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2016 DePuy Pinnacle Trial Update 6

Hi, this is Stuart Talley and I am here to do another update on the ongoing DePuy Pinnacle trial involving five plaintiffs. Today, we heard testimony from one of the plaintiff’s son. His son testified about how the hip revision surgery impacted his father’s life. It was very powerful testimony about how the revision surgery changed his father’s life in a dramatic way; he used to be very active, and after the surgery, had lots of problems.

Most of the day, however, was spent playing a video tape testimony of Dr. Tony Nargol, an orthopedic surgeon in Leeds, England. His office is about an hour from DePuy’s European Headquarters. Dr. Nargol was one of the first surgeons to use metal-on-metal hips. DePuy would fly him all over the world to promote the benefits of the operation and teach other doctors to implant metal-on-metal DePuy Pinnacle hips and DePuy ASR hips. Dr. Nargol discussed how he implanted hundreds of these hips. After a couple of years, he had patients following up with him and reporting lots of pain. During revision surgeries, they would find adverse reactions such as metallic fluid, black stained tissue and tissue destruction inside the hip. Other problems include release of metal particles, triggering inflammation and tissue damage. Sometimes this can lead to non-cancerous tumors. This started as a small problem for DePuy, and over time, it worsened.

Most these issues were initially reported in 2008. At the time, Dr. Nargol was reporting these adverse reactions to DePuy. He sent them pictures, videos and even had DePuy executives in the operating room during a revision surgery to show them what he was seeing. However, DePuy insinuated Dr. Nargol was at fault and that no one else was reporting these problems. DePuy also blamed the patients; proposing a hypothesis that his patients were hypersensitive and allergic to these hips. DePuy even went on to state it was the environment of Leeds, England. Dr. Thomas Schmalzried, a co-inventor of the hips, gave a lecture where he hypothesized there was something in the water that made people from Leeds suffer problems from the hips. The truth is DePuy was getting reports all over the world from other surgeons who were having problems with these hips. This was demonstrated during trial; there were emails and reports from numerous orthopedic surgeons reporting adverse reactions with the hips. DePuy’s response was blaming the doctor and the patient.

One of the most shocking revelations during testimony today regarded Dr. Nargol in 2012. At this time, Dr. Nargol was experiencing all these problems. He had implanted hundreds of these hips and he estimates that approximately nine percent of them required revision surgery, five years after the initial implant. Dr. Nargol, DePuy executives and the Medicines & Healthcare products Regulatory Agency (MHRA), the European equivalent of the Food and Drug Administration (FDA), had a meeting in 2012. During this meeting, Dr. Nargol explained that he thought the revision rates for these hips was nine percent. However, DePuy explained via their own internal documents that the revision rate was only four percent. They said Dr. Nargol was an outlier and placed blame on him. At the trial, it was revealed that DePuy’s internal documents showed the revision rate at five years was not four percent but 14%. DePuy knew these figures and never presented this data during the meeting.

It was a powerful day for the plaintiffs. The testimony divulged that DePuy was warned about adverse reactions in 2008, and they tried to sweep it under the rug. We are getting closer to the end of the trial.

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