DePuy spent millions of dollars on marketing. Their position in the case is that the marketing is irrelevant, and that it doesn’t matter what the ads say because they are false and fraudulent. They are taking the stance that doctors don’t decide what hip to implant into a patient based off an advertisement. So, Professor Drumwright was called to talk about how marketing does sway doctors and makes a difference in their decisions. She spoke about published literature on this issue. She also talked about DePuy’s overall marketing scheme.
The scheme involved paying a doctor to have a meeting with other doctors in the area, and the paid doctor would then tell the other doctors to promote and talk about the metal-on-metal hips. The problem is many of the doctors promoting the hips were receiving royalty payments upwards of millions of dollars. This was never disclosed to any of the other doctors that showed up to those meetings. There were other issues as well in regards to DePuy having medical journal articles ghost written by doctors (they write the article but remain anonymous).
Most of the day was testimony by Professor Drumwright and there was cross-examination of her. DePuy made the point that the doctors who performed the operations on the five plaintiffs were never present at the aforementioned meetings where the paid doctors were presenting; many said they never saw the advertisements for the hips. Nevertheless, Professor Drumwright pressed the point that when you are talking about devices in the medical community there is a consensus that is reached. The consensus is that when one surgeon in a surgical group starts using a certain product, word spreads to other surgeons that it’s a good product and they start using it. So, it’s the point isn’t whether or not a doctor saw an ad but if a doctor saw another surgeon who saw the ad start using the device, then that doctor might start using it too.
After Professor Drumwright, the plaintiffs called Pamela Plouhar, head of clinical research at DePuy during the Pinnacle development. Dr. Plouhar was in charge of clinical studies. A clinical study is conducted on people starting from initial implantation with a device and following their progress. DePuy used a clinical study called the PIN study. Basically, the PIN study was conducted on 1,100 patients who received metal-on-metal Pinnacles to examine the survival rate of the hips. The data of this study that DePuy paid for was used in marketing. The main statistic from the clinical trial that they reported often in their advertising was 99.9% of the Pinnacles implanted at the beginning of the study were still implanted after 5 years. The plaintiffs’ attorney went to great lengths to analyze and discuss the irregularities with that study. According to Dr. Plouhar, out of the 1,100 patients only one was revised in order to calculate to obtain the 99.9% statistic. The plaintiffs’ attorney analyzed all the documents and they found there was more than one revision occurring with those hips. At one point in the testimony, there were 8 revisions. DePuy was still using the 99.9% statistic even though they knew there were 8 revisions in this study. The point was clearly made that the 99.9% figure was false. Dr. Plouhar refused to admit it was false; she would say it was inaccurate but would not admit it was fraudulent.
There were many other irregularities with the study. One document was a case report for one of the patients in the study. The study was conducted starting with the implantation of the Pinnacle hip and subsequently the patient would follow up with the doctor at regular intervals after their surgery. The doctor would fill out a form which said the patient was seen on a particular day, the patient was doing well and calculate a “Harris Hip Score”, which essentially tells you how the hip is doing. The doctors would then submit these forms to DePuy. These forms were how DePuy kept track of the hips after they were initially implanted. One of the forms they analyzed was from a patient where the doctor implanted the hip in 2006, and there were several reports revealing the doctor had examined the patient in 2007, 2008 and 2009, and that the hip was doing great. Well, the plaintiffs’ attorney disclosed a document showing that the patient showed up at the surgeon’s office in 2010 and reported that their hip had actually been revised back in 2007, before the doctor said he had examined the patient.
The testimony and documents demonstrated that his doctor falsified data. He had falsely reported he had seen the patient and that the patient was doing well. The patient was not doing well and had the hip revised only a year after it was initially implanted.