Abbott Laboratories and the whistleblower involved in its recent false claims allegations asked for the lawsuit to be ended quickly, but the Texas federal judge denied this request.

The judge decided that there remained too many unanswered questions about whether or not the stent devices qualified for Medicare billing.

According to the Abbott whistleblower lawsuit, the company’s marketing of bile duct stents focused on off-label uses, violating the False Claims Act.

U.S. District Judge Barbara M.G. Lynn said that there were still disputed facts about the whistleblower lawsuit.

The whistleblower, Kevin C., argued that Abbott’s bile duct stent products had not been approved by the U.S. Food and Drug Administration (FDA) for vascular procedures, and that means any claim made to Medicare for vascular surgeries using those stents from 2004 to 2006 violated the FCA and were in fact Medicare fraud.

However, Judge Lynn said that the FDA approval of such products and the Medicare reimbursement process do not necessarily overlap, so the issue is more complicated. Because of the complexity, Judge Lynn dismissed the motion for summary judgment.

The whistleblower provided evidence of Abbott sales representatives marketing and selling their “biliary” stent products to doctors who perform vascular procedures, while also offering to advise those doctors on Medicare reimbursement procedures.

Abbott is in the process of disputing that the doctors actual usage of Medicare reimbursement information, but Judge Lynn says that the available evidence of material fact is compelling.

Kevin C. originally filed his whistleblower lawsuit in 2006. He is a former regional sales director for Guidant, a subsidiary of Abbott. As such, he claims to have firsthand knowledge of Abbott’s alleged practice of selling bile duct stents to doctors for off-label uses – in this case, vascular procedures.

Kevin C.’s original False Claims Act lawsuit alleged that Abbott, as well as Johnson & Johnson’s Cordis Corp. and Boston Scientific Corp., specifically directed doctors to seek Medicare and Medicaid payments for vascular stent products when biliary stents were used instead.

Johnson & Johnson and Boston Scientific were both dropped from the Medicare fraud lawsuit in 2013, leaving Abbott Laboratories as the sole defendant.

The False Claims Act lawsuit is presented as something quite simple: biliary stents were not approved to be used in vascular procedures between 2004 and 2006, but Abbott billed Medicare for such vascular procedures that used biliary stents. Therefore, the whistleblower lawsuit claims the company violated the False Claims Act and committed Medicare fraud.

However, Judge Lynn says that the situation is not so simple. Determining whether a medical process or device is reasonable and necessary does not necessarily align with FDA approval

“A device may be approved or cleared by the FDA and still not be eligible for Medicare coverage,” writes Judge Lynn. “Further, lack of FDA approval or clearance for a specific use does not categorically disqualify a device from Medicare coverage. Medicare reimbursement for off-label uses is permissible in some instances.”

An Abbott spokesperson stated that the company looks forward to showing that the use of biliary stents for vascular surgery has been standard, and so should be included in Medicare coverage.

Whistleblower Lawsuits

Whistleblowers are individuals who report the fraud and illegal activities against the government of their current or former employers. While a person considering becoming a whistleblower may be worried that they will get in trouble for their actions, the whistleblower is typically given a substantial reward – often between 15 and 30 percent of the money recovered in the subsequent whistleblower lawsuit.

Many employees choose to come forward as whistleblowers because they do not feel right about their employer’s actions. A whistleblower lawsuit can be filed while working at the company, but can also be filed after having left the company.

If you believe you have witnessed some kind of fraud by your current or former employer, you may be able to file a whistleblower lawsuit (also known as a qui tam lawsuit) against your employer on behalf of the government.