Articles and Blogs

As illustrated by two recent cases, there has been an uptick in Government enforcement action related to pharmaceutical manufacturer donations to patient assistance funds designed to assist patients with copay obligations. Earlier this month, the U.S. District Court for the District of Massachusetts denied Regeneron Pharmaceuticals’ motion to dismiss a lawsuit in which the... READ MORE

The First Circuit ruled that an employer would not have acted against a whistleblower ‘but for’ their engaging in conduct the FCA protects. It joined other circuits that have found the FCA’s statutory protections much like other federal employment statutes. Background In this case[1], the Defendant is a medical device company that had several... READ MORE

In health care, actions under the False Claims Act (“FCA”) typically allege conduct that is knowingly in violation of one or more of Medicare’s conditions of payment—part of an amorphous contract between a government agency and a provider—that results in a fraudulently obtained overpayment to the provider for services rendered. Last week, the Ninth... READ MORE

On July 1, 2020, the U.S. District Court for the Central District of Illinois granted summary judgment in favor of a number of pharmacy defendants who argued that they could not be liable under the False Claims Act (“FCA”) because their interpretation of an applicable law was objectively reasonable, though incorrect, at the time... READ MORE

On June 19, 2020, the Department of Justice (the “DOJ”) announced its Final Rule[1] increasing the penalties assessable under the False Claims Act (“FCA”). The DOJ raised the minimum penalty for a single false claim from $11,181 to $11,665; the maximum penalty from $22,363 to $23,331. Under the False Claims Act,[2] any person who... READ MORE

An accepted doctrine of FCA pleading requires whistleblowers or the Government to assert an “objective falsehood” in their complaints. Last week, the Ninth Circuit nixed the requirement. The Ninth Circuit reversed a district court’s dismissal tied to a failure to plead an objective falsehood under FCA. The Court held that whistleblowers or the Government... READ MORE

The Southern District of Indiana recently held that a whistleblower must present sufficient evidence to support each alleged false claim, not just one, to survive summary judgment.[1] This holding is a win for FCA defendants that deal in a high volume of claims submitted to the government—like hospitals—and requires whistleblowers to identify every claim... READ MORE

Earlier this week, the Second Circuit in Vierczhalek v. MedImmune, Inc.[1] affirmed the dismissal of a relator’s amended complaint, finding she was not an “original source” of new allegations that piggybacked on a public disclosure. Facts of the Case Relator Susan Vierczhalek, M.D., filed a qui tam action in 2009 alleging that drug manufacturer... READ MORE

On March 13, 2020, President Donald Trump declared a National Emergency Declaration in response to the COVID-19 pandemic. Congress is passing new emergency legislation daily, and the states are declaring emergencies and issuing orders out of governors’ offices and Departments of Health. While the global extent of the crisis is unprecedented, the country has... READ MORE

In a matter of first impression, the Third Circuit yesterday held that conflicting medical opinions can create a genuine dispute of material fact as to the element of falsity in a False Claims Act action.[1] Facts of the Case In U.S. v. Care Alternatives, relators alleged that Care Alternatives, a hospice facility, “admitted patients... READ MORE