[Congressional Record Volume 143, Number 91 (Wednesday, June 25, 1997)]
[Senate]
[Pages S6381-S6382]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   BIOMATERIALS ACCESS ASSURANCE ACT

 Mr. ABRAHAM. Mr. President, I rise to speak today on Senate 
bill 364, the Biomaterials Access Assurance Act, which I am proud to 
cosponsor. I have long been a proponent for civil justice reform and 
other legislative measures relating to product liability. As an 
original cosponsor of product liability reform legislation (S. 648), I 
have long supported the biomaterials liability reform provisions 
contained in it. I am also pleased to cosponsor those provisions as a 
separate measure, although in my view we need both general product 
liability reforms and biomaterials liability reforms.
  This Nation's tort system is in dire need of repair. To maintain the 
status quo is not only costing consumers millions of dollars each year 
but also many lives will be lost if change does not occur soon. The 
Biomaterials Access Assurance Act approaches the subject of tort reform 
from a different perspective--the perspective of millions of Americans 
who face life-threatening diseases. These are the people who have the 
most to gain and everything to lose if Congress refuses to listen to 
their pleas.
  The purpose of this act is straightforward. S. 364 attempts to gain a 
foothold on our legal system's slippery slope by shielding companies 
who supply raw materials to manufacturers of life-saving medical 
devices. The Biomaterials Access Assurance Act will prevent the 
impending shortage of biomaterials suppliers by permitting these 
companies to be quickly dismissed from a lawsuit provided they had no 
part in the manufacture or selling of a

[[Page S6382]]

device and all contractual specifications had been met. Currently it is 
common practice for suppliers to be dragged into costly litigation even 
though these companies are not involved in the creation or marketing of 
a product. In fact, in almost every case thus far, biomaterials 
suppliers are not found liable in these type of lawsuits. S. 364 
squashes illegitimate attempts for windfall profits and more 
importantly, ensures these life-saving medical devices will be in 
abundant supply.
  Right now, the escalating expense suppliers unfairly incur defending 
their product continues to drive many out of the U.S. market. As a 
result, it is becoming increasingly more difficult for manufacturers of 
medical devices to find biomaterials suppliers with the raw materials 
necessary to produce their products. Replacement heart valves, 
pacemakers, and brain shunts are but a small selection of the devices 
which rely on raw material suppliers.
  My colleague from Arizona, Senator McCain, mentioned in an earlier 
statement that 13 biomaterial supply companies have been driven out of 
business due to concerns about the risk of unwarranted litigation. 
Sadly, the people whose lives depend on these raw materials for 
survival are the ones who will pay the ultimate price. Unfortunately a 
family living in my home State of Michigan illustrates my point.
  Recently Mr. And Mrs. Traxler of Fremont, MI, told me of their 
family's desperate need to find help for their young daughter, Sarah. 
The parents explained to me when Sarah was 2 months old she experienced 
a traumatic brain injury. As a result of the injury, Sarah now requires 
a shunt that drains fluid away from her brain.
  The shunt will need replacing soon and her parents are deeply worried 
that if medical manufacturers are forced into bankruptcy, the shunts 
keeping Sarah alive will no longer be available. In their letter, 
Sarah's parents explain, ``Because of the recent lawsuits involving 
breast implants and other medical devices, many biomaterials 
manufacturers have discontinued supplying the raw materials used to 
make medical devices. Because the sale of these raw materials represent 
such a small percentage of their total revenues, they do not feel it is 
worth the risk of having to defend themselves in court and they have 
discontinued supplying these materials to medical device 
manufacturers.''
  This is a sad commentary on the state of this Nation's legal system. 
Clearly, reform is needed and must be implemented soon to help protect 
the life of Sarah Traxler and countless others like her. For this 
reason, I ask my colleagues many of whom are parents themselves, to 
support this critical legislation.

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