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From Health Law Daily, December 15, 2015

No evidence of compendia collusion found, court dismisses another claim

By Kayla R. Bryant, J.D.

Relators in a qui tam action offered no evidence that a drug manufacturer colluded with a compendia to further its fraud scheme. The U.S. District Court for the Southern District of Texas granted Solvay Pharmaceuticals, Inc.’s (SPI) motion for partial summary judgment on the issue of collusion with the DRUGDEX Information System (DrugDex), finding no support for the relators’ assertions that SPI colluded with or even attempted to mislead DrugDex (United States ex rel. King v. Solvay S.A., December 14, 2015, Miller, G).

Allegations. This motion is based on allegations that the SPI (now known as AbbVie Products, LLC) violated the False Claims Act (FCA) (31 U.S.C. §3729 et seq) related to reimbursements for prescriptions for Aceon®, AndroGel®, and Luvox®. The court has been slowly dismantling the larger case, as it granted SPI’s motion for partial summary judgment related to alleged violations of the Anti-Kickback Statute (AKS) (42 U.S.C. §1320a-7b) just four days before granting this motion (see Relators cannot establish that drug company intended to induce prescriptions, December 14, 2015). The relators’ claims include allegations that SPI somehow caused DrugDex to include additional uses for its drugs in compendia entries so that Medicare and Medicaid would provide reimbursement for prescriptions issued for more purposes. SPI allegedly suppressed negative research about the drugs, flooded literature about the drugs with positive but “scientifically irrelevant” studies, and ghostwrote DrugDex articles.The relators argued that a jury should decide as a factual matter whether “SPI defrauded, colluded with, or improperly influenced DrugDex.”

Lack of evidence. In order for health care programs like Medicare and Medicaid to reimburse for certain drug uses, these uses must be supported by compendia listings. In response to the relators’ allegations about SPI’s activity involving DrugDex, the company argued that there was no evidence showing that SPI submitted misleading information to DrugDex, deceived DrugDex into supporting off-label uses for its medications, or colluded with DrugDex to achieve more reimbursable uses for its drugs. Although the relators lacked direct evidence of communications that resulted in fraudulent activity, they argued that DrugDex invited “undue influence” and that SPI took advantage of the opportunity presented.

The court reviewed the circumstantial evidence presented by the relators, starting with the claims that SPI and its affiliates failed to publish negative results from studies on Luvox, but funded and published lower quality work with positive outcomes. The court found that although SPI did not seek to publish studies about off-label uses with negative outcomes, but it did not actively suppress those studies. Similarly, the court did not find sufficient evidence supporting the relators’ claims that SPI suppressed some negative information from one study and included the rest in DrugDex or attempted to include sub-par studies in the compendia entries to “subvert the literature.” Finally, the court deemed the allegations of ghostwriting to be unsupported, as the relators only provided “innuendo” about articles that might have been partially ghostwritten but were not included in the entries. All claims based on the theory that SPI defrauded or colluded with DrugDex were dismissed.

The case is Civil Action No. H-06-2662.

Attorneys: Evan C. Zoldan, Department of Justice, and Mary Michelle Zingaro, United States Attorney's Office, for United States of America. Bruce Davidson Oakley (Hogan Lovells US LLP) for Solvay North Amercia LLC, Solvay Pharmaceuticals Inc. and Abbott Products, Inc.

Companies: Solvay SA; Solvay Pharmaceuticals Inc.; Solvay North Amercia LLC; Abbott Products, Inc.; Solvay Pharmaceuticals SARL; DRUGDEX Information System; AbbVie Products, LLC

MainStory: TopStory CaseDecisions FCANews CMSNews AntikickbackNews DrugBiologicNews FraudNews PrescriptionDrugNews

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