This is a one hour talk.

Consumer’s Union had Dr Steve talk last month at Columbia School of Journalism.

It covers a lot of ground not only about the metal-metal hips but about hip replacement in general.

I am in the process of watching it myself and so can’t give you a big review here – but please post your thoughts and comments below.

I came across this story recently – and a very useful website you might like to take a look at.

http://www.hiphelp.org/mystory.html

here’s a snippet from Lise

In March, 2008, I received a new right hip. It was supposed to be the latest, most innovative hip manufactured by DePuy, a subsidiary of Johnson and Johnson.

I did not know much about joints or hip replacements before this procedure other than they are what “old” people have or those who have over-exercised their joints. I knew I had congenital arthritis from a birth defect known as dysplasia which affects a certain percentage of the population.

I was a dancer, (not professionally, just a passion), former cheerleader, a mom, wife, professional person, business owner,runner, hiker, and gym rat. At about age 49, the arthritis was making itself known to me. Since I am a business owner and now consultant, my livelihood and that of my family depends upon my good health.

I was armed with internet research. I asked my doctor if my device had any recalls or complaints with the FDA. All indications were, this was one of the most successful surgeries in general.

The device, heavily recommend by my physician was a metal on metal hip or MoM implant. It would wear at least 20 years and it is what all baby boomers and professional athletes who needed new joints were receiving (according to my surgeon).

The surgery, if you have ever seen on YouTube, is pretty brutal. They use tools that reside in your garage; hacksaw, drill, hammer and chisels. They dislocated the hip, saw off the head of the joint, ream out the hip socket, drill out the bone marrow in your thigh and tap in a 7 inch (est.) long metal “stake” in your thigh. They put a ball on the end, (metal, ceramic or combination of both), and then put a cup made of metal or plastic in the socket as you would have a ball rolling about in a bowl. They have different size cups and balls for every size but much depends on the skill of the surgeon. You can come out with a limp and face future dislocations, have one leg shorter than the other, or the best and most widely touted case is you will fare better off than you were before and be pain free!

The surgery went as expected. I went home after two days but had significant back pain – unusual for me since I never had any back issues prior to the surgery. I just assumed it was the result of a bad hospital bed.

Read more here http://www.hiphelp.org/mystory.html

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• Johnson & Johnson agrees to pay $2.5 billion to resolve thousands of hip replacement lawsuits (canadianbusiness.com)
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• J&J to settle hip-replacement suits for $2.5B (thedailyrecord.com)

Johnson & Johnson Fined $2.2 Billion for Reckless Drug Distribution

Posted on November 19, 2013 by Cal Warriner

One has to wonder how this will play with stockholders. Johnson & Johnson, the healthcare giant, has agreed to pay more than $2.2 billion to settle criminal charges over the marketing of its antipsychotic drug, Risperdal. The company’s Janssen Pharmaceuticals division is accused of marketing the drug to treat elderly patients with dementia, children and the disabled.

This case, brought by the Department of Justice, is a big win for American patients.

Risperdal was approved 20 years ago by the U.S. Food and Drug Administration (FDA) for managing psychotic disorders, not to keep the elderly subdued or children quiet.

In announcing the settlement this week, U.S. Attorney General Eric Holder called it among the largest healthcare fraud settlements in U.S. history.

J&J marketed Risperdal for unapproved uses from 1999 through 2005. And it had help. Omnicare, which dispenses drugs to nursing homes, billed the government for the unapproved drugs, and received kickbacks from Risperdal sales reps to prescribe the drug as well as another antipsychotic, Invega (for the treatment of schizophrenia) and Natrecor, a heart drug, according to a report in Bloomberg.

- See more at: http://www.searcymasstort.com/blog/2013/11/19/johnson-johnson-fined-2-2-billion-for-reckless-drug-distribution/#sthash.exfHp6zJ.dpuf

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Johnson & Johnson to Offer $2.5 Billion Hip Device Settlement

By BARRY MEIER

Published: November 19, 2013

Lawyers for Johnson & Johnson and patients injured by a flawed hip implant were expected to introduce a multibillion-dollar plan Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants.

Under the agreement, according to people briefed on the plan, the medical products giant will pay some $2.475 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device.

Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to some $3 billion, said those familiar with the proposal, who did not want to be identified.

The typical patient payment for pain and suffering caused by the device will be about $250,000 before legal fees, under the plan. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners.

Read the full NY Times article here.

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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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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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In May of 2007 at the age of 55, I underwent a hip resurfacing procedure in the right hip with fitment of a Smith and Nephew BHR metal prosthesis at Claremont Surgical in Cape Town, South Africa.  I had extensive and expensive rehabilitation and physiotherapy however I  never fully recovered and have suffered endless problems as follow:

• In 2008, my leg became swollen and the doctor fearing a thrombosis injected me with blood thinning medication.  I had a CAT scan which showed a bursar in the hip area which was collapsing the main vein – I then had a procedure to remove the liquid from the bursar but one week later the swelling returned.  I was advised to see a vascular surgeon who admitted me to hospital and inserted 2 stents, the first one collapsing under pressure from the bursar.

• In 2009 my leg again became swollen another scan showed the bursar had become tumerous and was pushing the vascular bundle against my pelvic bone and the stent had collapsed.  I was admitted to hospital where both orthopaedic and vascular surgeons operated – the stent being repaired and the tumerous mass being removed and the area around the prosthesis cleaned of debris.  The tissue was found to contain metal debris and I was found to be suffering from metallosis and an infection around the prosthesis.  I was put on a course of strong antibiotics to which I had a severe allergic reaction.  I was told no further operation on my hip was possible until this infection was cleared.  Since I can no longer afford the operation anyway I have not returned.

• From 2008, I was suffering from acute anxiety and depression which required hospitalisation and medication for several years.

• My one leg now being shorter than the other I have had stability and balance problems – unable to walk any distance because of pain and discomfort.  I believe this instability also contributed to a fall in 2010 and a second fall in 2011 – this time breaking my ankle.

• Lately I have noticed a marked deterioration in my sight as well as short term memory lapses and confusion with time lines.

I had no idea that all my problems mentioned above must clearly stem from the BHR metal prosthesis in my body, until reading an article in a magazine.

I would like to point out that besides the pain, discomfort and constant worry about what would happen next to my hip and the constant reminder because of the “clunk-clunk” when I move in certain ways, the time and the expense has taken its toll and today I have been unable to find a job and have neither pension nor savings nor medical aid as I am effectively destitute all being used to pay for the endless medical bills since my hip replacement.  I am now relying on my son for a living and am currently homeless, moving between various friends.

I approached a firm in South Africa who are involved in a class action against Du Puy.  They agreed to add me to the action as I did not realise there were a number of manufacturers of these prostheses – however on investigation they discovered I was not fitted with a Dupuy prosthesis but a Smith and Nephew “Birmingham” prosthesis. I subsequently went on line to find out what was being done to assist people who are suffering from the failure and after effects of this prosthesis in a case against this manufacturer as is being conducted against Du Puy and Johnson and Johnson.  I don’t see any cases being handled in South Africa and would like to ask your advice as to my next steps.

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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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