Earl's View » metal

Hanna’s Story – another Smith & Nephew BHR tale of disaster

earlstevens58 — Sat, 04 May 2013 01:12:42 +0000

My name is Hanna Viner, I am 61 years old and I live in Sydney, Australia. I had recently a left hip revision surgery from MoM BHR to ceramic THR. After subscribing to your blog and reading your very interesting articles and stories I have decided to share my experience with you. I have bilateral artificial hips. Left is ceramic THR, MoM BHR on the right side.

In October 2000 I had my first right hip MoM BHR put in due to severe osteoarthritis and 3 months after had developed a limp in the left leg and pain in the left hip. My surgeon, who was trained in BHR 6 months before my first operation, had gone to Birmingham to learn how to use Derek McMinn‘s BHR prosthesis and I was one of the first patient to receive this BHR prosthesis in Australia. Anyhow this operation was successful and help me enormously with the pain, which I had suffered for at least 3 years, I was 48 years old when I had my first operation.

Two years later in September 2002 I went and had left hip BHR inserted and this operation was not as successful as the first one. My surgeon has told me that the damage in the left acetabulum and femur head was not as great as in the right one therefore they have to insert a bigger socket and force it into the acetabulum, I think they maybe did not have the right size of the socket for damage I had there. The future CT Scan had showed an old healed fracture in my pelvis next to the left prosthesis. Anyhow i was happy to have the new hip resurfacing in and did not pay much attention to the details then.

From the beginning the left prosthesis was squeaking and made all sorts of noises while I was moving or bending, but I had a little pain and considered that ok. When I attended numerous check up visits with my surgeon I have told him about the problems but he dismissed them as normal. Over the years the noises and occasional pain were more disturbing and in 2007 my X-ray showed the lucency next to the left BHR, which again my doctor has dismissed and said that there is nothing to worry about.

So life was going on and I started having gait problem and developed excessive pronation in my feet, more severe on the left foot. I also developed bunions on both feet and I had to do something because due mainly to left foot drop I was falling while walking even on leveled ground and my feet were killing me, being very painful while walking or standing for prolonged periods.

After numerous fallings I have researched the cause for it and decided to go and see podiatrist, which of course diagnosed me with severe pronation of my feet, especially the left one. I was given orthotics and felt better immediately. I also stared to notice that the left leg was kind of weaker than the right one, but I did not pay too much attention and was living my life as normal.

Mean while this leg problems had affected my thoracic skoliosis and my shoulders were very uneven, more than ever before, the right one was now much lower than the left one. So I started paying attention to my posture. I work in the office and had to be aware the way I was sitting and using computer. My right knee developed Bakers cyst and was and is quite painful especially when I walk up the hill or up and down the stairs.

I also started being very fatigued and developed some chronic aches and pains all over my body, I had digestive problems, loss of vision especially at night and could not hear so well with my left ear. I also have done a comprehensive stool analysis test learning from it that i had some bacterias, amoebas and parasites, my immune system was already compromised and i did not know why. I was a healthy eater, non smoker and non drinker, I use to do lots of sport activities and i was very miserable, irritable and unhappy, thinking that all of this is due to menopause.

In 2009 I had an Idiopathic hemorrage in the back of my left eye,which disappeared after 4 months. My blood pressure was playing up, hot flushes and night sweets were there even I had finished menopause few years before (by the way that period of my life was a miserable one too) and I felt overall very sick. I started Chinese herbs and acupuncture treatment which somehow helped because it made my body stronger but many of my symptoms had never disappear.

Than in June 2012 I went to see my orthopedic surgeon for a check up, which was 5.5 years overdue, i should attend this check up 4 years after my las check up, it was 1.5 years overdue due to some family commitments in Poland, had to look after my elderly mother for 15 months there.

In winter 2011 in Poland I already realize that my left leg is getting weaker and weaker as I was not able to do long walks on the snow the way I was able to do it in winter 2010, but did not worry too much about it blaming the old age, I also developed thyroid problems, my TSH was climbing up and overall I looked terrible, I was swollen especially my face at the chin and neck and my hands and feet and started putting lots of weight.

When I came back to Australia I went and had all necessary blood tests including thyroid tests and tests showed a Hashimoto disease, all thyroid tests were at the normal range, but my thyroid antibodies were elevated to 208IU/mL and my cholesterol was slightly elevated and some of the liver functions as ALT GGT and ALP were elevated. This started to worry me a bit. I did hip X-rays and went for a check up. I have already read the description written by radiologist, which showed that I have some overgrowth on the femur near the left prosthesis. I had showed that o my surgeon and he decided that we need to investigate this further, he had send me for a CT scan and a nuclear bone scan and I had also requested the metal ions blood test.

We did all of that and, o boy, I had a big pseudo tumor next to my left hip, bone and surrounding tissues eaten away by metal debris and metal ions in thousands in my blood, I had no option but to have surgery ASAP so we have scheduled this surgery for hip revision for 25 October 2012. I was speechless and angry and I had no option but to go for this operation.

The operation was successfull but it was done at the lasy moment as the damage to my bone and surrounded tissue was so extensive that if I would left it unattended for a bit longer I wouldn’t have any hip left there.

My surgeon had to remove about a litter of fluid with metal debris and repair all surrounded tissue damage. I was given THR made out of ceramic with ceramic liner to last longer and with titanium stem, also he did a bone graft from my own bone scraps from the femur onto acetabulum and fix the socket there with 2 titanium screws. I was doing pretty ok after the op and after 5 days in hospital I went to rehab hospital for 2 weeks for further rehabilitation ( isometric exercises in the morning and hydrotherapy in the afternoon), this was a great help. When I got back home I have continued hydrotherapy every day of the week and it felt great. It has been over 5 months now after the operation, I do continue hydrotherapy attending sessions at least twice a week.

