IVC Filter Lawsuit
Last Updated: 02-01-2017
Recipients of retrievable inferior vena cava filters (IVCs), beware – these devices are known to pose a significant risk of failure. A defective filter can fracture, migrate to other parts of the body, and puncture veins and internal organs, causing potentially fatal complications.
Wilshire Law Firm is currently accepting IVC filter induced injury cases all throughout California. If you or a loved one has suffered adverse side effects due to an IVC filter, please contact our attorneys immediately for a FREE case consultation. We can provide you with a comprehensive understanding of your rights and legal options, as well as guide you through the complex claims process. Call us toll-free at (800) 522-7274. Our team of legal experts is on standby 24/7.
Recent FDA Reports
An IVC filter is a cone-shaped wire cage that catches clots in the blood stream, preventing them from moving to the lungs. They are for patients who are unable to take anticoagulants (blood thinners). Although IVCs are supposed to save lives, the U.S. Food & Drug Administration (FDA) discovered that the filters can actually harm or even kill. In 2010, the FDA received 921 adverse event reports. Of these reports:
- In 328 cases, the device moved to different parts of the body.
- In 146 cases, the filter broke, leaving pieces in the bloodstream.
- In 70 cases, the filter punctured the inferior vena cava.
- In 56 cases, the filter fractured.
In 2014, the FDA released a safety communication stating that these devices must be removed as soon as the patient’s risk of a pulmonary embolism subsides (within 29-54 days). Unfortunately, the warning came too late for some.
Who Typically Receives IVC Filters?
Patients who receive IVC filters most commonly have an elevated risk of blood clots but cannot take blood thinners due to being susceptible to uncontrolled bleeding.
Here are some cases in which the patient may receive an IVC filter:
- Car accidents
- Gunshot or stabbing injuries
- Dialysis treatment
- Spinal cord injury
- Cancer treatment
- Serious fall injuries
IVC filters a public crisis of epidemic proportions
As estimated 2 million patients in the United States alone have been implanted with (Inferior Vena Cava Filters) IVC filters over the past several decades. Many of those implanted with IVC Filters are at risk of serious injury and death however, the vast majority of these individuals are unaware of the risk they currently face. Additionally, these individual’s primary physicians may be unaware as well especially in situations where the IVC filter was implanted by a surgeon before the individual became their patient. This problem has been exacerbated by the changes in our healthcare system which have caused millions of Americans to switch their primary physician. The surgeons who initially implanted these filters have often discharged the IVC recipient from their care and many years have passed since the given patient has been under their care.
After a massive number of Adverse Event reports were filed with the FDA related to IVC filters and numerous studies demonstrated that many if not all IVC filters will eventually fail, the FDA finally took action.
In 2010 the FDA issued its first advisory regarding the safety of IVC ” FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicate
In 2014 the FDA issued an even stronger advisory: ” 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 2014 FDA Advisory also summarized the scope of the problem with IVC filters: “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 encourages all physicians involved in the treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.”
The 2014 FDA advisory also summarized the problems with IVC filters as well as the scope of the problems: “The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”
Why Do IVC Filters Pose a Massive Public Health Risk
For the majority of the past few decades in which IVC Filters have been implanted, the majority of filters implanted were designed to be “permanent”, after becoming aware of the problems with IVC filters manufacturers began designing IVC filters intended to be retrievable. In most cases the major difference in a “permanent” IVC filter and a retrievable IVC filter consists of the addition of a hook which will allow a surgeon to grasp with a wire or other retrieval device. These hooks are generally found on the top of the IVC filter and require the surgeon to approach the filter through the jugular vein to attempt removal.
In 2010 and more strongly in 2014, the FDA advised surgeons to consider removing the device when the extreme risk of Pulmonary Embolism lessened, In most cases this would mean the IVC filter would be removed within weeks of implantation. The FDA advisory undoubtedly caused many surgeons who implant these devices to change their practices after the advisory was issued however, this change in practice does nothing for patients implanted with an IVC Filter implanted prior to the change.
In that the implanting surgeon generally discharges the patient from their care, leaving the patient to the care of their primary care physician, the public health crisis we now face can be summed up as follows:
- As many as 2 million Americans Have IVC Filters.
- Most if not all IVC Filters Will Eventually Fail
- Most IVC Filter Patients are no longer under the care of the implanting surgeon.
- Many IVC Filter Patients are no longer under the care of the same primary physician that would have “followed up” and aware of their implant.
