In 1993, DuPont Co. sold $10.5 billion worth of the industrial fibers Dacron, Teflon, and Delrin. A mere $600,000 in sales, however, went to biomedical-implant manufacturers. But for more than eight years, DuPont ended up spending $50 million defending itself--successfully--against lawsuits involving a faulty jaw implant that contained 5 cents worth of Teflon. Deep pockets were the obvious target: The small implant maker went bankrupt soon after the suits were filed.
DuPont has since stopped selling its raw materials to medical-implant makers. According to a study released on Apr. 8, three-quarters of other materials suppliers have done the same. Most sell just a few thousand dollars' worth of raw materials for biomedical implants. In the study, funded by the Health Industry Manufacturers Assn., suppliers cited fear of liability as a top reason for dropping out of the market.
The result of these defections is that manufacturers of shunts, heart valves, and other implants are jumping through hoops to get raw materials. Innovation is stagnating, and supplies of some smaller-market items are shrinking. At risk is the health of many of the 8 million Americans who depend on such devices, many of which are lifesavers.
RESTRICTION? It's time for Congress to step in and solve the problem. A law to do so has already been introduced: the Biomaterials Access Assurance Act of 1997. Spun off from the larger product-liability reform legislation vetoed by President Clinton last May, this bill protects suppliers from lawsuits in which the company's only role was to provide the raw material. Makers and sellers of implants would still be liable. But biomaterials manufacturers would be liable only if the raw material involved did not meet a manufacturer's specifications. To facilitate passage in Congress, the legislation makes a specific exception for suppliers of silicone in breast implants, so that ongoing litigation could continue.
The Biomaterials Act, introduced in Congress on Feb. 26, is reasonable legislation with bipartisan support. The Health Industry Manufacturers Assn. and other interested parties obviously support the bill. But so do the American College of Cardiology and the Center for Patient Advocacy, a nonprofit group that fought for longer hospital stays for new mothers and limits on HMO gag clauses. "This bill in no way takes away a patient's right to sue in the event of a faulty medical device or faulty materials," says Dr. Neil Kahanovitz, president of the center.
As expected, the main opposition to the legislation is the Association of Trial Lawyers of America. They view it as an attempt to restrict a victim's right to sue manufacturers of faulty materials. In their view, the supplier of a raw material should be aware of how its material is used--and therefore responsible for subsequent failures.
The new study, conducted by Aronoff Associates, estimates that the first shortages of medical implants could start within a year, a contention the trial lawyers deny. Yet device manufacturers are clearly facing a crisis finding suppliers.
One consequence is a serious drag on innovation. At Medtronic, the Minneapolis maker of permanent heart devices, researchers discovered two new insulating materials that would have greatly improved the durability of a lead connecting a pacemaker to the heart. When both suppliers refused to sell to the company for this application, the project was shelved.
COMPROMISE. Other companies charge that money earmarked for research is being used to reformulate products and run tests on alternate suppliers' materials to meet Food & Drug Administration requirements. This can cost up to $500,000 per implant.
Sometimes, extraordinary measures are needed to retain suppliers. Small innovators with limited resources often miss out. Biomet Inc., a Warsaw (Ind.) maker of artificial joints, had to indemnify its main supplier for the value of the company--an estimated $600 million--before it would resume delivery.
The medical-implant industry is not squeaky-clean. And faulty raw materials can lead to product failures. The Biomaterials Act retains a victim's right to sue without allowing abusive legal action whose sole purpose is targeting deep pockets. Victims have rights--but so do patients who need implants to live or function. This bill offers the only clear compromise.