
It might not be readily apparent how a case being argued in the United States Supreme Court regarding the Federal Preemption Doctrine has a tremendous effect on the rights of Georgia citizens, but it does. The United State Supreme Court is hearing arguments today in Levine v. Wyeth Pharmaceuticals, Inc., and the high Court’s decision has far-reaching implication, even to the point of potentially limiting every Georgian’s right to recover against a drug manufacturer for negligent manufacture and distribution of all kinds of drugs we Georgians have come to believe are safe and therapeutic.
Not so fast I say. The first realization every Georgia citizen must come to is that simply because a drug has been approved by the Federal Drug Administration (the FDA) does NOT mean it’s safe nor does it mean it has been fully and accurately tested. One of the problems is that the FDA is way too close to drug manufacturers, which has resulted in lack of complete arms length transactions. For example, from 1992-2002, the drug companies paid $825 million dollars to the FDA In the Wyeth case, Wyeth Pharmaceuticals, Inc. is a drug manufacturer who made a drug called phenergan, which is used to combat nausea. On its label is a small warning that says if the drug was improperly injected it could lead to the onset of gangrene and the necessary amputation of a limb. Now you probably know where this is headed, right? Diana Levine, a professional guitarist, had the drug injected in her IV in her arm, which caused gangrene, which ultimately led to the amputation of her arm. Ms. Levine sued drugmaker Wyeth, claiming that the company had given insufficient warning of the possible severe effects of its product. A Vermont jury awarded her $6.7 million in compensatory and punitive damages.
Ms. Levine says the FDA is protecting the drug companies from lawsuits, rather than protecting consumers from dangerous drugs. “I had no idea what the risks were,” she says of her ordeal with the Wyeth-produced antinausea drug.