Andrew Testa for The New York Times

A faulty Articular Surface Replacement, or A.S.R., removed from a patient in 2010.

By BARRY MEIER

Published: November 12, 2013

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by Christy Rakoczy, a J.D.

Manufacturers of hip and knee replacement products made many promises to consumers.  This is especially true of DePuy Orthopaedics, Stryker, Zimmer and other manufacturers of the new generation of joint replacement products largely marketed as medical devices that would last longer and provide more flexibility than traditional joint replacement solutions.

Unfortunately, the marketing for many of the new hip replacement products may have turned out to be a lot of hype. In fact, many of the hip replacement products that came on the market in recent years not only fail to last longer but actually appear to have higher failure rates and may cause serious complications for many patients.  The extensive problems that patients allege they’ve experienced has even caused Consumer Reports to call for a “lemon law,” on replacement joints.

Consumer Reports Calls for a Warranty On Artificial Hips and Knees

Consumers Union, the policy arm of Consumer Reports, argues that medical device manufacturers should give consumers a warranty on hip and knee replacement products, promising to replace the medical devices at no costs.  This suggestion comes at a time when as many as 20 percent of all hip replacement procedures and 10 percent of all knee replacement procedures each year are revision surgeries that are necessary because of problems with the implanted artificial joint.

Consumer Reports believes a warranty would both be fairer to patients who need to undergo repeated surgeries and would prompt medical device manufacturers to make sure their products are safer and more durable.

While this idea has merit as a method of protecting customers, unfortunately a warranty may not be enough. Those whose artificial joints fail often experience significant pain and serious medical complications. A no-cost revision surgery wouldn’t compensate the victims of defective medical devices for these other losses, but a product liability claim can and does allow patients to take action for defective hip and knee replacement devices.

Patients Have Rights When Hip and Knee Products are Defective

A large part of the reason revision surgeries have become so common in recent years is that many of the newer hip replacement products are metal-on-metal devices that were brought to the market under a special FDA rule.

The FDA’s 501(K) clearance rules allow manufacturers to produce and sell medical devices with a fast-tracked approval process and minimal testing provided there are substantially similar devices on the market already. Unfortunately, many of the devices brought to market under these rules have now been recalled when it turned out the products weren’t so safe after all.

DePuy Orthopaedics, for example, instituted a voluntary recall of its ASR™ Hip System after data from a UK joint replacement registry indicated a higher-than-average failure rate. The Stryker Rejuvenate and ABG II Modular-Neck Hip Systems were also recalled because of high failure rates.

The FDA continues to review the safety and efficacy record of metal on metal hip implants. The agency continues to receive adverse event reports with regard to the devices.  Commonly alleged problems include:

• Aseptic loosening
• Infection
• Bone loss
• Metallosis (a/k/a “metal poisoning”)
• The formation of pseudo tumors
• Decreased range of motion and limited mobility
• Pain

Patients who experience these complications deserve to have the manufacturer of their defective device pay for revision surgery.  This is not all they deserve, though, and a warranty allowing for a no-cost revision procedure doesn’t go far enough. Victims whose lives are affected by defective medical products should also be compensated for time missed from work; for pain and suffering; for emotional distress and for any reduction they experience in their quality of life.

Bio:

Christy Rakoczy, a J.D. from the University of California, is a legal writer and advocate for consumer rights and patient safety. You can read more of her work on the Stryker hip implants, including recall information, complications, and ongoing legal action, at strykerhiprecall.co.

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• CIHI Study Reveals Problems with Metal-on-Metal Hip Implants (earlsview.com)

On July 18, 2013, the Canadian Institute for Health Information (CIHI) released the results of a study aimed at examining the longevity of artificial hip implants. Researchers studied outcomes of more than 59,000 hip replacement surgeries performed in Canada between 2003 and 2011. Data was included from all the Canadian provinces, with the exception of Quebec.

Researchers found that patients who were implanted with a large-diameter modular metal-on-metal hip implant device had a 5.9% chance of needing revision surgery within five years after the original procedure. Patients who received other types of hip implant devices had a 2.7% chance of requiring revision surgery during that same time frame.