I went back to work 2.5 months after the operation and I am taking systemic enzymes which are helping enormously with my scar tissue and swelling, they are great, I also detox with chlorella and am taking lots of supplements to keep me going, but I am still tired and the left leg is not fully healed yet, still getting a bit painful if I will overuse it. But the range of movement is great.

I have been back to see my surgeon with new xrays on 8/3/2013, the bone has healed terrifically well and my metal ions are substantially down: chromium from 1200 nmol/l to 574 nmol/l and cobalt from 1860 to 68, still high but much, much better. During this check up I have requested a removal of my right BHR prosthesis and my surgeon was surprised by my decision asking me – why do you want to remove a perfectly good device, I had answered that this is a ticking bomb an it could be blowing up at any rime, he answered yes potentially it can. We had scheduled another revision surgery for 26/6/13. Since then I had enough time to think about it and considering the fact that my left leg is still quite weak I have realized that I may not be well enough to perform the second revision so soon, besides my lower back is playing up since the last operation which is quite normal. I have requested an MRI scan for hips and lower back and measurement of metal ions in blood every three months and if all will be good and metal ions will gradually come down (I know it is a long process, sometimes up to 2 years) than I won’t rush to have another revision surgery. So this is my story.

Dear Earl, what do you think about my decision, do you think I have to do some other checking ups in regards to my problem. I will be glad to sue Smith and Nephew for producing such a horrible device, I have made enquiries in Australia and in one law firm in America but they refused to help me because there is not class action against S&N. So I will wait until many people will come forward and do the same as I want to do. If you know about any possible law suit against Smith and Nephew please let me know.

Looking forward to hear from you soon

Kind regards

Hanna Viner

Hip Resurfacing Procedures: A Viable Alternative to Hip Replacements (orthopedics.answers.com)
Study: Metal Hip Pain and Tissue Damage – Stryker Rejuvenate Hip Implant (earlsview.com)
Walking Better: Rehab After Hip Joint Prosthesis Surgery (orthopedics.answers.com)
Hip Hip Hooray! – Austin, TX (travelpod.com)
Surgeon Says Recalled Stryker Metal Hip Implant May Fail Half the Time (earlsview.com)
Mike’s Stryker problems ruin his life (earlsview.com)
Introducing Hip Resurfacing: A Minimally-Invasive Alternative to Hip Replacements (prweb.com)
Am I Too Old? Too Young for a Hip Replacement? (stpaulhip.wordpress.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Acetabulum, artificial hips, Australia, BHR, Derek McMinn, Health, hip, Hip Replacement, hip resurfacing, hip revision, Medicine, metal, surgery, Sydney

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

earlstevens58 — Sat, 06 Apr 2013 23:06:35 +0000

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

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

April 3, 2013 by Arezu Sarvestani

The lead physician designer of Johnson & Johnson subsidiary DePuy’s recalled metal-on-metal hip implant tells jurors that he wouldn’t implant the device today.

Johnson & Johnson’s (NYSE:JNJ) subsidiary DePuy Orthopaedics’ 1st defense witness in a lawsuit against its recalled metal-on-metal hip implants testified before a jury that, as an orthopedic surgeon, he would not implant the ASR XL hips in patients today.

Dr. Thomas Schmalzried was among the lead designers of the ASR XL implant, which DePuy pulled from shelves in August 2010. He testified on behalf of DePuy and J&J this week that the devices were properly designed and developed, but noted that he wouldn’t recommend the implant today were it still on the market, Law360.com reported.

Schmalzried has been something of a wild card in previous testimony as well, leading some to speculate as to whether his presence helps or hurts DePuy’s case.

Last month, amid the 1st DePuy ASR XL hip lawsuit to go to trial, Schmalzried testified that he had no knowledge of the so-called “vigilance department” that was designed by company policy to collect and monitor all complaints for the metal hip implants. He added then that he no longer implants metal-on-metal devices, according to the legal blog of medical device injury lawyers Maglio Christopher & Toale.

That 1st trial concluded in a jury verdict against J&J and DePuy, and $8.3 million in damages awarded to patient Loren Kransky. The new trial is taking place before Judge Deborah Dooling in Chicago’s Circuit Court of Cook County.

US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
DePuy ASR Hip Recall Website Launched by Bernstein Liebhard LLP to Keep Public Apprised of Ongoing DePuy ASR Litigation (prweb.com)
Peter J. Flowers, Chicago Trial Lawyer Begins Local DePuy ASR Trial (prweb.com)
DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)
DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
DePuy Pinnacle Hip Lawsuits: Bernstein Liebhard LLP Notes New Order in Federal DePuy Pinnacle Litigation (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: California Superior Court, circuit court of cook county, defense witness, DePuy, Food & Drug Administration, Hip implants, Hip Replacement, Johnson, judge deborah, Los Angeles, metal, Zellers

Study: Metal Hip Pain and Tissue Damage – Stryker Rejuvenate Hip Implant

earlstevens58 — Sat, 06 Apr 2013 22:39:08 +0000

Study: Metal Hip Pain and Tissue Damage – Stryker Rejuvenate Hip Implant.

Study: Metal Hip Pain and Tissue Damage

The annual meeting of the 2013 American Academy of Orthopaedic Surgeons (AAOS) in Chicago has just concluded and doctors delivered a mixed report on metal-on-metal hip replacements.

