Cobalt Chromium Toxicity

stryker hip recall litigation

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

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

Filing Deadlines For Oregon Stryker Rejuvenate and ABG II Recall Victims

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.

Oregon Stryker Rejuvenate and ABG II Recall

Our firm is leading the charge in cases against Stryker involving their defective Rejuvenate and ABG II hips. We are a part of a small group of attorneys, known as the plaintiffs’ steering committee, pursuing these cases. There are several thousand cases filed all over the country.

We are providing more information, especially to our Oregon clients, concerning the statute of limitations. Many clients are calling, and asking, when the statute of limitations starts to run, or if there are deadlines for filing a case. It is essential to know when the statute of limitations starts to run and when it ends, or expires. This is not always clear; this is a gray area.

Oregon has a two year statute of limitations. This means you need to file a case within two years of discovering, or reasonably knowing, injury from a product. It is difficult knowing when the statute of limitations starts to run. Did it start when Stryker announced a recall of their hip? Did it start to run on the date you found out about the recall? Did it start to run on the date you found out you had elevated levels of cobalt and chromium? Or, did it start when your surgeon stated your hip needs replacing? These are all potential start dates for the statute of limitations. It is safest to choose the earliest start date and file your case before that start date.

The statute of limitations start date was possibly July 6, 2012; the date Stryker first announced the recall of the Rejuvenate and ABG II hips. The best option is getting a case on file before July 6, 2014. Clients are asking, “What if I don’t have a problem with my hip? What if it doesn’t hurt? What if the doctor says it doesn’t need replacing at this time?” Filing a case anyways is the safest option. We have many Oregon clients who have not undergone revision surgery. We filed their cases to “preserve” the statute of limitations. Preserving the statute of limitations means that if anything bad were to happen in the future you would have protection. If you don’t file a case, you will not have protection.

We recommend everyone err on the side of caution, and call Kershaw, Cook & Talley immediately. We will get a case on file before July 6, 2014, the first potential deadline. We still urge you to call us after July 6 if that is not the actual date, and is in fact a later date.

If you have a Rejuvenate or ABG II hip, contact an attorney immediately and get protection. Contact an attorney at Kershaw, Cook & Talley even if you are not having problems with your hip.

Give us a call if you live in Oregon. We are licensed in Oregon and many of our clients are from Oregon. We are more than happy to get a case on file for you, and even get one on file the same day you call. Please contact us for a free evaluation with the number on the screen, or via our website and fill out the questionnaire. All of our cases are on contingency and there are no out of pocket expenses on your part.

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

Recall Attorneys Guide Patients with MoM Hip Implants

The civil justice law firm of Kershaw, Cook & Talley provides a comprehensive list of questions patients with metal on metal hip prostheses should ask their doctor.

Kershaw, Cook & Talley represents hundreds of individuals dealing with the physical and emotional toll from their defective hips. The partners at the firm are dedicated to providing the latest information concerning Stryker Rejuvenate and Stryker ABG II prostheses.

Many of our clients receive different opinions, and treatment options, regarding follow-up for their defective metal on metal hips. Some clients were informed revision surgery was a necessary solution, while others were told monitoring via repeat blood tests, x-rays, and physical examination was sufficient.

Kershaw, Cook & Talley attorneys compiled a list of questions every Stryker patient should ask their surgeon regarding the best course of action. The list serves as a guide to ensure your clinician takes the appropriate steps necessary for your treatment and protection.

For the comprehensive list, please refer to Questions To Ask Your Doctor.

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 log onto


Deadline Looms for Stryker Rejuvenate and ABGII Recall Victims

On June 29, 2012, Stryker announced the recall of more than 20,000 Rejuvenate and ABG II hips implanted in patients throughout the United States. These hips are alleged to have a very high failure rate. However, to date, only a small fraction of those with recalled hips filed lawsuits.  Attorneys at Kershaw, Cook & Talley are concerned individuals with affected hips may lose their opportunity to recover damages if they fail to file a claim before June 29, 2014.

In most states, the statute of limitations, or time in which you can file a lawsuit, is approximately two years.  Stryker could possibly argue this statute of limitations began to run on June 29, 2012; the date it first announced a recall of its Rejuvenate and ABGII hips.  Therefore, many victims will need to file their lawsuits before June 29, 2014.

Kershaw, Cook & Talley partner, Stuart Talley, reports,  “Over the past few days, many people are calling in.  People are very concerned about the statute of limitations and want us to file their cases prior to the June 29 deadline.”

According to Mr. Talley, the date the statute of limitations begins to run is not always set in stone. Stryker may argue it ran on the date it announced the recall even if the plaintiff was unaware of the recall.  Furthermore, Stryker might claim the deadline begins to run whether or not an individual underwent revision surgery or experiences any issues with their hip.

Specifically, Mr. Talley notes,  “People are unaware that if your hip is not hurting, or your doctor has not recommended surgery, the statute of limitations could arguably be running on your case.  It may be too late to bring a claim if you wait until your doctor says you need surgery. In order have protection down the road, it is critical to contact an attorney immediately.”

The attorneys Kershaw, Cook & Talley set up a statute of limitations information page which provides extensive information to victims.  On this page, Stuart Talley provides detailed information via video concerning the statute of limitations and how Stryker Rejuvenate recipients should proceed to protect their interests.  This website is just one of many Kershaw, Cook & Talley created in order to provide information for people impacted as a result of the Rejuvenate recall.  The most popular sections of the Cobalt Chromium Toxicity website include pages regarding cobalt and chromium toxicity, a medical research library, a reference page for Rejuvenate victims, and monthly updates on the Stryker rejuvenate litigation.

