Anonymous
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Anonymous
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a lot of mud slinging going on here.........definitely getting somewhere.
What I don't understand is: if there's such a problem with the lead, why hasn't it been forced into a recall. On the other hand, why is there such a bailout of top people and continual reorganization internally; from Woody to HR to some of the top CRM folks crossing lines.....
Change is in the air. Until then, I'll continue reading this entertaining banter between competitive, passionate people.
I agree w your assessment. The issue we have is that the FDA isn't proactive in recalling devices They won't go into stj and look at the data and classify. They only issue a recall based on a communication set forth from the manufacturer. In this case stj will not communicate despite a mountain of evidence against the Durata. They waited 9 years to communicate on Riata and only after intense outside pressure. Stj does such a poor job of managing data (I've had phys send in obvious failed devices only to get a letter back stating all is well w the returned device) that they will never admit to enough "failures" to issue a d'état do letter on the Durata. It's truly sad for pt's and phys.