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.
Lawyers for Wyeth say Levine’s lawsuit is preempted by federal law and federal regulations. They say the antinausea drug, Phenergan, is approved by the FDA and that the agency authorized the content of the company’s warning about the possible negative effects of the drug. A Vermont jury agreed with Ms. Levine and awarded her $6.8 million for her loss. Now the preemption argument comes into play. Wyeth, Inc. says because the FDA approved the label, it doesn’t matter what the Vermont jury thought of its conduct. The FDA is Wyeth, Inc’s “get out of jail free” card. And herein lies the problem. If Wyeth, Inc. wins, no Georgia citizen would ever be able to bring a lawsuit against a drug manufacturer for negligent conduct because the corporation would be able to hide behind an FDA approval. Justice denied. For example, in February, the Supreme Court ruled in a major preemption case that individuals injured by a defective medical device could not sue the manufacturer if the device received pre-market approval by the FDA. This is not headed in the right direction for the consumer, which should show you how important the Presidential election tomorrow is. If there continues to be appointments made to the United States Supreme Court of justices who show no hesitancy to restrict or even take away the rights of everyday Americans to seek justice in our courts, we can forget that great notion of “justice for all.” It will simply have no meaning in our courts, whether in Washington, D.C., Vermont or our beloved Georgia.
If interested, you can read the briefs filed in the United States Supreme Court in this case at http://www.scotuswiki.com/index.php?title=Wyeth_v._Levine This is such a crucial case in American jurisprudence that it is being closely watched by thousands.
So I will watch Levine v. Wyeth, Inc. closely (we won’t have the Supreme Court opinion issued for months) and will pray for the best, that the rights afforded us by the Constitution and the laws of the States will continue to allow Georgians to be able to obtain justice when they have, unfortunately, been wronged.