The United States attorney today charged a West Chester-based medical products company for illegally conducting human experiments.
A local medical device company was charged today with illegally conducting human clinical trials. Federal investigators say the experiments stopped only after three patients died during surgeries using the product.
Norian XR is a medical cement used as a bone filler. The subsidiary of West Chester-based Synthes that makes the product skirted the Food and Drug Administration’s approval process for clinical trials and went ahead with getting Norian XR used in spinal surgeries. That’s according to US Attorney Michael Levy’s indictment.
Levy: What they did here was they invited surgeons for training sessions about the use of this product. The product was approved for certain uses, but they were now using them for what we refer to as off-label, things that were not FDA approved…They left it up to themselves to make the decision whether the product was safe and effective. And of course we set up a program like the FDA’s to be sure that it’s somebody who has no financial interest in the outcome making that decision.
If convicted Synthes and its subsidiary could pay more than $30 million in fines. In a settlement with the New Jersey Attorney General last month, Synthes agreed to disclose all future payments to doctors involved in clinical trials. The company did not immediately return requests for comment.