[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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