We recently authored an article on False Claims Act (FCA) enforcement actions brought against pharmaceutical and medical device manufacturers during the past year. In the article, we analyzed the recent settlements for Ansun Biopharma, Inc. (formerly known as NexBio, Inc.); Smith & Nephew, Inc.; McKesson Corporation; and Stryker Corporation and Alliant Enterprises.

The article, “Lessons Learned From FCA Settlements With Pharmaceutical and Medical Device Manufacturers,” was published in BNA Medical Devices Law & Industry Report on February 18.

Following the federal government’s example, states are increasingly looking to their own false claims act (FCA) statutes to combat procurement and healthcare fraud. This trend is being driven by two main factors: (1) the huge recoveries by the Department of Justice (DOJ) under the federal FCA – $5.7 billion in Fiscal Year 2014 alone; and (2) a federal statute that provided a financial incentive for states to mirror their own FCAs on the federal FCA with regard to healthcare fraud. This state-level activity represents a new front in the battle against procurement fraud, one that government contractors must be aware of to fully analyze and mitigate risks when contracting with state entities. Currently, 33 states and the District of Columbia have a false claims statute. Of these, 11 states have FCAs that are limited to healthcare fraud; the remaining statutes penalize a broad range of false claims. Many – but not all – of these state FCAs have provisions allowing for whistleblowers to file qui tam actions on behalf of the state government and to share in any recovery.

Read the full analysis on the GovCon blog post “A New Front in the Battle Against Fraud – the Continued Expansion of State False Claims Act Liability.”

The Eleventh Circuit affirmed the district court’s dismissal of a relator’s qui tam lawsuit under the FCA’s public disclosure bar and, in doing so, concluded that the ACA’s amendments to the public disclosure bar created grounds for dismissal for failure to state a claim, rather than for lack of jurisdiction.  In U.S. ex rel. Osheroff v. Humana, Inc., the relator alleged that various Florida-based clinics and health insurers violated the FCA through the provision of various services to patients as kickbacks designed to induce and influence the patients’ healthcare decision-making.  Defendants pointed to allegations in state court litigation and news media as publicly disclosing the allegations upon which the relator based his qui tam lawsuit, and the district court agreed.

Continue Reading Eleventh Circuit Refines Public Disclosure Bar Standards

From the Bass, Berry & Sims Blog Network
From the Bass, Berry & Sims Blog Network

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