Cobalt Chromium Toxicity

depuy trial

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 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.

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?

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.

DePuy Pinnacle Trial Status (Week 6 10/6-10/9)

DePuy Pinnacle Trial Status (Week 6 10/6-10/9)

The defendants filed their 3rd motion for mistrial during the weekend of October 5th.

On Monday, October 6th, the defendants called their regulatory expert, Timothy Ulatowski. His testimony filled the entire day.

Tuesday, October 7th, the defendants had Dr. Schmalzried return to the stand for examination. His testimony occupied the entire day.

Dr. Schmalzried’s testimony concluded on Wednesday, October 8th. Dr. Heinrich, the defense orthopedist, returned to the stand and his testimony took the remainder of the day.

The defendants played video depositions on Thursday, October 9th. The video depositions were of the following individuals:

  • A 26 year DePuy employee and Tribology manager 
  • A J&J Worldwide director of Engineering systems
  • A former DePuy employee, mechanical engineer, and alternate bearing project team member 
  • Design Orthopedic Surgeon

DePuy Pinnacle Trial Update Four (Week 1 9/2-9/7)

Hi, I’m Stuart Talley with Kershaw, Cook & Talley LLP. Bill Kershaw and I are the partners responsible for providing a status update on the DePuy Pinnacle litigation.

We are providing an update on the recent DePuy Pinnacle trial that started in federal court in Dallas, Texas on September 2, 2014. The trial involves Kathleen Herlihy-Paoli’s case. This is the first case of more than 6,000 cases on file involving DePuy Pinnacle tried in front of a jury.

Today at trial, there was continued testimony from Andrew Ekdahl, ex-CEO of DePuy. The plaintiff’s attorney is unraveling the defense’s argument stating the risks of metal on metal hips were well known to the medical community. During opening statements, the defense attorney claimed everyone knew of the issues associated with metal on metal hips and they were well studied for 75 years. The plaintiff’s attorney presented Mr. Ekdahl with multiple internal DePuy documents indicating DePuy engineers and scientists repeatedly acknowledging the risks of metal ions, particularly cobalt and chromium, and the biological impact they have on the body is not well known, well studied, and more research is necessary. There are a myriad of documents demonstrating DePuy did not know the impact of metal ions before they launched the Pinnacle. There are other documents revealing people proposed performing studies and undergoing research regarding these issues, months and years the DePuy Pinnacle is released on the market. Mark Lanier, the plaintiff’s attorney, did a powerful job of presenting this testimony and evidence to the jury.

Mr. Lanier also discussed advertising for the DePuy Pinnacle. The Pinnacle was highly advertised. It was advertised directly to consumers, doctors, and even magazines. Mr. Lanier addressed numerous claims in the advertising as bogus. Mr. Ekdahl, the defense, did not concede they were bogus. But it was obvious from testimony, witnesses, and documents the claims were bogus. The claim that 99.9% of the hips survive for 5 years after implantation was considered the most bogus; statistics presented in the trial show this is false. There was also a document presented to the jury from the early 2000s. The document confirmed scientists, who studied problems with metal on metal hips, recommended to DePuy it was vital surgeons and patients were warned of the risks associated with metal debris, and the unknown nature of how it impacts the body. Mr. Lanier presented ads, brochures, and other marketing material provided to doctors and patients. He pointed out that none of the materials contained the “vital warning” from DePuy’s internal memos.

The other picture painted during testimony illustrated DePuy’s position in the industry during the time the Pinnacle was launched. DePuy did not have much market share when the Pinnacle was launched. Their market share position was low ranking and they struggled.  The documents show the metal on metal version of the Pinnacle was DePuy’s ticket; their foothold into the industry. At the time, their competition did not have metal on metal hips. Over time, this greatly increased their market share, and revenue, since they sold over a billion dollars’ worth of hips per year. The documents also showed the metal on metal hips comprised 50% of their revenue during this time period. DePuy had the big incentive to rush this product on the market with no concern for testing or anything which would hurt their sales.

DePuy Pinnacle Trial Update Three (Week 1 9/2-9/7)

Hi, I’m Stuart Talley with Kershaw, Cook & Talley. Bill Kershaw and I are the partners responsible for providing a status update on the DePuy Pinnacle litigation case.

We are providing an update on the recent DePuy Pinnacle trial that started in federal court in Dallas, Texas on September 2, 2014. The trial involves Kathleen Herlihy-Paoli’s case. This is the first case of more than 6,000 cases on file involving DePuy Pinnacle tried in front of a jury.

We are now on the third or fourth day of the trial. Today, we heard once more from Andrew Ekdahl, ex-CEO of DePuy and defendant in the case. He was responsible for the hip unit when the Pinnacle was first launched. This is his second day on the stand.

If you followed our previous video updates, an argument the defendants are making is the reason the plaintiff’s hips failed is a result of the surgeon’s error and not the DePuy Pinnacle. The plaintiff’s attorney, Mark Lanier, was cross-examining Mr. Ekdahl. Mr. Lanier asked him about the warnings and literature regarding the DePuy Pinnacle hip. Mr. Ekdahl admitted the literature lacks sufficient material concerning the dangers of implanting the hips at the wrong angle. Mr. Lanier demonstrated there were discrepancies in the literature. In the literature, they told doctors the hip should be implanted between 10 and 20 degrees, and then at another point 10 to 30 degrees. Mr. Ekdahl could not explain this discrepancy and basically said it was a typo. This typo was distributed to approximately 7,000 surgeons. This was powerful testimony.

Another aspect of trial focused on a series of emails that came out between 2008 and 2010. During this time period, DePuy is receiving reports the hips are failing. DePuy was placing the surgeon at fault instead of looking at or trying to see if their product was defective in some way. DePuy was saying the surgeons were lazy and implanting the hips at the wrong angle. There were emails between various individuals stating DePuy was losing credibility in the medical community about the angles. The medical community did not agree with DePuy’s position the hips were failing secondary to the angles.

DePuy then decided to create an “education campaign”. They wanted to educate surgeons on the importance of implanting these cups at the right angle. This was in stark contrast to DePuy’s opening statement where they told everyone the appropriate angles are well known. The emails proved DePuy was contemplating starting an educational program about the angles which DePuy previously considered obvious knowledge. The emails also showed the individuals in charge of the education campaign asked engineers and surgeons for advice on the ideal angle for their own hip. This substantiates DePuy, or their engineers, didn’t even know the appropriate angle for these hips years after it was released. This undercut DePuy’s defense that surgeons know the appropriate angle and the surgeon was at fault.

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