RICO and Off-Label Use Don’t Mix

November 7, 2008

By Bryon F. Powell

On November 4, 2008, the United States District Court for the Middle District of Florida granted Defendants AstraZeneca’s and Parexel’s Motions to Dismiss in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP.  In this case, the Plaintiffs, various union health and benefit funds and an individual consumer, claimed that the Defendants violated “the federal Rackeeteer Influenced and Corrupt Organizations ("RICO") statute and state consumer protection laws as well as common law claims for fraud, misrepresentation, civil conspiracy and unjust enrichment” on the basis that the Defendants allegedly misrepresented the safety and efficacy of the antipsychotic drug SEROQUEL (quetiapine fumarate), including via alleged off-label promotion.  The court dismissed the two RICO claims based on the Plaintiffs’ failure to show that their injuries were caused by the Defendants’ alleged scheme to defraud.

AstraZeneca Pharmaceuticals LP was represented by a number of law firms.  Parexel was ably represented by the Boston law firm of Sally & Fitch LLP through attorneys Kurt S. Kusiak, Peter E. Ball, Amber Anderson Villa, and William G. Cosmas.

This case continues a trend by the courts to dismiss off label use cases filed by private (non-government) plaintiffs.  See our earlier post on this subject: “Another Court Hammers an Off-Label Use Case.”

Categories: Enforcement