Cook Celect IVC Filter Lawsuit Filed Over Heart Lacerations
Cook Medical faces a product liability lawsuit filed by a Michigan man and his wife, which alleges that a piece of the company’s Celect Inferior Vena Cava (IVC) filter broke free inside his body, causing severe injury when it punctured his heart.
The complaint (PDF) was filed by Larry and Brenda Johnson in the U.S. District Court for the Eastern District of Michigan on February 20, indicating that the small filter designed to “catch” blood clots before they travel to the lungs actually caused a heart laceration, causing Larry Johnson so much pain that he drove off the road late last year.
Johnson received the retrievable IVC filter after undergoing knee surgery in October 2010, to prevent blood clots that may break free in the deep veins of his legs from causing a pulmonary embolism.
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More than four years after the small, spider like device was implanted in his vena cava, Johnson indicates that he began to experience sharp pains in his chest and back. On November 16, 2014, the pain became so intense that he lost consciousness and drove off the road. He was later discovered by a passer-by and rushed to a nearby hospital.
According to the lawsuit, it took four emergency heart surgeries before doctors discovered a thin wire had pierced his heart, and every time his heart beat, the piece of the Cook filter lacerated his heart even more.
Johnson’s case joins about 60 other Cook IVC filter lawsuits filed throughout the federal court system, which raise similar allegations of problems with the Celect and Gunther Tulip filters.
Since October 2014, all Cook Celect lawsuits and Cook Gunther Tulip lawsuits have been consolidated in the federal court system as part of an MDL, or multidistrict litigation, which is centralized for pretrial proceedings before U.S. District Judge Richard L. Young in the Southern District of Indiana.
The litigation raises similar allegations of design defects to those brought in Bard Recovery IVC filter lawsuits and Bard G2 IVC filter lawsuits, which have also been linked to reports of problems where the devices may fracture, migrate or perforate internal organs.
IVC Filter Health Concerns
IVC filters, or inferior vena cava filters, are implanted into the vena cava to “catch” blood clots when anticoagulant therapy is contraindicated or has not been effective.
According to allegations raised by plaintiffs in the lawsuits over the Cook IVC filters, a study was published in the medical journal Cardiovascular Interventional Radiology in April 2012, which found that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.
In August 2010, the FDA issued a warning about the risk of IVC filter problems, indicating that the agency had received hundreds of adverse event reports where filters broke free and travelled to other areas of the body or caused other injury.
A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.
Johnson’s lawsuit seeks damages for injuries that include a lacerated pericardium, extreme physical pain and suffering, an inability to enjoy daily activities, significant scarring of his sternum, economic losses, and medical expenses. The lawsuit charges Cook Medical with negligence and gross negligence.
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