http://news.yahoo.com/s/ap/20050916/ap_ ... lfunctions
See also excerts from NEJM below:
Let's see what comes of this one. Surely there's a lot of money to be made of off Guidant as well. Unlike the Merck case, I haven't heard a lot about the company motives and exact steps in the medical press, and the only lay media I take in is 1-2 minutes of NPR driving or the daily show. Nobody expects these devices to be perfect... and I think another factor is that AICDs (automated implanted cardioverter defibrillators) are
1) designed for sick people whose hearts might stop without warning, so deaths aren't a shock (pun intended)
2) "causing deaths" here only in the sense that they may fail to prevent them. Vioxx (rarely) caused heart attacks; Guidant's devices (rarely) failed to try to reverse a sudden death--and there's no guarantee a perfectly functioning device would have saved that life. Or that the person wouldn't have died 1-3 months later.
While I wouldn't be shocked if a lawsuit came out of this one too, and from the info I have Guidant needs to explain why it didn't warn people about known defects, there's very important math here:
In most of the patients that died, it will not be possible to prove the device failure was "more likely than not" responsible for the death.
So here's my gripe with the tort system. Individuals are not harmed by these errors; populations are. It can't be said if the exact person in question was harmed; honestly, all that can be said is that the average harm is, oh, a few percent, or whatever the math spits out. Everyone involved should receive that fraction of, say, lost wages. But this is not how it will play out, and of course, I don't believe tort is the best way to solve these problems either.
Steinbrok R. The controversy over guidant's implantable defibrillators. NEJM 2005 353:221-4.
Oukrop, then a 21-year-old college student, collapsed and died in a remote area of southeastern Utah during a spring-break bicycling trip with his girlfriend... When the manufacturer analyzed his ICD, it determined that the device had short-circuited internally while trying to deliver high-voltage therapy and had been permanently disabled (see diagram)...
In June, Maron recalled: "We became very concerned. We were keeping a secret not just from our patients and their physicians, but also from all the patients with the device and their physicians. On May 12, four Guidant officials came to my office and gave a very educational presentation. I asked, `What are we going to do about this? We are in an untenable situation ethically and morally with our patients. How are we going to get the word out?' They said, `Well, we are not. We don't think we need to. And we don't think it's advisable.' The officials expressed doubt that the patients would be able to understand the medical issues involved in determining whether or not to replace the devices. I said, `I think this is the biggest mistake you will ever make.' They said they didn't agree."
It was subsequently disclosed that Guidant, the second-largest manufacturer of implantable defibrillators, had identified the electrical flaws in the Prizm 2 DR in February 2002 and had made manufacturing changes, on April 16 and November 13 of that year, in an effort to prevent this rare but unpredictable and catastrophic type of failure...
Guidant, however, continued to sell devices that had been manufactured before that change was made and issued no public statements about the problem or the corrections. The company's first announcement came on May 23, 2005 — more than three years after Guidant had become aware of the problem and hours before the New York Times published an article about Oukrop's death...
On July 1, the FDA classified as class I recalls Guidant's recent notifications with regard to Prizm 2 DRs that were manufactured on or before April 16, 2002, and two other models of implantable defibrillators, the Contak Renewal Model H135 and the Contak Renewal 2 Model H155, that were manufactured on or before August 26, 2004. A class I recall indicates the highest level of risk, because "there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death."5 Of 42,000 affected devices of the three recalled types worldwide, 20,600 (including about 13,900 Prizm 2 DRs) are still implanted in patients....
In June 2003, Endovascular Technologies, a subsidiary of Guidant, pleaded guilty to 10 felony counts and agreed to pay $92.4 million in civil and criminal penalties related to its Ancure Endograft system, a stent–graft device inserted by means of a catheter for the treatment of abdominal aortic aneurysms. The company admitted that it had lied to the government and hidden thousands of serious health problems, including 12 deaths. The company stopped selling the system in March 2001, made changes, and reintroduced it to the market in August 2001....
Since the merger agreement was announced, Guidant executives have sold millions of dollars of company stock, according to filings with the Securities and Exchange Commission. For example, on May 17, 2005, Lorell, the chief medical and technology officer, sold 23,300 shares for $1.71 million. On May 23, 2005, the day before the problems with the Prizm 2 DR were the subject of a front-page article in the New York Times, she sold 22,667 more shares for $1.68 million. When asked to explain the transactions, Lorell did not respond. "
((I worked with Dr. Lorell at Beth Israel and knew only that she was the director of the cardiomyopathy clinic. No idea she was a multimillionaire! There are Martha Stewart overtones tho.))