Sunday, July 7, 2013

Time is running out in NY to file a suit: File or not? (Part Nine of x) Defense Opening Remarks

Time is running out in NY to file a suit: File or not? Index of transcript comments from the Depuy vs Kransky trial:

All statements below are statements or a synopsis of the position of the defense in this case unless the comment is in [brackets] which would be my comments.

The defense started out with a blanket statement telling the jurors that everything presented by the Plaintiffs was taken from snippets here and there of a voluminous amount of documents...inferring that things were taken out of context of discussions which occurred between the Depuy scientists and engineers who worked their tails off to produce a great product.  None of the plaintiff's allegations were true.

The three leading statements:

1)  Cobalt, Chromium and the ASR hip are not poison.
2)  The ASR was thoroughly researched and tested before it was used in people.
3) Mr. Kransky's medical issues were not caused by the ASR.

[ hum, well I don't think the plaintiff called the Cr and Co poison in opening remarks.  I think they called them toxic.]

Interesting:  at the time the Depuy hip was conceived, Poly of course was the state of the art and about one third of the younger  patients who had them implanted  required revision in 11 years!  [Never heard that before.]  Both poly and ceramic shed wear debris in various amounts.

This is why  metal  surfaced as a possibility in orthopedics.  Metal  was being used back in the late 50's and early 60s and some of the researchers noted that the metal was lasting longer than the Poly and ceramic.  Metal  was abandon some  believed due to primitive manufacturing technology.  25 years later, they came back on the scene in the 80s.   When Depuy entered the market, the scientists and others worked hard to deliver the best hip they could.

 [I don't doubt that engineers and scientists did the best they could to deliver a better offering.  Having managed both engineers and scientists for the last 10 years or so, I have never seen either a scientist or engineer try to deliver  something that they thought wouldn't work.]

The Depuy tech team was focused on bettering the hip offerings by addressing two things that caused revisions:
  • dislocation incidence
  • loosening
The Depuy team did 3 things to improve this situation:
  • they made a larger ball to make it harder to dislocate
  • they made a new instrument to make it easier to insert the hip in order to preserve the bone
  • they carefully calculated the amount of space between the ball and the cup that would enable synovial fluid to adequately lubricate the space to minimize wear (the distance of which is the width of a human hair.)
Depuy will present a surgeon during the trial who will testify that the Depuy hip was the most tested hips ever developed and sold in the US.  This surgeon was a developer of a competitive metal hip.

Kransky's own surgeon will testify that it is common knowledge that all hips regardless of the material generate ions; metal and otherwise.

Depuy's attorney will clearly demonstrate the  level of scrutiny that the ASR was subjected to over and over again even after this hip was released in the US.  Every piece of evidence was considered every step of the way in this process.....

Depuy ran what they called health hazard evaluations  4 times in 2008, 2009 and 2010 and each time the team working on the hip concluded the evaluations concluded positively.  It was in  the summer of 2010, that Depuy received information that led them to believe the hip should no longer be sold.  It was then recalled in August of 2010.  That information showed that the revision rate after 5 years was around 13% which they felt was too high. Depuy said the revision rates were high for a reason that could not be defined....not that the product was defective.

Defense will show that the revision rate spiked after the recall and it is hard to say why the revision rate  spiked.  Did the patients overall need them or was there a reaction to the recall that made these rates spike so high when the patients really didn't need the surgery?

"Depuy acted as a very responsible manufacturer and the evidence will show that Depuy  is a good conscientious company.  In no way did this hip cause any of Karansky's problems either while it was in or when it was taken out.  Even though the plaintiff lawyers claimed in the introductory remarks that  they are not blaming the ASR for his illness, apparently, Kransky did claim under oath a string of issues for which they did blame Depuy which included things like:
  • renal failure
  • worsening of his kidney disease
  • lethargy
  • lack of smell and taste
  • lack of appetite
  • etc
The defense claims that Kransky had  diseased blood vessels throughout his body.  A body has 60,000 miles of blood vessels in the body and the disease of these vessels cause problems in many organs if the blood is not delivered properly. Kransky's blood vessels were clogged and scarred.  Kransky had so much plaque in his blood vessels that at any time, his vessels could erupt and damage his brain, kidneys and other organs.  His own physician will testify to that.

