title III of H.R. 1075 essentially incorporates the provisions of H.R. 753, the Biomaterials Access Assurance Act, which I introduced to help assure adequate supplies of biomaterials for medical devices. Language has been added in H.R. 1075 to deal with the difficult issue of biomaterials suppliers who are alleged to have wrongfully withheld or misrepresented safety information or who know of fraudulent use of their materials. I believe strongly that conduct of this type should not go unpunished. Under current law, a medical device manufacturer can bring an action in such circumstances against the biomaterials supplier, and may recover from the supplier any damages that the manufacturer had to pay as a result of a lawsuit by an individual who has been injured. This is unchanged by title III of H.R. 1075. This is as it should be. The new language in title III, however, prevents a motion for dismissal by a biomaterials supplier if the injured individual claims misrepresentation or fraud. This will keep the deep pockets supplier in the case and subject to the same kind of costly litigation that now threatens to dry up the supply of biomedical materials. So the purpose of title III, to ensure the continuing availability of life-saving and life-enhancing medical devices made from these materials, will be thwarted. Again, let me emphasize that under existing law the manufacturer will have recourse against the errant supplier.
Editor's note · Context
Discussing provisions of H.R. 1075 related to biomaterials for medical devices.
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