Cobalt Chromium Toxicity

stryker hip recall litigation update

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.

June 2014: Stryker Rejuvenate and AGB II Litigation 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 June 24, 2014, I appeared at a status conference in Minneapolis, Minnesota. The majority of the Stryker Rejuvenate cases are pending in Minnesota. Judge Donovan Frank manages the litigation and tried moving the trial forward to July 2015. Judge Frank addressed several issues at the status conference.

First, he wanted a current status on the number of filed cases. Presently, there are over 2,000 cases filed around the country in various jurisdictions.

He also wanted an update regarding discovery. There was a lot of discussion about discovery. The plaintiffs observe that Stryker is not cooperating with discovery and refusing to produce documents. One of the biggest problems concerned emails. There are thousands of documents produced in the case but very few emails. The plaintiffs’ attorneys discussed how Stryker employees, intimately involved with the design and development of the Rejuvenate hip for years, only produced approximately 100 emails when there should be thousands of emails. At this point in the litigation, the plaintiffs intend to do some discovery to find out what happened to these emails. Were they destroyed? Why were they destroyed? If they were destroyed, were they backed up anywhere? Often, you can retrieve destroyed emails from backup tapes. We are in the process of pursuing this course of action.

Another discussion concerned depositions. Plaintiffs are trying to get dates for depositions of Stryker employees. Stryker is not forthcoming in providing dates for depositions. Stryker is attempting to delay the proceedings in an effort to push out the July 2015 trial date. Judge Frank did not agree with this plan. We expect court orders to discontinue the delay in discovery and slow-play process.

Currently, there are no meaningful settlement discussions. Stryker disclosed they settled roughly 27 cases of the thousands filed. All those settlements are confidential. No one knows the specific amounts or details about the cases. Judge Frank appeared frustrated from this fact and wants an open settlement process. An open settlement process is typically the only way these cases are resolved.

If you have any questions, please contact us via the phone number on the screen or visit our website and send us an email.

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 https://www.cobalt-chromium-toxicity.com

 

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 https://www.cobalt-chromium-toxicity.com

U.S. Food and Drug Administration (FDA) link about the Stryker Hip Recall (July 6, 2012):http://www.fda.gov/safety/recalls/ucm311043.htm

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 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0090838

 

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:

http://www.arthroplastyjournal.org/article/S0883-5403(14)00297-6/abstract

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:
10.1016/j.arth.2014.04.039

March 2014 Stryker Hip Recall Litigation Update


Hi, I’m Stuart Talley with Kershaw|Talley.  I’m the partner here responsible for providing an update on the status of the Stryker Rejuvenate and ABG II hip litigation.  We are happy to report that the court has recently set several important deadlines that will begin moving this case forward at a fairly rapid pace. This is the latest update for March 2014 Stryker Hip Recall Litigation Update.

As previously reported, we have had a very difficult time getting Stryker to cooperate in discovery.  To date, they have only produced a small fraction of the documents we have requested and have not yet produced any witnesses for deposition.  At the same time, Stryker is repeatedly advising the court that it is settling cases in other jurisdictions.  It appears its strategy is to convince the judge that no discovery should take place in our case since all of the cases will eventually be settled through its “settlement program.” Entire blog →

Stryker Hip Recall: Cancer Study


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

I am providing an update concerning recent developments about cobalt and chromium toxicity. The developments discuss whether or not high doses of the metals can cause or increase the risk of cancer. Recently, there was a scientific study issued from Finland. In the paper, the scientists examined individuals with metal on metal hips who had high cobalt and chromium levels. They compared these individuals with others implanted with metal-on-plastic hips. This specific research is ongoing since people continue to experience issues with metal on metal hips, and the release of cobalt and chromium ions from their hip joint.

So far, there are no studies suggesting a correlation between elevated levels of cobalt and chromium in the blood and an increased risk for cancer. However, this does not negate the fact that there may be a link; there is just no current evidence to substantiate a link.

In the Finland study, doctors analyzed 10,000 patients with metal on metal hips and compared them to 18,000 patients with conventional metal-on-plastic hips.  They found no statistical increase in the rate of cancer between the two groups from their previous study in 2012. Europe is making a conscious effort to monitor patients with metal on metal hips and metal-on-plastic hips in order to assess the risk of cancer. The link between metal on metal hips and an increased risk for cancer may become apparent in the future.

We represent hundreds of individuals with various metal on metal hips including Stryker Rejuvenate and Stryker ABG II. If you have any questions or concerns, please call us, toll free, at 888-635-3970 or visit our website www.defectivehipsettlementcenter.com and fill out the contact form for a free evaluation.

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