This week in the trial we continued with the defense case and the witnesses DePuy is putting on the stand. They introduced a series of expert witnesses to talk about all of the things DePuy did to test and get the Pinnacle hip approved by the FDA. The purpose of the testimony is to give jurors the impression that DePuy is a responsible company, and that they performed all the appropriate tests the FDA required, and really didn't do anything wrong. There is a problem with that argument. The way the FDA works is unique. A lot of people believe when the FDA approves a product, they thoroughly investigated the product and decided that it's a good product, it's safe, and the warnings are adequate. The truth is something different. With medical devices, such as hips, manufacturers are not required to test the device. They can get approval from the FDA to sell the device with almost no testing at all if they show the device is substantially similar to another design that is already on the market. The issue with whether FDA approval means the device is safer, or the company did the right thing, really doesn't mesh. So, when the FDA approves a device, they are not saying they tested it. The FDA doesn't really test devices. The FDA relies on manufacturers to test the devices, and the manufacturers tell the FDA they tested the device. That's when the FDA approves the device.
DePuy is trying to create the impression that because this was FDA approved it was a safe device and their testing was appropriate. In reality, this isn't true.
The next phase of the trial will be the plaintiff's rebuttal witnesses, present witnesses to rebut the arguments the defendants have made.