Day 8 of the Kransky trial resumed the live testimony of Mr. Graham Isaac. Plaintiff’s counsel then played excerpts of the video deposition of Paul Voorhorst. Mr. Voorhorst has been the most senior biostatistician at DePuy for almost twenty years, which includes the entire lifespan of the ASR device.
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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Plaintiff’s counsel began the day by playing an excerpt from the video deposition of a DePuy compliance manager, Jimmy Smith. Mr. Smith has worked at DePuy for 13 years. During that time, his job performing internal audits included an audit of the ASR. He also worked as manager of those engineers who supported the design and manufacture of DePuy products. Mr. Smith explained that when there is a health hazard evaluation for something such as cup loosening in the ASR, it is not considered a routine audit, but triggered by something out of the ordinary occurring.
Plaintiff’s counsel walked Mr. Smith through the design failure modes effect analysis, or “DFMEA,” which allows a design team to document what is known and suspected about a product’s failure modes before completing the design, and then allows that team to design out or mitigate against potential causes of failure. When asked if this was done with the objective for patient safety, Mr. Smith responded that it was simply a risk management exercise. When asked again if the purpose was to identify these failure modes before the product is ever put into people he responded, “the purpose is to identify risks and identify detection methods.”
Describing the employees that failed in their duties in this respect, Plaintiff’s counsel directly asked Mr. Smith, “And so in your review you found that Magnus Flett had committed a number of errors in his design failure modes effects analysis, the work he had done before the ASR was launched; right?” to which Mr. Smith answered, “There are a number of inadequacies in the design FMEA that was performed.”
Plaintiff’s counsel then called to the stand Graham Isaac, a development manager for the ASR XL. Mr. Isaac admitted that when DePuy marketed the ASR in 2006, the company did not know what a “safe” level of metal debris was in a human being. Mr. Isaac also admitted that if DePuy had written in the brochure that the company didn’t know what a safe level was, that would have been the truth. That information was not published in DePuy’s brochure.
Plaintiff’s counsel then discussed testing of the ASR with Mr. Issac. Only one cup size was tested (55). The method was that of simulator laboratory testing. The ASR was only tested at the “optimum” implantation angle, 45 degrees. It was not tested at any other degree of implantation.
Mr. Issac admitted that it was DePuy’s job to look for all of the ways the product could fail, and to test for those ways. He also admitted that DePuy had never made a device with these precise features. The ASR was the first monoblock, cobalt and chromium cup that included an inserted ring. Mr. Isaac acknowledged that DePuy had never made a cup like this before and that because of this, it was critical to identify all the ways in which it could hurt people.
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Plaintiff’s counsel payed video excerpts of the deposition of Mr. Andrew Ekdahl, the now president of DePuy. During the course of of the ASR’s lifetime, Mr. Ekdahl was a top marketing executive within the company. He testified that the ASR was recalled because it did not meet clinical standards. When asked whether the product was recalled because it was unsafe, Ekdahl testified the device was recalled because it did not meet clinical standards. When asked whether he thought the ASR was unsafe, he testified the device was recalled because it did not meet clinical standards. When asked whether he thought the ASR was hurting too many people, he testified the device was recalled because it did not meet clinical standards.
Ekdahl then testified that it’s his position that “patient safety should not be related to sales concerns.” He said that has always been his position and that he has instilled that notion in all of the people working at DePuy as long as he has worked there.
Please see the link below discussing the testimony of Mr. Ekdahl:
January 29th Morning session:
Plaintiff’s counsel continued their case by playing a video deposition excerpt of Dr. Thomas Vail, a member of the surgeon design team who helped to design the ASR and also received royalties from the sale of the device. Dr. Vail admitted that DePuy did not notify him beforehand that they were recalling the product. When pressed on the issue of whether he believed the ASR to be defective, Dr. Vail would not answer the question but only state repeatedly “I’ve not used the term ‘defective’ to describe the ASR product.”
