Earl's View » Cobaltism

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

earlstevens58 — Thu, 14 Nov 2013 09:05:42 +0000

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

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

Published: November 12, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.

The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future, the lawyers said. Under the plan, patients who have not had a replacement would not receive compensation, the lawyers said.

Read the full article here – New York Times

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants (nytimes.com)
J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (bloomberg.com)
Johnson & Johnson DePuy hip implant settlement reported (lawprofessors.typepad.com)
Johnson & Johnson said to reach settlement for hip-implant suits (denverpost.com)
Johnson & Johnson Reaches $4 Billion Settlement Over Hip Implants (theatlanticwire.com)
Johnson & Johnson Investors Sweat, but the Dow Bounces Back (fool.com)
Johnson & Johnson Offer Two Settlement Deals for the DePuy ASR Hip Replacements (prweb.com)
Johnson & Johnson said to reach $4 billion accord to settle hip-implant claims (nj.com)
Johnson & Johnson to pay $4 billion settlement over metal-on-metal hip implants: Report (cbsnews.com)
DePuy ASR Settlement Update: Rottenstein Law Group LLP Comments on $4 Billion DePuy Hip Settlement News (businesslawdaily.net)

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, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, Food & Drug Administration, Health, Hip Replacement, hip replacement failure, hip resurfacing, Human settlement, Johnson, Johnson & Johnson, Medical device, New York TImes, Patient, Product Liability

Consumer Reports Urges a Lemon Law For Joint Replacements

earlstevens58 — Thu, 17 Oct 2013 21:30:03 +0000

Consumer Reports Urges a Lemon Law For Joint Replacements

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.

CIHI Study Reveals Problems with Metal-on-Metal Hip Implants (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, Stryker, Stryker ABGII Modular Femoral Stem, Stryker Hip Implant Recall, Stryker profits, Stryker rejuvenate hip, Stryker ShapeMatch, Stryker Trident Hip Recall, Stryker Trident Hip Replacement System, Suffering, Total Hip Replacement Tagged: Consumer Reports, DePuy, Hip Replacement, hip replacement products, India, joint replacement, knee replacement, Medical device, metallosis, Stryker Hip Replacements, surgery, University of California

Frans story – DePuy ASR and then Blood Cancer

earlstevens58 — Sun, 28 Jul 2013 00:54:22 +0000

I had a Depuy Pinnacle (MOM) total hip replacement in Dec. 2007 due to osteoarthritis at the age of 56. I was told that metal on metal was the preferred implant since I was young, thin and fit. In fact, this remarkable implant might even last my lifetime!

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.

DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
Hip Replacement Lawsuits (hipreplacementlawsuits.wordpress.com)
DePuy ASR Hip Implant Lawsuit Filed by Wright & Schulte on Behalf of Texas Man Who Alleges His Serious Hip Injuries Were Caused by Defective Design of ASR Hip Implant (prweb.com)
Hip Replacement Recall (ehipreplacementrecall.wordpress.com)
Experts Advise Patients with MoM Hips to Undergo Blood Tests (hothealthnews.wordpress.com)
Fighting Rare Blood Cancers (23andme.com)
Lawmakers Mull over Actions for Hip Implant Safety (hipimplantlawyer.wordpress.com)
The New Design of DePuy ASR Hip (depuyrecall.typepad.com)
DePuy Hip Replacement Failure Rate (depuyrecall.typepad.com)
US Drug Watchdog Now Urges All DePuy Pinnacle Hip Implant Recipients To Call Them About A Blood Test To See If This Metal Hip Implant Has Failed-Time Is Of The Essence (prweb.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: baseline study, chronic lymphocytic leukemia, DePuy, Food and Drug Administration, groin pain, Health, Hematological malignancy, Hip implants, Hip Replacement, Johnson, Medicine, osteoarthritis, pinnancle, total hip resurfacing

Stuart Cain speaks out re DePuy Hell – Meet The Press, Episode 22, Sunday July 21 | News.com.au

earlstevens58 — Thu, 25 Jul 2013 20:43:07 +0000

Meet The Press, Episode 22, Sunday July 21 | News.com.au.

