Earl's View » arthritis

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

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

GOOD NEWS —- Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports – Watch List News

earlstevens58 — Thu, 25 Jul 2013 12:46:45 +0000

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports – Watch List News.

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports

July 24th, 2013

The Firm is currently investigating Smith & Nephew hip recall lawsuits on behalf of individuals who suffered metallosis, premature device failure and other complications allegedly associated with Smith & Nephew’s optional metal liner component for its R3 Acetabular Hip Replacement System.

New York, New York (PRWEB) July 24, 2013

A federal judge in Illinois presiding over a Smith & Nephew hip lawsuit has ruled that the Plaintiff’s claims of negligence and strict liability involving alleged quality control issues in the Birmingham Hip Resurfacing System may go forward, Bernstein Liebhard LLP reports. In an Order dated July 22nd, Judge Joan H. Lefkow of the U.S. District Court for the Northern District of Illinois rejected Smith & Nephew’s assertions that the claims were preempted by federal law. The Birmingham Hip Resurfacing System may be used with the optional metal liner component for the R3 Acetabular Hip Replacement System, which was the subject of a Smith & Nephew hip recall in June 2012.* (Tillman v. Smith & Nephew Inc., No. 1:12-cv-04977 (N.D. Ill.))

“We continue to hear from individuals who have suffered serious complications, allegedly due to Smith & Nephew hip replacements. We are encouraged by the decision in this case,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free Smith & Nephew hip lawsuit evaluations to patients who suffered serious complications, including metallosis and premature device failure, allegedly due to the recalled R3 metal liner component.

Smith & Nephew Hip Recall

The Smith & Nephew hip recall was announced in June 2012, due to the high failure rates associated with the optional metal liner component for the R3 Acetabular System. According to the Food & Drug Administration (FDA), the R3 metal liner is not cleared for use with the R3 Acetabular System, a total hip replacement system, but has been approved for use with the Birmingham Hip Resurfacing System.*

According to a report from Reuters, yearly revision rates among recipients of the recalled Smith & Nephew hip replacement device were above the rate Britain’s National Institute for Health and Clinical Evidence deems acceptable. Patients fitted with the device may be at risk for numerous complications, including infections, fractures and dislocations. However, Smith & Nephew has maintained that there is no evidence that the metal liner has caused metallosis, or increased metal debris in the body.**

Victims of serious complications allegedly associated with the Smith & Nephew hip recall may be entitled to compensation for their medical care, pain and suffering, and other damages. Additional information about filing a Smith & Nephew hip lawsuit is available at Bernstein Liebhard’s website. To arrange for a free, no obligation legal review of your case, please call 800-511-5092 today.

*fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm, FDA, June 1, 2012

**reuters.com/article/2012/06/01/us-smithnephew-hip-idUSBRE85010J20120601, Reuters, June 1, 2012

About Bernstein Liebhard LLP

Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.

Bernstein Liebhard LLP

10 East 40th Street

New York, New York 10016

800-511-5092

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

###

Contact Information:

Felecia L. Stern, Esq.

Bernstein Liebhard LLP

info(at)consumerinjurylawyers(dot)com

http://www.consumerinjurylawyers.com

For the original version on PRWeb visit: http://www.prweb.com/releases/smith-nephew-hip-recall/smith-nephew-hip-lawsuit/prweb10960667.htm

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports (prweb.com)
Smith & Nephew Letter (earlsview.com)
Biomet Hip Implants Alleged Poor Design Lead to Serious Problems (defectivehips.wordpress.com)
Stryker Hip Recall Claims Move Forward With Issuance of New Case Management Order in New Jersey Litigation, Bernstein Liebhard LLP Reports (prweb.com)
Smith And Nephew Unveils New Hip Device (smithnephewhip.wordpress.com)
$20 Million Lawsuit on Damages from Hip Replacement: Now, AttorneyOne… (prweb.com)
Increasing Number of Lawsuits for Smith & Nephew (debooramoore.wordpress.com)
Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
Hip Replacement Recall (ehipreplacementrecall.wordpress.com)