Next, Plaintiff’s counsel called to the stand Dr. Craig Swenson, an orthopedic surgeon, to testify about his experience with the ASR XL. Our own John Gomez performed the direct examination. Dr. Swenson took the jury through a “Hips 101,” explaining to them how that area of the body functions, when a hip replacement surgery is needed, how it is performed, possible consequences, and what can cause a need for a revision. He then went into detail about his experience with the ASR XL, the revisions he has performed on his own patients, and his beliefs regarding the efficacy and safety of the device. He described that he has a very high failure rate among his ASR patients and that in his opinion, the angle of implantation (one defense DePuy argued early on) did not matter with regards to the failure rate.
Dr. Swenson explained that some of his patients experienced pseudotumors and other soft tissue masses. He further explained, “It’s a soft tissue mass which goes down and communicates with the joint. The body has tried to – the movement of the parts of this hip, I believe, is generating metal particles, and the body’s responding to these metal particles by trying to contain them. Since the particles keep coming, the body responds by making fluid, and you develop this cystic getting bigger and bigger…But as the mass gets bigger, it displaces the normal tissue. The hip capsule gets destroyed by the mass. The muscles around the hip – in his case, the external rotators got destroyed by the mass, but in other patients the abductors have been destroyed by the mass, and in other cases, the bone and other muscles have been destroyed by the mass.”
Dr. Swenson went on to describe various ways the ASR has failed, including “bone removing injury” and very high metal ion levels in the blood due to the prosthesis wearing and grinding away. He also described the numerous symptoms his patients with the ASR experienced, including limping, grating, grinding, popping, and squeaking. To date, Dr. Swenson has put in 206 ASR hip implants. He has revised 70 patients, knows of 4 patients that have been revised by other surgeons, and has another 4 scheduled to perform a revision. His next ASR revision is this upcoming Monday.
Mr. Gomez then presented Dr. Swenson with a picture of a brochure by Johnson & Johnson and DePuy, which claimed a success rate of 99.2 percent at three years. Dr. Swenson recalled seeing such a brochure. When Mr. Gomez asked him if that was his experience with the device he answered “[n]ot at all.”
Dr. Swenson also testified as to what information he was told by DePuy while he was using and implanting the ASR in his patients. He was not told of the concerns about edge/rim loading, that in 2007 DePuy’s testing indicated the ASR would produce 16 times as much metal wear as compared to other hip implants Dr. Swenson was already using, that an DePuy engineer named Chris Hunt identified a number of these design flaws and suggested a redesign, or that Project ALPHA was a code name for a redesign project that was ultimately abandoned.
Trial ended in the afternoon, with Dr. Swenson’s direct examination to continue tomorrow.
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:
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Co-Counsel Michael Kelly, of Walkup, Melodia, Kelly & Schoenberger, delivered Plaintiff’s Opening Statement.
January 25th Morning session:
Mr. Kelly gave Plaintiff’s opening statement, walking the jury through DePuy’s original design of the ASR XL, the lack of testing done on the device before placing it on the market, and ultimately the severe harm Plaintiff Loren “Bill” Kransky suffered as a result of these actions.
He discussed how the ASR XL was put on the general European market in 2004, in Europe, Spain and India. And that as early as 2005 DePuy started to hear “noise” of questions and problems with the device. Mr. Kelly explained that the jury would hear evidence that, rather than deal with the news of these problems, DePuy and Johnson and Johnson blamed these problems on the implanting doctors’ technique, stating “and you will hear as we go forward that every time there is a problem the Johnson & Johnson response is to blame the doctor and claim it’s technique, to never look inward, do we have a problem with our product? The failure in the seating of the cup? Have we had a history of failures over the last year or is this phenomenon related to the wider rollout?”
