A new proposed bill, the Safety of Untested and New Devices (SOUND) Act, was introduced by Representative Edward Markey at a press conference last week. The bill would allow the Food and Drug Administration to require medical device manufacturers seeking approval for new devices based on older devices that have safety issues to provide documentation proving that the new product’s design has fixed potential problems. Personal injury attorneys are well aware of the injuries that have resulted from the absence of this regulation and fully support it’s passage.
Current laws require the FDA to approve certain kinds of medical devices even if they have reason to believe the device may harm or even kill patients. Rep. Markey aims to have the SOUND Act included in a larger medical device bill set to be voted on by Congress at the end of May. Neither the Senate nor the House version of that bill contains any language that would close the current loophole in the FDA approval process of medical devices.
The FDA has not given its official support of the SOUND Act, but the agency recognized that the bill would help to strengthen its medical device requirements and provide additional consumer protection.
According to an FDA spokesperson, about 28 medical devices are cleared each year based on a previous device that was already approved but has since been recalled. In those cases, the representative said, the new device is five times as likely to be recalled with a design flaw if it is based on an older device that was itself pulled for safety problems.
There are more than 550 lawsuits currently pending involving Johnson & Johnson/Ethicon’s Gynecare Prolift vaginal mesh implant. The device was automatically approved by the FDA based on its similarity to Boston Scientific’s ProtoGen. The ProtoGen was taken off the market shortly after Gynecare Prolift was approved. Still, even after ProtoGen was removed, several other vaginal mesh devices were given approval.
The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.