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Devon Glass
Devon Glass
Contributor •

Broken FDA Charged With Protecting America From Dangerous Drugs and Medical Devices

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How
many of you remember George
W. Bush
saying, while campaigning for the 2000 election, he was
going to usher in an era of personal responsibility? How many of you
believe personal responsibility applies to corporations as well as
individuals? Unfortunately, the United
States Supreme Court
disagrees with you. In April 2008,
defective
medical device
manufacturer Medtronic
was protected from lawsuits by the Supreme Court because the
defective device they manufactured was approved by the Food and Drug
Administration (FDA). This is the
same FDA who cannot keep our tomatoes
safe
from bacteria, our heparin
safe from contamination, or dangerous
drugs
off the shelf.

Time
and time again, the FDA is shown to be inept at protecting Americans
from danger. However, the Supreme Court says the FDA must be trusted
to keep us all safe because the threat of frivolous lawsuits might
prevent medical device innovation. Or at least that’s the line they
expect the citizens of America to swallow.

The
reality of the situation is this: preventing people injured by
dangerous products from suing the manufacturer does nothing to keep
you or your family safe. In fact, it most likely makes the world you
live in more dangerous. I think everyone would agree the Exxon
Valdez
disaster in 1989 was horrific. As a result of the
negligence by Exxon, they were successfully sued and the injured
parties were awarded $2.5 billion in damages by a jury. As you
probably heard, the Supreme Court stepped in and reduced that amount
to $500 million. This despite the fact that Exxon
posted a profit of $40.6 billion for 2007, so they could probably
handle a paltry 6% reduction in earnings.

But
what about drug manufacturers, do they enjoy protection from
liability? Not yet, but there is an excellent chance that will change
this fall. The case of Wyeth
v Levine
will be argued before the Supreme Court. The plaintiff
lost her arm after receiving an injection of Phenergan,
manufactured by Wyeth,
and she was successful in receiving an award by a jury. But since
Phenergan was approved by the FDA, the Supreme Court wants to
determine whether FDA approval prevents litigation. How do you think
they will decide?

Which
brings me back to my original point about personal responsibility.
Who do you think should be responsible for manufacturing dangerous
drugs
or defective
products
? Most people would say the company that made the
product. This makes sense because you should be held responsible for
your actions. But as you can see, the person who is actually held
responsible is the injured person. If drug and medical device
manufacturers have no incentive to produce safe products, do you
honestly believe they will try to produce safer products?