Included in Mr. Kelly’s opening statement were references to documents which reflected DePuy’s knowledge of the possible risks and effects of the release of metal ions into the body of those implanted with the ASR. These documents were intended to show that despite such knowledge related to the possible risks of the ASR, DePuy decided not to hire a toxicologist to study and learn more. The jury also heard evidence that Graham Isaac, a scientist working for DePuy wrote in an email to other employees “Yesterday we were given some clinical data which compares metal ion levels between the BHR [a similar metal-on-metal orthopaedic hip implant which the ASR was in direct competition with] and ASR. It shows that under certain conditions ASR is susceptible to extreme metal ion levels, but in the hands of the same surgeon, the BHR doesn’t have that problem. The concern, it has the potential to seriously affect our business.” Mr. Kelly followed up that email with the comment, “There is no mention in this email anywhere, which you’ll have in evidence, of a concern about the potential of hurting people.” Parenthetical explanation added.
Mr. Kelly went on to explain that DePuy for a short time considered redesigning the ASR XL to eliminate some of its most dangerous features, but that the program was given the code Project Alpha so as not to alert doctors and hospitals of these safety changes. Upon examining the costs of redesign, and considering current sales, the redesign program was later cancelled because, as Mr. Kelly put it, “the business case for the project could no longer be justified. There was no mention, no analysis of the number of patients who might go on to still get the device and suffer the elevated ions and the excessive metal.”
Mr. Kelly also discussed whether Bill Kransky had an infection before having his hip removed. DePuy’s primary and essentially only defense is that an infection was the reason for Mr. Kransky’s revision (a revision is the replacement of a hip implant), that an infection is not caused by a hip implant, and so DePuy is not liable for these related damages. Mr. Kelly introduced evidence from Mr. Kransky’s revision doctor who testified that he did not see any signs of infection in Mr. Kransky’s hip.
The opening statement ended with the request for a substantial award for what Mr. Kransky endured, as well as punitive damages.
Alexander Calfo for the Defendants DePuy and Johnson & Johnson followed up with his opening statement to the jury. In sum, he stated that the cobalt and chromium in the ASR did not poison Mr.Kransky, that the ASR was thoroughly tested and researched before it was implanted in people, and that Mr. Kransky’s illnesses and medical condition were not caused by the ASR.
January 25th Afternoon Session:
Former Depuy employee and head of the failure mode and effect analyses performed on the ASR, Magnus Flett’s video deposition excerpts were played. Flett agreed with the need to make sure any new product put on the market should be safe stating: “You need to understand as best you can the risks that you see, the failure modes that you see and any mitigation you can do to risk those.”
Flett also admitted that in these failure mode analyses, the effect of the implant loosening to the point where a revision was necessary was something to be avoided.
When pushed on the lack of clinical trials performed on the ASR itself, Flett stated that they looked at the clinical history of “equivalent” products:
- Q. You didn’t have any comparable products that used a monoblock cup with this specific under-reaming requirement, did you?
- A. We had an equivalent product in Durolac that we believed to be the same, same geometry, same morphology.
- Q. So its your testimony that your group decided that you would rely on the experience with Durolac as a reasonable way to conduct a failure mode and effect analysis for the ASR monoblock cup?
- A. We relied a lot on the clinical history of the Durolac, correct.
- ….Q. And the Durolac cups themselves are not monoblock systems, are they?
- A. They’re modular systems, correct
- Q. And that’s a difference from the ASR, isn’t it?
- A. The ASR is a monoblock cup system, correct.
Further, when pushed on clinical studies with regard to testing the initial fixation, Magnus Flett agreed that although this was necessary to prevent failure and subsequent revision, not one single study was done by DePuy.
To read articles related to the ongoing trial from the New York Times, the Wall Street Journal and others please click the links below:
As the pre trial commences, new information is becoming available to the public.
An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show. […]
The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.
The Law Offices of Dean Goetz and The Gomez law firm represent Loren Bill Kransky in the first Depuy ASR XL trial in the US taking place right now in Los Angeles.
Call 858-481-8844 if you want help.
Read emerging news on the trial:
J&J Failed to Warn of Hip Implant’s Risks, Jurors Told
January 25, 2013 Bloomberg News
Trial underway in hip implant lawsuit
Los Angeles Times January 25, 2013
Maker Aware of 40% Failure in Hip Implant
New York Times January 22, 2013