What is an IVC Filter?
IVC stands for inferior vena cava, which is a major blood vessel which returns blood from the lower extremities to the heart. Among those diagnosed with deep vein thrombosis or pulmonary embolism (blood clots) who are unable to take blood-thinning medications, or who are victims of trauma, an IVC filter can be implanted in the body to prevent blood clots from traveling to the lungs. The IVC filter is a tiny “cage” which is constructed of nitinol or stainless steel. The filter has small spider-like legs to hold it in place.
What are the Primary Problems with IVC Filters?
There are permanent IVC filter and retrievable, or removable IVC filters. Many people are implanted with retrievable IVC filters, then the filter is never removed. Further, many surgeons are implanting IVC filters used prophylactically, despite insufficient evidence to support this type of use. Trauma patients are often implanted with an IVC filter, because their injuries place them at an increased risk of blood clots, with a simultaneous risk of excess bleeding from the injuries to their body or head.
While the notion of an IVC retrievable filter seems to be appropriate for those who have experienced a trauma, in fact the majority of these patients are much younger than the “typical” patient who would receive an IVC filter. It makes sense that any device placed in the vena cava for an extended length of time brings a risk of complications, whether those complications are associated with device failure, migration, perforation or thrombotic complications. Retrieval of IVC filters are generally successful, however in some instances, retrieval is not possible due to filter tilt, ingrowth, or lack of patient follow-up.
Are IVC Filters Safe?
In fact, the retrievable IVC filters currently in use are comparable in quality to the permanent IVC filters, however while permanent filters can also cause patient problems they do have a longer track record of success compared to the newer retrievable filters. Removal of the retrievable filters can be technically challenging, but in general, the longer the retrievable IVC filter is left in place, the more difficult it is to remove.
The answer to the question of whether an IVC filter is safe is difficult to answer. In a case where the threat of a blood clot is greater than the risks associated with an IVC filter, then the filter would seem to be the better option, so long as the retrievable IVC filter is removed within the recommended period of time (29-58 days). Unfortunately, few retrievable IVC filters are actually ever removed, because most patients are unaware of the potential risks.
What are the Non-Life-Threatening Risks of IVC Filters?
Patients who have suffered migration of their retrievable IVC filter could experience chest pain, heart palpitations, dizziness or fainting, heart arrhythmia, hypotension, nausea, neck pain, internal bleeding, shortness of breath and/or confusion. If you have a retrievable IVC filter implanted in your body, and you experience any of the above symptoms, it is imperative that you seek medical attention immediately. Patients with a retrievable IVC filter which has migrated are also at a high risk for ventricular arrhythmia (a common precursor to a heart attack).
What are the Life-Threatening Risks of IVC Filters?
There are a significant number of IVC filter risks, including both short-term risks and long-term risks, and some of these are life-threatening. Cardiac tamponade is a potentially fatal medical emergency in which blood or fluids build up in the space between the heart muscle and the outer covering sac of the heart, preventing the heart ventricles from fully expanding. Other serious or life-threatening complications associated with IVC filters include:
· Increased risk of deep venous thrombosis;
· Migration of the IVC filter to surrounding organs or to the heart;
· Fracture of the IVC filter;
· IVC filter embolization;
· IVC filter occlusion;
· Vena cava stenosis;
· IVC filter perforation;
· Pulmonary embolism and
· Difficulty removing the retrievable IVC filter.
Are There IVC Filter FDA Safety Concerns?
In 2014, the FDA issued an update to an IVC filter FDA safety communications issued in August 2010. The updated IVC filter FDA notices actually contained no new safety concerns, simply advised physicians and patients that the agency received reports of adverse events and problems associated with retrievable IVC filters. The FDA stance on the IVC filters seems to be fairly neutral, although the safety communications did not there were long-term risks associated with IVC filters including lower limb deep vein thrombosis and IVC occlusion.
The IVC filter FDA safety communications recommended that retrievable IVC filters be removed as quickly as possible after the threat of a blood clot has passed, and that physicians consider the risks and benefits of filter implantation and removal for each individual patient. Despite IVC filter FDA warnings, it is unlikely there will be an IVC filter recall any time in the near future.
Have There Been IVC Filter Clinical Studies?
Eighty patients with retrievable IVC filters manufactured by C.R. Bard, were examined in 2010 at Pennsylvania’s York Hospital. Sixteen percent of those patients had at least one fractured strut on their IVC filter, while in 25 percent of the patients, at least one strut fragment had embolized and was headed toward the heart. Among those who suffered an embolized strut, the broken strut had entered the heart in 71 percent. Nearly half of the patients (43 percent) suffered some type of life-threatening symptom, and one patient died suddenly.
In another study done at Penn State’s Heart and Vascular Institute, there was a 12 percent fracture rate among the 63 patients implanted with a retrievable Bard IVC filter. Once the device had fractured, the pieces could be retrieved in only 50 percent of the patients. Researchers at UC San Francisco found 86 percent of 50 patients with a Cook Medical IVC filter experienced perforation of the vena cava between 1 and 880 days after implantation of the device. A 2012 paper published in Cardiovascular & Interventional Radiology suggested that IVC perforation was the rule rather than the exception, at least for Cook Medical IVC filter devices.
