The Food and Drug Administration has released a copy of the warning letter sent to Synthes Inc. last month. The letter serves as the FDA’s official notice to the medical device company of the ongoing investigation into its “failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints.” The letter also advises Synthes that it failed to “promptly correct” the violations and that the FDA may impose civil money penalties or other regulatory action. Personal injury attorneys find this behavior to be unbelievably irresponsible for a company manufacturing medical devices.
Synthes produces medical devices and tools, including surgical plates, rods, screws, and nails used for spinal procedures. The device making company is currently in the process of being bought by Johnson & Johnson. Synthes will likely be combined with Johnson & Johnson’s device division, DePuy.
The FDA warning letter is yet another legal hurdle for Synthes. Last fall, four of the medical device company’s former executives went to federal prison for their roles in an illegal clinical trial. The trials were done without FDA approval. Three patients died on the operating table in those trials.
The illegal trials tested bone cement which was not approved for use in a specific spine procedure. In addition, Synthes did not get approval to test the bone cement on humans before beginning their trials.
The Philadelphia personal injury attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury attorneys 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 attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.