- In that most implant patients were not told the filter would be removed, these individuals are not aware they are at risk.
- Although the FDA now recommends close “Follow Up” and quick removal of IVC Filters, in many if not most cases, the implanting IVC Surgeon is no longer in the picture and the patient’s current primary care physicians are not “following up” unless the patient becomes symptomatic and present for care. Unfortunately, the first symptom in many cases may be death.
- Making the crisis even more is the fact that many of the IVC filter indwelling in patients, even those designed to be retrieved will have embedded and will require open cavity surgery to retrieve. In many cases the surgery necessary to retrieve a filter or filter part may also cause severe injury or death.
Conclusion: A massive number of Americans with indwelling IVC filters are seconds away from potential death. As this paper will explain, an IVC filter patient could be perfectly fine one moment and within less than a second, the IVC filter or part of the IVC could migrate, often to the heart, and the first symptom is often severe life altering injury or death.
The Function of the Inferior Vena Cava
The inferior vena cava is the largest vein in the human body. It collects blood from veins serving the tissues inferior to the heart and returns this blood to the right atrium of the heart. Although the vena cava is very large in diameter, its walls are incredibly thin due to the low pressure exerted by venous blood. Read More
Dangerous Side Effects
If you have experienced any of the following injuries as a result of a defective IVC filter, you may be entitled to hundreds of thousands, even millions of dollars in compensation for medical bills, lost wages, pain and suffering, and more:
- Perforation of the heart
- Perforation of the lungs
- Hemorrhagic pericardial effusion (blood around the heart)
- Cardiac tamponade (disruption of the heart caused by excess fluid)
- Ventricular tachycardia (accelerated heart beat)
- Puncturing of the vena cava
How Quickly Can an IVC Filter Migrate to the Heart?
How long does it take for blood to make the round trip through the body? A typical human body contains 5.6 liters (6 quarts) of blood. “The heart pumps about 2,000 gallons (7,571 liters) of blood a day through its chambers.”2,000 gallons per day works out to 83 gallons per hour, or nearly 6 quarts per minute. So it takes about one minute for blood to make the round trip to the heart. If you are running fast, your heart is pumping more blood so the time would be less. Read More
The Function of the Inferior Vena Cava
The following image depicts the blood flow to and through the heart. Understanding the initial placement of IVC filters and the blood flow pathway to the heart will assist the reader in understanding why, where and how IVC Filters migrate to other parts of the body without necessarily having penetrated the Inferior Vena Cava wall. Read More
Common IVC Filter Devices
- ALN Implants Recoverable ALN filter
- Angiotech Option Vena Cava Filter
- B. Braun Vena Tech Filters
- Bard IVC Filters
- Cook Medical Celect Vena Cava Filter
- Cook Medical Gunther Tulip Filter
- Cordis Johnson & Johnson TrapEase and Optease
- Crux Biomedical Vena Cava Filter
- Gianturco-Roehm Bird’s Nest Vena Cava Filter
- Gunther Basket Filter
- Rafael Medical Technologies SafeFlo Vena Cava Filter
- Recovery Nitinol Filter
Effect of Blood Flow and Blood Pressure on IVC Filters
This increase and decrease in pressure exerted on and IVC filter causes a similar effect that would be achieved by taking a coat hanger and bending it back and forth until metal fatigue occurred and the coat hanger broke. Anyone who has ever locked themselves out of a car should be familiar with this concept. Read More
Contact Wilshire Law Firm Now
Because cases involving defective medical devices are complex and issues of federal safety and FDA approval may pre-empt state law, you need an experienced and competent team of high profile lawyers who are comfortable trying cases with huge potential outcomes.
At Wilshire Law Firm, we have the financial and technological resources, the brain power, the unsurpassed personnel, and the determination to fight an important battle on your behalf. We are so confident in our abilities that we are willing to take your case on contingency; in other words, you will pay us only if there is a successful settlement or verdict. This is our ironclad guarantee.
In addition to obtaining more than $100,000,000.00 in verdicts and settlements on behalf of clients, our attorneys have received the kind recognition of our local and national peers in the legal industry. Our awards and accolades include the prestigious Litigator Award by the Trial Lawyers Board of Regents, a title given only to the top 1% of all lawyers in the nation. Our firm has also earned an AV Preeminent Rating by Martindale-Hubbell, the most authoritative legal directory.
Call us at (800) 522-7274 for FREE legal advice. Our dedicated staff is on call 24 hours a day, 7 days a week, ready to help you out.