The Food and Drug Administration approved Menaflex under the 510(k) approval process, claiming the knee device was similar to an already approved shoulder implant, but some FDA scientists still disapproved of the device’s safety.
The whistleblowers complained to the FDA commissioner in May 2008, reporting medical device reviews were being routinely manipulated within the department, but when he failed to proceed with the inquiry, they did something unprecedented. The scientists sent a letter Congress in October 2008 asking for an investigation.
The House Committee on Energy and Commerce agreed. Through the investigation, the Project on Government Oversight and the Government Accountability Office revealed disturbing facts about the FDA. It found 228 medical devices had been fast-tracked during the period.
Menaflex had already entered the market, but by September of 2009, new FDA commissioner Margaret Hamburg and Deputy Commissioner Joshua Scharfstein publicly admitted that the Menaflex review process had been unduly influenced by both members of Congress and the old commissioner. They promised that the approval would be placed under review.
On October 13, 2010, the FDA rescinded its approval of the Menaflex knee device.
As a North Charleston personal injury lawyer, the FDA’s approval of Menaflex makes me wonder what else has been carelessly approved by the FDA. This case reminds me of DePuy Orthopaedic’s hip implant that was approved under the same process, but later recalled because it was a faulty product. If you or a loved one has been injured as a by a hip or knee implant, have your case evaluated by a Charleston hip implant attorney.
