NBC Exposes Bard IVC Filters
Inferior Vena Cava (IVC) filters are medical devices used in patients who are contraindicated for anticoagulant therapy. They are spider-shaped metal filters implanted into the largest vein in the body called the inferior vena cava, and are designed to prevent blood clots from traveling up to the heart and lungs.
Medical device giant, C.R. Bard, made an IVC filter known as the Recovery filter, which was associated with at least 27 deaths and hundreds of adverse events. Bard’s response was to modify the Recovery series. The modified series was called the G2 series.
NBC News reported recently that Bard knew within four months of the G2 series being put on the market that it had similar and potentially deadly defects as its Recovery IVC filter. Instead of recalling the G2 filter and the virtually identical G2 Express, Bard kept them on the market for five years, selling more than 160,000 of them. At least 12 deaths and hundreds of adverse events are now linked to the G2 IVC filters. NBC’s expose’ featured Dr. William Kuo, an interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic. The Clinic specializes in removing failed IVC filters. According to Dr. Kuo:
All of the data that we’ve seen in our own studies, as well as other clinician researchers, is that this device consistently fractures [and] consistently causes major complications. The number of complications [and] the frequency of severe failures makes it obvious that it was never safe to be implanted.
IVC filters have been implanted by physicians for decades, mostly without incident. In the last decade, the use of IVC filters skyrocketed with the introduction of “retrievable” IVC filters, which were designed for temporary use in trauma patients and patients undergoing bariatric (stomach) surgery. Unfortunately, over 85% of these retrievable filters were never removed. This is due to the fact that manufacturers sold them as permanent filters. Retrievable IVC filters enabled some medical device companies to triple their sales of IVC filters.
Bard hoped to gain a foothold in this lucrative market when it introduced the Recovery IVC filter. Soon after the 2002 introduction of the Recovery IVC filter, reports surfaced of deaths and injuries associated with the filter moving and breaking. A confidential study commissioned by Bard showed that the Recovery filter had the highest rates of relative risk for death, filter fracture, and movement (which could cause vein and organ damage) than all of its competitors. Notwithstanding this study, Bard failed to recall the Recovery IVC filter from the market. Instead, as reports of deaths and injuries mounted, in 2005 Bard simply replaced the Recovery with the G2 series of IVC filters.
A confidential memorandum written in December 2005 by a Bard executive outlined his concerns about “problems with …migration, tilting and perforation,” and noted that another Bard IVC filter on the market had virtually no reported complaints of adverse events. This prompted the executive to state- “Why shouldn’t doctors be using that one rather than the G2?” The answer was that Bard had spent a lot of money marketing the G2 and wasn’t willing to do the responsible thing by recalling it. By 2010, data known to Bard showed that the G2 series of IVC filters had more fractures, migrations, and reported problems than any of its competitors. Bard did not stop selling the G2 until late 2010.
Dr. Kuo estimated to NBC that in the last 10 years he has removed 1,000 failed filters, and that he’s removed more Bard IVC filters than any other make of IVC filter. He believes that both the Bard Recovery and the Bard G2 series of IVC filters should have been recalled.
This story illustrates a serious public health issue in this country. The FDA is largely ineffective. It does not have the resources to test the drugs, medical devices, and food that it is charged with regulating. Moreover, too many of the scientists working for the FDA either come from or will eventually work for the very industry that they are charged with regulating. They worry more about preserving their relationships with potential future employers and less about the safety and effectiveness of the products they regulate.
Michael Phelan is a Virginia trial attorney who practices with a special focus on traumatic brain injury (TBI) cases, pharmaceutical and medical device claims, product liability cases, and truck accidents. Michael’s peers have consistently recognized him for his excellence as a trial lawyer, and his clients have praised him for his commitment to deep research, his outstanding communication skills, and his sincerity and dedication.