In a study presented from New York State’s Hospital for Special Surgery (HSS), researchers found unexplained pain in metal-on-metal (MoM) hip implant patients is more likely due to tissue damage surrounding the prosthesis rather than wear of the implant.

Hip Replacement

HSS is ranked nationally No. 1 in orthopedics by U.S. News & World Report and researchers wanted to know what caused the increasing number of unexplained pain complaints that eventually lead to hip revision. Among the 9,000 hip implant procedures done by HSS annually, 10% are revisions.

Researchers compared 50 patients who had unexplained pain to a control group of 48 patients who came to HSS with infection, fracture misalignment or loosening of the hip. They measured adverse tissue reaction to metal ions and conducted a wear analysis on removed implants.

Among the group with unexplained pain, 60% had moderate to high rate of tissue reaction and 12% had a buildup of metal ions in soft tissues. The age, sex, body mass, size and length of the implant did not seem to explain pain and patients in both groups had similar wear on the implants. Some patients had a lot of tissue damage, but that was not related to wear, suggesting other factors are causing the damage.

When metal hips were introduced, the industry thought MoM hips were a positive innovation in their ability to remain well-lubricated which minimizes wear, but the thousands of lawsuits filed by injured patients tell another story.

Metal-on-metal hip implants have unique risks. In a MoM hip, the ball and socket is made of metal, usually chromium and cobalt. The metal components can come in contact during walking or running which can release metal particles around the implant, the tissue and surrounding muscles. The scientific community believes the metal ions causes damage that is irreversible and can lead to an early revision of the hip implant.

The suggestion is for doctors to closely follow hip implant patients with unexplained pain before there is significant tissue damage.

AAOS members also sang the praises of a total hip replacement (THR) concluding itincreases the life span and reduces the risk of heart failure, depression and diabetes among the 43,000 Medicare patients with osteoarthritis that were studied.

The study was undertaken to determine the cost-effectiveness of THR treatment seven years after implant but the findings reveal that hip recipients cost Medicare $6,000 more than non-THR patients.

Article Source: http://www.strykerimplantrecall.com/2013/04/04/study-metal-hip-pain-and-tissue-damage/

Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
Stryker Rejuvenate Hip Recall Lawsuit News: Updated Information for Stryker Hip Implant Recall Lawsuits In State & Federal Courts, Provided By Alonso Krangle LLP (prweb.com)
Stryker Revises Estimates Upwards As To Expenses Related To Defective Rejuvenate & ABG II Hips (prweb.com)
Signs Your Hip Implants Are Hurting You (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
Hip implant patients with unexplained pain likely to have tissue damage (medicalxpress.com)
Hip implant patients with unexplained pain likely to have tissue damage (eurekalert.org)
US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Stryker, Stryker ABGII Modular Femoral Stem, Stryker Hip Implant Recall, Stryker profits, Stryker rejuvenate hip, Stryker Trident Hip Recall, Stryker Trident Hip Replacement System, Total Hip Replacement Tagged: American Academy of Orthopaedic Surgeons, Chicago, Health, Hip implants, Hip Replacement, hip replacements, hip revision, Hospital for Special Surgery, Medicine, metal, metal ions, Patient, U.S. News & World Report, UNited States

Stuart Cain Reports – A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same!

earlstevens58 — Sun, 17 Mar 2013 21:09:53 +0000

A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same!

My apologies for not writing for some time! I have been following the progress of the many brave people who have been using Earl’s awesome blog and I continue to admire every one of you who have been able to speak up and even more so, those of you who are unable to share but use the site as a communication tool and information gathering service! I implore all of you to continue to speak out and seek answers, as I have found out (as has Howard, Bob, Brooks, Earl, Meg, Anna, Connie and so many others) these answers are often not there to be discovered, but if we all continue to push the medical world, the device manufacturers, governments and regulators, they may actually realise the importance of this and provide the funding to the researchers who are crying out for the opportunity to look into this terrible situation. My best wishes for 2013 to all, mine hasn’t started very well but I hope that the following will give each of you renewed vigour and the strength not to accept mediocrity in your treatment by the device manufacturers or the medical world!

Thanks to Johnson and Johnson/DePuy, Smith and Nephew and all the other companies that pushed MOM (Metal-on Metal) technology into the market place our lives will never be the same. Not only for the current issues that each and every one of us is experiencing, but for those that are going to continue to develop until we all die. I wanted to share with you my latest ‘issue’ and let it be a warning that there are darker days ahead for many of us who are yet to find out the true impact of what these implants and their associated ‘side-effects’ are doing to us.

I don’t know what each person was told, but I was assured that this ‘Rolls Royce’ of implants would allow me as a young person (37 at the time of implantation), to go back to my previous level of activity (with some obvious limitations) and that it would last longer than the alternatives. This was probably where the biggest mistake was made (apart from using the bloody thing in the first place). After 3 revisions of the hip, the insertion of a plate and 9 screws to hold my femur together and of course the painful rehab associated with this, I am now in a worse condition than I was before the initial implant. I know many of you will relate to this (30 operations now isn’t it Howard!). I almost wish the suspected infection that they thought was in my bone actually was there this week as even though it would suck, the treatment was possible! Unlike the ‘holding pattern’ I have been placed in whilst the medical world try to come up with why my health has deteriorated to the point that it has!

