anticoagulants were 2x as likely to suffer a recurring pulmonary embolism compared to patents on anticoagulants alone. The IVC filter patients were also more likely to die from PE compared to patients using just blood thinners.
IVC Filter Riskier for Trauma Patients, 2017
A study published in JAMA Surgery in January 2017 shows IVC filters may be riskier to trauma patients than not.
The single-center study looked at the mortality rates of trauma patients at risk for blood clots and found using IVC filters did not decrease their risk for death or other complications.
Researchers concluded IVC filters did not provide any additional lifesaving benefits to trauma patients and may actually be more risky for those patients because removal rates were so low.
Leaving a retrievable IVC filter in the body for too long can increase a person’s risk for additional complications.
Judicial Panel on Multidistrict Litigation. Pending MDLs by District. (March 15, 2017). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf
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