IVC Filter Lawsuit
Inferior vena cava (IVC) filters are small, cage-like medical devices inserted into the veins of patients at risk for pulmonary embolism (blood clot in the lungs). Implanted in an estimated 250,000 patients each year, IVC filters have legs or “struts” that extend to stop blood clots from traveling from the lower body to the heart or lungs.
Unfortunately, the U.S. Food & Drug Administration (FDA) has warned that vena cava filters made by C.R. Bard, Cook Medical and other manufacturers have been linked to thousands of reports of severe, potentially life-threatening complications including filter fracture, device migration, infections, organ perforation and death.
The article below provides a comprehensive overview regarding the many dangers of these controversial devices, as well as everything you need to know about how to file an IVC filter lawsuit.
Complications With IVC Filters After Implant
There are four general categories of complications that patients experience with IVC filters: tilting, penetrating, fracturing, and migrating. There can also be problems with implantation, which includes incomplete filter opening and filter misplacement.
Generally, when an IVC filter moves sideways away from its vertical angle and leans in a somewhat horizontal angle, “tilting” complications can occur. For example, some immediate issues involve reduced effectiveness for capturing blood clots and an increased risk of the vena cava wall being penetrated. Once that happens the stability of the filter is lost and the filter then becomes prone for fracture, further penetration, and migration.
Tilting also becomes problematic because the filter could become difficult to remove. A tilted filter provides the opportunity for tissue to grow over and around the apex, which is the source to collapse, capture, and snare the device out of the human body. So without that, patients and doctors are relegated to non-standard removal techniques. Further, tissue will incorporate the filter into the wall of the vena cava making it impossible to remove.
According to a study by Dr. David L. Gillespie, MD, FACS, a professor of surgery in the Division of Vascular Surgery at the University of Rochester School of Medicine and Dentistry, tilting becomes critical when it slants 15 degrees from the midline .
Notably, centering struts exist as a tilt-prevention mechanism, and this is a part of Bard’s G2 Eclipse. Yet, even these filters tilt, as a centering strut is not a guarantee that the vena cava filter remains in its intended position and angle following implantation. Snare-over guidewire, snare-over-loop guidewire, coaxial double-sheath dissection, and laser-assisted double-sheath dissection are all additional substitute techniques doctors may employ to remove tilted and indwelling filters. See http://evtoday.com/2012/11/advanced-ivc-filer-retrieval-techniques/
Subsequent problems with IVC filters can be lethal. Specifically, these medical devices can puncture the vena cava wall and harm neighboring organs such as the aorta, duodenum, and ureter. Due to the fact that many patients do not show current puncture-like symptoms, this event can be hard to diagnose even after a CT or angiogram .
According to one source, permanent IVC filters have a large variance of penetration rate that land between 3.5% and 38%, depending upon the type of filter.
The primary source of caval penetration by a vena cava filter’s strut is due to the throbbing of the aorta and movement dynamics of the respiratory system. A preceding study indicated that vena cava filters manufactured with smaller diameters also offer higher rates of punctures.
There are several studies revolving around IVC filter penetration.
In particular, a 3 year-long award-winning study conducted between 2006 and 2009 that monitored 591 patients who had been implanted with an IVC filter at Ohio State University Medical Center elaborated on several alarming problems.
In pertinent part, of the 262 patients that had sufficient post-filter CT scan availability:
- 16.4% had implants due to prophylaxis, and 83.6% had implants due to VTE
- A whopping 46% of filters showed penetration of the vena cava and adjacent organs
- Of the 46% showing penetration; 12 patients had a penetrated aorta; 26 patients had a penetrated duodenum; 6 patients had a penetrated colon, kidney, or spine, and; 7 patients had penetration of two organs
- 100 filters had indications of tenting of the vena cava due to the immediate adjacency to the external aspect of the vena cava
- A paltry 1.6% of temporary filters were removed
Dr. Michael Go, the surgeon who conducted the study, is from the division of vascular diseases and surgery at Ohio State Medical University in Columbus. He noted the overall danger of vena cava filters by stating, “IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE.”
Dr. R. Eugene Zierler, professor of surgery at the University of Washington in Seattle, and associate medical editor of Vascular Specialist added to Dr. Go’s comments by stating:
So these results certainly suggest that the majority of temporary filters become permanent filters, and a critical reappraisal of filter use is warranted.Dr. R. Eugene Zierler
Patricia Wendling, ACS Surgery News Digital Network, IVC Filter Complications Common, Retrieval Rare, October 29, 2013.