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

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Barack Obama, Cobalt chrome, Cobalt poisoning, David Gregory, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, hip resurfacing, Johnson, Meet the Press, Music and Audio, Press, Tavis Smiley, UNited States

Just Remember it is all Your Fault!!!

earlstevens58 — Fri, 19 Jul 2013 22:09:18 +0000

Just remember patients, this is actually your fault!

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

Smith & Nephew Letter (earlsview.com)
Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
Smith And Nephew Unveils New Hip Device (smithnephewhip.wordpress.com)
DePuy Defective Hip Implant Claims | eLocal (elocallawyers.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: Australia, australian orthopaedic association, chromium levels, chromium toxicity, Herald Sun, Meet the Press, Necrosis, peak professional body, Smith & Nephew, Smith and Nephew, Sunday, sunday herald sun, Sunday Mail, Sunday Telegraph

Data show hip replacement revision rate low, though higher with metal-on-metal – Winnipeg Free Press

earlstevens58 — Fri, 19 Jul 2013 22:01:33 +0000

Data show hip replacement revision rate low, though higher with metal-on-metal – Winnipeg Free Press.

Data show hip replacement revision rate low, though higher with metal-on-metal

By: Helen Branswell, The Canadian Press

Posted: 07/18/2013 2:51 PM |

TORONTO – New Canadian data suggest that people who have a type of metal-on-metal hip replacement are more likely to need a revision within five years, but even then, the rate of revisions is low.

The data show that people who had large-diameter modular metal-on-metal implants had a 5.9 per cent chance of needing to have the implant replaced within five years, compared to a rate of 2.7 per cent among people who received the more common metal-on-plastic implant.

The data, released by the Canadian Institutes for Health Information, show that nearly three out of every four hip replacements logged into the Canadian joint replacement registry were metal-on-plastic units.

Metal-on-metal hip replacements made up only nine per cent of the procedures recorded in the registry.

Metal-on-metal units were introduced with great optimism a few years ago; the thinking was the replacement hips would be more durable and better for younger patients than the metal-on-plastic type.

But data from a number of countries have shown that hasn’t been the case for a small subset of people who received the units.

Canadian orthopedic surgeons took a more conservative approach to the metal-on-metal implants and it turned out to be the way to go, says Dr. Michael Dunbar, an orthopedic surgeon from Halifax and co-chair of the joint replacement registry.

“It was the right side of the street to be on, for sure,” Dunbar says.

“It was the fact of the matter that in the United States in the late 2000s almost 45 per cent of every male in the country (who got a hip replacement) got metal-on-metal. So this is why it’s such a big issue in the United States.”

Dunbar says the differences between the U.S. and Canadian situations underscore why it’s important to gather information on joint replacements. Currently the joint replacement registry is a voluntary one, and only captures a portion of the procedures done in the country.

Two provinces — British Columbia and Ontario — are moving to make it mandatory for these procedures to be recorded in the registry. But Dunbar wishes others would follow suit.

“We have a voluntary system and until recently we’ve been down around 50 per cent. We think that all implants should be registered because this is important. We’re spending the nation’s treasure on this stuff. This is a top health-care priority in Canada,” Dunbar says.

“We want to make sure we can deliver the very best product to the patients in our country. And we want to make sure that the money that we’re spending … is best spent for the most appropriate implant for the most appropriate patient.”

The report is based on nearly 60,000 hip replacements done across Canada between 2003 and 2011. Data from Quebec were not included.

Data show hip replacement revision rate low, though higher with metal-on-metal (globalnews.ca)
Metal on Metal Long Term Risks Confirmed (earlsview.com)
Products Included in the Ceramic Hip Replacement Recall (arthritis.answers.com)
Risks, Benefits and Recovery From Birmingham Hip Procedures (arthritis.answers.com)
Metal-on-metal hip implants more likely to need replacement (cbc.ca)
Risks and Rewards of Cemented Hip Replacements (arthritis.answers.com)
Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
Understanding Hip Revision Surgery: A Medical Overview (orthopedics.answers.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Business, Cobalt chrome, Cobalt poisoning, DePuy, Health, hip, Hip Replacement, hip resurfacing, joint replacement, Medicine, science, Smith & Nephew, surgery, Technology, UNited States, Winnipeg Free Press