Cost of revision hip replacement surgery

According to researchers, cost and recovery time for revision surgery is much higher and much longer than patients’ original hip replacement surgery. CIHI says that patients having revision surgery remain in the hospital 17% longer and pay 45% more than they did during their initial hospitalization and rehabilitation.

Who gets metal-on-metal hip implants?

The majority of patients receiving metal-on-metal hip implants were men under the age of 55. Similar numbers have been found in studies conducted in Australia and the U.K. The metal-on-metal implants were originally marketed to this patient demographic, since they were highly touted for their increased mobility and durability.

“Metal-on-metal hip replacement implants were generally considered to be the most suitable implants for younger, more active patients who were traditionally at higher risk of repeat surgery due to the wear and tear they place on the implant,” Dr. Eric Bohm, orthopedic surgeon from the Concordia Hip and Knee Institute, was quoted as saying in the Canadian Institute of Health report.

Unfortunately, the choice to go with a metal-on-metal hip implant did not prove beneficial for some of those patients, as complications with the implants resulted in pain, reduced mobility and the need for subsequent surgery. In addition, CBC/Radio-Canada recently reported that some patients receiving these implants suffered tissue damage around the joint, after metal particles entered surrounding tissue and the bloodstream.

Legal trouble for makers of hip devices

In 2010, Johnson & Johnson issued a worldwide recall of its iconic metal-on-metal stars, DePuy ASR XL Acetabular System and the ASR Resurfacing System. A few short months after the recall was issued, the first class action lawsuit involving DePuy devices was filed in Quebec Superior Court.

Complaints about the devices include misalignment, loosening of the joint, dislocation, fracture, and metal debris around the joint. Plaintiffs have claimed that DePuy was aware of the potential problems with their devices, but refused to pull the devices from the market before patients were injured by the implants.

It is estimated that as many as 4,000 DePuy ASR hip implants have been used in Canadian patients. Over 37,000 of the devices were implanted in patients in the United States where the device manufacturer is also facing widespread and growing litigation.

Devices remain in wide use

Researchers in this recent study primarily focused on the large-diameter modular device. These devices feature a metal ball that fits inside a larger-than-normal metal socket. The purpose of the design was to improve mobility in younger, more active patients. Unfortunately, some surgeons have found the design is also more sensitive to malposition, which can increase the risk of metal particles rubbing off the device and entering the bloodstream.

The use of metal-on-metal hip implants appeared to peak between 2007 and 2008, but has been gradually decreasing since that time. Researchers in this study found the metal-on-metal devices only represented around 10% of the total number of devices examined. Metal-on-plastic devices were used in nearly three-fourths of the surgeries studied, and continue to be a popular choice for surgeons and patients today with seemingly fewer complications.

Bio:

Lance Andrews writes for Injury Lawyer News, where he reports on the effects of dangerous drugs and medical devices as well as recalled products. He is committed raising awareness about these issues to protect patient safety and consumer rights. His unique point of view comes from a combined education in journalism and medical studies.

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Eighteen months later, I was diagnosed with level one chronic lymphocytic leukemia.

I had every test imaginable regarding the leukemia and there were chromosomal abnormalities or deletions; however, never having a baseline study, it would be a stretch to say that there were changes.

A friend alerted me to the dangers of cobalt and chromium poisoning in 2012 and I requested the blood test, yet my surgeon did not encourage it as I was not symptomatic with hip issues. Both minerals tested were elevated but I was told they were not dangerously high at the time.

One year later, I requested to have the mineral blood test again so the results would be available for my annual appointment. Levels had risen significantly and I was having groin pain, hip pain and stability issues.

The orignial surgeon suggested a total hip resurfacing at some point, but certainly immediate surgery was not emphasized. I went for another opinion and that surgeon made room in his surgery schedule that week so that the Depuy Pinnancle could be removed.

My question is this: Are there others with metal on metal hip implants who then were diagnosed with blood cancer? I find it more than coincidental, yet when I ask medical professionals they state that there are no definitive studies linking the two.

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Stuart Cain talks about his horrific time post DePuy ASR revision.

Click here

Here is his interview/article from the SUnday Telegraph too.