Filed under: Birmingham Hip Resurfacing, Cobalt chrome, Cobalt Poisoning, 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: arthritis, Cobalt chrome, Cobalt poisoning, Food & Drug Administration, Hip Replacement, hip resurfacing, Illinois, Limited liability partnership, Nephew, Smith, Smith & Nephew

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

Paige’s Hunger Strike – cancelled on legal advice

earlstevens58 — Wed, 17 Apr 2013 13:01:36 +0000

Hi everyone

I took down Paige’s page earlier today at the request of her son as he advised that Paige had discontinued her hungers strike on legal advice.

Hopefully there is a solution in sight?

Cheers

Earl

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Hip Replacement, metal-on-metal hips, Smith & Nephew

How coral can help you grow a new knee | Mail Online

earlstevens58 — Sat, 06 Apr 2013 23:21:38 +0000

How coral can help you grow a new knee | Mail Online.

How coral can help you grow a new knee

By PAT HAGAN

PUBLISHED: 21:04 GMT, 1 April 2013 | UPDATED: 23:53 GMT, 1 April 2013

A tiny implant made from coral could help repair knee joints crippled by osteo-arthritis. The implant helps to stimulate the growth of new cartilage from stem cells — the body’s own immature cells that can turn into any type of tissue.

Scientists chose coral because its structure resembles human bone so closely, providing the perfect scaffold for new cartilage and blood vessels to form inside the knee.

An estimated eight million people in Britain have some degree of osteoarthritis, which causes the destruction of cartilage — this is the body’s built-in shock absorber, soaking up the impact from walking, running or lifting, so bones do not rub together and disintegrate.

The new implant was developed by coating coral with human growth factors, which stimulate the creation of new cells in the body

However, with age major joints such as the hips, knees and wrists suffer wear and tear. Other risk factors include being overweight, having a family history of the condition and suffering sports-related injuries.

The cartilage starts to break down, making joints swollen and extremely painful. There are no drugs to cure it and many sufferers rely on anti-inflammatory pain-killers to ease their suffering.

But around 60,000 people a year in the UK end up needing a knee replacement because their joints are too badly eroded.

In recent years, researchers have focused on finding ways to regenerate cartilage inside the knee.

Coral has been used for bone grafts for a number of years — without some form of scaffolding, the implanted cells struggle to take hold. The coral naturally degrades as the new bone replaces it.

Scientists at a number of centres around the world noted the success of coral bone grafts, and are now investigating its use in cartilage replacement.

A team of scientists in Slovenia developed the new implant — called Agili-C — by coating coral with human growth factors, which stimulate the creation of new cells in the body. Experiments have shown that it stimulated the formation of cartilage and blood vessels by attracting a certain type of stem cell — known as mesenchymal stem cells — out from nearby bone marrow on to the scaffold.

Major joints such as the knees, wrists and hips suffer wear and tear with age

Results from early-stage animal studies show that after six to 12 months, the stem cells had formed a healthy new layer of cartilage and the coral implant had completely dissolved.

The first patient in Europe to receive the implant was a 47-year-old former athlete who suffered knee swelling and pain. The implant reduced pain, and increased mobility. Six months after treatment he was able to ski and a year later completed a 120-mile cycle race. A trial in Slovenia involving around 20 patients, aged from 18 to 55, with damaged knees is under way and the final results are likely to be announced next year.

The implant has been cleared for sale in the UK and Europe and could be launched on to the market later this year.

Commenting on the implant, a spokeswoman for Arthritis Research UK said: ‘This is interesting research and the use of stem cells to regenerate cartilage in people with a joint injury and even osteoarthritis has huge potential.

‘For instance, we are currently investigating how stem-cell therapy could be improved by differentiating between ‘good’ stem cells, which grow rapidly and make cartilage tissue, and ‘bad’ stem cells, which fail to grow. However, it’s very early days, and it has to be stressed that this kind of treatment is not yet available in the UK.’

