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In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead...
The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device...
The Off-Label/Contraindicated-Use Theory The relator alleged “that Medtronic engaged in misbranding, mislabeling, and adulterating in violation of the Food, Drug, and Cosmetics Act (FDCA)” by marketing devices “without FDA approval or clearance for use in the cervical spine—an ‘off-label’ and indeed contraindicated use.” The Ninth Circuit rejected this theory because “the federal government does not distinguish between on-label and off-label uses in determining whether to pay for medical devices.” Thus, an allegation of off-label or contraindicated use was not enough. The re...
Enforcement William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18 U.S.C. § 1349 and eight counts of healthcare fraud in violation of 18 U.S.C. § 1347. Merino was convicted after a trial in the Central District of California. At trial, the government presented evidence that Merino was employed as a patient recruiter and marketer at a medical clinic. The government alleged that she worked with others fraudulently to bill Medic...
Enforcement William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18 U.S.C. § 1349 and eight counts of healthcare fraud in violation of 18 U.S.C. § 1347. Merino was convicted after a trial in the Central District of California. At trial, the government presented evidence that Merino was employed as a patient recruiter and marketer at a medical clinic. The government alleged that she worked with others fraudulently to bill Medi...