Cobalt Chromium Toxicity

DePuy ASR Lawsuit Upcoming Deadline


Hi, I am Stuart Talley. I am the partner responsible for the DePuy ASR litigation. I am providing information about a category of case that is involved in the DePuy ASR lawsuit relating to non-revised cases.

There are numerous claimants with cases on file against DePuy who still have their ASR hip. These are considered non-revised cases. There is an upcoming election process specific to non-revised cases. The election must happen before January 31, 2015. The election relates to your individual circumstances.

There are some non-revised cases where people have minimal problems with the hip. For instance, they have slight pain, low metallosis levels, and their doctors indicated they do not need revision surgery. Those individuals can elect to have their case dismissed without prejudice, preserving your rights if your case is dismissed. Additionally, the statute of limitations on your case is tolled. Tolling the statute of limitations is essentially delaying the statute of limitations. So, from the moment you dismiss the case to the moment you refile, the statute is not running.  You can refile your case if you require revision surgery in the future.

The other non-revised case is unique. There are individuals with a DePuy ASR who require revision surgery but are unable to undergo revision surgery because of an underlying medical condition. Many individuals underwent multiple hip surgeries before implantation with the DePuy ASR. Their surgeons do not want to operate even though the ASR implant is leeching cobalt and chromium and causing damage to their hip. If you fall into this category, your case does not need to be dismissed. This case can potentially go to trial and possibly win. The key to a case for an individual with a health issue is proving the cobalt and chromium ions cause tissue damage in the hip joint.  You need blood tests every six months and imaging studies (e.g. MARS MRI) to show the damage. The MARS MRI is an MRI for patients implanted with metal artifacts and implants. It can show pseudotumors and other inflammatory responses in the soft tissue of your hip.

 

J&J May Pay $250 Million to Settle 1,000 More Hip Claims


(Bloomberg)- Johnson & Johnson (JNJ) may pay more than $250 million to resolve suits over its ASR hip implants that were excluded from a $2.5 billion settlement of similar claims last year over the device’s failure, two people familiar with the accord said.

J&J, the world’s largest seller of health-care products, is weighing whether to settle more than 1,000 lawsuits over removals of the recalled hip implants that occurred after August 2013, said the people, who requested anonymity because they weren’t authorized to speak publicly about the accord. The hips were made by J&J’s DePuy unit.

The company is considering extending the same settlement terms that covered patients who had their ASR implants removed earlier than last summer, the people said. Under that accord, J&J agreed to pay an average of about $250,000 per surgery and cover related medical costs to resolve about 8,000 cases.

“This is a sign that J&J is trying to get a solid handle on its whole ASR problem,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “They are not done paying yet, but they are moving in the right direction.”

If J&J resolves the additional suits, it will have settled about 75 percent of its total U.S. caseload. The total cost of the settlements over ASR, which stands for articular surface replacements, may exceed $4 billion by the time J&J resolves the remaining implant cases, Tobias said. The accord doesn’t cover hip litigation outside the U.S.

For the article, please visit: J&J May Pay $250 Million to Settle 1,000 More Hip Claims – Bloomberg (Jef Feeley)

DePuy Hip Recall Tweets about Pinnacle Hip Help Website


Metal-on-Metal Hip Implants and Revision Surgery


Patients undergo hip replacement surgery in order to improve their quality of life. Hip replacement surgery is supposed to increase activity levels, improve range of motion, and ease pain and suffering. Unfortunately, after their index (initial) surgeries, individuals soon find their hip replacement is hindering rather than helping. This is often the case with metal-on-metal hip replacements.

Metal-on-metal hip systems such as the DePuy PinnacleDePuy ASRStryker Rejuvenate, Stryker ABG IIStryker AccoladeWright Pro Femur and Wright Conserve, have the highest failure rate compared to any other hip implant. Most individuals experience serious complications and subsequent failure with these implants. Complications from metal-on-metal hips include cobalt-chromium toxicity, metallosis, pseudotumors, infection, loosening and implant wear, joint stiffness, and fracture. These complications cause implant failure. Implant failure requires a second surgery, known as a revision surgery. A revision surgery requires removing the failed implant(s) and replacing with a new device.