Metal on Metal Long Term Risks Confirmed

earlstevens58 — Sun, 30 Jun 2013 02:44:50 +0000

Metal-on-Metal Hip Prostheses and Systemic Health: A Cross-Sectional Association Study 8 Years after Implantation

Patients with well-functioning metal-on-metal (MoM) hip resurfacing prostheses may experience systemic effects from chronic exposure to low elevated metal concentrations, according to a British study published online this month in the journal PLOS ONE. Investigators performed a cross-sectional health screen of 35 asymptomatic patients who had undergone MoM hip resurfacing and 35 age- and sex-matched patients who had undergone conventional hip replacement with a variety of bearing surfaces (metal-on-polyethylene [17]; ceramic-on-ceramic [17]; and ceramic-on-polyethylene [1]), at a mean follow-up of 8 years. Total body bone mineral density was 5 percent higher—and bone turnover was 14 percent lower—in the hip resurfacing patients compared to traditional hip replacement patients. In addition, in the hip resurfacing group, left ventricular and end-diastolic diameter was 6 percent larger, and cardiac ejection fraction was 7 percent lower. “Our data suggest mixed health effects, including potentially positive effects on systemic bone mass, but potentially deleterious effects on left ventricular function,” note the researchers. They call for the use of musculoskeletal and cardiac endpoints in future long-term epidemiologic studies to determine the risk of clinical disease.

Abstract

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0066186

There is public concern over the long term systemic health effects of metal released from hip replacement prostheses that use large-diameter metal-on-metal bearings. However, to date there has been no systematic study to determine which organs may be at risk, or the magnitude of any effect. We undertook a detailed cross-sectional health screen at a mean of 8 years after surgery in 35 asymptomatic patients who had previously received a metal-on-metal hip resurfacing (MoMHR) versus 35 individually age and sex matched asymptomatic patients who had received a conventional hip replacement. Total body bone mineral density was 5% higher (mean difference 0.05 g/cm2, P = 0.02) and bone turnover was 14% lower (TRAP 5b, mean difference −0.56IU/L, P = 0.006; osteocalcin, mean difference −3.08 ng/mL, P = 0.03) in the hip resurfacing versus conventional hip replacement group. Cardiac ejection fraction was 7% lower (mean absolute difference −5%, P = 0.04) and left ventricular end-diastolic diameter was 6% larger (mean difference 2.7 mm, P = 0.007) in the hip resurfacing group versus those patients who received a conventional hip replacement. The urinary fractional excretion of metal was low (cobalt 5%, chromium 1.5%) in patients with MoMHR, but creatinine clearance was normal. Diuretic prescription was associated with a 40% increase in the fractional excretion of chromium (mean difference 0.5%, P = 0.03). There was no evidence of difference in neuropsychological, renal tubular, hepatic or endocrine function between groups (P>0.05).

Our findings of differences in bone and cardiac function between patient groups suggest that chronic exposure to low elevated metal concentrations in patients with well-functioning MoMHR prostheses may have systemic effects. Long-term epidemiological studies in patients with well-functioning metal on metal hip prostheses should include musculoskeletal and cardiac endpoints to quantitate the risk of clinical disease.

Citation: Prentice JR, Clark MJ, Hoggard N, Morton AC, Tooth C, et al. (2013) Metal-on-Metal Hip Prostheses and Systemic Health: A Cross-Sectional Association Study 8 Years after Implantation. PLoS ONE 8(6): e66186. doi:10.1371/journal.pone.0066186

Editor: Joel Joseph Gagnier, University of Michigan, United States of America

Received: December 21, 2012; Accepted: May 2, 2013; Published: June 10, 2013

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, hip implants, hip preservation surgery, Hip Replacement, Hip Resurfacing, Metal ions, Metal on metal hip, metallosis

Smith and Nephew Hip Replacement LawyersSmith and Nephew Hip Replacement Lawyers

earlstevens58 — Sun, 05 May 2013 22:57:41 +0000

Smith and Nephew Hip Replacement LawyersSmith and Nephew Hip Replacement Lawyers.

Smith and Nephew metal-on-metal hip implants are currently affecting thousands of patients suffering from severe side effects across the United States. These devices are failing at a rate much higher than expected, posing serious health problems.

