Cobalt Chromium Toxicity

stryker hip recall

Stryker Rejuvenate Status Update: October 2015



My name is Stuart Talley and I am the partner at Kershaw, Cook & Talley responsible for the Stryker Rejuvenate recall litigation. The reason I am doing this video today is to give an update on the status of the litigation. We had a status conference with the court yesterday and we wanted to provide an update on where we are with these cases.

As many of you may know, the Stryker Rejuvenate litigation originally involved about eight thousand cases that were filed on behalf of people who had Stryker Rejuvenate hips. Most of those cases were consolidated in Minneapolis, Minnesota before Judge Donovan Frank. After year and a half litigation, there was a global settlement that was announced.  It was actually a global settlement program. Any individual who had a revision surgery as of November 2014 had the option of participating in the settlement program.

The hearing yesterday discussed the current situation regarding where certain cases stand, how many have been settled, how many remain. We learned there are many cases still pending in the court that have not been resolved. Those cases fall under different categories:

  • The first category includes people who have not had revision surgery. Stryker has offered nothing to those individuals and is not agreeing to settle their cases.
  • The second kind of case involves people who had revision surgery but after the settlement was announced in November 2014. So, if you had revision surgery after November 2014 you were not included in the settlement program.
  • The third kind of case that is sitting out there is for people who opted out of the settlement program. They decided they didn’t like the terms of the settlement and decided not to take it.
  • The last category of cases, 175 remaining, those will be tried to a jury. There is a lot of work right not to get those cases ready for trial. There’s a lot of discovery that’s being conducted with respect to Stryker and retrieving documents from Stryker. There are many depositions lined up for November of this year of various Stryker executives. There’s a lot of work and effort going into getting those cases ready for trial.

With respect to the unrevised cases, people who haven’t had revision surgery, there is a process that will be set in place. Essentially, Stryker has agreed to allow these people to dismiss their case. In the future, if they ever need revision surgery, they can refile the cases as if it was never dismissed in the first place. This process is called a “tolling agreement”. Stryker agreed to “toll”, or suspend, the statute of limitations. For example, you dismiss your case and are allowed to refile if you ever have revision surgery. If you do, it’s as if your case was never dismissed in the first place.

These cases are ongoing. There’s a lot that’s happening. Many cases have settled. If you have a Stryker Rejuvenate hip, and have not filed a case, we recommend you file one immediately. The statute of limitations could be running on your case. And unless you actually have a case on file, you are not protected even if your hip has not been revised. This tolling agreement only applies to individuals who have cases on file.

If you have a Stryker Rejuvenate hip, contact us for a free case consultation. You can call us toll-free at (888) 817-2527, or fill out and submit the confidential submission form found on this page.

Stryker Hip Settlement: Permanent Damage Compensation



Hi, I’m Stuart Talley. I’m the partner responsible for the Stryker Rejuvenate and ABG II litigation. I am doing this video to answer a question our clients asked regarding the Stryker hip settlement.

The question is, “Does the settlement agreement provide additional compensation for individuals who underwent revision surgery but sustained lifelong injuries?” These people had their hip revised but have a permanent disability secondary to soft tissue damage from the hip. Many of our clients are a year post-revision and still use a wheelchair, cane, or crutches. They are in chronic pain and taking pain medication. They are curious if the settlement provides additional compensation for their situation.

Unfortunately, the settlement does not give additional compensation for an “inoperable” problem. However, it does provide additional compensation for procedures. For instance, if you are in chronic pain and need another hip operation after revision surgery, you would receive additional compensation.

The problem with the settlement is not fairly compensating people with lifelong damages caused by soft tissue injuries from cobalt and chromium toxicity (metallosis). If you fall into this category, you have 2 options: accepting the settlement or not accepting the settlement.

Contact Kershaw, Cook & Talley for a free case consultation or with any questions about the settlement if you have a Stryker Rejuvenate or ABG II hip.

 

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?

What should I do if I have a metal on metal hip?


A series of product recalls involving prosthetic hips occurred recently. The design of these hips led to the release of toxic levels of cobalt and chromium (the metal the hips are made of) into the patients who receive them.  These metals cause extensive tissue damage in the hip and other areas of the body. This usually requires additional surgery to repair. Kershaw, Cook & Talley currently handles cases involving the following types of hips: DePuy PinnacleDePuy ASRStryker AccoladeStryker Rejuvenate, Stryker ABG IIBiomet, and Wright Medical.

Many individuals are unsure what to do when they find out their metal on metal hip is defective or recalled. Kershaw, Cook & Talley recommends the following steps:

A) Find out what name and model hip you have. There are various ways to do this:

  1. Contact your orthopedic surgeon by phone. 
  2. Request a copy of your medical records in writing from the orthopedic surgeon’s office or hospital where the surgery was performed. 
  3. Check your implant card. Often times, after surgery, your doctor gives you an implant card which states the hip name and type. 


B) Check to see if your hip implant was officially recalled (if not, you may still have a case).

  1. You might have received a recall letter notifying you that your hip implant was recalled. 
  2. If you did not receive a letter, ask your doctor if your hip implant was recalled. 


C) Have your blood tested for cobalt and chromium:

  1. Tell your doctor you want to get your blood tested specifically for cobalt and chromium. 


D) Get a MARS MRI:

  1. MARS MRI stands for Metal Artifact Reduction Sequence MRIA MARS MRI is an imaging technique which minimizes metal artifact (i.e. parts of the implant) while maintaining image quality.
  2. You will most likely have to request this imaging study from your orthopedic surgeon. 

F) Call our office for a free case consultation and if you have any more questions regarding your 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.

Stryker Hip Recall: Why Call an Attorney, Don’t Let Your Statute Of Limitation Run Out


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 are handling quite a few Stryker cases. Recently, we are receiving quite a number of calls on the statute of limitations issue.

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 

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