Karansky smoked 2 packs of cigarettes per day for 47 years.  This is a part of  what caused his problems not the ASR hip.  He was diagnosed as a diabetic with kidney disease well before the ASR was implanted.  He also had high blood pressure and high cholesterol  for years prior to the ASR implant.  Essentially the defense claims that experts will testify that none of Kransky's issues were caused by the ASR.  He had many illnesses but not any were associated the ASR.  All of the diseases preceded the ASR implant.

Further, you will see that most of the complaints above were existing well before the ASR implant and likely caused by his exposure to agent orange during the war.  Mr Kransky was deemed to be 100% disabled before he got the ASR implanted.  Mr Kransky had a kidney removed but had normal creatinine levels.  [It sounds like they are trying to convince  someone that the cancer wasn't caused by the hips which is correct.  Mr Kransky had kidney cancer prior to the hip.  The point he should be trying to make was the cancer was not exacerbated by the metals.  I have yet to hear him comment on that though.  Also, you can have normal creatinine levels with cancer!]

Mr Kransky then had an aortic aneurism burst which they say caused cholesterol and plaque to become dislodged which then shut down a kidney when they tried to repair it .  The creatinine levels then jumped to 5 which is a very abnormal level.

So the conclusion is that the chronic  kidney disease  impacted the ability  to excrete the chromium and cobalt ions.

The defense then explained the fact that the chromium and cobalt found in Mr. Kransky was not enough to cause a problem.  The Cr /Co in Mr. Kransky measured 47/53 ppb.  Hence,
the hip pain experienced by Mr. Kransky was caused by something else which they claim was  the fact that Mr Kransky fell off a roof when he was 16 years old and as a result, he had  developed osteoarthritis which caused the pain ultimately.  [Most hip replacements are undertaken as a result of osteoarthritis.]  The attorney asserts that while Mr. Kransky was completely fine with this hip for 3.5 years, when the attorneys began advertising for the suits on TV, he picked up on that and began blaming the Depuy  hip. [Yikes????]  Then Mr.  Kransky went to find a lawyer who then recommended a Surgeon to remove the hip.  Apparently the surgeon was a friend of the lawyers who had served as a witness on other cases for him.

It is then alleged by the defense attorney that the surgeon who removed the hip referred to the Cr and Co as poison because the family asked him to in order to expedite the trail. [ Yikes again!  Gee, this sounds like the old soap opera "As the World Turns."  Honestly, I just can not see an orthopedic surgeon using inappropriate language to describe something at the behest of the family of the patient????   Then it is alleged that Kransky's daughters who were nurses got involved in characterizing the illness from the hip.]  Kransky's surgeon said he was coached to use the word poison in his surgical notes????  [I can only say that all of this sounds so far fetched to me.  Sounds like this medical  case went off the runway into the cornfield....or at least the surgeon did if this is all true.  What orthopedic surgeon gets coached to write something in his notes that is not representative of what he believes?]  And then, to top it all off, the defense asserts that the surgeon is going to testify to the fact that he (Kransky's orthopedic surgeon) "drank the Kool- Aid."

[I think this story is so bazaar that no one could make this up!]

This portion of the opening remarks concludes with the attorney claiming that  Hanson (Kransky's orthopedic surgeon) will testify that the placement of the hip was not done at 45 degrees, the hip was infected and he needed antibiotics.  He did note that there was staining but that staining did not cause tissue damage nor the need to replace the hip.  Defense claims that the infection was caused the blood vessel problems, cancer, smoking etc.

Shockingly, Kransky's hip was not revised because there was no loosening and the tissue around the hip was healthy.


PS/ I know the close of these  opening remarks are well, somewhat far fetched but I will give the defense the benefit of the doubt and listen to the direct testimony......I will look forward to hearing  Kransky's  orthopedic surgeon testify to the fact that he was coached by the Kransky family members to write what they wanted to see in his surgical  notes and that he concludes his observation with "I drank the Kool-Aid."   Yikes! OMG.

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