Smith and Nephew continued to market these products in disregard to reports that showed metal-on-metal hip implants failing at a higher rate than metal on polyethylene hip implants and causing excessive cobalt and chromium ions being released into the body.

Symptoms of Injury

Due to the defective R3 Acetabular and Birmingham (BHR) total hip replacement implants, Smith

and Nephew Orthopaedics is facing a growing number of hip replacement lawsuits and mass tort actions.

Injured patients are reporting premature loosening, immobility, and implant failure –

along with many other painful symptoms, such as:

Bone chipping
Bone fractures
Tissue damage
Chronic pain

If you have suffered pain or injury because of your defective Smith and Nephew hip implant, you may be entitled to compensation through a Smith and Nephew hip implant lawsuit. Ask your surgeon which specific hip implant system you received during your surgery.

If it is the R3 Acetabular model that used R3 metal liners, then it has been recalled and you should consult with us about filing a Smith and Nephew hip implant lawsuit to recover the compensation you deserve. If you are not aware of which hip implant you have received, we’d be glad to assist you in finding out.

Know Your Rights: Do You Have A Case?

Due to their negligence, Smith and Nephew has been subject to hip implant lawsuits and mass tort actions. If you have received an R3 Acetabular System replacement hip or Birmingham (BHR) total hip replacement prosthesis manufactured by this company, you might have a case against the manufacturer. Damages in the form of monetary compensation could include coverage of your actual medical costs (to include future medical costs), loss of earnings, and pain and suffering.

Even if you do not know what type of implant you have received, our team would be happy to assist you in obtaining this information. It is essential that you call us today if you know that you have received a hip implant that has been recalled, even if you are not currently experiencing pain or physical symptoms.

“There are a lot of pitfalls you can fall into in this type of case,” said attorney Daniel Nigh, with Levin, Papantonio, Law Firm. “As soon as you find out that you even have a recalled product, regardless if you have any problems, you should call an attorney to ask about your rights given the recall.”

Just provide us with some basic information about your case and we will take it from there.

The History

Thousands of patients were implanted with Smith and Nephew metal-on-metal total hip replacements, and our attorneys have spoken with quite a few that have been injured by these hip replacements—specifically, clients that were implanted with the recalled Smith and Nephew R3 metal-on-metal hip prosthesis or BHR prosthesis during a total hip replacement procedure.

Smith and Nephew announced that unlike other metal-on-metal hip implants, the patients implanted with the R3 metal liner were not typically experiencing issues with cobalt and chromium ions being released from the implant and causing metallosis reactions. However, Levin Law attorney and advocate Daniel Nigh’s review of clients’ medical records who have had revisions to remove the R3 metal liner, or who have had revisions to remove the BHR cup-and-ball, has shown that these clients have had a variety of problems with the cobalt and chromium ions.

Smith and Nephew voluntarily withdrew the optional metal liner component of its R3 Aceabular System hip replacement implant due to the company’s analysis of clinical studies which showed “a higher than normal level of patient problems” were occurring with the device, meaning it wasn’t doing what it was designed to do. Clinical trials of the metal-cup component showed that 1.6 percent required revision surgery each year, the guideline in the U.K. where the company is based, was 1 percent.

“Companies unfortunately put money ahead of the safety,” said Ben Gordon, a patient advocate at Levin, Papantonio Law Firm who is assisting with Smith and Nephew cases. “Instead of focusing on patient safety and clinical trial outcomes, and how patients would do with a given product, they jumped onto a bandwagon with the notion that these devices were a huge marketing opportunity. They took it from a market of about 100,000 people in the United States to in the 90s to close to half a million people a year by 2010.”

Smith and Nephew BHR implants have been in the U.S. market since 2006, and though not currently recalled, many patients have also been suffering similar symptoms to other metal-on-metal complications to the R3 system.

Smith and Nephew’s R3 Acetabular System contains a metal liner component that was recalled by the FDA in June of 2012 due to its association with implant dislocation, infection and bone fracture that was causing patients to suffer and often requiring revision surgery. The recall followed the company’s analysis of clinical trials showing a “higher than normal level of patient problems with the device.” Smith and Nephew introduced the hip replacement liner in 2009, and since that time about 7,700 patients have had them implanted.

