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Boston Scientific faces a product liability lawsuit brought by the family of Ohio woman, which alleges that problems with a Greenfield Vena Cava filter caused severe internal injuries and death.
The complaint (PDF) was filed in the U.S. District Court for the Southern District of Ohio on January 12, by Julia and Raylyn Ratliff, administrators of the estate of Cinthia K. Ratliff.
Ratliff had the inferior vena cava (IVC) filter implanted in April 2004, for treatment of deep vein thrombosis (DVT). The small, spider-like filter is designed to “catch” blood clots that may break free, preventing them from traveling to the lungs and causing a pulmonary embolism.
According to allegations raised in the wrongful death lawsuit, design defects with the Boston Scientific Greenfield Vena Cava filter caused the device to fail and perforate her vena cava, resulting in severe internal bleeding, from which Ratliff died on May 3, 2013. According to an autopsy performed, the immediate cause of death was determined to be “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”
The family indicates that Boston Scientific knew or should have known that its Greenfield Vena Cava filter posed a risk of breaking free from its implantation site, migrating, perforating the vena cava and causing serious injury or death, according to the complaint.
IVC Filter Long-Term Risks
Amid hundreds of adverse event problems involving problems with retrievable IVC filters, the FDA issued a warning in August 2010, urging doctors to remove the devices once the danger of a pulmonary embolism has passed. One of the most common complications reported by the FDA involved IVC filters fracturing or breaking, allowing small pieces to migrating through the patient’s body and pose a potentially life-threatening risk.
In May 2014, the FDA issued an updated safety statement indicating that patients may face an increased risk of problems with IVC filters the longer they remain in place, advising doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.
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.
The Boston Scientific lawsuit over the Greenfield Vena Cava filter joins a growing number of claims brought against manufacturers of IVC filters in recent years, alleging similar design defects with products like the Bard Recovery IVC Filter, Bard G2 IVC Filter, and Cook Celect or Gunther Tulip IVC Filters.
Amid a growing number of complaints filed against Cook Medical, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order in October, consolidated all Cook IVC filter lawsuits pending throughout the federal court system before U.S. District Judge Richard L. Young in the Southern District of Indiana.