The two plaintiffs, Louis Motal, 63, and Bernice Hinojosa, 65, are surviving patients implanted with Guidant's Ventak Prizm 2 defibrillators in 2001. The lawsuit claims that Guidant "actively concealed the ... defect, suppressed reports, failed to follow through on FDA notification requirements, and failed to disclose a known defect to patients."
"Instead of revealing the defect," the plaintiffs allege, "defendants continued to represent their product as safe for intended use, and continued to sell the flawed [devices] despite knowing of the dangers."
Both plaintiffs claim they suffered extreme mental anguish from knowing that the defective devices could malfunction at any time.
As of April 2006, Boston became the proud owner of Guidant after winning a bidding battle with Johnson and Johnson, in what will certainly not go down in history as the deal of the century.
In addition to all the lawsuit already filed, according to Boston latest SEC filing, there are more than 3,300 claims of individuals that may or may not be filed, up from 3,000 claims in the earlier report.
The lawsuits all relate to defective defibrillators and pacemakers. Defibrillators are $30,000 devices that are wired directly to the heart and send electric shocks when abnormal heart rhythms are detected and pacemakers speed up hearts that beat too slowly, and cost between $4,000 and $20,000 for each unit, according to Bloomberg News on June 26, 2006.
According to Boston report, "the majority of claimants allege no physical injury, but are suing for medical monitoring and anxiety."
The numbers have really grown compared to Guidant's regulatory filing with the SEC on February 22, 2006, that predicted as many as 2,500 patients may seek damages. Those claims are distinct, Guidant noted in the filing, from the claims already filed by patients in 211 individual and class action lawsuits in the US and Canada.
And the potentially bleak future of Boston does not hinge entirely on what happens in civil lawsuits. Back on February 23, 2006, the Associated Press reported that the FDA, US Department of Justice, the Securities and Exchange Commission and several state agencies are investigating Guidant over its recalls.
The company is in fact being investigated by three attorneys general on behalf of 34 states, according to the article, Litigation Mounts Over Guidant Heart Devices, in Lawyers Weekly USA, on January 30, 2006
"In addition," the article states, "New York State and the city of Bethlehem, Pa. are suing Guidant for reimbursement of medical costs involved in replacing the devices."
All lawsuits pending in federal courts have been consolidated under multi-district litigation rules and moved to a US District Court in Minnesota, where Guidant has several manufacturing facilities, with the first federal trial scheduled to begin on March 15, 2007.
On June 13, 2006, the Minnesota Supreme court appointed one judge to preside over all state court cases involving lawsuits linked to last year's Guidant product communications, Boston Scientific notes in its report.
According to Lawyers Weekly USA, the lead counsel for the Texas plaintiffs, Robert Hilliard, of Hilliard & Munoz, said documents obtained during discovery show that Guidant knew about problems with its devices as far back as April 2002, but failed to alert doctors and patients for 3 years.
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