On cross exam, there was significant discussion of the info that DePuy provided to the FDA about this device. Specifically, it had to do with what they call clearance. Clearance is a specification in these MOM hip cases where it basically describes the difference in size of the ball and the cup. So, you have a ball and a cup, and if they are exactly the same size, you’re going to have no clearance. So, the ball has to be slightly smaller than the cup. And, they have done these studies that show that if you have too much clearance, you end up with lots of wear debris. So, you have to tightly control the clearance when you manufacture these devices. And so on cross exam, Ms. Turner admitted that DePuy had given incorrect information to the FDA about the clearance on the Pinnacle MOM hip; that the information given showed a smaller clearance than what was actually submitted. The smaller clearance would indicate less wear versus more wear. Ms. Turner testified that it was a mistake, an insignificant mistake and that it didn’t matter. There were several documents that were presented to her that showed it was more than an insignificant mistake. The FDA found out about the mistake in 2005, so five years later when DePuy tried to get approval for the ASR, in their submission, they said the ASR is just like the pinnacle and cited the clearance, the actual clearance on both hips. And the FDA said, “Whoa, wait a minute, we thought the clearance was something different because of what you submitted back in 2000 on the Pinnacle.” So, the FDA caught them on this error or mistake or however you’d like to describe it. The plaintiffs would describe it as a blatant lie to the FDA to get this product approved. There was also discussion about how the original design had less clearance and they decided to change the clearance the week before they submitted the application to the FDA to get approval. There was testimony that this decision to change the clearance was made only by the engineers. It wasn’t approved or run by the design surgeons who were involved in developing the hip and it was a last second change that was made. Again, I think the theme that the plaintiffs have in this case is that they were rushing this to the market.
With respect to the testing of the device, there was testimony about the types of tests that were run. So what the plaintiffs did on cross examination, was got Ms. Turner to admit that many of the tests that were run involved not the actual Pinnacle MOM hip that was released to the public, but pre cursor designs, different designs, different hips with difference clearance. A lot of the data provided to the FDA about how well this hip had performed in the simulation tests was data involving difference designs, not the actual pinnacle. There was also discussion about a clinical trial that was done. During the direct examination of Ms. Turner, she talked about a test that was done before 2000, where they were actually putting the MOM hips in certain patients and monitoring those patients. They call it an IDE, investigational device exemption. They were doing this study where they were following patients. She indicated that this was a legitimate clinical study. On cross, she admitted that the study was shut down after only two years. The ability of the study to determine to actually determine the biological impact of cobalt and chromium ions on tissue was very limited because most of the time, the problems develop well after two years. So, there was never any effort in that study to follow up patients. They never went back 10-15 years later to see how they did.
The cross of Ms. Turner has gone very well. The plaintiffs are reinforcing their theme that this product was rushed to the market, that there limited testing done, the testing was done involved different designs, no one really looked at what cobalt and chromium ions would do to people as far as systemic problems as well as problems with tissue and bone destruction. That was never really examined before this product hit the market. Stay tuned. We try to provide these updates as often as we can. It’s difficult because we have a lot to do around here. We are at the point now in the trial where plaintiffs are testifying about their injuries. There is a lot of testimony from doctors and surgeons that treated patients, and a lot is very specific to each plaintiff. We probably will not provide updates on that specific testimony. We will try to stick to the general stuff that impacts every case.