As reported by NBC News, an estimated 250,000 people in the United States are implanted with blood clot filters each year, and the number of people receiving these medical device-implants has increased steadily over time.
New Jersey-based medical device manufacturer C.R. Bard developed the small, spider-like blood clot filters that were implanted in the largest vein in the body (the inferior vena cava, thus “IVC filters”) designed to catch blood clots before such clots would reach the heart and lungs. But these retrievable IVC filters – the type of IVC filter most patients receive – were intended for short-term placement and were to be removed after the highest risk of blood clots passed.
Several studies have linked the prolonged presence of certain retrievable IVC filters to serious, even fatal, complications including device fracture, device migration, perforation of various organs, and an increased risk for blood clots (the exact danger the devices are intended to prevent).
Multiple Flaws, Multiple Deaths
NBC stated that Bard’s first blood clot filter device, the Recovery filter, had multiple flaws that would eventually be linked to 27 deaths. As a result, the company created a modified version of the device known as the G2 series filters. Despite concerns about the flaws and problems found with the altered device, Bard proceeded to put the G2 series filters on the market.
“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” explained Dr. William Kuo, an interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
IVC Filter Device Regulation Questioned
“What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices,” Kuo added.
The flawed G2 filter and the G2 Express were kept on the market for five years, until 2010, with over 160,000 devices sold. At least 12 reported deaths and numerous injuries have been associated with Bard’s G2 series filters.
“[I]n the interest of public safety and patient safety, absolutely these devices should have been recalled,” stated Kuo.
Manufacturers of medical devices owe a duty to patients to produce safe and effective products. This requires that manufacturers test their products for any defects prior to introducing them to the market. Further, medical device makers must inform patients and their physicians of any adverse health effects from the use of the devices. Failure to meet this duty leaves medical device manufacturers open to product liability and injury lawsuits.
Contact Lieff Cabraser IVC Filter Personal Injury Attorneys
Lieff Cabraser represents injured patients across the U.S. and families whose loved ones died in IVC filter injury lawsuits. Learn more about the IVC blood clot filter lawsuits and contact a Lieff Cabraser injury attorney here.