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Cook Medical IVC Faces Allegations of Serious Side Effects

Apr 14, 2017
Cook Medical IVC Faces Allegations of Serious Side Effect

A recent lawsuit was filed by an Arizona man against Cook Medical, Inc., alleging that the company's vena cava filter device caused severe damage. The device in question is the Gunther Tulip Vena Cava Filter. During the Inferior Vena Cava (IVC) filter placement, a filtering device is placed into the large vein in the abdomen that returns blood from the lower body to the heart. Blood clots in the veins of the legs and pelvis can occasionally travel to the lungs where they may cause a pulmonary embolism or blockage.

Purpose of the IVC Filter

IVC filters help reduce the risk of pulmonary embolism by trapping large clots and preventing them from reaching the heart and lungs. They have a high rate of success in patients who don't respond to or cannot be given conventional medical therapy.

Blood clots that develop in the veins of the leg or pelvis, a condition called deep vein thrombosis (DVT), occasionally break up and large pieces of the clot can travel to the lungs. An IVC filter is a small metal device that traps large clot fragments and prevents them from traveling through the vena cava vein to the heart and lungs.

IVC Complications

According to the vena cava filter lawsuit the plaintiff was implanted with the vena cava filter on July 31, 2015. However, after implantation of the device, the plaintiff began to experience serious complications. This could cause severe problems such as pain, difficulty breathing, shortness of breath, or even death.

The plaintiff filed this vena cava filter lawsuit on multiple counts, including failure to warn, design defect, negligence, breach of express and implied warranties, and others. The vena cava filter lawsuit was filed against multiple defendants, including Cook incorporated, Cook Medical LLC, and William Cook Europe ApS.

The vena cava filter lawsuit was filed against multiple defendants, including Cook Incorporated, Cook Medical LLC, and William Cook Europe ApS. This vena cava filter lawsuit was filed as part of an MDL, or (multidistrict litigation), which combines a number of similar lawsuits together. This is a process to streamline the procedure by having proceedings in one court, under one judge, to simplify complex litigation and expedite results.

Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from allegedly defective medical devices, including inferior vena cava filters.

An IVC filter, also known as an inferior vena cava filter, is a medical device meant to prevent blood clots from entering a patient's lungs and heart. But a growing number of reports in recent years have suggested that these devices can cause serious injuries and complications.

As always, benefits should outweigh the risks of any medical treatment or device. Vena cava filter lawsuits across the United States are maintaining that the product can be dangerous for patients. According to these lawsuits, IVC filter devices may not be worth the risk they pose to patients and allege that the devices themselves may be more harmful than the blood clots they are intended to treat.

Reports filed with the FDA concerning adverse events in the past decade show that hundreds of patients have suffered from punctured organs and filter migrations, which can cause major complications and injuries.

According to Lawsuits, Device Manufacturers Are Responsible for Adverse Effects

Device Manufacturers Are Responsible for Adverse Effects

The vena cava filter lawsuit, and many similar lawsuits claim say that Cook Medical should take responsibility for the devastating effects their devices have allegedly had on patients and families all over the country.

Perhaps the most disturbing aspect is that plaintiffs allege that Cook was aware that the device may lead to serious complications but continued to promote and sell it anyway: placing profit over patient safety.

FDA Response

The FDA recommends that retrievable IVC filters can only be used on a temporary rather than permanent basis, and only if other medication or treatments are deemed ineffective. Injured patients have filed IVC filter lawsuits against a number of companies that make the vena cava filter devices, citing a number of serious complications that include organ damage due to filter migration and breaks.

Plaintiffs in many IVC filter litigations point out that IVC filters were approved through FDA's 501(k), which allows devices to be approved without clinical testing. Manufacturers only need to show that devices are "substantially equivalent," or similar enough, to a previously approved device. This is sometimes considered a controversial practice, but it does bring a new product to market faster.

Legal Help for Inferior Vena Cava Filter Recipients

Parker Waichman LLP has had years of experience representing clients in numerous allegedly defective medical device lawsuits. The firm offers free, no-obligation case evaluations to anyone with questions about filing a lawsuit over adverse effects from medical devices. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).


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