IVC Filter Attorneys: Injured Patients Claim Severe Injuries In Thousands Of Lawsuits

IVC Filter Attorneys: Injured Patients Claim Severe Injuries In Thousands Of Lawsuits 2018-12-07T10:46:34+00:00

Rosen Injury Lawyers is currently accepting and investigating lawsuits against the manufacturers of IVC filters, including C.R. Bard and Cook Medical. Did you suffer:

  • IVC filter fracture?
  • IVC filter embolization?
  • IVC perforation?

Trust us to review your situation thoroughly and evaluate your legal options. Contact us today for a free consultation.

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Injured patients deserve a strong, compassionate advocate.

— Laurence Rosen, Esq.

Rosen Injury Lawyers is currently accepting and investigating lawsuits against the manufacturers of IVC filters, including C.R. Bard and Cook Medical. Did you suffer:

  • IVC filter fracture?
  • IVC filter embolization?
  • IVC perforation?

Trust us to review your situation thoroughly and evaluate your legal options. Contact us today for a free consultation.

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Injured patients deserve a strong, compassionate advocate.

— Laurence Rosen, Esq.
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Thousands of injured patients have filed IVC filter lawsuits, accusing medical device manufacturers large and small of concealing the risks of these dangerous devices. Alongside smaller players like Boston Scientific, major manufacturers C.R. Bard and Cook Medical are facing mounting litigation. In their lawsuits, patients and families claim that IVC filter manufacturers failed to warn the public of the devices' risks, despite growing evidence that IVC filters cause a host of severe complications in many patients.

IVC Filters, Designed To Catch Blood Clots, May Not Work At All

Designed to "catch" blood clots before they reach the lungs or heart, IVC filters have become increasingly controversial over the years.

With their spider-like appearance, the use of IVC filters seems intuitively plausible. Featuring a net of metallic struts, IVC filters, some doctors claim, can be implanted inside the inferior vena cava, the body's largest artery, where they will grab blood clots as they circulate along with blood through the body. Over time, device manufacturers allege, anti-clotting factors in the blood will naturally dissolve the blood clot, leaving the IVC filter's net unblocked and ready to catch more blood clots.

X-Ray Of IVC Filter Fracture

In reality, there is little to no evidence that IVC filters have a demonstrable effect on patient safety or quality of life. Even worse, a wealth of medical research studies, along with several safety communications from the US Food & Drug Administration, say that IVC filters, in many cases, can be unacceptably dangerous.

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FDA Warns Of Substantial IVC Filter Risks

In 2010, the FDA announced a major IVC filter safety warning, describing the results of its review of adverse event reports submitted to the agency over the preceding five years. In that five-year time span, the FDA wrote, the agency had received a total of 921 reports that outlined the substantial risks of IVC filter use.

Migration & Embolization

As the FDA reviewers noted, IVC filters could migrate inside the body, breaking away from their initial site of implantation and flowing along with the blood to threaten internal organs. A number of IVC filters, the FDA stated, had even "embolized," coming to block the blood vessel and impeding blood flow.

In other cases, IVC filters have literally broken apart inside the body, as struts from the device become detached and were carried away by the flow of blood. In several cases, these broken struts have flowed all the way to the heart, entering the organ's interior and threatening to perforate the heart wall. In several case reports, entire IVC filters have been discovered inside the heart.

IVC Perforations

Far more common, but no less troubling, are perforations of the inferior vena cava. In many patients, metal struts are found to have pierced the vessel in which they were implanted, the inferior vena cava.

In symptomatic cases, this complication can leave patients suffering from chronic pain and, in cases when the perforating strut proceeds to pierce the small intestines, severe abdominal distress, with increases in diarrhea and weight loss.

Arterial hemorrhage, in which the perforation leads to internal bleeding, is a possibility, one that may require immediate surgical intervention to avoid the patient's death.

Lawsuits Describe Horrific Complications

Product liability lawsuits set out these significant risks. In their complaints, plaintiffs from across the country describe horrific complications, including IVC filter migrations, embolizations, fractures and perforations.

Many patients have been forced to undergo painful and costly revision procedures in an effort to correct these complications. Tragically, a number of wrongful death claims have also been filed, alleging that a loved one died as a result of IVC filter complications.

Permanent Filters Fall Flat, Causing Host Of Severe Side Effects

In 2010, IVC filters were primarily designed for permanent implantation. Fearing that permanent implantation could pose a substantial risk of injury, the FDA urged industry stakeholders to design a new generation of retrievable IVC filters that could be removed after their risks began to outweigh their benefits. The next few years would see a wave of retrievable IVC filters hit the market, including models manufactured by industry leaders C.R. Bard and Cook Medical.

