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2016 DePuy Pinnacle Trial Update 28

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, there was more testimony from Dr. Tony Nargol. If you’ve been following our videos, you’d know that Dr. Nargol is a surgeon in Leeds, England. He was an early adopter of the DePuy ASR and DePuy Pinnacle. He was one of the first surgeons to reach out to DePuy to report that his patients were having problems, specifically reactions to metal wear debris.

During testimony, he extensively discussed a meeting he had in 2012 with DePuy and various government regulators from England concerning the Pinnacle. At this meeting, he presented data regarding the revision rates of his patients who were implanted with the DePuy Pinnacle. The DePuy ASR was recalled just two years before this meeting. Dr. Nargol reported he was seeing the same pattern with the Pinnacle that he saw with the ASR. However, DePuy presented evidence showing that the revision rate for the hip was not extraordinarily high but low and within standards. This was different than the data that Dr. Nargol was presenting. DePuy labeled Dr. Nargol an outlier meaning his revision rates were much higher than others. Dr. Nargol was concerned and felt bad. He believed he was doing something wrong with respect to how he was implanting the hips.

During the direct examination, Dr. Nargol was shown various internal documents at DePuy establishing that there were problems with the Pinnacle hip being reported by other surgeons around the world. He was asked if anyone at the aforementioned meeting had shared this information with him or the regulators. The answer was no. DePuy had not shared this information with him or the regulators. He was also presented with an internal study that was done looking at the failure/revision rate of the Pinnacle hips. This was an internal report prepared by DePuy explicitly looking at the Pinnacle. This report showed that at five years the revision rate for the Pinnacle was 14%. At that meeting, they had told the regulators and Dr. Nargol that the revision rate at five years was less than 5%. This internal document contradicted what DePuy had told Dr. Nargol and the regulators at this meeting.

After Dr. Nargol was done testifying, the defense attorney was able to cross examine him. On cross examination, the defense attorney made a point he’s made with numerous witnesses in this case. He stated that doctors implanting metal-on-metal hips knew that these hips could shed cobalt and chromium ions. They knew that the health impact of these ions was unknown at the time. So, the theme that DePuy is pushing in this trial is that doctors know the risks and if doctors decide to use a Pinnacle hip that’s on them, and not DePuy. This is a point they made multiple times.

DePuy made another point that essentially backfired. Dr. Nargol reported that DePuy wasn’t taking the situation seriously; they weren’t investigating his complaints. On cross examination, Dr. Nargol was presented with a document that detailed an investigation that occurred at a hospital in Cardiff, England. There was an email that illustrated DePuy representatives met with a surgeon at Cardiff, looked at this revision rates and that his revision rates were very low. In essence, supporting this idea that during this time period there was uncertainty as to whether or not there were problems with this hip. When Dr. Nargol was presented with this email, he responded that he didn’t believe the email. He thought the information was false because he had personally spoken with the surgeon at that hospital referenced in the email, and that surgeon had conveyed to him that his revision rates were also very high. This was a line of cross examination that really didn’t work out the way the defendants had hoped.

The defendants are not done with Dr. Nargol. They will have more questions for him in the next round of testimony. The plaintiffs will have a chance to redirect. I expect we will hear that DePuy’s theory that everyone knew metal hips would release metal particles maybe true but that no one knew the extent of the damage. Nobody knew the type of damage they could cause. Even though debris is released from all implants, metal-on-metal hips are different. They cause more damage to the hip joint. There was a lot more metal coming off this hip than anyone expected and DePuy should have been aware of these issues before releasing on the market and should have been proactive once someone raised the red flag.

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