INDIANAPOLIS - Members of an ANTEC panel on medical implants believe the Biomaterials Act, which was killed when President Clinton vetoed product liability reform, will have new life and pass eventually. Clinton vetoed a sweeping product liability bill May 2. The broad bill had political problems, especially its call to limit punitive damages to $250,000. Panel members said the Biomaterials Act itself has not attracted controversy and has broad bipartisan support. The act would have exempted materials suppliers and component makers from liability over defective implants. Initially, it was a separate piece of legislation, but political leaders decided to fold it into the product liability bill vetoed by Clinton.
Concerned about lawsuits, several large resin suppliers, notably Dow Plastics and DuPont Co., have pulled materials from the U.S. medical implant market. But because other countries are not as lawsuit-happy, resin makers continue to supply innovative materials outside the United States, panel members said during a May 7 ANTEC session.
``It seems that the research that's conducted in the United States and the medical-device edge that this country has can easily go overseas,'' said Udayan Patel, manager of materials technology for Guidant Corp., an Indianapolis implant maker.
Andy Rieth, Guidant's human resources director, said the Bio-materials Act would have isolated liability to the company that manufactures the implant, not resin suppliers. Resin suppliers still could be named in lawsuits, but as long as they were qualified and their products met specifications, they could be dismissed as defendants early in a case, he said.
``The issue is ... large and small raw materials and component manufacturers are being dragged into these product liability lawsuits where they really have no role,'' Rieth said. ``They were not involved generally with the original design of the product. They were not generally involved with the specifications that went into the product. This is the responsibility of the manufacturer.''
The title of the session, ``Betting the Company on 5 Cents' Worth of Plastic,'' referred to the hundreds of jaw-implant lawsuits faced by DuPont. Against DuPont's wishes, a Houston company, Vitek Inc., used DuPont's Teflon fluoropolymer in jaw implants. When the implants began to fail, Vitek went out of business and DuPont became the deep-pockets defendant, according to Douglas Behr, a lawyer for the Keller and Heckman law firm in Washington.
Vitek used 5 cents worth of Teflon in each implant.
DuPont ended up facing hundreds of lawsuits in 42 states and, while the company has lost only a single case, DuPont has spent an estimated $50 million in legal
bills, Behr said.
In 1993, DuPont sent out a ``dear customer'' letter asking that it stop using some grades of its plastics in medical implants.
Would resin makers re-enter the implant market if a Biomaterials Act became law? Most likely, panel members said.
``They would like to supply this market if at all possible,'' Rieth said, responding to an audience question.
Behr also said legislation could ease the resin supply.
Engineers play the key role. They must pick materials and design products that work inside the body.
Some lawsuits are fueled by overzealous marketing claims that imply an implant will work for the rest of a patient's life when that may not be true, according to Donald Duvall, senior consultant with Engineering Systems Inc. in Aurora, Ill. When it comes to implants, he said, engineers have a responsibility to design products in a thorough, deliberate fashion, even if that means cooling down the sales side and resisting management goals to bring new products to market quickly.