Cobalt Chromium Toxicity

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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 (Week 5 9/29-10/2)

The defendants filed their second Motion for Mistrial on Saturday, September 27th. On Monday, September 29th, the defendants finished cross examining Scott Bayley, an economist. He was followed by John Paoli, the plaintiff’s husband. Two additional witnesses will take the stand: Dr. Greg Sawyer, a tribologist, and Dr. Vicki Colvin, a cell biologist.  The Defense called Dr. Scott Nelson, an orthopedic pathologist, as their first witness. Plaintiffs will continue their presentation of their case at a later date.

Dr. Scott Nelson, defense orthopedic pathologist, returned to the stand for continued direct examination on Tuesday, September 30th.  He was then cross examined, subject to redirect, and excused.  His testimony was followed by defense witness Dr. Pat Campbell, UCLA Professor of Orthopedic Surgery.  She returned on Wednesday, October 1st, and took the stand for the day. She concluded her testimony on Thursday, October 2nd. Defense witness Dr. Matthew Henrich, an orthopedist specializing in hip and knee replacements, followed. His testimony was halted and the plaintiffs called Dr. Vicki Colvin to the stand. Dr. Heinrich will return to the trial at a later date.

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.

DePuy Pinnacle Trial Update Two (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 was an interesting day in court. The plaintiff called Andrew Ekdahl, ex-CEO of DePuy and defendant in the case, to the stand. He is the very first witness the plaintiff called. Mr. Ekdahl has absolutely no medical or engineering background. He advanced through the company as part of the sales division. He was always a salesman. The plaintiff’s attorney was adamant in establishing DePuy really had a culture of doing whatever it takes to sell. The people running the show were salesman, and were in the marketing arm of the company.

During the plaintiff’s attorney opening statement, he indicated people in sales and marketing were involved in decisions on the design of the hip and in testing the hip. This is essentially unheard of in the medical device industry. Generally, there is a separation between the people responsible for safety and the people responsible for selling the device. During Mr. Ekdahl’s testimony, it was clear those lines were blurred at DePuy.

Testimony established Mr. Ekdahl is a marketing man with limited experience in medicine or engineering. He demonstrated after all the problems with this hip, and other DePuy hips, nothing befell Mr. Ekdahl. In fact, he was promoted multiple times. The plaintiff’s attorney got the defendant to admit that instructions for the device contained little information about the angle at which the hip should be implanted. Mark Lanier, the plaintiff’s attorney, argued DePuy provided essentially no training for surgeons regarding implanting the cup at the appropriate angle.

DePuy Pinnacle Trial Update One (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.

The outcome of Herlihy-Paoli’s case is an important precedent for the other cases. Generally, in mass tort litigation, the first few cases going to trial are “bellwether” or test cases. A bellwether trial is a selection of representative sample of cases tried in front of a jury. Bellwether cases are normally demonstrative of matters which may arise in every injured party’s case. The idea of bellwethers is providing an indication of the outcome of future trials, and gaining enough information to determine whether or not cases should be settled and the approximate monetary compensation of those settlements.

Ms. Herlihy-Paoli suffered from a condition known as congenital hip dysplasia. Hip dysplasia is a deformity of the hip joints. It is a common condition requiring hip replacements. She was in her forties when implanted bilaterally (in both hips) with DePuy Pinnacles. She had pain and heard of the issues concerning metal on metal hips. She had blood tests which revealed her cobalt levels were over 400 parts per billion. Normal cobalt levels are less than one part per billion.

In respect to Herlihy-Paoli, her case is unique. The manufacturer provides minimal guidance on the appropriate angle of the cup. It is important the surgeon implants the cup at an angle that will ensure the hip is stable so that it doesn’t fracture or dislocate in the future. Due to Ms. Paoli’s hip dysplasia, her hips were implanted at an unusual angle, steeper than most people, during her index (initial) surgery. Subsequently, she required bilateral revision of her DePuy Pinnacle hip implants. In her first revision, the surgeon replaced the metal liner with a plastic liner but left the hip at an extreme angle. In the second revision, the surgeon replaced the cup entirely and changed the angle of the cup. After both revisions, both hips had plastic liners but one hip was at an extreme angle and the other at a more neutral angle. Ms. Paoli suddenly had a catastrophic failure of the hip remaining at an extreme angle. The plastic liner in that hip shattered and she required another surgery. She has undergone five hip surgeries since developing hip problems.

On September 3rd, we had opening arguments. Opening arguments consist of the plaintiff’s attorney, and defense attorney, telling their story to the jury and providing a summary of the evidence. Mark Lanier, the plaintiff’s attorney, is one of the best trial attorneys in the country. Mr. Lanier did an unbelievable job in his opening statement. He focused the case on the marketing for the DePuy Pinnacle. He discussed how surgeons were informed that the DePuy Pinnacle was indestructible. In DePuy’s advertising, they told surgeons 99.9% of the hips were still implanted. Essentially, they were telling surgeons the failure rate of the hip was 0.1%. According to Mr. Lanier, the failure rates were closer to 15% not 0.1%.  Mr. Lanier talked about numerous documents and witnesses that he will present. He is establishing DePuy knew the Pinnacle had a very high failure rate and knew it was not as good as the metal-on-plastic hips but hid this from the medical community; they did everything they could to prevent this information from getting out. This is the heart of the plaintiff’s case; the idea surgeons were misled regarding this hip and information about its dangers were kept hidden from the public.

