"Those at the top of the company," he states, "gamble with the lives of patients and the money of stockholders in equal bad faith when they engage in fraudulent and dishonest behavior that allows a dangerous product to be marketed."
Other legal experts agree that Guident executive may be in for trouble. "Company management should fear the prospect of being accused of deliberately refraining from physician disclosure in order to maintain a high market share that would enhance management's financial interests," says Genese Kay Dopson, special counsel at Sedgwick, Detert, Moran & Arnold LLP, in the May/June 2006, Medical Device Link.
"For example, in Guidant's case," she explains, "the aftermath of physician notification resulted in the decrease in the value of Guidant's stock."
And shareholders have, Ms Dobson says, initiated suits against Guidant for fraud.
In fact, it seems like it has been all downhill for the company, since June 2005. All total, Guidant has recalled or issued safety alerts on more than 200,000 pacemakers and about 88,000 defibrillators.
On June 20, 2005, the FDA issued a nationwide notification saying Guidant was recalling certain defibrillators because the devices could "develop an internal short circuit without warning, resulting in failure to deliver a shock when needed." The devices affected by the notification were:
PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
However, critics say the warning from the FDA was once again, too little too late, in light of the fact that the agency knew as early as February 2005, that Guidant defibrillators were malfunctioning, and allowed 4 months to pass before issuing a public alert.
According to Mr Turner, "it is absolutely inevitable that there will be a catastrophic incident soon in the US involving medical products whether they are drugs or devices."
The FDA has significantly failed to protect US citizens, he says, and is totally inept at preventing such a catastrophe. "The manufacturers consciously intervened in FDA business with the FDA's own acquiescence." he states.
"Undermining the safeguard that the FDA was supposed to be," Mr Turner says, "was part of a strategy which placed dangerous products on the market."
"Product after product, he points out, "has now been exposed as dangerous, after approval and with clear evidence that the manufacturer knew that before marketing."
"It is only a matter of time," he warns, "before there is another Vioxx, possibly next time much worse."
"There is after all nothing to stop it," he warns, "and every indication that the pharmaceutical companies have no intention of stopping their current deceitful practices."
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