Click on this link below:

Stuart Cain Sunday Telegraph Article

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I have just read with great interest Howard’s response to the letter from Smith and Nephew regarding the Birmingham hip and after my recent experiences with the ASR there is something I wanted to share with everyone. Firstly for those here in Australia, I have been interviewed for the Sunday edition of News Ltd Newspapers (Sunday Mail in Qld, Sunday Telegraph in NSW, Sunday Herald Sun in Vic, etc.) and I believe the story is going nationwide as the interview came out of Canberra, I am also appearing on the Current Affairs program “Meet the Press” on Channel 10 on Sunday morning for a panel discussion which I am led to believe (speaking to the interviewer today) is about everything from approval failures to my experiences to medical company/surgeon ethics! So as this is live it should be interesting, for those outside of Australia it should be available on the web, I will (in conjunction with Earl of course) put up any links after the event that may help everyone to view these.

But what I wanted to share and would be very interested in others experiences, is something that my surgeon told me last week and also after reading Howard’s letter response I think it is even more important. Here in Australia the peak professional body for Orthopaedic Surgeons (apparently these people are ‘independent’ of any medical company or other organisation) is the Australian Orthopaedic Association (AOA). The AOA has recently sent a memo to their members with the following directive:

“When discussing with patients the issue of elevated Cobalt/Chromium levels, please be mindful of the following points. Up until now elevated levels of these two elements have been referred to as ‘Cobalt/Chromium Toxicity’ or ‘Cobalt/Chromium Poisoning’. It is advised that in the current climate, that this should now be referred to as ‘Cobalt/Chromium Sensitivity’! In other words this ‘independent’ organisation is doing everything in their power to protect the medical companies who have produced these products by taking the inference of toxicity or poisoning out of the statement and replacing it with a ‘reaction’ type word in other words, it isn’t our fault for poisoning your bodies, it is your fault for actually daring to react to that poisoning!! Apart from being dumbfounded when I heard this, I must admit that I did very quickly become angry, I would be very interested to hear if anyone else has experienced anything such as this (remembering that I was fortunate that my surgeon shared this with me as he was ‘disgusted’ by the AOA’s actions). So as far as they are concerned the Strokes, Blood Poisoning, Kidney Failure, Poor Bone/Fracture Healing, Tissue Necrosis (death), Hearing/Sight loss/deterioration, just to name a few, are all actually our fault not theirs as our bodies reacted to the poison that was introduced to us, nothing at all to do with the fact that this stuff shouldn’t have been ‘roaming free’ within our systems in the first place!!

I hope everyone has a great weekend, I am looking forward to Sunday morning after 6 months of further declining health, pain and poor mobility I think keeping it ‘short and sweet’ will be my biggest challenge! I would be very interested to hear of others experiences regarding what I have written above and I will also be interested in feedback regarding the media stuff. I look forward to speaking to you all again soon!

Cheers,

Stu Cain

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My apologies for not getting back to anyone I owe a reply to, please feel free to remind me, the last couple of weeks have consisted of doctors, radiology, blood tests, pain and no sleep, so I have been very slack. I have been watching with keen interest what has been going on and sincerely hope that Paige is getting the assistance and recognition that she deserves! As we all do from time to time, I have taken a step back so that I could try to get my body together, unfortunately I haven’t won that one yet!!

I am sure that many of you will relate to the following scenario, but I just wanted to write about it as I am still adding it to my list of ‘firsts’ since my “ASR experience” began. In the last 3 months I have experienced more pain and decline in my health then I have for the last 6 years, and all this after I had supposedly undergone the ‘this will finally sort you out surgeries’. I am in no way being critical of my surgeon here, he has worked tirelessly in finding answers to the many complications I have faced and I retain complete faith in him. I have a fracture in my right femur (ASR Hip side) that has now been present for 18 months, despite the plate and 9 screws holding my femur together, it has decided to appear on x-ray at least to be breaking down completely, I can certainly back that up in pain and inability to weight bear! When presented with this evidence and the appearance on Bone Scans of fractures bilaterally (left and right) in both my feet, my left shoulder and also potentially in my lumbar spine, my surgeon thought it was time to seek opinion from further experts as to why my femur is degenerating and why these new fractures might be coming from. Against the background of Cobalt/Chromium toxicity and multiple hip revisions (3), my surgeon decided we needed to look at things from a ‘biological level’ and referred me to a colleague who is an Endocrinologist and experienced researcher.

