Some of the cage-like filters designed to stop blood clots from flowing from the lower part of the body to the heart apparently turned out to be defective. Victims of those defects from several states want a panel of federal judges to decide July 30 to centralize the product liability litigation before a single federal judge for more economical pretrial management.
The device is known as the inferior vena cava filter, or IVC filter. The IVC filter is often used when a patient at risk for a blood clot in the lungs, which is known as a pulmonary embolism, cannot be given an anticoagulant, according to the U.S. Food and Drug Administration. The IVC filter can be permanent or retrievable, depending on whether the patient needs long-term or short-term protection.
The FDA in 2010 checked its records of voluntarily submitted adverse events. A disturbing pattern developed that impelled the agency to issue a safety communication to the medical community.
"Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture," according to the FDA's 2010 advisory.
The filter has been intended to minimize the PE risk.
"Recent studies, however, have shown that the filters have no efficacy," according to a May 18 brief in support of plaintiffs' request to centralize before U.S. District Court for the Northern District of Texas those federal IVC lawsuits filed against manufacturer C.R. Bard. "In fact, the filters have been shown to double the risk of pulmonary embolism, the very condition which they are intended to prevent. The filed cases generally allege defective design, misrepresentation in marketing, and failure to warn doctors and patients adequately about the risks of the devices and for refusing to warn that the filters were not effective - in other words that they did not work - and that they increased the risk that the patients receiving their filters would be more likely to develop a pulmonary embolus than if there was no filter implanted at all."
Simply put, C.R. Bard either knew or should have known that the device could not withstand "normal and expected anatomical and physiological" pressures, plaintiffs assert. Additionally, plaintiffs say, Bard executives either knew or should have known that their corporation's IVC filters "were likely to fracture, tilt, perforate the vena cava wall and/or migrate, and thus cause injury," such as the device becoming an obstruction in a vessel or in the heart.
A study that the Archives of Internal Medicine published in 2010 examined the efficacy of a couple of Bard IVC filter models. The Department of Cardiology at Pennsylvania-based York Hospital examined 80 Bard IVC patients who received one of the IVC models from April 2004 until January 2009.
The results were not good.
As the authors of the study wrote, "Thirteen of 80 patients had at least one strut fracture (16 percent). At least one strut in seven of the 28 Bard Recovery filters fractured and embolized (25 percent). In five of these seven cases, patients had at least one fragment embolize to the heart (71 percent). Three patients experienced life-threatening symptoms of ventricular tachycardia [abnormally fast heart rhythm] and/or tamponade [pressure on the heart], including one patient who experienced sudden death at home. Six of 52 Bard G2 filters fractured (12 percent). In two of these six cases, the patients had asymptomatic end-organ fragment embolization."
The researchers concluded, "The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae."
And here we are in 2015, with the courts sorting out what should be done for the alleged victims.
Bard is not the only IVC filter maker in litigation. The panel of judges who will decide what to do with the Bard cases already has centralized 99 such lawsuits filed against Cook Medical. Those Cook cases are grouped at U.S. District Court for the Southern District of Indiana.
A patient who suffered injury that may have been linked to the failure of an IVC filter may want to consult an attorney to determine whether there is an entitlement to compensation for medical expenses and for other losses.