Day six of the Kransky trial continued with Plaintiff’s counsel first calling Dr. Robert Harrison, whose expertise is in occupational and environmental medicine. Specifically, Dr. Harrison’s specialty is related to the diagnosis and treatment of toxic chemical exposures and he works at the University of California San Francisco medical center. Dr. Harrison explained to the jury that he has testified in the past and was testifying in the present case about toxicology, the understanding of the effects of toxic chemicals on the body. He testifies about how these chemicals affect the body.
Dr. Harrison stated that he has treated patients for high cobalt and chromium levels as a result of having the DePuy ASR hip implant. He explained that these metal particles that come from the ASR hips cause harm to a human being in two ways. The first type of damage is local damage around the hip. The local damage is the small micro debris causing the body to react locally. This damage is what is seen on the MRI by the doctor and what is seen at the time of operation. Dr. Harrision described the second type of damage as what is called “systemic damage” where the metal particles leach into the blood stream. These metal particles travel around through the blood and can have effects elsewhere in the body.
Dr. Harrison agreed with Graham Isaac’s testimony the previous day that cobalt and chromium are toxic and cause harm to the body. Plaintiff’s counsel then walked Dr. Harrison through the various harmful effects of cobalt and chromium on the body – cytotoxic, genotoxic, bone health, and kidney problems.
Defendants in their opening statement made the following assertion “So I want you to remember three things if you forget everything else. No. 1 Cobalt and chromium and the ASR hip, ladies and gentlemen, they’re not poison. They did not poison Mr. Kransky.” When asked if Dr. Harrison agreed with the statement he stated he did not, responding, “It’s just incorrect. Plain and simple. It’s incorrect to say that cobalt and chromium are not poisonous. They are most certainly poisonous. They’re toxic. We’ve known this for decades from occupational and environmental studies and contamination episodes. As I’ve explained cobalt and chromium, when they get out into the blood, those microparticles can cause really severe local tissue damage around hips. Those have been studied and published on. And potentially can cause systemic damage.”
Dr. Harrison testified that the California Poison Control Center considers cobalt levels over 7 micrograms per liter to be toxic and that a normal person without a metal-on-metal hip is typically expected to have levels below 2. Dr. Harrison also testified that in reviewing Mr. Kransky’s cobalt levels he found that at a minimum, he had levels at 53.6, between seven and eight times that which was set by the California Poison Control Center. He also explained that chromium has a normal range of 1.4 and in looking at a lab report of Mr. Kransky’s chromium levels, his was at one point 24.2.
Dr. Harrison also testified that a responsible, safety-conscious manufacturer or seller of a product that is to be used by human beings would consult a toxicologist for the “precautionary principle,” which is the idea that before a product or chemical is put out on the market, you need to show its safe by doing the proper testing, analyses in animals, human studies and trials if need be. He further testified that if he had been consulted by DePuy for the ASR, he would have advised two things: 1. that DePuy should perform a very careful and thorough analysis of cobalt and chromium toxicity and the potential that it could be a problem from this particular hip design, and 2. that if there is any possibility that these harms could be the result of the design of this particular kind of hip, that these studies should be done before it is put on the market.
Dr. Harrison also testified that as to Mr. Kransky’s various other comorbidities, whether it be exposure to second-hand smoke, smoking himself, Agent Orange exposure, hardening of the arteries, and so on, that it is his expert opinion that none of these things were related to his metal levels. He agreed that none of these things would cause the metallosis and the need for a revision.
Dr. Harrison ultimately testified that in his expert opinion, Mr. Kransky’s hip did not fail as a result of infection, but failed as a result of a toxin.
February 1st Afternoon Session:
The afternoon session resumed the direct examination of Graham Isaac from yesterday. Mr. Kelly for the Plaintiff conducted the direct. Mr. Kelly introduced an email from January of 2007. The email was authored by a manager of DePuy hip products, Paul Lewis, discussing the fact that ASR devices were sent to a Professor Morlock in Germany for review. Mr. Lewis in discussing the results of this review stated “As I understand, the edge loaded cups were on average inclinated approximately 58 degrees and demonstrated a 10 times increase in wear.” Mr. Kelly then asked about the need for concern in these findings, remarking “and the reason you would be concerned is this bearing is advertised to have the lowest wear of any metal-on-metal articulation on the market; true?” Mr. Isaac would not directly admit that he was concerned with these findings, but did acknowledge that it was among his responsibilities to be sure that that there was a sound technical basis for the marketing literature that was produced by DePuy. He further acknowledged that he was the most knowledgeable person about the bearing wear of the ASR and was involved from the very beginning to the very end, even as a member of the group that decided to take it off the market.
Mr. Kelly then discussed with Mr. Isaac that as early as January of 2007, people at DePuy were already talking about a proposed ASR shell with a different desing, one that would remove the internal groove. The groove was a cause of the excessive wear of the device.
Mr. Isaac testified that he had knowledge regarding the concept of pain accompanied by high metal ion levels in the blood in 2006. Mr. Kelly also discussed with him the fact that one of DePuy’s “key opinion leaders,” a highly reputable doctor who used the ASR notified the company as early as 2006 that he was going to stop using the device.
Q. And then he says — then he mentioned that so far he will not, in capital letters, “use ASR anymore for this reason.”
Q. Now, you got this information in June of 2006, didn’t you?
A. It came into the company, yes.
Q. And once you got this information, did you make it a point to go find out from Dr. Bom what was the problem with his patients?
A. I don’t recall whether I did directly or not.
Q. Did you get on the phone and call Dr. Bom and say, “I want to talk to you about these patients, about their angles, about their pain complaints, about their characteristics”?
A. No. I think it would have gone to the vigilance department.
Q. But you — at this point you knew more about the tribology and the design of the device than anyone in the company; correct?
A. Well, that’s correct. But I mean, I wasn’t copied on this E-mail. I don’t know when I knew about it, but it would have gone to the vigilance department.
Q. I know you weren’t copied on the E-mail, but when an important doctor who is working with you on the study quits using the product, that’s a piece of information that would have made its way to you; correct?
THE COURT: Is the process that this is a
document that would have been sent to you in the normal course of business?
THE WITNESS: This particular type of document?
THE COURT: Yes.
THE WITNESS: In all likelihood, this is something that could have come to me, yes.
Additionally, when discussing whether its would be appropriate to have individuals involved in marketing the ASR also in charge of safety and reporting (the “vigilance” department), Mr. Isaac conceded that doing so would be a conflict of interest.
BY MR. KELLY: Q. Is it possible to answer my question yes or no? It would be a conflict of interest to have marketing in charge of safety and reporting?
A. They’re not in charge of safety and reporting.
THE COURT: All right. You need to answer his question. Would it be a conflict, yes or no?
THE WITNESS: If they were in charge, yes. Yes, it would be a conflict.
In discussing the vigilance department of DePuy, Mr. Isaac agreed that if a complaint department is working correctly, it should always be as accurate as any outside registry. Mr. Kelly then introduced the fact that another surgeon who was a close friend and colleague of Mr. Isaac actually stopped using the ASR in May of 2007 because his own staff reported that his ASR patients were having much more pain than those patients with other devices.
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