Andrew Ekdahl, former CEO of DePuy, was on the stand again. He was CEO when the Pinnacle hip was developed. During cross-examination of Mr. Ekdahl, there was a lot of startling admissions that were made by him throughout the trial and a lot of interesting information was revealed. First, the plaintiffs’ attorney was able to get Mr. Ekdahl to admit that when the Pinnacle metal-on-metal hip was released to the public, DePuy had no idea the health impact of metal ions released from the head. There were a series of documents back in 2000 and 2001 where engineers and doctors working for DePuy were having some concerns about metal ions released from the hip. Mr. Ekdahl admitted they sold the product for many years without knowing what the true health impacts were.
Another line of questioning went into the safety of the Pinnacle. One of the defenses DePuy has brought up is that the reason the failure rate and the revision rate for the Pinnacle is so high is because of lawyer advertising. They’ve painted this picture that there’s ads on television and that people with perfectly good hips ran to their surgeons and asked to have their hips revised because they saw it on television. The plaintiffs’ attorney did a good job defusing that entire line of defense. The reason the hips were being revised and the reason DePuy stopped selling so many was due to so many problems with the hips.
There was a series of articles and medical literature during 2008 through 2010 calling into question metal-on-metal hips. There was also a series of newspaper articles describing problems with these hips and the fact that doctors had to revise them. And so the idea that the Pinnacle was taken off the market because of lawyer advertising and because of people getting unnecessary revision surgeries was invalidated. There was a slew of evidence that the reason doctors stopped using the metal-on-metal hips was because they were having problems with them.
A different line of questions that took place was shocking. It involved DePuy’s conduct with a ball called the A-sphere. The story told at trial was that in 2008 lots of doctors were calling into question metal-on-metal hips. So, 2008 through 2010 articles are released indicating metal-on-metal may not be as safe as the manufacturers would have us believe. Internally, DePuy was concerned about these articles. DePuy came up with a plan to create a new ball and call it the A-sphere. They would then tell the medical community that this new ball was much better than the old ball because it greatly reduced metal wear debris. So, they came out with the A-sphere and there was a series of emails between marketing and engineering where they are discussing the A-sphere ball. In those emails, it becomes clear that the A-sphere was no different than the other ball and it was purely a marketing trick. There is an email from an engineer saying why don’t we take the old balls and change the name because it’s the same thing. That line of questioning was shocking and you were able to see behind the scenes of how marketing and profits drove a lot of the decisions of this company.
During opening statements, the defense attorney made a lot of comments about how DePuy and Johnson and Johnson are great companies. The judge ruled that opened the door for the plaintiffs introducing evidence they aren’t good companies. One of the key pieces of evidence that was introduced with Mr. Ekdahl is called a deferred prosecution agreement. Back in 2006 and 2007, DePuy was in trouble because they were caught paying bribes to surgeons to use their hips. The FBI investigated and eventually DePuy entered into the deferred prosecution agreement. So, they agreed to change their practices and not bribe surgeons anymore. They acknowledged that they were doing it and they took responsibility for it. As a result, the attorney general agreed not to prosecute them criminally. Mr.Ekdahl was asked about the deferred prosecution agreement but he refused to acknowledge any of the facts in there. When he was asked whether DePuy paid bribes to doctors and surgeons he said that they didn’t. And when he was asked why he was not taking responsibility, he didn’t have an answer.
There was a lot of advertising for the Pinnacle about a 99.9% success rate. They were telling doctors and advertising that there was one study where they put in 3,000 of these hips and none of them were revised when this was false. The defense argued during openings statements that these advertisements really don’t matter. They argued doctors do not rely advertising; when they make medical decisions they rely only on the science. During the cross-examination of Mr. Ekdahl, the plaintiffs’ attorney was able to show that DePuy spent millions of dollars on advertising. They had a sales force that would go out and advertise and try to get doctors to use their products. They also spent millions of dollars during the 2008 Olympics on direct-to-consumer advertising; television ads, newspaper ads and magazine ads using Coach K as their spokesperson. Coach K never actually had a DePuy Pinnacle hip but they used him as a spokesperson anyway. So, if advertising doesn’t matter, why was doing spending so much time and money doing it? Mr. Ekdahl was unable to answer these questions.
The final part of the day concerned medical research that had been done. There was a point in time about concern with metal-on-metal and the impact of metal ions on patients. There was a series of emails between the people at DePuy and a surgeon in the medical community who agreed on performing a clinical study. He would do a study with individuals to show how the Pinnacle hip compared to other hips. The interesting part of the emails was how Mr. Ekhdal and the researcher discussed how they would structure the funding of the study so if the study came out negatively, DePuy could claim they had nothing to do with the study; if it is a DePuy funded study, and it has negative results, DePuy has to live with that. But if it’s a study without an association to DePuy, and it is negative, they can criticize it.
These emails and testimony revealed this company is guided by sales and profits more than the safety of their devices and the benefit and welfare of patients.