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Latest Personal Injury News Secretly-Developed FDA Rule Puts Americans at Risk
Source: Arizona Trial Lawyers Association (AZTLA)
January 25, 2006
This article was published in the January 24, 2006 issue of the AZTLA newsletter. "Last week the Food and Drug Administration (FDA) issued a new rule – developed in consultation with the drug companies – that is designed to eliminate state drug safety protections. The preamble of the rule states the FDA's position that if a drug company failed to warn doctors and patients about a drug's dangers and killed thousands – but the warning label was approved by the FDA – the company should be immune from liability. For instance, the drug Vioxx had an FDA-approved warning label, but still killed as many as 55,000 Americans according to a top FDA scientist. The new rule represents a fundamental rollback of drug safety. Under current law, a drug company that meets a minimum federal standard but still acts negligently in failing to warn doctors and patients about a drug's dangers can be held accountable under state law. As a federal judge in Minnesota recently wrote in rejecting the argument that meeting minimum federal warning label standards grants a drug company immunity, "federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability. ... state-law protections reinforce and enhance" federal efforts to protect the public from negligent pharmaceutical companies and deadly drugs. Americans are already in danger from drug company executives that put profits before safety and an FDA that is beholden to the drug companies it is supposed to regulate. Eliminating the ability of individuals to hold negligent drug companies accountable only puts patients at greater risk." For more information, visit http://ncsl.org/statefed/health/FDArule.htm << Back to News |