The defense attorney told the jury to ignore all the marketing issues and failure rates, and focus on the fact these hips were implanted at an extreme angle. From the defense standpoint, no matter what kind of liner Herlihy-Paoli had in the cup, she was going to have problems anyway. Their supporting evidence is the fact that the hip with the plastic liner, the one which failed recently, was at an extreme angle. In the defendant’s mind, the proof is regardless of the liner type, she was going to have these problems and surgeries anyway. The defense is blaming the surgeon. He stated all surgeons know about the “safe zone” or range of angles to implant these hips without any problems. He argued the surgeon who implanted Ms. Paoli with her hip violated the safe zone.

Later, the plaintiffs will call their first witness, Andrew Ekdahl, ex-CEO of DePuy and defendant in the case, to the stand. He was heavily involved with the development and marketing of the hips. As the trial progresses, visit our website for further updates.


Trial is Underway Regarding Johnson & Johnson’s DePuy Pinnacle

Tuesday, September 2, 2014 marked the first bellwether trial regarding the Johnson & Johnson (J&J) DePuy Pinnacle metal on metal hip implant. As of yet, the device is not recalled but gained notoriety over several reports of side effects from design flaws and metal poisoning.

The DePuy Pinnacle, similar to its recalled counterpart, DePuy ASR, places patients at significant risk for elevated levels of cobalt and chromium in their blood. Additional problems with the DePuy Pinnacle may include infection secondary to metallosis, pseudotumors, severe hip pain, and other life threatening complications. An internal memo via DePuy highlights concern from Dr. Thomas Schmalzried who foreshadowed the release of metal debris into the bloodstream.

Kathleen Herlihy-Paoli, a Montana resident, the first of the bellwether trials, claims the DePuy hips leeched cobalt and chromium into her blood stream precipitating an infection. Consequently, the pain from infection required removal of the devices. Mark Lanier, Herlihy-Paoli’s attorney, suggests J&J knew of the metallosis poisoning from the hips as early as 2001.

Voir Dire (jury selection) occurred on September 2. The trial will proceed with a nine member jury composed of five women and four men, including an attorney and a PhD pharmacist. Subsequently, on Wednesday, September 3, opening statements occupied the morning. In the afternoon, Andrew Ekdahl, ex- DePuy President, took the stand. He was head of marketing during key periods in question. Currently, he is chairman of DePuy Synthes unit’s global orthopedic business. Ekdahl implies this is a promotion from his previous position. His testimony monopolized all of Wednesday afternoon as well as Thursday, September 4. Trial is not held on Fridays.

On Monday, September 8th the parties are scheduled to question Polly Cary, Product Director of Marketing for DePuy, and Dr. John Abramson, DePuy’s Healthcare Policy/Information Integrity expert.

* The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 12- cv-3590, U.S. District Court, Northern District of Texas (Dallas).

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

Broadspire and Hip Recalls

Stryker and Depuy hip manufacturers employ Broadspire, a third party claims administrator, to deal with individuals filing claims concerning their recalled prosthetic hips. Broadspire essentially functions like an insurance claims adjustor. They obtain information confirming people are implanted with recalled Stryker and Depuy hips. Subsequently, they decide the “appropriate” compensation for individuals who accrued out of pocket expenses secondary to their recalled hips.

According to the Depuy website, Broadspire will “address recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages, and travel costs.” However, Broadspire does not provide compensation for pain and suffering, or other problems, as a result of revision surgeries for your hip. They will not pay any impending medical expenses or lost wages you will incur. Unfortunately, adverse effects associated with recalled hips frequently arise in the future. Individuals may exhibit signs and symptoms from these adverse effects and require revision surgery in years to come. Broadspire has no legal or monetary obligation related to your pain and suffering.

Stryker and Depuy have no obligation to pay for anything once the statute of limitations expires on your case. The statute of limitations requires individuals claiming an injury from a product file a lawsuit within a certain period of time. Depending on the state, this time period is approximately one to two years. In addition, determining when and how someone is injured is subject to interpretation. Stryker and Depuy may claim you suspected an injury from your hip when you first learned about the recall. These dates were August 2010 (Depuy ASR) and June 2012 (Stryker Rejuvenate and ABG II). It is critical to file a lawsuit soon in order to protect yourself, and ensure you will receive medical compensation in the future.

Your health insurance company may partially cover your medical expenses. They have a right to reimbursement for your treatment regarding your injuries. If so, Broadspire does not reimburse the insurance company for any expenses they pay.  Hypothetically speaking, your insurance company pays $60,000 for your revision surgery. Broadspire pays you a $60,000 settlement. The health insurance company can collect the entire $60,000 settlement you receive from your Stryker or Depuy case, leaving you with nothing. This is something to consider before settling your case directly with Broadspire. We highly encourage consulting an attorney prior to dealing with Broadspire.

Broadspire works for the hip manufacturers. At Kershaw, Cook & Talley, we work on your behalf.

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