In a remarkable move, the Department of Justice (DOJ) recently sought dismissal of 11 False Claims Act (FCA) cases, each of which assert that patient assistance services supplied by pharmaceutical manufacturers constitute unlawful kickbacks. The 11 complaints were brought against various pharmaceutical companies by what DOJ described as “shell companies” backed by the National Healthcare Analysis Group, a company formed for the purpose of filing FCA cases. In seeking dismissal, DOJ argued that the suits ran counter to government interests and wasted “scarce government resources.”

According to the DOJ, the 11 lawsuits involved “essentially the same theories of FCA liability” concerning “white coat marketing,” free “nurse services,” and “reimbursement support services.” Specifically, in a motion to dismiss filed on December 17, 2018, in the Eastern District of Texas, DOJ seemingly defended these manufacturer programs noting the government’s “strong interest” in ensuring that “patients have access to basic product support related to their medication, such as access to a toll-free patient-assistance line or instructions on how to properly inject or store their medication.” The government further argued that the allegations “conflict with important policy and enforcement prerogatives” of federal healthcare programs, and asserted that the relators “should not be permitted to indiscriminately advance claims…against an entire industry that would undermine common industry practices the federal government has determined are, in this particular case, appropriate and beneficial to federal healthcare programs and their beneficiaries.”

The DOJ filed similar motions in related cases in other federal district courts against AbbVie Inc., Amgen Inc., AstraZeneca PLC, Bayer Corp. Biogen Inc. Eli Lilly & Co, and Teva Pharmaceuticals USA Inc., among others.

The filings underscore the government’s adherence to the Granston Memo, which outlined the DOJ’s interest in dismissing meritless qui tam FCA cases pursuant to the government’s dismissal authority under 31 U.S.C. § 3730(c)(2)(A). This development marks the DOJ’s willingness to exercise its right to dismiss an FCA suit in order preserve government resources and avoid adverse precedent. Also noteworthy is that DOJ summarily called out plaintiffs’ duplicitous and dishonest methods of interviewing potential whistleblowers under the poorly-veiled guise of “qualitative research.”

The cases are:
1. U.S. ex rel. Health Choice Group LLC v. Bayer Corp et al., No. 5:17-00126 (E.D. Tex.)
2. U.S. ex rel. SAPF, LLC, v. Amgen, Inc., No. 16-cv-5203 (E.D. Pa.)
3. U.S. ex rel. SMSPF, LLC v. EMD Serono, Inc., No. 16-cv-5594 (E.D. Pa.)
4. U.S. ex rel. SMSF, LLC v. Biogen, Inc., No 1:16-cv-11379-IT (D. Mass.)
5. U.S. ex rel. NHCA-TEV, LLC v. Teva Pharms., No. 17-cv-2040 (E.D. Pa.)
6. U.S. ex rel. SCEF, LLC v. Astra Zeneca PLC, No. 17-cv-1328 (W.D. Wash.)
7. U.S. ex rel. Miller, v. AbbVie, Inc., No. 3:16-cv-2111 (N.D. Tex.)
8. U.S. ex rel. Carle, v. Otsuka Holdings Co., No. 17-cv-966 (N.D. Ill.)
9. U.S. ex rel. CIMZNHCA v. UCB, Inc., No. 3:17-cv-00765 (S.D. Ill.)
10. U.S. ex rel. Health Choice Alliance, LLC v. Eli Lilly & Co., No. 5:17-cv-123 (E.D. Tex.)
11. U.S. ex rel. Health Choice Advocates, LLC v. Gilead, et al., No. 5:17-cv-121 (E.D. Tex.)