This was the start of one of ‘those days’! My wife and I, after waiting the usual couple of months to get in to see this doctor (and I appreciate that we got in quickly for those of you who have had to wait much longer for medical review), entered the waiting room with a great deal of trepidation. We were called, introduced to the doctor and escorted to the consulting room. After being seated the following statement was made: “I can see you are in pain, but I see a very depressed man sitting in front of me, are you talking to someone about this”. Then turning to my wife: “I can see you are depressed too, you should be talking to someone about this”. So it began. This was our first interaction with this doctor ever, to say we were taken aback was an understatement. We had gone there seeking answers to why my health/body was deteriorating so quickly and as my wife says “I am watching my husband deteriorate in front of my eyes”, this was not what we had expected to be hearing.

We were then given a lecture about ‘our need’ to be getting psychological/psychiatric help, and that Anti-depressants mightn’t be a bad idea. It was then pointed out to me that I was ‘obese’ and that I needed to address this. I had let her go on the first part about our Mental Health thinking that she was trying to help, however I now was starting to see red as we hadn’t so much as mentioned why we there in the first place which was to try to find some answers as to why my bones are breaking and the one that is really broken isn’t healing. The ‘fresh set of eyes’ that was to review my case was now just irritating me! I was then advised that I should stop being lazy and just go to Weight Watchers so that I could do something about my Obesity! If I wasn’t depressed when I walked in the door I was now!! I was also starting to get that burning feeling of anger and resentment that I know so many of you have experienced through your dealings with medical professionals over your journeys.

We finally actually started talking about ‘how it was that I came to be in this situation’, at this point I was almost relieved to be talking about bloody hip replacements!! However I naively expected that she may have read some of the 20 odd pages of notes that my surgeon sent with my referral and referred to my Johnson and Johnson/DePuy implant merely as an “ASR”. She stopped me immediately and said, “what is an ASR?” We should have stood up and left, but stupidly we stayed on, and with much reminding me that she wasn’t an ‘Orthopod’ and not really interested in the surgical side of things, we eventually got up to what medications I was taking. Earlier in the discussion her thoughts had varied between me being on ‘too much’ pain relief, to ‘that is probably nowhere near enough’, so now we were discussing the merits of me visiting a ‘pain clinic’, but even she then admitted that they probably wouldn’t be able to help as they wouldn’t understand or know how to treat this kind of ‘experience’ or pain process.  I was also asked to explain ‘why I was taking these medications’, when I replied that they had been prescribed and that I was merely following Doctor’s instructions, I was told that I should have taken control of this and ‘known better’. Now I am a mere Nurse, I know we are all probably far more knowledgeable about our conditions than most of the doctors we speak to, but even I have to stop short of prescribing and planning my own medication routine! I feel sorry for those of you out there with no formal medical education, I wonder what she would have said to you?

Continuing in the medication, I mentioned that I take a number of natural medicines (Fish/Krill Oil, Rose Hip Extract, Glucosamine, Chondroitin, Boron etc), I was asked how much I spend on these a month? I replied about $300. I was then told I would be far better off spending that on Weight Watchers for all the good it was doing me! After completing the medication review, we finally pulled out some of the scans and x-rays I had brought along for a casual glance. When she noticed the difference of over 10 cms (approx. 3 inches) in my femur fracture in roughly a month, she thought that I had got the dates wrong as this wasn’t possible. Adding the x-rays of my fractures in both feet, I was then asked if I had been in a car accident? I pointed out that no, I hadn’t, and then she said that I must have had a fall. When this was not also true, the gravity of what she was looking at must have finally sunk in as she offered my wife a tissue (Karrin wanted to belt her over the head with the box I found out later)!

The next part of the appointment was almost ‘humane’ as she empathised with us that this was indeed a truly ‘unique set of circumstances’ in her experience. I was told that I should be in a wheelchair as ‘what am I trying to prove by walking around in pain’, I did point out that I had actually been asked to try to walk by my surgeon. This was followed up by more contradictory comments about my ‘pain threshold’ and we were nearing the end of our time together!

