By Manvin Mayell (June 6, 2017, 12:17 PM EDT) -- In recent years, plaintiffs in False Claims Act, 31 U.S.C. § 3729 et seq. (2006), cases have sought to expand FCA liability of pharmaceutical and medical device companies alleging that these companies caused the submission of false claims by concealing safety risk data from the U.S. Food and Drug Administration or minimizing risks or overstating benefits to the medical community. These actions, which often are an outgrowth of product liability cases these companies routinely face, present starkly different issues regarding the falsity of government claims and materiality than typical FCA cases alleging off label promotion or kickbacks. The off-label falsity theory is premised on the government's contention that claims for off label uses are not statutorily reimbursable and therefore "false or fraudulent." The kickback falsity theory is based on providers' certifications to comply with the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b (2012) ("AKS"), the government's enforcement history and a 2010 amendment to the AKS expressly providing that claims resulting from kickbacks are false....