Cobalt Chromium Toxicity

depuy pinnacle attorney

DePuy Pinnacle 2016 Trial Update 2

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the ongoing DePuy Pinnacle metal-on-metal hip trial that is currently taking place in Dallas, Texas. This cases involves five separate plaintiffs who allege they were injured as a result of metal debris that was being released from these metal-on-metal hips.

So, the plaintiffs called Andrew Ekdahl, DePuy’s former CEO, to the stand. Mr. Ekdahl has a long history of being in sales and marketing. He eventually worked his way to becoming CEO of this company. There was a big emphasis on the cross-examination of Mr. Ekdahl about his marketing background, and how someone with his background was running the company as opposed to someone with an orthopedic or scientific background.

One of the things that took up a lot of the day was cross-examination concerning memos from 1995. The story that’s being told through this trial is that in 1995 DePuy became aware that other manufacturers of hips were coming out with other bearing surfaces. So, at this point in time, most hips were made out of metal and plastic; plastic liners with the metal ball. There was a push in the industry to come out with metal-on-metal hips.

In 1995, DePuy got its lead scientists together to look at these other bearing surfaces. There is a detailed memo that was prepared by DePuy’s head of science where he describes the different bearing surfaces for the hips. He concludes that metal-on-metal has a history of not being a very good bearing surface. He talks about how in the sixties and seventies manufacturers came out with metal-on-metal hips, and there were lots of problems with metal wear debris.

In this memo, he talks about how the failure rate of these hips was much higher than with metal-on-plastic, how the metal-on-metal hips were leeching cobalt and chromium, and how toxic and poisonous those metals can be compared to hips with plastic.  Hips with plastic debris typically do not cause a lot of problems compared to the metal debris. In the memo, the head scientist at DePuy also says from the standpoint of innovation it makes more sense to come out with a better plastic, and modify the metal-plastic design than it does to go with the metal-on-metal design that has been shown to fail in the past. For some reason, the advice of DePuy’s head of science did not carry the day. DePuy eventually went into the metal-on-metal market with the DePuy Pinnacle, and then eventually the DePuy ASR Hip, which is recalled.

Interestingly, in the cross-examination there was also discussion about a meeting that took place with several doctors hired to come in and talk about these different bearing surfaces. There are minutes of this meeting which occurred back in 1995. The plaintiffs’ attorneys discuss how in 1995 the doctors who were consulting with DePuy indicated that a metal-on-metal design could potentially lead to litigation. So, there was this knowledge back in 1995 that metal-on-metal hips have failed in the past, that their failure rate was bad, that the danger from a metal-on-metal hip in the debris was much different, and more dangerous for the patients than the metal-on-plastic design. For some reason, DePuy chose to ignore all this advice in 1995 and went ahead with the metal-on-metal hip design. Apparently, this decision was based on market share.

There was also discussion at the trial with Mr. Ekdahl about the marketing and the way DePuy marketed its hips. DePuy spent millions of dollars on taking surgeons to dinner, go to conferences to talk about the benefits of metal-on-metal hips. The plaintiffs’ attorney went through some of the financial records in the budgets and it turns out that DePuy was actually spending more money on marketing and advertising than it was on research and development during this time period.  There was a big push to get market share.

The other issue that was mentioned during trial was that the doctors, the ones who were flying all over the country getting paid millions of dollars to talk about how great the metal-on-metal hips were, stopped using those hips almost within a year or two after they started. There were some doctors who only used it for two years. They saw the problems with the hips and they stopped using it. Despite, DePuy continued selling the Pinnacle hips to the public.

At the end, there was also lots of discussion about the way the DePuy Pinnacle was approved by the Food and Drug Administration (FDA). The defendants like to make a big deal of the fact the hips were approved by the FDA, so it must be a good product. During trial, it was stated that the hip was approved through a loophole in the FDA process. It was approved via the 510K process, a process where you can go to the FDA with a product, a product substantially similar to one approved previously but has a minor modification. Essentially, that’s how the hip was approved. DePuy submitted something similar to a hip that was already approved and on the market, and the FDA rubber stamped it. So, there was no testing, no clinical trials and nothing submitted to the FDA to prove that the device was safe and effective. Instead, all DePuy had to prove was that the Pinnacle was substantially similar to something else that was already on the market. The problem is that the device that was substantially similar to the Pinnacle was eventually pulled from the market because it was defective and had problems with metal wear debris. That respective device was also pulled from the market because it was shown to be substantially similar to these hips back in the sixties and seventies that were also pulled from the market.

The plaintiffs’ attorney did a great job demonstrating the “chain of devices” that led to the Pinnacle hip. The demonstration showed all of these devices had failed in the sixties and seventies, they failed in the early two thousands and they failed at the end of 2010. This completed the testimony for the day and it was definitely a good day for the plaintiffs. The defense has yet to go but there are some really damaging documents that were presented. The 1995 memos were very good for the plaintiffs and they support the fact that DePuy really knew there were problems with these metal-on-metal hip designs before they released the device on the market.

Closing Arguments in the DePuy Pinnacle Trial began October 21, 2014

Closing arguments in the DePuy Pinnacle Trial started Tuesday, October 21, 2014. Closing arguments are essentially where each side, plaintiffs and defendants, summarize the evidence put forth at trial and argue their case to the jury.

In this case, Mark Lanier, the plaintiff’s attorney, will likely argue that DePuy was at fault for the plaintiff’s injuries and the jury should award her damages accordingly.

On the other hand, the defendants will likely argue that the plaintiff’s injuries were not caused by the Pinnacle implant but rather caused by negligence from her doctor, or other factors, and should deny recovery.

DePuy Hip Recall Tweets about Pinnacle Hip Help Website

DePuy Pinnacle Trial Status (Week 7 10/13-10/16)

DePuy Pinnacle Trial Status (Week 7 10/13-10/16)

Monday, October 13th was Columbus Day and the courts were closed.

On Tuesday, October 14th, the defendants called Dr. Roger Emerson, an Orthopedic Independent Medical Examiner, to the stand.

Dr. Emerson returned to the stand on Wednesday, October 15th. His testimony was followed by Dr. Math, an orthopedic radiologist.

Andrew Ekdahl, the ex-president of Johnson & Johnson’s DePuy unit, returned to the stand via video deposition on Thursday, October 16th. He was followed by Dr. Lisa Pruitt, defense witness, and a mechanical and biomedical engineer who teaches at the University of California, Berkeley. Her testimony will resume Monday, October 20th.

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. 

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