My ‘ASR experience’, as Johnson and Johnson/DePuy like to refer to it as, has come crashing down on me in the last week. After a rapid deterioration in my health over the last 2 months I had an x-ray which showed that not only had my 15 month-old fracture in my femur not healed (as it previously appeared to finally be), but it has now increased in size and ‘crossed’ over 2 of the screws in my femur. This has occurred during a month where I was virtually chair and bed bound as I had incredible pain, increasing fatigue without actually being able to sleep and couldn’t weight bear without a great deal of assistance. I had also developed intense pain in the foot on the opposite side to the implant, pain in my opposite shoulder and lower back. After a series of blood tests (to rule out infection), Nuclear Bone Scans and CT Scans, it is confirmed that I have ‘stress fractures’ in my foot and signs of developing fractures in my shoulder and lower back. No, I wasn’t in a car crash, these ‘fractures’ have developed ‘spontaneously’ as described by my surgeon. In his words: “how can an otherwise healthy individual (not counting my destroyed hip of course) develop stress fractures, especially when you haven’t been doing anything”.

In the absence of research and evidence (as no-one either has the funding or genuine interest, or if it has been done is too damning for us to see!) on the effects of Cobalt and Chromium toxicity on the body, my surgeon after seeing ‘some very interesting side effects’ in his other patients firmly believes that we are now starting to see the true effects of Cobalt and Chromium toxicity in the human body. He also notes that it is an interesting correlation between the higher levels of side effects in those people who were more ‘active’ after being implanted with a MOM device. I should note that my surgeon has never used any MOM technology as he felt when it was released that it wasn’t tested and investigated enough for not only its long term sustainability but also for the possible side effects that it may create. This was on the basis of research in the 1990’s and early 2000’s into the ‘wear’ of such devices and how there was little evidence of what this ‘wear’ might do to the patient. It is amazing that the very small number of surgeons, such as him, are now given almost ‘charlatan’ status now if they have the courage to speak out amongst their own colleagues about MOM implants, I am sure that Dr Steve may well appreciate this!

So now as I enter a new week of more doctors and tests, the ever-present company of pain, not being able to walk without crutches and the mental anguish of not only ‘not knowing’ where to turn from here, let alone what effect this is having on my wonderful wife and amazing family, I want all of you to be aware that there is so much more that none of us are aware of about the effects of MOM implants and as I have now experienced, the medical world have even fewer answers when it does happen! I even approached Johnson and Johnson/DePuy direct to see what they are doing about research into the effects of these devices, surprisingly they were more concerned about the multitude of pending legal cases than what these wonderful devices will continue to do to us patients as long as we live! I implore each and every one of you who have had a MOM implant (or your loved ones) to monitor your health with diligence, as I found out it isn’t just the area of concern (your implanted hip/s) that you need to consider, this poison can hit you anywhere! I should have known as part of my ‘initial’ raft of side effects was a very rare form of anaemia caused by of all things “heavy metal poisoning”, this is a systemic problem we all need to be aware of now. Please also remember, the removal of the offending device is not the ‘end of the road’ as far as your problems go, if you had a recognised toxicity to Cobalt or Chromium, or even one that wasn’t investigated, the damage has been done, we are all just waiting to see now how that damage presents to us all!

I would be very interested to hear from anyone else, who has had problems with either poor fracture healing after Cobalt/Chromium toxicity or of course the development of ‘random fractures’, I also encourage anyone who has had any as yet ‘unexplained’ side effects to please let us know as I would like to try to develop a data base of any side effects that have or may be attributed to Cobalt or Chromium toxicity. I have tried to see if such a list exists and I am yet to find one (please let me know if I have had a ‘boy look’ and missed it if it does indeed exist), although I suspect that as many of these effects are only now coming to prominence that a list would be inaccurate anyway. I would be very interested to hear if anyone has had any luck with any sorts of treatments (western or eastern medical, alternative or otherwise) to do with their complications from their MOM implant so that these can be shared to the wider group.

I hope that everyone has a better week! I am going to fight to get to the bottom of this in my circumstance as to be honest I am truly scared of where this might lead and I think my family have suffered enough through all of this without having to sit back and watch me slide even further into the mire of declining health! I am very aware that there are many of you out there in a worse position than me so please don’t think I am in any way diminishing your experiences, I can only imagine what you are going through and lend my support in any way I can! I am also determined that regardless of compensation payouts and court cases, that Johnson and Johnson/DePuy, Smith and Nephew and any other ethically challenged medical device manufacturer is truly held to account for what has happened to each of us and apparently what is continuing to happen to each of us! I encourage you to keep up the fight, share your experiences with us or at the very least seek answers to any questions regardless of what people (especially doctors who may have a reason (financial or conscience) to keep you in the dark) try to tell you, if you don’t believe them or have doubts about the answer/s you have been given look elsewhere until you are satisfied!

One final thought: “Hope is the essence of life, no-one can live without hope!”, this Buddhist quote is one that I wear (literally) around my neck every day, I think that we can all draw some strength from it as I believe it is vital to us all getting through this (although it has been sorely tested in the last couple of weeks!! J).

Take Care, Stuart Cain

Metal-on-metal hip replacement toxicity | NPS MedicineWise (earlsview.com)
FDA cracks down on all-metal hip replacements (earlsview.com)
Biomet M2a Metal Hip destroys 46 year olds life… (earlsview.com)
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
Expert Witness Says Hip Implant Harmless (polymersolutions.com)
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (earlsview.com)
J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: chromium, chromium toxicity, Cobalt, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Earl, Health, Hip Replacement, hip resurfacing, hip revision, Johnson, Johnson & Johnson, metal, Metal on metal hip, Smith & Nephew

VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com

earlstevens58 — Sat, 09 Mar 2013 06:47:08 +0000

Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com.

VICTORY & JUSTICE:

J.&J. Loses First Case Over Faulty Hip Implant

By BARRY MEIER

Published: March 8, 2013

A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.