***************************************************************************************

Meanwhile, scientists have discovered why arthritic knees hurt so much, and now hope to develop more effective painkillers for the condition.

Although the source of discomfort in severe arthritis is clear, as the bones can start to rub together, experts are still mystified why mild to moderate osteoarthritis causes pain. However, U.S. researchers, writing in the journal the Proceedings of the National Academy of Sciences, now believe they have found the molecule that triggers discomfort.

In lab-based experiments, they found that damaged cartilage releases a compound called monocyte chemoattractant protein, which triggers nerves to send pain signals to the brain.

They say that further drugs that either prevent the release of, or soak up, this compound may help to eliminate pain.

******************************************************************************************

Acupuncture might offer a shorter-term answer for painful knees. An NHS study of 90 patients, published in the journal Acupuncture in Medicine, revealed that a two-year course of the treatment (given once every six weeks) reduced discomfort and increased mobility.

How coral can help you grow a new knee (dailymail.co.uk)
How coral can help you grow a new knee (thisismoney.co.uk)
Controlling the Risk Factors for Osteoarthritis (everydayhealth.com)
The Stages of Osteoarthritis Progression (everydayhealth.com)
Protista #1 (biodiversitypulausemakau.wordpress.com)
Obesity and Knee Pain (everydayhealth.com)
Osteoarthritis and ACL Injury (an3blog.wordpress.com)
Zooxanthellae (biodiversitypulausemakau.wordpress.com)

Filed under: Knee Implants, knee injury, Knee Pain, Knee Replacement, Knee Replacement Recall, Knee revision, Knee surgery, Stem Cell Therapy, Stem Cells Tagged: arthritis, bone grafts, Cartilage, cartilage replacement, Conditions and Diseases, Coral, Health, Knee, knee mail, osteoarthritis, shock absorber, Stem cell

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

Smith & Nephew Hip Implant Patient Diagnosed with Metallosis

earlstevens58 — Tue, 05 Mar 2013 09:44:48 +0000

Smith & Nephew Hip Implant Patient Diagnosed with Metallosis.

Smith & Nephew Hip Implant Patient Diagnosed with Metallosis

March 3, 2013, 08:00:00AM. By Jane Mundy

Ramona, CA: Increasingly, more people are experiencing hip and knee replacement failure and undergoing revision surgery. Karen was given a metal-on-metal hip replacement and has recently been diagnosed with metallosis. “I had to get hip revision surgery and my kidneys are finally filtering out the heavy metals,” she says, exasperated.

Metallosis isn’t Karen’s only concern. She is also worried that the statute of limitations is running out – her first hip replacement was done in 2008; she had problems right from the get-go and they got worse.

“First of all it’s a pretty scary operation,” Karen says. “If you have ever bought a chicken and disjointed the leg from the breast you will know exactly how the surgeons bend you in half and pop the hip joint out of its socket.” Just eight weeks after she had that surgery Karen had her other hip done – she was only 60 years old.

“I got up the next day (after the second surgery) and discovered that my right leg was one inch longer than my left leg,” Karen explains. “They suggested that I wear orthotics – what a joke! Ten days later they pulled the staples, went back in and made my leg an inch shorter. Now I am about level. The right hip doesn’t have metal-on-metal everything; it has a plastic spacer. Why didn’t my first (left hip) replacement have the plastic spacer? Now my left hip is causing all the problems but the wear is uneven and my new surgeon is closely monitoring this issue.

“It wasn’t until the summer of 2011 that I researched metal-on-metal hips. About that time the DePuy recall hit the fan. I was never told that I had a metal-on-metal hip. I phoned my surgeon’s office and asked one of his staff if I had a DePuy hip. She said, ‘Don’t worry, you have a Smith & Nephew hip.’ My relief was temporary…”

(In June 2012 Reuters reported that Smith & Nephew recalled its metal hip replacement component due to a high incidence of complications associated with the device. At issue was the metal liner, which was marketed in 2007 – one year before Karen had her hip replacement. An estimated 7,700 individuals have been affected by the Smith & Nephew hip recall. According to the company, the majority of the recalled metal liners were used in stemmed total hip replacements.)

