Defective Devices

• by SMITTY
• 2007-12-04 01:12:16
• General Posting
• 2734 views
• 1 comments

Many of us feel like we may be walking around with a disaster waiting to happen in our chests. The following excerpts from an article on defective devices will not help those feelings but it is something very real that we have to consider. The article was of great interest to me because it tells me many things about what my recourse may be in the event I get a defective device as my replacement pacemaker, which will probably be in 2008.

From the Austin American Statesman - “The case dates back to a 1976 law enacted in response to the public health disaster caused by the Dalkon Shield intra-uterine birth control device. At the time, the federal government did not regulate medical devices. After lawyers for injured victims uncovered evidence that the manufacturer knew the devices were dangerous but marketed them anyway, Congress empowered the Food and Drug Administration to regulate medical devices in much the same way it regulates prescription drugs.

Because several states already devices, Congress included a provision prohibiting states from imposing “requirements” inconsistent with those of the FDA. Known as an express preemption clause, it did not limit lawsuits brought by victims of defective devices. Because it apparently never occurred to anyone that a state law claim for compensation could impose a “requirement,” for several years, state courts routinely awarded compensation to victims of defectively designed or marketed medical devices.

Then, in a 1992 case involving cigarette warning labels, the Supreme Court held that the word “requirement” in an express preemption clause could include litigation-induced changes to products. Armed with this defense of “federal preemption,” medical device manufacturers argued that common law courts must dismiss cases before information from their files about their negligence or fraud saw the light of day. The Supreme Court rejected this argument more than a decade ago, but it left open the question of whether common law claims involving approved devices were preempted.

That critical issue is now before the court.”

The entire article by Thomas McGarity, a University of Texas law professor appears in today’s (12-04-07) edition of the Austin American Statesman. More on this subject can be found there or at www.progressivereform.org.