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December 15, 2005 --
With his record, a call from state Attorney General Eliot Spitzer is enough to give even innocent defendants a heart attack. So it's a good thing Indianapolis-based Guidant Systems makes defibrillators, pacemakers and other cardiac devices: It just became Spitzer's latest target. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Guidant stands accused of concealing information about an alleged design flaw in its products. In the past few years, the company has had to recall or issue warnings on several models of pacemakers and implanted defibrillators—affecting thousands of patients—after a small number of malfunctions were discovered.
Spitzer claims that Guidant should have issued the recalls and warnings sooner. Compared with almost any other product on the market, however, pacemakers and implanted defibrillators are among the safest available. While burnishing his own image, Spitzer may actually be putting more lives at risk.
A <?xml:namespace prefix = u1 /><?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />Harvard Medical School study found that doctors implanted more than 2.25 million pacemakers and 400,000 defibrillators in the United States from 1990 to 2002. Malfunctions were directly responsible for just 61 deaths (half from each type of device). While every accidental death is tragic, a fatal error rate of 0.002 percent hardly appears to be the malfeasance these lawsuits suggest.
The biggest problem for manufacturers is deciding exactly when a string of isolated cases becomes an indication of a bigger problem. When a patient dies or deterioates, it's rarely clear whether the medical device or the pre-existing condition is to blame. And removing a pacemaker is no small matter—surgery carries its own risks.
Spitzer's solution of (supposedly) "erring on the side of caution" would make matters worse. After all, these devices are important medical treatments. Mistakenly recalling a device that turns out not to be defective causes harm to people just as surely as mistakenly leaving a faulty product on the market too long.
Does Spitzer even care that his recommended course of action exposes tens of thousands of patients to potentially risky surgery that most don't need?
As it turns out, Guidant probably made the right choice in waiting to issue the recalls. The Harvard research found that some 17,000 of the 2.6 million cardiac devices implanted in the 12-year study period were removed due to confirmed malfunctions. However, the malfunction rate generally declined over the period in the study.
More importantly, the study found that implanted defibrillators saved the lives of about 30,000 patients who would have died without them. That certainly compares favorably against 31 deaths caused by defibrillators.
Of course, Spitzer's is not the only legal attack on medical device manufacturers. One major class-action suit against Guidant and two other cardiac-device makers has been filed by Minnesota-based law firm Zimmerman Reed.
That has generated a lot of press attention. It's probably no coincidence—as the St. Paul, Minn., Pioneer Press reports—that Spitzer met with several Zimmerman Reed attorneys to discuss his campaign for New York governor only a week before announcing his own case against Guidant.
With yet another high-profile prosecution, Spitzer gets to polish his image as a champion of the little guy.
Unfortunately, the cardiac-device industry's envious track record of safety will be of little help in court. Merely having to defend against such lawsuits is time-consuming and expensive. Perhaps most importantly, innocent defendants don't always prevail when clever lawyers frame the case as meek Davids against corporate Goliaths. (One member of a Texas jury that delivered a multimillion-dollar judgment against drug-maker Merck this summer thought voting for the plaintiff would get her on the Oprah Winfrey show.)
In the end, Spitzer's frivolous lawsuit is worst not for medical drug and device manufacturers, but for patients. It is they who rely on an increasingly sophisticated stream of new therapeutic products to combat their illnesses. And it is patients who suffer when frivolous suits raise the price of bringing these treatments to market—or keep potentially life-saving drugs and devices off the market altogether.