Revision surgery is more complex and risky than the index surgery because it is more invasive. Therefore, the risk of complications is greater with a revision surgery than initial surgery. The implants are more likely to loosen, migrate, and fracture since the bone and hip joint are severely manipulated from the previous implant.

Hip Surgery: The Importance of Doctor-Patient Communication


An open and honest dialogue with your doctor before surgery contributes to better outcomes. This means providing your physician with a comprehensive medical, surgical, and social history. This also ensures the doctor gives you the best care in creating a plan that fits your specific needs. Before any surgery, it is essential to voice any questions or concerns you might have.

The American Academy of Orthopedic Surgeons (AAOS) created a list of questions which may help in discussions with your doctor:

  • What are your experiences with specific hip implant devices and how often do you use one over the other?
  • What are the risks and benefits of different devices (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, and ceramic-on-ceramic devices)?
  • If applicable, what is the surgeon’s personal experience and outcomes with the respective devices?
  • If your surgeon recommends a certain device, ask why that hip implant is the best for your situation.
  • What are the major and/or most frequent complications of surgery?
  • Is the skill and experience of the orthopaedic surgeon more important than the device or procedure?
  • Can you give me any information on outcomes and complication rates?
  • If I do not have surgery, what is the risk?
  • How much pain can I expect, and how will it be managed in the hospital and after I go home?
  • How long will the device last, and what can I do to make it last as long as possible?
  • What are the pros and cons of minimally invasive (mini-incision) surgery? Does it really make a meaningful difference in the result, or does it pose unnecessary risks?
  • What will I be able to do/not do after my total joint replacement?
  • Is therapy necessary after surgery?
  • How long will I be in the hospital?
  • Will I be able to contact you after the surgery if I have a question or problem?

What should I do if I have a metal on metal hip?


A series of product recalls involving prosthetic hips occurred recently. The design of these hips led to the release of toxic levels of cobalt and chromium (the metal the hips are made of) into the patients who receive them.  These metals cause extensive tissue damage in the hip and other areas of the body. This usually requires additional surgery to repair. Kershaw, Cook & Talley currently handles cases involving the following types of hips: DePuy PinnacleDePuy ASRStryker AccoladeStryker Rejuvenate, Stryker ABG IIBiomet, and Wright Medical.

Many individuals are unsure what to do when they find out their metal on metal hip is defective or recalled. Kershaw, Cook & Talley recommends the following steps:

A) Find out what name and model hip you have. There are various ways to do this:

  1. Contact your orthopedic surgeon by phone. 
  2. Request a copy of your medical records in writing from the orthopedic surgeon’s office or hospital where the surgery was performed. 
  3. Check your implant card. Often times, after surgery, your doctor gives you an implant card which states the hip name and type. 


B) Check to see if your hip implant was officially recalled (if not, you may still have a case).

  1. You might have received a recall letter notifying you that your hip implant was recalled. 
  2. If you did not receive a letter, ask your doctor if your hip implant was recalled. 


C) Have your blood tested for cobalt and chromium:

  1. Tell your doctor you want to get your blood tested specifically for cobalt and chromium. 


D) Get a MARS MRI:

  1. MARS MRI stands for Metal Artifact Reduction Sequence MRIA MARS MRI is an imaging technique which minimizes metal artifact (i.e. parts of the implant) while maintaining image quality.
  2. You will most likely have to request this imaging study from your orthopedic surgeon. 

F) Call our office for a free case consultation and if you have any more questions regarding your metal-on-metal hip. 

Is your DePuy Pinnacle harming you?


People might think because the DePuy Pinnacle is not recalled it may not be harmful. This is false!  

The DePuy Pinnacle is a metal on metal hip replacement system: the ball and socket of the device are made of metal. Nowadays, the words “metal on metal” are enough to trigger a worried response from individuals implanted with these types of hips. And rightfully so.

