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

Devon Glass

Attorney
(866) 735-1102 Ext 431

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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?