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Drug company Wyeth has been sued by a Vermont musician after an injection with an anti-nausea drug resulted in a gangrene that made doctors amputate her arm from below the elbow.
The case Wyeth v. Levine might be a tide changer for these kind of lawsuits, as one argument arose on Monday coming from the Wyeth side. The basic argument is that if the FDA approved the drug and clearly informed doctors and users of the possible side-effects, then they bare no blame. If this argument is going to pass as logical and natural, we might see a big change in the cases of people suing companies. This would not extend only to drug companies, but to everything that is FDA approved, including motor vehicles, household products and even chemicals.
The court is trying to decide if the warnings were made clearly enough by the FDA and if all risks were being taken into consideration. This means that if the FDA didn’t expose the risks resulting in different ways the drug can be administered, Levine wins. On the other hand, if the FDA considered the risks involved in the IV push administration method, then Wyeth would win.
The court should also take in consideration the balance between risks and benefits in the anti-nausea medication. The drug is not a life saver, being designed to relieve people from nausea, and in the same time it bears the risk of gangrene, which can lead to amputation of one’s arm or leg. All in all, this is an historic lawsuit which can have serious implications in how the law is applied in this field.
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