[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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