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California Woman Has Cook Celect Filter Arm Lodged in Her Heart

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On August 22, 2016, a California woman filed a new Cook IVC filter lawsuit in the Central District of California. She named Cook Medical as the defendants.

The plaintiff asserts that after being implanted with a Cook IVC filter, she suffered serious injuries. She seeks compensatory and punitive damages in excess of $75,000.

Cook Celect IVC Filter Lodges in Plaintiff’s Heart

According to her complaint, the woman received a Cook Celect IVC filter at the Hoag Memorial Presbyterian Hospital in Newport Beach, California, on January 11, 2008. She had been diagnosed with an extensive thrombosis (blood clot that developed in a vein deep in the body), and was believed to be a good candidate for the filter.

This small, cage-like device is designed to be inserted into the inferior vena cava (IVC), the main vain taking blood back from the lower legs to the heart and lungs. Once there, it is supposed to trap and hold any potential blood clots until they dissipate, preventing a pulmonary embolism (PE, or blood clot in the lung).

The devices are typically used in patients at risk for serious blood clots who for one reason or another, can’t take anticoagulant drugs. They are temporary devices, however, and optimally, are removed within a few months of implantation, as soon as the risk for PE has passed.

In the plaintiff’s case, she still had the Cook Celect IVC filter inside her on October 30, 2015, when she went to Stanford University Medical Center. At that time, doctors determined that two limbs and one arm from the device had broken off and lodged in the right side of her heart. The filter had also moved from where it was initially implanted and perforated her inferior vena cava, actually protruding into her right kidney.

The doctors decided to remove the filter, but they weren’t able to get it all on the first try. One fractured arm remained in the plaintiff’s heart. On November 18, 2015, doctors tried again, but they eventually abandoned the effort because of the complexity of the injury and their inability to remove the device without causing further complications.

The plaintiff had to undergo extensive medical care as a result of these issues, and will continue to suffer from significant medical expenses, pain and suffering.

Studies Show Cook Celect IVC Filter Prone to Perforation and Fracture

A number of studies have reported problems with Cook IVC filters. In 2009, for example, researchers noted that between July 2006 and February 2008, doctors attempted 130 retrievals, but in 33 of the cases, the standard retrieval method failed because the filters had moved or penetrated the IVC.

In another review of clinical data related to 73 patients who had a Cook Celect IVC filter implanted between August 2007 and June 2008, doctors found that the filter was linked to a high incidence of penetration. Follow-up scans in 18 of the patients revealed that 39 percent had filter-related problems, which included penetration of the filter legs and fracture/migration of the filter components.

The plaintiff brings counts of failure to warn, design defect, negligence, negligence per se, breach of warranties and violation of California law prohibiting consumer fraud and unfair and deceptive practices. She claims that the defendants knew that their filters lacked appropriate warnings regarding the risk of fracture, migration, and/or perforation, but intentionally and/or recklessly failed to disclose those risks.

On August 22, 2016, a California woman filed a new Cook IVC filter lawsuit in the Central District of California. She named Cook Medical as the defendants.

The plaintiff asserts that after being implanted with a Cook IVC filter, she suffered serious injuries. She seeks compensatory and punitive damages in excess of $75,000.

Cook Celect IVC Filter Lodges in Plaintiff’s Heart

According to her complaint, the woman received a Cook Celect IVC filter at the Hoag Memorial Presbyterian Hospital in Newport Beach, California, on January 11, 2008. She had been diagnosed with an extensive thrombosis (blood clot that developed in a vein deep in the body), and was believed to be a good candidate for the filter.

This small, cage-like device is designed to be inserted into the inferior vena cava (IVC), the main vain taking blood back from the lower legs to the heart and lungs. Once there, it is supposed to trap and hold any potential blood clots until they dissipate, preventing a pulmonary embolism (PE, or blood clot in the lung).

The devices are typically used in patients at risk for serious blood clots who for one reason or another, can’t take anticoagulant drugs. They are temporary devices, however, and optimally, are removed within a few months of implantation, as soon as the risk for PE has passed.

In the plaintiff’s case, she still had the Cook Celect IVC filter inside her on October 30, 2015, when she went to Stanford University Medical Center. At that time, doctors determined that two limbs and one arm from the device had broken off and lodged in the right side of her heart. The filter had also moved from where it was initially implanted and perforated her inferior vena cava, actually protruding into her right kidney.

The doctors decided to remove the filter, but they weren’t able to get it all on the first try. One fractured arm remained in the plaintiff’s heart. On November 18, 2015, doctors tried again, but they eventually abandoned the effort because of the complexity of the injury and their inability to remove the device without causing further complications.

The plaintiff had to undergo extensive medical care as a result of these issues, and will continue to suffer from significant medical expenses, pain and suffering.

Studies Show Cook Celect IVC Filter Prone to Perforation and Fracture

A number of studies have reported problems with Cook IVC filters. In 2009, for example, researchers noted that between July 2006 and February 2008, doctors attempted 130 retrievals, but in 33 of the cases, the standard retrieval method failed because the filters had moved or penetrated the IVC.

In another review of clinical data related to 73 patients who had a Cook Celect IVC filter implanted between August 2007 and June 2008, doctors found that the filter was linked to a high incidence of penetration. Follow-up scans in 18 of the patients revealed that 39 percent had filter-related problems, which included penetration of the filter legs and fracture/migration of the filter components.

The plaintiff brings counts of failure to warn, design defect, negligence, negligence per se, breach of warranties and violation of California law prohibiting consumer fraud and unfair and deceptive practices. She claims that the defendants knew that their filters lacked appropriate warnings regarding the risk of fracture, migration, and/or perforation, but intentionally and/or recklessly failed to disclose those risks.