In less than 30 years, the medical community’s reliance on IVC filters, small cage-like devices intended to capture travelling blood clots, has increased to an unprecedented degree. In 1979, only 2,000 patients had the medical devices implanted to reduce the risk of pulmonary embolism. By 2007, nearly 167,000 IVC filters were being used to trap clots before they reached the lungs. But a series of Safety Communications released by the US Food & Drug Administration, along with the results of medical research, have pointed to a number of potentially life-threatening risks presented by retrievable IVC filters.
Hundreds File Lawsuits Over Severe Injuries
In response, many patients injured by IVC filters have joined a growing litigation, claiming device manufacturers inadequately warned of their products’ risks and marketed a device that was defectively designed from the start.
More than 100 injured patients have already filed IVC filter lawsuits, and the legal community expects many others to step forward in the coming months.
Plaintiffs claim that IVC filters literally broke apart inside their bodies, “migrating” toward internal organs, puncturing vital tissues and often causing irreparable damage. Beyond device failure, patients say IVC filter manufacturers were fully aware of their products’ dangers – but failed to warn the health community or public.
What Are IVC Filters?
In the condition known as Deep Vein Thrombosis (DVT), a blood clot, or “thrombus,” forms in veins that lie far from the skin’s surface, usually vessels in a patient’s leg.
In some cases, these clots can “embolize,” breaking away from the vein in which they formed and following blood flow into other vessels throughout the body. Traveling in this way, some clots reach the pulmonary artery, a vessel that transports blood from the heart’s right ventricle to the lungs.
Are IVC Filters A Life-Saving Device For Patients At Risk?
Larger clots can block the artery entirely, cutting off blood flow and impairing the body’s ability to remain oxygenated. The result is known as “pulmonary embolism,” a condition marked by:
- Difficulty breathing
- Chest pain
- Pain and / or swelling in the legs
- Cyanosis – a bluish tint to the skin caused by inadequate oxygen supplies
- Abnormal sweating
- Dizziness, disorientation or a feeling of “lightheadedness”
- Elevated heart rate or arrhythmia (an abnormal heart rhythm)
Pulmonary embolism is a potentially fatal medical emergency. According to the Mayo Clinic, one-third of patients suffering from undiagnosed or improperly treated pulmonary embolism “don’t survive.” In the absence of properly oxygenated blood, the body can experience a host of adverse complications, many of which are life-threatening:
- Myocardial infarction, or heart attack
- Pulmonary infarction, in which a portion of lung tissue dies
- Pulmonary hypertension, high blood pressure in vessels throughout the lungs
- Pleural effusion, a condition in which fluids build up between the lining of the chest cavity and the exterior of the lungs
- Paradoxical embolism, a blood clot that travels abnormally, rather than along the course of normal blood flow, and can eventually reach the brain
How IVC Filters Work
IVC filters were designed to “catch” blood clots before they reach the pulmonary artery. Implanted directly beneath the kidneys in the inferior vena cava (IVC), a large vein that carries deoxygenated blood from the body’s lower half to the heart, these small conical nets capture passing blood clots and stop them from reaching the vessels they could block.
In case number 120800814, a class action filed in the Court of Common Pleas for Philadelphia County, Plaintiffs use the image of an “upside down umbrella with the fabric removed” as a “rough” analogy for the IVC filter’s appearance.
Because IVC filters are permeable, rather than solid, they allow blood flow to continue around the captured thrombus. Over time, anticoagulants found naturally in blood can break the clot down.
Do Filters Work At All?
Recent research has found that, for many patients, IVC filters may not present any increased benefits over traditional methods of blood clot treatment.
In fact, the Journal of the American Medical Association (JAMA) published an editorial entitled “The Inferior Vena Cava Filter: How Could A Medical Device Be So Well Accepted Without Any Evidence Of Efficacy?” as early as 2013. In JAMA’s explicit critique, the journal noted that IVC filters should work in theory, but that the device’s true benefits have “never been validated by empirical studies.”
Disturbingly, the article’s authors could point to only one “randomized controlled trial” investigating the potential benefits of retrievable IVC filters in relation to traditional anticoagulant treatments like warfarin.
This French study, called PREPIC, followed 400 patients at high risk for pulmonary embolism over the course of 8 years. Around half of these patients were treated using blood thinners alone, while the other half received both anticoagulants and an IVC filter.
After only two years, the study “found no difference in mortality between the 2 groups but a 10% […] higher rate of DVT among those who received the filter.” In other words, IVC filters actually increased the risk of Deep Vein Thrombosis, one of the very conditions they were intended to treat.
After 8 years, 35.7% of patients with IVC filters had suffered DVT, while only 27.5% of the patients using anticoagulants alone had. And again, the difference between mortality rates in the two groups was “indistinguishable.” In the researchers’ own words, their “findings do not support the use of this type of filter in patients who can be treated with anticoagulation.”
