1960

Albert Starr’s (a protégé of Alfred Blalock) successful surgical implanting of “ball and cage” prosthetic mitral valve. The Starr-Edwards artificial valve dominated the market until 1979, when the Bjork-Shiley convex-concave valve was released. Within months of first implantation, reports began appearing of patients dropping dead without warning: owing to a production fault a part was prone to come loose, “falling into the bloodstream and causing catastrophic regurgitation, but – disgracefully – almost 85,999 devices were implanted in patients before the faulty models were finally withdrawn from sale. By 2005 more than 600 of them had failed, making the Bjork-Shiley valve the most dangerous medical device ever to be used clinically. It later emerged that Pfizer,. . . had long known about the problem and hid the evidence from regulators, a transgression which cost it hundreds of millions of dollars in compensation and fines” (Morris, loc 2473ff.).