“Finally the pain got so bad that I found a new doctor,” Karen adds. “He took a lot of x-rays and ordered lab tests – I was diagnosed with heavy metal poisoning. The x-rays revealed the hip parts with no spacer and noted that the metal cup had slipped and was rubbing against a leg tendon with every step I took. That was the killer.”

Karen’s lab results showed dangerously high elevated levels of chromium and cobalt that are released into the blood as the metal components rubbed against each other. She was also diagnosed with stage 3 kidney failure, a direct result of metallosis. Her doctor recommended immediate revision surgery to get rid of metal components. Needless to say, she was shocked.

“In November 2011, two surgeons performed the surgery because they knew beforehand it was going to be difficult,” Karen says. “They removed the Smith & Nephew ball and cup, added the plastic spacer and secured the cup with a screw to my hip bone so it won’t slide. I still have a lot of soft tissue damage in both hips. To this day I can’t lie on my side, I have to sleep propped up and I have constant pain on bending my hips.

“I guess my kidneys are healing themselves but I can’t help but think if I had a better surgeon (than the first one) I wouldn’t be addicted to painkillers. Every time I complained and cried, he just kept giving me more Vicodin: Now I am totally hooked: I take six pills a day for pain and there is nothing more the surgeon can do, nothing can alleviate my problems. I am stuck with this.”

Back in 2008, Karen began to develop severe pain upon walking and it kept getting worse. She was very athletic and chalked it up to overuse. She found her original surgeon from an article in the San Diego newspaper “bragging” about how he did a hip replacement on a female firefighter and she was back on the job in six weeks. She contacted the woman who raved about this surgeon. What better recommendation could you get?

“I didn’t feel my age in 2008 but I sure do now,” she adds. “I found out that a lot of people in the US have Smith & Nephew parts. How do these medical device companies think their product is any different than, say, DePuy? I think the hammer is inevitably going to fall on all of them.

“I recently asked my new surgeon about all the pain in my hips and he just shrugged. I see a pain management specialist next week – I might have to go through a full drug withdrawal program; the more you take, the more you build up to the point that it can cause liver damage. Vicodan does nothing but dull the pain; it does not make me happy. It has just become a vicious cycle.

“I hate taking pills and now I am at my wits end, and I have spent tons of money with these revision surgeries. I just hope that a hip replacement lawsuit will get me some compensation.” Karen adds that she has kept all her surgery reports, all lab tests and she has the removed metal components from her first left hip surgery to serve as evidence.

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: arthritis, Cobalt chrome, Cobalt poisoning, DePuy, Health, hip, hip implant, Hip Replacement, hip revision, implant patient, Medicine, metal-on-metal hips, metallosis, NephewSmith, ramona ca, San Diego, Smith, Smith & Nephew, surgery

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg

earlstevens58 — Fri, 01 Mar 2013 23:51:32 +0000

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg.

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues

By Maurice Possley & David Voreacos - Mar 1, 2013 12:17 PM ET

Johnson & Johnson (JNJ)’s pursuit of profit led it to sell a defective metal-on-metal hip that failed faster than any similar device, a lawyer argued at the first of 10,750 lawsuits over the recalled implant to go to trial.

Jurors in Los Angeles heard closing arguments today on claims by Loren Kranksy, 65, that J&J’s DePuy unit defectively designed its ASR hip and failed to warn of the risks. Kransky attorney Brian Panish asked for compensatory damages of $5.3 million and punitive damages of as much as $179 million.

J&J, the world’s largest seller of health-care products, failed patients before recalling 93,000 ASR hips in August 2010, Panish said. At the time, J&J’s DePuy unit said 12 percent failed within in five years, requiring follow-up revision surgeries. The Australian rate hit 44 percent in 2012, he said.