FDA Warns Of Risks
On August 9, 2010, the FDA released an “Initial Communication” titled “Removing Retrievable Inferior Vena Cava Filters,” warning surgeons that if an IVC filter can be removed, it should be as soon as medically appropriate. Among other concerns, the FDA raised alarms that many retrievable IVC filters were not being removed after the risks of pulmonary embolism had passed.
The agency reported that between 2005 and August of 2010, 921 adverse event reports involving severe IVC filter complications had been submitted through the FDA’s Adverse Event Reporting System:
- 328 involved “device migration,” in which an IVC filter itself detached from the point of implantation and began traveling through blood vessels
- 146 involved “embolizations,” in which an IVC filter or its fragmenting parts traveled to vessels supplying the heart or lungs with blood
- 70 involved “perforation,” in which one of the filter’s legs (or “struts”) pierced the inferior vena cava’s vessel wall, or a migrating element of the device perforated another blood vessel or internal organ
- 56 involved “filter fracture,” in which an IVC filter broke apart inside the inferior vena cava
The FDA noted that many of these complications may be related to the amount of time an IVC filter is allowed to remain in place.
In response to the extraordinarily high number of adverse events, the agency announced it would complete a review of the existing medical literature on IVC filters and conduct a statistical analysis to determine the device’s true risk-benefit profile.
It would take the agency nearly four years to complete its review.
Second FDA Warning Provides Industry Guidance
An updated FDA Safety Communication was released on May 6, 2014. From the results of its analysis, the agency suggested IVC filters be removed between 29 and 54 days after implantation, unless a patient is still at risk of developing pulmonary embolism. FDA also announced that current filter manufacturers would be required to participate in two ongoing studies investigating the device’s putative benefits and the extent of its risks.
While the results of those studies have yet to be published, independent researchers have conducted their own examination of the IVC filter’s risk-benefit profile. As we’ve mentioned, several studies have found that the device may present no benefit to patients at all. In fact, IVC filters may even increase the risk of conditions they supposedly treat. In light of this discovery, any risk presented by the device may appear to be too much.
Studies conducted on the rate of IVC filter failure and perforation have presented equally troubling results. In some patient populations, IVC filters were found to have punctured the inferior vena cava’s wall in 100% of patients. To read more about studies that have estimated the extraordinary likelihood of IVC filter risks, click here.
NBC Investigation Reveals Evidence Of Fraud, Forgery
With no medically-demonstrated benefits and a host of serious risks, IVC filters stand at the center of a growing litigation. In more than 100 lawsuits, Plaintiffs accuse medical device manufacturers of concealing vital safety information and marketing an intrinsically dangerous product to physicians and patients nationwide.
Recent investigations have uncovered troubling evidence that seems to support these allegations. In December 2015, NBC News acquired a trove of damning internal documents from New Jersey medical device giant C.R. Bard, memos indicating that:
“[the] company that made a blood clot filter associated with 27 deaths and hundreds of problems replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market.”
Rather than recalling its “second generation” G2 filter, a device over which company representatives expressed serious safety concerns, C.R. Bard “decided to keep them on the market for five years, until 2010, selling more than 160,000 of them,” according to NBC. Much like the earlier Recovery filters, the company’s G2 models have been linked to multiple deaths and “hundreds of problems.”
“Never Safe To Be Implanted”
In a subsequent interview, IVC filter removal expert Dr. William Kuo told reporters:
“All of the data that we’ve seen in our studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications. The number of complications, the frequency of severe failures make it obvious that it was never safe to be implanted.”
Kuo runs the IVC Filter Clinic at Stanford University.
C.R. Bard Forged My Signature, FDA Consultant Claims
C.R. Bard hired Kay Fuller, a consultant on FDA regulation, in 2002, hoping that her expertise would help the company gain federal approval for its Recovery IVC filter. The FDA had already denied Bard’s application once and, soon after joining the team, Fuller found out why: the device had performed poorly in clinical trials. But after voicing her concerns, Fuller says Bard refused to show her “important safety performance test results.”
To her mind, the suggestion was clear: “continue to pursue these questions” and you’ll be fired. Fuller, though, wouldn’t compromise her ethics. She refused to sign the FDA application, according to an interview with NBC News, and then reported her worries to the FDA. Soon after, Bard submitted its second application for the Recovery filter – complete with what seemed to be Kay Fuller’s signature.
“That’s not my signature,” she told NBC, “I did not sign it.”
Can Patients Still File Suit?
More individuals may be eligible to file claims against the companies behind IVC filters. If you received an IVC filter and suffered serious complications as a result, contact the experienced personal injury attorneys at Banville Law. Our IVC filter lawyers offer a free consultation at no obligation. To learn more about your legal options and discuss case eligibility, call or fill out our contact form now.
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