Consumers of Dangerous Drugs Have Uphill Battle-Doctrine of Federal Preemption Protects Drug Companies

Like most Georgia injury lawyers, we are seeing more and more dangerous drug cases being dismissed because of the doctrine of federal preemption. An example of this came to our attention recently. A Kentucky man developed a drug-induced neurological disease after using a gastric reflex drug for years. He filed a lawsuit asserting state law products liability, negligence and breach of warranty claims against both the brand manufacturer and the generic manufacturers of the drug, claiming that it caused him to develop the disease. He alleged the makers of the drug failed to warn him of the long-term side effects of taking it. The drug manufacturers filed a motion to dismiss on the basis of federal preemption. They argued that under federal law, drug labeling is approved by the FDA, and manufacturers cannot unilaterally alter the labeling; thus, stricter requirements by virtue of state common or statutory law would be in conflict with federal requirements. The plaintiff contended that the manufacturers knew or should have known of the adverse affects of the drug and could have proposed a label change to the FDA. He also contended that preemption of his claims would encourage manufacturers to suppress warnings of adverse side effects. Unfortunately, the Court noted that under the Food, Drug and Cosmetic Act, generic approval requires the manufacturer to use labeling already approved for the listed version of the drug. Congress presumably considered the type of arguments advanced as to reasons for not applying preemption, but maintained the same-label requirement. The Court held that permitting state law claims to second guess FDA approved labeling would conflict with federal law and it granted the generic drug manufacturers’ motion to dismiss.
Under the Bush administration, much headway was made by the drug companies, their lobbyist and conservative, big business politicians to effect this type of “back door tort reform”. Lets hope under the new administration, things will change and the innocent consumer will be able to take advantage of the broader protection afforded under most state law.