Boston Scientific Device Woes Grow |
|
FDA Expects Higher Rate of Failure than Guidant |
|
Bloomberg News |
|
|
June 23, 2006—A Guidant Corp. implantable heart device may fail about 10 times more often than the company projected last year, according to a U S Food and Drug Administration analysis released in a Texas lawsuit. The confidential FDA document , written on June 16, 2005, was unsealed in a product liability lawsuit involving Guidant's defibrillators, $30,000 devices that restart hearts with electrical impulses. The FDA analysis found thousands of units of one Guidant model may experience malfunctions within five years. After Guidant began its recall, it said no more than 292 of the units were likely to break down. The agency's higher projection may hurt Boston Scientific in lawsuits by patients who received the devices. "This is as damaging a document as we're going to come across," Hunter Shkolnik, one of many lawyers representing patients suing Guidant, said last week. Boston Scientific bought Indianapolis-based Guidant in April for $27.5 billion. The Wall Street Journal also reported yesterday that some US hospitals are slowing their use of drug-coated heart stents, citing a Swiss study that found uncoated stents had fewer complications. The only drug-coated stents in the US market are made by Boston Scientific (Taxus Stent) and Johnson & Johnson (Cypher Stent). Boston Scientific said in a regulatory filing last month that more than 3,000 patients may pursue liability claims related to the defibrillators. There are about 340 cases in the courts so far, the company said. Guidant recalled 109,000 faulty defibrillators in 2005. In its memo, the FDA said "most" of the 16,000 recalled Contak Renewal defibrillators may have damaged insulation within five years, and 40 percent of those damaged devices would fail to produce an adequate electrical shock in a medical emergency. At that rate, at least 3,200 Renewal units were likely to fail. |
Contact Us |
Guidant News |
Guidant Owner OKs $195 Million Settlement Boston Scientific Recalls Some Guidant Heart Devices Boston Scientific Device Woes Grow |