Cobalt Chromium Toxicity

stryker lawsuit

Stryker Status Conference Update


On Thursday,  January 22nd, there was a status conference regarding In Re: Stryker Rejuvenate and ABG II hip implant products liability litigation (MDL 13-2441). The conference occurred before Judge Donovan W. Frank in the United States District Court, District of Minnesota in St. Paul, Minnesota.

The conference began with an update concerning the two-step process of the litigation. The first step was having all cases formally registered with the Defendant and the settlement processor. All plaintiffs should have registered their claims whether the case was filed, unfiled, qualified, or unqualified. It was reported that the majority of potential plaintiffs completed registration successfully. The second step is the actual and formal enrollment of those individuals who are qualified and choose to enroll in the settlement. The enrollment process is more complicated than registration. The enrollment process opened on January 16th and ends on March 2nd, 2015. Depending on your individual circumstances, your attorney should guide you to make an informed decision as to whether or not to participate in the settlement.

The formal website for the Stryker Hip Litigation is www.strykermodularhipsettlement.com. If you are trying to settle your case without a lawyer, the site contains the appropriate forms to participate in the settlement.

Another status conference is set with a tentative date of March 27th.

Stryker Rejuvenate and ABG II Hip Claims Deadline


Hi, this is Stuart Talley. I am the partner here responsible for the Stryker Rejuvenate and ABG II cases.

I am discussing important deadlines regarding the recently announced Stryker Rejuvenate and ABG II settlement agreement. There are essentially 2 deadlines you have to be concerned about if you have a Stryker Rejuvenate or ABG II hip.

The first deadline is what we call the registration deadline. The registration deadline is December 14, 2014. This means you have to register with Stryker before that date if you are a potential claimant. A potential claimant is anyone who has a Stryker Rejuvenate or ABG II hip. If you have or do not have a case filed you need to register even if your hip has not been revised.  This applies to everybody. The reason you want to register with Stryker is so they know who you are so they can send you notices and tell you what is going on with the litigation. It’s very important to register. By registering in the settlement program you are not agreeing to the settlement.

This leads to the next deadline, March 2, 2015. This is the deadline to enroll in the settlement program. Now, the settlement program is only open to people who’ve had a revision surgery. This enrollment is the process where you are agreeing to the settlement terms, and agreeing to participate in the settlement. After you enroll in the program, you have to submit a lot of paperwork to Stryker and the settlement administrator. You have to submit medical records to prove that you had a Stryker Rejuvenate or ABG II hip, that it was revised, and an estimate of your damages. This is a complex process.

Another complex issue is determining what you receive from the settlement. The settlement agreement is a 100 page document. You have to look at the settlement agreement and look at the medical records to figure out what you would get under the agreement, and it’s not that easy.

If you have a Stryker Rejuvenate or ABG II hip, and have any questions about enrolling or about registering, we are here to help.

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?

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.

Stryker Litigation Update: August 2014


 

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

We had a status conference on August 21st. We addressed a number of issues at the status conference. Approximately four thousand cases are filed in various courts nationwide. We were meeting in the multi district litigation (MDL) in St. Paul, Minneapolis. There are two thousand cases pending in St. Paul, and we are currently engaging in discovery. We are taking depositions of corporate representatives on various scientific subjects, and electronic storage of information subjects which are central to the trials. We are also in the process of selecting Bellwether cases 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. We are picking roughly twelve cases and they will go to trial next summer. Those cases will inform us how to handle many of the other cases pending since thousands of cases cannot be tried. The hope is these cases provide a blueprint how to resolve litigation later on. The Plaintiff’s Steering Committee believes it is critical we obtain discovery and understand what is happening with the cases before we settle.

The next status conference is September 22nd. We have reached an agreement with Stryker with respect to foreign entities to toll the statute of limitations for any claims against those entities so any claims those individuals have might have will be preserved going forward.

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

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.

Modularity and Total Hip Arthroplasty


Total hip arthroplasty (THA), also known as a hip replacement, involves replacing the hip joint with a prosthetic implant. The surgical procedure is supposed to improve a patient’s quality of life and function. The outdated method of hip replacements was called monoblock. Modularity, implants with at least one modular junction, is employed for total hip arthroplasty. Modularity involves prosthetic hip implant components available in multiple segments, or parts, rather than a single piece (monoblock implants). The popularity of modular implants results from their variations in leg length and size, degree of offset, and version. Modular implants are meant to accommodate a patient’s unique anatomy.

Unfortunately, corrosion, fretting, and fatigue failure of the implants are progressively occurring in the dual modular implants. Evidence suggests a revision rate of 8% to 15% among metal on metal total hip arthroplasty. As a result, modular implants are now under close supervision.

Modularity evolved with the development of the modular femoral head-neck junction. The modular head-neck junction utilizes metallic alloys head alternatives, leg length and offset adjustment, and bearing replacement resulting from wear. Modularity of the head-neck junction occurs at a taper functioning by joining two rotating components in the hip implant. The two components of the taper are a trunnion and bore. The trunnion compresses the bore when it expands, interlocking the two parts, creating stability. A larger head-neck taper may lead to an increased dislocation rate because the prosthesis is impacted faster by different range of motions. However, smaller tapers may lead to increased junction fretting and corrosion.

The article differentiates between two design features: metaphyseal neck-stem modularity (DePuy), and modular neck or proximal modular stems (Stryker). A metaphyseal modular stem has an implant with a distal junction placed distal to the femoral neck. Whereas the proximal modular stem has the distal junction proximal to the femoral neck. The taper connections undergo various physiological stresses depending on the location of the modular junction. Both tapers have the potential to cause neck-body dissociation, elevated levels of metal debris, fretting, and corrosion. Corrosion is the main source for modular implant failure.

Many modular femoral stems are composed of a cobalt-chromium or titanium alloy. The metal implant can corrode from stresses and disruptions. Metal ions are released secondary to the corrosion resulting in elevated serum metal ion levels. Corrosion and fretting cause loss of mechanical integrity of the implant, local tissue infiltration, and adverse local tissue reactions (ALTR). There are multiple sources for head-neck taper corrosion including crevice, fretting, and galvanic. Fluid can enter a gap between the trunnion and bore causing crevice taper corrosion. Fretting corrosion can occur from movement of the head relative to the neck; this is the main source for failure at the modular junctions. Crevice corrosion is reported in 35% to 40% of mixed-metal tapers, and 9% to 28% in single- alloy tapers.

Corrosion is time-sensitive and accelerated with mechanical stresses. Increased local and systemic metal particle exposure is connected to increased corrosion at the taper. Even in properly working metal on metal hip implants, cobalt chromium levels are roughly five fold higher than in patients with other hips. Head-neck interface corrosion results in inflammatory responses, local osteolysis and synovitis. Subsequently, metal particles were found in various organs. Corrosion byproducts stem from adversely affected metals at the taper junctions. Chromium phosphate is one such byproduct associated with femoral head-neck junction corrosion and substantial inflammation. This inflammation causes bone resorption and osteolytic reactions (bone loss). Corrosion and metallosis results in elevated cobalt levels in synovial fluid; this is linked to thyroiditis, auditory disturbances, and granulomatous lesions. Arthroprosthetic cobaltism, increased cobalt levels, is connected to systemic symptoms from malfunctioning hip implants.

Source: Modularity of the Femoral Component in Total Hip Arthroplasty 

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

Real Time Web Analytics