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.