WASHINGTON — In a quick about-face that ended more than a year of stalled negotiations, Congress last week passed bills that exempted resin companies from liability for materials used in medical devices.
The Senate passed the legislation late during the night of July 30, a day after the House passed the same bill. Both chambers passed it by voice vote. It now awaits President Clinton's signature.
The measure had been stalled in the Senate because it was a ``political sweetener,'' placed in a broader product liability bill to win support for more controversial parts of that legislation, said Rep. George Gekas, R-Pa., a key sponsor of the House bill.
But when the Senate's efforts at broad product liability reform fell apart in early July, that cleared the way for a biomaterials bill to move on its own, said Karen Alcorn, spokeswoman for the Washington-based Health Industry Manufacturers Association.
The bill would exempt suppliers of raw materials like plastic resin from liability for medical device failures, provided the material is not at fault and the resin supplier had no role in the design or manufacture of the medical device.
HIMA said that 75 percent of suppliers of current biomaterials have banned sales to the U.S. medical implant market, and others are reconsidering.
Medical sales are often a small part of resin companies' overall sales, making it more expensive to fight lawsuits than supply materials, HIMA said. For example, of the $1.3 billion market for polyacetal resin in the United States, only about $3,300 goes into implants for heart tissue valves, HIMA said.
President Clinton is expected to sign the legislation, Gekas said. White House officials could not be reached.