As C.R. Bard is targeted by a growing number of plaintiffs alleging injury and wrongful death due to its inferior vena cava (IVC) filter, a research study published in the October issue of Annals of Surgery reports that the filters are not only injuring and killing people, they’re doing so while offering no benefit whatsoever to patients. The study, which was carried out at the University of Michigan, examined data on over 800 patients who had received IVC filters between 2010 and 2014.
The IVC filter was designed to prevent blood clots from entering the lower chamber of the heart and traveling to the lungs. Resembling a spider, the device is implanted into the largest vein in the body, leading from the lower extremities to the heart. The filter is used primarily for patients who are at risk for what is known as deep-vein thrombosis (DVT). This is a condition in which a blood clot forms in one of the limbs (usually a leg), and is in danger of breaking loose and traveling to the lungs, thus blocking blood flow. Patients who have had joint surgery are at particular risk for this condition, since they are usually unable to move for extended periods. Although they are intended for temporary use until the danger of an embolism has passed, IVC filters are extremely difficult and dangerous to remove.
IVC filters are associated with high failure rates. Once implanted, they are known to break, sending small, jagged pieces of metal through the bloodstream. The results are serious, and in some cases, fatal. What is more, evidence has emerged in recent months showing that Bard executives were not only aware of the dangers and chose to conceal this information, they were willing to commit criminal fraud in order to get their product to the market.
Now, medical researchers have discovered that the IVC filter is actually useless – and in fact, actually exacerbates the condition it was designed to treat. Results showed that the majority of patients who had an IVC filter implanted were far more likely to have DVT – but the presence of the IVC filter did nothing to reduce the risk of an embolism. The researchers’ conclusion: “High rates of prophylactic IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events.”
To date, there have been 27 fatalities and well over a thousand more non-fatal injuries attributable to the IVC Filter. The FDA did eventually issue a warning about the device in 2010 of its propensity to break and migrate, resulting in organ perforation. While the warning stopped short of ordering doctors to stop using them, it did recommend that the IVC be removed as soon as a patient was recovered and no longer in danger of suffering an embolism. However, many patients have had them for years.
One interesting aspect of this issue is the consolidation of two dozen lawsuits into multi-district litigation (MDL) under a federal judge in Arizona. Although all patients suffered the same types of injuries, the cases involve three different C.R. Bard IVC filter models. The judge decided that the cases were similar enough to warrant consolidation. One reason this should come as no surprise has to do with an FDA loophole called “(510)k Clearance.” In short, this loophole allows a pharmaceutical company or medical device manufacturer to bypass the usual clinical trials and testing if the new drug or device is “substantially similar” to an earlier model previously approved.
The implications of such a regulatory loophole should be apparent. While those who came up with this process allegedly had good intentions, it has enabled medical manufacturers like C.R. Bard to rush products to market. In most cases, it all comes down to the numbers for these corporations. If projected revenue is high enough, estimated fines and judgments are simply considered costs of doing business. Such payments can even be written off on corporate tax returns as business expenses.
Unfortunately, those “costs of doing business” also include human lives. Levin Papantonio attorney Jeff Gaddy recently discussed this on Ring of Fire. He said, “These medical manufacturers love to say they put the patients first. But when we get in there and start to look at the corporation documents and look at how they really act, we see that’s not the case at all.” Watch Papantonio’s interview with Gaddy IVC Filter Lawsuits Arise From the High Failure Rate and Severe Injuries.