The entire medical industry - from doctors to device makers - faces a crisis that threatens to deprive perhaps millions of patients in the United States of the medical implants they need to stay alive. The crisis involves the availability of materials - in large part, plastic materials. The decision of many large material suppliers to stop selling their much-needed biomaterials into the implantable medical device market triggered the crisis. Why? They fear lawsuits - claims for injuries that result when these devices fail.
You might wonder how they can be made to pay for such injuries if they don't make the device, and have not done anything negligent in providing the materials used in the device. These materials suppliers are generally not being held liable but they are being sued because big chemical companies always have been good targets for plaintiffs' lawyers looking for deep pockets.
The costs of defending these suits sometimes can exceed the total sales of materials into this medical market. The prospect of such costs, not to mention the potential for a jury to find a way to make these companies pay for another firm's mistakes, have materials suppliers rightly running scared.
As the horded supplies of these materials dwindle, implant manufacturers, hospitals, doctors and particularly patients become more fearful that critical life-saving devices will no longer be available in the United States. The sad reality is U.S. citizens may have to go abroad to get the treatments they need to stay alive.
Congress is considering a proposal - the Biomaterials Access Assurance Act - that could remedy this situation. The bill enjoys widespread support in both the Senate and the House, and was part of the product liability legislation passed by Congress earlier this year but vetoed by President Clinton because of his objections to some of the other provisions.
Indications are Clinton would support this proposal as a stand-alone bill. The proposal would provide a biomaterials supplier with a quick escape from a lawsuit arising from a failed medical device made with the supplier's material. The supplier would simply have to show that its material met the customer's specifications and that the supplier was not in-volved in the manufacture or sale of the finished device. An early exit would relieve suppliers of much of the cost of defending these suits and may discourage plaintiffs from even naming them as defendants.
Sounds fair, so what's holding it up?
It appears that a few senators may be concerned that the bill goes too easy on negligent material suppliers. However, a materials supplier that fails to meet the agreed-upon specifications or otherwise fails to live up to its contractual commitments is not eligible for the protection provided by the bill.
Moreover, the legislation aims to place responsibility for selecting and testing the right materials on the manufacturer who designs the device, gets it approved by the Food & Drug Administration, and enjoys the financial rewards from its sale. Thus, the bill would further exclude from its protection a materials supplier that gets involved in the manufacture or sale of the device itself.
It seems the bill has struck the right balance. Unfortunately, under the norms of senatorial courtesy, a single senator can derail a bill by putting a ``hold'' on it. It's time for the plastics industry to support its medical customers, and the doctors and patients that they serve, by urging their support of the Biomaterials Access Assurance Act.
We think this bill may be just what the doctor ordered to get the plastics industry back in the business of helping to save lives.
Heckman is the longtime general counsel for the Society of the Plastics Industry Inc. in Washington and a partner in Keller and Heckman LLP.