A 2012 study that examined a large number of Cook Celect and Gunthër Tulip filters found that an astounding 86% of the filters had perforated through the vena cava of the patients. The study estimated that 100% of the Cook Celect and Gunthër Tulip filters would perforate the vena cava if left in the body. In fact 100% of the filters left in the body after 71 days did perforate the vena cava. So, because Cook Celect and Cook Gunthër Tulip filters – like almost all filters – are left in the body permanently, it logically follows that almost all patients who have these filters will, soon after their placement, suffer from a perforated vena cava.
Fracturing and Embolization Complications
One of the most serious complications vena cava filters experience is fracturing and embolization (detachment of device components). The problem experienced with this dangerous event, according to David. L. Gillespie, MD, FACS, includes the following:
- Fracturing could predispose the filter or its parts to embolization
- Fracture could lower the efficacy of the filter’s ability to prevent PE
- Fracture could generate a predilection to caval thrombosis
- Fractured parts could end up in organs, tissue, arteries, veins, and subsequent or simultaneous puncturing of organs, arteries, and veins
The filters that have likely received the most exposure of fracturing have been the Bard Recovery Vena Cava Filter and the Bard G2 Vena Cava Filter.
One of the most popular studies originated from Dr. William Nicholson, MD of Pennsylvania’s York Hospital. This study included 80 patients, and focused on filter fracture and embolization of the two filters.
Some of the findings included fragmentation and embolization in 7 out of 28 Bard Recovery filter patients (25%), and 6 out of 52 Bard next-generation G2 filter patients (12%).
Fluoroscopy was administered on the 80 patients still living with the device implant, and it showed that at least one of the struts had fractured in 13 patients (16%) after being implanted for an average of 37.8 months.
After analyzing the results of the study, the commentary to the study indicated that over 7,000 Americans could be walking around with a fractured G2 filter.
An example of the lethal problems associated with the Bard Recovery were that all filter fragments from that particular device passed through the body to an end organ. As for the G2 filter, fragments landed in the hepatic vein, the lung, or remained close to the device after fracture.
The author and co-authors of the study stated, “Because nitinol metal fatigue may play a role in the filter fracture, it is reasonable to assume that the incidence of filter fracture would be directly proportional to the time that the filter is allowed to dwell in the patient after implantation.”
When a vena cava filter migrates, it has moved from its intended implanted position to another part of the anatomy.
Serious and even deadly complications could arise from such filter migration. In less serious situations, percutaneous explantation of the filter can be the remedy. In more dangerous events, such as migration to the pulmonary outflow tract, heart valves or ventricle, surgery would be the likely means of retrieval compared to percutaneous retrieval. But surgical removal alone could be a dangerous proposition because it could result in additional problems, such as arrhythmia or death.
Underscoring the complications with filter migration, in August 2010, the FDA acknowledged the severity of the risks after it reviewed over 900 adverse events connected to IVC filters. The alert determined that 328 of the events were due to migration, and that was the primary problem associated with these devices.
IVC Filter Retrieval – Reasons, Obstacles, and Complications Associated with Retrieval
Reasons for IVC Filter Retrieval
Initial observations and studies, even the FDA, dictate that IVC filters should be removed when pulmonary embolism issues or contraindications to anticoagulants pass. Clearly, this is due to the abundance of problems associated with these devices that include titling, fracturing, migration, and penetration. Additionally, studies mention increased rates of VTE for patients with filters that are indewelling. All these well-documented reasons provide ample justification for a more aggressive approach to IVC filter explantation.
Obstacles to IVC Filter Retrieval – Lost Follow-Up and Indwelling
Notwithstanding the clear decrease in harm when filters are removed, a significantly large majority of patients implanted with these devices fail to have them extracted. The primary reason is due to lost follow-up, or lost communication lines with the patient. For example, trauma patients are the largest categorical segment of patients that do not get filters removed. Interestingly, these patients have filters implanted for emergency prophylactic purposes, and not for permanent use.
Significantly, as time goes on and a filter remains in the body, more difficulties could occur. According to the Journal of Vascular Surgery, “Indwelling retrievable IVC filters were associated with significantly higher complication rates than permanent filters.” Tina R. Desai, “Complications of indwelling retrievable versus permanent inferior vena cava filters,” Society for Vascular Surgery. Published by Elsevier Inc.
IVC Filter Retrieval Techniques and Time Frames
It should be noted that standard explantation strategies are based upon whether a filter is permanent or optional. For example, filters such as Bard’s G2 Eclipse that do not define specific removal time frames provide an open-ended window for retrieval pursuant to the manufacturer’s instructions.
Nonetheless, the FDA has recommended these filters be removed as soon as the purpose of the implanted device goes away. This could be based on a decrease in VTE events or an elimination of contraindication to anticoagulants. Generally speaking, doctors suggest that patients have filters removed prior to hospital discharge, or within 2 weeks of discharge.
