The company said it notified government regulators. But did they really? Was full disclosure made about the problem/flaw? It is beginning to appear from various Guidant lawsuit allegations, that in filings made with the FDA, rather that disclose a defect, Guidant attempted what some call a silent recall -- simply saying that they were making "enhancements" or "improvements" to a perfectly good device. Instead of coming out and disclosing the problems with its implantable pacemaker defibrillator, Guidant kept the information about wrongful deaths as a "trade secret." In reality, Guidant did not alert doctors until three years after the problem was apparently fixed.

The forms that get filed with the FDA are called 501(k) and PMA (Pre-Market Approval) forms. Lawyers for the plaintiffs (injured patients and those walking around with defective devices) as well as those that had to undergo an otherwise unnecessary surgery for removal and replacement, are studying the filings that Guidant made with the FDA. Plaintiffs intend to show that Guidant failed to show what it knew about the defects and that it did not comply with its duties under 501(k) and/or the PMA process.