The lawsuit was filed by Andrew K., a man who was surgically implanted with the retrievable Cook Celect® IVC filter at Wellspan Health Hospital in York, Pennsylvania in June 2012.
Inferior vena cava (IVC) filters are spider-like wire devices implanted inside one of the largest blood vessels in the body to catch blood clots before they get into the lungs.
His doctor allegedly said there was no need for any follow-up medical care, despite FDA recommendations to the contrary. In 2010, the FDA told doctors to retrieve IVC filters as soon as the patient’s risk of blood clots subsided — ideally within 29 and 54 days after implantation.
The plaintiff had surgery to remove the filter in December 2015, over two years after it was implanted.
Unfortunately, his doctors discovered that the filter was tilted. The hook at the apex was embedded in the wall of the vena cava. One of the filter arms had broken and moved into his heart.
In January 2016, the plaintiff had open heart surgery to remove the broken piece of the filter from his heart. Unfortunately, surgery was unsuccessful. The piece could not be retrieved and it remains embedded in his heart.
He is now at risk of severe health problems, migrations, perforations, and even death from the fractured filter arm. He will need ongoing medical care and monitoring for the rest of his life.
Cook Medical is accused of concealing risks and falsely promoting the filter as safe. The company specifically said the chonichrome metal “reduces the risk of fracture,” according to the lawsuit.
Lawyers say the filter is too weak to withstand normal forces in the body. Furthermore, they say it was never adequately studied. The Celect was approved with a 510(k) application, which does not require safety studies if a new device is “equivalent” to an approved device.
The plaintiff’s surgeon is accused of failing to follow-up or remove the filter when he no longer needed protection against blood clots.
The lawsuit was filed on May 19, 2016 in the Court of Common Pleas in York County, Pennsylvania — Case No. 2016-SU-1406-71.
The plaintiff is represented by Ben C. Martin of the Law Offices of Ben C. Martin.