Painkiller abuse has become a big problem in the past decade, and now, three governmental entities are seeking to hold pharmaceutical companies responsible. The City of Chicago and two California counties have filed separate lawsuits alleging that “aggressive marketing” by several pharmaceutical companies has purportedly led to addiction and abuse of painkillers by their taxpayers. The named defendants are Jansen Pharmaceuticals, Purdue Pharma, Actavis, Endo Health Solutions Inc., and Cephalon. The core allegation in these suits is that the companies fraudulently downplayed the known risks of painkiller addiction in their marketing materials, which allegedly misled the public and led physicians to overprescribe the drugs. This conduct allegedly costs taxpayers and the government millions of dollars in the form of unnecessary prescriptions and emergency medical care. The City of Chicago’s complaint alleges that in Chicago alone there were over 1,000 ER visits attributable to painkiller abuse in 2009.
These lawsuits are an interesting attempt to regulate, through litigation, what is already one of the most heavily regulated industries in the United States. Matters relating to prescription drugs typically fall under the jurisdiction of the FDA. Moreover, federal laws and regulations already require that pharmaceutical promotional materials must be supported by substantial scientific evidence and must reflect a “fair balance” in describing the benefits and risks of the drugs. See, e.g., 21 U.S.C. 352(a); 21 C.F.R. 201(e)(g).
Not surprisingly, the pharmaceutical companies are already angling to dismiss these lawsuits. Earlier this month, they moved to dismiss the City of Chicago’s complaint on, among other grounds, the ground that this matter should be decided by the FDA under the primary jurisdiction doctrine. The primary jurisdiction doctrine is a judicial doctrine whereby a court tends to favor allowing an agency an initial opportunity to decide an issue in a case in which the court and the agency have concurrent jurisdiction.