Earlier this month, NBC News completed a year-long investigation of medical device manufacturer CR Bard. It is the company responsible for the Recovery IVC filter, a device inserted into a major vein in order to prevent blood clots from reaching the lungs. Designed to be “retrievable” once the patient is no longer in danger from blood clots, this device has been implicated in 30 fatalities and 300 injuries. NBC News found evidence that Bard executives were fully aware of the dangers to patients who had the device implanted as far back as 2004.
That year, CR Bard commissioned a study on the IVC filter. The results were not what they had hoped for; it linked the Recovery device to higher fatality rates due to fractures and migration of fragments through the vascular system. The author of the study wrote that “further investigation…was urgently warranted.” Instead of issuing a recall or even an advisory, Bard continued to sell over 34,000 more units – after which a slightly modified version of the Recovery was introduced as the “G2 IVC Filter System.” Bard allegedly has gone so far as to forge the signature of a regulatory specialist on an application for FDA approval.
Finally, in 2010, the US Food & Drug Administration (FDA) reported that Bard’s IVC Filters were the cause of come 900 “adverse events.” The FDA recommended that the filters be removed within seven weeks. However, three years later, the Journal of the American Medical Association (JAMA) reported that retrieval was successful in only 1 out of 10 cases.
Bard, which also manufactured and sold pelvic slings and vaginal meshes, has again been targeted in injury lawsuits from across the country. In August, the US Judicial Panel on Multi-District Litigation (JPML) consolidated all federal IVC lawsuits against Bard before an Arizona district court. Pre-trial motions are currently being filed and discovery (in which each side makes evidence available for examination by the other) is underway. A number of IVC lawsuit clients are being represented by Brandon Bogle of the Levin Papantonio law firm in Pensacola, Florida. The lawsuits allege that the Recovery and G2 IVC filters are defective and prone to fracture, shift positions and travel through the veins, causing serious injury and, in some cases, premature death.
CR Bard may have problems beyond the growing number of IVC civil lawsuits. If charges of forgery and fraud can be proven, company executives may face criminal charges (of course, we’ll believe that when we see it). In the meantime, people who have been injured by CR Bard’s IVC devices continue to come forward. Considering that the IVC litigation comes so soon in the way of the company’s recent $200 million settlement of vaginal mesh lawsuits, it appears that, although corporations may be “people,” they are incapable of learning from past mistakes – or (as is more likely) so blinded by psychopathic greed that they are unable to rise above their imperative to maximize profits at any and all costs, including human life.
