IVC Filters: What are they, a Trap for Thrombus or Life?
An inferior vena cava filter (IVC Filter) is a medical device implanted in the inferior vena cava, below the kidneys, to capture a blood clot (pulmonary emboli) which has dislodged from the pelvic and leg veins (deep vein thrombosis) and prevent it from reaching the lungs. DVT/PE increases the mortality rates up to 30% and has become one of the leading life-threatening diseases in the United States.
Statistics show that more than half a million Americans are diagnosed with Deep Vein Thrombosis every year; according to the Centers for Disease Control and Prevention, it causes more than 75,000 deaths annually. The standard treatment is anticoagulation, but in situations where anticoagulation is contraindicated, using an IVC filter remains the only suitable option. According to National Hospital Discharge Survey, there was a 20 fold rise in the use of IVC filters from 1979-1999, and this trend continued till the early 2000s. The presence of IVC filters in the market before the Medical Device Act of 1976 and the 510 (k) gateway were two important factors that propelled the sales of IVC filters to such astronomical levels. This growth was also supported by off-label prescription for prophylactic indications like surgery, trauma and other medical conditions with high risk of clot development. This, surprisingly, captured a reasonable market share although they are not yet recommended by the existing guidelines.
Inferior Vena Cava (IVC) Filter implantation continued to see an upward trend in recent years, until complaints and adverse effects started getting reported in large numbers. Around 2010, the FDA began receiving adverse events and product problem reports which included device migration, filter fracture, embolization, perforation of the IVC, and difficulty in removing the device. After receiving more than 900 of such adverse event reports the FDA issued warnings in August 2010, about the risks associated with the removal of IVC filters. In 2012, the first lawsuits were filed in California followed by consolidation of several class action lawsuits in 2014. The FDA issued a safety communication in 2014 for filter removal, suggesting it should be done between 29 and 54 days after implantation.
As of May 2017, two MDLs have already been formed: MDL No. 2570-RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation; and MDL:2641-IN RE: Bard IVC Filters Products Liability Litigation, each with more than 1,500 cases. Allegations of injuries like migration, fracture of device, perforation, and risk injuries leading to permanent disability and even death, in some instances, have been made in these litigations.
MDL 2641 is overseen by Hon. David G. Campbell. Each of the Bard IVC lawsuits filed is due to its retrievable model. The first settlement had come from Bard in just 10 days post-trial, in 2012, although the details were not revealed. This was followed by a couple of other settlements post the September 2015 10-Q filing. The circumstances indicate that Bard is moving toward a settlement soon.
MDL 2570 is overseen by Chief Judge Richard L. Young and U.S. Magistrate Judge Tim A. Baker. Judge Baker has recently scheduled three additional IVC filter settlement conferences starting July 2017, eyeing a settlement before the bellwether trials begin. During these conferences, the potential of each case, discovery and trial preparation, and a tentative settlement would be discussed confidentially. The allegations faced by Cook primarily are faulty design, negligence for concealing the known risks and failure to warn doctors and patients about the scientifically known dangers.
IVC filter litigation is a complex MDL where patients trusted to have an IVC Filter implant over all the other uncertain options and to their dismay, resulted in unexpected complications and even fatalities. The unresolvable nature of injuries in patients with pre-existing complicated medical conditions has deteriorated their health condition further.
This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email us at [email protected] or call +1-844-NIT-TEAM (648-8326).