With metal on metal implants, like the DePuy Pinnacle, the metal ball and metal socket rub against each other during activities. Metal is also released from implant parts where two components connect. Metal release results in metal ions to wear off the device causing damage to bone and soft tissue surrounding the implant and joint. This is known as an adverse local tissue reaction or adverse reaction to metal debris.

Adverse reaction to metal debris can cause pain, device failure, and implant loosening which may lead to needing a revision surgery. When metal ions are released into the bloodstream, it can precipitate a systemic reaction and cause other issues including skin rash, cardiomyopathy (a heart condition), neurological impairment, psychological changes, and thyroid abnormalities. The long term effects of exposure to these metal devices is unknown.

We highly recommend you speak to a doctor immediately if you have a DePuy Pinnacle whether or not you are experiencing the aforementioned symptoms. 

DePuy Pinnacle Trial Update: Week 6 10/6-10/9



We are providing an update on the ongoing DePuy Pinnacle trial now pending in federal court in Dallas, Texas. This is the very first case to be tried in front of a jury in the country. There are about 6,000 cases now pending against DePuy by people who were injured by their Pinnacle hips. We are now in the sixth week of the trial.

This week in the trial we continued with the defense case and the witnesses DePuy is putting on the stand. They introduced a series of expert witnesses to talk about all of the things DePuy did to test and get the Pinnacle hip approved by the FDA. The purpose of the testimony is to give jurors the impression that DePuy is a responsible company, and that they performed all the appropriate tests the FDA required, and really didn’t do anything wrong. There is a problem with that argument. The way the FDA works is unique. A lot of people believe when the FDA approves a product, they thoroughly investigated the product and decided that it’s a good product, it’s safe, and the warnings are adequate. The truth is something different. With medical devices, such as hips, manufacturers are not required to test the device. They can get approval from the FDA to sell the device with almost no testing at all if they show the device is substantially similar to another design that is already on the market. The issue with whether FDA approval means the device is safer, or the company did the right thing, really doesn’t mesh. So, when the FDA approves a device, they are not saying they tested it. The FDA doesn’t really test devices. The FDA relies on manufacturers to test the devices, and the manufacturers tell the FDA they tested the device. That’s when the FDA approves the device.

DePuy is trying to create the impression that because this was FDA approved it was a safe device and their testing was appropriate. In reality, this isn’t true.

The next phase of the trial will be the plaintiff’s rebuttal witnesses, present witnesses to rebut the arguments the defendants have made.

The correlation between prostheses failure and elevated metal ion levels in patients


This study focuses on whether or not higher metal ions in the blood could help determine the likelihood of prostheses failure in patients with metal on metal (MOM) implants or total hip arthroplasty. The study involved 597 patients who received hip implants approximately one year prior. Patients with failed prostheses and patients with non-failed prostheses were compared via their blood metal ion levels. A prosthetic was considered a failure if they were revised, a revision was pending, or the patient reported poor hip function.

Patients with failed implants had elevated cobalt and chromium blood levels compared to patients with non-failed hips.  Patients with failed hip resurfacing (replacement of the joint’s articular surface) had less blood cobalt levels than patients with failed total hip arthroplasty (surgical removal of the femur’s neck and insertion of a stem deep within the bone connecting with the pelvic socket and liner). There was not a significant difference in blood chromium levels between the two procedures.

The presence and amount of the metal ions were good indicators of whether or not a hip would fail. There was a 23% increase in failure among patients with a total hip arthroplasty for each increase in 1 part per billion (µg/L) of metal ions. Whereas, patients with hip resurfacing had a 5% increase in failure with each increase in 1 part per billion (µg/L ) of metal ions.

In conclusion, there was a direct correlation between higher levels of blood metal ions and metal on metal hip resurfacing and total hip arthroplasty failures.

Source: Surveillance of Patients with Metal-on-metal hip resurfacing and total hip prostheses

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