Cobalt Chromium Toxicity

metal on metal hip

October 2014 Stryker Litigation Update



Hi. This is Stuart Talley. Bill Kershaw and I are the attorneys responsible for the Stryker Rejuvenate and ABG II hip cases. We are providing an update on the litigation status currently pending in Minneapolis, Minnesota before Judge Donovan Frank.  Right now, there are about 4,000 cases filed and that number goes up every day. We receive phone calls from new people every day who are having problems with their Stryker hips. By the next update, there will probably be around 6,000 cases on file.

We have not had a status conference with the court for a couple of months. The next one is set for November 6, 2014. In the interim, there was a lot of paper work filed with the court on discovery issues. Discovery is the process where we get documents from the defendants; we take depositions of the defendants, their engineers, executives, salesmen. The idea is developing evidence we will need for trial.

One of the big battles brewing in this case involves documents. In this case, Stryker informed us they produced all their documents. To date, we received about 700,000 pages. It seems like a lot but in the context of cases like this, it’s really a drop in the bucket. In other hip cases we’ve handled, defendants typically produced anywhere from 20 to 60 million pages of documents.  We’ve looked at Stryker’s documents and discovered enormous gaps in email production. Email production is where you see most of the documents. There are generally millions of emails between engineers, between sales reps, where we find the best evidence for the case. We discovered certain key witnesses produced one email or none at all. From our standpoint, it appears documents were destroyed or simply not produced.

We are trying to get a deposition from a Stryker representative to find out what happened to all the documents. We also want to know if they were destroyed. And if so, is there a way to get them back. Sometimes, emails or deleted documents off a server can be retrieved from backup tapes. Companies often have servers with large amounts of data backed up on tapes. Those tapes are then stored in a separate, safe location apart from the facility with the servers. This ensures that if there is a disaster they can use the tapes to restore data. We hope there are the backup tapes on emails we can use to fill in the gaps.

Stryker does not want us to take that deposition, and filed a motion to quash the deposition. They asked the judge to prevent us asking questions regarding the documents and where they went. This issue will be decided on November 6. If it’s determined Stryker destroyed documents, and they destroyed documents knowing of an impending lawsuit (after the recall), it poses serious consequences for Stryker. If you can show the knowing destruction of evidence, judges have lots of remedies available to punish the party that destroyed the evidence. Judges can impose monetary sanctions, issue sanctions, or jury instruction sanctions. An issue sanction is when the judge has an issue deemed admitted by Stryker. For example, say there are key documents showing Stryker knew about the problems with the hip before it was put on the market. If we can’t prove this as a result of documents that were destroyed, the judge might enter an issue sanctioned so jurors are told at the trial Stryker knew there were problems with the hip before they put it on the market. With a jury instruction sanction, you can have the judge advise the jury that Stryker destroyed evidence in the case, and for purposes of deciding the case, they can assume there were documents that probably would have hurt Stryker down the road.

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

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