This modular metal-on-metal hip replacement system contains both metal cup and head components that were originally designed to last longer than their ceramic and plastic counterparts. Experts now believe there are additional health risks, including chromium and cobalt poisoning caused by loose metal fragments shed by the device.

Levin Law Firm will be your advocate, fighting for patients who have needlessly suffered injury as a result of the R3 system.

Another problematic Smith and Nephew product is the Birmingham Hip Resurfacing (BHR) System, which has also seen a high rate of complications in both resurfacing and total hip replacement patients. This metal-on-metal device was the first of its kind approved in the United States. Many other manufacturers have mimicked its design and have recently been linked to high rates of complications, failures and recalls.

In September 2012, Smith & Nephew issued an “Urgent Field Safety Notice” for the Birmingham Modular Head hip implant. They stated: “The average revision rate for the Birmingham hip with all stems is currently 1.29 revisions per 100 observed component years.”

Our law firm is taking on cases where the system was used in total hip replacement procedures. Contact our team today to discuss your potential claim and start the process to be compensated for your needless pain and suffering. We would be glad to help you understand your legal rights today!

Hip Replacement Lawsuit Website Launched by Bernstein Liebhard LLP to Provide Updated Information on Hip Replacement Recalls, Growing Metal Hip Implant Litigation (prweb.com)
Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick… (earlsview.com)
Risks, Benefits and Recovery From Birmingham Hip Procedures (arthritis.answers.com)
Biomet Video Released by d’Oliveira & Associates Informs Public of Dangers Associated with the Metal-on-Metal Device. (prweb.com)
Biomet Video Released by d’Oliveira & Associates Informs Public of… (prweb.com)
Study: Metal Hip Pain and Tissue Damage – Stryker Rejuvenate Hip Implant (earlsview.com)
Birmingham Hip Resurfacing System: A Treatment Overview (arthritis.answers.com)
HUNGER STRIKE – Smith & Nephew BHR problems drive Paige to Ruin & Desperate Measures – HUNGER STRIKE (earlsview.com)
Hanna’s Story – another Smith & Nephew BHR tale of disaster (earlsview.com)
Profits Drop 4% at Smith & Nephew (fool.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Smith & Nephew, Smith & Nephew BHR Problems, Smith & Nephew Hip Recall, Smith & Nephew R3 Hip Liner Recall, Total Hip Replacement

Smith and Nephew: Motion to Consolidate | Smith and Nephew Hip Replacement LawyersSmith and Nephew Hip Replacement Lawyers

earlstevens58 — Sun, 05 May 2013 22:51:00 +0000

Smith and Nephew: Motion to Consolidate | Smith and Nephew Hip Replacement LawyersSmith and Nephew Hip Replacement Lawyers.

Apr-9-2013

IN THE CIRCUIT COURT OF SHELBY COUNTY, TENNESSEE

FOR THE THIRTIETH JUDICIAL DISTRICT, AT MEMPHIS

(plaintiff name witheld for privacy)

Plaintiff, v.

SMITH & NEPHEW, INC.

Defendant.

Docket No. CT-004783-12

Division VII

MOTION TO CONSOLIDATE

Comes now the Plaintiff, (plaintiff name witheld for privacy), pursuant to Rule 42.01 of the Tennessee Rules of Civil Procedure and Local Rule of Practice Twenty-Two, and moves this honorable court for an order permitting consolidation of all after-filed cases relating to the Birmingham Hip Resurfacing Devices, R3 Metal Liners, and all other Metal-on-Metal modular hip implant components manufactured by defendant, Smith and Nephew, and would state as follows:

