Top scientists and career employees at the Food and Drug Administration (FDA) have issued a report to the U.S. House Committee on Oversight and Government Reform objecting the federal agency’s own rule that weakens consumers’ ability to file product liability lawsuits against drug manufacturers for not labeling medicines and medical devices properly. According to this Associated Press article, the report highlights internal FDA documents, which show high-ranking career officials in the agency repeatedly pointed out the dangers of drug makers not being required to update labels to give consumers complete information about the medications they use.
The 2006 drug-labeling rule basically limits when people can sue in state court over personal injury claims involving medications. The FDA maintains that federal regulations prevail when it conflicts with state law. This concept is called pre-emption.
Preemption was a strategy consistently adopted by the FDA, other federal agencies and the Bush Administration to shield manufacturers of dangerous and defective products.
According to a recent report called “Get Out of Jail Free” issued by the American Association of Justice(AAJ), the Bush Administration has authored language aimed at preempting product liability litigation to 50 federal rules that govern everything from auto products to drugs and medical devices.
This issue is particularly receiving attention in light of a Supreme Court case involving Diane Levine, a Vermont woman who sued Wyeth after her right arm was amputated following a high-volume injection of the drug Phenergan. The injection accidentally punctured an artery, causing gangrene. Attorneys for the woman argued that Wyeth had the duty to warn consumers that such injections could have devastating consequences. The state courts agreed, awarding her nearly $7 million. Wyeth appealed saying it was protected by FDA’s preemption rule. As long as the drug maker received initial approval from the FDA, lawyers for the company argued, it had no responsibility to update its label.
The recent report cited Dr. John Jenkins, the highest official in FDA’s new drug review process, who writes about exactly why the preemption rule hurts consumers. Dr. Jenkins states: “Much of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”
Product manufacturers, not consumers, should be held responsible for defective or dangerous products and the mislabeling of products. We all know and understand that medicines have side effects. But it is extremely important that drug manufacturers clearly list those side effects and other important information on their labels so consumers can make informed choices about their health. These preemption clauses take away consumer rights by denying them access to the courts for justice and that is not only wrong, but also un-American.