A 2013 JAMA study examined the complications of retrievable IVC filters in 680 patients. Doctors were only able to successfully remove 58 retrievable IVC filters from the 680 patients, making 13 unsuccessful removal attempts, eleven of which occurred in patients who had their IVC filter for more than 85 days. Among the 13 unsuccessful removal attempts, the IVC filters were embedded in 8 of the patients, the IVC filter protruded through a blood vessel in 3 of the patients, the IVC filter had migrated to an abnormal position in 2 of the patients, and one patient also had a blood clot located inside the IVC filter.
Is There an IVC Filter Failure to Warn on the Part of IVC Filter Manufacturers?
The question of manufacturer failure to warn is one which is likely to arise during the upcoming bellwether trials. According to an NBC news report, it was alleged that C.R. Bard was aware there was a problem with their Recovery IVC filter, as their initial application was denied by the FDA after a small clinical trial raised questions about the safety of the Recovery IVC filter. Kay Fuller, a regulatory specialist, was hired by the company to obtain FDA approval. Fuller was not satisfied by the safety performance of the Recovery, and resigned, yet her signature appears on the application to the FDA which was later approved.
In 2004, the Lehman Report was released, which compared the Bard Recovery with other IVC filters, concluding the Recovery filter had “high reporting rates of total death, filter movement, filter embolization and filter embolization death reporting,” and an adverse event reporting rate which was twice as high as those of other IVC filters combined. While this is for only one brand of IVC filter, it appears there could have been a failure to warn on the part of this manufacturer, and possibly others as well.
Has There Been an IVC Filter Recall?
There is currently no recall associated with any brand of retrievable IVC filter. Many may wonder why such a recall has not occurred, considering the fairly high risk of patients with a retrievable IVC filter having serious side effects. Despite the fact that the FDA has received more than 1,000 adverse event reports regarding IVC filters, the agency has not mentioned an IVC filter potential recall, and the manufacturers of the IVC filters have no interest in a recall until they have paid out a significant amount in settlements to those injured by an IVC filter. Since the first IVC filter bellwether trials are scheduled to begin later in 2017, it remains to be seen whether an IVC filter potential recall will be issued.
Do I Have an IVC Filter Case?
The best way to determine whether you have an IVC filter case is to speak to a knowledgeable attorney from Sullo & Sullo. Our attorneys are highly experienced in IVC filter cases, both from the medical side, as well as the legal side. If our attorney determines you do have a valid IVC filter case, your options will be clearly laid out so you can choose the best course of action for you, and for your injuries.
What are My Potential IVC Filter Damages?
There are a number of factors which can influence the amount of compensation you might be entitled to after filing your IVC filter lawsuit. These factors include the following:
· Were you forced to be off work, therefore lost wages as a result of your IVC filter injuries?
· If this is a wrongful death claim, how many people were financially dependent on the deceased?
· What are your past and future medical expenses related to your IVC filter injuries?
· What level of pain and anguish have you experienced because of your IVC filter injuries?
· Did you require surgery or hospitalization as a result of your IVC injuries (i.e., how serious were your IVC filter complications, such as filter migration or vein perforation)?
· Did your spouse suffer loss of companionship as a result of your IVC injuries?
How Likely is an IVC Filter Settlement?
The judge presiding over the Cook IVC filter multidistrict litigation in Indiana has selected three bellwether trials set for 2017, which will set the bar for the hundreds of other IVC filter lawsuits. The first bellwether case set for trial is for Elizabeth Jane Hill of Florida, who stated her doctors were unable to remove her IVC filter, and that she has suffer from persistent and severe gastrointestinal symptoms, fatigue, vomiting and abdominal pain as a result of her IVC filter.
Hill’s doctors found that the IVC filter punctured Hill’s vein, imbedding into her intestines. Hill’s lawsuit claims Cook was aware of the dangers and risks of the IVC filter, yet concealed those risks and failed to warn patients and doctors. Settlement talks were held in 2016, yet none of the three bellwether trials were able to be settled. It is unlikely an IVC filter settlement will be discussed, until the outcome of the bellwether trials is known.
How Do I Protect My IVC Filter Case?
When those who have been injured by a dangerous drug or medical device hire an experienced attorney to file a lawsuit on their behalf, they are much more likely to receive an equitable settlement than if they try to file their own case. The attorneys of Sullo & Sullo are highly experienced in product liability claims, and will ensure your claim is fully protected. Part of that protection lies in knowing when your statute of limitations deadline is, and having a thorough understanding of the fact that missing a deadline can result in permanent relinquishment of your right to bring suit against the negligent party.
Our attorneys can provide you with the specific information you need regarding IVC filter lawsuits, guide you through the legal process and advise you on the best way to move forward with your claim regarding your IVC filter injuries. Our attorneys will coordinate with you and your physician to ensure you receive the medical care you require, while we fight aggressively for your rights and your future.