On February 8, 2016, Judge Gray H. Miller of the Southern District of Texas granted summary judgment on the relators' remaining claims against pharmaceutical manufacturer Solvay S.A. United States ex rel. King v. Solvay S.A., No. 06-2662, 2016 U.S. Dist. LEXIS 14804 (Feb. 8, 2016 S.D. Tex.). Relators and governmental plaintiffs have increasingly pressed a "formulary influence" theory of liability, alleging that off-label promotion or kickbacks caused states to wrongfully include a drug on their formularies or give them preferred formulary status. King provides an excellent example of how putting plaintiffs to their proof can dispense of such claims.
In King, the relators filed suit against Solvay related to its promotion of three prescription drugs. Among other allegations, the relators contended that Solvay pushed off-label information on members of states' pharmaceutical and therapeutical (P&T) committees to obtain placement of its drugs on state Medicaid formularies or Preferred Drug Lists and "wined and dined" P&T members to influence their decisions. In a careful and detailed opinion, Judge Miller parsed the evidence plaintiffs could muster on summary judgment as to each specific state at issue and ended up dismissing each of the claims.
For example, the relators claimed that Solvay engaged in off-label promotion when it (1) sent dossiers that included off-label information to P&T committees, and (2) distributed a supplement to an American Journal of Managed Care article that similarly included off-label information. But the district court noted that relator had offered no evidence that these actions constituted off-label promotion based on the specific facts. Rather, Solvay had sent the dossiers to the committees at their request when they asked for all available data about the drug. Second, the court held that the relators lacked evidence that Solvay violated any promotional regulation with regard to a supplement to a medical journal containing off-label information. Relator alleged that the supplement was written by a Solvay consultant but failed to back up that claim with evidence. Moreover, Solvay expressly warned its sales representatives not to use the supplement in promoting their drugs.
The court also dismissed claims that the defendant improperly "wooed" several states' P&T committees due to lack of causation. The relators pointed to a number of call notes showing visits between doctors who served on P&T Committees and company sales representatives. But the court surveyed the evidence and found that no reasonable jury could conclude that the visits caused states to put the drug on their preferred drug lists. In many cases, for example, the temporal connection between the visits and the P&T committees' decisions was just too tenuous.
The court's ruling shows the potential vulnerabilities of the "formulary influence" theory. Even if such allegations are able to pass muster at the motion to dismiss phase, proving them can be a harder task.