[Congressional Record Volume 140, Number 81 (Thursday, June 23, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: June 23, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                 THE BIOMATERIALS ACCESS ASSURANCE ACT

 Mr. McCAIN. Mr. President, I am pleased to cosponsor S. 2215, 
the Biomaterials Access Assurance Act of 1994. This important bill 
would help to ensure the continued availability of materials for a wide 
variety of life-saving medical devices, such as brain shunts, heart 
valves, artificial blood vessels, and pacemakers.
  Currently, the manufacturers and suppliers of such materials are 
subject to substantial legal liability for providing relatively small 
amounts of materials which generate small profits and are used for 
purposes beyond their control. This bill would substantially reduce 
their potential liability, and allow them to make their essential 
materials available. It will thereby address one important aspect of 
our broken medical products liability system.
  This issue recently 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 that 
our medical liability system 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. Our bill 
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 Biomaterials Access 
Assurance Act of 1994 to ensure that the lives of Tara and thousands of 
other Americans are not jeopardized. I request that a New York Times 
article which was reprinted in the Arizona Republic entitled ``Implant 
Makers Facing Loss of Raw Materials,'' be included in the Record 
following my remarks.
  The article follows:

               [From the Arizona Republic, Apr. 25, 1994]

    Implant Makers Facing Loss of Raw Materials: Chemical Firms Say 
                         Lawsuits Forcing Hand

       Chicago.--Big chemical companies and other manufacturers of 
     materials used to make heart valves, artificial blood vessels 
     and other implants quietly have been warning medical-
     equipment companies that they intend to cut off deliveries 
     because of fears of lawsuits.
       The suppliers' new policies have not yet forced important 
     products from the market, but medical-equipment manufacturers 
     scrambling to protect themselves from the impending cutoffs 
     say they are having trouble lining up replacement suppliers.
       Industry executives and doctors say the trend eventually 
     could make some lifesaving implants hard to come by and have 
     a devastating effect on the development of new devices.
       About 100 equipment companies already have had supply 
     problems, according to the Health Industry Manufacturers 
     Association, a Washington-based trade group for the equipment 
     makers.
       The materials manufacturers, including such giants as E.I. 
     du Pont and Dow Chemical Co., are dropping the medical 
     business in response to the high risk of being dragged into 
     lawsuits filed against implant makers by consumers who say 
     they have been injured by defective products.
       Suppliers already have been named in hundreds of suits 
     involving jaw implants, silicone breast implants and other 
     devices.
       Equipment makers say the litigation that has spurred the 
     suppliers' withdrawals also has made it harder to obtain the 
     materials indirectly through distributors or other middlemen.
       In addition, some equipment companies say electronics 
     companies and other important subcontractors that assemble 
     high-tech components for the most-sophisticated 
     implants increasingly are reluctant to take on such 
     business.
       ``You can see a monster scenario where this gets totally 
     out of hand,'' said Curtis Holmes, vice president for 
     technology at Wilson Greatbatch Ltd. of Clarence, N.Y., a 
     supplier of lithium batteries for heart pacemakers.
       Wilson is scrambling to replace the pinch of Du Pont Teflon 
     it uses in each battery. Replacing the Teflon ultimately 
     could cost as much as $300,000 in testing and regulatory 
     hearings and take researchers away from developing products. 
     But that is not what really worries Holmes.
       ``What if the lithium companies decide they don't want to 
     sell to us?'' he asked. ``Or the iodine, stainless-steel or 
     titanium producers?''
       Despite behind-the-scenes lobbying, equipment makers and 
     medical groups so far have raised little concern in 
     Washington about the trend.
       Consumer groups say the chemical companies' moves simply 
     are part of a broader campaign by industry to pressure 
     Congress to limit the redress available in courts for those 
     injured by defective products.
       One leading supporter of product-liability-reform 
     legislation is convinced the implant makers' plight is a 
     special case.
       ``This is a public-health time bomb,'' said Sen. Joseph 
     Lieberman, D-Conn., who said he hopes to hold hearings on the 
     subject next month.
       Lieberman said that although the proposed changes in 
     product-liability laws would reduce materials suppliers' 
     exposure to lawsuits, the problem might have to be dealt with 
     in health-care-reform legislation being written on Capitol 
     Hill.
       The medical-equipment makers fear that partial protection 
     from litigation will not be enough to bring back the big 
     chemical and plastics suppliers, because they have so little 
     to gain from the medical business.
       Medical devices typically use small quantities of raw 
     materials, compared with other applications.
       Polyester yarn, for example, is used in artificial blood 
     vessels, heart valves and sutures left in the body after 
     internal surgery. Total annual sales for such uses are less 
     than $200,000, a tiny fraction of 1 percent of the $9 billion 
     market for such yarn in clothing, homes and industry, 
     according to a recent study for the Health Industry 
     Manufacturers Association.
       Another material withdrawn by Du Pont and Hoechst Celanese 
     is polyacetal resin. The automotive, industrial, plumbing and 
     consumer-products sectors buy $1.3 billion of it annually; 
     the implant industry buys just 550 pounds, valued at $3,300, 
     for use in heart valves.
       Pelletrane, a polyurethane that Dow Chemical began pulling 
     from the medical market in 1990, is used in such products as 
     automobile hoses and athletic shoes.
       The medical market is so small that Dow said it did not 
     realize that companies such as Medtronic Inc., the world's 
     largest pacemaker manufacturer, used Pelletrane as a coating 
     until three years after Dow acquired the business from Upjohn 
     Co. in 1985.
       In the past, companies such as Du Pont have made products 
     available to medical companies accompanied by warnings that 
     they had not been tested in any way to establish their 
     suitability for medical applications.
       ``Everything is manufactured for industrial and consumer 
     purposes,'' said Katherine Knox, the manager overseeing Du 
     Pont's transition toward cutting off all such sales. ``But 
     for 30 years, we had a policy that we wouldn't withhold 
     materials from the medical sector because we didn't want to 
     inhibit development.'' 

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