Proposed federal rule

A proposed federal labeling rule that would not allowed injured consumers to seek damages from drug and medical device makers in state court has drawn criticism from the AAJ, who says that the rule “goes against Congressional intent.” The rule concerns warning labels that are placed on products which warn about the potentially dangerous side effects that might accompany a drug or medical device. Specifically, the preamble of the labeling rule preempts state law product liability lawsuits when the FDA has the “final word” on whether or not to approve a drug or medical device for use on the U.S. market.

According to a statement from the AAJ, “If a court defers to the FDA’s opinion on pre-emption, drug manufacturers will have complete immunity from lawsuits brought by [those] injured by dangerous drugs and will prevent them from seeking recourse.”

All eyes on the Supreme Court

All eyes are now on the U.S. Supreme Court who will decide the matter of preemption as it relates to drugs. The controversial case of Wyeth v. Levine will be decided by the court this fall and will determine whether consumers would be allowed to sue drug manufacturers for injuries related to the drug or be barred from doing so. The court recently decided a similar case concerning medical devices and sided with manufacturers as long as they complied with FDA requirements.

However, many drug manufacturers have been accused of not providing the FDA with complete results (good and bad) from their clinical trials as they know that the FDA is understaffed and generally can’t police the entire pharmaceutical industry. Since many drug companies seek to develop “the latest and greatest” drugs, reporting unfavorable clinical results may hurt their chances of receiving FDA approval and may hinder consumer perception of the drug. However, it’s consumers who ultimately pay the price for those shortcuts as drugs such as Vioxx, Bextra and Trasylol are later discovered to be harmful.