[Congressional Record Volume 142, Number 69 (Thursday, May 16, 1996)]
[Extensions of Remarks]
[Pages E825-E826]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             THE BIOMATERIALS ACCESS ASSURANCE ACT OF 1996

                                 ______


                          HON. GEORGE W. GEKAS

                            of pennsylvania

                    in the house of representatives

                         Thursday, May 16, 1996

  Mr. GEKAS. Mr. Speaker, today I am introducing the Biomaterials 
Access Assurance Act

[[Page E826]]

of 1996, legislation to ensure the availability of implantable medical 
devices, which include: pacemakers, heart valves, artificial blood 
vessels, angioplasty cathetes, left ventricular assist devices, and hip 
and knee joints. This bill is almost identical to H.R. 753, which I 
introduced last year, and is the same language that was included as 
title II of the Product Liability Fairness Act conference report which 
passed both Houses of Congress.
  The measure that I, along with a bipartisan group of 23 cosponsors, 
introduce today will provide for expedited dismissal from lawsuit of 
suppliers of raw materials used in the manufacture of lifesaving and 
lifeenhancing medical devices--biomaterials. The Biomaterials Access 
Assurance Act of 1996 will not limit recovery from a biomaterials 
supplier where the supplier is also the manufacturer or seller of the 
device, or where the supplier failed to provide the biomaterials 
described in an applicable contract or specifications.
  A looming crisis exists which necessitates adoption of the 
Biomaterials Access Assurance Act. Biomaterials suppliers have stopped 
selling raw materials to medical device manufacturers. The suppliers, 
named in lawsuits involving medical implants because they are 
considered deep pockets, have been forced to pay millions to defend 
themselves. Although these suppliers are rarely found liable, the 
litigation costs are not offset by the profits realized by selling to 
the device market. Sales to the device market make up only a small 
percentage of the overall sales of these materials to alternative 
markets. Raw materials used in the manufacture of these devices--
polyester yarn, resins, polyurethane--have other commercial 
applications. For example, polyester fibers used in medical implants 
account for less than $200,000 of sales in a $9 billion worldwide 
polyester yarn market.
  Twelve suppliers have withdrawn from the biomaterials market in the 
past 2 years. Device manufacturers have been forced to seek overseas 
suppliers, many of whom refuse to sell raw materials to U.S. 
manufacturers. The result is a critical shortage of biomaterials. The 
ultimate losers are the people who depend on medical devices to extend 
and improve their lives.
  The Product Liability Fairness Act, which contained the exact 
language that I introduce today, passed the House of Representatives by 
a vote of 259 to 158, and the Senate by a vote of 59 to 40. Despite the 
President's veto of the Product Liability Fairness Act, he stated that 
this provision in particular was ``a laudable attempt to ensure the 
supply of materials needed to make lifesaving medical devices.'' 
Although the President went on to express certain reservations that he 
has concerning this legislation, I intend to work closely with the 
cosponsors and the administration to ensure enactment of this 
lifesaving measure.

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