The Supreme Court handed down an opinion today that doesn’t seem to be about suppression of scientific information, but it is.
Diana Levine lost her arm when a drug manufactured by Wyeth, was administered to her improperly. Wyeth knew of the risk of this method of administration, but did not disclose it in its warning label. Because the label had been approved by the FDA, Wyeth claimed her suit should be barred. The Supreme Court disagreed.
It’s an obvious victory for Levine and others like her who are injured by negligence. But it’s more than that. Understandably, drug companies might prefer not to disclose information that would hurt sales of drugs on the market. Since the FDA’s limited resources don’t allow it to closely monitor them, the agency is forced to rely on industry self-reporting. The system has obvious flaws in expecting corporate officials to act against their own interests; the fox can’t be trusted to guard the chicken coop. Recognizing this situation, the Supreme Court observed that “state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”
Personal injury actions provide a critical back-up system to imperfect regulatory oversight. Through information revealed in discovery and trial, they often provide the first indication, or confirmation, that a drug has unreported side effects and that questions relating to safety and negligence should be investigated.
When the government can’t, or doesn’t collect, vital health and safety information, there are a few other ways to obtain it. Private litigation is one. Thanks to the Supreme Court, this kind of self-help is still an option.
The National Coalition Against Censorship filed an amicus brief in August showing the 1st amendment ramifications to this case.