A Strong Case For Product Liability & Consumer Protection Laws

Anatomy of a Flawed Company

While most GOP members are seeking liability caps, so-called liability and personal injury law suit reforms, and protective measures against suing big corporations (including health insurance corporations), the rest of us are shaking our heads wondering how these morons come up with these ideas. The following article demonstrates what we need are stronger protections and consumer protection laws with teeth to make these folks do the right thing. Business folks always seek to maximize profits without genuinely considering their decisions beyond the cost factors... it's a principle that has been proven time and time again.

A manufacturer allowed its product engineers to keep faulty cardiac devices on the market without considering the medical impact and failed to alert doctors and patients when the devices started to malfunction. That is the damning conclusion of experts who evaluated how the company, the Guidant Corporation, reacted to evidence that some of its implanted defibrillators had short-circuited when they were supposed to stabilize the chaotic heartbeats of patients. At least seven patients died when their defibrillators failed to work.

The Guidant devices came under a cloud last May when The Times revealed that a college student had died when his defibrillator short-circuited and that the company had known about the flaw for three years but had never told doctors or patients. The company subsequently disclosed defects in other devices as well, recalled tens of thousands of flawed units and was hit with a barrage of lawsuits and investigations.

Now a panel of experts commissioned by the company has issued an independent verdict on the fiasco. It finds that Guidant's devices are generally reliable and among the best in the industry, but it faults the company's failure to protect patients from rare but life-threatening malfunctions. Indeed, it is astonishing how cavalier the company was. It left key decisions in the hands of low-level product performance engineers who were content if failure rates remained within predicted limits, regardless of the consequences for hapless patients. Its chief medical officer paid little attention to patient safety and learned about the failure problem late and inadvertently. Even after an improved version of the flawed defibrillator was developed, the company allowed some 4,000 of the older devices to be implanted in patients who weren't informed of the risks.

Guidant is now scrambling to put patient safety high in the decision-making process. Nobody knows how the company compares with others in the industry when it comes to handling defects. But it seems likely that all device manufacturers could benefit from the panel's advice that companies be far more forthcoming about publicizing defects and that a high priority be placed on preventing deaths from even rare malfunctions.