[Congressional Record Volume 141, Number 19 (Tuesday, January 31, 1995)]
[Senate]
[Page S1803]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                 THE BIOMATERIALS ACCESS ASSURANCE ACT

  Mr. McCAIN. Mr. President, I am pleased to be the primary cosponsor 
of the Biomaterials Access Assurance Act of 1995 to ensure the 
availability of raw materials and component parts for implantable 
medical devices. This bill, which we introduced as S. 2215 last year, 
is necessary for Americans to have continued access to a wide variety 
of life-saving devices, such as brain shunts, heart valves, artificial 
blood vessels, and pacemakers.
  Currently, the manufacturers and suppliers of materials used in 
implantable medical devices are subject to substantial legal costs and 
possibly liability for selling small amounts of materials to medical 
device manufacturers. These sales generate relatively small profits and 
are often used for purposes beyond their direct control. Consequently, 
some of the manufacturers and suppliers of these materials are now 
refusing to provide them for use in medical devices.
  It is absolutely essential that a continued supply of raw materials 
and component parts is available for the invention, development, 
improvement, and maintenance of medical devices. Most of these devices 
are made with materials and parts that are not designed or manufactured 
specifically for use in implantable devices. Their primary use is in 
non-medical products. Medical device manufacturers use only small 
quantities of these raw materials and component parts, and this market 
constitutes a small portion of the overall market for such raw 
materials.
  While raw materials and component parts suppliers do not design, 
produce or test the final medical implant, they have been sued in cases 
alleging inadequate design and testing of, or warnings related to use 
of, permanently implanted medical devices. The cost of defending these 
suits often exceeds the profits generated by the sale of materials. 
This is the reason that some manufacturers and suppliers have begun to 
cease supplying their products for use in permanently implanted medical 
devices.
  Unless alternative sources of supply can be found, the unavailability 
of raw materials and component parts will lead to unavailability of 
life-saving and life-enhancing medical devices. The prospects for 
development of new sources of supply for the full range of threatened 
raw materials and component parts are remote, as other suppliers around 
the world are refusing to sell raw materials or component parts for use 
in manufacturing permanently implantable medical devices in the United 
States.
  The legal concerns that are causing the unavailability of raw 
materials and component parts for medical implants are part of a larger 
product liability crisis in this country. Immediate action is necessary 
to ensure the availability of such materials and parts for medical 
devices so that Americans have access to the devices they need. 
Addressing this problem will solve one important aspect of our broken 
medical product liability system.
  This issue initially came to my attention when I was contacted by one 
of my constituents, Linda Flake Ransom, about her 7-year-old daughter, 
Tara, who requires a silicon brain shunt. Without a shunt, due to 
Tara's condition called hydrocephalus, excess fluid would build up in 
her brain, increasing pressure, and causing permanent brain damage, 
blindness, paralysis, and ultimately death. With the shunt, she is a 
healthy, happy, and productive straight-A student with enormous promise 
and potential.
  Tara has already undergone the brain shunt procedure five times in 
her brief life. However, the next time that she needs to replace her 
shunt, it is not certain that a new one will be available due to the 
unavailability of shunt materials. This situation is a sad example of a 
medical liability system that is out of control. It is tragic, but not 
surprising that manufacturers have decided not to provide materials if 
they are subject to tens of millions of dollars of potential liability 
for doing so.
  It is essential that individuals such as Tara continue to have access 
to the medical devices they need to stay alive and healthy. Enacting 
the Biomaterials Access Assurance Act of 1995 
would help to ensure the ongoing availability of materials necessary to 
make these devices. It would not, in any way, protect negligent 
manufacturers or suppliers of medical devices, or even manufacturers or 
suppliers of biomaterials that make negligent claims about their 
products. However, it would protect manufacturers and suppliers whose 
materials are being used in a manner that is beyond their control.
  Mr. President, we must act quickly to pass the bill to ensure that 
the lives of Tara and thousands of other Americans are not jeopardized.


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