Lawsuits surrounding Inferior Vena Cava Filters (IVC Filters) has been surging lately as the first lawsuits are prepared to go to trial this September. Manufacturers like Boston Scientific, C.R. Bard, Cook Medical, and Cordis Corporation are all facing lawsuits both in the United States and in Canada.
What Is An IVC Filter?
IVC filters are medical devices implanted into the largest vein in the body, the inferior vena cava, to carry blood from the body to the right atrium of the heart. The purpose of an IVC filter is to prevent blood clots in the lower extremities from traveling into the heart or lungs. They are commonly used in patients at risk for Pulmonary Embolism (PE), patients who have experienced trauma, or patients who have recently undergone surgery.
In 2010, the Food and Drug Administration (FDA) released a safety communication warning doctors and patients that IVC filters could cause severe and life threatening side effects. Between 2005 and 2010, the FDA received 921 reports of device failure of IVC filters. Of these reports, 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the inferior vena cava wall, and 56 involved filter fracture. The FDA also warned that the risk of experiencing one or more of these complications greatly increases with time in the body.
C.R. Bard, one of the largest IVC Filter manufacturers in the world, has contested liability every step of the way. Currently facing over 3,000 lawsuits, the company will face its first bellwether trial on March 14, 2018 in an Arizona court. U.S. District Court Judge David Campbell is overseeing what is anticipated to be a several weeks long jury trial.
The bellwether plaintiff alleges Bard failed to warn of the failure risk associated with its IVC Filters. Once implanted, IVC Filters can tilt, migrate, fracture, and perforate the vein, making removal difficult if not impossible. As one of the largest IVC Filter manufacturers, the outcome of Bard’s litigation could set a precedent for other IVC Filter litigations.
Expert Witness Testimony
Bard lost its bid last December to have all of the plaintiffs’ expert witnesses disqualified. Plaintiffs engaged the expertise of four doctors from Northwestern University’s Interventional Radiology department who had extensive experience with Bard’s IVC Filters. The judge overseeing the case ruled three of the four doctors could give testimony.
2018 and Beyond
While no other IVC Filter trials have been scheduled for 2018 so far, it is likely Bard will face more bellwether trials this year. Other IVC Filter manufacturers like Cook Medical, Cordis Corporation, and Boston Scientific, among others, will likely use Bard’s experience as a litmus test for their own litigations. Cook Medical came close to settling its cases last year, but both sides were unable to finalize an agreement. However, depending on the outcome of Bard’s bellwether trials, manufacturers might go back to the negotiation table.
IVC Filter Lawsuits
With thousands IVC filters implanted in patients each year, the litigation against IVC filter manufacturers has quickly grown. The first manufacturer to go to trial this year will be Cook Medical. Cook has tried to settle its cases since February, but the two sides were unable to come to an agreement and the first bellwether trials are scheduled for this September.
The outcome of Cook’s lawsuits could set a precedent for other IVC filter manufacturers like Bard, facing its own trials scheduled to begin in mid-2017. The bellwether selection process is underway and it is anticipated to conclude in January or February of next year.