In the meantime, FDA researchers were busy reviewing the available medical literature to develop a complete picture of IVC filter side effects and complications. Their review, which lasted four years, relied on complex mathematical models to estimate with precision the ideal time period in which an IVC filter should be removed.

FDA Advises Doctors To Remove Filters After 29 To 54 Days

In a second safety communication, published in May 2014, the FDA announced the results of its analysis, stating that IVC filters, when used for the treatment of pulmonary embolism, should be removed between 29 and 54 days after their implantation. During this time period, the FDA reviewers noted, the risks of an IVC filter come to outweigh its benefits.

In short, IVC filters are a short-term prophylactic, to be used only when patients are at an increased risk for dangerous blood clots. IVC filters should be removed immediately after the risk of pulmonary embolism has passed. The FDA also ordered IVC filter manufacturers to perform comprehensive studies on device risks. A major trial, known as PRESERVE, is still ongoing.

Unfortunately, despite the FDA's warning that IVC filters should be removed after a brief period of implantation, doctors on the ground are still leaving IVC filters implanted for extended periods of time.

Lawsuits: IVC Filters Don't Work As Intended

There is very little evidence that IVC filters are an effective way of managing pulmonary embolism and deep vein thrombosis, the medical conditions for which they are indicated. That fact, however, did not stop IVC filter manufacturers from hailing the technology as a major breakthrough in the treatment of blood clots.

To date, only one randomized controlled clinical trial, considered the gold standard for medical devices, has been conducted to support or disconfirm the use of IVC filters. This study, a French trial known as PREPIC that was completed in 2005, found unequivocally that, while IVC filters appeared to reduce the incidence of pulmonary embolism, they were associated with an increased risk for deep vein thrombosis.

Study Finds No Effect On Patient Survival

The devices, the PREPIC study group wrote, had no effect on patient survival. Drawing on these results, a number of recent medical reviews have suggested that IVC filters present little to no benefit when compared with traditional techniques of blood clot management, including blood thinners. Considering the severe medical complications associated with IVC filters, these devices may well be more dangerous than traditional treatment methods.

Based on the available evidence, IVC filters do not seem to reduce the risk of severe cardiovascular events in any appreciable way. In fact, the devices may even increase the risk for deep vein thrombosis, one of the conditions they are meant to treat.

Medical Experts Question IVC Filter Use

This stunning fact has shocked medical researchers around the world. In 2013, one of the world's most prestigious medical journal, the Journal of the American Medical Association, published a scathing editorial titled, "The Inferior Vena Cava Filter: How Could A Medical Device Be So Well Accepted Without Any Evidence Of Efficacy?" In their report, JAMA's editorial board noted that, while IVC filters should work in theory, the device's actual benefits "have never been validated by empirical studies."

Shockingly, the board could identify only 1 randomized controlled clinical trial on the safety and efficacy of IVC filters - the PREPIC study, which found that IVC filters actually increase the risk for deep vein thrombosis and have no impact on patient survival.

Filing An IVC Filter Lawsuit Is Still Possible

Without any demonstrable benefits, and posing a host of severe risks, IVC filters lie at the heart of a growing litigation. In thousands of product liability lawsuits, plaintiffs from across the country accuse a number of prominent medical manufacturers, including C.R. Bard and Cook Medical, of hiding vital safety information from the public and marketing an innately unsafe product to doctors and patients throughout the United States.

NBC Finds Evidence Of Data Concealment, Wrongdoing

At the same time, investigative reporting has discovered evidence of substantial misconduct on the part of IVC filter manufacturers. In December 2015, NBC News published a damning report, accusing IVC filter manufacturer C.R. Bard of concealing disturbing safety results from the public.

According to the reporting of NBC News, Bard chose to keep two filters on the market despite mounting reports of severe safety risks. Bard's Recovery and G2 series filters were both linked to a higher rate of filter fractures, migrations and patient deaths than any other filters on the market.

Even so, Bard decided to keep the filters on the market for five years, selling over 160,000 units in that timespan. Worse yet, NBC News has raised the possibility that, in seeking FDA certification for its Recovery filter, Bard may have forged the signature of a "veteran regulatory specialist," Kay Fuller, who was hired to help the company gain FDA approval.

Attorneys Launch Full IVC Filter Investigation

In light of these damning revelations, the experienced product liability attorneys at Rosen Injury Lawyers have opened a full investigation into IVC filter risks. Did you or a loved one suffer complications after being implanted with an IVC filter? Our dedicated personal injury lawyers can help.

Contact Now For A Free Consultation

Some injured patients and loved ones may be eligible to pursue justice by filing a product liability lawsuit. Learn more about your legal options at no cost and no obligation. Contact our compassionate legal team today for a free consultation.

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