The Clearest View

Posted on Friday 27 January 2006

Before the proverbial ink dried on the previous post (about the battle between J&J and Boston Scientific for Guidant, the troubled medical device maker), we learned yesterday that the FDA is hammering Boston for serious quality troubles of its own.

So, investors (and J&J critics) should rethink this "win" for Boston Scientific.

Seems to me that this is merely the combination of two medical device firms with apparently serious quality issues in their implantable device product lines. And while FDA wrist-slapping is common, this powerful regulator does not let go easily when it gets its teeth into a problem firm. Not only can it legally and unilaterally shutdown a manufacturing operation, but its actions can and will eventually get the market's attention, not only damaging the erstwhile credibility of the firm but its enterprise value as well.

Does anyone remember Schering-Plough? While now on the mend (with a completely different management team), it was a one-hit wonder (with allergy pill Claritin) that had chronic quality and safety problems in its production facilities. So while Wall Street and then-management were dazzled by current cash flow, they ignored the admonishments of those concerned about generics and the repeated violation notices from the FDA. It's a miracle the company has survived.

Stay tuned; should be a good show.

– Peter J. Leitner

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