Thursday, June 13, 2013

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

Hello fellow patients,

Seems as though the  news surrounding the Depuy hip has died down to say the least.  Traffic will pick up again when the next suit is litigated though.   Depuy won one case (Carol Strum), one was settled pre trial and one win by the patient (Kransky).(BTW/if you want to know details about that case, you can just type that into the search engine on the blog or open the litigation category for January of 2013.  You can follow the case from the press's perspective at least.)

This blog has followed the  news surrounding this issue since December of 2010.  The news  consisted largely of  medical studies, legal perspectives on litigation  and some consumer news, in that order. 

I have many conflicted thoughts  about this filing and  thought I would share my thoughts with you below.  So, in my case, reading the transcripts from the first case litigated (Kransky)  is my next step.

My objective is to come to a decision one way or another (file or not.)  My fellow New Yorkers only have  a few more months  or so to make the decision.  There  is the statute of limitations of 3 years to file this suit from I believe[check with your attorney] the day you were made aware of your hip recall.   Most patients  were informed  via  snail mail from their physicians sometime between  August 2010 and mid to late October 2010. I was notified in mid October that my hip was affected but had read the story in the Wall Street Journal in August.

So, what are the critical issues to me?  Well, I have worked  in the medical industry with two different companies over a period of 6 years or 7 years many years ago and I learned a lot about how companies in the medical business operate.  I had the opportunity to work on new product release teams (on the sales side) in my very early career for both medical products and pharma. There are two key issues to me:

1. Tradeoffs:

There are tradeoffs in the medical arena and in all areas where new products are released.  In the medical arena though, the tradeoffs perhaps are more pronounced  because there are effects on patients if there is a mistake made or something overlooked in the process of making those  trade offs. 

There is no such thing as creating a device or medication that is perfect.  That is, you always must weigh the  patient benefits (efficacy)  against such things as  side effects, mortality* and morbidity*.  Generally, the manufacturer tries to balance these things.  I would never go into a medical procedure, take medicine or use a device without thinking about the potential downside of these things.

In this case, I never could have imagined a revision.  But , my issue is not whether the device resulted in  a problem but rather:
  • What did the designers of the device know when they created it and
  • When did they become aware of the problem?   
  • What did they then do about the problem when they became aware?  

Don't get me wrong.  I am not happy about this revision process. No patient would be. I wouldn't wish a revision on anyone but it occurred to me that I did not have enough information on the proverbial question from the Nixon, Watergate hearings//remember those? :  "What did they know and when did they know it?"  In my mind, that question has not been clarified,  at least not to my satisfaction but I can say, by reading the transcripts, that answer is becoming much clearer to me. 

The video that I published over a year ago  (from the "Triumvirate"  including  Dr. Tony Nargol)  had a big impact on me but I never heard the other side of the story.   I am examining the other side of the story by reviewing the transcripts so I can make a more  informed decision. (See the Dr. Tony Nargol video here:  While many found these  videos  to be really graphic in nature, I was most interested in the timing of "what did Depuy know and when did they know it."

My hip has given me mobility where I had none before  and I am grateful for that mobility  but as you know from my past blog posts, I encountered  real issues with this revision.

2)  Is it possible that companies who release devices make errors, sometimes egregious errors  when releasing them to the market?  This, I can answer unequivocally yes, at least from my own experience inside the medical arena.

My second encounter (I am skipping the first one because to this day, that case saddens me), I was selling devices that control the fluid of IVs entering the body.  I was on the sales team, and had just begun a trial in a hospital for monitoring the patients in the  ICU unit.

When these devices were first introduced to the market, the business model was based on  the hospitals buying  the devices.....for each patient....but that business model didn't work well as funds in a hospital are limited  so we adopted a new business model.  That model was based on marking up the price of the IV tubing that went inside of the machines hence, the new model enabled a hospital to afford many more units and in effect, the machines were paid for over time.

The problem with this model was twofold: 
  • We were experts in making IV equipment but NOT in making IV tubing.  We contracted the IV tubing out to a third party and  we had no experience with IV  tubing before release.
  • We  did not contemplate that when a unit like the ICU switched over to the IV equipment and IV tubing, that the IV tubing would be used without the equipment.
Being the diligent salesperson I was, I  planned to work the three shifts to ensure that the nurses understood how to use the equipment.  The operations folks at the hospital pulled all of the old tubing because there was no need for it prior to the in-service training.  They didn't want any confusion as to what tubing should be used inside the machines.

 I was well trained to deal with an installation but no one foresaw the potential problem;  non essential IVs were hung with no instruments controlling the drips.  When the training was completed, I went home to bed.  Shortly after I got home, I got a call @ 2:00 AM,  that all of the IVS  which were not on machines ran away (ran quickly)....into the patients!  I was horrified and just so lucky none of the patients died on the unit.

Little did I know that the most horrifying piece was yet to come.  I quickly got a type written letter (yes, this dates me doesn't it!) to the new CEO of the company and insisted that all of the salespeople be notified immediately and the IV tubing be pulled from the market. I described the problem in detail.

Promptly upon receipt of the letter the following occurred: (I was maybe all of  27 or 28 years young and  naïve at that!)

I was told that "The company comes first!"  I later learned that the letter was destroyed.  We are talking about something that happened almost 25 years ago or so.
I will never forget that incident.  I just could not comprehend such a reaction especially in light of the fact that our start up  company was bought by a major Pharma company! Now this was quite some time ago but  I have never forgotten that event.  This incident  left an indelible mark on me. I left that company shortly thereafter.

Conclusion to part one.

I know there are tradeoffs in releasing products to the market.
I know there are medical companies that don't put the patients first.

I will post things that I find  in the transcripts which might help me come to a conclusion about filing.  This was not a closed trial as you all know.  Many have reported on the proceedings. Reading these transcripts is very time consuming so I won't be publishing each day but will post a few times per week on any findings that help me better understand:  What did they know and when did they know it.


Morbidity refers to the state of being diseased or unhealthy.
Mortality is the term used for the number of people who died within a population

My next post will address Dr Schmalzride's testimony.  He was an inventor of the Depuy hip.  I found many things in that testimony interesting.  Stay tuned for part two.

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