Monday, April 22, 2013

Trial News: DePuy Hip Implant Patient Likely Hypersensitive, Jury Hears [Normal wear on the explant was claimed)

Depuy argued it was Carol Strum's individual biology not its product that made her revision  surgery necessary.

This post is interesting because it reviews the reason the jury came to  the conclusion it did.  I was curious as to what happened in the first trial that was missing in the second one.  This review by a Chicago law firm provides that information. 


DePuy Hip Implant Patient Likely Hypersensitive, Jury Hears

by Peter J. Flowers who is  a partner in the Chicago law firm of Meyers & Flowers

 Chicago (April 11, 2013, 5:38 PM ET) -- An orthopedic surgeon testified Thursday at a trial over Johnson& Johnson subsidiary DePuy Inc.'s ASR XL metal hip that he believed the plaintiff had developed a hypersensitivity to a normal amount of debris from the device, and that he found no evidence in her implant of excessive wear.




 
   
DePuy has argued, meanwhile, that it was Strum's individual biology and health issues, not its product, that made her revisionary surgery necessary.

Cuckler told jurors Thursday that he had found no evidence of excessive or abnormal wear on Strum's implant, and that during his review of that device and Strum's own medical information, he had also not found any evidence that excessive wear had caused Strum to need a revision surgery.

He testified that he believed Strum had developed a hypersensitivity that caused her body to overreact to a normal amount of wear debris from device, and that Strum's reports that she has experienced a slower recovery and continuous pain since her ASR XL was replaced with another metal-on-meta hip were typical of a hypersensitivity reaction.

Strum is likely someone who just does not react well to a normal amount of metal wear debris, Cuckler testified, telling jurors, "The design has nothing to do with this."


 
 Cuckler also said that younger, more active patients who receive hip implants are more likely to need revision surgeries later.

Strum received her implant before age 50, which placed her in a higher-risk group for needing a revision surgery, Cuckler confirmed when questioned by DePuy attorney Richard Sarver of Barrasso Usdin Kupperman Freeman & Sarver LLC.

On cross-examination by Peter Flowers of Meyers & Flowers LLC, Cuckler said he did not believe that the ASR hip replacement system, which DePuy recalled in 2010, was defective and said it should still be implanted in human beings today.

The trial began in mid-March and is steadily heading toward closing arguments.

On March 8, a Los Angeles jury hit DePuy with an $8.3 million verdict at the first trial over the ASR devices but declined to award punitive damages, which Strum is seeking in her case.

DePuy voluntarily recalled its ASR hip system in August 2010 after receiving data from a registry for England and Wales that indicated a jump in revision rates for the devices.

Strum is represented by Denman Heard of Heard Robins Cloud & Black LLP, Herbert Orlandah Phillips IV of Phillips Law Office PLLC, Douglass A. Kreiss of Aylstock Witkin Kreis & Overholtz PLLC, and Peter J. Flowers of Meyers & Flowers LLC.

DePuy is represented by Richard Sarver and Celeste Coco-Ewing of Barrasso Usdin Kupperman Freeman & Sarver LLC, Michael Conner of Barnes & Thornburg LLP, David Sudzus of Drinker Biddle & Reath LLP and Sanford Watson of Tucker Ellis LLP.

The case is Carol Strum v. DePuy Orthopaedics Inc. et al., case number 2011-L-009352, in the Circuit Court of Cook County in Illinois.

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Gee, if all of this is factual, I think a few points should be emphasized:

1) Make sure you document everything about that revision.
2) Make sure you surgeon saves the debris!!!  Mine didn't and he said he didn't because I didn't ask him to prior to the surgery.
3) Make sure the company who reviews your explant has done many of these  exams before and has the right equipment to testify on the wear issues of your explant. (Shocking to me that someone would go to court with a hip that has no evidence of wear!  Yikes!)
4) Get a consulting surgeon to reaffirm the specific  need for the surgery.  
5) Get all of the right MRI protocols to document the tissue damage/bone damage etc  which can't really be done properly by most MRIs (you need the MAVRIK protocol used especially for the tissue damage.)  
6) If you are going to sue someone, best to have evidence for  the need for the revision and it better be iron clad with world class experts verifying the need for the revision.

Given there are no standards that would lead a surgeon to say..."this fits the revision rule", you as a patient better darn well do your homework to ensure that the revision must be done, especially if you are asymptomatic (from outwardly visible symptoms.  Examples of evidence:  very high Cr and Co levels, MRIs that document tissue damage, etc... and post explant, get that explant viewed by expert labs in looking at hip explants.  Ask them how many of these they have done over what period of time.)

I am flabbergasted that she lost this case based on the defense testifying that the plaintiff had no excessive wear from the device and that in fact, she was just hypersensitive to a normal amount of debris shedding.  It sounds to me as though the plaintiff group was ..................ill prepared perhaps?

hey/what do I know?

Connie

5 comments:

  1. Her cobalt was in the 90s, a fact the jury apparently disregarded. As to "no evidence of wear," the so-called expert said he didn't see any. That may or may not be the same as "there was no wear." With the astronomical failure rates at present of the ASR, any rational person has to wonder about the credibility of ny surgeon who says he would implant one today.

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    1. Listen, I had this defective hip implanted in 2005 after which I had no pain. My decision to have revision surgery was made after becoming aware of marginally high metal readings in my bloodstream. DO THINK ANYONE IN THEIR RIGHT MINDS WOULD ALLOW METAL CONTAMINATION IN THEIR BLOODSTREAM TO CONTINUE A MOMENT LONGER ? I am not interested in the so-called medical opinions, no-one could gaurantee to me that continuation of this contamination would not affect my long-term health and I wasn't prepared to take that chance. How the jury found against the plaintiff I will never know, justice not served.

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  2. Thanks for your comment.

    Wear rates are not (should not be) subjective since they are measurable and quantifiable. I don't think this is a matter of opinion.

    I hired a group in England who have the equipment to perform these measurements. the report issued shows what the rate of wear is and provides a commentary on the level of ware rate for context.

    I am missing why the lawyer couldn't dismiss that in cross? Something is strange here from my perspective.

    I would have asked: "Can you tell me what the wear rate measurements yielded in your examination? the examination for the plaintiff presumably had a second opinion on the wear rate who could provide the actual wear rate

    There are no metrics for what constitutes definitively what a cobalt rate of 90 means in this circumstance. they can link those rates to that which is considered toxic environmentally. Too bad the plaintiff didn't have a biochemist on the expert list!

    What do I know!

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  3. I have a revision due to high toxic chroninum and colbalt with pseudo tumor and fluid but my surgery said no much wear showing but color was different, it is not normal for rates of metal to be in the 90's and this is what causes the hypersensitivity in the hip is the metal? I don't understand how they could have lost this case. There must be more facts that are not clear or something? The MRI did not show anything. I was in alot of pain and could hardly move my hip. My surgeon recommended surgery due to high levels of poisoning and that it must come out. So is Johnson and Johnson oh well it is ok to have toxic metals in your body there will be no need for revision surgery not our fault??? I don't understand the verdict.

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