[Congressional Record Volume 144, Number 105 (Thursday, July 30, 1998)]
[Senate]
[Pages S9500-S9501]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
BIOMATERIALS ACCESS ASSURANCE ACT OF 1997
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate
proceed to the immediate consideration of H.R. 872, which is at the
desk.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:
A bill (H.R. 872) to establish rules governing product
liability actions against raw materials and bulk component
suppliers to medical device manufacturers, and for other
purposes.
The PRESIDING OFFICER. Is there objection to the immediate
consideration of the bill?
There being no objection, the Senate proceeded to consider the bill.
Mr. McCAIN. Mr. President, the effort to pass legislation dealing
with biomaterials has been a long fight. I want to thank Senator
Lieberman, and Congressman Gekas for their extraordinary leadership and
hard work on the issue. It has been a great privilege and honor working
with them over the past several years to gain passage of this vital
legislation.
I want to stress to my colleagues the importance of passing the
Biomaterial Access Assurance Act. Over seven million lives depend upon
an ample and reliable supply of medical devices and implants, such as
pace makers and brain shunts.
Unfortunately, the supply of these life-saving products is in serious
danger. Those who provide the raw materials from which medical implants
are fashioned have been dragged into costly litigation over claims of
damage from the finished product. This is the case even though such
suppliers are not involved in the design, manufacture or sale of the
implant. Many suppliers are unwilling to expose themselves to this
enormous and undue risk. This bill will extend appropriate protection
to raw material suppliers, while assuring that medical implant
manufacturers will remain liable for damages caused by their products.
It would permit suppliers of biomaterials to be quickly dismissed from
a lawsuit if they did not manufacture or sell the implant and if they
met the contract specifications for the biomaterial.
Mr. President, as my colleagues are aware, the bill's provisions do
not extend to suppliers of silicone gel and silicone envelopes used in
silicone gel breast implants.
I want to be quite clear this ``carve-out'' as it's been called, is
intended to have no effect on tort cases related to breast implants.
The question of whether and to what degree silicone breast implants are
hazardous is a determination that must be made by scientific experts.
The question of whether and to what degree raw material suppliers are
or are not liable is a determination that the courts must render.
Determining the safety or efficacy of a medical device is not the
function of the Senate nor the United States Congress. This is not our
role and nothing in this legislation should be construed otherwise. So,
the exemption should not be interpreted as a judgement about silicone
breast implants.
Our goal in this regard remains simply to ensure that this
legislation draws no conclusion about and has no impact upon pending
suits.
Finally, I would like to mention that this exemption should not be
considered an invitation for additional carve-outs or exemptions for
other raw material or component part suppliers.
I do not wish to see suppliers, who trusting in the protections of
this act, return to the medical device manufacturing marketplace only
to find themselves again targeted as deep pockets in tort actions, and
thereby threaten the supply of life saving products. I appreciate the
opportunity to make this very important point about a bill vital to
public health.
This is an important piece of legislation and it will make a great
difference to millions of Americans.
Mr. President, I would now like to enter into a colloquy with the
distinguished Senator from Wisconsin regarding several aspects of this
legislation.
Mr. FEINGOLD. Mr. President, I rise to express my concern regarding
three provisions of the Biomaterials Access Assurance Act of 1998.
Although I have broader concerns with the bill including federalism
issues, consumer protection issues, and evidentiary issues, I would
like clarification from one of the sponsors of the bill, Senator
McCain, on three specific points.
First, Section 7(a) the language reads that only ``after entry of a
final judgment in an action by the claimant against a manufacturer''
can a claimant attempt to implead a biomaterials supplier. I am
concerned that this could be interpreted to mean that the manufacturer
must lose the underlying suit before the claimant may implead the
supplier. Is this correct?
Mr. McCAIN. No. Although I do not believe that the situation you pose
could happen very often--specifically that a supplier could be liable
when the manufacturer is not--the language should be interpreted to
mean that the claimant could bring a motion to implead the supplier
whether or not the manufacturer is found liable in the underlying case,
as long as the judgment is final.
Mr. FEINGOLD. Second, I am concerned that there would not be a
sufficient introduction of evidence demonstrating the liability of the
supplier in the underlying suit against the manufacturer for the court
to make an independent determination that the supplier was an actual
and proximate cause of the harm for purposes of the impleader motion as
required in Sections 7(1)(A) and 7(2)(A) of the bill.
Mr. McCAIN. Under current FDA regulations and under current tort law,
the manufacturer is responsible for the entire product they produce,
including defects in the raw materials. Therefore, the claimant may
enter evidence in the underlying action against the manufacturer
regarding defect in the biomaterials used.
Mr. FEINGOLD. Finally, I am concerned that in a case where the
manufacturer has gone bankrupt, the claimant will be unable to recover
from the liable party. Does your bill address this issue?
Mr. McCAIN. Yes it does. Section 7(a)(2)(B) provides that in a case
where the claimant is unlikely to recover the full amount of its
damages from the manufacturer, if the other requirements of Section 7
are satisfied, the claimant can bring an action against the supplier.
This covers bankruptcy and other scenarios where the manufacturer
cannot satisfy an adverse judgment.
Mr. FEINGOLD. Senator McCain, I thank the Senator for addressing my
concerns.
Mr. LIEBERMAN. Mr. President, I rise in strong support of the bill we
are about to take up and vote upon, the Biomaterials Access Assurance
Act. I am proud to have co-sponsored the Senate version of this bill
with Senator McCain. We have worked together on this bill for a number
of years now, and it is quite gratifying to see it now about to move
toward enactment.
