Congress again is wrangling over laws to shield biomaterials suppliers from lawsuits when medical devices do damage.
Two years ago, MODERN HEALTHCARE reported that suppliers, faced with billion-dollar legal judgments, were limiting sales of silicone and other materials vital to certain medical devices (June 28, 1993, p. 90). Congress debated-but never passed-measures to protect materials suppliers from product suits if they didn't help make the troublesome device.
Today, the possibility of a crippling materials shortage still haunts devicemakers. Dow Corning Corp., hit with billions of dollars in injury claims over silicone breast implants, filed for bankruptcy in May. The company has been selling silicone to medical manufacturers that promise legal protection, but bankruptcy might end those arrangements, said Jim Benson, a senior vice president at the Health Industry Manufacturers Association.
Meanwhile, 41% of devicemakers in a HIMA survey reported difficulties obtaining polyester and silicone. Those materials are used in artificial finger joints, pacemakers, vascular grafts and other devices.
Unfortunately, legislation that could soothe skittish materials suppliers is part of a broader product-liability package. Consumer groups and lawyers, unhappy with many of its provisions, are putting up a fight. And that could mean fears of a biomaterials shortage will persist.