The 12-member panel, however, declined to issue punitive damages, saying the company’s DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in mid-2010.

In a statement, the company described the verdict as “mixed” and said that it planned to appeal the damage award. It disputed the finding by the jury that the A.S.R. was defectively designed.

It was impossible to say what the verdict, which came in a Los Angeles state court, would mean for other A.S.R.-related cases. A trial on a second lawsuit is scheduled to begin Monday in Chicago, with other cases expected to proceed later this year.

In its decision, the panel ordered Johnson & Johnson to pay the case’s plaintiff, a retired Montana prison guard, Loren Kransky, $338,000 to cover his medical expenses. It also ordered him to be paid $8 million to cover his pain and emotional suffering.

Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve.

Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.

The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.

It was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use in the United States in standard hip replacements that used the same cup component as the resurfacing device.

However, the A.S.R.’s design caused the cup and ball to strike against each other as a patient moved, resulting in the shedding of metallic debris. That debris inflamed and damaged tissue and bone, causing pain and, in some cases, permanent injuries to patients.

Today, all-metal hips like the A.S.R. are rarely used by surgeons because most models suffered from similar problems. But data from orthopedic registries suggests that the A.S.R. was far worse than many competing products.

An internal Johnson & Johnson document introduced at the Los Angeles trial estimated that close to 40 percent of patients who received an A.S.R. will need to undergo a second operation within five years of the first to have the implant removed and replaced. In a recent filing with the Securities and Exchange Commission, Johnson & Johnson said that there are 10,750 A.S.R. lawsuits.

Traditional artificial hips, which are made of metal and plastic, are expected to last 15 years or more before needing to be replaced, and the normal replacement rate for early unexpected failures is about 5 percent after five years.

The lawsuit heard in Los Angeles was not originally scheduled to be the first over the A.S.R. but it was moved up because Mr. Kransky was found to have terminal cancer. Before the start of the Los Angeles trial, which began in late January, Mr. Kransky’s lawyers had not expected him to live through it.

Internal Johnson & Johnson documents that became public during the trial indicated that company executives were told by surgeons, who were also paid consultants to the device maker, that the design of A.S.R. was flawed. In addition, some surgeons also urged the device maker to slow sales of the implant or stop them completely, records show.

In the case, evidence was also presented that showed that Johnson & Johnson considered redesigning the A.S.R. to reduce its problems, but then abandoned the project because the implant’s sales did not justify the costs of the redesign. One of the DePuy executives involved in that decision was Andrew Ekdahl, who now heads Johnson & Johnson’s orthopedics division.

Johnson & Johnson executives like Mr. Ekdahl have said throughout the A.S.R. episode that they acted responsibly and moved to recall the device in 2010 when data from an orthopedic registry in Britain showed that its failure rate was higher than normal.

Before reaching its verdict Friday, the jury that heard Mr. Kransky’s case deliberated for more than five days. Mr. Kransky’s lawyers, citing what they described as the unethical behavior of DePuy executives in failing to warn doctors and patients of the device’s defects, asked jurors to punish Johnson & Johnson by awarding their client $36 million to $144 million. Jurors declined to do so.

Nonetheless, lawyers representing Mr. Kransky hailed the verdict.

“This is a victory for Mr. Kransky and thousands of other badly damaged A.S.R. patients who have yet to get their day in court,” Brian Panish, one of Mr. Kransky’s lawyers, said in a statement. “Jurors across the country will return similar verdicts until J.&J. takes full responsibility.”

A DePuy spokeswoman, Lorie Gawreluk, said in the company’s statement that it planned to appeal Friday’s verdict, contending that the A.S.R.’s design was not defective.

The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
Damages awarded in J&J’s DePuy hip implant case (wfaa.com)
Parker Waichman LLP Weighs-In on $8.3 Million Verdict in DePuy ASR Hip Implant Trial (prweb.com)
Johnson & Johnson to award security guard $8.3m over faulty implant (guardian.co.uk)
Recalls-R-US… Johnson & Johnson Confirms Inquiry Into Hip Devices – NYTimes.com (earlsview.com)
DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
Johnson & Johnson Pays Out $8 Million In Lawsuit (huffingtonpost.com)
Jury awards damages in Johnson & Johnson hip case (kfwbam.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: Chicago, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Kransky, lawsuit, Los Angeles, metal, Metal on metal hip, metal-on-metal hips, metallosis, New York TImes, science, Smith & Nephew, UNited States

Metal on Metal Hips – New Video • Lampkin & Co Solicitors

earlstevens58 — Tue, 05 Mar 2013 21:24:13 +0000

Metal on Metal Hips – New Video • Lampkin & Co Solicitors.

Metal on Metal Hips – New Video

Posted by Lampkins Admin on Mar 5, 2013

Metal on Metal Hips – Understanding the Problems

We have released a new information video to help people understand the problems associated with the failure of their Metal on Metal Hip implants.

Watch our information video

In this video, we use animated graphics to illustrate what happens inside the body when the Metal on Metal Hip implant begins to fail. We’ve aimed at making it easy to understand and Mark Lampkin talks about the problems and how they can cause various issues throughout the body without any unnecessary medical or legal language.

Lampkin & Co Solicitors are leading the way on legal action in the UK regarding Metal on Metal Hip products that are failing and we are now representing a cohort of over 100 clients.

Many of our clients had heard about problems with Metal on Metal Hip Replacements but were not sure exactly what was happening. It’s estimated there could be around 50,000 people affected in the UK so we are quite sure there will be thousands more patients in the UK that don’t fully understand the problems and thus, the potential harm to their health.

