In the June 17, July 1 and July 8 issues you carried articles on the medical device dilemma. We may have occasioned some misperception on this subject since one of us authored the Page 11, June 17 Perspective column ``Biomaterials bill could be a life-saver.'' Another was quoted in a Roger King story as hailing the Supreme Court's decision in the Medtronics case as good news for the plastics industry. And in your July 8 editorial ``Ruling is Pyrrhic victory,'' you very properly pointed out that the Supreme Court probably did no one but the trial lawyers a real favor in its triple-headed opinion of June 26.
In the hope that this will at least clarify our position, here is where we stand. First, we urge that everyone in the industry write, call or visit their congressional representatives to urge passage of the Biomaterials Access Assurance Act at once.
Unless this bill becomes law there is a real chance that device manufacture and innovation will move offshore because there may be no American companies willing to supply the raw materials needed to make devices here. The Medtronics decision may mean that raw materials suppliers will have co-defendants if a Food and Drug Administration-cleared de-vice becomes the subject of a salvo of product liability suits. But we do not believe that having the company of a device maker if they encounter legal misery will be enough to induce polymer producers to stay in a business where the volume is low and profit is minuscule, compared with the risk of heavy legal expenses to defend spurious suits.
With respect to the comments attributed to us to the effect that the Medtronics decision was ``excellent news for the plastics industry,'' we need to add the grains of salt we inadvertently left out when the comment was made to your reporter.
To the degree that the case holds that no one who makes a device which has been the subject of an FDA application is automatically home free from civil suits filed under state tort laws, it will cut down on the unfairness that could occur if such suits against the device manufacturer were held to be preempted. However, a suit could be maintained against the supplier of the material from which the device is made.
That the law as it stands can permit this result is just plain ridiculous. On the other hand, in a practical sense the court's holding is of no help to any part of the device supply chain. What is needed is passage of the Biomaterials Access Assurance Act and an amendment to the federal Food, Drug and Cosmetic Act to make it clear enough to keep the majority of the court from ruling again that civil suits are not preempted even when a device has been subjected to FDA scrutiny, has passed muster and is being made in accordance with good manufacturing practices.
We need to give reasonable protection to our device industry and its suppliers when they are operating in good faith in their own areas of responsibility and with due care for the regulations designed to govern their products.
Jerome H. Heckman
John B. Dubeck
Keller and Heckman LLP