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2016 DePuy Pinnacle Trial Update 7

Hi, I’m Stuart Talley here to do another update on the DePuy Pinnacle hip trial that is currently ongoing in Dallas, Texas. Today, we had more testimony from Dr. Tony Nargol. You may recall from my last update that Dr. Nargol is a surgeon in Leeds, England who was involved in early efforts to use metal-on-metal hips. He was a big proponent of Pinnacle and ASR hips, which was subsequently recalled. Dr. Nargol reported problems with these hips back in 2008. DePuy said he was the outlier, and that no other issues were reported, and essentially blamed him for poor surgical techniques.

At the trial, Dr. Nargol spoke about the joint registry. In England, and other countries, the government buys the prosthetic hips that are implanted in the respective country. They have laws requiring every surgeon to enter information into a database about every hip they implant and every time they have to revise a hip. The government examines this data and create reports about which hips work best, and which are problem hips. He described interesting facts about the National Joint Registry in England. A board of editors analyzes the data from the registry and release an annual report. Dr. Nargol revealed that a DePuy executive is on the board of the National Joint Registry in England.

At the beginning of the case, DePuy spoke about how the Pinnacle hip succeeded on the joint registry. Dr. Nargol explained the reason the Pinnacle succeeded was because of the three different kinds of inserts that can go into the cup. Not all Pinnacle hips are metal-on-metal; some are metal-on-plastic and other metal-on-ceramic. Now, when they did the registry and kept track of the performance on the Pinnacle hips, they didn’t differentiate between the type of bearing surface; the metal-on-metals were combined with the metal-on-plastics, which was the vast majority of Pinnacle hips implanted. So, the data showing the revision rate for the Pinnacle, was not accurate and did not indicate the true success rate for the metal-on-metal Pinnacle. The data DePuy mentioned at the start of the trial was inaccurate, and misleading in many respects. In 2013, DePuy separated the data between the different Pinnacle hips; the new data revealed the metal-on-metal Pinnacle hip had a significant failure rate. It was eight times more likely to fail than the metal-on-plastic. However, the data on the registry showed a low revision rate was because the metal-on-plastic lowered the average.

Dr. Thomas Schmalzried was the other witness we heard. Dr. Schmalzried is an orthopedic surgeon in Los Angeles, and co-inventor of the DePuy Pinnacle and DePuy ASR. He was a big proponent of metal-on-metal hips. He was a consultant for DePuy who traveled around the country, and spoke at meetings about the new design and different kinds of hips. He was paid a royalty for every Pinnacle and ASR hip that was implanted. There was testimony regarding the fact Dr. Schmalzried never disclosed the royalty payments when he spoke to other surgeons about the hips. Dr. Schmalzried made millions of dollars from the Pinnacle and ASR. At trial, it was revealed that the exact amount he made from these hips was 24 million dollars. He earned additional sums from the work he has done for DePuy with respect to these hips as well as the litigation work. Even after the ASR was recalled, and after the Pinnacle was removed from the market, he’s made a lot of money being involved in the lawsuits.

Dr. Schmalzried discussed and insisted he was merely a design surgeon; he only helped design the hips. The plaintiffs’ attorney wanted him to admit he was involved in the marketing of these hips and not solely the design. He would not admit he was a marketer for DePuy. So, the plaintiffs’ attorney went through multiple documents which revealed Dr. Schmalzried’s detailed discussions with the marketers at DePuy regarding how to sell more hips. He was involved in and helped draft the marketing and promotional materials that went to patients. During his testimony, there was attention concerning the speeches he gave before the DePuy’s salesmen. DePuy had an annual meeting and he presented information about the Pinnacle and ASR hips. The speech discussed how they could sell more, what tactics to employ, and what responses to give to doctors if they questioned them about the hips and their problems.

The theme of the day, and throughout the trial, was DePuy putting profits over people. Another theme involved how the metal-on-metal hips were not designed to help patients but to make more money. Throughout the day, there was testimony from plaintiffs and plaintiffs’ doctors discussing how the revision surgeries have impacted their lives. For some of the plaintiffs, it has been dramatic. There was powerful testimony about how the hips have adversely affected the plaintiffs’ lives

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