The two standard means of removing an IVC filter are by a jugular vein approach or a femoral vein approach. Instructions for retrieval is included within the kits designed for the procedure. The retrieval typically involves local anesthesia and an incision at the right jugular area or right femoral vein area, then introduction of a sheath within the body.
For retrieval via the jugular vein, it begins with an introduction and advancement of a pigtail catheter over a guidewire through the caval confluence. Finally, a venography is performed (which is when an injection of dye is injected in the veins to allow an x-ray) to determine the status of any thrombus burden remaining, which would preclude explantation.
If the results of the venography are negative, the removal proceeds with the introduction and advancement of a stiff guidewire that is put under the filter, followed by advancement of the retrieval device. These explantation kits include either a cone-like retrieval device that fits over the filter like an umbrella, or a hook-like retrieval device that loops through the filter’s hollow, circular tip). Once the retrieval device has secured the filter it is removed by retracing it backwards through the sheath.
There are two categorical situations that could prevent retrieval by these means. First, the filter may have tilted, which does not allow the apex of the filter to be grasped, hooked, or snared. Second, strong attachment to the vena cava wall, tissue, or organ that prevents it from retracing through the sheath.
If either of these situations arise, a more aggressive surgical approach may be employed. However, such techniques come with dangers like caval injury and hemorrhage, and remain outside the scope of the manufacturer’s explantation instructions.
FDA Communication Updates and Warnings
August 2010 FDA Safety Communication
On August 9, 2010, the FDA released a safety communication regarding adverse events with IVC filters. What may be the primary focal point of the safety communication is that the government agency stated it “has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients.”
The FDA further emphasized that some IVC filter complications “led to adverse clinical outcomes in patients.”
In the safety communication, the FDA pointed out that leaving vena cava filters in the body for “long periods of time, beyond the time when the risk of pulmonary embolism has subsided” could be related to the adverse events.
Finally, the communication mentioned that “[k]nown long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
May 2014 FDA Safety Communication Update
Close to 4 years later, the FDA followed up on the initial Medwatch safety communication by issuing an update on May 6, 2014.
The update included “information on recently published research and postmarket studies for these devices” such as “product problems associated with IVC filters.” These problems included “device migration, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device.”
July 2015 FDA Warning Letter to C.R. Bard, Inc.
On July 13, 2015, Bard was issued a warning letter by the FDA that focused on the retrieval device it provides to explant their IVC filters.
In the warning letter, the agency stated that, “FDA has learned that your firm manufactures the Recovery Cone Removal System, Model RC-15 in the United States without marketing clearance or approval, in violation of the [Federal Food, Drug, and Cosmetic] Act.”
This violation brought to light the allegation that Bard had “misbranded” the retrieval system because the company “did not notify the agency of [its] intent to introduce the device into commercial distribution.”
Relatedly, the device was determined to be “adulterated” because the company “[did] not have an approved application for premarket approval” or obtain “an approved application for an investigational device exemption.”
The letter continued to highlight misfilings associated with Bard’s Quality System Regulations at its Tempe location. The agency pointed out an event related to the company’s G2 filter, in which a patient experienced “embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the right lung [that] was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death.”
Adverse Event Reports Involving IVC Filters
Involved Embolizations (detachment of device components)
Involved Perforation of the IVC
Involved Filter Fracture
Frequently Asked Questions
What is the risk of fracture?
In general, 9-25% of IVC filters fracture, but some devices have higher risks than others. In one study from 2010, (http://archinte.jamanetwork.com/article.aspx?articleid=226212), 25% of Bard Recovery filters broke (7 out of 28 patients), compared to 12% of Bard G2 filters (6 out of 52 patients).
What is the risk of vena cava perforation?
Some filters also have higher rates of perforation into the vena cava. In 2015, a study (http://www.ncbi.nlm.nih.gov/pubmed/25791334) linked the Cook Celect filter with a 43% rate of perforation compared to 0% for the Option filter made by Rex Medical.
Do studies support IVC filter safety?
Only one randomized controlled trial of IVC filters (PREPIC) was conducted in 1998 with 400 patients: 35% of patients with filters developed DVT and the filter did not improve survival.
How were the Bard Recovery and G2 filters approved?
The Bard Recovery and G2 were approved with a 510(k) application, which allows new devices on the market without new studies if they are “substantially equivalent” to other devices. In this case, temporary Bard filters were “equivalent” to permanent IVC filters designed in the 1960s and 80s that were plagued with problems.
Did the manufacturers of IVC filters know they could be dangerous?
