West Virginia and Johnson & Johnson's subsidiary, Janssen Pharmaceutica, Inc., offer a cautionary tale for all companies regulated by the Food and Drug Administration (FDA) regarding the potential ramifications of FDA enforcement actions. Following a 2004 warning letter by FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) to Janssen for promotional materials sent to doctors on Risperdal® and Duragesic® citing omission of material information, minimization of risks and misleading comparative claims, West Virginia sued Janssen under its Consumer Protection Act, claiming that the materials were false and misleading as a matter of law based on the warning letter and FDA's expertise. The trial judge awarded the state a $4.5 million penalty against Janssen. Washington Legal Foundation has now petitioned the West Virginia Supreme Court of Appeals to hear the case, citing a disregard for First Amendment precedent and protection by the lower court. The case provides an example for all FDAregulated companies as to how states may use local consumer protection laws to piggy-back on FDA enforcement actions.