Bellwether Trials for Medical IVC Filter U.S. District Judge Richard L. Young, who is presiding over the Cook IVC filter litigation in Indiana, has selected three bellwether cases for trial in 2017.
The outcome of these trials could influence the outcome of hundreds of other lawsuits filed by plaintiffs who allege the Cook Medical blood clot filters have caused injuries including punctured organs, Drugwatch.com reports.
Doctors implant inferior vena cava (IVC) filters in patients to prevent blood clots from traveling to the heart or lungs. These small, cage-like devices anchor inside the inferior vena cava, the body’s largest vein. The filter traps blood clots that develop in the legs and keeps them from developing into dangerous pulmonary embolisms or strokes.
By 2012, more than a quarter of a million IVC filters had been implanted in patients, Drugwatch reports.
The Food and Drug Administration (FDA) recommends that the filter is removed one to two months after insertion or after the blood clot danger has passed. But these devices can prove difficult to remove and some may break while inside a patient.
Forty-three percent of Cook’s Celect filters puncture the vena cava within two months after insertion. Filter fragments that break off can puncture organs or travel to the heart.
Patients Filed Lawsuits Against Cook Medical IVC Filter
Hundreds of patients filed have filed IVC filter lawsuits against Cook Medical and these lawsuits were centralized before Judge Young in the Southern District of Indiana.
The first bellwether case to go to trial involves a Florida woman whose doctors were unable to remove her IVC filter. According to legal documents, for three years she suffered “persistent severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain.”
Doctors discovered the IVC filter had punctured the vein and embedded- in the intestine. After treatment at several hospitals to remove the filter, she suffers from “narrowing at the explant site of the inferior vena cava and the bowel.”
The lawsuit alleges Cook concealed the “known risks and failed to warn of known or scientifically knowable dangers.”
Some experts say there is insufficient proof IVC filters are effective. A 2015 study in the Annals of Surgery showed that IVC filters may not actually improve survival for those at blood clot risk after a traumatic injury.
Trauma patients who received IVC filters also had an increased rate of deep vein thrombosis, according to Drugwatch.
The order signed by Judge Richard L. Young names three Cook IVC filter cases scheduled for trial in 2017. Two cases involve the Celect filter and one involves the Günther Tulip filter. Last year, Judge Young scheduled a series of settlement talks, hoping to resolve the cases before trial. In addition to the Cook Celect and Günther Tulip, IVC lawsuits also name C.R. Bard’s G2 and Recovery filters in lawsuits. If the parties fail to reach a settlement in the Cook cases, the bellwether trials will proceed in 2017.