If you’ve had or know someone that has had a Metal on Metal Hip procedure after 2004, contact us for advice. You can download our fact sheet on our Metal on Metal Hip page.

Please help spread the word so other sufferers can be helped – feel free to share this page via email, Facebook or Twitter.

These posts may also be of interest

High Failure Rate For Metal-On-Metal Hip Implants
Lampkins offering advice following widespread concern as research confirms high failure…
Metal Hip Implant Patients Need Life Long Checks
Lampkins specialist legal team already representing metal hip implant patients ahead…

Inportant information about legal action on metal hip – originally posted – implantsinfo@metalhipproblems.co.uk (earlsview.com)
Smith & Nephew Hip Implant Patient Diagnosed with Metallosis (earlsview.com)
FDA cracks down on all-metal hip replacements (earlsview.com)
Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants (earlsview.com)
US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Food & Drug Administration, hip, Hip Replacement, Johnson, Medicine, metal, Metal on metal hip, metal-on-metal hips, metallosis, NephewSmith, Smith & Nephew, surgery, UNited States

DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

earlstevens58 — Tue, 05 Mar 2013 09:56:43 +0000

Trial plaintiff says J&J hips defective, company says not liable.

Trial plaintiff says J&J hips defective, company says not liable

3/1/2013

By Deena Beasley

(Reuters) – Johnson & Johnson‘s DePuy unit was well aware of defects in its all-metal hips when plaintiff Loren Kransky was implanted with one of the devices in 2007, lawyers for the 65-year-old man said in closing trial arguments.

The lawsuit filed by the retired Montana prison guard is the first to reach court out of more than 10,000 filed against J&J in the wake of its 2010 recall of the ASR artificial hips.

Kransky attorney Brian Panish told Los Angeles Superior Court jurors that J&J should be ordered to pay around $5 million for Kransky’s pain and suffering, and as much as $179 million in punitive damages. The proceedings were monitored over the Courtroom View Network.

J&J recalled 93,000 of its ASR metal hips after determining that they were failing at a higher-than-expected rate.

Kransky’s attorneys argued that the design of the hip was defective, leading to the shedding of metal debris that caused tissue poisoning and pain as well as the need for the plaintiff to undergo hip revision surgery.

“Any compensation should not be reduced simply because the plaintiff was more susceptible to injury than a normally healthy person,” Panish said.

Both sides in the case agreed that Kransky’s medical problems, including diabetes, cancer, kidney disease, heart disease and vascular disease, were not related to the ASR hip implant.

J&J attorney Michael Zellers argued that Kransky’s ASR hip was implanted at an incline that was steeper than company guidelines advised. He also said the plaintiff’s need for revision surgery was caused by an infection.

Testimony in the trial included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs’ lawyers contend that they should have tested it using multiple angles.

“We know there is no perfect hip design. There are always trade-offs,” Zellers said, adding that the company designed the all-metal device with the aim of developing a longer-lasting hip that would show less wear than existing devices.

The J&J attorney argued that there is no medical consensus on what levels of chromium and cobalt, the metals shed by ASR hips, could cause harm to patients.

“Ultimately the product did not perform as DePuy wanted it to perform or expected it to perform,” he said.

All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants.

Michael Kelly, another Kransky attorney, told jurors the evidence shows that J&J’s DePuy unit was primarily focused on making money from the all-metal ASR hips at the expense of patient safety.

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)
Parker Waichman LLP Reviews Closing Arguments of DePuy ASR Trial and Discusses Risks of Metal-on-Metal Hip Implant (prweb.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
DePuy ASR Hip Lawsuit News: Plaintiff’s Attorney Alleges J&J Pursued Profits Over Safety; Asks for as Much as $180 Million in Damages (prweb.com)
US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)

Filed under: 510k process, Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Courtroom View Network, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson, Johnson & Johnson, joint replacement, Kransky, Medicine, metal, Metal on metal hip, metal-on-metal hips, Plaintiff, Reuters, Smith & Nephew, Zellers

Stryker Encourages Monitoring of Australian Rejuvenate and ABG II Hip Recipients – February 25, 2013

earlstevens58 — Fri, 01 Mar 2013 23:36:34 +0000

Stryker Encourages Monitoring of Australian Rejuvenate and ABG II Hip Recipients – February 25, 2013.

The July 2012 recall of Stryker Rejuvenate and ABG II hip replacement devices has affected recipients worldwide, prompting government health agencies in various countries to issue directives to encourage citizens who have been implanted with the company’s devices to undergo regular monitoring.

According to an article published on February 20, 2013, on the medical device industry news Web site, MassDevice.com, Australia’s Therapeutic Goods Administration (a government agency similar to the U.S. Food and Drug Administration) has issued a set of guidelines in conjunction with Stryker’s Australian division, advising recipients of the recalled hip replacements to be mindful of symptoms that could be associated with failure of the devices.

Guidelines Recommend Regular Follow-Up

The guidelines recommend regular blood testing and imaging for asymptomatic patients, as well as additional follow-up and evaluation if symptoms of failure are present. If testing reveals evidence of increased levels of metals in the blood, revision surgery might be necessary to explant and replace the defective Stryker hip.

The recommendations were issued because the Therapeutic Goods Administration continues to receive reports that an increasing number of hip replacement recipients patients are being diagnosed with soft tissue injuries in addition to elevated levels of metal in the blood. At least one patient who developed symptoms shortly after an initial evaluation turned out to have both increased levels of metal ions in the blood, and soft tissue damage, according to the MassDevice article.

