Justia Government Contracts Opinion Summaries

Articles Posted in Drugs & Biotech
by
Plaintiff alleged that Bayer defrauded the United States government through its marketing and sale of the cholesterol-lowering drug Baycol. On appeal, plaintiff challenged the dismissal of the qui tam action she brought against Bayer Healthcare under the False Claims Act (FCA), 31 U.S.C. 3729-3733. Based upon the court's review of plaintiff's allegations regarding the Department of Defense (DoD) contracts, the court concluded that her complaint satisfied Rule 9(b)'s requirements and survived a motion to dismiss under Rule 12(b)(6). Accordingly, the court reversed the district court's judgment with regard to her allegations regarding the DoD contracts and remanded for further proceedings. However, the court affirmed the district court's judgment with respect to the allegations involving federal health insurance reimbursement claims under United States v. ex rel. Roop v. Hypoguard USA, Inc.View "Simpson v. Bayer Healthcare, et al." on Justia Law

by
Zizic is the former CEO of BioniCare, which sold the BIO-1000, a medical device designed to treat osteoarthritis of the knee. BioniCare attempted to bill Medicare for the BIO-1000, but many claims were denied as not medically necessary. Q2A contracted with the government to review such claim denials across the nation. Q2A’s denials were reached without physician review, which is required by the Medicare Act, 42 U.S.C. 1395, HHS regulations, and its contract. A former Q2A employee testified that it implemented an internal policy to deny all BIO-1000 claims, which were reviewed by a single nurse rather than a panel of physicians; later allowed non-physician subcontractors to prepare BIO-1000 appeals for review by a single physician; and finally developed a mail merge letter that automatically denied BIO-1000 claims without any review. BioniCare’s trustee in bankruptcy became aware of and disclosed these practices. Zizic filed a qui tam suit under the False Claims Act, 31 U.S.C. 3729-33. The district court dismissed, concluding that it lacked jurisdiction because the allegations against Q2A and RTS were based on prior public disclosures and because Zizic was not an original source of that information. The Third Circuit affirmed.View "Zizic v. Q2Adm'rs LLC" on Justia Law