“That design was defective from the first day they put it out,” Panish argued to the state court jury at a trial that began Jan. 25. “It was beyond what any hip had ever done to anyone in the history of the world. It’s not even close.”

J&J, based in New Brunswick, New Jersey, denies that it defectively designed the device or failed to warn of the risks associated with it. Analysts say resolving the lawsuits could cost the company billions of dollars.

After the summations, Judge J. Stephen Czuleger instructed jurors on the law. Deliberations are expected to begin tomorrow.

Kransky, a retired prison guard from Montana, had his hip implanted in December 2007 and removed in February 2012. His “diabetes, cancer, kidney disease, heart disease, vascular disease and his many other health problems are unrelated” to his hip, J&J attorney Michael Zellers said in his summation.

Injury Causation

“This case is about what caused Mr. Kransky’s injuries,” Zellers said. “The evidence is clear that Mr. Kransky’s injuries were not caused by a defect in the ASR hip. It’s not a case about a recall. It’s not about revision rates of the ASR today.”

Zellers denied claims by Kransky and his attorneys that the tissue around his hip was damaged because the device, made of chromium and cobalt, shed metal ions.

Kransky testified that he believed the debris was poisoning him, and he feared the revision because he thought it would kill him. Records show his metals level was eight times higher than the level DePuy considered acceptable.

“There is no scientific support that Mr. Kransky’s metal ions were toxic,” Zellers said. “The evidence in this case was that Mr. Kransky was not being poisoned and that the cobalt and chromium levels in his system were not toxic.”

Hip Infection

Zellers said Kransky’s revision came after his hip grew infected, not because of problems with the ASR.

“Mr. Kransky had an infected hip,” Zellers said. “That caused him pain. That pain caused the revision.”

Panish asked jurors to award Kransky $338,000 for his medical expenses and $5 million for his pain and suffering. Jurors also should impose punitive damages of $72 million to $179 million on DePuy, or 2 percent to 5 percent of the company’s value, Panish argued.

“This is a company that needs a solid message sent to them,” Panish said. “Nobody has ever accepted responsibility from DePuy. For a company in today’s world to do this to patients — unfortunately, it happens because the money corrupts. They don’t have a soul.”

J&J failed to test the ASR adequately before it was sold in the U.S. in 2005, and ignored reports by leading surgeons of mounting patient complaints, Panish said.

Metal Cup

Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup. Panish said DePuy failed to test the cup at any angle other than the optimum one of 45 degrees. Witnesses said that the steeper the angle, the greater the amount of metal debris that was shed.

Panish said the ASR was “unsafe at any angle.”

Zellers responded to Panish’s criticism of DePuy for failing to conduct a clinical study before selling the ASR.

“This was the mostly extensively tested device in DePuy history at the time,” he said. “They worked hard to develop a product that had low wear and would last a long time.”

He denied that DePuy hid its testing data.

“DePuy shared its information with everyone,” he said. “This was not something DePuy hid and kept in its laboratory.”

Implant Angle

He said the evidence showed that Kransky’s hip was implanted at an angle greater than 55 degrees.

“If you are going to put a cup in at that angle, you are going to get more wear,” he said.

Zellers told jurors that complaints about the hip jumped after the recall, and not because it was defective.

“When the recall occurred,” he said, “there were many, many, many complaints related to the ASR. That’s understandable. There was a lot of publicity. There was worry by patients.”

Kransky’s lawyers “have tried to make you angry at DePuy,” Zellers said. “They have tried to convince you that DePuy acted maliciously. DePuy set out to make the very best hip device they could make. DePuy is a good company. It has a superb reputation. DePuy is an open and honest company.”

In a rebuttal argument, Kransky attorney Michael Kelly derided Zellers for suggesting that revisions rose after the recall because of lawyers, like it was a “global conspiracy.”

He said revisions came two to four years after the implant, with the biggest year of U.S. sales in 2007, at 10,581.