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 log onto

U.S. Food and Drug Administration (FDA) link about the Stryker Hip Recall (July 6, 2012):

Metal on Metal Hip Prostheses and Total Hip Arthroplasty Effects on Auditory and Visual Health

In the United States, there are over half a million patients implanted with metal on metal (MOM) hip prostheses. The typical elements released by the metal on metal hip prostheses are cobalt and chromium. The normal levels of cobalt and chromium within the body are below a microgram per liter of blood, or below a part per billion. The term microgram per liter is analogous to parts per billion. There are studies demonstrating that a normal range is within 0.1 to 0.3 micrograms per liter. According to this study, patients with well functioning MOM hips, had cobalt-chromium blood levels between 1.5 and 2.3 micrograms per liter. This is ten times higher than normal physiological levels and significantly contributes to the potential for cobalt-chromium toxicity, or metallosis. In association with metallosis, the study indicates that failure with prostheses was connected to visual and auditory issues resulting from elevated cobalt-chromium levels. There is a strong correlation between device failure with visual and auditory dysfunction.

In addition to the aforementioned findings, the study determines whether or not chronic low levels of metal exposure result in obvious physiological effects on the auditory and visual systems as well. In order to determine the effects of chronic low levels of cobalt-chromium, participants met with both an otolaryngologist and an ophthalmologist in order to determine primary or pre-existing pathologies within the ears and eyes, respectively. Subjects then underwent objective and subjective audiometric testing in order to assess auditory health and function. Similarly, the subjects demonstrated their visual health and functioning via subjective and objective visual testing. There were two types of participants in this study: those with MOMHR and those with total hip arthroplasty (THA). The participants in this study were then separated into groups based on their age and time since surgery. The participant’s blood tests also revealed that those with MOMHR had a blood, plasma, urinary cobalt and chromium levels that were 5 to 10 times higher than the THA participants. In terms of objective audiometric and visual findings between the MOMHR and THA groups, there was no observable difference, and patients in each group had similar auditory and visual function.

There is no conceivable evidence between MOMHR and altered brain stem responses for patients with exposure to chronic low metal levels. However, there is optic nerve atrophy (damage) in patients with exposure to high metal levels in their system  which reflects visual loss among this specific population. Whereas patients with long term exposure to low metal levels had no obvious association with auditory or visual defects, the patients with malfunctioning hip prostheses and elevated metal levels (up to hundreds in micrograms per liter) suggested visual and auditory defects.

Source: Auditory and Visual Health after Ten Years of Exposure to Metal-on-Metal Hip Prostheses: A Cross-Sectional Study Follow Up


Influence of Femoral Stems with Modular Neck Designs on Health Consequences and Presence of Metal Ions

Metal on metal (MOM) prostheses have different designs. One such MOM stem design, Profemur Z, includes a femoral stem with a modular neck that enables adjustments which are separate from femoral fixation. There is concern with the potential for fracture of the modular neck in relation to the modular junction. Fracturing of this junction may potentially lead to the production and release of metal debris and ions causing adverse local tissue reactions, or ALTR.

The Profemur Z allows for a modular neck-body junction which can be inserted with a variety of orientations, angles, and directions. The neck has a taper where a modular head may attach. These models only used titanium alloy necks until cobalt chromium alloy necks were available. There are many cases of corrosion and modular neck fracture secondary to failure of the Profemur Z stem design. According to the Australian Orthopedic Association’s National Joint Replacement Registry, there is an 11% failure rate for patients with this device over a 5 year period. This is a significant failure rate compared to other femoral stems.

An increase in serum chromium and cobalt levels was indicated in patients with MOM hip prostheses. The modular head-neck junction, and bearing surface, is the main cause of the cobalt and chromium release in the blood stream. There was a significant elevation in cobalt and chromium serum levels as a result. Whereas titanium alloy prostheses, had low elevations of cobalt and chromium serums, the adverse local tissue reaction, results from the release of cobalt and chromium in those stem designs produced with a modular neck made from a cobalt-chromium alloy. The etiology of modular neck fractures stems from fatigue failure and crack formation from corrosion due to metalurgical reactions of the device with body chemistry. In addition, those stem designs with a modular neck-body junction made of both chromium-cobalt and titanium have the ability to cause even more detrimental local tissue reactions.

Crack formations on the neck-body interface are the result of oxide-formation and oxide-driven stress. Over time, pitting and formation of cracks are exacerbated by increased stress corrosion and oxidation surrounding the interface of the mechanism. Stress corrosion causes the dissolution process of metal ions. The consequences of elevated metal ion levels from the cobalt-chromium stems in patients include pseudotumor formation, severe pain, osteolysis, and taper corrosion.

Subsequently, there is an increased revision rate for prostheses with this femoral stem design. During revision surgeries, findings illustrated significant corrosion at the modular neck-body interface.

The Full Article can be read at:

Source: Silverton Craig D., Jacobs Joshua J., Devitt Jeffrey W.,
Cooper H. John, Midterm Results of a Femoral Stem with a Modular Neck Design:
Clinical Outcomes and Metal Ion Analysis, Journal of Arthroplasty (2014), doi:

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