Arlen Specter: “another very important product involved the Bjork-Shively heart valve where internal company documents show the company…”

“another very important product involved the Bjork-Shively heart valve where internal company documents show the company was notified by the inventor in 1982 of the manufacturing defect, with the handwritten notations on the memo by the inventor to try to ``settle him down,'' a defect which was not fixed for years resulting in damages to thousands of people who used these heart valves. Last night a 60 year old man, with a double valve (mitral and aortic valve) replacement performed--August 24, 1981 with a * * * degree, 25 mm in aorta and 31 mm in mitral, had rupture of the smaller strut and pulmonary edema. During the night, I re-operated the broken mitral valve and the * * * strut was localized in the pulmonary vein. The patient has now woken, but has neurological seguele. It is evident by now that the manufacture of the prosthetic valve is not acceptable. The small strut must be made in one piece and much more effort and priority must be put on this than has been done so far. Your programmed conferences, in Atlanta and California in the end of August, are extremely ill timed--before an acceptable production can be achieved. Dear friends, I am serious. Viking O. Bjork.”