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2016 DePuy Pinnacle Trial Update 29

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 Andrew Ekdahl provided at the trial. Mr. Ekdahl was the CEO of DePuy when the Pinnacle was released to the public and for much of the time period at issue in this litigation.

Mr. Ekdahl was asked extensively about some of the advertising that DePuy issued for their Pinnacle metal-on-metal hip cases. One of the items that shows up in a lot of the advertising is a claim that DePuy made that at “five years the Pinnacle had a 99.9% survival rate.” There’s a reference in the advertising to a PIN study. The PIN study was done to examine the survival rate of DePuy Pinnacle metal-on-metal hips. During cross-examination of Mr. Ekdahl, it came out that there was a discrepancy regarding the PIN study.

The plaintiffs were making the argument that the reference and statistic used in the advertising was misleading because of how the PIN study was conducted. DePuy had looked at revision rates of individuals implanted with Pinnacle metal-on-metal hips and they determined what percentage of those hips were revised and what percentage were “surviving” at five years. However, they did this study in a particular way different than how most studies are done. For purposes of determining whether a hip was revised, they used a definition of revision that included or only encompassed situations where the cup was removed. So, if somebody had a metal-on-metal Pinnacle implanted and experienced problems, and replaced the cup, that was considered a revision. However, with Pinnacle metal-on-metal hips that is rarely the way they are revised. In most cases, the surgeon replaces the metal liner that’s inside the cup with a plastic liner, and then replace the ball on top of the stem. This is how most Pinnacle revisions are done.

So, during the cross- examination there was a lot of discussion about what the word “Pinnacle” meant in the advertisements. The advertisement detailed the “Pinnacle System” but Mr. Ekdahl continually argued the only “Pinnacle” was the cup. So, his definition of Pinnacle as used in the advertisement meant the cup. He was trying to argue that the advertisements were not misleading because the statistics only referred to the cup not the entire system. This was a big point of contention during the cross-examination. I think overall the testimony went well for the plaintiffs. However, there will be a chance for DePuy to rehabilitate Mr. Ekdahl on redirect where his attorneys will ask him questions about the advertising.

There was also some discussion about the deferred prosecution agreement. During the trial, the plaintiffs brought up on multiple occasions an agreement that DePuy entered with various governmental entities that they would not pay “kickbacks” to doctors for using their products. At one point, there were allegations that DePuy was paying kickbacks that were described as consulting agreements or various other types of agreements in order to encourage or get doctors to use their products. There were regulatory agencies who investigated and DePuy eventually entered this agreement that they wouldn’t pay these kickbacks anymore. There was a lot discussion about that from the plaintiffs’ side. In response, DePuy moved for a mistrial arguing that evidence of this deferred prosecution agreement wasn’t relevant and that it was prejudicial and it was an effort to make DePuy look bad when there was no actual allegations that any of the doctors involved in the plaintiffs’ surgeries were receiving kickbacks of any kind. The motion for mistrial was denied by the Judge. Thus far, all motions for mistrial have been denied.

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