Probably only because the facts of this unfortunate scenario were documented in a series of New York Times articles in May of 2005, Dr Maron told the committee, "have these problems in this sector of the defibrillator industry---in what has come to be known as the Guidant Affair---now become evident to all."
He pointed out that the case involved the largest recall of defibrillators and pacemakers in the 25-year history of the industry. "To make it a crime to knowingly sell defective defibrillators to be implanted into high risk patients would I believe have the desired effect on the willingness of companies to make full disclosure," Dr Maron concluded.
Joshua's other physicians, Dr Robert Hauser, told the New York Times, he was irate to learn that the FDA was given the information about the defects in February 2005, and that if the agency had disclosed the problem, it might have saved Joshua's life.
As for the FDA, in what is becoming a common occurrence, the agency once again has managed to provoke the ire of the powerful Republican Senator from Iowa, Charles Grassley, who chairs the Senate Finance Committee which oversee Medicare and Medicaid, by refusing to turn over Guidant's annual reports to the New York Times, claiming the documents contained trade secrets.
After learning of the refusal, the Senator wrote a letter to the FDA commissioner, asking for an explanation of why the agency does not make all annual reports received from device makers available to the public. "The F.D.A. needs to find reasons to make information public rather than working overtime to withhold findings that the public deserves to know about," Senator Grassley said. "Amid the scrutiny of the last year, the F.D.A. has acknowledged that the public wants and needs to know, but so far the agency's actions haven't matched its words."
Over the past 2 years, the FDA and the pharmaceutical industry have both come under fire from Senator Grassley's committee for hiding the results of clinical trials that showed the dangers of Vioxx and the use of antidepressants with children for years. The Guidant situation now appears to have expanded the interest of the committee into the area of medical devices.
As of February 6, 2006, at least seven deaths have been linked to the devices recalled last year, according to the Associated Press. In its regulatory filing on February 22, 2006, Guidant said as many as 2,500 patients may seek damages and that the company had learned of approximately 1,700 claims the previous month, and expected more. Those claims are distinct from the claims already filed by patients in 211 individual and class action lawsuits in the US and Canada, Guidant noted.
A month later, in March 2006, an extremely damaging report was released by an independent panel, appointed to conduct a review of the product recalls, that said the company had relied too heavily on engineers to evaluate the safety of its products and said Guidant should have made a greater effort to consult doctors.
The report also revealed that Guidant had allowed about 4,000 faulty defibrillators to be implanted in patients after the company found a flaw in the devices in 2002.
On March 22, 2006, a report in Dow Jones Market Watch, said Guidant faces more than 200 individual and class action product liability suits tied to product recalls. "Only a small number of cases are thought to be tied to patient deaths, however," it said. "The vast majority involve living patients who allege problems with the devices."
The fact of the matter is, just about every kind of lawsuit known to man has been filed against company. A wrongful death suit was filed in St Paul, on March 21, 2006, on behalf of the wife of Allan Gohde, age 53, of Birchwood, WI, who died of sudden cardiac arrest on July 28, 2005, at his home.
In this case, to add insult to injury, at the funeral home, Ms Gohde heard a loud beeping noise coming from her husband's chest when she was giving him a last kiss and hug goodbye in his coffin. As it turns out, the beeping was from his defibrillator, which was among the devices recalled by Guidant.
After the funeral, the Prizm 1861 defibrillator was sent to Guidant for analysis and in a report to Mr Gohde's physician, the company stated that "high voltage damage" to the defibrillator had been found and that the beeping sound was a result of the shorted condition.
The report also said that, at the time of Mr Gohde's death, the defibrillator detected "ventricular fibrillation," attempted to shock and "became non-responsive during this attempt."
On February 11, 2002, Mr Gohde was implanted with a Prizm 1861 device that was later determined defective. Despite making design changes to correct the flaw, the lawsuit alleges, Guidant continued to sell defibrillators manufactured before April 2002, without disclosing that the devices contained a serious design flaw.
When Guidant did issue a recall on June 17, 2005, and reported that approximately 13,900 Prizm 1861 devices manufactured before the April 2002, change were implanted in patients and that at least 28 devices had short circuited because of the flaw, and had resulted in one death, Guidant recommended that the devices not be replaced.