Part two of the Mangus Flett (MF) interview by the plaintiffs (These notes are summaries with some quotes.)
Attorney: In 8/4/06, one of the highest priorities was to get metal ion data out to the sales people correct?
A discussion ensued about why the data was not released from the internal tests that were being conducted on metal ions. The attorney asked why they were not released and MF confirmed that is was not because the results were bad (high blood levels of ions that they were trying to conceal) but rather the results were "spurious."
The plaintiff lawyer made sure that he confirmed if any adverse information was found, it would be incumbent on Depuy to release it to the surgeons which MF did agree with as long as the data was first studied internally. [Seems as though this line of questioning resulted in something contrary to what MF indicated he might do with information from this study.]
The discussion then moved on to a study which was apparently being conducted comparing the ARS to the Pinnacle hip, both of course are Depuy hips. MF asserted that he didn't know anything about the details of the study but confirmed he knew of the study.
Attorney: Would it have been helpful if the surgeons knew that the revision rate found in that study was 8xs higher for the ASR than the Pinnacle at the time?
MF: I don't believe that to be clinically relevant.[ He offered that the rate was low so placing an 8 x multiple on that was not really material.]
Attorney: was there a "Dear Doctor" letter delivered?
MF: No. There was one delivered in 2010.
Attorney: In 2008, you oversaw a committee that was responsible for getting information to surgeons right?
Attorney: In 10/08, did you not state that you were "under pressure from both Oz (the Australian joint registry?) and Tony Nargol ( a surgeon in England who was one of the early observers of the ASR issues) to answer questions re the issues with the ASR?
[2008 is 2 years prior to the recall.]
Attorney: And Graham Isaac [Depuy person] agrees in an e-mail "we are starting to look weak in the smaller sizes[heads] right?
Attorney: And then this e-mail goes on to suggest that the ASR redesign might be cancelled due to cost? Do you see that?
Attorney: Then you say, "there are certain things we must do." and you listed them. #3 says we must reexamine the bearings portfolio. Given the small size of the cups, we need to put in place an option for patients who need this option." Do you see that?
Attorney: So, things must be done and it is October of 2008. The "To do" list contains things like cup placement, update the surgical technique etc. These aren't ORs AND you must find a replacement for the small cup true?
MF: Yes we have to find an option for patients who need this option
Attorney: At any time during 10/28 and two years later, when the recall occurred, did you ever tell the surgeons to STOP using the ASR and switch over to the Pinnacle?
Attorney: Did you ever tell the Surgeons:
- Pinnacle was an excellent alternative?
- Revision rates were 8 xs higher with the ASR?
- Australian registry had evidence of high revision rates?
- There were complaints about Pseudotumors from Surgeons?
MF: I can't tell you at what point we would have been in a position to declare this information
Attorney: Can we agree that had this information been imparted to the surgeons, they would have switched?
MF: I just told you I did not agree with the information as you presented it [he alluded to the fact that 8 x's a small number is a small number, that there were ongoing conversations with Tony Nargol's observations of Pseudotumors in his patients.]
Attorney: Is it accurate to say that the ASR was singled out as the cause of high revisions and the Pinnacle was not?
Attorney: At any time between the time that you wrote the e-mail stating that "we must find another alternative to the small cups" in 2008 and the recall in 2010, did Depuy ever tell the surgeons to STOP using the ASR..we have another option which is the Pinnacle?
MF: I don't believe we did.
They moved to another subject
Attorney: Is this an e-mail in April of 2009 from the director of international marketing executive at Depuy to Mr Isaac and cc'd to you?
Attorney: Does it say: "Urgent travel required to Australia, ASR communication to address..... the Depuy monoblock cup issue.....a road show is required to meet with key surgeons and salespeople?"
Attorney: And did you go?
Attorney: Does this e-mail say, "MF met with 18 heavy users and had discussions with them about the importance of cup positioning and patient selection?
Attorney: Can we agree that there was insufficient evidence at the time to indicate that the revisions in Australia were due to either the surgical technique or patient selection for the ASR?
MF: look at my presentation from that visit [unclear to me whether this question was answered.]
Attorney: You talked about low clearance right? and this low clearance implied decreased wear right? and that was all a part of the marketing for ASR right?
Attorney: In 2009, Depuy purchased a company called Finsbury right? and you were a part of the team that identified the opportunity right?
Attorney: And one of the products in that acquisition was the Adept product which was targeted to replace the ASR right? by late 2009, you had announced you would not continue selling the ASR correct?
MF: Not sure of the timing on the replacement but we would discontinue the ASR.
Attorney: From 2003-2010, Depuy had continued to market the virtues of low clearance of the ASR correct?
Attorney: And now you want to sell the surgeons higher clearances with the Adept?
Attorney: In the Adept Q and A in this exhibit, there is a question: " Would the increase clearance levels of adept increase the ion levels?" and your answer was : "There is some evidence that increased clearances result in marginally increased ion levels during the run in phase however, there is no evidence to suggest that the differences are clinically significant." Is that what you wrote?
MF: yes, that's what I wrote.
Attorney: And when you bought Adept for resurfacing, Adept had a lower revision rate than the ASR right?
MF: yes, I think so.
Attorney: so the other questions in the QA were addressing Commercial rationalization-slowly removing a product from the market. What is commercial rationalization?
Attorney: So in the process, some patients may require resurfacing so you would use the Adept product right?
Attorney: And you made the assessment that it was safe right?
Attorney: it says in this e-mail that Adept has a better brand and has a proven clinical history in the registries right?
MF : yes
Attorney: Do you recall why the ASR failed?
MF: Things that were mentioned were taper corrosion, acetabular fixation, rim ware.
Attorney: Which was the major cause?
MF: I don't know.
Attorney: Do you recall earlier in the day we talked about the internal study comparing ASR and Pinnacle right? ...and it looks like there was an e-mail proposing that the study look at all of the things we just discussed right?
Attorney: Then it looks like there is a response from you that says: "Guys, this study seems like suicide to me...you will prove that one of them is better than another" which means that one was worse than the other.
MF: I think they did the study anyway but I don't know if the details of the study were published. [Recall the opening question in this interrogatory above.)
Attorney: Would this information have enabled a surgeon back in 2007 to decide whether to use the ASR or the Pinnacle?
MF: It would have given a good comparison between the two products.
End of MF testimony.
Well, it seems clear in my mind that MF was well aware of the issues with this hip and Depuy did not release any of the data that would have prevented more ASR's being used in patients for at least 2 years prior to the recall.