The above-styled case involves a modular Metal-on-Metal Hip Implant manufactured by defendant, Smith and Nephew;
Counsel for the above-listed plaintiff have also filed a case styled (plaintiff name witheld for privacy) etc, case no. CF000452-13, and this case now rests in Division I;
The (plaintiff name witheld for privacy) case has a higher docket number than the (plaintiff name witheld for privacy) case;
Undersigned counsel represent a number of additional plaintiffs who will soon be filing additional cases in this court for injuries and damages relating to the same hip implant platform, or components thereof, including the now-recalled R3 Metal Liner, the modular metal “heads,” and the Birmingham Hip Resurfacing Device;
Undersigned counsel are aware of at least three other attorneys who intend to file a limited number of other, similar cases, alleging substantially similar injuries and damages relating to failures involving the very same products at issue in this case.
Although coordination under Local Rule of Practice twenty-eight is another option, counsel for plaintiff are aware of only a handful of additional cases relating to the devices at issue to be filed in this court, and, therefore, there are not adequate numbers of these cases to be filed to warrant handling of this group of cases as a Mass Tort Docket pursuant to Local Rule of Practice Twenty-Eight;
Nevertheless, there is a sufficient identity of issues in the cases that are being filed to justify consolidation under Tennessee Rule of Civil Procedure 42, which states as follows:
“When actions involving a common question of law or fact are pending before a court, the court may order all the actions consolidated or heard jointly, and may make such orders concerning proceedings therein as may tend to avoid unnecessary costs or delay.”
Here, there exist numerous common issues of fact and liability to justify consolidation all after-filed cases with the matter before this court.
In addition, Local Rule of Practice twenty-two provides, in pertinent part, that “[i]n instances in which consolidation of cases for trial is appropriate, and the cases have been assigned to different divisions of the court by the Clerk, in the absence of important reasons to the contrary, the case with the higher docket number should be transferred into the division of court which has the case with the lower docket number.
Counsel believe that there consolidation of all cases filed against Smith and Nephew relating to the R3 Metal liner, the modular metal heads, and other components of metal-on-metal hip implants relating to the Birmingham Resurfacing and/or Total Hip Arthoplasty devices will promote judicial economy, enhance efficiency for the parties, avoid delays, limit duplicative discovery and motion practice, and eliminate the risk of inconsistent rulings on issues common to all cases.
Finally, undersigned counsel is not aware of any lawyer for other plaintiffs who opposes this proposed action, and, in fact, is authorized to represent that counsel for several such additional plaintiffs who intend to file cases in the near future also support consolidation of their cases with this action.

Accordingly, plaintiffs respectfully move this court to accept transfer of cases with higher docket numbers, beginning with the case of [plaintiff] vs. etc., and to allow all subsequently filed cases relating to the above-described devices to be transferred to this court for consolidation with this matter.

DATED: March 21, 2013

Respectfully submitted,

LEVIN PAPANTONIO

/s/Ben W. Gordon, Jr.___________________

Ben W. Gordon, Jr. (FL Bar # 882836)

bgordon@levinlaw.com

Daniel A. Nigh (FL Bar #00030905)

dnigh@levinlaw.com

Levin, Papantonio, Thomas, Mitchell,

Rafferty, & Proctor, P.A.

316 S. Baylen Street, Suite 400

Pensacola, FL 32502

Telephone 850-435-7091

Facsimile 850-436-6033

Profits Drop 4% at Smith & Nephew (fool.com)
HUNGER STRIKE – Smith & Nephew BHR problems drive Paige to Ruin & Desperate Measures – HUNGER STRIKE (earlsview.com)
Hanna’s Story – another Smith & Nephew BHR tale of disaster (earlsview.com)
Profits Drop 4% at Smith & Nephew (dailyfinance.com)
Hip Replacement Lawsuit Website Launched by Bernstein Liebhard LLP to Provide Updated Information on Hip Replacement Recalls, Growing Metal Hip Implant Litigation (prweb.com)
Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick… (earlsview.com)
Biomet Video Released by d’Oliveira & Associates Informs Public of Dangers Associated with the Metal-on-Metal Device. (prweb.com)
Metal-on-Metal Hip Implants: Bernstein Liebhard LLP Comments on New Study Finding Increased Metal Ion Levels May Predict Problems with Metal-on-Metal Hip Replacements (prweb.com)
SDNY Sinks “Circumstantial Case for Products Liability” (druganddevicelaw.blogspot.com)
Emerging Markets Heat Up for Device Makers (dailyfinance.com)

Filed under: Birmingham Hip Resurfacing, Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Smith & Nephew, Smith & Nephew BHR Problems, Smith & Nephew Hip Recall, Smith & Nephew R3 Hip Liner Recall, Total Hip Replacement Tagged: Birmingham Hip Resurfacing Device, Hip Replacement, Nephew, NephewSmith, Plaintiff, R3 Metal Liner, Smith, Tennessee

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

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