We are fully into the defense case, the defense are putting on witnesses to try and argue that the problems with the plaintiffs’ hips were not the result of the Pinnacle metal-on-metal design that they received. They’ve called lots of expert witnesses. Today, I want to talk about one of the expert witnesses Dr. Brian Haas. He is an orthopedic surgeon involved in designing the metal-on-metal Pinnacle. He testified primarily about the evolution of metal-on-metal, and why they went with metal-on-metal. His goal was to downplay the problems that the plaintiffs had by showing that metal-on-plastic can also cause problems when the plastic deteriorates. The flaw with that logic is that the kinds of problems you have with plastic are a lot different than the kinds of problems you have with metal debris. The reaction to metal debris is much more significant. Also, how often it happens is different with the metal-on-metal hips. Metal-on-metal hips have a higher failure rate than you do with metal-on-plastic hips.
On cross-examination, the plaintiffs’ attorney went to great lengths to impeach Dr. Haas’s credibility. They focused on his relationship with DePuy over the years. The evidence that came out on cross-examination was pretty shocking. On direct examination, Dr. Haas testified that he received five million dollars in royalty payments from DePuy over the years. On cross-examination, it turned out that the number was much more than five million, upwards of ten million dollars. It was shocking how his consulting arrangement was set up with DePuy. So, there was testimony showing that he would work on what’s called a design team; there were several prominent surgeons that were called in from around the United States and they would meet at a resort. They’d have a meeting to talk about new designs for hips. All the surgeons on the design team had consulting agreements. The consulting agreements did two things: first, it allowed them to get paid for their time showing up at these meetings, and also the consulting agreements actually required the surgeons to exclusively use DePuy products in their practice.
The Federal Government and European Authorities fined DePuy for this arrangement because they considered those consulting agreements to be kickbacks to doctors. The set up for these design meetings was interesting because the doctor would show up and get paid an hourly fee; lots of money but not huge money. Then, the doctor would give their ideas on new hip designs and so would the other surgeons. At trial, it was revealed that after the DePuy Pinnacle had patented, approved by the FDA, and sold on the market, DePuy enters a royalty agreement with Dr. Haas. He gets a percentage of all hips that are sold in the United States. The consulting agreement was completely unnecessary. It really wasn’t an agreement to compensate the doctor for the work he did previously because he had already been compensated for that. It was an agreement to get him to go out, promote the hip, and sell it to other doctors. The compensation for Dr. Haas would be a percentage of all the sales. The implication from this arrangement was that it was put in place because DePuy wanted a prominent doctor to sell the hips without anyone knowing he was being paid to do so.
The other matter revealed in court was that Dr. Haas has two partners who also have similar arrangements with DePuy. One partner made thirty million and the other partner made twenty million over the years with the consulting arrangements. Another piece of evidence involved a letter that Dr. Haas wrote to the CEO of DePuy after a meeting with the design team. The letter basically discusses a meeting the design team had before the Pinnacle was launched, and it mentions that surgeons on the design team had reservations and concerns about the health impact of metal ions, and Dr. Haas mentioned conducting studies at his lab. The important part of the letter was the doctor suggesting to the DePuy CEO that if they funded the study in a certain way, through an Unrestricted Grant, the lab could report the results of the study without mentioning that DePuy was involved. The letter specifically stated if DePuy gave Dr. Haas an unrestricted grant, he could do the study without tying it back to DePuy. So, there was a lot of discussion about why Dr. Haas sent that letter, and whether or not his suggestion was ethical.
The other effective line of questioning during cross-examination included doctors weighing the risks and benefits of the hips, especially Dr. Haas and his practice. Dr. Haas was paid to only use DePuy products. He was receiving a royalty interest on all hips that were sold but he never told this to any of his patients. He would tell his patients he had a relationship with DePuy and nothing more. He wouldn’t tell them that he was required to use DePuy products and that he made millions of dollars from the company. This was another method to undermine his credibility. There was also discussion about the risks and benefits of these products, and how the risk that something goes wrong was entirely on the patient; if something went wrong, they took all the risk. The benefits all went to DePuy and the doctors. The benefit is if a hip needs revision, DePuy gets to sell another hip and the doctor gets paid for doing another surgery. All the benefits go to DePuy and all the risk goes to the patients. This theme was emphasized during cross-examination of Dr. Haas.
This case shows you what happens behind the scenes and behind the cloak of these medical device companies. We’ve also seen this in other cases and situations where sales and market share is the driving force behind decisions made by these companies. Earlier in the case, it was revealed that metal-on-plastic hips were fine and there was no reason to design metal-on-metal hips other than increasing market share. This is compared to electronic companies that come out with a new product every year to drive sales and keep people buying their products, and this paradigm has been shifted over to medical devices.