Not that this is exactly surprising news, but Johnson & Johnson (J&J) announced today that the Cypher stents manufactured by its Cordis division are defective. Technically, J&J warned customers that the stents may not meet design specifications for proper functioning – essentially, they’re defective.
Like other J&J divisions, Cordis has been plagued by manufacturing woes. The company received its first warning letter in 2004, just two years after William Weldon assumed the helm at J&J. Those violations were not resolved with the FDA until 2007. Two months ago, J&J was again warned by the FDA for quality problems at its Puerto Rico plant. Such obvious manufacturing violations stand in stark contrast to recent comments from J&J’s CEO William Weldon: “I think that everything has been overshadowed by one company [McNeil]. This is not a systemic problem. This is not an issue around J&J.” All evidence to the contrary.