Cook Medical IVC Filter Lawsuits

Cook Medical IVC Filter Lawsuits 2018-09-25T12:25:11+00:00
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Cook Medical faces nearly 5,000 IVC filter lawsuits. In their claims, plaintiffs allege that the medical devices can migrate and break apart inside the body, leading to severe injuries. Our experienced product liability attorneys can help.

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Medical device manufacturers that threaten public health must be held accountable.

— Laurence Rosen, Esq.

Cook Medical faces nearly 5,000 IVC filter lawsuits. In their claims, plaintiffs allege that the medical devices can migrate and break apart inside the body, leading to severe injuries. Our experienced product liability attorneys can help.

  • Call today for a free consultation
  • Millions recovered in compensation
  • You owe nothing until we secure damages

Some patients may be eligible to pursue justice in court. Learn more about your options in a free, confidential consultation today.

24/7 Free IVC Filter Consultations

(866) 807-4631

Medical device manufacturers that threaten public health must be held accountable.

— Laurence Rosen, Esq.
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Major medical device manufacturer Cook Medical faces thousands of lawsuits over the company's IVC filters. In these lawsuits, plaintiffs from across the country accuse Cook of concealing the substantial risks of its medical products, while marketing a dangerous device with few, if any, benefits to patients.

IVC Filter Failures Drive Cook Medical Litigation

Over the last two decades, IVC filters have been linked to a host of severe complications. These small net-like medical devices, designed to catch blood clots inside the body's largest artery, appear to fail at extraordinary rates.

Doctors During Operation

Risks & Complications

As countless medical studies have shown, IVC filters can tilt or migrate inside the inferior vena cava, the vein in which they are implanted, leading to serious side effects. With their multiple metal struts, the filters frequently perforate the inferior vena cava. In severe cases, metal struts have extended further, piercing other internal organs and leaving patients at risk of infection, nerve damage and internal bleeding.

At the same time, IVC filters appear prone to breakage. In these cases of filter fracture, broken pieces of the IVC filter can be carried away by the flow of blood, entering the heart or lungs and causing substantial damage inside the organs. These "embolizations" have been blamed for causing dozens of patient deaths. In fact, the FDA has received hundreds of reports of severe IVC filter-related injuries.

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Cook Filters Fail At Unacceptable Rate, Lawsuits Allege

Created to reduce the risk of pulmonary embolism and deep vein thrombosis, Cook Medical manufactures a number of IVC filter models, including:

  • Celect
  • Celect Platinum
  • Günther Tulip
  • Bird's Nest

The majority of Cook Medical IVC filter lawsuits involve injuries allegedly caused by the Günther Tulip and Celect product lines.

Studies Find High Rate Of Perforation

Like the models manufactured by other companies, Cook Medical's IVC filters appear to fail at a high rate.

Inferior vena cava perforations are particularly prevalent, according to researchers in the Journal of Vascular and Interventional Radiology. In their study of 415 Cook Medical IVC filter patients, researchers at Ohio State University found that, after an average of 277 days, the filters had perforated the inferior vena cava in nearly 50% of cases.

At 49%, the perforation rate for Cook's Celect filter came out the highest, followed closely by the company's Günther Tulip model at 43%. A similar device manufactured by Boston Scientific, the Greenfield filter, on the other hand, caused few perforations. At the mean follow-up time of 277 days, only 1 out of 50 Greenfield filters had perforated the inferior vena cava. Additional studies have found even higher rates of perforation.

A 2012 report in Cardiovascular and Interventional Radiology found a perforation rate of 100% among Cook's Celect and Günther Tulip filters after an average follow-up period of 71 days. The filter's struts were found to have fully perforated the vein in 86% of cases, while 40% of the filters were observed to have tilted out of position.

FDA Warns Of Extended Implantation

The FDA has addressed these risks on multiple occasions. Faced by a rising tide of adverse event reports, in which IVC filters were described breaking apart inside patients, the FDA issued an urgent warning to patients and their health care providers in 2014.

Noting that the risks of an IVC filter appear to increase the longer the device is implanted, federal experts advised physicians to remove the filters as soon as possible, ideally within 29 to 54 days of their implantation, so long as the risk of pulmonary embolism or deep vein thrombosis has passed.

Do Filter Risks Outweigh Benefits?

There is, however, a serious question as to whether or not IVC filters do any good at all. Despite their widespread use, IVC filters are not supported by rigorous medical evidence. While it is true that the idea behind an IVC filter, catching a blood clot as it passes through the vein, is intuitively plausible, there is a surprising lack of evidence to demonstrate the benefits in practice.

In fact, as experts in the Journal of the American Medical Evidence explained in 2013, only 1 randomized controlled clinical trial has ever been conducted to evaluate the IVC filter's efficacy. This trial, known as PREPIC, was conducted by French researchers, who reported their results in a 2005 issue of Circulation. Unfortunately for patients, the PREPIC study group could find little evidence to support the widespread use of IVC filters.

Studying 400 patients over 8 years, the group found that IVC filters appeared to reduce the risk for pulmonary embolism, but increased the risk for deep vein thrombosis. Comparing IVC filter patients to patients taking traditional anticoagulants, PREPIC found no difference in survival rate. "Mortality," researchers wrote in the Journal of the American Medical Association, "was indistinguishable between the groups."

Cook IVC Filter Claims Consolidated In Indiana

As of September 2018, over 4,600 IVC filter lawsuits have been filed against Cook Medical. In their lawsuits, patients who suffered severe IVC filter-related injuries accuse Cook of manufacturing a dangerous and defective medical device and marketing the product as a medical breakthrough without any evidence to support its continued use.

As we've seen, the only randomized controlled clinical trial to consider the IVC filter's efficacy came to a dispiriting conclusion; the risk for pulmonary embolism was reduced, but the risk for deep vein thrombosis was increased, without any overall affect on mortality. Taken together with the severe risks of IVC filter fracture, perforation and embolization, plaintiffs argue that IVC filter manufacturers, including Cook Medical, foisted an unsafe product off on unsuspecting plaintiffs in a shameless grab for profit.

The Cook Medical MDL

The IVC filter claims against Cook Medical have been consolidated in the United States District Court for the Southern District of Indiana, where Judge Richard L. Young has been appointed to preside over the litigation. In Indiana, the lawsuits have moved through key aspects of pre-trial proceedings as a coordinated group, allowing plaintiffs' attorneys to pool their resources in pursuit of justice.

To date, two test cases, selected from the consolidated Multi-district litigation, have gone to trial. Unfortunately, Cook Medical has prevailed in both of these so-called "bellwether" trials, which are designed to help inform the decision-making process for both sides as they work toward a resolution for the coordinated litigation.

Jury Awards $1.2 Million In Texas Lawsuit

While plaintiffs have, until now, proved unsuccessful in these bellwether trials, juries from other jurisdictions have held Cook Medical liable for IVC filter injuries. In May 2018, a state court jury in Houston ordered the company to pay $1.2 million in compensation to a Texas man who was severely injured after being implanted with one of Cook's Celect IVC filters, Mass Device reports.

In a press release published following the verdict, the plaintiff's attorneys said that, after implantation, the Celect IVC filter had tilted inside the vein, perforated the plaintiff's inferior vena cava and pierced both his small intestines and aorta. Ultimately, the tilted device came to press against the man's spine, making non-invasive removal attempts impossible. After two removal attempts failed, the plaintiff was forced to undergo an open laparotomy surgery to have the device removed.

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