The things I was to take away from the appointment was that even though I had gone there looking for answers, I should realise I probably won’t get any, I should start at Weight Watchers as soon as possible ‘as it is plain that you are obese’, I needed to see a Psychologist at least ‘to help me cope’, I should stop trying to be a hero by trying to walk, my wife was also to seek Mental Health guidance as I was obviously putting her ‘through a lot’ and I should learn to ‘get over my anger with Johnson and Johnson’ as that isn’t going to help me get any better (needless to say at this point in time I firmly believed that no-one else apart from my family and I were going to help me ‘get better’)!! We are to return in 6 weeks’ time when she will have done ‘some looking into all this’, spoken to the many doctors who have treated me over the journey (all of which she seemed to know very well according to her), reviewed all of my blood tests, x-rays, scans etc. and she will have a report for us.

Needless to say I am not holding my breath, I am more determined than ever that we all have to look after ourselves as even ‘the experts’ seem to treat us all as either a: ‘broken puzzle’, ‘a novelty’ or just a ‘pain in their arse’!! I wanted to talk about this appointment as I have spoken to so many people who have had shocking experiences with Doctors and other health professionals that I just wanted to re-assure you that you weren’t on your own. I also think that this is also a very good therapy for my ‘depression’, as it allows me to vent, express and share, things which unfortunately most poor souls who suffer from depression rarely get to do and please don’t think I am in any way diminishing the terrible impact that depression has on many of our lives as we go through this horrible experience called Metal-on-Metal. Indeed I encourage any of you who are currently, have previously or are not quite sure if depression is in your life, to please reach out and talk to someone about it as I believe we are all going through enough torture without adding that type of torture to the mix. As this doctor finally said to us, “if I was in your shoes, I would probably be depressed”, not much relief at the time, but after what she had just put us through it was almost a sense of vindication.

I wish all of you the best of health at this time, I am getting away with my wife for a short break where we can’t be disturbed and just have a nice waterway to watch and can do a bit of fishing. I hope that no matter whether you are battling Johnson and Johnson/DePuy, Smith and Nephew, another manufacturer or just the failings of your own health, that you are supported and loved by those around you, because I know that without this blessing I wouldn’t be here. I keep hoping that it can’t get any worse, but sadly I don’t think I have hit bottom yet, I just need to be able to hope. To Earl, Brooks, Howard, Meg, the 2 Connies, Belinda, Mary, Paige, Morgan and all of the other wonderful people I have had the pleasure of meeting here, I hope your days are reasonably comfortable, you are ‘getting better’ and for all of us that there is some justice just around the corner!

Take Care

Stu Cain

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After losing two jury trials, Johnson & Johnson/DePuy can now celebrate the fact that a jury has ruled in its favor regarding the company’s ASR all-metal hip implant.

The company’s unexpected good fortune comes on behalf of an Illinois jury, Reuters reports, which declined to award damages to plaintiff Carol Strum. A DePuy spokeswoman commented to Reuters after the decision that the company took “appropriate and responsible” action to help Strum, including an initiative to address medical costs she faced after dealing with her initial ASR hip implant. As the story explains, Strum sued because she claimed her 2008 implant was defective and it doctors were forced to replace it three years later.

Assuming Strum’s attorneys don’t file an appeal, the outcome is a much more positive one then Johnson & Johnson’s ($JNJ) first U.S. jury trial defeat in March (in Los Angeles), which will cost Johnson & Johnson $8.3 million. And then there’s the New Jersey jury that ordered the company to pay $11.2 million to an ASR plaintiff who endured a number of repeat surgeries after the implant failed.

Read more: For J&J, a hip lawsuit trial victory – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/jj-hip-lawsuit-trial-victory/2013-04-17#ixzz2Qkl4C1KN

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Trial Judge Reduces Final Judgment in DePuy ASR Hip Case to $8.26 Million

April 2, 2013

LOS ANGELES — A California Superior Court judge has issued a final judgment of $8,260,790.85 after the recent trial in a DePuy ASR hip implant case, representing a reduction of $77,345.27 in the jury’s award of compensatory damages.

Los Angeles Superior Court Judge J. Stephen Czuleger said in issuing the judgment March 22 that the parties agreed that the $338,136.12 awarded for medical expenses should be reduced under Montana law to account for amounts payable by a collateral source.

The judgment left intact the jury’s award of $8 million in non-economic damages to plaintiff Loren Kransky.

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Doc who designed DePuy’s metal hip tells jury he wouldn’t implant the device today

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