Cobalt Chromium Toxicity

depuy pinnacle hip trial

DePuy Pinnacle 2016 Trial Update 5

Hi, Stuart Talley here, doing another update on the DePuy Pinnacle trial currently pending in Dallas, Texas. We are a couple weeks into the trial now. We have Dr. Pam Plouhar, head of clinical research at DePuy, on the stand today talking about a study and clinical trials that were done on the Pinnacle hip after it was released to the market. She was subjected to intense cross-examination by the plaintiffs’ attorney about the study and clinical trials.  In particular, there was an advertisement released by DePuy that was submitted to doctors, published by medical journals, and published in media directly designed for patients. One of the key phrases in the advertisements for Pinnacle hips reads as follows:

“There were nearly a million [Pinnacle hips] implanted over 10 years. 5 years after surgery, 99.9% are still in place.”

The implications from the ad is that there were millions of hips put in over 10 years, and if you look at all the hips that were in for 5 years, 99.9% of them were still in place. Today, we learned this is not entirely accurate. In fact, it’s blatantly false. The study they used to support that statement was called the PIN study. Dr. Plouhar was responsible for that study. The PIN study didn’t look at the million hips that were implanted; it looked at about a thousand hips that were implanted over a short period of time. When DePuy states the hips are still in place, well, the study doesn’t look at how many hips were still in place. These Pinnacle hips have multiple parts: stem, ball, cup, and inside the cup is a liner. The PIN study only looked at the number of hips that were replaced with respect to the cup. So, if the cup had been removed, that was considered a failure under the study. When they supposedly looked at all these hips, a thousand that were implanted, there was only one hip where the cup had been removed. However, it turns out, there were many hips requiring revision but they did not involve removing the cup. Many times the way a Pinnacle hip is potentially revised if the patient has metallosis is replacing the liner within the cup. So, there were a lot of revision surgeries that took place but they did not involve removing the cup. This study that said there was a 99.9% statistic was only looking at removal of the cup.

As the trial progressed, we learned there were many problems with that study. It was false when the study announced there was only one cup removed. There were lots of cups that were removed, much more than one. Another issue with the study, is DePuy told everyone in the medical community that this was a “prospective study”. A prospective study follows a group of similar individuals who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome, over a period of time. In this case, it means you bring potential hip patients into a doctor’s office, you enroll them into the study, they have an initial surgery and you follow their progress.  A prospective study is important because if it is not a prospective study then there is a risk the doctor could cherry pick patients; meaning the doctor could say, “I think this hip works great on this patient. I am gonna put them in the study.” But then if someone comes in who is possibly overweight or has other medical problems, the doctor could say, “I won’t put that person in the study”. So, by informing the public it was a prospective study, DePuy was announcing that it was a reputable study; all patients requiring a hip implant would receive one, despite their different factors, and they would be enrolled in the study. It turns out, many of the patients who were implanted with the hip were not admitted into the study. Rather, DePuy had admitted people into the study who were already implanted months before the study began. This was a serious case of cherry picking.

The other submission made in court was the way this study was drafted. This study was presented at the American Association of Orthopaedic Surgeons (AAOS). However, even though DePuy was the author of this study, there name was not on it. There are emails at DePuy, once the study was completed and the results of the study were drafted, between executives wondering who would be the author of the study.  There are email chains back and forth between DePuy executives where they are wondering who would be the best author for this study that they had already drafted. Once they decided the author, minor edits were made and then it was submitted. This is a classic problem that occurs in the medical device community and pharmaceutical industry where you have companies using scientific literature to sell their products. But the companies do not inform the doctors or the patients that the cited and published studies are actually funded by the companies and the final results are drafted by the company. The plaintiffs made a good showing that this was occurring with DePuy.

From the very beginning, this PIN study was a marketing study. DePuy was not researching and analyzing how good their product was and how they can improve or change it. They did not have some scientific inquiry on how to better their product but instead this study was the brain child of the marketing department. They wanted to do the study in order to gain market share. There are emails from the DePuy marketing department showing them asking how much it would cost to do the study, approximately $400,000, and then there was an analysis of how much the study would increase sales. There is a memo demonstrating the study would cost a certain amount but then generate millions of dollars in sales.

This is currently the progress of the case. We have a situation where the manufacturing of this hip was dominated by the marketers at DePuy. This is not unusual considering the CEO of DePuy was a marketer; he worked his way from marketing to CEO. The culture of this company is one where sales are the driving force.

DePuy Pinnacle 2016 Trial Update 2

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the ongoing DePuy Pinnacle metal-on-metal hip trial that is currently taking place in Dallas, Texas. This cases involves five separate plaintiffs who allege they were injured as a result of metal debris that was being released from these metal-on-metal hips.

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.

DePuy Pinnacle Trial Update (Week 5 9/29-10/2)

The defendants filed their second Motion for Mistrial on Saturday, September 27th. On Monday, September 29th, the defendants finished cross examining Scott Bayley, an economist. He was followed by John Paoli, the plaintiff’s husband. Two additional witnesses will take the stand: Dr. Greg Sawyer, a tribologist, and Dr. Vicki Colvin, a cell biologist.  The Defense called Dr. Scott Nelson, an orthopedic pathologist, as their first witness. Plaintiffs will continue their presentation of their case at a later date.

Dr. Scott Nelson, defense orthopedic pathologist, returned to the stand for continued direct examination on Tuesday, September 30th.  He was then cross examined, subject to redirect, and excused.  His testimony was followed by defense witness Dr. Pat Campbell, UCLA Professor of Orthopedic Surgery.  She returned on Wednesday, October 1st, and took the stand for the day. She concluded her testimony on Thursday, October 2nd. Defense witness Dr. Matthew Henrich, an orthopedist specializing in hip and knee replacements, followed. His testimony was halted and the plaintiffs called Dr. Vicki Colvin to the stand. Dr. Heinrich will return to the trial at a later date.

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