Mr. President, the Biomaterials bill is the response to a crisis
affecting more than 7 million Americans annually who rely on
implantable life-saving or life-enhancing medical devices--things like
pacemakers, heart valves, artificial blood vessels, hydrocephalic
shunts, and hip and knee joints. They are at risk of losing access to
the devices because many companies that supply the raw materials and
component parts that go into the devices are
[[Page S9501]]
refusing to sell them to device manufacturers. Why? Because suppliers
no longer want to risk having to pay enormous legal fees to defend
against product liability suits when those legal fees far exceed any
profit they make from supplying the raw materials for use in
implantable devices.
Let me emphasize that I am speaking here about--and the bill
addresses--the suppliers of raw materials and component parts--not
about the companies that make the medical devices themselves. The
materials these suppliers sell--things like resins and yarns--are
basically generic materials that they sell for a variety of uses in
many, many different products. Their sales to device manufacturers
usually make up only a very small part of their markets--often less
than one percent. As a result--and because of the small amount of the
materials that go into the implants--many of these suppliers make very
little money from supplying implant manufacturers. Just as importantly,
these suppliers generally have nothing to do with the design,
manufacture or sale of the product.
But despite the fact that they generally have nothing to do with
making the product, because of the common practice of suing everyone
involved in any way with a product when something goes wrong, these
suppliers sometimes get brought into lawsuits claiming problems with
the implants. One company, for example, was hauled into to 651 lawsuits
involving 1,605 implant recipients based on a total of 5 cents worth of
that company's product in each implant. In other words, in exchange for
selling less than $100 of its product, this supplier received a bill
for perhaps millions of dollars of legal fees it spent in its
ultimately successful effort to defend against these lawsuits.
The results from such experiences should not surprise anyone. Even
though not a single biomaterials supplier has ultimately been held
liable so far--let me say that again: Not a single biomaterials
supplier has ultimately been held liable so far--the message
nevertheless is clear for any rational business. Why would any business
stay in a market that yields them little profit, but exposes them to
huge legal costs? An April 1997 study of this issue found that 75
percent of suppliers surveyed were not willing to sell their raw
materials to implant manufacturers under current conditions. That study
predicts that unless this trend is reversed, patients whose lives
depend on implantable devices may no longer have access to them.
What is at stake here, let me be clear, is not protecting suppliers
from liability and not even just making raw materials available to the
manufacturers of medical devices. Those things in and of themselves
might not be enough to bring me here. What is at stake is the health
and lives of millions of Americans who depend on medical devices for
their every day survival. What is at stake are the lives of children
with hydrocephalus who rely on brain shunts to keep fluid from
accumulating around their brains. What is at stake are the lives of
adults whose hearts would stop beating without implanted automatic
defibrillators. What is at stake are the lives of seniors who need
pacemakers because their hearts no longer generate enough of an
electrical pulse to get their heart to beat. Without implants, none of
these individuals could survive.
We must do something soon to deal with this problem. We simply cannot
allow the current situation to continue to put at risk the millions of
Americans who owe their health to medical devices.
Senator McCain, and I and the bill's sponsors in the House have
crafted what we think is a reasonable response to this problem. Our
bill would do two things. First, with an important exception I'll talk
about in a minute, the bill would immunize suppliers of raw materials
and component parts from product liability suits, unless the supplier
falls into one of three categories: (1) the supplier also manufactured
the implant alleged to have caused harm; (2) the supplier sold the
implant alleged to have caused harm; or (3) the supplier furnished raw
materials or component parts that failed to meet applicable contractual
requirements or specifications.
Second, the bill would provide suppliers with a mechanism for making
that immunity meaningful by obtaining early dismissal from lawsuits. By
guaranteeing suppliers in advance that they will not face needless
litigation costs, this bill should spur suppliers to remain in or come
back to the biomaterials market, and so ensure that people who need
implantable medical devices will still have access to them.
Now, it is important to emphasize that in granting suppliers
immunity, we would not be depriving anyone injured by a defective
implantable medical device of the right to compensation for their
injuries. Injured parties still will have their full rights against
anyone involved in the design, manufacture or sale of an implant, and
they can sue implant manufacturers, or any other allegedly responsible
party, and collect for their injuries from them if that party is at
fault.
We also have added a new provision to this version of the bill, one
that resulted from lengthy negotiations with representatives of the
implant manufacturers, the American Trial Lawyers Association--ATLA--
the White House and others. This provision responds to concerns that
the previous version of the bill would have left injured implant
recipients without a means of seeking compensation if the manufacturer
or other responsible party is bankrupt or otherwise judgment-proof. As
now drafted, the bill provides that in such cases, a plaintiff may
bring the raw materials supplier back into a lawsuit after judgment if
a court concludes that evidence exists to warrant holding the supplier
liable.
Finally, let me add that the bill does not cover lawsuits involving
silicone gel breast implants.
In short, Mr. President, the Biomaterials bill is--and I am not
engaging in hyperbole when I say this--potentially a matter of life and
death for the millions of Americans who rely on implantable medical
devices to survive. This bill would make sure that implant
manufacturers still have access to the raw materials they need for
their products, while at the same time ensuring that those injured by
implants are able to get compensation for injuries caused by defective
implants. This is a good bill, and I urge my colleagues to support it.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the bill be
considered read a third time and passed; that the motion to reconsider
be laid upon the table; and that any statements relating to the bill be
placed at the appropriate place in the Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
The bill (H.R. 872) was considered read the third time and passed.
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