So, the plaintiffs called Andrew Ekdahl, DePuy’s former CEO, to the stand. Mr. Ekdahl has a long history of being in sales and marketing. He eventually worked his way to becoming CEO of this company. There was a big emphasis on the cross-examination of Mr. Ekdahl about his marketing background, and how someone with his background was running the company as opposed to someone with an orthopedic or scientific background.
One of the things that took up a lot of the day was cross-examination concerning memos from 1995. The story that’s being told through this trial is that in 1995 DePuy became aware that other manufacturers of hips were coming out with other bearing surfaces. So, at this point in time, most hips were made out of metal and plastic; plastic liners with the metal ball. There was a push in the industry to come out with metal-on-metal hips.
In 1995, DePuy got its lead scientists together to look at these other bearing surfaces. There is a detailed memo that was prepared by DePuy’s head of science where he describes the different bearing surfaces for the hips. He concludes that metal-on-metal has a history of not being a very good bearing surface. He talks about how in the sixties and seventies manufacturers came out with metal-on-metal hips, and there were lots of problems with metal wear debris.
In this memo, he talks about how the failure rate of these hips was much higher than with metal-on-plastic, how the metal-on-metal hips were leeching cobalt and chromium, and how toxic and poisonous those metals can be compared to hips with plastic. Hips with plastic debris typically do not cause a lot of problems compared to the metal debris. In the memo, the head scientist at DePuy also says from the standpoint of innovation it makes more sense to come out with a better plastic, and modify the metal-plastic design than it does to go with the metal-on-metal design that has been shown to fail in the past. For some reason, the advice of DePuy’s head of science did not carry the day. DePuy eventually went into the metal-on-metal market with the DePuy Pinnacle, and then eventually the DePuy ASR Hip, which is recalled.
Interestingly, in the cross-examination there was also discussion about a meeting that took place with several doctors hired to come in and talk about these different bearing surfaces. There are minutes of this meeting which occurred back in 1995. The plaintiffs’ attorneys discuss how in 1995 the doctors who were consulting with DePuy indicated that a metal-on-metal design could potentially lead to litigation. So, there was this knowledge back in 1995 that metal-on-metal hips have failed in the past, that their failure rate was bad, that the danger from a metal-on-metal hip in the debris was much different, and more dangerous for the patients than the metal-on-plastic design. For some reason, DePuy chose to ignore all this advice in 1995 and went ahead with the metal-on-metal hip design. Apparently, this decision was based on market share.
There was also discussion at the trial with Mr. Ekdahl about the marketing and the way DePuy marketed its hips. DePuy spent millions of dollars on taking surgeons to dinner, go to conferences to talk about the benefits of metal-on-metal hips. The plaintiffs’ attorney went through some of the financial records in the budgets and it turns out that DePuy was actually spending more money on marketing and advertising than it was on research and development during this time period. There was a big push to get market share.
The other issue that was mentioned during trial was that the doctors, the ones who were flying all over the country getting paid millions of dollars to talk about how great the metal-on-metal hips were, stopped using those hips almost within a year or two after they started. There were some doctors who only used it for two years. They saw the problems with the hips and they stopped using it. Despite, DePuy continued selling the Pinnacle hips to the public.
At the end, there was also lots of discussion about the way the DePuy Pinnacle was approved by the Food and Drug Administration (FDA). The defendants like to make a big deal of the fact the hips were approved by the FDA, so it must be a good product. During trial, it was stated that the hip was approved through a loophole in the FDA process. It was approved via the 510K process, a process where you can go to the FDA with a product, a product substantially similar to one approved previously but has a minor modification. Essentially, that’s how the hip was approved. DePuy submitted something similar to a hip that was already approved and on the market, and the FDA rubber stamped it. So, there was no testing, no clinical trials and nothing submitted to the FDA to prove that the device was safe and effective. Instead, all DePuy had to prove was that the Pinnacle was substantially similar to something else that was already on the market. The problem is that the device that was substantially similar to the Pinnacle was eventually pulled from the market because it was defective and had problems with metal wear debris. That respective device was also pulled from the market because it was shown to be substantially similar to these hips back in the sixties and seventies that were also pulled from the market.
The plaintiffs’ attorney did a great job demonstrating the “chain of devices” that led to the Pinnacle hip. The demonstration showed all of these devices had failed in the sixties and seventies, they failed in the early two thousands and they failed at the end of 2010. This completed the testimony for the day and it was definitely a good day for the plaintiffs. The defense has yet to go but there are some really damaging documents that were presented. The 1995 memos were very good for the plaintiffs and they support the fact that DePuy really knew there were problems with these metal-on-metal hip designs before they released the device on the market.