U.S. ex rel. King v. Solvay S.A. (Summary)

FALSE CLAIMS ACT

U.S. ex rel. King v. Solvay S.A., No. H-06-2662 (S.D. Tex. Oct. 12, 2011)

In this False Claims Act case, the United States District Court for the Southern District of Texas granted several of a pharmaceutical company’s motions to dismiss various theories put forth by the relators, two of the company’s district sales managers. The pharmaceutical company and its affiliates allegedly marketed three FDA-approved drugs for various off-label uses nationwide. It also allegedly provided kickbacks to physicians who prescribed the drugs and targeted physicians who had high percentages of patients who received governmental medical assistance and physicians who served on committees which could place the drugs on the state’s list of covered drugs under such medical assistance programs. The relators based their claims on alleged violations of the federal False Claims Act (“FCA”) and its various state law versions, as well as the federal Anti-Kickback Statute.

For starters, the court denied the company’s motion to dismiss the relators’ claims that the company’s off-label marketing had led physicians to prescribe the drugs for those off-label uses for governmental health plan patients for failure to allege fraud with sufficient particularity, because there was evidence that such prescriptions were filled and the relators alleged specific instances of this occurring in one state. These specific examples were also sufficiently particular for the court to deny dismissal of the relators’ anti-kickback claims based on the same grounds. The court concluded that specific examples linking each type of kickback to a prescription for one of the drugs was unnecessary. However, because there were no particular incidents linking a kickback to a prescription for one of the drugs at issue, all anti-kickback claims based on prescriptions for that drug were dismissed.

Some states restrict coverage of drugs to uses that are “medically accepted.” Thus, where off-label uses were not “medically accepted,” i.e., did not appear on approved lists of appropriate uses, a physician who submitted a claim for reimbursement for such use submitted a false claim. As the relators alleged that such claims were submitted for only one of the drugs at issue in the qui tam case, the court denied the company’s motion to dismiss as to claims based on that particular drug, but granted the company’s motion to dismiss as to the other two drugs. However, insofar as the relators alleged that the off-label uses were approved through allegedly false medical literature produced by the company or through the company’s attempts to “woo” committee members who could get the drugs on a covered drug list, the court denied the company’s motions to dismiss the relators’ FCA claims based on such activities.

The relators also claimed that the company provided physicians with diagnosis codes under which the drug would be covered, so that the physicians could prescribe the drugs for off-label use, but be reimbursed by the relevant governmental health plan. The court dismissed this claim, because the relators’ examples did not show that the diagnoses did not reflect the patients’ symptoms.

Many of the relators’ claims based on state FCA laws were also dismissed, but with prejudice, either because the pertinent statute of limitations had run or because the statute was not in effect when the conduct complained of occurred.