ALISON ST. JOHN: Do you know anyone who has had a hip replacement and if you do, you know how painful and trying hip problems can be. One company has installed tens of thousands of faulty hip replacements even after they knew that the replacement had problems. In another case that raises questions about what a company do before going ahead with the damaging product we now look at a hip replacement that has been planted and 90,000 people worldwide. And has proven to be defective. About 10,000 of those people are currently pension lawsuits. Our guests are in studio, Dr. Scott Ball with the department of orthopedic surgery at UC San Diego and has used in the DePuy hip replacement system implant in surgeries for several patients but since the news of problems has come out he has spent significant time researching the problem. Dr. Ball, thanks for joining us SCOTT BALL: My pleasure. Thanks for having me ALISON ST. JOHN: And then we have Lisa Markham, who got implanted with the device back in 2008. Full disclosure, she is a friend of a member of the KPBS staff and she's here to give us the patient's perspective, thanks for joining us, Lisa. LISA MARKHAM: You're welcome, thank you. ALISON ST. JOHN: I need to mention that we contacted the company DePuy for an interview, they declined but send a statement that reads in part, DePuy acted in the best interest of patients and decided to voluntarily recall the SRM system and in creating a program to work with patients and their health insurers to address medical costs directly associated with the recall, DePuy (inaudible) vigorously defends itself against the allegations raised in the litigation. So, Lisa I just need to start with you. You actually have to hip implant installed give us a brief description of how that (inaudible). LISA MARKHAM: It was installed in 2008 by Dr. Craig Swanson also gave testimony to the first in the world trial in Los Angeles. Last week. And he's done about 5000 hits and about 270 views, so he has some very good experience in this and I think his testimony bore out the statement that you just read by the company. And was in fact a statement issued over two years ago that has proven not to be the case and in my particular case ALISON ST. JOHN: How long did the device last for you? LISA MARKHAM: It is not a question of a lasting, it is a question of a deteriorating and the pain it causes in addition to cobalt poisoning which I received. And those levels just to give you an idea, most normal people have between .1 and .2 ppb naturally I have metals occurring in your body. I have talked to people that have had 178. I had 40,000 times the amount. I had metal coming out of my mouth and my ears were bleeding because of the metal and the corrosion of the device. But I was in extreme pain and for over two years went back inside 11 different orthopedic surgeons. Not only throughout San Diego but throughout the country. And, none of them questioned the device. Until the Australian joint registry and Barry Meyer of the New York Times kind of doubted the device. ALISON ST. JOHN: Okay thank you for that description Dr. Ball, you have used the device ASR hip replacement system as it is called. Describe how it is different from other devices of its kind. SCOTT BALL: The ASR was designed to have a larger femoral head and that goes with it, so putting this in perspective of hip replacements, back in 2000 the biggest problem that orthopedic surgeons was facing was plastic was wearing out and the plants had a propensity for dislocation maybe about 5% of patients one dislocate. So, DePuy and numerous other companies thought if we could get a metal implant that may be more wear resistant and if we could provide a very large ball that would decrease the rest of dislocation. ALISON ST. JOHN: Why someone would choose this one. SCOTT BALL: That is why a lot of surgeons embrace the technology because it seems to address the problems in other versions. ALISON ST. JOHN: Are there a lot of models on the market? SCOTT BALL: There's a lot of implants. ALISON ST. JOHN: How many of the procedures did you perform and what was your patients experience? SCOTT BALL: So I think my experience has been similar to other surgeons like Dr. Swenson's, that some of the patients seem to do fine a lot of the patients actually will do fine for a period of time before there may be accumulation of some of the metal layer debris. And not all of them are failing, there are a number that I would say properly the current estimate is about 30% or so of the ASR are going to fail, maybe a few more LISA MARKHAM: 40 to 60% actually the newest information that came out of the trail. ALISON ST. JOHN: So that is a large percentage that is pretty high, doctor before we go hired you have a financial interest in the company? SCOTT BALL: I've been doing research on metal related problems with hip replacements, not just the ASR, but other metal implants and actually I did get a grip from DePuy to study problems with metal the grant is a year old my research dates back to 2008 on the problem. ALISON ST. JOHN: You have never received any direct income from DePuy? LISA MARKHAM: There is a law that was changed on the DePuy website, all of the physicians are listed and who receives compensation and one can go look at that and see directly what Dr. Paul did receive in consulting income. For professional services in 2011 and 2012 which were double. For commercial airtime, direct expense reimbursement and meals and that is what the public can now see. ALISON ST. JOHN: So at what point Dr. Ball were you informed by the company that this was officially defective? SCOTT BALL: Their official recall I think was around August of 2010. Prior to that I think I think it was December of 2009 when the company decided they were going to no longer distribute the