An American Right In Jeopardy
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By Eddie Farah on June 28, 2008
We hear it all the time. People tell us, "I'm not the type who sues..." and then they tell us about a horrible injury they or a loved one has endured. We tell them, it’s okay, you are an American and the courts are set up for citizens like you to find a remedy when they’ve truly been injured. It’s an American right.
It was an American right for the widow of Charles Riegel. Riegel died in 1996 when a balloon catheter made by Medtronic burst in his chest after it was inserted during an angioplasty. She sued, but in February of this year, the U.S. Supreme Court sided with Medtronic.
The reasoning is bizarre and frightning, and generated by business interests to protect the bottom line. Here it is - since the medical device was approved by the FDA, the court decided that the states (in this case New York where the suit was filed) don’t have the right impose liability over a faulty product. In other words- FDA approval is the final word on medical devices.
Given the FDA's track record, that is a frightening thought. (Not that there aren't many good people working there, but there is just too much to do and too few resources to do it.)
Now another case, this one against drug maker Wyeth, is going before the Supreme Court and the business community will be using the same argument, called federal pre-emption, to get blanket immunity for drug liability.
A Vermont musician won $6.8 million judgment, awarded by a jury, against drugmaker Wyeth after her arm had to be amputated because a Wyeth anti-nausea drug was improperly injected. Wyeth wants to overturn the case so will ask for blanket immunity before the Supreme Court. The drug and its warning label was approved by the FDA, after all.
The business community will be waiting and watching. The outcome of the Wyeth case may seal the fate for hundreds of other lawsuits, filed by people who are hurt by dangerous drugs. As it stands now, if you are injured by a medical device pre-approved by the FDA, such as a defibrillator or heart stent, you are basically out of luck.
To remedy this situation - legislation is pending called the Medical Device Safety Act of 2008 (HR 8381) that would overrule the Riegel decision, restoring the right for the injured to seek compensation from medical device manufacturers.
It basically says that traditional state common-law remedies that the injured have always turned to should be restored, and that right doesn’t undermine the FDA’s powers to protect consumers.
Product liability lawsuits are intended to compensate people - the kind of people who are truly injured, the kind of people who tell us, “I’m not the sort of person who sues.” #