Alleged Manipulation of Compendia Process Held Insufficient to Withstand Summary Judgment on Off-Label Marketing Claims
A district court granted summary judgment to Solvay Pharmaceuticals on claims that it influenced the public body of scientific research in order to manipulate the compendia DrugDex into supporting off-label uses of its products. U.S. ex rel. King v. Solvay S.A., No. H-06-2662 (S.D. Tex. Dec. 14, 2015). The opinion provides helpful guidance on the high bar that relators must satisfy to pursue FCA claims based on alleged manipulation of scientific research so that ordinary disputes about the weight to be given to scientific research are not challenged as “fraud” under the FCA.
Federal law requires state Medicaid programs to reimburse drugs prescribed for a “medically accepted indication,” which can include uses supported “by one or more citations” in certain approved compendia, including DrugDex. The relators alleged that Solvay inappropriately influenced DrugDex and convinced the compendia to support off-label uses for three of the company’s products. The relators raised four theories of manipulation, which together allegedly caused “DrugDex employees to turn to low quality studies for inclusion in the compendia” in support of the off-label uses.
Under the first theory, Solvay allegedly suppressed the negative results of large, robust studies on off-label uses, while funding smaller, lower-quality studies that generated positive results. The relators argued that “this distribution of lower quality studies while withholding higher-quality studies with negative results resulted in fraud on DrugDex.” The court acknowledged evidence could establish that Solvay’s R&D department did not affirmatively attempt to publish studies with negative outcomes. However, the court found no evidence of Solvay actively suppressing the negative studies. Relators were attempting to establish an issue of material fact under a “fraud by omission” theory. However, such a theory can only succeed if the party has a duty to disclose, and the relators had not shown that Solvey had a duty to publish negative results. While the relators also argued that Solvay’s partial disclosure of studies constituted a false statement that required correction, the court disagreed. As the court explained, “[i]f the larger study merely provides more reliable information about how efficacious a drug is for treating a condition overall, but the smaller study accurately reported the results as to the patients treated in that small study, then there is no actual misstatement or partial disclosure to correct. Moreover…it is unclear why Relators believe it is the drug company’s burden to inform all drug compendia about the new study.”
The relators’ second theory alleged that Solvay manipulated the results of studies DrugDex listed in support of off-label uses. The court refused to credit allegations that Solvay “directed” a study’s progress and revised a final manuscript as creating a material issue of fact as to whether Solvay manipulated study results. The court explained that because Solvay was funding the study, “it makes sense [Solvay] would be monitoring the study,” and “[k]eeping track of the study and ‘directing’ the study are not synonymous.” Additionally, while the relators pointed out that a lead investigator in one study had received speaking honoraria from Solvay prior to publication, the court viewed this as too tenuous to raise legitimate questions about whether Solvay defrauded DrugDex into listing the study.
The third theory advanced by relators alleged that Solvay paid for publication of studies in non-peer-reviewed supplements to journals. The relators viewed this practice as an attempt to flood the market with positive studies that were effectively paid advertisements. The court dispatched with this argument quickly because the only supplements cited in support of an off-label use for one of the drugs at issue were published before Solvay acquired the license for the product.
The relators’ final theory relates to ghost-writing. The relators alleged that Solvay commissioned and directed small studies and found key opinion leaders (“KOLs”) to lend their names and credibility to the publications. The court viewed the evidence as falling short of establishing that any KOLs merely “lent” their names to articles drafted by Solvay writers. Furthermore, relators also failed to link any supposedly ghost-written articles to one of the DrugDex entries supporting off-label uses.
This significant victory for Solvay comes less than a week after the court also dismissed a host of kickback allegations against Solvay, regarding certain of the company’s physician speaker and consultant programs. See U.S. ex rel. King v. Solvay S.A., No. H-06-2662 (S.D. Tex. Dec. 10, 2015).
A copy of the court’s compendia opinion and kickback opinion can be found here and here.