The United States, and other countries in addition to Australia, have also suggested that hip replacement recipients remain vigilant and undergo regular screening for symptoms of device failure. While pain and swelling of the hip are obvious concerns, many patients might not experience symptoms associated with elevated metal levels in the blood, and should undergo regular testing, even if they are not experiencing any other symptoms.

Stryker recalled the Rejuvenate and ABG II hip implants because of high failure rates brought on by fretting and corrosion of the device components. These hip replacements were originally intended to provide orthopedic surgeons with the ability to provide patients with a better fit, along with greater mobility and flexibility. Unfortunately, the Stryker devices proved problematic, along with other metal-on-metal hip replacement devices manufactured by other companies.

The Rottenstein Law Group Helps Patients Who Have Been Injured by Recalled Stryker Hips

It is important to consult your orthopedic surgeon to determine whether the symptoms you might be experiencing are consistent with a failed hip replacement and if that implant was manufactured and sold by Stryker.

Lawsuits are currently being filed across the country by recipients of the recalled Stryker implants. Plaintiffs are seeking compensation for pain and suffering, unforeseen medical expenses, lost wages, and other claims. The lawyers at the Rottenstein Law Group have over 25 years of collective experience advocating for individuals who have been harmed by dangerous drugs and defective medical devices. If you feel you have reason to sue Stryker, fill out our confidential contact form or call 1-888-224-9712 for a free case evaluation. One of our lawyers will be in touch with you shortly.

Stryker Hip Implant Recall Claims (christopherfearley.typepad.com)
Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
Stryker Hip Recall Lawyers Now Offer No-Cost, No-Obligation Claim Review for Persons with Recalled Stryker Rejuvenate Hip Replacement Systems Nationally (prweb.com)
RLG Responds to Report of Higher Metal-on-Metal Hip Replacement Failure Rates in Women (earlsview.com)
d’Oliveira & Associates Issues Stryker Infographic Providing Information on Stryker Hip Replacment Recalls (virtual-strategy.com)
Stryker Hip Recall for Rejuvenate and ABG II Modular-Neck Hip Stems | Patients Advised to Undergo Clinical Screening, Wright & Schulte LLC Reports (prweb.com)
Stryker Hip Replacement Recall News: New Jersey Case Consolidation Progressing, Rottenstein Law Group Reports (businesslawdaily.net)
PALM BEACH, Fla.: Artificial hips corrode, poisoning some patients, lawsuits say | Health | Macon.com (earlsview.com)
DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)

Filed under: Cobalt Poisoning, Hip Replacement, Hip Revisions, Metal on metal hip Tagged: Arterial blood gas, Australia, Food & Drug Administration, Health, Hip Replacement, Medicine, metal, science, Stryker, Therapeutic Goods Administration, UNited States

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery

earlstevens58 — Sat, 23 Feb 2013 01:45:24 +0000

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery.

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery

February 20, 2013 By Lillian Chan

Overview: Johnson & Johnson’s recalled DePuy ASR hip implant has sparked international safety concerns over metal-on-metal hip implants. Following a recall of 93,000 hips in 2010, the company is facing 10,000 lawsuits alleging injuries from the device. The first lawsuit has gone to trial in Los Angeles state court. According to Bloomberg, Plaintiff Loren Kransky testified that he feared his hip revision surgery would kill him; ultimately, he said he only agreed to the procedure because he felt the implant would present a life-threatening risk either way. Throughout the trial, Johnson & Johnson has repeatedly insisted that the ASR did not poison Kransky by generating metallic debris.

According to Loren Kransky’s testimony, he was afraid that the revision surgery to remove his ASR would kill him; he told jurors he agreed to the operation because thought he would die with the implant regardless
Kransky was told that his ASR hip implant may be poisoning him; his cobalt levels were exceedingly high compared to the amount recommended by the MHRA
Kransky’s lawsuit is one of thousands alleging that the ASR is defective and released toxic amounts of metal ions, causing complications and the need for revision surgery

Product: DePuy ASR Hip Implant

Manufacturer: DePuy Orthopaedics/ Johnson & Johnson

Side Effects & Complications

High failure rate
Necrosis (tissue death)
Increased levels of cobalt and chromium ions
Pain at the implant, sometimes spreading to the groin and back
Osteolysis (bone loss)
Fluid collections/solid masses around the hip joint

Kransky’s Testimony

Bloomberg reports that Kransky testified before jurors in Los Angeles state court. His lawsuit alleges that the ASR hip implant is defective and caused a number of injuries since he received in 2007. According to his testimony, he described feeling “a kind of stabbing type of pain. It was debilitating. I couldn’t do anything, couldn’t walk long distances.” Kransky recalled fearing for his life before undergoing revision surgery to remove the hip implant last February. “I thought that surgery was going to kill me. I thought I was going to die.” he said. Kransky testified that he only got the revision surgery because he believed the implant presented a life-threatening risk if it remained in his body. “I came to believe that I was going to have to do it because I was told that something in my body was poisoning me…I was told it could be the hip. I thought, ‘I’m going to die either way.’ One way would be slow and one would be fast. I took the lesser of two evils.”

DePuy ASR Safety Issues

At the time of the recall, Johnson & Johnson cited unpublished data indicating that the hips failed in 12 percent of patients in five years. Kransky’s attorneys have claimed that, according to data from an Australian registry, the hip’s failure rate exceeds 40 percent. The ASR recall has come to be known as one of the biggest medical device failures in recent history, and analysts estimate that the litigation could cost J&J billions. The FDA has recently issued new guidelines for patients with metal-on-metal hip implants such as the DePuy ASR, recommending metal ion testing for the first time. Many of the lawsuits point out the fact the ASR was never clinically tested for safety, something that the FDA is also trying to address by proposing new regulations.

