On March 4, 2009, the US Supreme Court ruled that Diana Levine could sue the parmaceutical company Wyeth for risks Wyeth knew but did not disclose. 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.
Background: In October 2006, the Supreme Court of Vermont held that Plaintiff Diana Levine’s state law claim against Defendant Wyeth for failure to warn was not preempted by Food and Drug Administration (FDA) regulations. Levine v. Wyeth, 944 A.2d 179 (2006). Defendant has appealed this decision to the United States Supreme Court which will hear the case in its upcoming Fall term. Read the merit briefs here and here. A Supreme Court holding in Wyeth v. Levine that failure-to-warn cases are preempted, would impede FDA’s ability collect the “accurate, science-based information” it is obligated to distribute and subsequently would undermine the public’s corresponding right to receive such information. See the FDA Mission Statement (June 18, 2008) online.
The Knowledge Project: Censorship & Science of the National Coalition Against Censorship believes that this case directly implicates the rights to speak and know that are guaranteed by the First Amendment.
The Right to Speak: Wyeth’s First Amendment right to publish truthful information about the risks associated with its drugs forecloses any argument that it is preempted from complying with both federal and state labeling requirements. Acting as Amicus Curiae, NCAC’s The Knowledge Project,in collaboration with Sharon Arkin of The Arkin Law Firm and Erwin Chemerinsky of University of California, Irvine School of Law, submitted this First Amendment argument in a brief to the Supreme Court. Click here to read the brief.
Access to Information: As The Knowledge Project argues in this article, the discovery process in product liability litigation is crucial in compelling pharmaceutical companies to reveal important knowledge about drug safety. If litigation is blocked by pre-emption, FDA and the public would not have access to information about the safety and efficacy of widely-used drugs, and would not know how to evaluate the objectivity of that information. Obstructing access to the important drug risk information discovered in litigation not only frustrates FDA’s information-driven regulatory process designed to protect the public, but also has the potential to seriously harm people dependent on widely available medicines.
Lower court decision:
Links to merit briefs: