The first IVC filter multidistrict litigation (MDL) bellwether trial is slated to begin October 2 in the U.S. District Court for the Southern District for Indiana, the Indianapolis Business Journal recently reported. Judge Richard L. Young will preside over the nearly 2,000 combined claims against IVC filter maker Cook Medical, according to the U.S. Judicial Panel on Multidistrict Litigation.
The blood-clot filter is implanted in the inferior vena cava – the body’s largest vein, as Beasley Allen has described previously. The filter is intended to catch blood clots that form in the legs before they reach vital organs such as the heart and lungs. It is used as an alternative to the anticoagulant Heparin in trauma patients to prevent venous thromboembolism prophylaxiss.
Unlike permanent IVC filters, those of the retrievable variety have a high rate of failure. They are more fragile in design, often leading them to fracture, migrate or tilt within the body and potentially cause life-threatening injuries.
The first case, involving a Florida woman, demonstrates the device’s potential danger. She was implanted with a Cook Medical Celect Cava in 2010 and returned to her doctor to have it removed four months later. When the doctor’s attempts to remove the filter failed, an endoscopy procedure revealed that it had pierced a large blood vessel and the woman’s small intestine. She was transferred to another hospital where it was finally removed.
There are 10 other IVC filter manufacturers including C.R. Bard, Inc. and Cordis – both are also facing mounting lawsuits in their own MDLs. The Jere Beasley Report notes that the Bard MDL is pending in U.S. District Court in Arizona, and cases involving Cordis IVC filters are consolidated in California state court.
Recent scientific research also challenges the necessity and reliability of the filters. A study published in May by the scientific journal JAMA Surgery shows that using fewer vena cava filters did not result in an increase of pulmonary embolism among trauma patients. And, as Beasley Allen has previously discussed, a 2016 study revealed IVC filter use did not indicate any significant difference in the patient’s survival, but low removal rates could be even riskier to the patient’s health.
Indianapolis Business Journal
U.S. Judicial Panel on Multidistrict Litigation
Jere Beasley Report (March 2017) – IVC Filter Litigation Update, page 15
The JAMA Network Surgery