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.

More resources:

Lower court decision:
http://www.libraries.vermont.gov/sites/libraries/files/supct/current/op2004-384.txt

Links to merit briefs:
http://www.abanet.org/publiced/preview/briefs/nov08.shtml#wyeth
http://www.scotuswiki.com/index.php?title=Wyeth_v._Levine