How Life Sciences Firms Can Reduce DOJ Enforcement Risks
Sidley lawyers Jaime L.M. Jones, Brenna E. Jenny, and Jack Pirozzolo recently published an article in Bloomberg Law entitled How Life Sciences Firms Can Reduce DOJ Enforcement Risks. Scrutiny of life sciences companies, from their relationships with physicians to their promotional practices, has become one of the few constants in the evolving government enforcement landscape. But life sciences companies can mitigate this risk by making targeted updates to their compliance programs to address areas of particular interest to the Department of Justice.
A copy of the article is available here.
Department of Justice Closes Two Pharmacies In Connection With Opioid FCA Investigation
DOJ recently took the unusual step of obtaining a temporary restraining order (“TRO”) to shut down two healthcare providers in conjunction with the filing of a False Claims Act lawsuit based on the dispensing of medically unnecessary prescriptions.
On October 26, 2017, the Secretary of the Department of Health and Human Services (“HHS”) declared the opioid epidemic a national public health emergency. As further detailed in the Complaint, according to the Center for Disease Control and Prevention (“CDC”), retail opioid prescriptions were dispensed in 2017 at a national rate of 58.7 prescriptions per 100 persons, and Tennessee’s dispense rate is nearly double the national rate, according to the United States. See Complaint, at ¶15. In Clay County, in particular, the United States contends that opioids were dispensed “at a rate sufficient for every man, woman, and child in the county to get their own prescription – twice.” See Complaint, at ¶16. (more…)
Assessing the Implications of the Supreme Court’s Pending Decision in Escobar
Sidley partner Joshua Hill recently published an article in the Daily Journal about the “implied certification” theory of falsity, which is at issue in the pending Supreme Court case Universal Health Services v. United States ex rel. Escobar, as discussed here. The Supreme Court heard oral argument in Escobar on April 19th, and its upcoming decision has important implications for the scope of the False Claims Act.
Sidley partners Jack Pirozzolo and Scott Stein, and associate Brenna Jenny, published an article in BNA’s Health Law Reporter analyzing the oral arguments in Escobar. We reflect on what the Court’s questioning may portend for its ultimate resolution of the case, and how the Court’s approach to redefining materiality will impact the future of implied certification cases.
A decision in the case is expected by the end of the term.