“Surprise, surprise, these are the ones that are hurting people right on schedule,” Kelly said.

He said for DePuy to say Kransky had an infected hip was “complete, total, utter bunk.”

Kelly also told the jury that Zellers said there’s “no perfect hip.”

“Ladies and gentlemen, this is not an imperfect hip,” he said. “This is a public health disaster.”

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 atmauricepossley@gmail.com; David Voreacos in Newark at dvoreacos@bloomberg.net

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

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues (bloomberg.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
Johnson & Johnson Plaintiff: Profit Motive Led to Defective Hip Implant (counselheal.com)
J&J Expert Says Infection, Not Defect, Led to Hip Failure – Bloomberg (bloomberg.com)
J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – 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)
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)
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: arthritis, California Superior Court, Cobalt chrome, Cobalt poisoning, David Voreacos, Defective Hip, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Los Angeles, maurice possley, metal-on-metal hips, metallosis

J&J gambled on hip implant safety, lawyer alleges – latimes.com

earlstevens58 — Fri, 01 Mar 2013 23:27:35 +0000

J&J gambled on hip implant safety, lawyer alleges – latimes.com.

J&J gambled on hip implant safety, lawyer alleges

Johnson & Johnson ‘knew this hip was defective’ but failed to warn patients, a plaintiff‘s attorney says. The company said it acted properly and ‘put patients above money.’

Loren Kransky, shown in court with his wife, Sheryl, alleges he suffered metal poisoning and other health problems from Johnson & Johnson’s ASR XL hip implant. (Al Seib, Los Angeles Times / February 28, 2013)

By Chad Terhune, Los Angeles TimesFebruary 28, 2013, 5:59 p.m.

Healthcare giant Johnson & Johnson played “Russian roulette” with patient safety by ignoring high failure rates and surgeons’ complaints about its once-popular artificial hip, a Los Angeles jury was told during closing arguments at a high-stakes medical trial for the company.

Jurors heard arguments from both sides Thursday in a case that pits the world’s biggest seller of medical products against Loren Kransky, a 65-year-old former prison guard in Montana who claims he suffered metal poisoning and other health problems from the company’s ASR XL hip implant he received in 2007.

The company “knew this hip was defective long before Mr. Kransky got it,” Brian Panish, one of Kransky’s attorneys, told the 12 jurors and one alternate. “They wanted to play Russian roulette with patients. This defendant didn’t care about patient safety.”

J&J has denied Kransky’s claims that it designed a defective hip implant and failed to warn patients about the risks. Attorneys for J&J have said that Kransky’s ailing health was due to his diabetes, kidney cancer and other long-standing medical problems.

Based in New Brunswick, N.J., the company recalled about 93,000 ASR artificial hips in 2010 after they were tied to higher-than-expected failure rates. Last week, the company disclosed that federal officials are investigating the marketing of these hip replacements, a lucrative business as baby boomers age and their joints give out. The company said it is cooperating fully with the government inquiry.

The closely watched trial began Jan. 25, and it’s the first of several thousand suits to reach trial nationwide about this all-metal hip, introduced in 2005 by DePuy, the orthopedic division of J&J. The outcome of this case could portend what the financial fallout will be for J&J. Last year, the company took a $3-billion charge to cover costs related to the ASR hip recall, legal expenses and other related items.

The case went to the jury Thursday and deliberations are expected to begin Friday.

In closing arguments, Kransky’s attorneys portrayed J&J’s DePuy business as a “ruthless competitor” that repeatedly put profit ahead of patients.

Panish implored jurors to send a message to the company’s top executives that they couldn’t easily dismiss. He suggested that jurors award Kransky $5 million for his pain and suffering and up to $179 million in punitive damages against the company.

“All they care about is the money,” Panish said. “They aren’t looking at patients. They’re looking at balance sheets.”

The plaintiff’s attorneys showed jurors photos of Kransky smiling with his children and grandchildren before his hip surgery and then subsequent photos of him in drab hospital gowns while he battled severe medical problems.

