Kransky v. DePuy Trial – Day One January 25, 2013

Co-Counsel Michael Kelly, of Walkup, Melodia, Kelly & Schoenberger, delivered Plaintiff’s Opening Statement.

January 25th Morning session:

–          Mr. Kelly gave Plaintiff’s opening statement, walking the jury through DePuy’s original design of the ASR XL, the lack of testing done on the device before placing it on the market, and ultimately the severe harm Plaintiff Loren “Bill” Kransky suffered as a result of these actions.

–          He discussed how the ASR XL was put on the general European market in 2004, in Europe, Spain and India. And that as early as 2005 DePuy started to hear “noise” of questions and problems with the device. Mr. Kelly explained that the jury would hear evidence that, rather than deal with the news of these problems, DePuy and Johnson and Johnson blamed these problems on the implanting doctors’ technique, stating “and you will hear as we go forward that every time there is a problem the Johnson & Johnson response is to blame the doctor and claim it’s technique, to never look inward, do we have a problem with our product? The failure in the seating of the cup?  Have we had a history of failures over the last year or is this phenomenon related to the wider rollout?”

–          Included in Mr. Kelly’s opening statement were references to documents which reflected DePuy’s knowledge of the possible risks and effects of the release of metal ions into the body of those implanted with the ASR.  These documents were intended to show that despite such knowledge related to the possible risks of the ASR, DePuy decided not to hire a toxicologist to study and learn more. The jury also heard evidence that Graham Isaac, a scientist working for DePuy wrote in an email to other employees “Yesterday we were given some clinical data which compares metal ion levels between the BHR [a similar metal-on-metal orthopaedic hip implant which the ASR was in direct competition with] and ASR.  It shows that under certain conditions ASR is susceptible to extreme metal ion levels, but in the hands of the same surgeon, the BHR doesn’t have that problem.  The concern, it has the potential to seriously affect our business.”  Mr. Kelly followed up that email with the comment, “There is no mention in this email anywhere, which you’ll have in evidence, of a concern about the potential of hurting people.” Parenthetical explanation added.

–          Mr. Kelly went on to explain that DePuy for a short time considered redesigning the ASR XL to eliminate some of its most dangerous features, but that the program was given the code Project  Alpha so as not to alert doctors and hospitals of these safety changes.   Upon examining the costs of redesign, and considering current sales, the redesign program was later cancelled because, as Mr. Kelly put it, “the business case for the project could no longer be justified.  There was no mention, no analysis of the number of patients who might go on to still get the device and suffer the elevated ions and the excessive metal.”

–          Mr. Kelly also discussed whether Bill Kransky had an infection before having his hip removed.  DePuy’s primary and essentially only defense is that an infection was the reason for Mr. Kransky’s revision (a revision is the replacement of a hip implant), that an infection is not caused by a hip implant, and so DePuy is not liable for these related damages.  Mr. Kelly introduced evidence from Mr. Kransky’s revision doctor who testified that he did not see any signs of infection in Mr. Kransky’s hip.

–          The opening statement ended with the request for a substantial award for what Mr. Kransky endured, as well as punitive damages.

–          Alexander Calfo for the Defendants DePuy and Johnson & Johnson followed up with his opening statement to the jury.  In sum, he stated that the cobalt and chromium in the ASR did not poison Mr.Kransky, that the ASR was thoroughly tested and researched before it was implanted in people, and that Mr. Kransky’s illnesses and medical condition were not caused by the ASR.

January 25th Afternoon Session:

–          Former Depuy employee and head of the failure mode and effect analyses performed on the ASR, Magnus Flett’s video deposition excerpts were played.  Flett agreed with the need to make sure any new product put on the market should be safe stating: “You need to understand as best you can the risks that you see, the failure modes that you see and any mitigation you can do to risk those.”

–          Flett also admitted that in these failure mode analyses, the effect of the implant loosening to the point where a revision was necessary was something to be avoided.

–          When pushed on the lack of clinical trials performed on the ASR itself, Flett stated that they looked at the clinical history of “equivalent” products:

  • Q. You didn’t have any comparable products that used a monoblock cup with this specific under-reaming requirement, did you?
  • A.  We had an equivalent product in Durolac that we believed to be the same, same geometry, same morphology.
  • Q.  So its your testimony that your group decided that you would rely on the experience with Durolac as a reasonable way to conduct a failure mode and effect analysis for the ASR monoblock cup?
  • A.  We relied a lot on the clinical history of the Durolac, correct.
  • ….Q.  And the Durolac cups themselves are not monoblock systems, are they?
  • A.  They’re modular systems, correct
  • Q. And that’s a difference from the ASR, isn’t it?
  • A.  The ASR is a monoblock cup system, correct.

–          Further, when pushed on clinical studies with regard to testing the initial fixation, Magnus Flett agreed that although this was necessary to prevent failure and subsequent revision, not one single study was done by DePuy.

 

To read articles related to the ongoing trial from the New York Times, the Wall Street Journal and others please click the links below:

Maker Aware of 40% Failure in Hip Implant

Maker Hid Data About Design Flaw in Hip Implant, Records Show

 

When J&J Learned of Implant Problems 

 

Posted in: DePuy Trial Daily Updates
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