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By: Irvin Jackson | Published: June 18th, 2012
A class action lawsuit has been filed by shareholders against St. Jude Medical over recent problems with recalled defibrillator leads.
The St. Jude class action lawsuit was filed last week, alleging that the medical device manufacturer artificially inflated it’s stock value by withholding information from shareholders about problems with the Riata and QuickFlex defibrillator leads, which were both recalled last year.
Plaintiffs indicate that the information may have changed how people invested in the company.
The Riata, Riata ST, QuickSite and QuickFlex defibrillator leads have all been found to contain potential defects that may make the wires prone to penetrating through the insulation. This may cause patients to suffer dangerous and potentially life-threatening shocks or prevent the defibrillator from delivery a life-saving jolt when it is needed.
Shareholders claim that St. Jude knew about the defibrillator lead problems long before the recalls were issued, but deceived its shareholders into thinking that the products were profitable and that there were no looming issues. They also claim that when problems came to light, St. Jude downplayed them.
According to a study presented last month at a meeting of the Heart Rhythm Society in Boston, the St. Jude Riata defibrillator lead problems may be more widespread than originally believed. Out of 712 devices identified in a seven-hospital survey, at least 67 had failed by the end of December. When x-ray images were reviewed for 110 patients, researchers found that the small wires had pierced through the insulation in about 25% of the cases.
Earlier this month, a report of similar problems with the St. Jude Durata defibrillator leads was filed with the FDA, which sent the value of St. Jude shares tumbling.
According to the report filed with the FDA’s MAUDE Adverse Event Reporting System, a doctor indicates that a patient implanted with a St. Jude Durata lead, which has not been recalled, was found to have the conductor poking through the insulation.
The internal defibrillators are designed to be implanted near a patient’s heart, monitor the heart rhythms and give life-saving electrical shocks if necessary. The defibrillator leads, which deliver the electrical charge, are supposed to remain covered by insulation once implanted. However, in some cases it appears that the St. Jude lead wires have poked the insulation, leaving parts of the leads are bare and uncovered inside patients’ bodies.
Reports have suggested that the recalled leads pose a serious health concern for patients, as it is largely impractical for patients to have the small lead wires removed. This causes patients to require more frequent medical follow up examinations and the only thing they can do is hope that they do not experience any of the problems associated with the small wires that connect their implanted defibrillator to their heart.