Panish then displayed charts showing a 44% ASR hip failure rate among Australian patients who had the implant seven years. He also cited an internal DePuy analysis from 2011, a year after the recall, that estimated that 37% of patients who received the ASR hip implant may need to have it replaced within five years.

At trial, Kransky testified he was in constant pain, had difficulty walking and thought debris from the metal device was poisoning him. In the courtroom Thursday, Kransky sat just behind a row of attorneys in a charcoal gray suit and silver tie. He was surrounded by his wife, Sheryl, and other family members.

A few steps away, Michael Zellers, an attorney for J&J’s DePuy unit, urged jurors to focus solely on what caused Kransky’s injuries.

“The evidence is clear,” he told the jury. “Mr. Kransky’s injuries were not caused by a defect in the ASR XL hip or any conduct of DePuy.”

Zellers said the company had done extensive testing of the product before its launch and while it was on the market. Even with that, he said, debris from normal wear and tear on an implant is expected, as are a certain number of revisions, or replacement surgeries, to fix the original device. “There is no perfect hip design,” Zellers said.

Zellers told jurors that the company initiated the voluntary hip recall in 2010 because the product wasn’t meeting its performance standards. He said that action showed it “put patients above money.”

In Kransky’s case, Zellers said that the Montana retiree had an infected hip unrelated to his implant and that pain caused him to need a second surgery. “Mr. Kransky was not being poisoned,” Zellers said.

All-metal hips accounted for an estimated 40% of all U.S. hip replacements in 2008. But since then, they have fallen out of favor as concerns grew about their effectiveness and safety.

In an interview, Lisa McGiffert, director of Consumers Union‘s Safe Patient Project, said the ASR device and other metal hips have been used in an estimated 750,000 patients nationwide and many of those people have suffered serious medical problems as a result.

“These metal-on-metal hips are the poster child for what’s wrong with the way medical devices are brought onto the market,” McGiffert said. “The failure and complication rate from these hips was significantly higher than other hip replacements.”

Overall, product safety issues have become a major headache in recent years for J&J, long admired by consumers as a trusted medical name. The company has issued more than 30 product recalls since 2009.

Many of the recalls have involved common medications such as children’s Tylenol. The U.S. Food and Drug Administration put the company’s manufacturing practices under tighter scrutiny as a result.

These miscues haven’t damped investor enthusiasm for the company. Shares of J&J are trading near a 52-week high and were down just 21 cents Thursday at $76.11.

Jeff Jonas, a portfolio manager at Gamco Investors in New York and a J&J shareholder, said there was some concern about the amount of litigation against the company and the potential damage awards from juries. But he said investors remained confident J&J could weather the legal storm.

“It’s something that the company can easily afford,” Jonas said. “They appeal these cases and drag them out for years and years.”

Superior Court Judge J. Stephen Czuleger ruled against a defense motion for a mistrial Thursday after Kransky’s attorney mentioned the thousands of other patients who are suing J&J’s DePuy unit when asking jurors to award punitive damages.

chad.terhune@latimes.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.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
Business: Washington Post Business Page, Business News (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 Defective Hip Implant Claims | eLocal (elocallawyers.com)
Johnson & Johnson Plaintiff: Profit Motive Led to Defective Hip Implant (counselheal.com)
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (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, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, Johnson, Johnson & Johnson, latimes.com, Lawyer, Medicine, Metal on metal hip, Plaintiff, Smith & Nephew, UNited States

Earl's View » arthritis

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

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

Published: November 12, 2013

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J&J Profit Pursuit Led to Defective Hip, Lawyer Argues

Injury Causation

Hip Infection

Metal Cup

Panish said the ASR was “unsafe at any angle.”

Implant Angle

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J&J gambled on hip implant safety, lawyer alleges – latimes.com

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Johnson & Johnson ‘knew this hip was defective’ but failed to warn patients, a plaintiff‘s attorney says. The company said it acted properly and ‘put patients above money.’

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