January 28, Morning Session:
Plaintiff continued with the video depositions excerpts from Magnus Flett, a former DePuy employee in the marketing department who headed the failure mode and effect analyses performed on the ASR.
An email was introduced from Chris Hunt, a bioengineer, regarding health hazard evaluations of the ASR.
- Q. And he indicates here in this email that a health hazard evaluation is outstanding with respect to the ASR; is that correct? …
- A. Yes.
- Q. If you read the entire e-mail, it indicates that the health hazard evaluation relates to ASR loosening; true?
- A. I think that you’re right, yes, ASR loosening rationale.
- Q. In 2008, you oversaw the committee that was responsible for getting the message to the surgeons about the ASR, were you not?
- A. That was part of my – that was part of my role, yeah.
- Q. And if a health hazard evaluation makes a determination that there is a health hazard with respect to a product, certainly you would have some responsibility in getting that message to the surgeons; correct?
- A. I expect to see the output of that.
Plaintiff’s attorneys then went on to introduce Mr. Flett’s deposition testimony regarding Project ALPHA, the secret code name for a redesign project of the ASR, intended to make safety changes. Mr. Flett admitted in an email that he believed by October of 2008, that DePuy was “under pressure” from the Australian Joint Registry and stated, “…showing a higher than normal failure rate for Corail and XL heads (and we can respond to this) and also the data from Tony Nargol looks bad for ASR, especially the small sizes. Here we have significantly inferior performance to that of the BHR … And Graham agrees we are starting to look weak in smaller sizes…Based on the projected costs, E&O instrument costs, it’s likely – it’s looking like it will not stand up.” It was noted by Plaintiff’s counsel that there was no mention of anything other than costs and business reasons for why the redesign might not go forward.
Mr. Flett also admitted that in Fall of 2009, DePuy had already announced commercial rationalization of the ASR, which was simply a euphemism for slowly taking a product off the market, and was done so, in Magnus Flett’s words, “for business reasons.”
Plaintiff then called Dr. George Samaras, a medical device engineer and testifying expert, to discuss the design effects mode analysis of the ASR and how DePuy did not do so appropriately.
During Dr. Samaras’ direct examination, Plaintiffs introduced an exhibit showing DePuy failed its own safety test and then rather that fix the device, changed the test. In his explanation, Dr. Samaras stated, “Well, ‘at least as good’ means that it is identical to – it’s less than or equal to. ‘Similar’ allows it to be close to the same, but it could be more…[t]hat violates the international standard on medical device quality management systems. It’s – their design input was ambiguous and incomplete…it’s horrible practice. That’s not what good engineers do.”
Dr. Samaras further testified that the initial results of the ASR overall performed something on the order of 16 or 17 times worse, meaning the amount of metal that wore off during that testing process was 16 or 17 times more than their previous product. When asked what DePuy should have done upon receiving these results was the following, “[w]hat I tell my medical device manufacturing consultants when they encounter something like this is stop and go fix the design because, obviously it’s no good.”
In wrapping up whether DePuy was acceptable in their risk analyses performed on the ASR, Dr. Samaras stated they violated every fundamental engineering principle regarding risk management.
Michael Zellers, of Tucker Ellis then cross-examined Dr. Samaras. Mr. Zellers’ argued on cross that DePuy compared the 63mm size ASR to other DePuy hip products on the market that had good clinical studies. He further argued that because those other sizes had a decent clinical study it was a reasonable conclusion that the ASR 63mm was not any worse than the other devices. Zellers also questioned the fact that Dr. Samaras essentially determined that his expertise was better than the DePuy individuals.
Next, Plaintiff’s counsel called to the stand, Dr. Brooke, Mr. Kransky’s medical doctor for a period of time. Dr. Brooke practices general orthopedic surgery.
One main issue related to Dr. Brooke’s testimony was whether he believed Mr. Kransky had an infection, which could in turn support DePuy’s argument that they are not liable for Mr. Kransky’s damages. When asked why Dr. Brooke and another physician, Dr. Linderman, tested for infection, Dr. Brooke stated that he tested Mr. Kransky not because he believed he actually had an infection, but rather to disprove any theory of its existence.
Dr. Brooke also stated that he believed Mr. Kransky needed to have a revision given his left hip pain and elevated cobalt serum level. When asked why Dr. Brooke himself did not elect to perform the revision surgery he responded, “[i]t was my opinion that this hip revision was going to be difficult, a lot of blood loss. We weren’t sure what we were going to find, and that with his co-morbidity, that is, you know his cancers and whatnot, that he was at high risk to have repeat surgery. I think he told me that was his concern also. I think I mention in my note he was reticent to have something done. He was afraid of dying.” Dr. Brooke also mentioned several times in his deposition excerpt that Mr. Kransky had very high levels of cobalt, and believed the revision surgery was absolutely necessary.
Following the direct examination of Dr. Brooke, Plaintiff’s counsel called Dr. John Baron to the stand.
Dr. Baron is an epidemiologist, someone who studies disease patterns in humans. He testified as to his opinion on whether the ASR XL exhibited a higher revision rate than a typical him implant from 2003-2010. He found that the ASR XL did in fact fail at a higher rate.
On defendants’ cross-examination, Mr. Zellers pointed out that while Dr. Baron’s studies looked at the ASR’s higher revision rate, there are several reasons for a revision surgery. Mr. Zellers also questioned Dr. Baron on his expertise in epidemiology, rather than general orthopedic practice.
To read articles related to the trial please click the links below:
When J&J Learned of Implant Problems
Documents Show J&J Concealed 40% Hip Implant Failure Rate
J&J’s Hip Device Not Defective, Designer Testifies
Court Documents Show DePuy Knew Nearly 40 Percent Of Its Hip Implants Failed Within 5 Years