implant. ALISON ST. JOHN: Were you getting a lot of patients for whom it was having these very devastating side effects already? SCOTT BALL: So the problem with this is that a lot of patients are having side effects and actually don't know about it so there is a little bit of a delay between, I think that is part of the problem here is that patients were having problems and a lot of patience did not know they were having problems. I did have one patient who needed a revision prior to the recall. ALISON ST. JOHN: How did you feel as a doctor, you know, that the company did not inform you in a timely fashion about a procedure that you are doing with patients that you are responsible for curing? SCOTT BALL: I mean, I think, you know, the disclosure from their standpoint was after I had stopped using the plan. ALISON ST. JOHN: What made you stop using the plan? SCOTT BALL: I did not use it too much to begin with. As I mentioned there are numerous choices on the market of different ones to use. ALISON ST. JOHN: You stopped using it anyway. SCOTT BALL: It was something I thought have a very high risk for dislocation was usually when I would use it to get the really large all that goes with it so I did not use it too much. ALISON ST. JOHN: Have doctors been able to reverse the damage caused by the implant? SCOTT BALL: When you do the rotation it depends on how much damage there is. Sometimes the implant can cause significant local damage so it can damage the muscles, damage the bone and those things are your personal. If you can get in there and fix it before it causes a large problem, some patients I think are going to do just fine when they get revised, but if it's done a lot of damage some of the damages totally reversible. ALISON ST. JOHN: Lisa let me ask what has happened in your case? LISA MARKHAM: First of all I talked to us 575 patients I started a website that helps people. I get calls from all over the world and e-mails and every single one has told me horror stories and every single one has been in pain and they've gone to their doctors and quite frankly many of them in the beginning were very confused. They didn't know. They did not know how severe the pain is when you get this device. Think of it like an engine. It is a piston engine. If you don't put oil in and it's going to burn up inside of you, so it is not just a local damage that Dr. Paul references, but it is what induced to your body, how it changes the cellular structure, how it changes your DNA are and I've talked to many people that have autoimmune diseases now and of course the company wants to say well, you are just getting old, that what happens but none of the people had issues before the device, all they had was a bad hip. ALISON ST. JOHN: Dr. Scott, sorry Dr. Scott Ball, what are you recommending to patients who have had the hip replacement that you installed who are having problems now what do you recommend? SCOTT BALL: So I think most patients who have the device, hopefully at this point have already been looked at him the examined and screened. And again there's a lot of other metal implants on the market from the pew and other companies as well and I think that anybody with a metal implant needs to be aware that they could also have a similar type problem and in terms of screening if somebody is having pain of course that is something that needs to be investigated. Some patients do not have pain, they simply feel movement in my hip. A normal hip replacement should feel almost like a normal. You should not be getting clicking, crunching anything like that so if you have mechanical symptoms coming from the joint it suggests that it may be generating more where ALISON ST. JOHN: Lisa, I wanted to ask you, the statement from dip use as they are acting in the best interest of patients creating a program to work with them and address the medical costs associated with the recall. How is that working out? LISA MARKHAM: First of all that has not happened and that is unexpected statement that you can expect from a company like Johnson & Johnson. So, I am not surprised ALISON ST. JOHN: Johnson & Johnson owns DePuy. LISA MARKHAM: In fact, I know Dr. Ball knows and Dr. Phil (inaudible) hired by DePuy orthopedic surgeons to design this, they received upwards of the received $12,000 in royalty they never told the patients they were receiving financial incentives to put the device in. And they sent me a letter saying that it's all your fault, the same letter they sent to every patient, they blame the patient saying that it is your fault, you did something. And I have the letter to prevent. ALISON ST. JOHN: We have run out of time here but I understand there's a lawsuit currently going on in Los Angeles was could be a precedent and precedent-setting soon, so we will keep track of that and we like to thank you both for filling us in on the case. Lisa Markham, thank you LISA MARKHAM: Thank you Allison ALISON ST. JOHN: And Dr. Scott Ball of UC San Diego thank you for coming in, Dr. Ball. SCOTT BALL: Thank you for having me.
Internal documents reveal that artificial hip maker Johnson & Johnson knew there were problems with the DePuy ASR Hip Replacement System years before they recalled them.
This information has come out in the first trial against Johnson & Johnson in a Los Angeles courtroom.
DePuy declined to be interviewed for this story, but released this statement.
DePuy acted in the best interests of patients in deciding to voluntarily recall the ASR Hip System and in creating a program to work with patients and their health insurers to address medical costs directly associated with the recall. DePuy will vigorously defend itself against the allegations raised in the litigation and believes the evidence to be presented at trial will show the company acted appropriately and responsibly.