The Bard Recovery was introduced in 2002 and there were many reports of injury and death by 2004. An investigation by NBC News found a confidential study conducted by Dr. John Lehmann in 2004 that linked the Recovery to higher rates of complications than other filters on the market. Instead of recalling it, Bard sold about 34,000 of the Recovery filters before replacing it with the G2 in 2005.
What are the most serious side effects of IVC filters?
Fracture, migration, embolization, perforation of the vena cava, DVT, obstruction of the filter, cardiac tamponade and pericardial effusion, unrecoverable pieces, and organ damage.
When did the FDA warn about IVC filters?
In 2010, the FDA issued a public warning (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm) after receiving 921 adverse events since 2005. The agency recommended that retrievable filters should be removed when they were no longer necessary. In 2014, the FDA recommended (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm) removing the filters 1-2 months after the patient’s risk of PE subsided.
How long will my IVC Filter lawsuit take?
It’s difficult to determine how long it will take to resolve a personal injury lawsuit. Each case is unique; therefore, no time frame can be established for personal injury cases. Some cases settle in a matter of months after the injury while others can take years to get to settlement or trial.
How much is my case worth?
Each personal injury case is different. Because of this, until your case has been fully investigated, determining the worth of your personal injury is merely impossible in the early stages. Your claim’s worth will depend on factors including but not limited to the severity of your injuries, the details of the case, insurance limits and the identity of the defendant. Full compensation may include payment of medical bills, pain and suffering, mental anguish, loss of ability to enjoy life, lost wages, and/or diminished earning capacity.
How much will this cost?
All personal injury cases are different. The Schmidt Firm, PLLC handles personal injury claims on a contingency fee basis, which means that our fee is a percentage of the recovery that our firm is able to obtain for you.
Will I have to go to trial?
Most personal injury cases handled by our firm are settled outside of court. However, there are occasions where it is in the plaintiff’s interest to take their case to trial.
How much time do I have to file an IVC filter lawsuit?
The statute of limitations varies from state to state. These laws limit the amount of time a claimant can wait to file a lawsuit. The type of claim is important for determining when the limitations period begins to run. With few exceptions, plaintiffs are barred from filing a claim if they wait too long after the statute of limitations begins to run. For example, rules in one state may allow a plaintiff with a personal injury claim one year from the date of injury to file suit and in another state, personal injury plaintiffs may have two years to sue. We encourage you to contact someone as soon as possible to determine your statute of limitations and prevent you being barred from pursuing your claim further.
Video: Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?
Now to an NBC News investigation that we’ve been working on for a year. Looking into a medical device that was designed to save lives, but is instead putting lives at risk. Its been implanted in thousands of Americans, many walking around with it right now, in people who may not know it could be deadly. NBC’s Stephanie Gosk has the first of our two-part report…
Video: Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?
We’re back with our NBC News investigation about a medical device implanted in thousands of people that is linked to more than two dozen deaths. Tonight, an exclusive interview with a former company insider and even more questions. Did the maker dismiss early warning signs of potential fatal flaws and did the company forge a signature on a key document submitted to the FDA. NBC’s Stephanie Gosk reports…
Click to Expand and View Additional Content
- In general, IVC filters perforate the vena cava in 9-24% of cases – some filters have higher risks than others. http://http://www.ncbi.nlm.nih.gov/pubmed/22717360
- Fracture and Embolization of Bard Recovery/G2 – November 2010 (http://archinte.jamanetwork.com/article.aspx?articleid=226212) – 25% of Recovery filters broke and embolized; 12% of G2 filters fractured. Conclusion: “The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.”
- Vena Cava Filters dont reduce mortality for most patients with pulmonary embolism: http://www.amjmed.com/article/S0002-9343(11)00481-5/fulltext “Only a small percentage of patients suffering from a pulmonary embolism are in shock or in need of ventilation support, and therefore only a small proportion need a filter.”
- How Could a Medical Device Be So Well Accepted Without Any Evidence of Efficacy? (http://archinte.jamanetwork.com/article.aspx?articleid=1669099) – Studies do not back up safety of IVC filters; Bard Recovery/G2 approved through 510(k) based on “equivalence” to filters from the 1960s.
- Only 50% of surgeries to implant IVC filters were actually necessary (September 2010) http://archinte.ama-assn.org/cgi/content/short/170/16/1456
- Cook Celect: June 2015 study (http://www.ncbi.nlm.nih.gov/pubmed/25791334) linked Celect with 43% rate of vena cava perforation, compared to 0% for Rex Medical Option. In 2012, a study (http://www.ncbi.nlm.nih.gov/pubmed/21448771) of 27 Celect filters found that all had some degree of vena caval perforation after 71 days.
- Litigation Status: Bard IVC filter lawsuits centralized in MDL No. 2641; Cook Medical IVC filter MDL No. 2570
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