Statement on Signing the Biomaterials Access Assurance Act of 1998

I am pleased to sign today the Biomaterials Access Assurance Act of 1998, which should help to ensure the continued availability of lifesaving and life-enhancing medical devices. The bill protects certain raw materials and parts suppliers from liability for harm caused by a medical implant. Congress heard evidence that these biomaterials suppliers are increasingly unwilling to sell their goods to implant manufacturers. Although these suppliers have never been found liable, they fear that their costs to defend themselves, if dragged into litigation over the medical device, would far outweigh the profits they would earn from supplying the raw materials. But without those materials, Americans would have to live without the heart valves, jaw implants, artificial hips, and other medical devices (including many not yet imagined) that can help the victims of disease and injury stay alive or improve the quality of their lives.

This bill addresses concerns that I raised, when I vetoed the product liability bill in 1996, about that bill's biomaterials provision. This bill is very narrowly crafted to accomplish its specific objective—maintaining the supply of biomaterials.