Business: Washington Post Business Page, Business News (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg (earlsview.com)
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg (earlsview.com)
DePuy ASR Trial Update: J&J Engineer-Suggested Redesign Meant to Minimize Metallic Debris Never Implemented, Parker Waichman LLP Reports – SFGate (earlsview.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: DePuy, hip, Hip implants, Hip Replacement, Johnson, lawsuit, Loren Kransky, Los Angeles, metal, metal ions, metallic debris

Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg

earlstevens58 — Sat, 23 Feb 2013 01:39:52 +0000

J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg.

J&J’s Toxicologist Says Metal From Recalled Hip Harmless

By Maurice Possley & David Voreacos – Feb 22, 2013 3:01 PM ET

A Montana man suing Johnson & Johnson (JNJ)’s DePuy unit over his recalled hip implant wasn’t harmed by the chromium and cobalt debris that entered his tissues and bloodstream, a toxicologist told a jury.

Dennis J. Paustenbach testified yesterday on J&J’s behalf at the first of 10,000 lawsuits to go to trial over the ASR hips, which the company recalled in August 2010. In the case, Loren Kransky, 65, claims the hip implant was defectively designed and J&J failed to warn of the risks.

“I believe that the cobalt and chromium from the ASR implant did not cause or worsen Mr. Kransky’s systemic health problems,” Paustenbach told jurors in state court in Los Angeles. Kransky’s chromium levels were “of insignificant health risk, basically of no health risk.”

Kransky, a retired prison guard, testified earlier that he believed the metal debris was poisoning him. He had a metal cup planted in his hip, and a ball placed atop his femur rotated in the cup. J&J’s lawyers claim the elevated levels of metal in Kransky’s body can be traced to conditions including diabetes, high blood pressure and cholesterol, strokes and kidney cancer. They claim he has diseased blood vessels throughout his body.

J&J, the world’s biggest seller of health-care products, recalled the hips in August 2010 after saying at least 12 percent failed. Since then, the rate has climbed, reaching 40 percent in Australia. Analysts say it could cost New Brunswick, New Jersey-based J&J billions of dollars to resolve the cases.

$5 Million

Paustenbach said his firm ChemRisk Inc. has billed DePuy at least $5 million over the past 18 months. He was part of a team of 40 people who spent thousands of hours studying medical literature and found virtually no research on the effects of cobalt prior to the ASR recall.

“What systemic health effects have you found?” J&J attorney Alexander Calfo asked Paustenbach.

“I saw none,” Paustenbach said.

“Was Mr. Kransky poisoned by the ASR hip?” Calfo asked.

“Absolutely not,” Paustenbach said.

He said he also found no evidence of an increased cancer risk. He said the presence of cobalt is “not an issue to be concerned about at concentrations observed in patients with implants.”

Jurors were shown a January publication from the Mayo Clinic in Rochester, Minnesota, which said that “elevated chromium and cobalt concentrations may indicate implant wear, but they are not indications of toxicity.”

Anemia Patients

Paustenbach described an examination by his firm of clinical studies from the 1950s of anemia patients given varying doses of cobalt. His firm created a formula to convert the dosages to blood level readings.

“In the blood, we found that there were virtually no adverse effects in the people who had levels up to 300 parts per billion,” Paustenbach said. Kransky’s highest cobalt reading was 57 parts per billion.

Paustenbach also described a study he conducted of five men and five women who were given dosages of over-the-counter cobalt over 30 days. They showed no adverse effects, he said, although the men reached blood levels of 32 parts per billion and the women hit 91 parts per billion, he said. The unpublished study has been submitted for peer review, he said.

Paustenbach also said that cobalt stimulates the growth of red blood cells. Kransky was chronically deficient in red blood cells, which was further evidence that the cobalt ions weren’t affecting him, the witness said.

“There is no apparent response” to the cobalt levels, he said.

‘Go-To Guy’

On cross-examination by Kransky attorney Brian Panish, Paustenbach reacted angrily when asked if he had been referred to as the “go-to guy for industry.”

“That’s ridiculous,” Paustenbach said. He then acknowledged he had been described in that manner.

In an attempt to depict Paustenbach as biased in favor of industry, Panish read a list of dozens of multinational corporations for which Paustenbach has conducted chemical research. His work, paid for by the companies, has been used to attempt to undermine concerns about exposure to carcinogens such as asbestos and benzene.

Paustenbach was questioned extensively about his firm’s role in a 1997 article published in the Journal of Occupational and Environmental Medicine under the names of two Chinese scientists. The article reversed an earlier study by one of the scientists that found a significant association between chromium in drinking water and higher rates of cancer in rural China.

In 2006, the journal retracted the 1997 article because it failed to disclose that the paper was written by his company, Paustenbach said. His firm had been retained by companies accused of being responsible for chromium pollution.

J&J began presenting its defense case Feb. 20, after Kransky’s lawyers rested. The trial began Jan. 25.

The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

To contact the reporters on this story: Maurice Possley in Los Angeles Superior Court at mauricepossley@gmail.com; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance (earlsview.com)
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)
J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg (earlsview.com)
J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)
J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg (earlsview.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, California Superior Court, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Environment, FDA, Food & Drug Administration, Health, Hip recall, Hip Replacement, hip replacement failure, hip revision, Johnson, Johnson & Johnson, Kransky, Los Angeles, Mayo Clinic, Medicine, metal, Metal on metal hip, metal-on-metal hips, metallosis, New Brunswick New Jersey, science

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