In case after case detailing injuries patients sustained after receiving the surgically implanted inferior vena cava filter, plaintiffs in these product liability lawsuits have heaped upon the court scientific evidence of device failure rates. As IVC lawsuits continue to be filed across the nation, a federal panel of judges are preparing to decide, perhaps as soon as August, whether one court should receive similar IVC lawsuits filed against Bard for uniform pretrial management.
The IVC is the “main vessel returning blood from the lower half of the body to the heart,” according to the U.S. Food and Drug Administration, which described IVC filters as “cage-like” devices designed to stop blood clots from reaching the lungs.
The federal agency announced in 2010 and reiterated in May that it has received reports of patient complications.
“Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device,” the FDA wrote. “Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”
Naturally, there is science supporting the experiences of injured patients. For instance, the Texas Heart Institute Journal in its April 2015 edition published a piece centered on a 53-year-old man who came to the emergency room in 2010 with “sudden onset of left-sided chest pain.” As it turned out, “he had also had a Bard G2 retrievable IVC filter placed during his hospitalization for the intracranial hemorrhage.”
The authors went on to report the findings of a 2010 study. They recapped, “Nicholson and colleagues conducted a retrospective study of 80 patients to determine the prevalence of fracture and embolization of the Bard Recovery and G2 vena cava filters. Thirteen of 80 patients had at least one strut fracture (16 percent). Of the 28 Recovery filters, seven had at least one fractured and embolized strut (25 percent). Six of 52 G2 filters fractured (12 percent). The average time between Recovery filter implantation and evaluation of filter integrity was 1,498 days; for the G2 filter, it was 717 days.”
The Journal of Vascular and Interventional Radiology in February 2012 also published a piece on IVC filter failure rates. Authors in this study reported, “A total of 63 fractured IVC filters were discovered among 548 patients presenting for retrievable filter removal between April 2004 and November 2010 at a single institution. Device type, duration of implantation, component fracture, and embolization events were recorded. Success rates and techniques for removal of components were recorded … A total of 63 fractured Recovery, G2, and G2 Express IVC filters were identified, for an overall fracture rate of 12 percent.”
A Florida woman received a Bard G2 IVC filter in February 2008, and the device moved into and damaged her left renal vein. An attempt to surgically remove the migrated device was unsuccessful about a year after she received it. The meter, so to speak, is still running on her extensive medical treatment allegedly linked to the failed device. She filed suit against the manufacturer. Indeed, hers is among 23 IVC filter lawsuits that the U.S. Judicial Panel on Multidistrict Litigation on July 30 will consider for centralization before U.S. District Court for the Northern District of Texas.
There are numerous allegations. One of them – and this will appear in similar litigation – is that the defendants failed to tell the whole truth about health risks.
“The information distributed by Defendants to the public, the medical community and 27 Plaintiff’s health care providers was in the form of reports, press releases, advertising campaigns, labeling materials, print advertisements, commercial media containing material representations, which were false and misleading, and contained omissions and concealment of the truth about the dangers of the use of the G2 Filter,” the plaintiff’s petition reads. “Defendants made the foregoing misrepresentations knowing that they were false or without reasonable basis. These materials included instructions for use and [a] warning document that was included in the package of the G2 Filter that was implanted in Plaintiff.”
Moreover, the plaintiff asserted, the G2 is not safe “for human use in its intended and reasonably foreseeable manner.” In fact, she claimed, “The use of the G2 Filter is hazardous to the user’s health, and said device has a serious propensity to cause users to suffer serious injuries, including, without limitation, the injuries Plaintiff suffered. Further, the device has a significantly higher rate of failure and injury than do other comparable devices.”
Wherever the cases are tried, patients whose injuries may be traced to the migration or breakage of a Bard IVC filter may learn from an experienced product liability attorney whether they may be entitled to compensation for medical treatment and for other losses.