Bard Medical, also known as C.R. Bard, may have been willing to commit a felony that would merit a long prison term for a natural person in order to preserve its profit margin. As recently reported on several media web sites, someone in the company allegedly forged the signature of an in-house regulatory specialist in order to get FDA approval for a product the company knew to be dangerous.
Kay Fuller, a former Bard employee, refused to sign off on an FDA application for the Recovery IVC Blood Clot Filter after the single clinical trial demonstrated potentially deadly problems with the device. After she was pressured by Bard management, Ms. Fuller resigned her position. Recently, a company application to the FDA has surfaced with a signature claiming to be that of Ms. Fuller. She states, however, that she did not sign the document. Furthermore, the signature on the FDA application is substantially different from her own.
To date, the Recovery IVC Filter has been implicated in 27 patient fatalities and at least 300 non-fatal adverse events. Instead of investigating and issuing a voluntary recall, C.R. Bard has hired a publicist to assist in maintaining its corporate image. At the same time, corporate attorneys for Bard have been filing motions in court attempting to get Recovery IVC Filter lawsuits dismissed. So far, these attempts have been unsuccessful, and lawsuits are proceeding forward.
The Recovery and G2 IVC Filters are implanted in major veins in order to prevent clots from traveling to the heart and lungs, thereby reducing the risk of embolisms. However, they are known to fall out of place and even fracture and break, sending small metal pieces through the vascular system. They can break through vein walls and become lodged in organ tissue – including that of the heart and lungs. These filters are also implicated in the formation of clots at the insertion site – the very condition they were designed to treat.
These IVC filters can be removed surgically, but the procedure is difficult, uncertain, and extremely painful. Litigation against C.R. Bard involving IVC Filters is being handled on a national by Brandon Bogle, mass tort attorney with Levin Papantonio. He has stated that the allegations of forgery, if true, represent corporate greed taken to an entirely new level. When any person is willing to commit a felony in order to maximize its profits, it should not matter whether that person is natural or “corporate” – they need to be held accountable.