Cobalt Chromium Toxicity

stryker status

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.

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.

Ongoing Updates Regarding Stryker Rejuvenate and ABG II Litigation


Attorneys at Kershaw, Cook & Talley are actively involved in the ongoing Stryker Rejuvenate and ABGII Hip Implant Products Liability litigation (Case No. 13-MD-2441) now pending in the United States District Court for the District of Minnesota. These cases are among more than 2,000 Stryker Rejuvenate and ABG II cases occurring throughout the country. Kershaw, Cook & Talley recently launched a litigation update page in order to better advise their clients. The page contains a series of videos from partner, Stuart Talley, concerning the status of the litigation.

In the most recent video, Mr. Talley provides a description of what occurred during the court’s June status conference in Minneapolis. According to Mr. Talley, there are conflicting agendas between the parties. During the status conference,plaintiffs discussed how Stryker was still refusing to produce documents and failed to produce witnesses for deposition. These issues will most likely resolve through a series of motions to compel.

In Mr. Talley’s most recent video update, he provides a more detailed description of these discovery disputes along with his opinions on how the litigation is progressing and what is expected for the future.

Kershaw, Cook & Talley is a Sacramento-based firm representing individuals nationwide in defective medical device cases. The firm generates hundreds of millions of dollars in recoveries for their clients and the classes they represent. Individuals impacted by Stryker’s hip systems are entitled to compensation for wage losses, medical bills, and pain and suffering. For a free case evaluation, and more information about the status of the case, feel free to call Bill Kershaw or Stuart Talley directly at (888) 817-2527 or visit https://www.cobalt-chromium-toxicity.com.

MDL 13-2441: Transcript of Status Conference, June 12, 2014

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.

Adverse local tissue responses in hip implants with dual-taper stems


Within the last two decades, modularity in hip implants became the prevalent paradigm. Modularity means prosthetic hip implant components are available in multiple segments, or parts, as opposed to a single piece (monoblock implants). Modular components generally consist of a femoral stem with an extra modular junction between the neck and stem body, known as a dual-taper stem. Dual-taper stems are popular since they allow for variations in length, shape, size, degree of offset, and rotation of the implant. Most hip replacement manufacturers have models with the modular neck design option.

However, this extra modular junction is under scrutiny for potentially causing corrosion between the neck and body stem. Studies show metal debris and adverse local tissue reactions (ALTR) secondary to taper corrosion at the head-neck junction analogous to patients with failed metal on metal hips. This study highlights patients with ALTR from modular neck-body junction corrosion.

The study involves eleven patients, eight women and three men; with a total of twelve hips (one patient had bilateral total hip arthroplasty). The patients were evaluated for ALTR secondary to modular femoral neck-body taper junction corrosion. According to the study, the patients presented with pain approximately 8 months after their initial surgery. The pain among the patients was mainly localized in the groin. However, some patients pain radiated to their buttocks, trochanters (parts of the femur), or thighs. Others experienced severe limps, weakness, and significant leg swelling. Stryker rejuvenate was among the models of implanted metal on metal hips in the patients. Patients were all implanted with hips constructed with a cobalt-chromium alloy modular neck and a titanium-alloy stem.

Before undergoing revision surgery, patients had a preoperative workup. The preoperative workup included blood tests which analyzed elevated white blood cells (checking for inflammation), erythrocyte sedimentation rate (reveals inflammatory activity), and serum metal ion levels (checking for metal sensitivity). Additionally, patients underwent a metal artifact reduction sequence (MARS) MRI to evaluate for any abnormalities.

Serum metal ion lab results demonstrated considerable elevation in serum cobalt and serum chromium levels (cobalt was worse than chromium). The MARS MRI indicated large fluid collections and hypertrophic soft-tissue reactions (pseudotumor formation) in ten of the eleven patients (90.9% of patients). Patients were later diagnosed with taper corrosion and underwent revision surgery roughly 9 months after their symptoms first appeared. Revision surgery in the patients revealed capsular hypertrophy (increased tissue growth) and necrosis (death) of the soft-tissue structures involving the hip joint. Several patients had large soft-tissue masses. The modular junction between the femoral component neck and body established marked corrosion, with taper fretting and black, flaky material deposits at the base of each hip. Microscopic testing showed obvious corrosion at the modular femoral neck-body junction in all devices along with fretting and metal debris.

This study confirms dual-taper stem designs with modular cobalt-chromium-alloy necks may cause pain and significant soft-tissue destruction and death surrounding the implanted hip eventually leading to joint failure. Adverse local tissue reactions and metal debris result from fretting and corrosion at the head-neck junction of the cobalt-chromium alloy head and cobalt-chromium alloy stem. Extensive pitting corrosion and fretting was found in many patients. Head-neck taper corrosion resulted in elevated serum cobalt and serum chromium levels. The cobalt levels were much higher than chromium in the cobalt-chromium alloy.  Blood tests also determined inflammation due to adverse local tissue responses secondary to taper corrosion. The study establishes substantial soft tissue damage from corrosion at the modular neck-body taper of a dual-taper femoral model.

Source: Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual- Taper Stem with a Cobalt-Chromium Modular Neck, The Journal Of Bone and Joint Surgery

February 2014: Stryker Hip Recall Litigation Hearing Update


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

On February 20, 2014, the court in the Stryker Rejuvenate MDL held a status conference to discuss the status of the litigation. It was reported to the court that there are now more than 1,500 individual Stryker lawsuits that have been filed throughout the United States.  Judge Donavan Frank, the judge assigned to hear these cases, reported that he had reached out to several state court judges who are presiding over cases in other jurisdictions to discuss coordinating their efforts to ensure that the cases are litigated as efficiently as possible.

The second issue that was brought up at the hearing involved a discussion of efforts at settlement.  Stryker reported to Judge Frank that in New Jersey it had successfully reached settlement agreements in 9 cases.  However, because the settlements are ”confidential” the amounts of the settlement are unknown and the facts underlying each plaintiffs’ case are unknown.  Judge Frank reported that he would be sending a magistrate judge to New Jersey to meet with the mediators who helped settle the 9 cases. The purpose of this order is to examine whether it’s possible that a global settlement program could be put in place with respect to all the pending cases.

At this point, plaintiff’s counsel advised the court that they were very concerned that Stryker was using the prospects of settlement as a means of delaying the progression of the litigation. Specifically, it was reported that Stryker had only produced a small fraction of the several million pages of documents that have been requested by the plaintiffs and has refused to provide any timeline or dates for the depositions of Stryker employees and executives.  The plaintiffs are very concerned that Stryker is trying to ram through a settlement before the plaintiffs are able to fully discover the facts which led to the eventual recall of the Stryker Rejuvenate hips.  Judge Frank advised the parties to meet and confer on the discovery issues and then bring any unresolved issues to the magistrate’s attention before the next status conference.

The next status conference in the case is set for March 20, 2014.  We will be providing an update after this conference.

If you have a Stryker hip and you want more information about the litigation, how it’s progressing, or you need a legal advisor to evaluate your case, feel free to give us a call. You can reach us at 888-635-3970 or through our website at www.defectivehipsettlementcenter.com

 

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