[Congressional Record Volume 143, Number 40 (Tuesday, April 8, 1997)]
[House]
[Pages H1293-H1294]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




NEUTRAL MATERIALS FOR MEDICAL DEVICES SHOULD BE ABSOLVED FROM LIABILITY

  The SPEAKER pro tempore. Under the Speaker's announced policy of 
January 21, 1997 the gentleman from Pennsylvania [Mr. Gekas] is 
recognized during morning hour debates for 5 minutes.
  Mr. GEKAS. Mr. Speaker and Members of the House, there are some 7.5 
million fellow Americans who at this very moment are alive or are 
living a little better because in their bodies there is implanted a 
medical device that has helped to cure a particular

[[Page H1294]]

malady that is suffered by that individual. We are talking about brain 
shunts, heart valves, pacemakers, artificial hearts, knee implants, 
hip; we know the whole list of new and wondrous devices that have been 
developed over the last several years and which now become almost 
routine in the lifesaving capacity in which they find themselves.
  Mr. Speaker, we have run into a serious problem which we have tried 
to address both in the last Congress, and now we are going to attempt 
again to do so. We came across a situation which is very serious. A 
supplier of materials to a company, let us say, that makes brain 
shunts, the supplier sends a little piece of wood, sells a little piece 
of wood to this brain shunt company. I am just doing a hypothetical. 
The brain shunt company takes this little piece of wood that is 
innocuous and neutral in its application and uses it as a component 
part of the brain shunt.
  Now, something once in a while may go wrong with the brain shunt and 
the person who is hurt by it, if it happens that way, will sue not just 
the doctor, not just the hospital, not just the device-maker, not just 
the scientist who developed this brain shunt, but also the supplier way 
back here in the chain of events who supplied a little piece of 
material that had nothing to do with whether or not the medical device 
worked. In other words, this company was supplying this wood to 
thousands of different companies for thousands of different things; it 
is just that innocuous, neutral item of material.
  So now what do we have? We have this scenario whereby a multimillion 
dollar suit is launched against this supplier back here of the wood 
particle, the little bitty part that went into this medical device. 
What has that caused? These companies have to defend these suits and 
they spend millions of dollars defending them, and in every single case 
they have been absolved from liability because all they supplied was a 
neutral piece of material.
  However, Mr. Speaker, the cost of doing business with these medical 
devices, the cost of litigation, lawyers' fees, court fees and costs 
and so forth, has caused these companies to make a policy decision not 
to deliver, not to sell these materials any longer to these people who 
develop these medical devices. That is a tragedy. That means that new 
medical devices and the continued use of the ones that have been so 
miraculous thus far, like the brain shunt and the pacemaker and all of 
those things, are running short of the capacity to meet the demand and 
the need of the American people.
  So last term I introduced a bill, the counterpart is over in the 
Senate, and we have done so again this year, to allow the material 
suppliers out here in the world, suppliers that have nothing to do with 
the ultimate injury if any occurs, to be absolved in the early part of 
a suit from the possibility of multimillion dollar lawsuits, and thus 
give them incentive to continue to supply these materials to the 
medical device companies.
  What happened last year, we passed such a bill, we passed a products 
liability bill that contained some other features of the same type, and 
the President vetoed it. We were stunned because we had received 
signals from the White House that indeed he was going to sign this 
bill, that he is in favor of those kinds of concepts, yet he vetoed it. 
We were not able to muster enough votes then to override the veto, so 
we have to try again this session.
  What startled me about the veto, Mr. Speaker and Members, was this: 
that when the President signed the welfare bill, he said there is a lot 
wrong with it, and he went on to outline how many things were wrong 
with the welfare bill, but he said there are enough good things in it 
that I am going to sign it and we will fix it later, or words to that 
effect. But on this lifesaving measure that we presented, which if he 
found flaws in it he could easily have said, I will sign it and we will 
take care of what I think is wrong with it later, but he failed to do 
that and vetoed the whole concept.
  We are going to try again to convince the President with massive 
public opinion and understanding of this issue, and we hope to prevail.

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