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2016 DePuy Pinnacle Trial Update 27

Hi, Stuart Talley here to do an update on the DePuy Pinnacle metal-on-metal hip trial that is currently ongoing in Dallas, Texas.

Today, I wanted to talk about the testimony that was provided by a plaintiffs’ witness named Dr. Tony Nargol. Dr. Nargol is a surgeon in Northern England who was hired by DePuy at various points in time to do studies for them and to teach other surgeons how to implant hips. He was one of the first surgeons in the world to start using metal-on-metal hips. He was involved with a study that DePuy was doing in metal-on-metal resurfacing (a specific way to implant a hip). Specifically, it involved the DePuy ASR, a recalled metal-on-metal hip.

Dr. Nargol told an interesting story. He started using the DePuy ASR and his patients began experiencing lots of problems. The big problem was his patients’ reactions to metal wear debris. He had multiple conversations with DePuy engineers and executives. Every time he spoke with them, they told him that he was the only one having problems with the ASR. This made him feel concerned that he was going something wrong and that all these patients having problems were his fault.

Later, as you get into 2009-2010, Dr. Nargol starts telling DePuy that there’s also problems with the DePuy Pinnacle metal-on-metal hips. He testified that when he brought up the Pinnacle he said it sort of touched a nerve at DePuy; that they took it very seriously and they came out with studies and research and a whole team of people to meet with him to try and convince him that there was nothing wrong with the Pinnacle. He said that during these meetings he was led to believe that he was the only one that was reporting problems with this device.

He also testified that some of the engineers or others at DePuy were trying to make suggestions that the patients were the cause of the problems. In particular, they speculated that maybe there was something genetic wise with respect to people in Northern England where they were having more of a reaction to cobalt than a normal person. The other thing they speculated about was whether there was cobalt in the water that patients were drinking and maybe this contributed to the reaction. Again, DePuy was adamant that Dr. Nargol was the only one reporting these problems.

During direct examination of Dr. Nargol, he was presented with numerous documents and emails that demonstrated he was not the only one having problems with the Pinnacle. The sum of these emails showed that many doctors in the United States and Italy were having problems with the hip. In particular, some of the design surgeons, the surgeons who actually were part of the group that developed the Pinnacle and ASR, had stopped using the hip because they were having problems. None of this was told to him. At one of the meetings, in 2012, there were DOH regulators that were present at the meeting. During the meeting, DePuy repeated that Dr. Nargol was the only one having problems with these hips.

So, Dr. Nargol, as it turns out, was sort of the whistleblower at the very beginning. He was the one who brought all of these issues to the attention of regulators and the medical community in general that metal-on-metal hips were not a good idea. But what you see in the paperwork and in the story that Dr. Nargol tells is that DePuy really didn’t want this story to get out. At least, this is what you get from Dr. Nargol’s testimony.

He will be cross-examined again and we will provide more updates.

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