Forged Signature May Have Led to Approval of Dangerous Medical Device
Blood clot filters are supposed to stop potentially deadly clots from reaching the lungs or heart, but new allegations suggest a major manufacturer of the devices forged a signature to get its product onto the market. Bard, which manufactures the Recovery IVC blood clot filter, has sold 34,000 of the devices. It is estimated the devices have been associated with 27 deaths and several hundred injuries.
Recovery blood clot filters are tiny metal traps that fit inside a major vein to block blood clots, but the devices may be dangerous. An NBC News study claimed the Recovery filter was associated with more adverse events and higher rates of death than blood clot filters made by competitors.
In 2002, Food and Drug Administration (FDA) officials denied an application for the manufacturer to sell the product. To get the product FDA approval, the manufacturer hired a regulatory specialist. According to the regulatory specialist, she had serious concerns about the product and voiced her opinions to company executives. Her concerns were ignored and she refused to sign any future FDA applications until safety issues could be resolved. This did not stop someone at the company from allegedly forging the regulatory specialist’s signature on an FDA approval application. To this day, she denies signing the application.
Why Are Recovery Blood Clot Filters Dangerous?
The Recovery blood clot filters have been called unsafe for good reasons. One woman who used the Recovery filter almost died when a piece broke off and pierced her heart. Another died when her vein pushed the entire device into her heart.
After hundreds of adverse events and dozens of deaths, a class action lawsuit was filed against Bard, the company that manufactures the Recovery blood clot filters.
Patients must be able to depend on medical devices to save their lives. When companies take advantage of this trust, patients can face serious injuries and death. This is not fair to the families who lose loved ones and to the patients themselves.
Shapiro Law Group – Tampa Bay Medical Malpractice Attorneys