However, records reveal that by this time Guidant had already sold most of its inventory.
Earlier in 2004, the documents show that company officials drafted a memorandum for their sales representatives explaining why it was asking them to return all the unsold Contak Renewals, but the memorandum was never sent either.
Some documents provide strong evidence that Guidant weighed the risks to patients and the loss of profits and chose to place profits over the lives of patients. For instance, one company document shows that Guidant estimated it would lose about $9 million by purging its inventory of defective Contak Renewal units and parts.
Attorney Hilliard says other documents reveal that Guidant performed a risk analysis that showed there was a possibility the devices could short-circuit, and if they did, "the likelihood of death or serious injury was very likely."
He also told Lawyers Weekly that Guidant also violated federal regulations by redesigning the devices to eliminate the flaw in 2002, without informing the FDA, and that Guidant continued selling the older devices without notifying patients of the risks.
In what experts are calling the strongest evidence to present to a jury, testimony in a 168-page deposition taken in January 2006 in the Texas case, that was made public in February 2006, has Guidant executive, Fred McCoy, acknowledging that the company made changes to one of its defibrillators in 2002, and incorrectly told the FDA that it had no effect on the product's performance.
Mr McCoy testified that Guidant made two modifications to the Ventak Prizm 2 in 2002, to keep it from short-circuiting and that neither was approved by the FDA.
And as it turns out, only one of the changes was disclosed in the company's annual report that year also, and Guidant said that change had no affect on the device's performance.
In addition, in a report filed two years later, the company said that it had received FDA approval to make the changes when it had not.
Mr Hilliard told the Associated Press on February 22, 2006, that Mr McCoy's testimony proves that Guidant sold an unapproved defibrillator in violation of federal law.
In the deposition, Mr McCoy claims that he did not learn about problems with the devices until May 2005.
More damning evidence was revealed on June 23, 2006, when the Pioneer Press reported that, "Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit."
"A judge in a product-liability lawsuit involving Guidant's defibrillators," the newspaper said, "recently unsealed the FDA document dated June 16, 2005."
Back when Guidant began its recall in the summer of 2005, the firm said no more than 292 of the units were likely to break down. "But the FDA said "most" of the 16,000 recalled Contak Renewal defibrillators may have damaged insulation within five years of use," the Press wrote, "and 40 percent of those damaged devices would fail to produce an adequate electrical shock in a medical emergency."
At that rate, it said, at least 3,200 Renewal units would be likely to fail.
Legal experts predict that the higher projection will hurt Boston Scientific in lawsuits. "This is as damaging a document as we're going to come across," said Attorney Hunter Shkolnik, one of many lawyers representing patients suing Guidant, in an interview with Pioneer Press.
Earlier in 2004, the documents show that company officials drafted a memorandum for their sales representatives explaining why it was asking them to return all the unsold Contak Renewals, but the memorandum was never sent either.
Some documents provide strong evidence that Guidant weighed the risks to patients and the loss of profits and chose to place profits over the lives of patients. For instance, one company document shows that Guidant estimated it would lose about $9 million by purging its inventory of defective Contak Renewal units and parts.
Attorney Hilliard says other documents reveal that Guidant performed a risk analysis that showed there was a possibility the devices could short-circuit, and if they did, "the likelihood of death or serious injury was very likely."
In what experts are calling the strongest evidence to present to a jury, testimony in a 168-page deposition taken in January 2006 in the Texas case, that was made public in February 2006, has Guidant executive, Fred McCoy, acknowledging that the company made changes to one of its defibrillators in 2002, and incorrectly told the FDA that it had no effect on the product's performance.
Mr McCoy testified that Guidant made two modifications to the Ventak Prizm 2 in 2002, to keep it from short-circuiting and that neither was approved by the FDA.
And as it turns out, only one of the changes was disclosed in the company's annual report that year also, and Guidant said that change had no affect on the device's performance.
In addition, in a report filed two years later, the company said that it had received FDA approval to make the changes when it had not.
Mr Hilliard told the Associated Press on February 22, 2006, that Mr McCoy's testimony proves that Guidant sold an unapproved defibrillator in violation of federal law.
In the deposition, Mr McCoy claims that he did not learn about problems with the devices until May 2005.
More damning evidence was revealed on June 23, 2006, when the Pioneer Press reported that, "Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit."
"A judge in a product-liability lawsuit involving Guidant's defibrillators," the newspaper said, "recently unsealed the FDA document dated June 16, 2005."
Back when Guidant began its recall in the summer of 2005, the firm said no more than 292 of the units were likely to break down. "But the FDA said "most" of the 16,000 recalled Contak Renewal defibrillators may have damaged insulation within five years of use," the Press wrote, "and 40 percent of those damaged devices would fail to produce an adequate electrical shock in a medical emergency."
At that rate, it said, at least 3,200 Renewal units would be likely to fail.
Legal experts predict that the higher projection will hurt Boston Scientific in lawsuits. "This is as damaging a document as we're going to come across," said Attorney Hunter Shkolnik, one of many lawyers representing patients suing Guidant, in an interview with Pioneer Press.
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